金水宝胶囊治疗慢性肾功能衰竭的系统评价

Systematic Evaluation on Jinshuibao Capsule for Chronic Renal Failure

目的:评价金水宝胶囊治疗慢性肾功能衰竭(CRF)的疗效和安全性,为指导临床获得更好的循证医学依据。方法:按Cochrane标准,运用系统评价方法,全面检索图书馆PubMed(1966～2011年),中国生物医学文献数据库(1977～2011年11月)和中国期刊全文数据库(1994～2011年11月)等数据库,收集以金水宝胶囊为干预措施治疗慢性肾功能衰竭的随机对照试验(RCT)。按Cochrane系统评价方法,由2位研究者独立地对符合纳入标准的试验进行资料提取,并进行研究方法的质量评估和对提取的有效数据进行Meta分析。结果:有8个试验,共710例CRF患者符合纳入标准,Meta分析结果显示,在常规治疗的基础上加用金水宝胶囊治疗CRF能更好改善肾功能,提高患者的生存质量。其改善指标数据如下:血尿素氮[MD-2.23,95%CI(-2.60,-1.85),P<0.000 01];血肌酐[MD-40.71,95%CI(-45.68,-35.75),P<0.000 01];24 h尿蛋白定量[MD-0.17,95%CI(-0.31,-0.03),P=0.02];内生肌酐清除率[MD-25.71,95%CI(-26.36,-25.06),P<0.00001]。结论:现有证据表明,在常规治疗的基础上联合金水宝胶囊可有效延缓慢性肾功能衰竭患者肾功能的进展且副作用较小。由于本研究样本量小,又缺乏高质量的多中心、双盲、随机对照实验,故对金水宝胶囊治疗慢性肾功能衰竭的有效性及安全性做出全面肯定的评价还有待进一步研究。

Objective：To obtain the effect and safety of Jinshuibao capsule in treatment of patients with chronic renal failure（CRF）.Method：We searched PubMed（1966—2006）,CNKI（1994—2011） databases and so on,and retrieved by computer and manual search to collect randomized controlled trial（RCT） on Jinshuibao capsule in treatment of chronic renal failure from 1979 to 2011.Two researchers independently executed a data extraction according to the inclusion criteria of Trials and quality assessment,Meta analysis was carried out.Result：A total of 8 trials involving 710 patients were included in the meta-analysis,which indicated that Jinshuibao capsule combined with conventional treatment in curing of chronic renal failure was more effective in ameliorating renal function and improving the quality of life than only using Jinshuibao capsule.These indexes included as follows：blood urea nitrogen（BUN）;serum creatinine（SCr）;24 hpro;creatinine clearance rate（CCr）.Conclusion：Based on conventional treatment,Jinshuibao capsule can effectively relieve the progress of renal function in patient with chronic renal failure and has low side-effect,but further research work should be needed.