Huo Ai-Xin, Chen Wen-Hui, Liu Yu-Hong, Gao Peng, Li Jing
Department of Immunology and Rheumatology, Yanan University Affiliated Hospital, Yan'an.
Department of Dermatology, Shaanxi Provincial Institute of Dermatology and Venereology, Xi'an, China.
Medicine (Baltimore). 2019 Oct;98(43):e17607. doi: 10.1097/MD.0000000000017607.
This study aims to provide the best possible evidence-based information on the efficacy and safety of sifalimumab for treatment of skin injury (SI) caused by systemic lupus erythematosus (SLE).
In this study, electronic databases of MEDLINE, EMBASE, Cochrane Library, PsycINFO, CINAHL Plus, Global Health, WHO Global Index Medicus, Virtual Health Library, Social Care Online, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure will be searched comprehensively from inceptions to June 30, 2019 without language restrictions. We will include randomized controlled trials (RCTs) on evaluating the efficacy and safety of sifalimumab for SI caused by SLE. Two investigators will conduct study selection, data extraction, and risk of bias assessment independently. We will use RevMan 5.3 Software to perform statistical analysis.
This study will lie in the exhaustive and systematic nature of the literature search and its methods for evaluating quality and analyzing RCTs data. Considering the controversial efficacy of the treatment for sifalimumab, this study is responsible for improving the existing evidence on the efficacy and safety of sifalimumab for SI caused by SLE.
The results of this study will provide latest evidence for judging whether sifalimumab is an effective intervention for patients with SI caused by SLE or not.
CRD42019148225.
本研究旨在提供关于西法莫单抗治疗系统性红斑狼疮(SLE)所致皮肤损伤(SI)的疗效和安全性的最佳循证信息。
在本研究中,将全面检索MEDLINE、EMBASE、Cochrane图书馆、PsycINFO、CINAHL Plus、全球健康、世界卫生组织全球医学索引、虚拟健康图书馆、社会护理在线、护理及相关健康文献累积索引、补充与替代医学数据库、中国生物医学文献数据库和中国知网等电子数据库,检索时间从建库至2019年6月30日,无语言限制。我们将纳入评估西法莫单抗治疗SLE所致SI的疗效和安全性的随机对照试验(RCT)。两名研究人员将独立进行研究筛选、数据提取和偏倚风险评估。我们将使用RevMan 5.3软件进行统计分析。
本研究将基于文献检索的详尽性和系统性及其评估质量和分析RCT数据的方法。考虑到西法莫单抗治疗效果存在争议,本研究旨在完善现有关于西法莫单抗治疗SLE所致SI的疗效和安全性的证据。
本研究结果将为判断西法莫单抗是否为SLE所致SI患者的有效干预措施提供最新证据。
CRD42019148225。