雷公藤治疗小儿紫癜性肾炎疗效及安全性系统评价和Meta分析

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目的:系统评价雷公藤治疗小儿紫癜性肾炎的疗效及安全性。方法:通过检索The Cochrane Library、Pub Med、EMBASE、CBM、CNKI、VIP和Wan Fang Data,纳入雷公藤治疗小儿紫癜性肾炎的RCT研究,检索时限为建库至2015年4月9日,语言不限。2位研究者按纳入与排除标准筛选文献、提取资料,并对文献进行质量评价,采用Rev Man 5.2软件进行Meta分析。结果:共纳入16个RCT,总人数1086。结果显示:(1)完全缓解率:雷公藤联用糖皮质激素优于单用激素(RR1.29,95%CI 1.11~1.49,P=0.000 7);CTX联用激素优于雷公藤联用激素(RR0.35,95%CI 0.16~0.75,P=0.007)。(2)总缓解率:将血尿、蛋白尿与基线值相比下降50%作为缓解基准时,在常规治疗基础上用或不用雷公藤治疗未见统计学差异(RR1.21,95%CI 0.74~1.98,P=0.45),而当将血尿、蛋白尿与其基线值相比下降30%作为基准时,见统计学差异(RR1.26,95%CI 1.04~1.51,P=0.02);雷公藤联用激素较单用激素组有优势(RR 1.25,95%CI 1.16~1.34,P<0.000 01);CTX联用激素优于雷公藤联用激素(RR 0.68,95%CI 0.47~0.99,P=0.04)。(3)复发率:雷公藤联用激素较单用激素组能降低疾病复发率(RR0.18,95%CI 0.05~0.69,P=0.01)。(4)不良反应:1肝功能损害发生率:单用雷公藤未见肝损(RR 3.27,95%CI 0.16~66.82,P=0.44);联用激素后出现了肝损(RR 3.39,95%CI 1.31~8.74,P=0.01)。2血白细胞下降发生率:单用雷公藤未见血白细胞下降(RR 3.93,95%CI 0.45~34.49,P=0.22);联用激素后却反见血白细胞下降(RR 7.49,95%CI 2.03~27.62,P=0.003);雷公藤或CTX联用激素均未见血白细胞下降(RR 1.12,95%CI0.08~16.52,P=0.94)。结论:雷公藤可在一定程度上缓解紫癜性肾炎的血尿、蛋白尿,联用糖皮质激素能协同紫癜性肾炎的疗效且可降低疾病复发。就肝功能损害及血白细胞下降等不良反应而言,雷公藤总体安全。 Objective: To systematically evaluate the efficacy and safety of tripterygium wilfordii in the treatment of purpura nephritis in children. METHODS: The RCT study of Tripterygium wilfordii for the treatment of purpura nephritis in children was included in the search of The Cochrane Library, Pub Med, EMBASE, CBM, CNKI, VIP and Wan Fang Data. The search period was from April 9 to April 15, limit. Two investigators screened the literature by inclusion and exclusion criteria, extracted data, and assessed the quality of the literature. Meta-analysis was performed using Rev Man 5.2 software. Results: A total of 16 RCTs were included, with a total number of 1086. The results showed that: (1) the complete remission rate: Tripterygium combined glucocorticoid better than single hormone (RR1.29, 95% CI 1.11-1.49, P = 0.0007); CTX combined with triptolide better than hormone Hormone (RR 0.35, 95% CI 0.16-0.75, P = 0.007). (2) Total remission rate: When hematuria and proteinuria were reduced by 50% from the baseline value as the baseline of relief, no significant difference was found in the treatment with or without tripterygium on the basis of conventional treatment (RR1.21, 95% CI 0.74 ~ 1.98, P = 0.45). When hematuria and proteinuria were reduced by 30% from their baseline values, the difference was statistically significant (RR 1.26, 95% CI 1.04-1.51, P = 0.02) Combined hormones had advantages over single hormones (RR 1.25, 95% CI 1.16-1.34, P <0.000 01); CTX combined with hormones was superior to that of tripterygium wilfordii (RR 0.68, 95% CI 0.47-0.99, P = 0.04). (3) Relapse rate: Tripterygium combined with hormones can reduce the disease recurrence rate (RR 0.18, 95% CI 0.05-0.69, P = 0.01) compared with single hormone group. (4) Adverse reactions: (1) The incidence of hepatic dysfunction: There was no hepatic damage (P> 0.05) % CI 1.31 ~ 8.74, P = 0.01). 2 The incidence of leukopenia: There was no leukopenia in tripterygium wilfordii alone (RR 3.93, 95% CI 0.45-34.49, P = 0.22); while the combined use of hormones decreased in antileukocytopenia (RR 7.49, 95% CI 2.03 ~ 27.62, P = 0.003). No decrease in leukopenia was found in tripterygium or CTX combined with hormone (RR 1.12, 95% CI0.08-16.52, P = 0.94). Conclusion: Tripterygium can alleviate the hematuria and proteinuria of purpuric nephritis to a certain extent. The combination of glucocorticoid and purpuric nephritis can reduce the relapse of the disease. In terms of adverse effects such as liver function impairment and leukopenia, Tripterygium is generally safe.
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