The Efficacy and Safety of a Patent Pending Combination of Ginger and Goldenrod Extracts on the Management of Cold Symptoms: A Randomized, Double-Blind Controlled Trial

Objective: In a randomized, double-blind, exploratory, active-controlled trial, the efficacy and safety of a patent-pending combination of Ginger and Goldenrod extracts (BDI-630) in alleviating cold symptoms in community-dwelling adults was compared to a combination of standardized amounts of Echinacea (EC) components. Methods: 44 healthy adults, experiencing new onset of cold symptoms were randomly assigned to receive either BDI-630 (900 mg) or EC (500 mg) twice daily for 10 days. The severity of cold symptoms and the quality of life was assessed by self-reporting of subjects using the Wisconsin Upper Respiratory Symptom Survey (WURSS-21? 2004). Results: The intent-to-treat population (ITT) consisted of 44 subjects (n = 22 for BDI-630;n = 22 for EC). The modified ITT (mITT) population consisted of 40 subjects, excluding four subjects with major protocol deviations related to inclusion/exclusion criteria and/or use of prohibited drugs from the efficacy analysis (n = 3 for BDI-630 and n = 1 for EC). Results indicated a sig-nificant difference between the two groups: the superiority of BDI-630 over EC was particularly noticeable between Day 1 and Day 7, as demonstrated by a 14-fold difference of the mean percentage of change of total score from baseline in the mITT population. Adverse events (AEs) following the intake of BDI-630 were mostly limited to mild gastrointestinal intolerance in less than 10% of the subjects. Conclusions: BDI-630 was shown to be more effective than EC in alleviating cold symptoms in the adult population, particularly during the first 7 days of treatment. BDI-630 was very well tolerated by all subjects.

Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis:study protocol of a multicenter randomized controlled trial

BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.

Efficacy and safety of Huzhang Granule,a compound Chinese herbal medicine,for acute gouty arthritis:A double-blind,randomized controlled trial

Background:Acute gouty arthritis(AGA)is an inflammatory joint disease with a high prevalence.Typical medical interventions,including nonsteroidal anti-inflammatory drugs,colchicine and glucocorticoids,can have serious adverse reactions.Huzhang Granule(HZG),a compound Chinese herbal medicine,has been used to treat AGA for more than 30 years with satisfactory effects and no significant adverse reactions.However,the efficacy and safety of HZG in AGA patients remains unknown.Objective:The present investigation was designed to examine the efficacy and safety profile of HZG in managing AGA patients.Design,setting,participants and interventions:The current study was conducted as a noninferiority,randomized controlled clinical trial on 180 eligible enrolled participants.Participants were randomly assigned into the HZG and etoricoxib groups.Treatments were administered for 5 d,during which the HZG group received HZG and placebo etoricoxib,while the etoricoxib group received etoricoxib and placebo HZG in the same ratio(1:1).Main outcome measures:The primary outcome was pain experienced by the patient in the gout-afflicted joint from days 2 to 5 of the treatment window.The pain level was measured via a visual analogue scale,ranging from 0 mm to 100 mm.The secondary outcomes comprised joint tenderness and swelling,reduction of inflammatory biomarkers,and the patient’s and investigator’s global evaluations of therapeutic response.Results:The mean reduction in pain was-51.22 mm(95%confidence interval[CI],[-53.42,-49.03]mm)for the HZG and-52.00 mm(95%CI,[-54.06,-49.94]mm)for the etoricoxib groups.The mean difference between the two groups was 0.78 mm(95%CI,[-2.25,3.81]mm).All additional efficacy endpoints,covering decreased inflammation and pain relief,yielded compelling proof of noninferiority.Patients in the HZG group exhibited a comparatively lower rate of adverse events compared to those in the etoricoxib group(4.44%vs 13.33%;P≤0.05).Conclusion:HZG and etoricoxib groups demonstrated similar levels of analgesic effectiveness.The safety and efficacy of HZG indicates that it can be used as a potential therapeutic option for treating AGA.

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-to moderate 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 (Aβ 42) were detected with enzyme linked immunosorbent assay kits. The scale assessments were conducted at baseline, the 3rd and 6th months of treatment, respectively. Biochemistry tests were conducted at baseline and the 6th 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 P<0.01). Both treatments remarkably reduced the serum levels of AchE and Aβ 42 (both P<0.05). The CM-SS total effective rate of HYF was significantly higher than donepezil [75.00%(21/28) vs. 54.17%(13/24), P<0.05]. No severe adverse events were observed in both groups. Conclusion: HYF is effective and safe for improving the cognitive function in mild to-moderate AD patients.[Trial registration: Chinese Clinical Trial Registry (Reg No. ChiCTR-IOR-17011746)].

Evaluation of the effect of acupuncture on hand pain,functional deficits and health-related quality of life in patients with rheumatoid arthritis--A study protocol for a multicenter,double-blind,randomized clinical trial

BACKGROUND： Rheumatoid arthritis（RA） is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not shown conclusive positive results. Acupuncture is regarded as a reflex therapy that has effects on the human autonomic nervous system. By establishing a traditional Chinese medicine（TCM） diagnosis first, the practitioner is able to choose acupoints according to the state of each individual patient.METHODS/DESIGN： We are interested if acupuncture, using a classical diagnostic procedure to allocate acupoints to the patient according to the Shang Han Lun theory, can be effective in relieving pain, improving hand function and increasing health-related quality of life in RA.The authors intend to harmonize TCM diagnosis according to clinical and genetic profiles. Patients with the TCM diagnosis of a so-called Turning Point syndrome will be followed up in a randomized, prospective, double-blind, placebo-controlled, multicenter and three-armed parallel-group study with a standardized treatment in order to optimize potential therapeutic effects of acupuncture on pain, strength and muscle function of patients with RA as well as the influence on inflammation and quality of life.DISCUSSION： The findings of this study will provide important clinical information about the feasibility and efficacy of acupuncture treatment for RA patients. In addition, it will explore the feasibility of further acupuncture research.TRIAL REGISTRATION NUMBER： Clinical Trials.gov Identifier NCT02553005.

Evaluation of the Potential Inhibitory Activity of A Combination of L.Acidophilus,L.Rhamnosus and L.Sporogenes on Helicobacter Pylori：A Randomized Double-Blind Placebo-Controlled Clinical Trial

Objective： To investigate whether three strains of probiotics, L. acidophilus, L. rhamnosus, and L. sporogenes, had significant inhibitive effects on Helicobacter pylori（H. pylori）. Methods： This is a 4-week, randomly assigned, parallel-group, doubled-blind, and placebo-controlled study. Fifty patients with a positive H. pylori infection urea breath test（△UBT） result 〉 10% and without ulcer symptoms were randomized into a treatment group and a placebo group by a computer generated allocation sheet with 1：1. These subjects took one capsule of probiotics or placebo twice daily. The primary measurement was the change in △UBT values. Results： The △UBT values during the 4-week treatment period and the 2-week follow-up period were not significantly different between the treatment group and the placebo group, indicating that the inhibitive effects on H. pylori were comparable between both groups. The monocyte count（%） was 5.77±1.11 in the treatment group versus 5.09±1.12 in the placebo group（P=0.044）, and the basophile count was 0.55±0.32 in the treatment group versus 0.36±0.23 in the placebo group（P=0.024） at week 2 of the treatment period, both of which reached statistical significance. The monocyte count was 5.75±1.26 in the treatment group and 4.72±0.99 in the placebo group at the end of the follow-up period（P=0.003）. Conclusions： There was no significant inhibitive effects of the three probiotic strains（L. acidophilus, L. rhamnosus, and L. sporogenes） on H. pylori. Probiotics can not play the same role as antibiotics in the eradication of H. pylori, the role of probiotics is likely to be important as adjuvant to the triple or quadruple therapy for H. pylori, especially in resistance cases.

Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels： a double-blind placebo-controlled randomized clinical trial

Background： Lipid-lowering effect ofRhus coriaria L. （Rhus） has been investigated in multiple animal stud- ies with promising results. Nonetheless, its clinical efficacy has not been adequately examined. Objective： The aim of this study was to evaluate the lipid-lowering effects of Rhus among patients with hyperlipidemia. Design, setting, participants and interventions： The study was designed as a two-arm, double-blind placebo-controlled randomized clinical trial, using a parallel design. Eighty patients with primary hyper- lipidemia were randomly assigned to receive Rhus capsules or placebo for 6 weeks. Main outcome measures： The serum lipid levels, apolipoprotein-A1 （Apo-A1） and apolipoprotein-B （Apo-B） were measured. Results： Mean serum high-density lipoprotein cholesterol （HDL-C） and Apo-Al levels were significantly increased in the Rhus group, compared with the placebo group, after 6 weeks of intervention （P= 0.001）. The analysis of covariance test including age, gender, body mass index （BMI）, and smoking as co-variables revealed that the increase in HDL-C and Apo-A1 levels remained significant, and increases in HDL-C were dependent on the increase in Apo-A1 levels. No significant difference was observed between Rhus and placebo groups in terms of mean reductions in total cholesterol, low-density lipopro- tein cholesterol and triglyceride levels; however, more significant improvement was observed among obese patients （BMI≥ 30 kg/m^2）. Conclusion： The study showed significant increases in HDL-C and Apo-Al levels in response to Rhus sup- plementation in patients with hyperlipidemia. Trial registration： ClinicalTrials.gov ID： NCT02295293.

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 （P〈0.01）. 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 （P〈0.05）. 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.

中医药联合核苷(酸)类似物治疗慢性乙型病毒性肝炎抗病毒疗效及安全性:基于随机、双盲、对照临床试验的Meta分析

目的中医药联合核苷(酸)类似物治疗慢性乙型病毒性肝炎抗病毒疗效仍存在争议,本文拟系统性评价中西医联合抗乙肝病毒效果及安全性。方法在中英文电子数据库(中国知网、万方、维普、中国生物医学等中文数据库和Embase、PubMed和Cocharane Library英文数据库)中检索中医药联合核苷(酸)类似物治疗慢性乙型病毒性肝炎的相关文献,筛选随机、双盲、对照临床试验文献进行统计分析。结果:共纳入随机、双盲、对照、临床试验文献9篇,共含2752例慢性乙型肝炎患者,试验组1376例,对照组1376例。结果与单用核苷(酸)类似物相比,试验组治疗能显著提高治疗(≥48周)结束时的乙肝病毒e抗原阴转率乙肝病毒e抗原血清转换率和乙型肝炎表面抗原转阴率。在治疗24周后的乙肝病毒的脱氧核糖核酸阴转率、谷丙转氨酶复常率方面,解毒类方试验组明显优于对照组。试验组与对照组两组在治疗(≥48周)结束时的乙肝病毒的脱氧核糖核酸阴转率、谷丙转氨酶复常率、肝脏炎症分级和纤维化分期变化率及不良反应发生率方面,差异无统计学意义。结论中医药联合核苷(酸)类似物治疗慢性乙型病毒性肝炎抗病毒疗效优于核苷(酸)类似物单药治疗,且不增加不良反应发生率。

Efficacy and safety of Shenyankangfu Tablet,a Chinese patent medicine,for primary glomerulonephritis:A multicenter randomized controlled trial

Background:Shenyankangfu Tablet(SYKFT)is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.Objective:This trial compared the efficacy and safety of SYKFT,for the control of proteinuria in primary glomerulonephritis patients,against the standard drug,losartan potassium.Design,setting,participants and intervention:This was a multicenter,double-blind,randomized,controlled clinical trial.Primary glomerulonephritis patients,aged 18-70 years,with blood pressure≤140/90 mmHg,estimated glomerular filtration rate(eGFR)>45 mL/min per 1.73 ㎡,and 24-hour proteinuria level of 0.5-3.0 g,were recruited in 41 hospitals across 19 provinces in China and were randomly divided into five groups:SYKFT,losartan potassium 50 mg or 100 mg,SYKFT plus losartan potassium 50 mg or 100 mg.Main outcome measu res:The primary outcome was change in the 24-hour proteinuria level,after 48 weeks of treatment.Results:A total of 735 participants were enrolled.The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78%±2.56%(P=0.006)more than that in the losartan 50 mg group,which was 0.51%±2.54%(P=1.000)less than that in the losartan 100 mg group.Compared with the losartan potassium 50 mg group,the SYKFT plus losartan potassium 50 mg group had a 13.39%±2.49%(P<0.001)greater reduction in urine protein level.Compared with the losartan potassium 100 mg group,the SYKFT plus losartan potassium 100 mg group had a 9.77%±2.52%(P=0.001)greater reduction in urine protein.With a superiority threshold of 15%,neither was statistically significant.eGFR,serum creatinine and serum albumin from the baseline did not change statistically significant.The average change in TCM syndrome score between the patients who took SYKFT(-3.00[-6.00,-2.00])and who did not take SYKFT(-2.00[-5.00,0])was statistically significant(P=0.003).No obvious adverse reactions were observed in any group.Conclusion:SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients,with no change in the rate of decrease in the eGFR.SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.Trial registration number:NCT02063100 on ClinicalTrials.gov.

穴位埋线双盲试验设计之初探

目的探讨穴位埋线双盲设计的可行性,为埋线相关随机对照试验提供盲法思路。方法分别采用新鲜猪肉和4位志愿者作为治疗师及患者的设盲对象,通过比较治疗师猜中率及患者穴位感觉有无,来评价盲法成功率。结果(1)猪肉试验时治疗师总猜中率55%,志愿者试验治疗师猜中率51.58%;不同治疗师猜中率最高63.3%,最低45%,各治疗师间猜中率差异无统计学意义(P=0.545)。(2)志愿者试验植入线体的穴位出现感觉占比34.32%,此后逐渐下降到第5天剩0.59%;没有植线出现感觉的穴位19.30%,此后下降至第5天完全消失;两者比较从第1天~第4天差异均有统计学意义(P<0.05),但第5天差异无统计学意义(P>0.05)。结论穴位埋线出现感觉的比例并不高,采用一穴一针提前备好针线的真假埋线法,能够同时实现对治疗师和患者的设盲,是一个值得推荐用于穴位埋线的双盲方案。

认知行为治疗改善精神分裂症患者生活质量的随机单盲对照试验

目的:探讨认知行为治疗对精神分裂症患者生活质量的效果及相关因素,为寻找有效改善精神分裂症患者生活质量的方法提供依据。方法:本研究为单盲随机对照临床试验。选取符合美国精神障碍诊断与统计手册第4版(DSM-IV)中精神分裂症诊断标准的医院门诊和住院患者共120例,随机分配到认知行为治疗组(CBT组,n=60)和支持性心理治疗组(ST组,n=60),在药物治疗基础上分别接受15次认知行为治疗和支持性心理治疗。在基线采用世界卫生组织生存质量量表简表(WHOQOL-BREF)、阳性和阴性症状量表(PANSS)、应付方式问卷(CSQ)、非理性信念量表(IBS)及自编药物副反应问卷对两组患者进行盲法评定。第12周、24周采用WHOQOL-BREF和自编药物副反应问卷对患者进行随访评估。结果:第12周,CBT组患者WHOQOL-BREF总分各因子分均高于基线[(77.0±13.9)vs.(73.1±13.8),(22.4±4.5)vs.(21.5±4.7),(18.9±4.1)vs.(17.8±4.3),(9.3±2.2)vs.(8.9±2.3),(26.4±5.0)vs.(24.7±5.3),均P<0.05],而ST组患者仅环境因子有显著改善[(23.9±4.7)vs.(25.0±5.2),P<0.05],其余因子差异无统计学意义(P>0.05)。第24周,两组在WHOQOL-BREF的社会关系和环境因子分上组间效应显著(F=6.77,7.21,均P<0.05),CBT组得分均高于ST组。Logis-tic回归分析发现,基线应对方式分数较低、接受CBT及男性对患者的生活质量有正性预测作用(B=-0.25,2.31,-1.64,均P<0.05)。结论:认知行为治疗能够有效改善精神分裂症患者的生活质量,且基线应对方式得分相对更低、能接受认知行为治疗及男性患者更容易从治疗中获得生活质量的改善。

齐拉西酮与氟哌啶醇治疗精神分裂症随机双盲双模拟多中心对照研究

目的:评价齐拉西酮治疗精神分裂症的疗效及安全性。方法:将235例精神分裂症病人随机分为齐拉西酮组(118例)和氟哌啶醇组(117例),齐拉西酮和氟哌啶醇最低日剂量分别定为40 mg·d^(-1)和8 mg·d^(-1),最高日剂量分别限定为160 mg·d^(-1)和20 mg·d^(-1),每日分2次服用。进行为期6 wk的多中心双盲双模拟对照研究。采用阳性和阴性症状量表(PANSS)、临床总体印象量表(CGI)、不良反应量表(TESS)及有关实验室检查评价疗效和安全性。结果:治疗结束时,2组PANSS评分较入组时均显著减低(P＜0．05);PANSS减分率——齐拉西酮组为(64±s 19)%,氟哌啶醇组为(67±24)%;临床总有效率——齐拉西酮组为81．1%,氟哌啶醇组为80．2%;2组疗效差异无显著意义。不良反应的发生率2组间比较差异无显著意义,但心电图的异常率氟哌啶醇组明显高于齐拉西酮组,差异有显著意义(P＜0．05)。结论:齐拉西酮治疗精神分裂症的疗效与氟哌啶醇相似,对心电图的影响比氟哌啶醇轻而少,是一种有效、安全的抗精神病药物。

度洛西汀肠溶胶囊治疗抑郁症的多中心随机双盲对照临床研究

目的评价度洛西汀肠溶胶囊治疗抑郁症的疗效和安全性。方法采用随机、双盲、双模拟、氟西汀平行对照、剂量固定的多中心研究。受试者分别口服度洛西汀肠溶胶囊60 mg·d^(-1)或氟西汀胶囊20 mg·d^(-1),共观察6 wk。结果意向性分析集(ITT)抑郁症病人238例,其中度洛西汀组(试验组)117例和氟西汀组(对照组)121例。符合方案集(PP)病人228例,其中试验组111例,对照组117例。根据PP样本,治疗6 wk后,试验组和对照组汉密尔顿焦虑量表(HAMD)17项总分减分值分别为(15±s 5)分及(16±6)分,与基线相比均存在非常显著差异(P<0.01),但组间无显著差异(P>0.05);试验组和对照组的有效率分别为89.2%和88.0%,2组相比差异无显著意义(P>0.05)。试验组总不良反应发生率为35.0%,对照组为24.8%,2组相比差异无显著意义(P>0.05)。结论度洛西汀肠溶胶囊治疗抑郁症的疗效、安全性以及治疗抑郁症伴焦虑的疗效均与氟西汀相似,是一种安全有效的抗抑郁药。

血府逐瘀汤拆方临床研究

目的 :探讨血府逐瘀汤不同拆方治疗冠心病心绞痛血瘀气滞证的临床疗效 ,以期进一步阐明该方作用机理及配伍规律。方法 :12 3例冠心病心绞痛病人随机分为血府逐瘀汤原方组、精制血府逐瘀组、药对配伍组、安慰剂组 4组进行干预治疗。结果 :① 4组心绞痛与血瘀气滞证证候疗效依次为血府逐瘀组 ,精制血府逐瘀组 ,药对组 ,安慰剂组 (P <0 .0 1) ;②血液流变学 :疗后血府逐瘀组全血黏度、血小板黏附性降低 ,红细胞变形性升高 (P <0 .0 5 ) ;精制血府逐瘀组全血黏度、血小板黏附降低 (P <0 .0 5 ) ;药对组血小板黏附、血浆黏度降低 (P <0 .0 1) ;安慰剂组血小板黏附降低、红细胞变形性升高 (P <0 .0 1) ;③ 4组治疗后血脂变化无显著性差异。④ 4组治疗后一氧化氮升高 ,拆方各组有显著性差异 (P <0 .0 5 ) ;4组间治疗后ET无显著性差异 (P >0 .0 5 )。血府逐瘀组组织型纤溶酶原激活物疗后有显著性差异 (P <0 .0 5 ) ;⑤炎症指标 :血府逐瘀组、精制血府逐瘀组、药对组治疗后IL 6均降低 ,安慰剂组治疗后IL 6升高 ,经t检验有显著性差异 (P <0 .0 5 ) ,4组间比较有显著性差异 (P <0 .0 5 )。结论 :①临床疗效及客观指标改善与方剂组成及方证对应的程度相关 ;②血府逐瘀系列拆方药物具有其相同的物质作用基础 ,随着复?

伊托必利治疗功能性消化不良的随机双盲对照试验104例

目的:观察国产伊托必利片治疗功能性消化不良的疗效和药物安全性。方法:将209例功能性消化不良病人,采用随机双盲、阳性药物对照试验方法,随机分为2组,伊托必利(受试)组给伊托必利50mg,餐前口服,每日3次;多潘立酮(对照)组给多潘立酮10mg,餐前口服,每日3次。疗程均为2或4wk。结果:伊托必利组治疗功能性消化不良总有效率为89%,与对照组多潘立酮(89%)相比无差异(P>0.05);明显改善病人消化不良临床症状和体征,显著改善胃排空功能(P<0.01),与对照组相比无差异。伊托必利组不良反应发生率为4%,与多潘立酮组(5.9%)比较无统计学差异。结论:伊托必利治疗功能性消化不良是安全、有效。

白细胞干扰素喷雾治疗慢性宫颈炎的初步研究

作者应用小剂量人脐血白细胞干扰素以随机双盲对照法对宫颈表面直接喷雾试治慢性宫颈糜烂215例,总有效率达93.02％,显效率以上达49.77％,与对照组相比有非常明显差异。根据作者的研究结果表明,宫颈糜烂的程度和类型与疗效有关。糜烂程度轻则治愈率高;三种类型的宫颈炎,以单纯型较易治,其显效率以上可达67.57％,其次是颗粒型(51.25％),最难治的是乳头型(26.23％)。此外,本文还讨论了干扰素治疗慢性宫颈炎的机制问题。

单唾液酸四己糖神经节苷脂治疗急性脑梗死随机双盲对照多中心研究

目的:评价国产单唾液酸四己糖神经节苷脂钠注射液(GM1注射液)治疗急性脑梗死的有效性和安全性。方法:本研究采用多中心、随机双盲对照的方法,分别给予试验组(n=67)和对照组(n=70)病人国产和进口GM1注射液100 mg,iv,qd,连续使用14 d。结果:国产及进口GM1注射液对急性脑梗死NIHSS评分及Barthel指数评分治疗前后有显著差异(P<0.05);2组治疗前后NIHSS评分及Barthel指数评分的差值及变化率组间比较无显著差异(P>0.05)。试验组在整个试验过程中没有发生不良反应,实验室检查结果与治疗前及对照组比较没有临床意义。结论:国产GM1注射液对急性脑梗死具有显著的疗效,并且安全性好。

达立通颗粒治疗痞满证(功能性消化不良)的随机对照双盲试验

目的 评价达立通颗粒治疗痞满证 (功能性消化不良 )的疗效和安全性。 方法 根据本研究的纳入与排出标准 ,选取痞满证 (功能性消化不良 )患者 12 0例 ,按 3 1随机分为达立通颗粒组 (治疗组 ) 90例和西沙必利组 (对照组 ) 30例 ,进行随机对照双盲双模拟试验。治疗组口服达立通颗粒 ,每日 3次 ,每次 6 g ;对照组口服西沙必利片 ,每日 3次 ,每次 5mg ,疗程均为 2周。 结果 对中医证候疗效而言 ,意向性治疗(intention to treat,ITT)分析结果显示 ,治疗组总显效率 6 2 37% ,总有效率 99 5 5 % ;对照组总显效率 5 8 0 8% ,总有效率 90 33%。符合方案数据分析 (per protocolpopulation ,PP)结果显示 ,治疗组总显效率为 6 4 4 5 % ,总有效率 96 6 7% ;对照组总显效率为 6 0 0 0 % ,总有效率为 93 33%。两组中医证候疗效比较无统计学意义(P >0 0 5 )。对痞满证候疗效而言 ,ITT分析显示 ,治疗组总显效率 5 3 76 % ,总有效率 86 0 2 % ;对照组的总显效率 4 8 38% ,总有效率 80 6 4 %。PP分析显示治疗组的总显效率 5 5 5 6 % ,总有效率 88 89% ;对照组总显效率 5 0 0 0 % ,总有效率为 83 33%。两组痞满证疗效比较无统计学意义 (P >0 0 5 )。胃排空试验 (PP人群 )显示 ,治疗组总显效率 72 4 2 % 。

枳术宽中胶囊治疗功能性消化不良403例的Ⅱ期临床试验

目的 :观察枳术宽中胶囊治疗功能性消化不良 (FD )的疗效及安全性。方法 :采用双盲双模拟对照方法 ,将 4 0 3例FD病人随机分为治疗组(196例 ) ,给枳术宽中胶囊 3粒 ,po ,tid ,同时给西沙必利模拟片B ;对照组 (10 5例 ) ,给西沙必利 5mg ,po ,tid ,同时给枳术宽中模拟胶囊A ;开放组 (10 2例 ) ,给枳术宽中胶囊 3粒 ,po ,tid。 2wk为一个疗程。结果 :治疗组、对照组对中医证候的总有效率分别为 86 .7% ,77.1% (P >0 .0 5 )。开放组对中医证候的总有效率为 89.2 %。服药后治疗组与对照组胃排空的比较 ,差异无显著性 ,未发现治疗组有明显不良反应。结论 :枳术宽中胶囊治疗功能性消化不良安全有效。