| 摘要: |
| [目的] 系统评价正清风痛宁在膝骨关节炎（KOA）治疗中的有效性及安全性。[方法] 基于中成药临床证据数据库（EVDS）进行系统评价，纳入建库至2026年4月2日收录的正清风痛宁治疗KOA的随机对照试验（RCT）。试验组采用正清风痛宁单用或联合常规治疗，对照组采用常规治疗。文献筛选、数据提取、质量评价及Meta分析均通过EVDS数据库自动化进行。[结果] 共纳入25项RCT，涉及2 286例患者。试验组单用正清风痛宁、联用常规治疗（CT）分亚组进行Meta分析，结果显示单用正清风痛宁在Lequesne指数、Lysholm膝关节评分、白细胞介素（IL）-1β、IL-6方面优于CT；在CT基础上加载正清风痛宁在Lequesne指数、Lysholm膝关节评分、临床疗效、IL-1β、IL-6方面表现更优。12项研究报告117例不良事件，试验组49例、对照组68例，主要为胃肠道反应、皮肤瘙痒、皮疹及局部皮肤反应，未见严重不良事件报告。[结论] 正清风痛宁在KOA的治疗中可能安全有效，但研究结论仍需高质量、大样本、多中心RCT进一步验证。 |
| 关键词: 正清风痛宁 膝骨关节炎 Meta分析 随机对照试验 临床疗效 |
| DOI：10.11656/j.issn.1673-9043.2026.08.11 |
| 分类号:R684.3;R2-03 |
| 基金项目: |
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| Efficacy and safety of zhengqing fengtongning in the treatment of knee osteoarthritis：A systematic review and meta-analysis based on the EVDS database |
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XU Peng1, YU Tingting1, CHEN Yongshuai1, DAI Chunze1, CUI Jialu1, SANG Zifan2
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1.Department of Rehabilitation, Beichen District Hospital of Traditional Chinese Medicine, Tianjin 300400, China;2.Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
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| Abstract: |
| [Objective] To systematically review the efficacy and safety of Zhengqing Fengtongning in the treatment of knee osteoarthritis（KOA）。[Methods] A systematic review was conducted based on the Evidence Database of Chinese Patent Medicine（EVDS）. Randomized controlled trials（RCTs）on Zhengqing Fengtongning for KOA were included from database inception to April 2，2026. The experimental group received Zhengqing Fengtongning alone or combined with conventional treatment（CT），while the control group received CT alone. Literature screening，data extraction，quality assessment，and meta analysis were performed automatically through the EVDS database. [Results] A total of 25 RCTs involving 2 286 patients were included. Subgroup meta-analyses were performed based on whether the experimental group received Zhengqing Fengtongning alone or combined with CT. The results showed that Zhengqing Fengtongning alone was superior to CT in Lequesne index，Lysholm knee score，IL-1β，and IL 6. Adding Zhengqing Fengtongning to CT showed better outcomes in Lequesne index，Lysholm knee score， clinical efficacy，IL-1β，and IL-6. A total of 117 adverse events were reported in 12 studies，with 49 cases in the experimental group and 68 cases in the control group. The main adverse events were gastrointestinal reactions， pruritus，rash，and local skin reactions，with no serious adverse events reported. [Conclusion] Zhengqing Fengtongning may be safe and effective in the treatment of KOA，but the conclusions still need to be further validated by high-quality，large-sample，multicenter RCTs. |
| Key words: zhengqing fengtongning knee osteoarthritis meta-analysis randomized controlled trial clinical efficacy |
