中药联合环磷酰胺治疗儿童难治性肾病综合征疗效的Meta分析

Meta-analysis of the efficacy of traditional Chinese medicine combined with cyclophosphamide in the treatment of refractory nephrotic syndrome in children

目的对中药联合环磷酰胺治疗儿童难治性肾病综合征的疗效进行系统评价,为临床应用提供循证依据。方法 系统检索CNKI、Wanfang Data、VIP、CBM、PubMed、EMbase及The Cochrane Library数据库,发表时间为建库至2019年6月1日。根据纳入及排除标准,筛选出中药联合环磷酰胺治疗儿童难治性肾病综合征的随机对照试验,记录相关数据,采用Cochrane协作网制定的标准评价文献质量,采用RevMan 5.3软件进行Meta分析。结果 共纳入10个研究,涉及患儿758例。 Meta分析结果显示,中药联合环磷酰胺治疗与对照组相比,可明显提高总有效率[ RR =1.16,95% CI (1.10,1.23), P <0.000 01]、提高总治愈率[ RR =1.33,95% CI (1.15,1.55), P =0.000 2]、减少复发率[ RR =0.31,95% CI (0.20,0.47), P <0.000 01]。同时还可显著升高血清白蛋白[ RR =6.28,95% CI (4.20,8.36), P <0.000 01]、显著减少24 h尿蛋白定量[ RR =-1.05,95% CI (-1.45,-0.64), P <0.000 01]、显著降低总胆固醇[ RR =-1.80 ,95% CI (-2.46,-1.15), P <0.000 01]。结论 中药联合环磷酰胺治疗儿童难治性肾病综合征的疗效确切,可提高总有效率及总治愈率,减少复发率,极大改善患儿生活质量。但本研究纳入的文献质量偏低,上述结论仍需更多高质量的临床试验予以验证。

Objective To systematically evaluate the efficacy of traditional Chinese medicine combined with cyclophosphamide in the treatment of refractory nephrotic syndrome in children, and provide evidence-based evidence for clinical application. Methods Retrieve systematically the CNKI, Wanfang Data, VIP, CBM, PubMed, EMbase and The Cochrane Library databases. The publication time was from the inception of the database to June 1 st , 2019.According to the inclusion and exclusion criteria, a randomized controlled trial of Chinese medicine combined with cyclophosphamide in the treatment of children with refractory nephrotic syndrome was selected. The relevant data were recorded. The quality of the literature was evaluated by the standard developed by the Cochrane Collaboration. Meta analysis was performed by RevMan5.3 software. Results A total of 10 studies involving 758 children were included.Meta-analysis showed that the combination of traditional Chinese medicine with cyclophosphamide significantly increased the total effective rate compared with the control group[ RR =1.16, 95% CI (1.10, 1.23), P <0.000 01], increased the total cure rate[ RR =1.33 95% CI (1.15, 1.55), P =0.000 2],and reduced recurrence rate[ RR =0.31, 95% CI (0.20, 0.47), P <0.000 01]. At the same time, serum albumin was significantly increased[ RR =6.28, 95% CI (4.20, 8.36), P <0.000 01], 24 h urine protein quantitation was significantly reduced [ RR =-1.05, 95% CI (-1.45,-0.64)), P <0.000 01], and the total cholesterol was also significantly decreased[ RR =- 1.80, 95% CI (-2.46,- 1.15), P <0.000 01]. Conclusion Traditional Chinese medicine combined with cyclophosphamide is effective in the treatment of refractory nephrotic syndrome in children. It can increase the total effective rate and total cure rate, reduce the recurrence rate, and greatly improve the quality of life of children. However, the quality of the literature included in this study is low, and the above conclusions still need to be verified by more high-quality clinical trials.