环孢素A治疗自身免疫性疾病的疗效和安全性系统评价

Systematic Evaluation of the Efficacy and Safety of Cyclosporin A in the Treatment of Autoimmune Diseases

摘要: 目的：综合分析并比较CsA治疗AIDs的疗效及安全性，以期为临床使用CsA治疗AIDs提供一定的参考依据。方法：采用主题词结合自由词的方式检索，检索知网、万方、维普、the Cochrane Library、PubMed、FMJS数据库，搜索有关CsA治疗AIDs的随机对照试验，时限为从建库至2024年12月24日，采用RevMan 5.4.1及Stata 15.1软件进行Meta分析和发表偏倚检验。结果：本研究共纳入45篇文献。分析结果显示，CsA组治疗AIDs提高临床总有效率(P < 0.00001)，升高HGB (P < 0.00001)、WBC (P < 0.00001)、PLT (P < 0.00001)，多毛发生率(P = 0.01)与牙龈增生发生率(P < 0.00001)方面与对照组相比，差异具有统计学意义；CsA组降低UTP (g/24h) (P = 0.46)和Scr (P = 0.38)，震颤(P = 0.42)、肝功能损伤(P = 0.73)、肾功能损伤(P = 0.27)与血压升高发生率(P = 0.77)与对照组相比，差异无统计学意义。结论：CsA治疗AIDs在提高临床总有效率，升高HGB、WBC及PLT方面优于对照组，降低UTP (g/24h)与Scr效果不明显，虽然不良反应中多毛与牙龈增生症状发生率略高，但停药后可缓解，具有一定的安全性。

Abstract: Objective: To comprehensively analyze and compare the efficacy and safety of CsA in the treatment of autoimmune diseases (AIDs), in order to provide a reference basis for the clinical use of CsA in the treatment of AIDs. Methods: A subject term combined with free word search was used to search CNKI, Wanfang, VIP, the Cochrane Library, PubMed, and FMJS databases for randomized controlled trials of CsA for AIDs, with a timeframe from the establishment of the database to December 24, 2024. RevMan 5.4.1 and Stata 15.1 software were used for the Meta-analysis and publication bias test. Results: A total of 45 studies were included in this study. The results of the analysis showed that the CsA group treated AIDs to improve the overall clinical effectiveness rate (P < 0.00001), elevated HGB (P < 0.00001), WBC (P < 0.00001), PLT (P < 0.00001), and the incidence of hirsutism (P = 0.01) and gingival hyperplasia (P < 0.00001) were statistically significant compared with the control group. The CsA group reduced UTP (g/24h) (P = 0.46) and Scr (P = 0.38), and the differences in tremor (P = 0.42), hepatic impairment (P = 0.73), renal impairment (P = 0.27), and the incidence of elevated blood pressure (P = 0.77) were not statistically significant compared with the control group. Conclusion: CsA treatment of AIDs was superior to the control group in improving the overall clinical efficacy rate, elevating HGB, WBC, and PLT. The effect of reducing UTP (g/24h) and Scr was not obvious. Although the incidence of hirsutism and gingival hyperplasia symptoms in adverse effects was slightly higher, these symptoms could be relieved after stopping the drug, indicating a certain degree of safety.