雷公藤多苷片治疗狼疮性肾炎的有效性和安全性：系统评价和 Meta 分析。
Effectiveness and safety of tripterygium glycosides tablet for lupus nephritis: a systematic review and Meta-analysis.
机构信息
Department of Rheumatology, the Second Affiliated Hospital, Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou 510006, China.
Department of Nephrology, Jiangmen Hospital of Chinese Medicine Affiliated to Jinan University, Jiangmen 529000, China.
出版信息
J Tradit Chin Med. 2022 Oct;42(5):671-680. doi: 10.19852/j.cnki.jtcm.2022.05.001.
OBJECTIVE
To investigate the effectiveness and safety of tripterygium glycosides (TG) tablet for the treatment of Lupus nephritis (LN).
METHODS
Several databases were systematically searched including PubMed, Embase, Cochrane, Wiley, China National Knowledge Infrastructure Database, SinoMed and Wanfang Library till June 20, 2020. Revman5.3 was utilized to analyze the data according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement.
RESULTS
In total, 8 randomized controlled trials involving 583 participants were identified. Meta-analyses showed that, compared with glucocorticoids (GC) alone, the combination with TG tablet provided a statistically significant improvement in total remission (TR) ( = 1.27, 95% : 1.08-1.50, = 0.004), complete remission (CR) ( = 1.61, 95% : 1.05-2.47, = 0.03) and C3 levels ( = 0.27, 95% : 0.14-0.39, < 0.000 1), C4 levels ( = 0.12, 95% : 0.07-0.17, < 0.000 01). No significant differences were seen in TR, CR, proteinuria, serum creatinine, C3 and C4 (TR: = 1.00, 95% : 0.87-1.16, = 0.95; CR: = 1.10, 95% : 0.78-1.56, = 0.58; proteinuria levels: = -0.06, 95% : -0.13 to 0.01, = 0.10; serum creatinine levels: = -0.01, 95%: -7.36 to 7.35, = 1.00; C3 levels: = 0.01, 95%: -0.06 to 0.07, = 0.84; C4 levels: = -0.01, 95%: -0.03 to 0.01, = 0.49) between azathioprine (AZA) / leflomit (LEF) + GC and TG tablet + GC. Adverse events (hepatic dysfunction, nausea, vomitting) showed no statistical differences between the TG tablet + GC group and the GC group. There were more new onset of irregular menstruation in the TG tablet + GC group than those in the AZA + GC ( = 3.57, 95% : 1.40-9.11, = 0.008) /LEF+ GC ( = 6.69, 95% : 2.42-18.46, = 0.000 2) group, but leucopenia lower than those in AZA + GC group ( = 0.38, 95% : 0.17-0.85, = 0.02) and alopecia ( = 0.14, 95% : 0.03-0.77, = 0.02) and rash ( = 0.09, 95% : 0.01-0.69, = 0.02) lower than those in LEF + GC group.
CONCLUSIONS
This review indicates that TG tablet maybe effective in LN treatment. Nevertheless, adverse events cannot be ignored. Large sample, multi-center, high-quality clinical studies are needed to verify the exact effects and safety of TG tablet in treatment of LN.
目的
探讨雷公藤多苷（TG）片治疗狼疮性肾炎（LN）的有效性和安全性。
方法
系统检索 PubMed、Embase、Cochrane、Wiley、中国知网、中国生物医学文献数据库、万方数据库，检索时间截至 2020 年 6 月 20 日。采用 Revman5.3 软件进行数据分析，并按照系统评价和荟萃分析报告的首选报告项目进行报告。
结果
共纳入 8 项随机对照试验，涉及 583 名参与者。Meta 分析结果显示，与糖皮质激素（GC）单独治疗相比，TG 片联合治疗在总缓解率（TR）（ = 1.27，95%：1.08-1.50， = 0.004）、完全缓解率（CR）（ = 1.61，95%：1.05-2.47， = 0.03）和 C3 水平（ = 0.27，95%：0.14-0.39， < 0.000 1）、C4 水平（ = 0.12，95%：0.07-0.17， < 0.000 01）方面有统计学意义的改善。TR、CR、蛋白尿、血肌酐、C3 和 C4 方面未见统计学差异（TR： = 1.00，95%：0.87-1.16， = 0.95；CR： = 1.10，95%：0.78-1.56， = 0.58；蛋白尿水平： = -0.06，95%：-0.13 至 0.01， = 0.10；血肌酐水平： = -0.01，95%：-7.36 至 7.35， = 1.00；C3 水平： = 0.01，95%：-0.06 至 0.07， = 0.84；C4 水平： = -0.01，95%：-0.03 至 0.01， = 0.49）。与 AZA/LEF+GC 联合 TG 片治疗相比，TG 片联合 GC 组与 GC 组之间的不良反应（肝功能障碍、恶心、呕吐）无统计学差异。与 AZA+GC（ = 3.57，95%：1.40-9.11， = 0.008）/LEF+GC（ = 6.69，95%：2.42-18.46， = 0.000 2）组相比，TG 片联合 GC 组新出现不规则月经的发生率更高，但白细胞减少的发生率低于 AZA+GC 组（ = 0.38，95%：0.17-0.85， = 0.02）和脱发（ = 0.14，95%：0.03-0.77， = 0.02）和皮疹（ = 0.09，95%：0.01-0.69， = 0.02）的发生率低于 LEF+GC 组。
结论
本综述表明，TG 片可能对 LN 治疗有效。然而，不良反应不容忽视。需要更大样本、多中心、高质量的临床研究来验证 TG 片在 LN 治疗中的确切疗效和安全性。
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