联合利妥昔单抗治疗天疱疮有效性和安全性的系统评价  

Efficacy and Safety of Rituximab for Pemphigus: A Systematic Review

作　　者：伏箫燕 陈玲[1] 钟薇[1] 王浩[1] 胡巧织 FU Xiaoyan;CHEN Ling;ZHONG Wei;WANG Hao;HU Qiaozhi(Department of Pharmacy,Xindu District People's Hospital of Chengdu,Chengdu 610500,China;Department of Pharmacy,West China Hospital,Sichuan University,Chengdu 610000,China)

机构地区：[1]成都市新都区人民医院药剂科,四川成都610500 [2]四川大学华西医院药剂科,四川成都610000

出　　处：《中国皮肤性病学杂志》2022年第1期42-47,共6页The Chinese Journal of Dermatovenereology

基　　金：成都市医学科研课题(2020114);成都药学会赞邦药学科研基金(201919)。

摘　　要：目的系统评价联合利妥昔单抗(rituximab,RTX)治疗天疱疮的有效性和安全性。方法计算机检索PubMed、Embase、Cochrane图书馆、中国学术期刊全文数据库、中文科技期刊数据库、中国生物医学文献数据库,得到RTX联合糖皮质激素(cor-ticosteroids,CS)±免疫抑制剂(immunosuppressive agent,ISA)治疗天疱疮的对照研究,进行数据提取和质量评价后使用RevMan5.3软件进行Meta分析。结果共纳入6项对照研究。Meta分析结果显示:RTX联合CS±ISA在完全缓解率和复发率方面均明显优于单用CS±ISA,差异具有统计学意义(完全缓解:RR=2.41,95%CI:1.65~3.53,Z=4.53,P<0.01;复发:RR=0.50,95%CI:0.29~0.86,Z=2.53,P=0.01);不同剂量RTX联合CS±ISA在完全缓解率和复发率方面差异均无统计学意义(完全缓解:RR=1.09,95%CI:0.81~1.46,Z=0.56,P=0.57;复发:RR=0.57,95%CI:0.11~3.01,Z=0.66,P=0.51);一线和二线RTX治疗之间的完全缓解率和复发率差异亦无统计学意义(完全缓解:RR=1.03,95%CI:0.77~1.37,Z=0.20,P=0.84;复发:RR=1.41,95%CI:0.54~3.62,Z=0.69,P=0.49);不良事件方面,RTX联合CS±ISA的不良事件发生率明显较单用CS±ISA更低,在使用不同剂量RTX治疗的患者中不良事件发生率差异无统计学意义。结论联合使用利妥昔单抗治疗天疱疮可有效缓解患者症状,减少糖皮质激素与其他免疫抑制剂的用量,避免使用糖皮质激素及免疫抑制剂带来的严重并发症,同时还可在大多数患者中得到持续的缓解。由于纳入文献数量和质量的限制,还需要开展高质量、大样本、长期随访的对照研究,对其有效性和安全性进行进一步的评估。Objective To analyze the efficacy and safety of rituximab(RTX) for pemphigus.Methods Cochrane library, PubMed, Embase, CNKI, VIP and CBM database were searched to collect the comparative studies of rituximab combined with corticosteroids(CS) ± immunosuppressive agent(ISA) in the treatment of pemphigus.Data were extracted and quality was assessed for comparative studies, and Meta-analysis was conducted by using RevMan5.3 software.Results Six trials were included.Meta-analysis showed that RTX combined with CS±ISA was more efficacious than CS±ISA in complete remission(CR) and relapse rates(CR:RR=2.41,95%CI:1.65~3.53,Z=4.53,P<0.01;relapse rate: RR=0.50,95%CI:0.29~0.86,Z=2.53,P=0.01).No significant differences in complete remission and relapse rates between patients treated with high-dose vs.low-dose RTX combined with CS±ISA(CR:RR=1.09,95%CI:0.81~1.46,Z=0.56,P=0.57;relapse rate: RR=0.57,95%CI:0.11~3.01,Z=0.66,P=0.51).There is no difference between patients treated with first-line vs. second-line RTX(CR:RR=1.03,95%CI:0.77~1.37,Z=0.20,P=0.84;relapse rate: RR=1.41,95%CI:0.54~3.62,Z=0.69,P=0.49).The frequency of adverse events(AEs) was lower in treatment of RTX combined with CS±ISA, and there was no statistical significance between high-dose and low-dose RTX in AEs.Conclusion Rituximab combined with CS±ISA against pemphigus is effective and safe.However, due to the limited quantity and quality of included studies, higher quality studies with large sample sizes and long-term follow-up periods are still needed to verify the above conclusion.

关 键 词：利妥昔单抗 天疱疮 META分析 系统评价 

分 类 号：R758.66[医药卫生—皮肤病学与性病学]