摘要
目的:通过Meta分析评价地舒单抗治疗类风湿关节炎(RA)患者骨质疏松症(OP)的有效性及安全性。方法:检索PubMed、Web of Science、Embase、Cochrane Library、中国知网(CNKI)、万方(Wanfang)、维普(VIP)和中国生物医学文献数据库(CBM),查找从建库至2021年10月国内外正式期刊发表的有关地舒单抗治疗RA患者OP的随机对照试验(RCT)、前瞻性和回顾性比较研究,将检索到的文献由2名研究人员独立筛选,并按照Cochrane 5.1手册推荐的偏倚风险评估工具对纳入文献进行方法学质量评价,采用Revman 5.3软件进行数据统计分析。结果:最终纳入符合标准的文献8篇,共1399例患者,其中试验组735例,对照组664例。Meta分析结果显示,地舒单抗治疗12个月后,能够有效提高未接受过BPs类药物治疗的RA患者腰椎BMD水平(MD=3.08,95%CI:1.73~4.42,P<0.00001),但与BPs类药物相比,地舒单抗改善腰椎BMD效果无明显差异(MD=0.02,95%CI:-0.03~0.06,P=0.49);地舒单抗还可保护关节,降低Sharp评分(MD=-0.53,95%CI:-0.77~-0.29,P<0.0001)和关节间隙狭窄评分(MD=-0.12,95%CI:-0.17~-0.06,P<0.0001),抑制骨侵蚀,降低关节骨侵蚀评分(MD=-0.49,95%CI:-0.84~-0.15,P<0.0050),且安全性较好,不良事件发生率与对照组相似(一般不良事件:RR=1.05,95%CI:0.76~1.45,P=0.75;严重不良事件:RR=0.73,95%CI:0.52~1.04,P=0.08;死亡事件:P=0.36)。结论:地舒单抗能够显著提高腰椎BMD,降低关节损伤及骨侵蚀评分,缓解关节间隙狭窄,抑制骨侵蚀破坏,最大程度保护关节,维持关节功能且安全性较好,但本研究结论仍需更大样本量验证以及进一步延伸研究。
Objective:To evaluate efficacy and safety of denosumab in treatment of osteoporosis(OP)of rheumatoid arthritis(RA)patients by Meta analysis.Methods:Databases of PubMed,Web of Science,Embase,Cochrane Library,CNKI,Wanfang,VIP and CBM were searched for randomized controlled trials(RCT),prospective and retrospective comparative studies about denosumab in treatment of OP with RA patients published in domestic and foreign official journals from establishment of database to October 2021.Retrieved literatures were screened independently by two researchers,and methodological quality of included literatures was evaluated according to bias risk assessment tool recommended by Cochrane 5.1.Data were statistically analyzed by Revman 5.3.Results:A total of 1399 patients from 8 articles in accordance with criteria were included,including experimental group(n=735)and control group(n=664).Meta analysis results showed that after 12 months of treatment,denosumab could effectively increase level of lumbar BMD in RA patients who have not been treated with BPs(MD=3.08,95%CI:1.73~4.42,P<0.00001).However,compared with BPs drugs,there was no significant difference in effect of improving lumbar BMD of denosumab(MD=0.02,95%CI:−0.03~0.06,P=0.49).Moreover,denosumab could protect joint and reduce Sharp score(MD=−0.53,95%CI:−0.77~−0.29,P<0.0001)and joint space narrowing score(MD=−0.12,95%CI:−0.17~−0.06,P<0.0001),inhibit bone erosion and reduce joint bone erosion score(MD=−0.49,95%CI:−0.84~−0.15,P<0.0050),had good application safety and incidence of adverse events was similar to control group(general adverse events:RR=1.05,95%CI:0.76~1.45,P=0.75;serious adverse events:RR=0.73,95%CI:0.52~1.04,P=0.08;death event:P=0.36).Conclusion:Current evidence shows that denosumab can significantly increase BMD of lumbar vertebrae,reduce score of joint injury and bone erosion,alleviate joint space stenosis,inhibit bone erosion,protect joint to maximum extent,maintain joint function and has high safety.However,the conclusions of this study s
作者
姜平
赵佳男
魏凯
金晔华
常岑
许玲夏
何东仪(指导)
JIANG Ping;ZHAO Jianan;WEI Kai;JIN Yehua;CHANG Cen;XU Lingxia;HE Dongyi(Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《中国免疫学杂志》
CAS
CSCD
北大核心
2023年第9期1928-1933,共6页
Chinese Journal of Immunology
基金
国家自然科学基金面上项目(82074234)
国家中医药管理局区域中医(专科)诊疗中心建设项目(2018-2022)
上海市卫生健康委华东片区中西医结合关节病专科联盟项目[ZY(2021-2023)-0302]
上海市何东仪名中医工作室建设项目(SHGZS-202220)。
