摘要
目的评价沙利度胺治疗强直性脊柱炎的安全性。方法分别检索VIP、CNKI、CBM、Wanfang、PubMed及EMbase数据库收集沙利度胺治疗强直性脊柱炎的随机对照试验(RCT)的文献,语种不限,由两名研究者对文献进行质量评价及数据提取,采用STATA软件对数据进行Meta分析。结果本研究共纳入12项RCT,纳入患者共1110名。Meta分析结果显示沙利度胺治疗强直性脊柱炎较对照药物的严重不良反应增多[OR=4.34,95%CI(1.66,11.35),P=0.003],差异有统计学意义,主要为周围神经炎所致,此外,疲倦、嗜睡及口干等不良反应较对照组增加,而皮疹、胃肠道不适、肝功能异常等与对照组相当,未见肾功能受损的相关报道。结论沙利度胺治疗强直性脊柱炎安全性尚可,然而需大规模、多中心及大样本的高质量RCT进一步验证。
OBJECTIVE To systematically evaluate the safety of thalidomide in treating ankylosing spondylitis. METHODS Randomized controlled trials investigated thalidomide comparing with other drugs in ankylosing spondylitis were identified by searching VIP,CNKI,CBM,WanFang,PubMed and EMbase databases. Meta-analysis was performed by STATA software. RESULTS Twelve RCTs with a total of 1110 subjects were included. Meta-analysis showed that thalidomide had more serious side effects than the control drugs[RR = 4.34,95%CI( 1.66,11.35),P = 0.003],mainly because of peripheral neuropathy. In addition,the adverse reactions such as fatigue,drowsiness and dry mouth were increased compared with the control group,while the rash,gastrointestinal discomfort and abnormal liver function were similar to control group. CONCLUSION Thalidomide in treating ankylosing spondylitis was safe while we used properly. Future tails with high quality and large samples should be performed to confirm this conclusion.
作者
李朝霞
曾珊
吴会霞
朱丽花
任洁
周毅
LI Zhaoxia;ZENG Shan;WU Huixia;ZHU Lihua;REN Jie;ZHOU Yi(Department of Rheumatology, The First Affiliated Hospital,Jinan University,Guangzhou,Guangdong 510630,China)
出处
《今日药学》
CAS
2019年第6期420-426,共7页
Pharmacy Today
基金
广东省临床用药研究基金(2015FS04)
暨南大学科研培育与创新基金跃升计划项目(11617481)
