The George Institute for Global Health, University of Sydney, Sydney, Australia.
Am J Kidney Dis. 2013 Sep;62(3):515-30. doi: 10.1053/j.ajkd.2013.02.374. Epub 2013 May 10.
Preparations of the herb Tripterygium wilfordii Hook F are used widely for the treatment of chronic kidney disease in China. The efficacy and safety of Tripterygium preparations still have not been fully identified.
Systematic review and meta-analysis.
SETTING & POPULATION: Patients with chronic kidney disease.
Randomized controlled trials.
Tripterygium preparations (Tripterygium glycoside tablets, Tripterygium hypoglaucum Hutch tablets, and Tripterygium granules or extracts) versus placebo, standard care, or other immunosuppressive treatment.
Weighted mean difference and summary estimates of relative risk (RR) reductions with 95% CIs were calculated with a random-effects model. Outcomes analyzed included change in proteinuria, serum creatinine level, and creatinine clearance rate, as well as remission and relapse rate and drug-related adverse events.
We identified 75 trials that included 4,386 participants. Overall, Tripterygium therapy reduced proteinuria by protein excretion of 628 (95% CI, -736 to -521) mg/d and reduced serum creatinine level by 0.12 (95% CI, -0.17 to -0.06) mg/dL compared with controls (both P < 0.001) in a range of kidney conditions. Tripterygium preparations also increased the rate of complete remission by 56% (95% CI, 32%-85%; P < 0.001) and of complete or partial remission by 24% (95% CI, 17%-31%; P < 0.001) while reducing relapse by 58% (95% CI, 42%-69%; P < 0.001). Tripterygium preparations increased the rate of liver function test result abnormalities (RR, 4.03; 95% CI, 2.24-7.25; P < 0.001) and altered menstruation (RR, 5.29; 95% CI, 2.09-13.38; P < 0.001).
Suboptimal study quality, significant heterogeneity in the primary outcome.
Tripterygium preparations may have nephroprotective effects, but high-quality trials are required to reliably determine the balance of benefits and harms.
雷公藤制剂被广泛用于治疗中国的慢性肾脏病。雷公藤制剂的疗效和安全性尚未得到充分证实。
系统评价和荟萃分析。
慢性肾脏病患者。
随机对照试验。
雷公藤制剂(雷公藤多苷片、昆明山海棠片、雷公藤颗粒或提取物)与安慰剂、标准治疗或其他免疫抑制剂治疗相比。
采用随机效应模型计算加权均数差值和相对风险(RR)降低的汇总估计值,95%置信区间。分析的结局包括蛋白尿、血清肌酐水平和肌酐清除率的变化,以及缓解和复发率和药物相关不良事件。
我们确定了 75 项试验,共纳入 4386 名参与者。总体而言,与对照组相比,雷公藤治疗组蛋白尿减少 628mg/d(95%CI,-736 至-521),血清肌酐水平降低 0.12mg/dL(95%CI,-0.17 至-0.06)(均 P<0.001),涉及多种肾脏疾病。雷公藤制剂还使完全缓解率提高了 56%(95%CI,32%-85%;P<0.001),完全或部分缓解率提高了 24%(95%CI,17%-31%;P<0.001),同时使复发率降低了 58%(95%CI,42%-69%;P<0.001)。雷公藤制剂增加了肝功能试验结果异常的发生率(RR,4.03;95%CI,2.24-7.25;P<0.001)和月经改变的发生率(RR,5.29;95%CI,2.09-13.38;P<0.001)。
研究质量欠佳,主要结局存在显著异质性。
雷公藤制剂可能具有肾脏保护作用,但需要高质量的试验来可靠地确定其获益与危害的平衡。