Efficacy of Getong Tongluo Capsule(葛酮通络胶嚢)for Convalescent-Phase of Ischemic Stroke and Primary Hypertension:A Multicenter,Randomized,Double-Blind,Controlled Trial

Objective:To evaluate whether the efficacy of Getong Tongluo Capsule(葛酮通络胶囊,GTC,consisted of total flavone of Radix Puerariae)on improving patients'quality of life and lowering blood pressure are superior to the extract of Ginkgo biloba(EGB)for patients with convalescent-phase ischemic stroke and primary hypertension.Methods:This randomized,positive-drug-and placebo-controlled,double-blind trial was conducted from September 2015 to October 2017.Totally 477 eligible patients from 18 hospitals in China were randomly assigned in a 2:1:1 ratio to the following interventions,twice a day for 12 weeks:(1)GTC 250 mg plus EGB-matching placebo 40 mg(237 cases,GTC group),(2)EGB 40 mg plus GTC-matching placebo 250 mg(120 cases,EGB group)or(3)GTC-matching placebo 250 mg plus EGB-matching placebo 40 mg(120 cases,placebo group).Moreover,all patients were orally administered aspirin enteric-coated tablets 100 mg,once a day fo r 12 weeks.The primary outcome was the Barthel Index(Bl).The secondary outcomes included the control rate of blood pressure and National Institutes of Health Stroke Scale(NIHSS)scores.The incidence and severity of adverse events(AEs)were calculated and assessed.Results:The Bl relative independence rates,the clinical recovery rates of NIHSS,and the total effective rates of NIHSS in the GTC and EGB groups were significantly higher than the placebo group at 12 weeks after treatment(P<0.05),and no statistical significance was found between the GTC and EGB groups(P>0.05).The control rate of blood pressure in the GTC group was significantly higher than the EGB and placebo groups at 12,18 and 24 weeks after treatment(P<0.01).There were no statistically significant differences in the incidences of AEs,adverse drug reactions,or serious AEs among the 3 groups(P>0.05).Conclusion:GTC exhibited significant efficacy in improving patients'quality of life as well as neurological function and controlling hypertension.     

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.     

Study on Effect of Zhixinkang Capsule （脂欣康胶囊）in Treating Unstable Effort Angina and Hyperlipidemia and Its Function in Vascular Endothelium Protection

Objective:To observe the clinical effect and protection of vascular endothelium of Zhixin-kang Capsule (ZXKC) in middle-aged and old people with unstable effort angina and hyperlipidemia. Methods: Sixty-five patients with unstable effort angina were randomly divided into ZXKC group (34 cases) and control group (31 cases). Conventional western medical therapy was given to both groups, with ZXKC group receiving additional ZXKC treatment. Data of 20 healthy persons were taken as normal group. Forty-eight patients with hyperlipidemia were divided into ZXKC group treated with ZXKC (31 cases) and control group treated with Yixintong (17 cases). The changes of clinical symptoms and laboratory indexes in all the patients were observed before and after treatment. Results: In patients with unstable effort angina, the efficacy of treatment of ZXKC, the withdrawal rate of nitroglycerin, the relieving of symptoms, the improvement of the electrocardiogram, the counts of circulating endothelial cells, the content of p     

Effect of Shenzhu Guanxin Recipe (参术冠心方)on Patients with Angina Pectoris after Percutaneous Coronary Intervention:A Prospective,Randomized Controlled Trial

Objective:To evaluate the efficacy and safety of a combination therapy using Chinese medicine(CM) Shenzhu Guanxin Recipe(参术冠心方 SGR) and standard Western medicine treatment(SWMT) in patients with angina pectoris after percutaneous coronary intervention(PCI).Methods:Double-blind randomized controlled trial was used in this experimental procedure.One hundred and eighty-seven patients with coronary heart disease receiving SWMT after PCI were randomly assigned to the treatment(SGR) and control(placebo) groups.Outcome measures including angina pectoris score(APS),CM symptom score,and Seattle Angina Questionnaire(SAQ)score were evaluated in 1,2,3 and 12 months,and the death rate,restenosis and other emergency treatments were observed.The mixed-effects models were employed for the data analysis.Results:In the treatment group,a larger within-treatment effect size(d=1.74) was found,with a 76.7%reduction in APS from pretreatment to12-month follow-up assessment compared with the control group(d=0.83,53.8%symptom reduction);betweentreatment(BT) effect size was d=0.66.CM symptom scores included an 18.3%reduction in the treatment group(d=0.46),and a 16.1%decrease in the control group(d=0.31);d=0.62 for BT effect size.In regard to scores of SAQ,the BT effect size of cognition level of disease was larger in the treatment group(d=0.63),followed by the level of body limitation of activity(d=0.62),condition of angina pectoris attacks(d=0.55),satisfaction level of treatments(d=0.31),and steady state of angina pectoris(d=0.30).Two cardiovascular related deaths and one incidental death were recorded in the control and treatment groups,respectively.No significant difference in any cardiovascular event(including death toll,frequency of cardiovascular hospitalization or emergency room visits)was found between the two groups.Conclusion:The combination therapy of SGR and SWMT is effective and safe in patients with angina pectoris after PCI when compared with SWMT alone.     

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).     

Influence of Shengmai Capsule (生脉胶囊) on recovery of living capacity in patients after myocardial infarction

ABSTRACT Objective： To observe the effect of long-term application of Shengmai Capsule （生脉胶囊, SMC） on recovery of patients after myocardial infarction. Methods： A total of 120 myocardial infarction patients were assigned into two groups. Changes of angina pectoris, electrocardiogram （ECG）, living capacity and heart function in patients were observed after 6-month treatment. Results： The total effective rate in alleviating angina pectods was 90.0% and that in improving ECG figure was 93.3% in the treatment group, both were significantly higher than those in the control group, 73.4% and 70.0% respectively （P〈0.05）. The Karnofsky Performance Status scores of heart function were increased and the Activity of Daily Living scores in living capacity decreased in both groups, but the improvements were better in the treatment group （P〈0.01 and P〈0.05）. The parameters of cardiac function, including cardiac output, stroke volume, cardiac index and ejection fraction, were increased in both groups, but the increments in the treatment group were more significant （P〈0.01 or P〈0.05）. Conclusion： Long-term application of SMC could effectively prevent and treat angina pectoris, improve the living capacity and accelerate the recovery of heart function in patients after myocardial infarction.     

The Short-term Therapeutic Effect of the Three-part Massotherapy for Insomnia Due to Deficiency of Both the Heart and the Spleen——A Report of 100 Cases

Objective: To evaluate the short-term therapeutic effect of the three-part massotherapy on insomnia due to deficiency of both the heart and spleen. Methods: Two hundred cases were randomly divided into a treatment group and a control group, each consisting of 100 cases. Patients in the treatment group were treated with the three-part massotherapy, while those in the control group with oral administration of Guipi Wan (归脾丸 Pill for Invigorating the Spleen and Nourishing the Heart). The total clinical therapeutic effects, the total scores of Pittsburgh Sleep Quality Index (PSQI), Self-rating Anxiety Scale (SAS), and Self-rating Depression Scale (SDS) of the treatment group were compared with those of the control group. Results: After the treatment, the total therapeutic effects, PSQI, SAS, and SDS of the two groups all showed significant improvement (P<0.01), and the scores of the treatment group were superior to those of the control group (P<0.01). Conclusion: The three-part massotherapy has definite therapeutic effects on insomnia due to deficiency of both the heart and the spleen, which is safe and easy to operate, and worthy of popularization.     

Effect and Safety of Guanxinning Tablet(冠心宁片) for Stable Angina Pectoris Patients with Xin(Heart)-Blood Stagnation Syndrome:A Randomized,Multicenter,Placebo-Controlled Trial

Objective: To investigate the effect and safety of Guanxinning Tablet(冠心宁片, GXN) for the treatment of stable angina pectoris patients with Xin(Heart)-blood stagnation syndrome(XBSS). Methods: One hundred and sixty stable angina pectoris patients with XBSS were randomly assigned to receive GXN(80 cases) or placebo(80 cases, Guanxinning simulation tablets, mainly composed of lactose), 4 tablets(0.38 g/tablet), thrice daily for 12 weeks. After treatment, an exercise stress test(treadmill protocol), Chinese medicine(CM) syndrome score, electrocardiogram(ECG), and nitroglycerin withdrawal rate were evaluated and compared in the patients between the two groups. Meanwhile, adverse events(AEs) were evaluated during the whole clinical trial. Results: Compared with the control group, the time extension of exercise duration in the GXN group increased 29.28±17.67 s after treatment(P0.05); moreover, the change of exercise duration in the GXN group increased 63.10±96.96 s in subgroup analysis(P0.05). The effective rates of angina pectoris, CM syndrome and ECG as well as nitroglycerin withdrawal rate were 81.33%, 90.67%, 45.76%, and 70.73%, respectively in the GXN group, which were all significantly higher than those in the control group(40.58%, 75.36%, 26.92%, 28.21%, respectively, P0.05). Conclusion: GXN was a safe and effective treatment for stable angina pectoris patients with XBSS at a dose of 4 tablets, thrice daily.     

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).     

Clinical Study on Preventing and Treating Left Ventricle Remodeling after Acute Myocardial Infarction with Integrative Chinese and Western Medicine

Objective: To explore the clinical efficacy of Xuefu Zhuyu (血府逐瘀, XFZY) oral liquid combined with western medicine (WM) in reversing left ventricle remodeling (LVR) after acute myocardial infarction (AMI) in patients and its therapeutic mechanism. Methods: Sixty patients conforming to criteria were divided into the treated group and WM control group with randomly stratified method. Thirty cases were assigned to each group, they were given XFZY WM general treatment and WM general treatment respectively. Color Doppler ultrasonography was used to study the changes of LVR before and after treatment.Results: In both groups, before and after treatment the P value of such parameters as the changes of their left diastolic volume (LDV), left systolic volume (LSV), left ventricle ejection fraction (EF) was ＜0. 05, suggesting that the difference of various parameters was significantly different; but when compared with the results of the 12th week after medications, the change of LDV, LSV, EF showed that the LDV, LSV of the treated group were lower than that of the control group, the EF of the treated group was higher than that of the control group, and the P value of various groups was all ＜0. 05, suggesting that the different data of various groups showed significant difference. Conclusion: Conventional WM treatment and XFZY combined with WM could both, in treating AMI, effectively reverse the patients′ LVR; yet the use of integrative Chinese and western medicine on reversing patients LVR showed even better results than that of simple WM treatment.     

Clinical Observation on Effect of Yangxue Qingnao Granule(养血清脑颗粒剂)in Treating Patients with Cerebral Arteriosclerosis

Objective:To observe the efficacy of Yangxue Qingnao granule (YXQNG,养血清脑颗粒剂) in treating cerebral arteriosclerosis and to explore its mechanisms. Methods: One hundred and sixty-seven patients with arteriosclerosis were randomly divided into the treated group treated with conventional medical treatment plus YXQNG and the control group treated with conventional medical treatment alone, to observe the changes before and after treatment in scores of chief symptoms, mean velocity of cerebral blood flow (VM), plasma nitric oxide (NO), calcitonin gene related peptide (CGRP) and endothelin (ET) levels. Results: (1)After treatment in the treated group, the scores of chief symptoms such as vertigo, headache and tinnitus were significantly lower than those in the control group (P<0. 05 or P<0. 01) ; (2) NO and CGRP level in the treated group after treatment obviously elevated, and ET and VM markedly reduced ( P < 0. 01), while no evident change of these parameters was found in the control group (P<0. 01). C     

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.     

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.     

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.     

Clinical Observation in 45 Cases of Hemorrhagic Apoplexy of the Acute Stage Treated by Promoting Blood Circulation and Removing Blood Stasis

To explore the therapeutic effects of the method of promoting blood circulation and removing blood stasison hemorrhagic apoplexy of acute stage,45 cases were treated by the method and observed for theirconscious state and motor function,which were compared with 40 cases treated with regular western drugs.The results showed that the effective rate in the treated group was 82.2% and that in control group 60% witha significant difference(P<0.05) between the two groups.In the treated group,the scores of the consciousstate and the motor function after treatment were elevated dramatically(P<0.01),indicating a much bettereffect in the treated group than in the control group.     

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 Xuezhikang Capsule(血脂康胶囊)on Serum Tumor Necrosis Factor-αand Interleukin-6 in Patients with Nonalcoholic Fatty Liver Disease and Hyperlipidemia

<正>Objective:To evaluate the effect of Xuezhikang Capsule(血脂康胶囊) on the serum levels of inflammatory factors such as tumor necrosis factor-α(TNF-α) and interleukin-6(IL-6) in patients with nonalcoholic fatty liver disease(NAFLD) and hyperlipidemia,and to explore whether it has anti-inflammatory effect.Methods:A total of 84 patients were randomly assigned to two groups with stratified block randomization, the treatment group(42 cases) and the control group(42 cases).They were treated with Xuezhikang Capsule and polyene phosphatidylcholine capsule for twenty-four weeks,respectively.The changes in serum TNF-αand IL-6 were measured by enzyme linked immunosorbent assay before treatment and at the 12th and 24th week. Results:Compared with those before treatment,the serum levels of TNF-αand IL-6 significantly decreased in both groups after treatment(P0.01).There was no significant change between the two groups for the treatments at different time points(P0.05) and between the two groups for treatments at the same time points (P0.05).Conclusion:Xuezhikang Capsule can inhibit the serum inflammatory factor in patients with NAFLD and hyperlipidemia.     

Effect of the principle of activating blood circulation to break stasis on GMP-140 and D2 dimer in patients with acute cerebral infarction

Objective:To explore the clinical efficacy of the principle of activating blood circulation to break stasis (ABCBS) and its influence on platelet membranous protein particle (GMP-140) and D2 dimer (Ddimer) before and after treatment. Methods: Eighty-eight patients with blood stasis syndrome (BSS) of acute cerebral infarction (ACI) were randomly divided into two groups, both of which were treated with conventional treatment, i.e. with western medicine (WM), with Salvia injection added through intravenously dripping.One of the two groups was used as the control and the other group as the treated group who had ABCBS herbs orally taken in addition. The duration of treatment course for both groups was 3 weeks. Results: There were changes in both groups over clinical symptoms, nerve function deficit scoring and GMP-140, D-dimer, but the treated group showed significantly better than that of the control group, (P＜0.05). Conclusion: ABCBS principle could serve as an important auxiliary treating method for BSS of ACI, as it can effectively alter the blood of ACI patients which was viscous, condense, coagulant and aggregating.     

Effect of Shengmal Powder(生脉散) on Symptoms and Markers of Inflammatory Damage of Patients with Acute Viral Myocarditis

Objective: To evaluate the efficacy of Sheng-mai Power (SMP) in treating acute viral myocarditis. Methods: 102 patients with acute viral myocarditis were randomized to SMS group (n = 52) and placebo control group (n = 50 ). Semiquantitative integral methods were taken to observe changes of clinical symptoms such as dyspnea, palpitation and chest pain after 4 weeks of treatment, simultaneously EKG, 24h Holter, concentration of serum cardiac troponin-I, cardiac troponin T and neutralizing antibody test to the Coxsackie B virus were determined. Results: Dyspnea improved much more obvious in SMP group than in the placebo     

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.