丹参类注射液治疗原发性肾病综合征的系统评价

Salvia miltiorrhiza injections for primary nephrotic syndrome:A systematic analysis

目的评价丹参类注射液治疗原发性肾病综合征的有效性、安全性,为临床用药提供循证医学证据。方法按照国际Cochrane协作网的系统评价方法,计算机检索Cochrane图书馆CCTR、PubMed、CBM、CNKI、VIP、万方数据库;手工检索《中华肾脏病杂志》等10余种中文核心期刊。对所纳入的研究进行方法学质量评价,用Cochrane协作网提供的Rev Man 5.0.23进行统计分析。结果最终检索出符合标准的随机对照文章12篇。Meta分析提示丹参类注射剂能降低原发性肾病综合征患者的24 h尿蛋白、总胆固醇、甘油三酯、低密度脂蛋白、血肌酐、尿素氮、全血低切、血浆黏度、血细胞比容水平,提高血浆白蛋白水平,提高治疗有效率,但全血高切无明显改善。结论丹参类注射液能提高原发性肾病综合征的临床疗效,但由于纳入的临床试验方法学质量相对偏低,同时由于中药成分复杂,中药注射剂提纯工艺等因素的影响,故对本结果应持客观态度。

Objective To evaluate effectiveness and safety of salvia mihiorrhiza injections for primary nephrotic syndrome （NPS） and provide evidence-based medicine proof in clinical application. Methods By method of system evaluation in Cochrane Collaboration, computer retrieval was performed in Cochrane Controlled Trials Register （CCTR）, Pubmed, CBM, CNKI, VIP and Wanfang databases while manual searching in more than 10 kinds of Chinese core journals such as Chinese Kidney Magazine. The methodological quality assessment was applied in included researches and Rev.man 5.0.23, supported by the Cochrane Collaboration, was used for statistical analysis. Results Finally 12 articles of randomize controlled trial （RCT） were included. According to Meta analysis, salvia miltiorrhiza injections could lower level of 24-hour urine protein, total cholesterol, triglyceride, low-density lipoprotein, serum croatinine, urea nitrogen, low blood viscosity, plasma viscosity and haematocrit in patients with NPS, and increase level of plasma albumin and improve effective rate of treatment. However, high blood viscosity was not significantly improved. Conclusion The salvia miltiorrhiza injections could increase clinical therapeutic effect for primary nephrotic syndrome, however, due to relatively low methodological quality of included RCTs, complicated components of TCM herbs and purification technology of TCM injection, it is necessary to hold objective attitude to this result.