复方丹参方制剂治疗稳定型心绞痛随机对照试验的系统评价

[目的]评价复方丹参方制剂(与硝酸酯类作对照)治疗稳定型心绞痛的疗效和安全性。[方法]通过检索Cochrane Centre,MEDLINE,EMBASE,中国生物医学文献数据库(CBM),中文全文期刊数据库(CNKI)和维普中文期刊数据库(VIP)等数据库(截至2007年1月),全面搜集有关复方丹参方制剂(丹参、三七、冰片组成)治疗稳定型心绞痛的随机对照试验。质量评价参照Cochrane handbook4.26提供的标准。[结果]有33篇文献纳入评价。32个研究采用心绞痛症状改善为指标,合并效应量RR(random)及95%可信区间(CI)为1.16(1.10,1.23)。30个研究采用心电图改善为指标,合并效应量RR(random)及95%可信区间为1.38(1.25,1.51)。复方丹参方制剂的不良反应主要表现为轻度的胃部不适,发生率为3.4%,95%CI(2.5%,4.2%)。[结论]根据系统评价结果,提示复方丹参方治疗冠心病心绞痛与硝酸酯类相比,在改善心绞痛症状、改善心肌缺血状态等方面显示出一定的优势,且不良反应少。但由于原始研究质量较低,影响了结论的可靠性,有待高质量研究提供更有力的证据。     

复方丹参滴丸治疗稳定型心绞痛随机对照试验的系统评价

目的：系统评价复方丹参滴丸与硝酸酯类制剂治疗稳定型心绞痛的疗效和安全性。方法：搜集复方丹参滴丸与硝酸酯类制剂对照治疗稳定型心绞痛的随机对照试验文献,无语种限制。纳入试验的文献质量用Jadad计分表评价,运用异质性检验、Meta-分析、漏斗图分析、敏感性分析等方法统计相关数据。结果：符合纳入标准的论文共有28篇,均为中文发表。根据Jadad评分标准,大多数文献的得分均低于3分,属低质量文献。Meta-分析结果显示,总有效率比较的合并相对危险度（RR值）及99%的可信区间（CI值）为1.06[1.01,1.13]。结论：根据Meta-分析,复方丹参滴丸治疗稳定型心绞痛有效,且不良反应少,耐受性好。由于文献的质量普遍较低,目前尚不能得出复方丹参滴丸治疗稳定型心绞痛的疗效优于硝酸酯类制剂的结论。     

苦碟子注射液治疗不稳定性心绞痛随机对照试验系统评价

目的:系统评价苦碟子注射液治疗不稳定性心绞痛的有效性和安全性。方法:检索The Cochrane Library、PubMed、CNKI数据库、万方数据知识服务平台、中国生物医学文献数据库,搜集苦碟子注射液治疗不稳定性心绞痛的随机对照试验,按照Cochrane协作网推荐的方法评价纳入研究的方法学质量,提取相关数据,运用RevMan5.2软件完成异质性检验、Meta分析、敏感性分析、倒漏斗图分析等相关统计分析。结果:共纳入12项合格研究,共计1 114例患者,纳入研究方法学质量普遍较低,研究间具有异质性,Meta分析结果显示苦碟子注射液在提高不稳定性心绞痛的临床疗效方面合并效应量RR=1.25,95%CI[1.16,1.34],在改善不稳定性心绞痛的心电图表现方面合并效应量RR=1.33,95%CI[1.19,1.49],结果均具有统计学意义;敏感性分析提示结果稳定;倒漏斗图分析显示不对称;未见苦碟子注射液的不良反应报道。结论:联用苦碟子注射液治疗不稳定性心绞痛可提高临床疗效,改善心电图表现,且较为安全,但由于纳入研究的质量较低,尚需要开展样本量充足、设计合理、执行严格的临床试验以提供更加真实可靠的证据。     

理气活血方药治疗冠心病心绞痛随机对照试验的系统评价

目的:评价理气活血方药治疗冠心病心绞痛的疗效及安全性。方法:根据循证医学系统评价的要求,计算机检索CBM、CNKI、维普VIP、万方等数据库(各数据库起始年限至2011年)收录的理气活血方药治疗冠心病心绞痛的临床随机对照试验文献,应用Jadad评分标准评价合格研究的方法学质量,并用RevMan 5.1软件对相关数据进行统计分析。结果:①共检索到相关临床对照试验文献104篇,最终纳入合格文献60篇,总样本量6 074例。Jadad评分,3项研究得分≥3分,其余研究得分均<3分。②理气活血方药干预的治疗组在心绞痛疗效、心电图疗效、中医证候疗效以及不良反应发生率方面均优于对照组(P<0.05)。结论:①理气活血方药治疗冠心病心绞痛有较好疗效和安全性;②鉴于纳入研究整体质量偏低、存在发表性偏倚等多因素的影响,上述结果的稳定性和可靠性仍有待于今后临床开展设计严谨的高质量、大样本、多中心随机双盲对照试验来进一步证实。     

银杏叶片联用低分子肝素治疗不稳定型心绞痛临床研究

目的:探讨银杏叶片联用低分子肝素治疗不稳定型心绞痛的临床疗效。方法:将240例不稳定型心绞痛患者随机分为治疗组和对照组各120例,对照组采用常规西医治疗,治疗组在对照组基础上予以银杏叶片联用低分子肝素治疗,两组疗程均为14d,观察两组患者临床症状改善情况、治疗前后心电图的变化、凝血指标变化及不良反应。结果:治疗组与对照组比较,两组治疗前后临床症状均有改善,治疗组总有效率为90.8%,明显高于对照组68.3%,比较差异有统计学意义(P0.05),心电图改善率亦明显高于对照组(P0.05),凝血指标两组治疗前后比较差异有统计学意义(P0.001)。结论:银杏叶片联用低分子肝素治疗不稳定型心绞痛能明显改善临床症状,安全、无明显毒副作用。     

盐酸法舒地尔治疗不稳定型心绞痛的疗效的系统评价

目的:系统评价盐酸法舒地尔治疗冠心病不稳定型心绞痛的有效性。方法:通过计算机检索PubMed、The Cochrane Library、EMbase、中国知网、万方、维普等数据库,从中找到有关盐酸法舒地尔治疗不稳定型心绞痛的临床随机对照试验(RCT),检索时限为2005年12月至2015年12月。由2位评价者严格按照纳入与排除标准独立筛选文献、提取资料和严格评价文献质量后,采用Review Manager 5. 3进行系统评价。结果:共纳入27项RCT,共收集了2 261例患者的资料。Meta分析结果显示:与常规治疗组比较,在常规治疗基础上加用盐酸法舒地尔可有效改善患者的心绞痛症状[OR=4. 02,95%CI(3. 12,5. 18),P<0. 000 01]和心电图变化{心电图疗效[OR=3. 05,95%CI(2. 23, 4. 18),P<0. 000 01]、12导联ST下移的总和(∑ST)[MD=-2. 11, 95%CI(-2. 90,-1. 31),P<0. 000 01]、ST下移的导联数目(NST)[MD=-1. 93,95%CI(-2. 68,-1. 18),P<0. 000 01]、ST改变的最大值(STmax)[MD=-0. 50,95%CI(-0. 59,-0. 41),P<0. 000 01]、T波改变的数目(NT)[MD=-1. 81,95%CI(-2. 14,-1. 48),P<0. 000 01]},以及CRP水平降低[MD=-6. 14,95%CI(-7. 69,-4. 59),P<0. 000 01],心绞痛发作次数明显减少[MD=-2. 28,95%CI(-3. 46,-1. 10),P=0. 000 1],心绞痛发作持续时间明显缩短[MD=-2. 28,95%CI(-3. 46,-1. 10),P<0. 000 01]。结论:相比于常规治疗组,在常规治疗基础上加用盐酸法舒地尔可有效改善患者的心绞痛症状和心电图变化,降低炎症指标等。     

关于不稳定型心绞痛的中医药临床随机对照试验质量的评价

目的：评价我国关于不稳定型心绞痛的中医药临床随机对照试验的质量。方法：手工检索我国83种中医药杂志,其中最早者从1977年开始,均检索至最近一期。纳入标准：注明了“随机对照”、“随机分组”和“随机”的应用中医药治疗不稳定型心绞痛的临床研究文献,对文献进行逐篇阅读并分析。所有未将不稳定型心绞痛单独进行研究的文献被排除。结果：(1)纳入的临床随机对照试验研究文献共58篇,其中交代随机分配方法的7篇,占总数的12．07％;(2)交代了诊断标准及纳入标准的有54篇,占98．27％;(3)无l例提到分配隐匿;(4)仅有3篇提到了盲法,占5．17％;(5)交代了两组基线情况的有55篇,占94．83％;(6)无l篇交代样本含量计算依据;(7)有3篇文献的病例有丢失,占5．17％;(8)根据资料的种类和性质,对统计方法有明确说明的有37篇,占63．79％;其中正确运用统计方法的有33篇,占56．90％;错误运用的有4篇,占6．90％;没对统计方法进行说明的2l篇,占36．21％;对统计结果进行正确解释的26篇,占44．83％;(9)正确运用表格的有45篇,占77．59％。结论：关于不稳定型心绞痛的中医药随机对照的临床研究质量,还有待提高。     

不同银杏叶制剂治疗冠心病心绞痛疗效比较

银杏叶片银杏叶胶囊分别治疗冠心病１５９例，１２５例，对心绞痛总有效率８５．３％和９４．３％，对缺血性心电图改变总有效率为８３％和７１．１％。片剂和胶囊均能明显降低总胆固醇、甘油三脂和升高高密度脂蛋白胆固醇。     

PAF和vWF在银杏叶片治疗不稳定型心绞痛中的作用

目的观察银杏叶片治疗不稳定型心绞痛（UAP）患者血小板活化因子（PAF）、血管性血友病因子（vWF）的变化,探讨其对心血管的保护作用及机制。方法检测26例健康对照者和61例UAP患者血浆PAF、vWF和PAR水平,将患者随机分为常规治疗组（对照组）和合并银杏叶片治疗组（银杏叶组）,分别于治疗前和治疗28d后测定PAF、vWF和PAR水平。结果UAP组PAF、vWF和PAR水平均显著高于正常对照组（P〈0．01）。治疗前,银杏叶组与对照组PAF、vWF和PAR水平无显著差异（P〉0．05）,银杏叶组治疗后PAF、vWF和PAR分别显著低于治疗前（P〈0．01）;对照组治疗前后PAF、vWF和PAR水平差异均无统计学意义（P〉0．05）。结论银杏叶片可通过下调PAF和vWF水平,降低血小板聚集程度从而可有效治疗不稳定型心绞痛。     

异舒吉合并银杏叶制剂治疗不稳定型心绞痛的疗效观察

目的：探讨异舒吉合并银杏叶制剂治疗冠心病不稳定型心绞痛（UAP）与单用异舒吉的疗效对比。方法：对60例不稳定型心绞痛病人随机分为AB两组：A组为对照组，用异舒吉治疗（10mg静滴，每日1次）。B组为实验组，用异舒吉（10mg静滴，每日1次）＋银杏叶注射液（15ml静滴，每日1次）。疗程均为2周。结果：两药合用的临床疗效（87．9％）与心电图疗效（75．8％）均优于单用异舒吉（75．0％和59．4％），差异有显著性（P均〈0．05）；两组未见明显不良反应。结论：异舒吉合并银杏叶制剂治疗不稳定型心绞痛疗效优于单用异舒吉。     

Ginkgo Biloba Extract for Angina Pectoris: A Systematic Review

Objective: To evaluate the efficacy and safety of Ginkgo Biloba extract for patients with angina pectoris according to the available evidence. Methods: Electronic databases were searched for all of the randomized controlled trials (RCTs) of angina pectoris treatments with Ginkgo Biloba extract, either alone or combined with routine Western medicine (RWM), and controlled by untreated, placebo, Chinese patent medicine, or RWM treatment. The RCTs were retrieved from the following electronic databases: PubMed/MEDLINE, ProQuest Health and Medical Complete, Springer, Elsevier, and ProQuest Dissertations and Theses, Wanfang Data, China National Knowledge Infrastructure (CNKI), VIP database, China Biology Medicine (CBM), Chinese Medical Citation Index (CMCI), from the earliest database records to December 2012. No language restriction was applied. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards. RevMan 5.1.0 provided by Cochrane Collaboration The data were analysed by using. Results: A total of 23 RCTs (involving 2,529 patients) were included and the methodological quality was evaluated as generally low. Ginkgo Biloba extract with RWM was more effective in angina relief and electrocardiogram improvement than RWM alone. Reported adverse events included epigastric discomfort, nausea, gastrointestinal reaction, and bitter taste. Conclusions: Ginkgo Biloba extract may have beneficial effects on patients with angina pectoris, although the low quality of existing trials makes it difficult to draw a satisfactory conclusion. More rigorous, high quality clinical trials are needed to provide conclusive evidence.     

Ginkgo Leaf Extract and Dipyridamole Injection as Adjuvant Treatment for Angina Pectoris: A Meta-Analysis of 41 Randomized Controlled Trials

Objective: To provide information about the effectiveness and safety of Ginkgo Leaf Extract and Dipyridamole Injection(GD) as one adjuvant therapy for treating angina pectoris(AP) and to evaluate the relevant randomized controlled trials(RCTs) with meta-analysis. Methods: RCTs concerning AP treated by GD were searched in China Biology Medicine Disc(SinoMed), PubMed, the China National Knowledge Infrastructure Database(CNKI), the Chinese Scientific Journals Database(VIP), Wanfang Database, Embase, and the Cochrane Library, from inception to February, 2017. The Cochrane Risk Assessment Tool was adopted to assess the methodological quality of the RCTs. The Review Manager 5.3 software was utilized to conduct the meta-analysis. Results: A total of 41 RCTs involving 4,462 patients were included in the meta-analysis. The results indicated that the combined use of GD and Western medicine(WM) against AP was associated with a higher total effective rate [risk ratio(RR)=1.25, 95% confidence interval(CI): 1.21–1.29, P0.01], total effective rate of electrocardiogram(RR=1.29, 95% CI: 1.21–1.36, P0.01). Additional, GD combined with WM could decrease the level of plasma viscosity [mean difference(MD)=–0.56, 95% CI: –0,81 to –0.30, P0.01], fibrinogen [MD=–1.02, 95% CI: –1.50 to –0.54, P0.01], whole blood low shear viscosity [MD=–2.27, 95% CI: –3.04 to –1.49, P0.01], and whole blood high shear viscosity(MD=–0.90, 95% CI: 1.37 to –0.44, P0.01). Conclusions: Comparing with receiving WM only, the combine use of GD and WM was associated with a better curative effect for patients with AP. Nevertheless, limited by the methodological quality of included RCTs more large-sample, multi-center RCTs were needed to confirm our findings and provide further evidence for the clinical utility of GD.     

Conventional Acupuncture for Cardiac Arrhythmia: A Systematic Review of Randomized Controlled Trials

Objective:To exam the effect and safety of conventional acupuncture(CA) on cardiac arrhythmia.Methods:Nine medical databases were searched until February 2016 for randomized controlled trials.Heterogeneity was measured by Cochran Q test.Meta-analysis was conducted if I2 was less than 85% and the characteristics of included trials were similar.Results:Nine qualified studies involving 638 patients were included.Only 1 study had definitely low risk of bias,while 7 trials were rated as unclear and 1 as high.Meta-analysis of CA alone did not have a significant benefit on response rate compared to amiodarone in patients with atrial fibrillation(Af) and atrial flutter(AF) [relative risk(RR):1.09;95% confidence interval(CI):0.79–1.49;P=0.61;I2=61%,P=0.11].However,1 study with higher methodological quality detected a lower recurrence rate of Af in CA alone as compared with sham acupuncture plus no treatment,and benefits on ventricular rate and time of conversion to normal sinus rhythm were found in CA alone group by 1 study,as well as the response rate in CA plus deslanoside group by another study.Meta-analysis of CA plus anti-arrhythmia drug(AAD) was associated with a significant benefit on the response rate when compared with AAD alone in ventricular premature beat(VPB) patients(RR,1.19,95% CI:1.05–1.34;P=0.005;I2=13%,P=0.32),and an improvement in quality-of-life score(QOLS) of VPB also showed in 1 individual study.Besides,a lower heart rate was detected in the CA alone group by 1 individual study when compared with no treatment in sinus tachycardia patients(MD –21.84 [–27.21,–16.47]) and lower adverse events of CA alone were reported than amiodarone.Conclusions:CA may be a useful and safe alternative or additive approach to AADs for cardiac arrhythmia,especially in VPB and Af patients,which mainly based on a pooled estimate and result from 1 study with higher methodological quality.However,we could not reach a robust conclusion due to low quality of overall evidence.     

尿毒清治疗慢性肾脏病的系统评价

目的:评价尿毒清治疗慢性肾脏病的疗效和安全性。方法:收集使用尿毒清治疗慢性肾脏病的随机对照试验(RCT)。按纳入排除标准筛选试验、评价研究质量、提取有效数据,并采用Revman5.0进行统计分析。结果:共纳入27个RCT,均以中文发表,纳入文献质量均为C级。在常规治疗基础上,尿毒清在临床疗效和肾功能改善方面与空白对照比较差异有统计学意义;在改善血尿素氮和内生肌酐清除率方面与包醛氧淀粉比较差异有统计学意义;在改善血清肌酐方面与包醛氧淀粉没有统计学差异。尿毒清与其他中药(云南灯盏花胶囊、益肾宁方等)比较,在临床疗效、肾功能改善、24h尿蛋白、血压改善方面多不及其它中药。结论:由于纳入试验方法学质量普遍较低,缺乏必要的终点指标,尿毒清治疗慢性肾脏病的疗效及安全性尚不能确定,需开展大样本、高质量、设计合理的随机对照试验进一步证实。     

通心络胶囊治疗冠心病随机对照试验的系统评价

【目的】评价通心络胶囊与消心痛等西药治疗冠心病的疗效差异及安全性。【方法】两名作者独立收集资料和评价纳入文献质量,运用meta分析对资料进行定量综合,评价不良反应。【结果】（1）对17项研究的临床疗效有效率合并效应量的检验：OR合并=2.38,其95%CI为[1.83,3.09]（P〈0.01）;（2）对12项研究的心电图疗效有效率合并效应量的检验：OR合并=2.08,95%CI为[1.54,2.82]（P〈0.01）;（3）有4篇论文报道未发现通心络明显毒副作用,11篇报道胃肠不适、头痛等不良反应例数：通心络组17例,发生率为2.64%;对照组63例,发生率为10.92%;（4）在治疗前后对通心络组患者血、尿、粪常规、肝肾功能、心肌酶和电解质的检验,均未发现异常变化。【结论】现有证据提示通心络胶囊临床疗效和心电图疗效优于消心痛,且不良反应少。受纳入文献的质量限制,其疗效有待高质量的随机对照试验来评价。     

头针治疗帕金森病：一项随机对照试验的系统评价

Objective: To evaluate the effectiveness of scalp acupuncture (SA), a modern acupuncture technique specialized to neurological disorders, in managing motor function and symptoms for Parkinson''s disease (PD) patients. Methods: Two independent reviewers extracted data from all of the randomized clinical trials (RCTs) that assessed the efficacy of SA for PD compared with conventional therapies (CTs). Sixteen electronic databases were searched. The risk of bias was appraised with the Cochrane Collaboration tool, and the reporting of the included studies was evaluated by the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines. Results: In total, 4 RCTs met the inclusion criteria. As assessed by the Unified PD Rating Scale (UPDRS), 2 RCTs showed that SA combined with CTs proved superior to CTs alone [60 cases; weighted mean difference, –3.94; 95% confidence interval (CI), –6.05 to –1.84, P=0.01; I2=0%]. Based on the Webster scale, however, 3 RCTs showed no superior effect of SA when combined with CTs with high heterogeneity (154 cases; risk ratio, 1.29; 95% CI, 0.79 to 2.12, P=0.30; I2=84%). The Cochrane risk of bias, adherence to the CONSORT and the STRICTA checklist showed that the quality of all the included RCTs was generally low. Conclusions: The result of our systematic review and meta-analysis suggested that the effectiveness of SA for PD is promising, however, the evidence is not convincing. A sham-controlled RCT design that adheres to the CONSORT and STRICTA guidelines to overcome methodological weakness and that includes a large sample size is strongly recommended to confirm the precise effect of SA on PD.     

Astragalus Membranaceus Injection Combined with Conventional Treatment for Viral Myocarditis: A Systematic Review of Randomized Controlled Trials

Objective：To assess the efficacy and safety of Astragalus membranaceus Injection combined with conventional therapy in the treatment of viral myocarditis.Methods：Randomized controlled trials（RCTs） of A.membranaceus Injection combined with conventional treatment compared with conventional treatment alone were included.Study population characteristics and outcome results were extracted independently by two assessors.Meta-analysis was performed for data available.Results：Six RCTs,involving 639 participants,were included in this study.The methodological quality of the included trials was generally low,and there was high risk of publication bias in the included trials.The total effective rate of A.membranaceus Injection combined with conventional treatment was significantly higher than that of conventional treatment alone.Compared with conventional treatment,the cointervention treatment group showed significant recovery in myocardium enzyme levels and electrocardiography.Two RCTs reported there were no adverse effects from A.membranaceus Injection combined with conventional treatment.Conclusion：A.membranaceus Injection combined with conventional treatment appeared to be more efficacious compared with conventional treatment alone for treating viral myocarditis.However,this conclusion should be cautiously interpreted due to low methodological quality,small sample size,limited number of trials,and high risk of publication bias and other unidentified risks of bias.The safety of A.membranaceus Injection combined with conventional treatment remains uncertain.     

Oral Oxymatrine Preparation for Chronic Hepatitis B: A Systematic Review of Randomized Controlled Trials

Objective

To evaluate the efficacy and safety of oral oxymatrine preparation for the treatment of chronic hepatitis B (CHB).

Methods

Randomized controlled trials (RCTs) on oral oxymatrine preparation in treating patients with CHB were retrieved until October 2013 by searching PubMed, the Cochrane Library, Embase and four Chinese databases, irrespective of language and publication status. Data extraction and data analyses were conducted according to the Cochrane standards. The risk of bias for each included trials and the quality of evidence on pre-specified outcomes were assessed. The RevMan software was used for statistical analyses.

Results

Totally 52 RCTs enrolling 5,227 participants were included, of which 51 RCTs were included in meta-analyses. Oral oxymatrine preparation including oxymatrine capsule and oxymatrine tablet were associated with statistically significant effect on the clearance of hepatitis B virus (HBV) DNA, HBV surface antigen and HBV e antigen, and were beneficial to the normalization of serum alanine aminotransferase and aspartate aminotransferase. Nevertheless, the overall methodological quality and the quality of evidence in the included trials were poor. In addition, safety of oral oxymatrine preparation was not confirmed.

Conclusions

Oral oxymatrine preparation showed some potential benefits for patients with CHB. However, the overall quality of evidence was limited and the safety of oral oxymatrine preparation for CHB patients was still unproven. More high quality evidence from rigorously designed RCTs is warranted to support the clinical use of oral oxymatrine preparation for patients with CHB.

     

Evaluation on Effectiveness and Safety of Chinese Herbs in Treatment of Sub-health: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Objective: To evaluate the effectiveness and safety of Chinese herbs in the treatment of sub-health systematically. Methods: Nine databases were systematically and extensively searched to collect randomized controlled trials (RCTs) about Chinese herbs in the treatment of sub-health. The outcomes included overall effective rate, main symptoms, quality of life, etc. Literature screening, data extraction and quality assessment were conducted according to Cochrane Handbook 5.1. Meta-analysis was conducted to the included literature with Review Manager Software. Results: Seventy-two studies involving 9,296 patients with sub-health were included with 4,908 patients in experimental groups and 4,387 patients in control groups. The overall quality of included clinical research was not high. In the aspect of improving overall effective rate, relieving main symptoms, Pittsburgh sleep quality index (PSQI) score, Athens Insomnia Scale (AIS) score, Fatigue Scale-14 (FS-14), Cornell Medical Index (CMI) score and discontinuation rate, the effects of experimental groups were better than that of control groups. According to available research reports, adverse reactions in Chinese herb groups were mainly mild gastrointestinal symptoms, which did not affect the treatment. Conclusion: Chinese herbs have a curative effect in the treatment of sub-health. However, there are no clear criteria for diagnosis and curative effectiveness judgment globally, which would affect the accuracy of curative effect evaluation.     

他达那非治疗勃起功能障碍的有效性与安全性评价

目的 对他达那非治疗勃起功能障碍的疗效及安全性进行系统评价。方法 通过电子检索和手工检索尽可能全面地收集他达那非治疗勃起功能障碍的临床试验，进行系统评价。结果 本评价共纳入11篇质量较高的随机对照试验。“漏斗图”显示不对称图形，表明可能存在发表偏倚，结果 表明他达那非治疗使50％的患者国际勃起功能指数中有关勃起的评分达到正常（≥26分），与安慰剂相比，能提高评分7．52分，增加插入成功率25％、性交成功率40％，提高勃起功能改善率209％，提高国际勃起功能指数中性交满意度、治疗总体满意度评分分别达3．20分和3．08分。结论 虽然潜在的发表偏倚不可避免，纳入的研究质量不一，但目前的Men分析结果显示他达那非治疗勃起功能障碍有效，并且耐受性较好。