中国组织工程研究

中国组织工程研究 ›› 2021, Vol. 25 ›› Issue (33): 5404-5412.doi: 10.12307/2021.334

• 骨与关节循证医学 evidence-based medicine of the bone and joint • 上一篇    

不同药物治疗强直性脊柱炎的网状Meta分析

贾宏声1，李现林2，蔡  磊1，张冲锋1，陈祖闯1，张  也1   

  1. 1河南中医药大学，河南省郑州市   450000；2河南中医药大学第一附属医院骨伤科，河南省郑州市   450000
  • 收稿日期:2021-01-07 修回日期:2021-01-08 接受日期:2021-02-07 出版日期:2021-11-28 发布日期:2021-08-06
  • 通讯作者: 李现林，主任医师，硕士生导师，河南中医药大学第一附属医院骨伤科，河南省郑州市 450000
  • 作者简介:贾宏声，男，汉族，1996年生，河南省南阳市人，河南中医药大学在读硕士，主要从事中医药防治脊柱相关疾病的研究。

Network meta-analysis of different drugs for the treatment of ankylosing spondylitis

Jia Hongsheng1, Li Xianlin2, Cai Lei1, Zhang Chongfeng1, Chen Zuchuang1, Zhang Ye1   

  1. 1Henan University of Chinese Medicine, Zhengzhou 450000, Henan Province, China; 2Department of Orthopedics and Traumatology, First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, Henan Province, China
  • Received:2021-01-07 Revised:2021-01-08 Accepted:2021-02-07 Online:2021-11-28 Published:2021-08-06
  • Contact: Li Xianlin, Chief physician, Master’s supervisor, Department of Orthopedics and Traumatology, First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450000, Henan Province, China
  • About author:Jia Hongsheng, Master candidate, Henan University of Chinese Medicine, Zhengzhou 450000, Henan Province, China

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摘要：

文题释义：
强直性脊柱炎：是以骶髂关节和脊柱附着点、中轴骨骼炎症为主要症状，并以椎间盘纤维环及其附近结缔组织纤维化和骨化及关节强直为特点的慢性炎性疾病。
益赛普：为“注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白”，是一种生物制剂，一般为皮下注射，多用于活动性强直性脊柱炎、活动性类风湿性关节炎及银屑病的治疗。
目的：临床研究发现柳氮磺吡啶、依那西普、注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(以下简称为益赛普)及沙利度胺等其他药品治疗强直性脊柱炎可明显改善患者症状，提高患者生活质量，但缺乏系统评价。文章以此系统评价不同药物治疗强直性脊柱炎的临床疗效和安全性的差异。
方法：运用计算机检索中国知网、万方数据、维普、SinoMed中国生物医学文献服务系统、PubMed、Cochrane图书馆和Web of Science数据库，收集自建库至2020-09-30关于不同药物治疗强直性脊柱炎的随机对照试验类文章。运用EndNote软件筛选文献，采用Cochrane风险偏倚评估工具及RevMan 5.3对纳入的文献进行质量评价，采用Stata 14.2 进行网状Meta分析。
结果：文章共纳入29项随机对照试验，其中高风险文献21篇，低风险文献8篇；对照组治疗措施包括柳氮磺吡啶、益赛普、沙利度胺等3种用药措施，观察组采用益赛普、依那西普、沙利度胺及柳氮磺吡啶联合益赛普、益赛普联合沙利度胺治疗、沙利度胺联合柳氮磺吡啶、依那西普联合柳氮磺吡啶等7种用药措施。网状Meta分析结果显示：①临床总有效率：益赛普联合沙利度胺治疗(OR=0.07，95%CI：0.03-0.17，P < 0.05)、益赛普治疗(OR=0.23，95%CI：0.13-0.40，P < 0.05)、益赛普联合柳氮磺吡啶治疗(OR=0.18，95%CI：0.10-0.33，P < 0.05)均优于柳氮磺吡啶治疗，总有效率排序结果为：益赛普+沙利度胺治疗(97.0%)>柳氮磺吡啶+益赛普治疗(67.7%)>沙利度胺+柳氮磺吡啶治疗(60.0%)>益赛普治疗(52.2%)>依那西普+柳氮磺吡啶治疗(47.9%)>依那西普治疗(45.4%)>沙利度胺治疗(29.7%)>柳氮磺吡啶治疗(0.2%)；②不良反应发生率：益赛普治疗(OR=0.21，95%CI：0.05-0.81，P < 0.05)、沙利度胺治疗(OR=0.32，95%CI：0.17-0.61，P < 0.05)不良反应发生率较柳氮磺吡啶低，不良反应发生率由高到低排序为：依那西普治疗(91.8%)>柳氮磺吡啶治疗(84.8%)>依那西普联合柳氮磺吡啶治疗(58.8%)>柳氮磺吡啶+益赛普治疗(44.5%)>益赛普+沙利度胺治疗(32.3%)>沙利度胺治疗(24.9%)>益赛普治疗(12.9%)。
结论：基于不同药物治疗强直性脊柱炎的29项随机对照试验结果，在提高临床疗效和降低不良反应方面综合考虑，益赛普联合沙利度胺联合疗法可作为首选药物治疗方案，而益赛普单独治疗可作为次选药物治疗方案。

https://orcid.org/0000-0002-4685-6387 (贾宏声) 

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

关键词: 强直性脊柱炎, 柳氮磺吡啶, 依那西普, 益赛普, 沙利度胺, 联合用药, 随机对照试验, 网状Meta分析

Abstract: OBJECTIVE: Clinical studies have found that sulfasalazine, etanercept, Yisaipu (recombinant human tumor necrosis factor receptor type II antibody fusion protein for injection), thalidomide and other drugs can significantly improve the symptoms and quality of life of patients with ankylosing spondylitis, but there is no evaluation system. This article systematically evaluated the difference of clinical efficacy and safety of different drugs in the treatment of ankylosing spondylitis. 
METHODS: Computer was used to search CNKI, Wanfang Database, VIP, SinoMed China Biomedical Literature Service System, PubMed, Cochrane Library and Web of Science. The articles of randomized controlled trials of different drugs for ankylosing spondylitis from inception to September 30, 2020 were collected. EndNote software was used to screen the literature. Cochrane system evaluation and RevMan 5.3 were used to evaluate the quality of the included literature. Network meta-analysis was performed with Stata 14.2.
RESULTS:  A total of 29 randomized controlled trials were included in this study, including 21 high-risk articles and 8 low-risk articles. The control group was treated with sulfasalazine, Yisaipu and thalidomide, while the observation group was treated with Yisaipu, etanercept, thalidomide, sulfasalazine combined with Yisaipu, thalidomide combined with Yisaipu, thalidomide combined with sulfasalazine and etanercept combined with sulfasalazine. The network meta-analysis results showed that the total clinical effective rates were as follows: treatment with Yisaipu combined with thalidomide (OR=0.07, 95%CI:0.03-0.17, P < 0.05),  treatment with Yisaipu (OR=0.23, 95%CI:0.13-0.40, P < 0.05) and treatment with Yisaipu combined with sulfasalazine (OR=0.18, 95%CI:0.10-0.33, P < 0.05) were better than sulfasalazine treatment. The overall effective rate was ranked as: Yisaipu + thalidomide treatment (97.0%) > sulfasalazine + Yisaipu treatment (67.7%) > thalidomide + sulfasalazine treatment (60.0%) > Yisaipu treatment (52.2%) > etanercept + sulfasalazine treatment (47.9%) > etanercept treatment (45.4%) > thalidomide treatment (29.7%) > sulfasalazine treatment (0.2%). (2) The incidence of adverse reactions induced by Yisaipu (OR=0.21, 95%CI:0.05-0.81, P < 0.05) and thalidomide (OR=0.32, 95%CI:0.17-0.61, P < 0.05) was lower than that induced by sulfasalazine. The incidence of adverse reactions from high to low was: etanercept (91.8%) > sulfasalazine (84.8%) > etanercept combined with sulfasalazine (58.8%) > sulfasalazine + Yisaipu (44.5%) > Yisaipu + thalidomide (32.3%) > thalidomide (24.9%) > Yisaipu (12.9%).  
CONCLUSION: Based on the results of 29 randomized controlled trials of different drugs in the treatment of ankylosing spondylitis, in terms of improving clinical efficacy and reducing adverse reactions, Yisaipu combined with thalidomide can be used as the first choice of drug treatment, while Yisaipu alone can be used as the secondary choice of drug treatment.

Key words: ankylosing spondylitis, sulfasalazine, etanercept, Yisaipu, thalidomide, combination medication, randomized controlled trials, network meta-analysis

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