Wang Yuan, Liu Chun-Xiang, Zhang Jun-Hua, Qin Yi-Shan, Wang Hui, Liu Yuan
Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
Evidence-Based Medicine Center of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
Zhongguo Zhong Yao Za Zhi. 2018 Aug;43(16):3382-3390. doi: 10.19540/j.cnki.cjcmm.20180419.006.
The review aims to assess the effectiveness and safety of Zhengqing Fengtongning release tablets in treating ankylosing spondylitis (AS) systematically through searching relevant electronic databases and collecting relevant literature. Such Chinese databases as CNKI, VIP, Wanfang, and English databases as PubMed, EMbase and Cochrane Library, etc, were searched from the date of their establishment to September 2017. According to the inclusion and exclusion criteria, the methodology quality of included studies was evaluated by two independent reviewer using Cochrance evaluation system, and Meta-analysis on the clinical efficacy and safety of Zhengqing Fengtongning release tablets for AS was conducted with RevMan 5.3 software. Seven randomized control trials (RCTs) including 570 patients of AS were included, with 294 patients in Zhengqing Fengtongning treatment group and 276 patients in the western medicine control group. Meta-analysis showed that: Zhengqing Fengtongning alone treatment was superior to sulfasalazine groups in the effect on improving the total effective rate. Besides, as compared to sulfasalazine control group, the time of morning stiffness and the finger-to-floor distance were significantly shortened in Zhengqing Fengtongning treatment group. However, the cciput-to-wall distance, the chest expansion, Schober's test, disease activity score (DAS) in patients, disease activity score (DAS) in doctors, ESR, CRP showed no statistically significant differences. As compared with western medicine control group, Zhengqing Fengtongning combined with western medicine had a higher total effective, significantly shorten the time of morning stiffness, and increase Schober's test values; However, the cciput-to-wall distance, the finger-to-floor distance, the chest expansion, DAS in patients, DAS in doctors, ESR and CRP showed no statistically significant differences. Zhengqing Fengtongning had less adverse reactions in clinical application, and the main adverse reaction was skin rash or itching when used alone. The study showed: Zhengqing Fengtongning is effective for AS with high safety, but high quality clinical trials are still needed to further prove its clinical efficacy and safety.
本综述旨在通过检索相关电子数据库并收集相关文献,系统评价正清风痛宁缓释片治疗强直性脊柱炎(AS)的有效性和安全性。检索了中国知网(CNKI)、维普(VIP)、万方等中文数据库以及PubMed、EMbase和Cochrane Library等英文数据库,检索时间从各数据库建库至2017年9月。根据纳入和排除标准,由两名独立评价员采用Cochrance评价系统对纳入研究的方法学质量进行评价,并用RevMan 5.3软件对正清风痛宁缓释片治疗AS的临床疗效和安全性进行Meta分析。共纳入7项随机对照试验(RCT),涉及570例AS患者,其中正清风痛宁治疗组294例,西药对照组276例。Meta分析结果显示:正清风痛宁单药治疗在提高总有效率方面优于柳氮磺胺吡啶组。此外,与柳氮磺胺吡啶对照组相比,正清风痛宁治疗组晨僵时间和指地距明显缩短。然而,枕墙距、胸廓活动度、Schober试验、患者疾病活动度评分(DAS)、医生疾病活动度评分(DAS)、血沉(ESR)、C反应蛋白(CRP)差异无统计学意义。与西药对照组相比,正清风痛宁联合西药治疗总有效率更高,能显著缩短晨僵时间,增加Schober试验值;然而,枕墙距、指地距、胸廓活动度、患者DAS、医生DAS、ESR和CRP差异无统计学意义。正清风痛宁在临床应用中不良反应较少,单用时主要不良反应为皮疹或瘙痒。研究表明:正清风痛宁治疗AS有效且安全性高,但仍需高质量的临床试验进一步证实其临床疗效和安全性。