雷公藤多苷治疗特发性膜性肾病有效性及安全性的Meta分析

Meta-analysis of efficacy and safety of multi-glycoside of Tripterygium wilfordii in the treatment of idiopathic membranous nephropathy

目的评价雷公藤多苷(multi-glycoside of tripterygium wilfordii,GTW)治疗特发性膜性肾病(idiopathic membranous nephropathy,IMN)的有效性及安全性。方法检索The Cochrane Library、PubMed、EMbase、中国生物医学文献数据库(CBM)、中国知网(CNKI)、维普数据库(VIP)和万方数据库,纳入GTW治疗IMN的随机对照试验,筛选文献、提取资料和评价研究质量,采用RevMan 5.2软件进行Meta分析,观察治疗后第6、12个月时蛋白尿缓解率、复发率,血白蛋白(Albumin,Alb)、血肌酐(SCr)水平及不良反应。结果共纳入6项研究,886例患者,随访第6个月时,GTW亚组总缓解率优于对照组(P<0.05);随访第12个月时,GTW亚组总缓解率与完全缓解率均优于对照组(P<0.05)。随访第6、12个月时,GTW联合钙调神经抑制剂(calcineurin inhibitor,CNI)亚组与CNI亚组缓解率相当(P>0.05),GTM亚组与CNI亚组缓解率相当(P>0.05),GTW与CNI比较完全缓解率及总缓解率疗效相当(P>0.05),然而GTW组复发率低于对照组(P<0.05);GTW组治疗后Alb上升(P<0.05),SCr稳定(P<0.05);与对照组比较,SCr与Alb变化无统计学差异(P>0.05);GTW亚组肝酶升高及月经紊乱的发生率偏高。结论 24 h尿蛋白定量<4.0 g的IMN,单用GTW治疗有效,但起效较慢;24 h尿蛋白定量>3.5 g时,GTW与CNI的临床缓解率相当,但复发率较低,GTW联合CNI治疗,可相应减少CNI用量,但需注意GTW治疗可能导致肝功能损害,育龄期妇女慎用。

Objective To evaluate the efficacy and safety of the treatment of idiopathic membranous nephropathy （IMN） by multi-glycoside of Tripterygium wilfordii （GTW）. Methods The Co-chrane Library, PubMed, EMbase, CBM, CNKI, VIP and WanFang were searched to enroll the ran- domized controlled trials （RCTs）, followed by Study selection, data extraction, quality assessment, and data analyses were performed according to the Cochrane standards. RevMan 5.2 was used to ana- lyze the information about the remission and recurrence rate of proteinuria at 6 th or 12 th month fol- lowing treatment, blood levels of albumin （Alb） and serum creatinine （SCr） levels, and adverse e- vents. Results Six articles including 886 patients were retrieved and analyzed. At 6 th month after treatment, the GTW group had a higher total remission rate （TR） than the blank control group （P〈0. 05）, and at 12 th month after treatment, both TR and compete remission rate （CR） were higher in the GTW group than the control group. At 6 th or 12 th month after treatment, no significant differ- ence in TR or CR was observed between the GTW ＋ CNI group and the CNI-alone group or between the GTW group and the CNI group. However, the recurrence rate was significantly lower in the treatmemt group （P〈0. 05）. Elevation of blood Alb and stabilization of blood SCr were observed after treatment group, which were similar to those observed after control group （P〉0. 05）. Nevertheless, liver enzymes elevation and menstrual disorders were more frequent in the GTW group. Conclusions For IMN with total proteinuria less than 4. 0 g, GTW-alone worked effectively but slowly. For IMN with total proteinuria more than 3. 5 g, GTW showed a similar RT and a lower recurrence rate, as compared with CNI. When used in combination with GTW, the dosage of CNI can be reduced corre-spondingly. On the other hand, it＇s worth noticing that GTW may cause liver damage. Using GTW in women of reproductive age should be considered with caution.