TP化疗方案联合康莱特治疗宫颈癌的效果及对血清CYFRA21-1、CK19水平的影响

Objective: To study the effect of TP chemotherapy regimen combined with Kanglaite in the treatment of cervical carcinoma and its effect on the serum level of CYFRA21-1 and CK19. Methods: 74 patients with cervical carcinoma were admitted in our hospital from October 2015 to May 2017 and were randomly divided into observation group and control group according to random digital table method, 60 cases in each group. The control group was treated with TP chemotherapy and the observation group was treated with TP chemotherapy regimen combined with Kanglaite. The clinical efficacy, the quality of life, serum CYFRA21-1 and CK19 levels and adverse reactions were compared between the two groups before and after treatment. Results: After treatment, the clinical effective rate(83.78%) in the observation group was significantly higher than that of control group (62.16%), u=4.390,P=0.036, with statistical significance(P<0.05). The KPS scores of the two groups were significantly decreased, and the KPS scores in the observation group were significantly higher than those in the control group(u=6.538,P=0.000). After treatment, the serum levels of CYFRA21-1 and CK19 were significantly decreased in both groups, and the levels in the observation group were significantly lower than those in the control group (u = 6.659, 8.647, P=0.000). The adverse reactions were mainly myelosuppression, gastrointestinal reaction and phlebitis. The incidences of myelosuppression and gastrointestinal reaction of grade III-IV in the observation group were significantly lower than that in the control group, while the incidence of phlebitis was significantly higher in the observation group than in the control group ((u = 2.160, 2.000, 4.16, P = 0.030, 0.045, 0.041, respectively). Conclusion: The effect of TP chemotherapy regimen combined with Kanglaite on cervical carcinoma is significantly. It can effectively reduce serum CYFRA21-1 and CK19 levels, improve the quality of life and safety, which is worth popularizing in clinical application.     

Clinical Observation of Shuanghuang Shengbai Granule(双黄升白颗粒) on Prevention and Treatment of Myelosuppression Caused by Chemotherapy in Cancer Patients

Objective: To study the efficacy and safety of Shuanghuang Shengbai Granule(双黄升白颗粒, SSG), a traditional Chinese herbal medicine, on myelosuppression of cancer patients caused by chemotherapy. Methods: A total of 330 patients were randomly assigned to the treatment group(220 cases, analysed 209 cases) and the control group(110 cases, analysed 102 cases) with a 2:1 ratio by envelope method. The patients in the treatment group at the first day of chemotherapy started to take SSG for 14 days, while the patients in the control group took Leucogon Tablets. The changes of the blood routine, clinical symptoms and immune function in both groups were observed for safety and efficacy evaluation. Results: At the 7th day of chemotherapy, the white blood cells(WBCs) level in the treatment group was significantly higher than that in the control group(P0.05). After treatment, the WBCs rate in the normal range accounted for 50.2% in the treatment group, the myelosuppression of WBCs and neutrophil were mainly grade Ⅰ, while 8.1% and 5.7% of patients emerged grade Ⅲ and grade Ⅳ myelosuppression, respectively. The incidence of myelosuppression of the treatment group was significantly lower than that of the control group(P0.05). The total effective rate of Chinese medicine syndrome in the treatment group was significantly higher than that in the control group(84.2% vs. 72.5%, P0.05). The immune cell levels in both groups were maintained in the normal range. Compared with that before treatment, the levels of CD3~+ and CD4~+ cells were significantly increased in the treatment group after treatment(P0.05). The discrepancy of CD3~+ and CD4~+ cell activity before and after treatment in both groups were significantly different(P0.05). No obvious adverse event occurred in both groups. Conclusion: SSG had a protection effect on bone marrow suppression, and alleviated the clinical symptoms together with clinical safety.     

Clinical observation on treatment of depression by electro-acupuncture combined with Paroxetine

Objective:To observe the clinical efficacy and adverse reactions of Paroxetine combined with electro-acupuncture (EA) in treating depression.Methods:Forty-two patients with depression were randomly assigned to the observation group (22 patients) treated with EA combined with Paroxetine,and the control group (20 patients) treated with Paroxetine alone,and the therapeutic course for both groups was 6 weeks.The therapeutic efficacy and adverse reactions were evaluated with scores by Hamilton depression scale (HAMD) and treatment emergent symptoms scale (TESS), respectively.Results:HAMD scores determined at the end of the 1st,2nd,4th,and 6th week of the treatment course were significantly lower in the observation group than those in the control group (P<0.05).The significant improvement rate evaluated at the end of the 6-week treatment was remarkably higher in the observation group than that in the control group (72.7% vs 40.0%).No significant difference of TESS scores was found between the two groups.Conclusion:EA combined with Paroxetine has better clinical efficacy than that of Paroxetine alone,with milder adverse reaction and quicker initiation of effect.     

Effect of Yangxinkang Tablets(养心康片)on Chronic Heart Failure:A Multi-Center Randomized Double-Blind Placebo-Controlled Trial

Objectives:To investigate the safety and efficacy of Yangxinkang Tablets(养心康片) in patients with chronic heart failure(CHF) and syndrome of qi and yin deficiency,blood stasis,and water retention.Methods:In a double-blinded,randomized,placebo-controlled,multicenter clinical trail,228 patients with CHF New York Heart Association(NYHA) class Ⅱ or Ⅲ in stage C were assigned by randomized block method to two groups in a 1:1 ratio to undergo either conventional Western treatment or conventional treatment plus Yangxinkang Tablets for 4 weeks.The outcome measure were effect of cardiac function,Chinese medicine(CM) syndromes,scores of symptoms,signs,and quality of life measured by Minnesota Living with heart failure questionnaire(MLHFQ) before and after the treatment.Results:Totally 112 patients were analyzed in the treatment group and 109 in the control group.They were comparable in NYHA functional class,basic parameters and primary diseases before treatment.Cardiac function and CM syndromes were greatly ameliorated in both groups after treatment.Total effective rates of cardiac function and CM syndrome in the treatment group were significantly higher than those in the control group(P0.05).Total symptom score and sign score in the treatment group decreased significantly after treatment(P0.01),which were significantly lower than those in the control group(P0.05).There were statistically significant differences in post-treatment scores of gasp,cough with phlegm,pulmonary rales and jugular vein engorgement between the two groups(P0.05 or P0.01).Three MLHFQ scores decreased significantly in both groups after treatment(P0.01).Post-treatment total scale score and physical subscale score in the treatment group and the reduction of them showed statistically significant differences(P0.05) as compared with the control group.There was no significant difference between the two groups in emotional subscale score and the reduction after treatment(P0.05).There was no obvious adverse reaction in either group noted during the study.Conclusions:Yangxinkang Tablets were safe and efficacious in improving cardiac function,CM syndromes,symptoms,signs,and quality of life in patients with CHF class Ⅱ orⅢ in stage C on the base of conventional treatment.     

Menopausal depression: comparison of hormone replacement therapy and hormone replacement therapy plus fluoxetine

Background To compare the efficacy and safety of hormone replacement therapy (HRT) combined with fluoxetine, with HRT alone, in post-menopausal women suffering from depression.Methods A randomized, open-label, parallel trial was applied. HRT was administered to all patients for 2 cycles, with 14 days of estrogen therapy and 14 days of estrogen plus progesterone. Patients who were randomly assigned to the HRT plus fluoxetine group were given fluoxetine in combinationwith HRT. Hamilton Depression Rating Scale (HAMD), Kupperman Menopausal Index (KMI), and Clinical Global Impressions scale were used to measure the efficacy.Results One hundred and twenty-three post-menopausal patients with depression were enrolled in the study. Among them, 120 had at least one post-treatment visit and entered into the statistical analysis. The mean total HAMD scores were significantly lower, and the percentages of HAMD score reductions were higher in the HRT plus fluoxetine Group compared with the HRT Group, after at least 3 weeks of treatment, with an average difference of 5 points at the endpoint. The Clinical Global Impression-Severity and Clinical Global Impression-Improvement scores were significantly different in the 2 groups, in favor of the combination therapy. The mean total KMI was significantly lower in the Combination Group compared with the HRT Group, after at least 6 weeks of treatment, with an average 4. 5-point difference between the groups. No statistically significant differences were found in most of the adverse events reported in the Combination Group compared with the HRT group, with the exception of 3 symptoms, i. e., dry mouth, loss of appetite, and abdominal distention. They were mild to moderate in severity. Two patients in the HRT group, but none in the combination group, dropped out due to adverse events.Conclusion HRT plus fluoxetine therapy was effectivewith a satisfactory safety profile.in the treatment of menopausal depression with a satisfactory safety profile.     

Therapeutic Effect of Chang'an Ⅰ Recipe(肠安Ⅰ号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial

Objective: To evaluate the efficacy and safety of Chinese medicine(CM) decoction Chang'an Ⅰ Recipe(肠安Ⅰ号方) in the treatment of irritable bowel syndrome with diarrhea(IBS-D). Method: A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Based on the order of inclusion, the IBS-D patients were randomly assigned to the treatment group or the placebo control group, administrated with Chang'an Ⅰ Recipe or placebo, 150 m L/bag, 3 times daily, for 8 weeks. The primary indices of efficacy included the effective rates of IBS symptom severity score(IBS-SSS) and the differences in adequate relief(AR) responder; the secondary indexes of efficacy included the changes in scores of the IBS Quality of Life(IBS-QOL) and Hospital Anxiety and Depression(HAD) scales. The safety indices included adverse events and related laboratory tests. Results: A total of 216 patients were included, with 109 in the treatment group and 107 in the control group, and finally 206 were included in the full analysis set(FAS), 191 were included in the per protocol set(PPS). In FAS, the total effective rate was 67.6% and 40.2% for the treatment and control groups, respectively, with 95% confidence interval(CI) for difference in the effective rates between the two groups of 14.4%–40.2%; while in PPS, the total effective rate was 71.3% and 41.2% for the treatment and control groups, respectively(95% CI 16.6%–43.4%). The consistent conclusions of FAS and PPS showed a better efficacy in the treatment group. Both FAS and PPS showed higher AR responder in the treatment group(FAS: 59.6% vs. 35.5%; PPS: 62.8% vs. 38.1%). As for IBS-QOL, the total score and scores in various dimensions of IBS-QOL were not significantly different between the two groups(P0.05). Both anxiety and depression scales of HAD were not significantly different between the two groups(P0.05). No adverse events or laboratory abnormalities were found to be obviously related to the tested drugs or clinically significant. Conclusion: Chang'an Ⅰ Recipe was more effective than placebo in the treatment of IBS-D, with no obvious adverse reactions.(No.ChiC TR-TRC-09000328)     

Effectiveness and Safety of Umbilicus Treatment with Modified Dinggui Powder(加味丁桂散)in Patients with Chronic Nonbacterial Prostatitis:A Randomized,Double-Blind,Placebo-Controlled Clinical Trial

Objective:To evaluate the effectiveness and safety of Chinese herbal external umbilicus treatment with Modified Dinggui Powder(加味丁桂散,MDGP)in patients with chronic nonbacterial prostatitis(CNP).Methods:A randomized,double-blind,placebo-controlled clinical trial was conducted among 72 patients with CNP.Participants were randomly allocated to a treatment group and a placebo group using computer software in a 1:1 ratio,and received either MDGP external umbilicus treatment(MDGP group,36 cases)or placebo(control group,36 cases)at acupoints Shenque(CV 8),twice a week for 4 weeks.In addtion,patients all received herbal medicine treatment twice a day for 4 weeks.The primary outcome was the US National Institutes of Health Chronic Prostatitis Symptom Scores Index(NIH-CPSI)with a questionnaire at weeks 2 and 4.The secondary outcomes including prostatic fluid examination(white blood cells and lecithin bodies),the clinical efficacy evaluation,and the adverse events were also assessed during the entire trial.Results:The NIH-CPSI scores regarding pain or discomfort scores showed greater improvement in the MDGP group than placebo control group at weeks 2(P=0.001)and week 4(P=0.004),respectively.NIH-CPSI scores of symptom severity,total scores and leukocytes number in the prostatic fluid in the MDGP group were significantly improved(P<0.05).There was no statistical difference in the urinary symptoms,quality of life,lecithin and other scores between two groups(P>0.05).The clinical effective rate was 73.53%(25/34)in the MDGP group,which was significally higher than the placebo control group with 48.39%(25/31,P<0.05).Patients were blinded successfully,and no serious adverse effects were found during the trial.Conclusion:A 4-week course of umbilicus treatment with modified Dinggui Powder seems to relieve pain and symptom severity effectively and increase the amount of leukocytes number in patients with CNP(Trial registration No.ChiCTRI 800014687).     

Activating Blood Circulation to Remove Stasis Treatment of Hypertensive Intracerebral Hemorrhage: A Multi-Center Prospective Randomized Open-Label Blinded-Endpoint Trial

Objective:To investigate the efficacy and safety of the Chinese herbal therapeutic regimen of activating blood circulation(TRABC) in treatment of hypertensive intracerebral hemorrhage(HICH).Methods:This was a multi-center prospective randomized open-label blinded-endpoint(PROBE) trial with HICH admitted to 12 hospitals.Totally 240 participants were randomized to the treatment group treated with TRABC in addition to conventional Western treatment or the control group with conventional Western treatment equally for 3 months.Primary outcome was degree of disability as measured by modified Rankin Scale(mRS).Secondary outcomes were the absorption of hematoma and edema,National Institutes of Health Stroke Scale(NIHSS) scores and patient-reported outcome measures for stroke and Barthel activities of daily living index.Adverse events and mortality were also recorded.Results:After 3 months of treatment,the rate of mRS 0-1 and mRS 0-2 in the treatment group was 72.5%and 80.4%,respectively,and in the control group 48.1%and 63.9%,respectively,with a significant difference between groups(P0.01).Hematoma volume decreased significantly at day 7 of treatment in the treatment group than the control group(P=0.038).Average Barthel scores in the treatment group after treatment was 89.11 ± 19.93,and in the control group 82.18 ±24.02(P=0.003).NIHSS scores of the two groups after treatment decreased significantly compared with before treatment(P=0.001).Patient-reported outcomes in the treatment group were lower than the control group at day 21 and 3 months of treatment(P0.05).There were 4 deaths,2 in each group,and 11 adverse events,6 in the treatment group and 5 in the control group.Conclusion:The integrative therapy combined TRABC with conventional Western treatment for HICH could promote hematoma absorption thus minimize neurologic impairment,without increasing intracerebral hematoma expansion and re-bleeding.     

Effect of Xuefu Zhuyu Capsule (血府逐瘀胶囊) on the Symptoms and Signs and Health-related Quality of Life in the Unstable Angina Patients with Blood-stasis Syndrome after Percutaneous Coronary Intervention: A Randomized Controlled Trial

Objective: Compared with Shengmai Capsule (生脉胶囊, SM), the study was conducted to evaluate the efficacy and safety of Xuefu Zhuyu Capsule (血府逐瘀胶囊, XFZY) on the symptoms and signs and health-related quality of life (HR-QOL) in the unstable angina (UA) patients with blood-stasis syndrome (BSS) after percutaneous coronary intervention (PCI). Methods: A randomized, double-blinded, doubledummy, and placebo-controlled trial was applied. Ninety patients, diagnosed as UA and BSS after successful PCI, were enrolled and equally randomized into three groups, XFZY group, SM group, and placebo group, and administered with the corresponding medications respectively for four weeks. The clinical symptoms and signs (CSS), electrocardiography (ECG), and BSS scores were recorded and compared among groups during and after the treatment. Short-form 36 (SF-36) and Seattle Angina Questionnaire (SAQ) were applied to assess the HR-QOL in each group before and after the treatment. Safety indexes (blood routine and liver and kidney function tests) were also examined at the beginning and after the treatment. Results: Eighty-six patients completed the whole study. After the treatment, the total effective rates of the XFZY group in ameliorating CSS and ECG were 76.7% and 60.0%, respectively, which were obviously higher than those in SM (CSS: 53.3%; ECG: 36.7%) and the placebo (CSS: 43.3%; ECG: 30.0%) groups. After one week's treatment, BSS scores slightly decreased in each group, but no significant differences were found among three groups (P0.05). After four weeks' treatment, BSS scores in the XFZY group decreased to a lower level compared with SM (P0.05) and the placebo (P0.01) groups. After the treatment, the efficacy of XFZY group in improving body pain (BP), general health (GH), vitality (VT), society functioning (SF), role emotional (RE), angina stability (AS), angina frequency (AF), and treatment satisfaction (TS) were better than those in the placebo group (P0.05, P0.01). Meanwhile, the dimensions of BP, GH, SF, AS, AF, and TS were better improved than those in the SM group (P0.05). No obvious adverse reaction was found during and after the treatment except one case in the XFZY group reporting of stomach discomfort. Conclusions: Compared with SM Capsule treatment, a short-term treatment with XFZY Capsule exhibits better efficacy on CSS and BSS scores, and HR-QOL in UA patients with BSS after PCI. However, its long-term efficacy and safety still needs further investigation.     

Efficacy of Modified Qufeng Runmian Powder (加减祛风润面散) on Acne Vulgaris with Syndromes of Dampness and Blood Stasis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Objective: To evaluate the efficacy and safety of a Chinese medicine(CM) Modified Qufeng Runmian Powder(加减祛风润面散, MQFRMP) for the treatment of acne vulgaris with CM syndromes of dampness and blood stasis. Methods: In this multicenter, randomized, double-blind, placebo-controlled clinical trial, 220 acne vulgaris patients with CM syndrome of dampness and blood stasis were included and randomly assigned using a central area group random design to receive either MQFRMP or the placebo, with 110 cases in each group. MQFRMP or a placebo at 145 g/bag were administered once daily for 4 weeks, respectively. The primary index of efficacy was the effective rate according to the acne severity score(ASS). The secondary indices of efficacy included the changes in the dermatology life quality index(DLQI) score, VISIA scores(spots, pores, brown spots, porphyrins and red areas) and skin assessment(skin p H, sebum amount and hydration) according to a SOFT skin multianalyzer. Results:(1) Follow-up: a total of 204 patients completed the follow-up, with 103 in the treatment group and 101 in the control group.(2) Effective rate: the total effective rate of the treatment group was significantly higher than the control group [83.5%(86/103) vs. 31.7%(32/101), P0.01)] with 95% confidence interval of 39.3%–66.4%.(3) DLQI: DLQI scores were significantly decreased the treatment and control groups(both P0.01), but the treatment group was more obvious than the placebo group(P0.01).(4) VISIA scores: the scores of spots, brown spots and red areas in the treatment group decreased compared with baseline(P0.05). In the control group, the scores of brown spots and pores decreased compared with baseline(P0.05). The improvement was more obvious in the treatment group than in the control group for all items(P0.05).(5) Skin assessment : the p H and sebum score in the both groups decreased drastically compared with the baseline(all P0.01), however, the improvement was more obvious in the treatment group than in the control group(P0.01). The hydration amount in the two groups showed no statistically significant difference compared with the baseline(both P0.05).(6) Safety: two cases of mild drug allergy were observed in the treatment group. Conclusion: MQFRMP was effective and safe for the treatment of acne vulgaris with syndromes of dampness and blood stasis.(No. ChiCTR1900020479).     

Treatment of middle/late stage primary hepatic carcinoma by Chinese medicine comprehensive therapy: A prospective randomized controlled study

<正>Objective:To observe the efficacy of Chinese medicine comprehensive therapeutic project in treating the middle/late stage primary hepatic carcinoma(PHC).Methods:With prospective randomized controlled design, 97 patients with PHC were assigned to the test group(49 cases) treated with Chinese medicine comprehensive therapy using Oleum fructus bruceas intervention combining oral intake of Ganji Decoction(肝积方) and external application of Ailitong(癌理通),and the control group(48 cases) treated with chemotherapeutic agents combining iodized oil chemo-embolization and analgesics.The immediate and long-term efficacy,adverse reaction,pain-relieving initial time(PRIT) and pain-relieving sustained time(PRST) of the treatment,as well as the change in patients' quality of life(QOL) were observed.Results:The difference between the two groups in illness control rate was statistically insignificant(P0.05),but the adverse reaction occurence rate in the test group was lesser than that in the control group(P0.05).PRIT was insignificantly different in the two groups(P0.05),but the PRST was significantly superior in the test group than that in the control group(10.37±2.18 h vs 7.78±1.95 h,P0.01).After treatment,the increased Karnofsky scores in the test group indicated that the patients' somatic activity,symptoms and QOL were improved significantly,which were significantly superior to those in the control group(P0.05).The survival rate in the two groups was similar at the 3rd month after treatment,but the test group did show superiority in terms of half- and 1-year survival rate(65.9%vs 42.5%and 38.6%vs 18.1%,respectively,P0.05).The median survival time in the test group was 8.9 months and that in the control group was 5.3 months.Conclusion:Chinese medicine comprehensive therapy is an effective treatment for the middle/late stage patients of PHC,and it could extend the PRST,improve the patients' QOL and long-term survival with less adverse reaction.     

Is There An Advantage of Using Dingkun Pill (定坤丹) alone or in Combination with Diane-35 for Management of Polycystic Ovary Syndrome? A Randomized Controlled Trial

Objective: To evaluate the effects of Chinese medicine Dingkun Pill (定坤丹) alone or in combination with Diane-35 on patients with polycystic ovary syndrome (PCOS). Methods: This is a prospective randomized controlled trial conducted at Peking Union Medical College Hospital Beijing, China, from December 2016 to September 2017. Totally 117 PCOS patients were randomly assigned to the Dingkun Pill group (38 cases), Diane-35 group (40 cases), or combined group (39 cases). Patients in the Dingkun Pill group or Diane-35 group took daily 7 g of oral Dingkun Pill or 1 tablet of oral Diane-35, respectively, for 21 consecutive days followed by 7 drug-free days. And the combined group received a combination of Dingkun Pill and Diane-35. The treatment course was 3 months. Fasting plasma glucose and insulin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), free fatty acids (FFA) and sex hormones were analyzed, quantitative insulin sensitivity check index (QUICKI) was calculated, and menstruation and acne scores were recorded at baseline and after 3-month treatment. Results: Compared with before treatment, QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment (P<0.05); TC, LDL-C and FFA decreased significantly in the Dingkun Pill group (P<0.01), LDL-C also decreased obviously in the Diane-35 group (P<0.01), while TC increased significantly in the combined group (P<0.01), TG increased significantly in all groups (P<0.01); total testosterone (TT) and menstruation regularity was improved significantly in the Diane-35 and combined groups (P<0.01); acne scores were improved in all groups (P<0.01). After treatment, TC and FFA in the Dingkun Pill group were significantly lower than the Diane-35 group (P<0.05 or P<0.01); TT was lower and regular menstruation rate was higher in the Diane-35 and combined groups than the Dingkun Pill group (P<0.01), and no differences were observed between Diane-35 group and combined group (P>0.05). Conclusions: Dingkun Pill showed better effects than Diane-35 in improving insulin sensitivity, lowering TC and FFA. Diane-35 was more efficient in regulating menstruation and lowering androgen than Dingkun Pill. Combination of Dingkun Pill and Diane-35 may be a better choice to regulate menstruation, lower androgens while improve glucose metabolism in PCOS patients. (Registered on ClinicalTrials.gov, registration No. NCT03264638)     

Therapeutic Effect of Chang'an Ⅰ Recipe (肠安Ⅰ 号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial

Objective: To evaluate the efficacy and safety of Chinese medicine (CM) decoction Chang''an Ⅰ Recipe (肠安Ⅰ 号方) in the treatment of irritable bowel syndrome with diarrhea (IBS-D). Method: A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Based on the order of inclusion, the IBS-D patients were randomly assigned to the treatment group or the placebo control group, administrated with Chang''an Ⅰ Recipe or placebo, 150 mL/bag, 3 times daily, for 8 weeks. The primary indices of efficacy included the effective rates of IBS symptom severity score (IBS-SSS) and the differences in adequate relief(AR) responder; the secondary indexes of efficacy included the changes in scores of the IBS Quality of Life (IBS-QOL) and Hospital Anxiety and Depression (HAD) scales. The safety indices included adverse events and related laboratory tests. Results: A total of 216 patients were included, with 109 in the treatment group and 107 in the control group, and finally 206 were included in the full analysis set (FAS), 191 were included in the per protocol set (PPS). In FAS, the total effective rate was 67.6% and 40.2% for the treatment and control groups, respectively, with 95% confidence interval (CI) for difference in the effective rates between the two groups of 14.4%–40.2%; while in PPS, the total effective rate was 71.3% and 41.2% for the treatment and control groups, respectively (95% CI 16.6%–43.4%). The consistent conclusions of FAS and PPS showed a better efficacy in the treatment group. Both FAS and PPS showed higher AR responder in the treatment group (FAS: 59.6% vs. 35.5%; PPS: 62.8% vs. 38.1%). As for IBS-QOL, the total score and scores in various dimensions of IBS-QOL were not significantly different between the two groups (P>0.05). Both anxiety and depression scales of HAD were not significantly different between the two groups (P>0.05). No adverse events or laboratory abnormalities were found to be obviously related to the tested drugs or clinically significant. Conclusion: Chang''an Ⅰ Recipe was more effective than placebo in the treatment of IBS-D, with no obvious adverse reactions. (No.ChiCTR-TRC-09000328)     

A Multicenter,Randomized,Double-blind Clinical Study on Wufuxinnaoqing Soft Capsule(五福心脑清胶囊) in Treatment of Chronic Stable Angina Patients with Blood Stasis Syndrome

Objective:To confirm the efficacy and safety of Wufuxinnaoqing Soft Capsule(五福心脑清胶囊,WSC)in the treatment of chronic stable angina(blood stasis syndrome).Methods:A multicenter,randomized,double-blind,placebo-controlled trial with superiority test was designed.A total of 240 patients with chronic stable angina(blood stasis syndrome)from multiple centers were randomly and equally assigned to the treatment group and the control group.Based on standard treatment of Westem medicine,the treatment group was given WSC,while the control group was given WSC mimetic,both for 12 weeks.Observed indicators included the efficacy in angina,the efficacy in Chinese medicine syndrome,the withdrawal or reduce rate of nitroglycerin and routine safety indices.Results:After 12-week treatment,the significant effective rate and total effective rate of the treatment group were significantly better than those of the control group(23.5%vs.9.2%,64.7%vs.30.8%),respectively,with statistically significant difference(P0.01).After 12-week treatment,the decreased points and the decreased rate of angina symptom score in the treatment group were better than in the control group(5.1±4.2 points vs.2.8±3.5 points,44.9%±37.2%vs.25.4%±30.7%)respectively,with significant difference(P0.01).After 12-week treatment,the significant effective rate and total effective rate of the treatment group were better than the control group(respectively,30.3%vs.15.0%,67.2%vs.45.0%,P0.01).After 8-or 12-week treatment,the decreased points and the decreased rate of Chinese medicine syndrome score in the treatment group were better than the control group(P0.05 or P0.01).After 12-week treatment,nitroglycerin withdrawal rate and the withdrawal or reduce rate in treatment group were better than the control group(P0.01).On safety evaluation,the incidence of adverse events(7.563%vs.7.500%)and the incidence of cardiovascular events(0.840%vs.0.000%)in the treatment group were similar with the control group,and the difference was not statistically significant(P0.05).Conclusion:In treatment of chronic stable angina(blood stasis syndrome),WSC can reduce angina attacks and consumption of nitroglycerin,decrease angina severity degree,effectively relieve the blood stasis syndromes,such as chest pain,chest tightness,palpitations,dark purple tongue and other symptoms.Besides,adverse events and cardiovascular adverse events in the treatment group and the control group showed no difference.All shows that the drug is safe and effective.[This study was registered in Chinese Clinical Trial Registry(ChiCTR),with registration number:ChiCTR-TRC-14005158.]     

Effect of acupoint catgut-embedding on the quality of life, reproductive endocrine and bone metabolism of postmenopausal women

Objective: To observe the influence of acupoint catgut-embedding therapy on the quality of life (QOL),the reproductive endocrine and bone metabolism of postmenopausal women.Methods:AA ttoottaall of 65 women with climacteric syndrome were enrolled and randomly assigned to two groups,thirty-three in the treatment group on whom acupoint catgut-embedding was performed with Shenshu (BL23),Sanyinjiao (SP6) and Guanyuan (CV4) as main acupoints,and thirty-two in the control group who were only medicated with Fufuchun Capsule (妇复春胶囊))..The treatment course for both groups was 3 months.Before and aafftteerr treatment,the clinical symptoms,the QOL score,serum follicle stimulating hormone (FSH),luteinizing hormone (LH),eessttrraaddiiooll ((EE 2 ),testosterone (T),osteocalcin (BGP),parathyroid hormone (PTH),,ccaallcciittoonniinn (CT) aaannnddd alkaline phosphatase (AKP) were measured.In addition,another 28 women with childbearing potential and normal regular menstrual cycle were selected and the reproductive endocrine hormone were tested in the ovulatory period as controls.Results: The levels of serum FSH and LH of postmenopausal women were higher,and serum E 2 and T were lower than those of normal women (P00..0011))..After treatment,the levels of serum EE 2 in both groups and T in the treatment group were increased,while in the control group the serum E 2 increase was more significant than that in the treatment group (P0.05),and serum T showed no statistical difference.The levels of serum FSH,LH,BGP,CT,PTH and AKP were reduced significantly in both groups after treatment (P00..0055))..The QOL scores were increased remarkably in both groups on physiological functioning,bbooddiillyy pain,general health,vitality,and mental health after treatment (P00..0055)),,but the improvement of bodily ppaaiinn and mental health in the treatment group were better than those in the control group (P0.01).There was no significant difference in the therapeutic effect between the two groups after treatment (P00..0055))..Conclusions: Acupoint catgut-embedding showed an obvious effect on climacteric syndrome,and enhanced the QOL in postmenopausal women.The therapy could regulate the hypothalamic-pituitary-ovarian axis to raise the serum E 2 level which may be significant in preventing and curing the osteoporosis in postmenopausal women.     

Tiaobu Xinshen Recipe (调补心肾方) Improved Mild Cognitive Impairment of Alzheimer's Disease Patients with Xin (Heart) and Shen (Kidney) Deficiency

Objective: To observe the intervention effects of Tiaobu Xinshen Recipe(调补心肾方, TXR) on patients with mild cognitive impairment caused by Alzheimer's disease(MCI-AD). Methods: Totally 88 MCI-AD patients with syndrome of Xin(Heart) and Shen(Kidney) deficiency were assigned to the experimental group(47 cases, treated with TXR) and the control group(41 cases, treated with donepezil hydrochloride) using a random number table. Final recruited qualified patients were 44 cases in the experimental group and 39 cases in the control group. The therapeutic course was 12 weeks. Neuropsychological scales [mini mental state examination(MMSE) and Montreal cognitive assessment(MoCA)], and Chinese medicine(CM) dementia syndromes scales were performed in all patients, and results were compared between groups or intra-group before and after treatment. Results: MMSE and Mo CA scores of the two groups were increased after treatment compared with those before treatment(P0.05). But there was no statistical difference in MMSE or MOCA scores after treatment between the two groups(P0.05). CM dementia syndrome score was significantly decreased after treatment in the experimental group compared with the control group(P0.01). Visual spatial and executive function scores and delayed recall scores of the two groups were increased compared with those before treatment(P0.01). Conclusion: TXR could effectively improve cognitive impairment of MCI-AD patients with syndrome of Xin and Shen deficiency.     

Effect and Safety of Huannao Yicong Formula(还脑益聪方) in Patients with Mild-to-Moderate Alzheimer's Disease: A Randomized,Double-Blinded,Donepezil-Controlled Trial

Objective: To assess the effect and safety of Huannao Yicong Formula(还脑益聪方, HYF) in the treatment of patients with mild-to-moderate Alzheimer's disease(AD). Methods: Sixty patients with mild-tomoderate AD were evenly randomized into HYF group and donepezil group with the random number method. Patients in the HYF group took 5 g of HYF granules twice daily and 5 mg placebo of donepezil once daily. Patients in the donepezil group took 5 mg donepezil once daily and 5 g placebo of HYF granules twice daily. The intervention lasted for 6 months. Clinical researchers, participants and statisticians were blinded to the treatment assignment throughout the study. The primary outcomes were scores of Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-Cog) and Chinese Medicine Symptom Scale(CM-SS). The secondary outcomes were scores of Montreal Cognitive Assessment(MoCA) test and Mini-Mental State Exam(MMSE). The serum levels of acetylcholinesterase(AchE) and amyloid-β protein 42(Aβ42) were detected with enzymelinked immunosorbent assay kits. The scale assessments were conducted at baseline, the 3 rd and 6 th months of treatment, respectively. Biochemistry tests were conducted at baseline and the 6 th month of treatment. Results: A total of 52 patients completed the trial, 28 in HYF group and 24 in donepezil group. Compared with the baseline, HYF and donepezil significantly decreased the total scores of ADAS-Cog and CM-SS, and significantly increased the scores of MoCA and MMSE after 6-month treatment(all P0.01). Both treatments remarkably reduced the serum levels of AchE and Aβ42(both P0.05). The CM-SS total effective rate of HYF was significantly higher than donepezil [75.00%(21/28) vs. 54.17%(13/24), P0.05]. No severe adverse events were observed in both groups. Conclusion: HYF is effective and safe for improving the cognitive function in mildto-moderate AD patients. [Trial registration: Chinese Clinical Trial Registry(Reg No. ChiCTR-IOR-17011746)]     

Efficacy of Aidi Injection (艾迪注射液) on Overexpression of P-Glycoprotein Induced by Vinorelbine and Cisplatin Regimen in Patients with Non-Small Cell Lung Cancer

Objective:To investigate the efficacy of Aidi Injection(艾迪注射液) on overexpression of P-glycoprotein(P-gp) induced by vinorelbine and cisplatin(NP) regimen in patients with non-small cell lung cancer(NSCLC), and study the difference between intravenous administration and targeting intratumor administration of Aidi Injection with thoracoscope. Methods:Totally 150 patients with NSCLC were randomly assigned to the control group, the intravenous group and the intratumor group by the random envelope method, 50 cases in each group. The patients were treated with NP regimen(2 cycles), NP regimen(2 cycles) plus Aidi intravenous injection, or NP regimen(2 cycles) plus Aidi intratumor injection with thoracoscope, respectively for 6 weeks. The clinical efficacy was observed based on Response Evaluation Criteria in Solid Tumors(RECIST) rules, the expression of P-gp in the tumor tissue was tested before, 3 and 6 weeks after treatment, the safety was evaluated by monitoring the toxicity in the process of treatment, and the progressionfree survival(PFS) was measured. Results:Fifteen cases dropped out because of the irreconcilable conditions which had no relationship with the treatment, 4 in the control group, 5 in the intravenous group, and 6 in the intratumor group, respectively. Compared with the control group, the response rates(complete remission + partial response) and the disease control rates(complete remission + partial response + stable disease) were significantly higher, the P-gp expressions were significantly decreased after 3 and 6 weeks of treatment, and the Kaplan-Meier survival curves of PFS were significantly longer in the intravenous and intratumor groups(P0.05 or P0.01), and the intratumor group showed better effects than the intravenous group(P0.05 or P0.01). Compared with the control group, the occurrences of rash, nausea and leukocytopenia were significantly decreased in the intravenous and intratumor groups(P0.05), but without significant difference between the intravenous and intratumor groups(P0.05). Conclusion:Aidi Injection not only improves the efficacy of NP regime, but also has the function of reducing adverse events and preventing against overexpression of P-gp induced by chemotherapy of NP regimen.     

Clinical Study on Treatment of Primary Hepatocellular Carcinoma by Shenqi Mixture(参芪合剂)Combined with Microwave Coagulation

Objective: To observe the short-term efficacy and safety of Shenqi mixture (参芪合剂,SQM) combined with microwave coagulation in treating primary hepatocellular carcinoma (HCC). Methods:Seventy-two patients with primary HCC of stage Ⅱ - Ⅲ, Karnofsky scoring ≥50 scores and predicted survival period ≥3 months were selected and randomly assigned into two groups, the treated group and the control group, 36 in each. Microwave therapy was applied to both groups by double leads, 60 W, 800 sec once a week for two weeks. To the treated group, SQM was given additionally through oral intake of 20 ml, three times a day for 1 month. The changes in tumor size, main symptoms, serum level of alpha-fetoprotein (AFP), immune function and adverse reaction were observed after treatment and the immune parameters of the patients were compared with 30 healthy persons in the normal control group. Results: (1) In the SQM treated group, after treatment 3 patients got completely remitted (CR), 24 partial remitted (PR), 4 unchanged (NC) and 5 progressively deteriorated (PD), the effective rate being 75.00%; while in the control group, 1 got CR, 19 PR, 9 NC and 7 PD, the effective rate being 55.56%. Comparison of the effective rate between the two groups showed significant difference ( P＜0.05). (2) AFP level decreased after treatment in both groups, but the decrement in the treated group was significantly higher than that in the control group (P＜0.01). (3) After treatment, in the treated group, CD3 , CD4 , CD4 /CD8 and NK activity were improved, Karnofsky scores increased and liver function bettered, with these improvements significantly superior to those in the control group (P＜0.01). (4) The improvement in symptoms such as hepatic region pain, fever, weakness, poor appetite and jaundice in the treated group after treatment was also superior to that in the control group ( P＜0.01). (5) The 12-month, 18-month and 24-month survival rates were higher and the recurrence rate was lower in the treated group than those in the control group, showing significant difference (P＜0.05). Conclusion: Combined therapy with SQM and microwave coagulation could not only kill the tumor and residue tumor cells to prevent recurrence, but also enhance the cellular immunity of organism. It is one of the effective therapies for patients with middle-advanced hepatocarcinoma, who have lost the chance of surgical operation. it could improve clinical symptoms, elevate the quality of life, prolong the survival period of patients, but shows no evident adverse reaction.     

Clinical Efficacy and Safety of Bathing with Chinese Medicine Taohong Siwu Decoction (桃红四物汤) for Treatment of Diffuse Cutaneous Systemic Sclerosis: A Randomized Placebo-Controlled Trial

Objective:To examine the efficacy and safety of bathing therapy with Taohong Siwu Decoction(桃红四物汤,TSD) in the treatment of early-stage,mild-moderate diffuse cutaneous systemic sclerosis(dc SSc).Methods:This randomized,placebo-controlled trial enrolled 148 men and women(18–60 years) with dc SSc(disease duration 12 months) and baseline modified Rodnan skin score(MRSS) 10.Patients were randomized into a TSD group(71 cases bathing with TSD plus oral prednisone) or control group(71 cases bathing with placebo plus oral prednisone).Bathing(40 ℃,30 min) of the upper and lower limbs was carried out once daily for 12 consecutive weeks.The primary outcome measure was MRSS;secondary outcomes were Raynaud's phenomenon(RP) score,quality of life(QOL),physician visual analogue scale(VAS),patient VAS,percent predicted diffusing capacity for carbon monoxide(DLCO),percent predicted forced vital capacity(FVC),erythrocyte sedimentation rate(ESR),C-reactive protein(CRP) level and overall treatment effect.Results:The final analysis included 135 patients(control group,68 cases;TSD group,67 cases).Primary and secondary outcome measures after 2 weeks of treatment showed no improvement(versus baseline) in both groups,with no differences between groups.At 12 weeks,QOL,physician VAS,patient VAS,ESR and CRP were improved in both groups,but MRSS and RP score were improved only in the TSD group(all P0.05).MRSS,RP score,QOL,physician VAS,patient VAS,ESR and CRP differed significantly between groups(all P0.05).Meanwhile,the overall treatment effect was significantly higher in the TSD group than in the control group(P0.05).Adverse events in the two groups were similar(P0.05).Conclusions:Bathing with TSD plus oral prednisone achieves better outcomes than oral prednisone alone in patients with dcS Sc and is not associated with serious adverse events.