A randomized controlled single-blind clinical trial on 84 outpatients with psoriasis vulgaris by auricular therapy combined with optimized Yinxieling Formula (银屑灵优化方)

Objective:To explore the therapeutic effect of auricular therapy combined with optimized Yinxieling Formula(银屑灵优化方) on psoriasis vulgaris.Methods:A randomized controlled single-blind clinical trial on 84 outpatients with psoriasis vulgaris was conducted.The patients were randomized to a treatment group(43 cases treated by auricular therapy combined with optimized Yinxieling Formula) and a control group (41 cases treated by optimized Yinxieling Formula alone) according to a random number generated by SPSS 17.0 software.The treatment duration for both groups was 8 weeks.The therapeutic effect was comprehensively measured by the primary outcome measure[Psoriasis Area and Severity Index(PASI) reduction rate]and the secondary outcome measure[PASI,Visual Analogue Scale(VAS),Dermatology Life Quality Index(DLQI), Self-rating Depression Scale(SDS),and Self-rating Anxiety Scale(SAS)].The outcomes of both groups were obtained and compared before and after the intervention.Results:The PASI reduction rate in the treatment group was 74.4%(32/43),which was higher than that in the control group(36.6%,15/41,P<0.01).The PASI scores decreased in both groups after treatment and was lower in the treatment group compared with the control group (P<0.01).With stratified analysis,there were significant differences between the PASI scores in the following subgroups:age 18-30,baseline PASI>10 and stable stage(P<0.05).DLQI decreased in both groups on some categories after treatment,but there were no significant differences between the two groups in SDS,SAS and VAS(P>0.05).No obvious adverse reactions were found in either group.Conclusion:The therapeutic effect of auricular therapy combined with Optimized Yinxieling Formula was superior to Optimized Yinxieling Formula alone with no obvious adverse reaction.     

Efficacy of Modified Wuzhuyu Decoction Granule(加减吴茱萸汤颗粒剂)for Migraine Patients with Cold and Stasis Obstructing Meridian Syndrome:A Randomized,Double-Blind,Placebo-Controlled Trial

Objective: To study the efficacy of modified Wuzhuyu Decoction Granule(加减吴茱萸汤颗粒, MWDG) in the treatment of migraine patients with cold and stasis obstructing meridian syndrome. Methods: This study was a randomized, double-blind, placebo-controlled trial. A total of 78 migraine patients with cold and stasis obstructing meridian syndrome were recruited and randomly assigned by a ratio of 2:1 into a treatment group(51 cases) and a placebo group(27 cases). Patients in the treatment group were treated with MWDG while placebo granules were applied in the control group. The treatment course lasted for 12 weeks with a follow-up of 4 weeks. The primary outcome measures included frequency and days of migraine attacks and the secondary outcome measures were analgesics consumption and visual analogue scale(VAS) scores. All outcome assessments were conducted respectively at baseline, the 4 th, 8 th and 12 th week, and the end of follow-up. Results: In the treatment group, significant decrease in frequency of migraine attacks were observed since the 4 th week and that of analgesics consumption since the 8 th week(both P0.05). While, in the placebo group, significant decrease in frequency of migraine attacks were observed since the 8 th week and that of analgesics consumption since the 12 th week(both P0.05). No significant decrease in days of migraine attacks and VAS scores of migraine pain were observed in both groups. Between the two groups, there were significant differences in VAS scores and intensity of pain appeared in the 8 th week(P0.05). However, no significant differences were found in days and frequency of migraine attacks and analgesics consumption(P0.05). Conclusions: MWDG was probably effective in the treatment of migraine especially for alleviating pain intensity. Furthermore, MWDG could reduce the frequency of migraine attacks and analgesics consumption sooner than the placebo.     

Effect of Huanshuai Recipe Oral Liquid (缓衰口服液) on Renal Dysfunction Progression in Patients with Atherosclerotic Renal Artery Stenosis

Objective:To investigate the effect of Huanshuai Recipe Oral Liquid(缓衰口服液,HSR) on retarding the progression of renal dysfunction in patients with atherosclerotic renal artery stenosis(ARAS).Methods:A total of 52 ARAS patients with the Chinese medicine(CM) syndrome of qi deficiency and blood stasis,phlegm and dampness retention were recruited and randomly assigned into the treatment group(36 cases) and the control group(16 cases).Both groups received a basic treatment(high-quality low-protein diet,blood pressure control,lipid-lowering,correcting the acidosis,etc.).In addition,the treatment group received 20 mL HSR and the control group received placebo,3 times a day for 6 months.Renal function(serum creatinine,blood urea nitrogen and uric acid) and blood lipids(cholesterol,triglycerides and low density lipoprotein) were examined monthly.The estimated glomerular filtration rate(eGFR) and CM syndrome score were compared between groups.Results:After treatment,compared with the control group,the serum creatinine level,uric acid level and CM syndrome score of the treatment group were significantly decreased(P0.05 or P0.01),and the eGFR in the treatment group were significantly increased(P0.05).Conclusion:HSR can effectively improve the renal function and clinical symptoms of ARAS patients.     

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.     

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).     

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.]     

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 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)]     

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.     

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.     

Effect of Yitangning Granule on Glycometabolism and Urinary Micro Albumin of Diabetes B Patients

One hundred and twenty patients with diabetes B that belong to the type of kidney deficiency andblood stasis were randomly divided into a treatment group treated with Yitangning Granule ( 益糖宁颗粒), a control group A treated with Jiangtangshu Capsule (降糖舒胶囊) and a control group B treated with Glurenorm Tablet (糖适平片). A better total effective rate was found in the treatment group, as compared with the two control groups, but there was no obvious difference. However, the treatment group was superior to the two control groups (P＜0.05 or P＜0.01) in the reduction of blood sugar and urinary micro albumin. It indicates that Yitangning Granule can improve the clinical symptoms and glycometabolism in patients with diabetes B and has a reverse effect on early diabetic nephropathy (DN).     

Efficacy of Chinese Medicine Acupoint Application Combined with Montelukast on Children with Perennial Allergic Rhinitis: A Randomized Controlled Trial

Objective: To evaluate the efficacy of Chinese medicine acupoint application(CMAA) combined with Western medicine for perennial allergic rhinitis(PAR) in children. Methods: In this prospective, parallel, randomized, placebo-controlled and single-blind trial from August to September, 2017, 180 children with PAR were randomly assigned to an integrative group(CMAA and Montelukast), CMAA group(CMAA and placebo tablet), or Montelukast group(placebo CMAA and Montelukast). Participants were applied with CMAA for 6 sessions over 2 weeks, and/or Montelukast Chewable Tablet orally once daily for 12 weeks. The changes in severity of symptoms were measured by Visual Analog Scale(VAS) and rhinitis control assessment test(RCAT) at 0, 2, 4 and 12 weeks of treatment. Blood samples were collected for serum interleukin-4, interferon gamma γ and T helper type 1(Th1)/Th2 flow cytometric analysis at the time points of 0, 4 and 12 weeks. Results: Eight cases dropped out from the trial, 3 in the integrative group, 2 in the CMAA group and 3 in the Montelukast group. The VAS scores decreased significantly while the RCAT scores increased significantly in all three groups at 4 and 12 weeks compared with baseline(P0.01 or P0.05). The VAS scores were significantly lower while the RCAT scores were significantly higher in the integrative and CMAA groups than the Montelukast group at 2 and 4 weeks(P0.01 or P0.05). At 2, 4 and 12 weeks, the scores of nasal congestion, sneezing, sleep problem, and rhinitis symptom control in the integrative and CMAA groups increased significantly compared with baseline(P0.01 or P0.05). The least percentages of Th2 and the most alleviated Th2 shift(highest Th1/Th2) were observed in the integrative group at 12 weeks compared with the other two groups(P0.05). Conclusion: The combination of CMAA with Montelukast might be more effective and appropriate than either option alone for children with PAR.(Registered at Chinese Clinical Trial Register, registration No. Chi CTR-IOR-17012434)     

Xinfeng Capsule(新风胶囊)for the Treatment of Rheumatoid Arthritis Patients with Decreased Pulmonary Function—A Randomized Controlled Clinical Trial

Objective:To determine the effectiveness and safety of Xinfeng Capsules(新风胶囊,XFC) for the treatment of rheumatoid arthritis(RA) patients with decreased pulmonary function.Methods:This was a randomized controlled clinical trial of 80 RA patients.Participants were assigned to the trial group(40 cases) and the control group(40 cases) by block randomization.The trial group was treated with XFC,three pills each time three times daily for 2 months.The control group was treated with tripterygium glycoside(TPT),two pills each time three times daily for 2 months.Both groups were followed up after 2 months.The clinical effects,changes in joint and pulmonary function,and quality of life before and after treatment were observed;safety indices were also evaluated.Results:Pain,swelling,tenderness,and duration of morning stiffness of joints were obviously decreased after treatment in both the trial and the control groups compared with baseline(P0.01).Compared with before treatment,hand grip strength increased significantly after treatment in the trial group(P=0.0000);pulmonary function parameters such as forced expiratory volume in the first second of expiration/forced vital capacity(FEV_1/FVC),50%of the expiratory flow of forced vital capacity(FEF_(50)),carbon monoxide diffusing capacity(DLco) were increased(P0.01 or P0.05);measures of quality of life such as role-physical,body pain,vitality and mental health were also improved after treatment in the trial group(all P0.05).Joint swelling in the trial group decreased compared with the control group(P=0.0043),while hand grip strength was increased after treatment(P=0.0000).The increase in FEF_(50),DLco,and the dimensions of quality of life such as vitality and mental health were all significantly greater in the trial group than the control group(P0.05 or P0.01).Conclusions:XFC not only relieved joint pain in RA patients,but also significantly improved the ventilation and diffusion function of the lungs.Therefore,XFC could improve the whole body function and enhance the quality of life of RA patients.     

A Multi-center,Randomized,Controlled and Open Clinical Trial of Heyan Kuntai Capsule (和颜坤泰胶囊) and Hormone Therapy in Perimenopausal Women

Objective: To evaluate the efficacy and safety of Heyan Kuntai Capsule(和颜坤泰胶囊, HYKT) and hormone therapy(HT) on perimenopausal syndromes(PMSs). Methods: From 2005 to 2008, 390 women with PMSs were recruited from 4 clinic centers. The inclusion criteria included ages 40 to 60 years, estradiol(E2) below 30 ng/L, and follicle stimulating hormone(FSH) above 40 IU/L, etc. The patients were randomly assigned to HYKT group or HT group by random number table method, administrated HYKT or conjugated estrogen with/without medroxyprogesterone acetate tablets for 12 months. During treatment, the patients were interviewed quarterly, Kupperman Menopausal Index(KMI) scores, hot flush scores, insomnia scores, Menopause-Specific Quality of Life(MENQOL) scores and adverse effects were used for evaluating drug efficacy and safety respectively. The last interview was made at the end of 12-month treatment. Results: After treatment, KMI scores of HYKT group and HT group were both significantly decreased compared with baseline(P0.01) and there was no significant difference between groups(P0.05), except that KMI of HYKT group was higher after 3-month treatment(P0.05). After treatment, hot flush and insomnia scores were both improved significantly in two groups(P0.01); and HT had a better performance than HYKT in improving hot flush(P0.05). MENQOL were significantly improved in both groups after treatment(P0.01); but there was no significant difference between two groups(P0.05). The incidence of adverse event in the HYKT group was much lower than that in the HT group(P0.01). Conclusions: HYKT could effectively relieve PMSs and improve patient quality of life without severe adverse reactions. Although HYKT exerted curative effects more slowly than hormone, it possessed better safety profile than hormone.     

Influence of Fuzheng Huayu Tablet (扶正化瘀片) on mental state and social function of patients with post-hepatitis B liver cirrhosis

Objective:To observe the influence of Fuzheng Huayu Tablet(扶正化瘀片,FZHYT)on mental state and social activity of patients with post-hepatitis B liver cirrhosis(LC-HB).Methods:Adopting grouped randomized double-blinded control method,180 LC-HB patients in 3 research centers were distributed to 2 groups,the treated group and the control group,90 in each group.Patients in the treated group were administered with FZHYT;while those in the control group treated with conventional therapy combined with placebo,the course for ail patients were 6 months.Their mental state and social activity were evaluated before treatment,after 3 months’ treatment and at terminal of the 6-month therapeutic course by estimating with Zung self-rating anxiety scale(SAS),self-rating depression scale(SDS)and social deficit screening scale(SDSS). Additionally,the basic demographic materials,liver function,cirrhosis index,hepatic and splenic images,blood coagulation function,etc.in the patients were tested and compared as well.Results:As compared with before treatment,the normal rate of SAS and SDS scores increased and the social deficit rate decreased in the treated group significantly after treatment,showing statistical significance(P<0.05 or P<0.01);while in the control group, change was only shown in the social deficit(P<0.01),inter-group comparisons after treatment showed significant differences in all the three indexes(P<0.05 or P<0.01).Additionally,after treatment,levels of liver function, cirrhosis,blood coagulation function and splenomegaly in the treated group were all improved significantly (P<0.05 or P<0.01),and the improvements were better than those in the control group(P<0.01)in levels of total bilirubin(TBIL),albumin(ALB),typeⅣcollagen(Ⅳ-C),prothrombin time(PT),prothrombin activity(PTA). Conclusion:Most patients of LC-HB have mental disturbance and social activity deficit,which could definitely be improved by intervention with Chinese FZHYT.     

Clinical Study on Electro-acupuncture Treatment for 30 Cases ofMental Depression

To observe the clinical therapeutic effects of electro-acupuncture therapy for mental depression, 30 cases were treated by electro-acupuncture on Baihui (GV20), Yintang (EX-HN3) and the differential points.Maprotiline was used in the control group of 31 cases. After the treatment, the scores in HAMD for both groups were found to be obviously decreased as compared with those before the treatment (P＜0.01),without significant between-group differences (P＞0.05). The total effective rate in the treatment group was 96.7%, and that of the control group was 90.3%, showing no significant between-group differences (P＞0.05). After the treatment, the two groups all showed obvious decrease in the TCM symptomatic integrals (P＜0.01), with significant between-group differences (P＜0.05), the integral of the treatment group showing obvious superiority to that of the control group. And the decrease of the Asberg scores testing the side effect of antidepressants of the treatment group was obviously superior to that of the control group. After the treatment, the cortisol (CORT) content and the endothelin-1 (ET-1) content of the two groups were all obviously decreased (P＜0.01), and basically turned to normal, without significant between-group differences (P＞0.05). Conclusion: Electro-acupuncture therapy can produce the same clinical therapeutic effect as that produced by the tetracyclic drug maprotiline, giving less side effect and better symptomatic improvement.     

Effect of Tanreqing Injection(痰热清注射液)on Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease with Chinese Medicine Syndrome of Retention of Phlegm and Heat in Fei(肺)

<正>Objective:To explore the effect of Tanreqing Injection(痰热清注射液,TRQI) on the treatment of acute exacerbation of chronic obstructive pulmonary disease(AECOPD) with Chinese medicine syndrome of retention of phlegm and heat in Fei(痰热阻肺证,RPHF).Methods:In a prospective randomized controlled clinical trial,90 patients with AECOPD of RPHF syndrome were randomly assigned to 3 groups,TRQI and controls A and B,each with 30 cases.The TRQI group was administered with the intravenous injections of 20 mL TRQI once a day and conventional Western medicine treatment.Control group A was administered with the intravenous injection of 15 mg ambroxol hydrochloride twice a day and conventional Western medicine treatment,and control group B was administered with conventional Western medicine treatment only.The treatments were administered for 10 days.Chinese medical symptoms and signs were scored,and plasma concentrations of interleukin(IL)-8 and neutrophil elastase(NE) were recorded.Results:(1) The Chinese medical symptoms (cough,sputum amount,expectoration,dyspnea and fever) and signs(tongue and pulse) improved significantly in the TRQI group(P0.05 or P0.01),and improvements in cough,sputum amount and expectoration were better in the TRQI group than control group B(P0.05);there was no significant difference between the TRQI group and control group A(P0.05).The sign of tongue was also improved significantly in the TRQI group (P0.05).(2) The overall effects in the TRQI group and control group A were significantly better than in control group B(P0.05),with no significant differences between the TRQI group and control group A(P0.05).There was no significant difference in the total effective rate among the three groups(P0.05).(3) After treatment, the plasma concentrations of IL-8 and NE decreased in the TRQI group and control group A(P0.05),and the concentration of IL-8 in control group B decreased(P0.05).The difference in IL-8 was greater in the TRQI group than in control group A and B before and after treatment,and the change in NE was greater in control group A than in the TRQI group and control group B,but there was no statistical significance among the three groups with regards to the change in IL-8 or NE(P0.05).Conclusion:TRQI could improved the Chinese medical signs and symptoms in the patients with AECOPD,possibly because of the decreasing plasma levels of IL-8 and NE which could improve response to airway inflammation and mucus hypersecretion.     

The Therapeutic Effects of Rehmannia Oral Liquid for the Syndrome of Heat Accumulation with Yin Consumption in Esophagus Cancer Patients Undergoing Radiotherapy——A Report of 60 Cases

Objective: To observe the clinical therapeutic effects of Rehmannia Oral Liquid on the syndrome of heat accumulation with Yin consumption in intermediate or late esophagus cancer patients undergoing radiotherapy. Methods: The IFN-α, TNF-α, IL-1β and TGF-β1 levels in sera were determined by the method of ABC-WLISA before and after the treatment with Rehmannia Oral Liquid. At the same time, the observation was carried out on the patient's general condition, symptoms and signs, barium meal or CT examinations, and biopsy. Another 30 cases of esophagus cancer were treated singly with radiotherapy as the control group. Results: Rehmannia Oral Liquid could obviously improve the patient's general condition, and the symptoms and signs after radiotherapy. Based on the X-ray examination and biopsy, the short-term local control rate of the treatment group and the control group was 70.0% and 40.0% respectively, showing a significant difference (P<0.05). Before the treatment, the level of serum IFN-α of both cancer groups was lower and the levels of TNF-α, IL-1β and TGF-β1 were higher than that of normal group. After treatment, the level of IFN-α in both treatment group and control group increased significantly (P<0.01), and the treatment group improved more obviously than the control group (P<0.05). The level of TNF-α of both groups decreased significantly (P<0.01) after treatment, and the level of IL-1β decreased in treatment group and increased in control group without the significant difference as compared with that before treatment. The level of TGF-β1 was significantly increased in control group (P<0.05) and decreased in treatment group (P>0.05) after treatment. The difference between groups was significant (P<0.05). Conclusion: Rehmannia Oral Liquid can obviously reduce the radiotherapy reaction, improve the quality of life, and raise the therapeutic effects. The action mechanism of the Liquid may lie in balancing the cytokine network and regulating the disordered signal transmission.     

Effect of Compound Zhuye Shigao Granule (复方竹叶石膏颗粒) on Acute Radiation-Induced Esophagitis in Cancer Patients: A Randomized Controlled Trial

Objective: To observe the efficacy and safety of the Chinese medicine(CM) Compound Zhuye Shigao Granule(复方竹叶石膏颗粒, CZSG) on acute radiation-induced esophagitis(ARIE) in cancer patients. Methods: In a blinded, randomized, Kangfuxin Solution(康复新液, KFX)-controlled, single-centre clinical trial, 120 patients with lung, esophagus or mediastinal cancer were prospectively enrolled and assigned to the treatment group(60 cases) and control group(60 cases) by the random number table method. All patients received concurrent or sequential radiotherapy(2 Gy per day, 5 times per week, for 4 weeks) and were treated for 4 weeks since the radiation therapy. Patients in the treatment group were given 12 mg CZSG orally, thrice daily, while patients in the control group were given 10 m L KFX orally, thrice daily. The major indicators were observed, including the incidence and grade of esophagitis, time of occurrence and duration. Minor indicators were changes of CM symptoms, weight and Karnofsky Performance Status(KPS) Scale during 4 weeks from the beginning, recorded once a week. Blood routine examination and hepatorenal function were detected at the 2nd and 4th weeks. Results: The incidence and grade of ARIE were significantly decreased in the treatment group compared with the control group(P0.05). CZSG appeared to significantly delay the time of ARIE occurrence and reduce the duration compared with KFX(P0.05). The scores of CM symptoms, KPS and weight were improved significantly in the treatment group compared with the control group(P0.05). There were no blood routine and hepatorenal function abnormal or obvious side-effects in both groups. Hemoglobin was improved and neutrophil and interleukin 6 were decreased in both groups after 4-week treatment compared with before treatment(P0.05), and there was no significant difference between the two groups(P0.05). Conclusions: CZSG can decrease the incidence and grade of ARIE, delay the time of occurrence, reduce duration and alleviate the damage of ARIE. It is safe and effective in the prevention and cure of ARIE.     

Clinical Observation on Influence of Chinese Medicines for Promoting Blood Circulation to Remove Blood Stasis on FIB and DD in Plasma of Patients with Cerebral Thrombosis

to study the influence of Chinese medicines for promoting blood circulation to removeblood stasis on fibrinogen(FIB)and D-dimer(DD)in plasma of patients with cerebral thrombosis.Method:73 inpatients with acute cerebral thrombosis were randomly divided into a control group of34 cases and a treatment group of 39 cases.The content of FIB and DD in plasma was detectedbefore treatment and on the 7th and 14th days after treatment.Result:FIB content in plasma aftertreatment was lower than that before treatment in the control group(P<0.01)and more remarkablein the treatment group(P<0.001).There was an obvious difference in DD content before and aftertreatment in both groups.DD content on the 7th and 14th days after treatment in the treatmentgroup was obviously higher than that in the control group(P<0.01 and P<0.05 respectively).Conclusion:Chinese medicines for promoting blood circulation to remove blood stasis can reducethe FIB content in plasma of patients with cerebral thrombosis,raise the DD content in plasma,cause the peak of DD content appear earlier and obviously improve hypercoagulability of blood inpatients with cerebral thrombosis.