Clinical study on the treatment of premature ejaculation by Uighur medicine Gu-jing-mai-si-ha Tablet (固精麦斯哈片)

Objective:To observe the effect of Uighur medicine Gu-jing-mai-si-ha Tablet (固精麦斯哈片,GJMSHT) for treatment of premature ejaculation (PE) and to explore part of its mechanism. Methods:The condition of patients was scored by related questionnaire,and the intravaginal ejaculation latency time (IELT) was observed before and after GJMSHT treatment,with the blood levels of nitric oxide (NO) and prostaglandin F_(2α)(PGF_(2α)) detected in PE patients as well.The results were compared with those in the control group.Results:After treatment,the scores of PE and IELT,as well as the levels of NO and PGF_(2α) all increased significantly compared to those before treatment in the treated group (P<0.01),while in the control group,all the parameters were insignificantly changed (P>0.05). Therefore,the difference of these parameters between the two groups after treatment all showed statistical significance (P<0.01).Conclusion:GJMSHT could treat PE effectively,its mechanism is possibly by strengthening the coordination of the related smooth muscles through increasing the blood levels of NO and PGF(2α),and the endurance of patients to the cavitary effect of prostatico-urethral pressure,thus postponing the arrival of urgent ejaculatory feeling.     

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.     

Short-term Effect of Combined Therapy with Jinlong Capsule(金龙胶囊)and Transcatheter Arterial Chemoembolization on Patients with Primary Hepatic Carcinoma and Its Influence on Serum Osteopontin Expression

<正>Objective:To observe the clinical combination effect of Jinlong Capsule(金龙胶囊,JLC) and transcatheter arterial chemoembolization(TACE) on the patients with primary hepatic carcinoma(PHC) and JLC's influence on serum osteopontin(OPN) expression and elucidate the correlation between the serum OPN level and curative effect of JLC and TACE.Methods:A total of 98 patients with PHC were observed in a randomized controlled trial(RCT).They were assigned to the Chinese medicine(CM) group(53 patients who were treated with TACE and JLC) and the intervention group(45 patients who were treated with TACE only).The serum OPN levels were measured before and after treatment by quantitative sandwich enzyme-linked immunosorbent assay(ELISA).Forty healthy people were assigned to the control group.The clinical efficacy was observed and Karnofsky score(KPS) was graded.Results:The clinical efficacy of the CM group(60.38%) was better than that of the intervention group(40.00%),and the KPS(84.35±12.19) was higher than the intervention group(69.86±11.58)(P0.05).The serum OPN levels before and after treatment in the patients with PHC were significantly elevated compared with those in the control group(P0.01).After treatment,the OPN levels in CM group(117.69±78.50) were significantly lower compared with those in intervention group(151.09±83.90,P0.05).The OPN levels of responders were remarkably lowered than the non-responders after treatment,and the level of OPN in the CM group was lower than the intervention group(P0.05).Conclusions:The short-term clinical efficacy and the quality of life of patients with PHC can be improved by combining JLC with TACE.The serum OPN levels in PHC patients can reflect the curative effect of treatment and the prognosis of the disease.     

Treatment of Non-alcoholic Fatty Liver Disease by Qianggan Capsule(强肝胶囊)

<正>Objective:To observe the therapeutic effect and safety of Qianggan Capsule(强肝胶囊,QGC) in treating non-alcoholic fatty liver disease(NAFLD),using polyene phosphatidylcholine capsule(PPC) as a reference.Methods:Eighty-eight patients with NAFLD were randomly assigned to two groups,45 in the treatment group treated with QGC and 43 in the control group treated with PPC.The course of treatment lasted for 6 months.Changes in liver function,blood lipids,and iconographic indexes before and after treatment were observed,and clinical efficacy was evaluated.Results:In the treatment group,alanine aminotransferase(ALT) was lowered significantly from 56.02±32.59 IU/L before treatment to 38.27±22.68 IU/L after treatment,and CT liver/spleen ratio significantly increased from 0.69±0.18 to 0.91±0.25,showing statistical significance(P0.05);in contrast,the corresponding changes of the two indexes in the control group were 56.56±26.33 IU/L to 49.67±26.22 IU/L, and 0.66±0.20 to 0.75±0.24,respectively,the pre-post treatment difference showing insignificant difference(P0.05). No severe adverse reactions occurred during the whole treatment course.Conclusion:QGC is an effective and safe remedy for the treatment of NAFLD.     

Effect of Gan-Pi regulatory needling in treating chloasma

<正>Objective:To study the effect of Gan(肝)-Pi(脾) regulatory needling(GPRN) in treating chloasma and its influences on female sex hormones,superoxide dismutase(SOD),lipid peroxide(LPO) and melanocyte-stimulating hormone(MSH).Methods:Ninety chloasma patients were equally randomized to three groups,the treatment group treated with GPRN,the control group treated with conventional Westem medicine and the blank group untreated. Changes in the scores of skin lesion(area and color) and symptom,as well as blood levels of female sex hormones, MSH,SOD and LPO were observed and compared after 3 months of treatment.Results:In the treatment group,the scores of skin lesion area and color were reduced from 2.76±0.96 and 2.48±0.78 before treatment to 1.42±0.42 and 1.03±0.41 after treatment,respectively,while in the control group they were from 2.78±1.06 and 2.53±0.88 to 1.58±1.23 and 1.28±0.96,respectively,all showing significant changes(P0.05);the scores were insignificantly changed in the blank group(P0.05).At the same time,the score of symptoms in the treatment group significantly improved after treatment(P0.05),significantly different from that of the other two groups.Comparison of female sex hormones among groups showed no significant differences either before or after treatment.The level of LPO decreased and SOD increased in both the treatment group and the control group significantly(all P0.05),but significant lowering of MSH was only seen in the treatment group(P0.05).Conclusions:GPRN can effectively lessen the size and lighten the color of chloasma,improve the accompanying symptoms in patients and decrease LPO and MSH levels and increase the SOD level,but will not affect the level of the female sex hormones.     

Relation of Blood Arsenic Concentration with Effect and Safety of Arsenic-Containing Qinghuang Powder (青黄散) in Patients with Myelodysplastic Syndrome

Objective: To investigate the relation of blood arsenic concentration(BAC) with clinical effect and safety of arsenic-containing Qinghuang Powder(青黄散, QHP) in patients with myelodysplastic syndrome(MDS). Methods: Totally 163 patients with MDS were orally treated with QHP for 2 courses of treatment, 3 months as 1 course. The BACs of patients were detected by atomic fluorescence spectrophotometry at 1, 3, and 6 months during the treatment, and the effective rate, hematological improvement and safety in patients after treatment with QHP were analyzed. Results: After 2 courses of treatment, the total effective rate was 89.6%(146/163), with 31.3%(51/163) of hematological improvement and 58.3%(95/163) of stable disease. The hemoglobin increased from 73.48±19.30 g/L to 80.39±26.56 g/L(P0.05), the absolute neutrophil count increased from 0.81±0.48×10~9/L to 1.08±0.62×10~9/L(P0.05), and no significant changes were observed in platelet counts(P0.05). Among 46 patients previously depended on blood transfusion, 28.3%(13/46) completely got rid of blood transfusion and 21.7%(10/46) reduced the volume of blood transfusion by more than 50% after treatment. The BACs were significantly increased in patients treated for 1 month with 32.17±18.04 μg/L(P0.05), 3 months with 33.56±15.28 μg/L(P0.05), and 6 months with 36.78±11.92 μg/L(P0.05), respectively, as compared with those before treatment(4.08±2.11 μg/L). There were no significant differences of BACs among the patients treated for 1, 3 and 6 months(P0.05). The adverse reactions of digestive tract during the treatment were mild abdominal pain and diarrhea in 14 cases(8.6%), and no patients discontinued the treatment. The BACs of patients with gastrointestinal adverse reactions were significantly lower than those without gastrointestinal adverse reactions(22.39±10.38 vs. 37.89±11.84, μg/L, P0.05). The BACs of patients with clinical effect were significantly higher than those failed to treatment(40.41±11.69 vs. 23.84±12.03, μg/L, P0.05). Conclusion: QHP was effective and safe in the treatment of patients with MDS and the effect was associated with BACs of patients.     

Effect of Shenmai Injection(参麦注射液)on Ventricular Diastolic Function in Patients with Chronic Heart Failure:An Assessment by Tissue Doppler Imaging

<正>Objective:To assess the effect of Shenmai Injection(参麦注射液,SMI) on left ventricular diastolic function(LVDF) in patients with chronic heart failure(CHF) by tissue Doppler imaging(TDI).Methods:Sixty-four CHF patients were randomly assigned to two groups,the observation group and the control group.Basic treatment including polarized liquid therapy was given to all the patients.In addition,SMI was given to patients of the observation group.The treatment duration was 14 days.TDI was performed in all the patients 3 days prior to the initiation of the treatment and one week after the medication to measure the average movement velocity of the mitral ring of the left ventricle at the early systolic stage and late diastolic stage(Ea and Aa);the outcomes were compared with the corresponding parameters obtained from blood flow Doppler echocardiography, namely,the velocity of the E-wave(E) and A-wave(A).Results:After treatment,Ea and Ea/Aa increased and Aa decreased significantly in the observation group(P0.05).In the control group,although some improvement was seen,there was no statistically significant change(P0.05).No statistical significance was shown between groups in these parameters after treatment.Conclusion:TDI assessment shows that SMI could effectively improve the LVDF in CHF patients.     

Effect of Yiqi Yangyin Decoction(益气养阴方) on the Quality of Life of Patients with Unstable Angina Pectoris

<正>Objective:To observe the effect of Yiqi Yangyin Decoction(益气养阴方,YQYYD) on the quality of life(QOL) of patients with unstable angina pectoris(UAP).Methods:A total of 108 patients with UAP of qi-yin deficiency syndrome confirmed by coronary angiography were enrolled and assigned to the treated group(treated with YQYYD and conventional therapy of Western medicine) and the control group(treated with conventional therapy of Western medicine),by the use of the PROC PLAN of the SAS 6.12 software,in a prospective, randomized,controlled design.The clinical total effective rate,symptom score,QOL scale[Seattle Angina Questionnaire(SAQ)]and incidence of important clinical events were defined as the observation indices to evaluate the interventional effect of YQYYD on the QOL of patients with UAP of the qi-yin deficiency syndrome. Results:During the study,three cases dropped out in the treated group,one case dropped out in the control group,and 104 cases,including 51 cases in the treatment group and 53 cases in the control group,finished the trial.After four weeks of treatment,the total clinical effective rates in the treated group and the control group were 80.4%and 75.5%respectively,and there was no obvious difference between them(P0.05).However,the symptom score of the treated group(9.31±2.02) was significantly lesser than that of the control group(11.62±3.04,P0.05),and the total score of the QOL scale of the treated group(68.76±5.74) was significantly higher than that of the control group(61.06±3.31,P0.01).Among those in the treated group physical limitation, angina stability,angina frequency,and treatment satisfaction were significantly ameliorated when compared with the control group after treatment(P0.05,P0.01).The incidence of important clinical events in the treated group(3.9%) was lower than that in the control group(5.7%) during the 8-month follow-up period,but the difference was insignificant(P0.05).Conclusion:YQYYD could improve the clinical symptoms of patients with UAP of qi-yin deficiency syndrome and greatly improve their QOL.     

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 Ling Gui Zhu Gan Tang Mixture in 50 Psychotic Patients with Obesity Induced by the Psychoactive Drugs

In order to observe the therapeutic effects of Ling Gui Zhu Gan Tang Mixture (芩桂术甘汤) on obesity induced by psychoactive drugs, 100 psychotics with obesity induced by psychoactive drugs were randomly divided into a treatment group (50 cases)and a control group (50 cases) for a 8-week treatment.The changes were determined by means of the Brief Psychiatric Rating Scale (BPRS) and the Treatment Emergent Symptom Scale (TESS) with the body weight recorded before and after treatment. The results showed that the total effective rate was 72% in the treatment group, and 14% in the control group,with the former obviously superior to the latter (P＜0.01). The BPRS scores were 33.02t7.34 in the treatment group and 32.39± 3.51 in the control group before treatment; and 20.38±5.10 in the treatment group and 20.82± 1.75 in the control group after treatment. The BPRS scores were obviously reduced after treatment in the two groups (both P＜0.01), but with no significant difference between the two groups (P＞0.05). This indicates that the Ling Gui Zhu Gan Tang Mixture does not influence the curative effect of the psychoactive drugs while showing the body weight-reducing effect. Therefore, the Ling Gui Zhu Gan Tang Mixture can be used for those psychotic patients with obesity induced by the psychoactive drugs (the incidence is 10-25%) in their continuous course of treatment with the latter drugs.     

One Hundred and Seven Middle-Aged and Senile Cases of Coronary Heart Disease with Ventricular Premature Beat Treated by Qing Xin An Shen Fang

The therapeutic principle of clearing away the heart-heat to induce tranquilization was adopted in107 middle-aged and senile patients with ventricular premature beat of coronary heart disease on thebasis of pathogenic features of phlegm,heat,blood stasis and deficiency in this condition.Qing XinAn Shen Fang(清心安神方 a formula for clearing away the heart-heat to induce tranquilization)wasused in the treatment group and compared with mexiletine and Fu Fang Dan Shen Tablets(复方丹参片 Compound Salvia Tablets)used in the control group.The results turned to be that the markedlyeffective rate was 85.1% and the total effective rate 96.3% in the treated group,better than that inthe control group,with the former having a good antihypertensive and antihyperlipemic effect and aneffect of improving microcirculation and clinical symptoms.     

Clinical Study on the Treatment of Knee Osteoarthritis of Shen(肾)-Sui(髓) Insufficiency Syndrome Type by Electroacupuncture

<正>Objective:To study the clinical efficacy of electroacupuncture(EA)on treating knee osteoarthritis (KOA)of Shen(肾)-Sui(髓)insufficiency(SSI)syndrome type.Methods:A total of 245 patients(279 knees)of KOA-SSI were randomly assigned to two groups by lottery:141 knees in the treatment group and 138 knees in the control group.The treatment group was managed with EA at the dominant points of Neixiyan(Ex-LE4) and Waixiyan(Ex-LE5)as well as the conjugate points of Xuanzhong(GB39)and Taixi(KI3)for 30 min,once a day,with 15 days as one course;2 courses were applied with a 5-day interval in between.The control group was treated with intra-articular injection of 2 mL hyaluronic acid into the affected joint every 7 days for 5 times in total.The clinical effects on the patients in different stages were observed,and their symptom scores of knee and contents of cytokines,including interleukin-1(IL-1),interleukin-6(IL-6),tumor necrosis factor-α(TNF-α), prostaglandin E_(2α)(PGE_(2α)and matrix metalloproteinases-3(MMP-3),in the knee joint fluid were measured before and after treatment.Results:The study was completed in 235 patients(263 knees);four patients(7 knees) in the treatment group and six patients(9 knees)in the control group dropped out.Comparison of therapeutic effects(excellent and effective rates)between the two groups showed insignificant differences(P0.05). Symptom scores of knee and contents of cytokines in the knee fluid after treatment were lowered significantly in the patients of stageⅠ-Ⅲin both groups(P0.05 or P0.01).However,the lowering of the total symptom score of knee in the patients of stageⅢin the treatment group was more significant(P0.05).Conclusions:EA could effectively alleviate the clinical symptoms in KOA patients of stage 1,showing an effect superior to that of hyaluronic acid.EA also shows action in suppressing the secretion of IL-1,IL-6,TNF-α,PGE_(2α)and MMP-3 in the knee fluid.     

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.     

Effectiveness and Safety Evaluation of Qixiong Zhongzi Decoction (芪芎种子汤) in Idiopathic Asthenozoospermia Treatment: A Randomized Controlled Trial

Objective: To evaluate the clinical effectiveness and safety of the Chinese medicine(CM) Qixiong Zhongzi Decoction(芪芎种子汤, QZD) in the treatment of patients with idiopathic asthenozoospermia. Methods: A total number of 66 patients with idiopathic asthenozoospermia were included and randomly divided into treatment and control groups by SAS-generated code from January 2015 to August 2016, 33 patients in each group. Patients in the treatment group were administered with 150 m L of QZD twice a day, whereas those in the control group were given 1 g of levocarnitine oral liquid twice a day. The two groups received the indicated medication for 12 weeks and were then followed up for 4 weeks. The primary outcome was sperm motility, and the secondary therapeutic indices were sperm volume, density, pregnancy probability, and CM syndrome score. The comparison between groups was carried out at 4, 8 and 12 weeks, respectively. The safety was determined before and after treatment. Results:(1) Drop-off: 5 cases(7.58%) were lost after treatment(2 from the treatment group and 3 from the control group).(2) Primary outcomes: after 8-and 12-week treatment, the progressive sperms in the two groups were significantly higher than the baseline(all P0.05); however, the treatment group showed greater improvement compared with the control group at 12-week treatment(22.7%±9.0% vs. 14.1%±8.8%, P0.05). The increasement of non-progressive grade sperms at both groups was observed at 8-and 12-week treatment with statistical difference(all P0.05), however, the treatment group showed remarkable improvement compared with the control group at 12-week treatment(38.7%±14.1% vs. 26.2%±15.4%, P0.05).(3) Secondary outcomes: no significant statistical differences were found in semen volume and density(4, 8, and 12-week treatment) and pregnancy probability of patients' wives(12-week treatment) between two groups(all P0.05), however, the CM syndrome score of the treatment group significantly declined compared with baseline level at each time points(all P0.05).(4) Safety: no obvious side reactions were found during the treatment in both groups. Conclusions: QZD could improve the progressive and non-progressive grade sperm in the treatment of idiopathic asthenozoospermia. It is safe with no obvious side effects.     

Effect of Feitai Capsule(肺泰胶囊) on Quality of Life and Progression-Free Survival of Patients with Unresectable Non-Small Cell Lung Cancer

<正>Objective:To examine the effect of a Chinese medicinal herbal formula(Feitai Capsule,肺泰胶囊) on the quality of life(QOL) and progression-free survival(PFS) of patients with unresectable non-small cell lung cancer(NSCLC).Methods:Sixty-two patients were randomly divided into the treatment group(31 cases) and the control group(31 cases).For the treatment group,4 capsules(1.2 g/capsule) of Feitai Capsule were administered 3 times a day after meals for 3 weeks;then no drug was administered for 1 week.This schedule was continued for at least 3 more cycles(12 weeks totally).If there were no obvious toxic reactions,the treatment was extended.The patients were evaluated at least once every 8 weeks until progressive disease(PD). For the control group,the regular follow-up and evaluation were performed at least once every 8 weeks until PD.Clinical symptoms,objective response,physical constitution and energy,QOL,and PFS were evaluated regularly.Analysis of variance(ANOVA),a non-parametric test,and analysis of covariance were used to compare clinical features,amelioration of clinical symptoms,physical constitution and energy,and QOL.Kaplan-Meier analysis was used to compare the two-group PFS.Results:Sixty patients finished the final evaluation, with 30 patients in each group.Baseline characters between groups were not significantly different(P0.05). The control group had a 36.7%improvement in clinical symptoms,while the treatment group had a 73.3% improvement.This difference was statistically significant(Z=-2.632,P=0.008).The control group had a 26.7% improvement in the Karnofsky performance status(KPS),while the treatment group had a 53.4%improvement. This was also significantly different(Z=-2.182,P=0.029).A comparative analysis indicated a positive correlation (r=0.917,P0.001).Compared with the control group,QOL in the treatment group was significantly improved, except in the social/family condition and doctor-patient relationship indicators.The PFS of the treatment group and control group were 6.23 months and 4.67 months,respectively(P=0.048).Conclusion:Feitai Capsule,a Chinese medicinal herbal treatment could improve the QOL and extend the PFS of the unresectable NSCLC patients.     

Efficacy and Safety of Quxie Capsule (祛邪胶囊) in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial

Objective:To verify the efficacy and safety of Quxie Capsule(祛邪胶囊) in patients with metastatic colorectal cancer(mC RC).Methods:The present study was a randomized,double-blind,placebo-controlled trial.Sixty patients with mC RC were randomized into two groups at a 1:1 ratio by sealed envelope.The treatment group received conventional therapy combined with Quxie Capsule for 3 months.The control group was treated with conventional therapy combined with placebo for 3 months.Main outcome measures were overall survival(OS) and progression-free survival(PFS).Subgroup analysis was performed according to age,right or left-sided disease,and second-line therapy to determine the differences in PFS and OS between the two groups.Patients were followed up every 3 months until Dec 31 st 2016.Results:The median OS was 23 months in the treatment group [95% confidence interval(CI):15–not calculated] vs.14 months in the control group(95% CI:11–22,P=0.060).The OS of the treatment group tended to be longer than that of the control group(P0.05).In the subgroups of patients 65 years old,left-sided colon,and 2 nd-line therapy,the treatment group showed a significant survival benefit compared with the control group(P=0.006,0.038,0.013,respectively).There were no significant differences between the two groups in PFS(P0.05).Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group.Conclusions:Quxie Capsule showed good safety and efficacy,and could prolong the OS of patients with mC RC.     

Clinical Study on Kangquan Recipe (康泉方) for Benign Prostatic Hyperplasia Patients: A Randomized Controlled Trial

Objective：To observe the effectiveness and safety of Kangquan Recipe（康泉方,KQR） for benign prostatic hyperplasia（BPH） patients.Methods：One hundred and six BPH patients were randomly assigned to the treatment group（53 cases） and the control group（53 cases） according to a random number table.The treatment group was given KQR orally;the control group was given cemilton orally.After 24-week treatment,the clinical effect and safety were evaluated using the International Prostatic Symptom Score（l-PSS）,quality of life（QOL）,maximum flow rate（Qmax）,average flow rate（Qave）,residual urine volume（RUV）,total prostatic volume（TPV）,etc.Results：After treatment,the score of l-PSS was decreased from 16.9 ±5.6 to 12.5 ±4.6in the treatment group,significantly lower compared with the control group;the levels of Qmax and Qave were from 10.9 ±3.5 to 15.6 ±4.5 and 5.4 ±2.1 to 7.3 ±2.5（mL/s） in the treatment group,significantly higher compared with the control group;the levels of RUV and TPV were from 70.8 ±28.2 to 35.2 ±21.8 and37.2 ± 16.9 to 30.1 ± 10.8（mL） in the treatment group,significantly lower compared with the control group（all P〈0.05）.The incidence rate of adverse reaction was similar between the two groups（P〉0.05）.Conclusion：KQR is effective and safe for the treatment of BPH.     

Clinical evaluation of Soothing Gan (肝) and invigorating Pi (脾) acupuncture treatment on diarrhea-predominant irritable bowel syndrome

Objective:To explore the effect of Soothing Gan(肝) and invigorating Pi(脾)(SGIP) acupuncture treatment on the clinical symptoms and quality of life(QOL) in patients with diarrhea-predominant irritable bowel syndrome(IBS-D).Methods:With a single-blinded randomized control study adopted,63 patients who met the inclusion criteria were assigned by a random number table to two groups,31 in the treatment group and 32 in the drug control group.The treatment group received SGIP acupuncture therapy; while the control group was treated orally with pinaverium bromide.The treatment duration of both groups was 28 days.The clinical efficacy was evaluated and compared by scoring patient’s symptom and QOL.Results: A significant difference was found by variance analysis in efficacies between the two groups(P<0.01),shown as the quicker initiation of effect(P<0.05) and the more evident clinical improvement in symptoms along the increase in treatment duration,as well as the more significant elevation of QOL in the acupuncture treatment group(P<0.01).SGIP displayed its superiority especially in improving dysphoria,conflict behavior,dietary restrictions,and social responses.Conclusion:SGIP acupuncture treatment could effectively alleviate the degree and frequency of symptoms’ attack in IBS-D patients,such as abdominal pain,diarrhea,abdominal distension,etc.,markedly relieve the tenesmic sensation,with the efficacy better than that of pinaverium bromide,showing a preponderance in improving patient’s QOL.     

Clinical Observation on the Treatment of Atrial Fibrillation with Amiodarone Combined with Shenmai Injection (参麦注射液)

Objective: To observe the therapeutic efficacy and safety of amiodarone combined with Shenmai Injection (参麦注射液) on atrial fibrillation. Methods: A total of 351 patients with atrial fibrillation caused by cardiovascular diseases and idiopathic atrial fibrillation were assigned to amiodarone group (control group, 128 cases) and amiodarone combined with Shenmai Injection group (treatment group, 223 cases). The patients in the control group received intravenous injection of 150 mg amiodarone in 10 min, followed by intravenous drip infusion at 1 mg /min and 6 h later at 0.5 mg /min until 48 h or cardioversion. The patients in the treatment group received the same treatment of amiodarone, while in addition, they received an injection of Shenmai Injection of 100 mL simultaneously. Blood pressure, ventricular rate, and cardioversion were observed. Results: The total efficiency rate was 98% (control group) and 99% (treatment group) (P0.05). The mean ventricular rate decreased 23% and 31% in the control group and the treatment group, respectively (P0.05). The mean cardioversion time of the two groups was 570±211 min and 351±123 min, respectively (P0.05). Only mild side effects were observed in both groups. Conclusion: Compared with amiodarone, amiodarone combined with Shenmai Injection takes effect more quickly with low side effects on the treatment of atrial fibrillation.