摘要
目的系统评价真实世界中贝利尤单抗治疗中国成人狼疮性肾炎(LN)患者的有效性和安全性。方法计算机检索PubMed、Embase、Web of Science、Cochrane Library、万方、中国知网、维普、中国生物医学文献数据库,搜集贝利尤单抗治疗中国成人LN患者的真实世界研究,检索时限均从建库至2023年7月7日。由2位评价员独立筛选文献、提取资料并评价纳入研究的质量后,采用RevMan 5.3软件进行Meta分析。结果共纳入10篇真实世界研究,包括253例中国成人LN患者。Meta分析结果显示,贝利尤单抗治疗中国成人LN患者的肾脏完全缓解率、肾脏部分缓解率、不良反应发生率分别为61%(95%CI为46%~76%,P<0.00001)、23%(95%CI为2%~44%,P=0.03)、30%(95%CI为16%~43%,P<0.00001);贝利尤单抗可显著降低24 h尿蛋白水平(MD=-1.71,95%CI为-3.02~-0.40,P=0.01)、尿总蛋白肌酐比值(MD=-1.76,95%CI为-2.06~-1.46,P<0.00001)、系统性红斑狼疮疾病活动度指数(MD=-8.63,95%CI为-12.12~-5.13,P<0.00001)和糖皮质激素用量(MD=-18.65,95%CI为-31.82~-5.48,P=0.006),显著升高补体C3水平(MD=0.19,95%CI为0.08~0.30,P=0.0006)和补体C4水平(MD=0.06,95%CI为0.02~0.09,P=0.001),但不能改善血清肌酐水平和估算肾小球滤过率(P>0.05)。结论贝利尤单抗对中国成人LN患者具有良好的有效性和安全性。
OBJECTIVE To systematically evaluate the real-world effectiveness and safety of belimumab in the treatment of lupus nephritis(LN)in Chinese adult patients.METHODS Retrieved from PubMed,Embase,Web of Science,Cochrane Library,Wanfang data,CNKI,VIP and CBM,real-world studies on belimumab in the treatment of LN in Chinese adult patients were collected from the inception to July 7th,2023.Two reviewers independently screened the literature,extracted data,and assessed the quality of the included studies.Meta-analysis was then performed using RevMan 5.3 software.RESULTS A total of 10 realworld studies were included,involving 253 Chinese adult patients with LN.The results of the meta-analysis demonstrated that the complete renal response rate,partial renal response rate,and the incidence of adverse reaction rate in Chinese adult patients with LN treated with belimumab were 61%(95%CI was 46%-76%,P<0.00001),23%(95%CI was 2%-44%,P=0.03),and 30%(95%CI was 16%-43%,P<0.00001),respectively.Belimumab could reduce the 24-hour urinary protein(MD=-1.71,95%CI was-3.02--0.40,P=0.01),urine protein-creatinine ratio(MD=-1.76,95%CI was-2.06--1.46,P<0.00001),the systemic lupus erythematosus disease activity index(MD=-8.63,95%CI was-12.12--5.13,P<0.00001),and glucocorticoids dosage(MD=-18.65,95%CI was-31.82--5.48,P=0.006).In addition,it could elevate the levels of complement C3(MD=0.19,95%CI was 0.08-0.30,P=0.0006)and complement C4(MD=0.06,95%CI was 0.02-0.09,P=0.001).However,belimumab could not improve the levels of serum creatinine and estimated glomerular filtration rate(P>0.05).CONCLUSIONS Belimumab has good efficacy and safety in Chinese adult patients with LN.
作者
李鎛江
潘红霞
傅一星
方梅荣
胡祥
董建华
肖友文
LI Bojiang;PAN Hongxia;FU Yixing;FANG Meirong;HU Xiang;DONG Jianhua;XIAO Youwen(Dept.of Nephropathy,the People’s Hospital of Leshan,Sichuan Leshan 614000,China)
出处
《中国药房》
CAS
北大核心
2024年第7期853-859,共7页
China Pharmacy
基金
四川省基层卫生事业发展研究中心科研项目(No.SWFZ21-Y-24)
四川省医学会(泰阁)专项科研课题(No.2022TG09)
四川省医院协会青年药师科研专项资金项目(No.22008)。
作者简介
第一作者:李鎛江,主治医师,硕士。研究方向:肾小球疾病及血液净化。E-mail:L546195249@163.com;通信作者:肖友文,主任医师。研究方向:肾小球疾病及血液净化。E-mail:youwenxiao@yeah.net。
