中国药房2025，Vol.36Issue(5)：619-623,5.DOI:10.6039/j.issn.1001-0408.2025.05.20
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
摘要
Abstract
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＜0.000 01]and oral dryness visual analogue scale(VAS)score[MD=-3.97,95％CI(-5.08,-2.86),P＜0.000 01]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＜0.000 01]and Schirmer score[MD=0.19,95％CI(0.18,0.20),P＜0.000 01]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Key words
primary Sjögren syndrome/rituximab/efficacy/safety/meta-analysis分类
医药卫生引用本文复制引用
李纪高,刘瑞林,王子华,王荷珺,苏培培,周全..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[J].中国药房,2025,36(5):619-623,5.基金项目
河南省中医药科学研究专项课题(No.2023ZXZX-1071) （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) （No.豫卫中医函[2023]64 号）
