利妥昔单抗治疗原发性干燥综合征疗效及安全性的Meta分析  

Meta-analysis of the efficacy and safety of rituximab in the treatment of primary Sjögren syndrome

作　　者：李纪高[1] 刘瑞林[1] 王子华[1] 王荷珺 苏培培 周全[1] LI Jigao;LIU Ruilin;WANG Zihua;WANG Hejun;SU Peipei;ZHOU Quan(Dept.of Rheumatology,the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450099,China)

机构地区：[1]河南中医药大学第一附属医院风湿病科,郑州450099

出　　处：《中国药房》2025年第5期619-623,共5页China Pharmacy

基　　金：河南省中医药科学研究专项课题(No.2023ZXZX-1071);河南省第二批中医药青苗人才培养项目(No.豫卫中医函〔2023〕64号)。

摘　　要：目的评价利妥昔单抗(RTX)治疗原发性干燥综合征(pSS)的疗效及安全性。方法检索Cochrane Library、PubMed、Embase、Medline、Web of Science、维普网、中国知网、万方数据等数据库,收集RTX(试验组)对比安慰剂(对照组)治疗pSS的随机对照试验(RCT),检索时限为建库至2024年2月。对文献进行资料提取和质量评价后,采用RevMan 5.3软件进行Meta分析。结果最终纳入7篇RCT,共计518例患者。Meta分析结果显示,试验组患者的欧洲抗风湿病联盟干燥综合征疾病活动指数(ESSDAI)评分[MD=-1.17,95%CI(-1.52,-0.82),P<0.00001]、口干视觉模拟(VAS)评分[MD=-3.97,95%CI(-5.08,-2.86),P<0.00001]均显著低于对照组,未刺激唾液流速[SMD=0.64,95%CI(0.41,0.87),P<0.00001]、希尔默试验(Schirmer)评分[MD=0.19,95%CI(0.18,0.20),P<0.00001]均显著高于对照组;两组患者的应答率[RD=0.10,95%CI(-0.04,0.23),P=0.16]、疲乏VAS评分[MD=-12.50,95%CI(-35.14,10.15),P=0.28]、欧洲抗风湿病联盟干燥综合征患者自我报告指数(ESSPRI)评分[MD=0.33,95%CI(-0.53,1.18),P=0.46]、健康调查简表-物理部分(SF36-PCS)评分[MD=0.90,95%CI(-2.97,4.78),P=0.65]、健康调查简表-心理部分(SF36-MCS)评分[MD=0.11,95%CI(-0.41,0.63),P=0.68]、总唾液腺超声评分[SMD=-1.91,95%CI(-4.01,0.19),P=0.07]、不良反应发生率[OR=1.15,95%CI(0.62,2.13),P=0.66]比较,差异均无统计学意义。结论RTX可改善pSS患者的ESSDAI评分、未刺激唾液流速、Schirmer评分和口干VAS评分,且安全性较好,但对改善疲乏VAS评分、ESSPRI评分、SF36-PCS评分、SF36-MCS评分和应答率无显著优势。OBJECTIVE To evaluate the efficacy and safety of rituximab(RTX)in the treatment of primary Sjögren syndrome(pSS).METHODS Randomized controlled trials(RCTs)on the effects of RTX(trial group)versus placebo(control group)in the treatment of pSS were searched from the Cochran Library,PubMed,Embase,Medline,Web of Science,VIP,CNKI,Wanfang,and other databases during the inception to February 2024.After literature screening and quality evaluation,meta-analysis was performed by using RevMan 5.3 software.RESULTS Seven RCTs were finally included,involving a total of 518 patients.Results of meta-analysis showed that European League Against Rheumatism Sjögren syndrome disease activity index(ESSDAI)score[MD=-1.17,95%CI(-1.52,-0.82),P<0.00001]and oral dryness visual analogue scale(VAS)score[MD=-3.97,95%CI(-5.08,-2.86),P<0.00001]in the trial group were significantly lower than the control group;unstimulated salivary flow rate[SMD=0.64,95%CI(0.41,0.87),P<0.00001]and Schirmer score[MD=0.19,95%CI(0.18,0.20),P<0.00001]were significantly higher than the control group.There was no statistical significance in response rate[RD=0.10,95%CI(-0.04,0.23),P=0.16],fatigue VAS score[MD=-12.50,95%CI(-35.14,10.15),P=0.28],European League Against Rheumatism Sjögren syndrome patient reported index(ESSPRI)score[MD=0.33,95%CI(-0.53,1.18),P=0.46],Short-form 36 health survey physical component summary(SF36-PCS)score[MD=0.90,95%CI(-2.97,4.78),P=0.65],SF-36 mental component summary(SF36-MCS)score[MD=0.11,95%CI(-0.41,0.63),P=0.68],total salivary gland ultrasound score[SMD=-1.91,95%CI(-4.01,0.19),P=0.07]or the incidence of adverse drug reactions[OR=1.15,95%CI(0.62,2.13),P=0.66]between 2 groups.CONCLUSIONS RTX has advantages in the improvement of ESSDAI score,unstimulated salivary flow rate,Schirmer score and oral dryness VAS score in pSS patients,and has a good safety profile.However,it did not exhibit significant improvement in fatigue VAS score,ESSPRI score,SF36-PCS score,SF36-MCS score or response rates.

关 键 词：原发性干燥综合征 利妥昔单抗 疗效 安全性 META分析 

分 类 号：R986[医药卫生—药品] R593.2[医药卫生—药学]