中医药治疗前列腺炎随机对照试验的系统评价

Traditional Chinese Medicine for Prostatitis:A Systematic Review of Randomized Controlled Trials

目的系统评价中医药疗法治疗前列腺炎的疗效与安全性。方法用Cochrane协作网系统评价方法,检索Cochrane临床对照试验资料库、中国循证医学/Cochrane中心数据库、PubMed、CBM、中国学术会议论文全文数据库、中国学位论文全文数据库及中国中医药数据库检索系统,结合手工检索相关期刊及灰色文献,检索时间截至2007年1月15日,纳入中医药疗法治疗前列腺炎的随机对照试验(RCT)。由2名评价者采用改良Jadad量表共同评价纳入研究的方法学质量,采用RevMan4.3软件对临床同质性研究进行Meta分析,反之则进行定性评价,潜在的发表偏倚采用"倒漏斗"图示分析。结果在有效性方面,共纳入52个以中文发表的RCT(n=5209),其中22个报告了随机分组方法,9个为高质量(改良Jadad量表评分≥4分)。结果显示,部分中医药疗法或联合西医疗法用于前列腺炎患者在缓解症状、改善前列腺液指标及尿流率方面具有一定疗效。有29个RCT报道了安全性(n=2502),其中15个报告了随机分组方法,8个为高质量(改良Jadad量表评分≥4分)。结果表明,与对照组比较,部分中医药疗法所致患者下消化道症状更为显著,前列泰片口服与前列安栓塞肛治疗出现了性功能异常。结论现有临床证据表明,中医药治疗前列腺炎在缓解患者症状、改善前列腺液指标及尿流率方面可能具有一定效果。在安全性方面,与对照组比较,部分中医药疗法可引起患者一定程度不良反应。由于本系统评价所纳入研究用药变异性大且时间不同,因此无法进行总体的效应合并分析,对整体效果尚需大量研究支持。

Objective To evaluate the effectiveness and safety of traditional Chinese medicine therapies （TCMT） for prostatitis. Methods We searched Cochrane Controlled Trials Register （CCTR）, China EBM/Cochrane center da- tabase （CEBM/CCD）, PubMed, Chinese Biomedical Literature Database （CBM）, Papers on Academic Conference of China （PACC）, Chinese Dissertation Database Full-Text （CDDBFT）, and Evidence-based Traditional Chinese Medicine Database （EBTCMD）. All searches were updated on January 15, 2007. We also performed a manual search of the RCTs of TCMT for prostatitis among periodicals related to TCM, researched the related studies by correlative websites, such as ＂Baidu＂ and ＂Google＂, gray literatures, and studies included in the references of eligible studies. At least two reviewers independently screened the studies for eligibility, evaluated the quality, and extracted the data from the eligible literatures, with a cross-check to confirm accuracy. Different views were settled by a third party. We evaluated the quality of eligible studies with the revised j＇adad＇s scale, and extracted valid data using data tables. Meta-analyses were performed for homo- geneous studies using RevMan 4.3 software. If heterogeneity existed among the studies, descriptive analysis was conduct- ed. The potential publication-bias was analyzed by funnel plot analysis. Results A total of 52 randomized clinical trials of TCMT for prostatitis （n=5 209） among 1 282 original studies were identified. The methodological quality ranked high in 9 RCTs （the revised scale were ~〉 4 scores）, and 22 RCTS reported the methods of random sequence production. The analysis indicated some TCMT were more effective than the treatments in the controls in relieving the proatatitis patients＇ pain or discomfort, paruria, impact of symptoms and NIH-chronic prostatitis symptom index （NIH-CPSI）, improving the EPS-WBC and urine flow rate etc. Of the trials, 29 randomized clinical trials of TCMT for prostatitis that studied safety （n=2 502） were identified. The methodological quality ranked high in 8 RCTs （the revised scale were I〉 4 scores）, and 18 RCTs reported the method of random sequence production. Analysis indicated some TCMT may cause lower digestive tract symptoms when compared to the control therapies and some Chinese herbs formulas- may cause sexual disfunction. Conclusion Some TCMT may be more effective than the controls in relieving the patients＇ pain or discomfort, paruria, impact of symptoms and NIH-CPSI, improving the prostatic tenderness with DRE, improving the EPS-WBC, lecithin lipophore, and urine flow rate etc. However, some TCMT of the trials included may cause lower digestive tract symptoms when compared to the controls, and some Chinese herbs formulas cause sexual disfunction. Because of the generally low methodological quality and the variations of the herbs used, the overall effects cannot be pooled for analysis. More evi- dence is needed to support this finding.