昆仙胶囊治疗肾病综合征有效性和安全性的系统评价

目的系统评价昆仙胶囊治疗肾病综合征(nephrotic syndrome,NS)的有效性和安全性。方法通过检索CNKI数据库、万方数据库、VIP数据库、CBM数据库、中国临床试验注册中心、PubMed、Cochrane图书馆和Clinical Trials.gov,纳入昆仙胶囊治疗NS的随机对照临床试验(RCTs)。采用RevMan 5.3软件进行数据处理和分析。筛选出5个RCTs(437名患者),对照组均采用糖皮质激素或糖皮质激素加环磷酰胺或糖皮质激素加中药治疗,A组在对照组治疗基础上加用昆仙胶囊治疗,R组用昆仙胶囊代替对照组中的某种药物治疗。结果与对照组相比,A组显示昆仙胶囊可以显著降低24 h蛋白尿[P<0.00001,MD=-0.82;95%CI(-0.98^-0.65)]、降低血肌酐[P<0.00001,MD=-9.57;95%CI(-13.12^-6.01)]、降低胆固醇[P=0.003,MD=-1.40;95%CI(-2.32^-0.48)]、降低甘油三酯[P=0.03,MD=-0.97;95%CI(-1.83^-0.11)]、升高有效率[P<0.00001,OR=4.80;95%CI(2.76~8.36)]。而R组各项指标与对照组相比,差异无统计学意义(P>0.05)。结论在NS治疗中,常规治疗加用昆仙胶囊可显著降低蛋白尿、改善肾功能、降血脂、提高有效率。昆仙胶囊替代某些常规治疗药物无法获得更好的结果。然而,昆仙胶囊治疗NS的疗效尚需更多高质量、多中心RCTs来进一步证实。

The Efficacy and Safety of Kunxian Capsule for Nephrotic Syndrome:A Systematic Review

Objective To systematically evaluate the efficacy and safety of Kunxian capsule in the treatment of nephrotic syndrome(NS).Methods A literature search was performed using CNKI Database,Wanfang Database,VIP Database,CBM Database,Chinese Clinical Trial Register and PubMed,Cochrane Library,and Clinical Trials.gov.The randomized controlled trials(RCTs)concerning the effects of Kunxian capsule in the treatment of NS were included.The RevMan 5.3 software was applied to evaluate the effects.After filtering,five RCTs(involving 437 participants)were included in this study.The control group was treated with glucocorticoid or glucocorticoid plus cyclophosphamide or glucocorticoid plus traditional Chinese medicine.The group A was treated with Kunxian capsule on the basis of the control group.The group R was treated with Kunxian capsule replaced a drug of the control group.Results In comparison with the control group,group A lowered 24 hour urinary protein[P<0.00001;MD=-0.82;95%CI(-0.98,-0.65)],decreased serum creatinine[P<0.00001;MD=-9.57;95%CI(-13.12,-6.01)],reduced cholesterol[P=0.003,MD=-1.40;95%CI(-2.32,-0.48)],declined triglyceride[P=0.03,MD=-0.97;95%CI(-1.83,-0.11)],and improved overall effective rate[P<0.00001;odds ratio=4.80;95%CI(2.76,8.36)].However,there was no statistical difference in the outcomes of group R(P>0.05).Conclusion Kunxian capsule is likely to be effective,added to conventional therapies,in the treatment of NS through lowering proteinuria and improving renal function.However,Kunxian capsule cannot get better outcomes by replacing conventional therapies.Therefore,the efficacy of Kunxian capsule should be estimated by more large-sample RCTs.