中药外用制剂治疗膝骨关节炎的随机对照试验证据图

Evidence map of randomized controlled trial of topical preparations of traditional chinese medicine in the treatment of knee osteoarthritis

关键词:  中药外用制剂  膝骨关节炎  随机对照试验  证据图

Key words:  topical preparations of traditional Chinese medicine  knee osteoarthritis  randomized controlled trial  evidence map

摘要:

[目的] 系统检索并筛选中药外用制剂治疗膝骨关节炎（KOA）的随机对照试验（RCT），运用证据图梳理证据分布特点，发现存在的问题和可能的改进方向。[方法] 检索从建库至2024年7月中国知网（CNKI）、中国生物医学文献数据库（CBM）、万方数据知识服务平台、维普资讯中文科技期刊数据库（VIP）、PubMed、Embase、Cochrane library、Web of Science中英文数据库，根据纳排标准筛选中药外用制剂治疗KOA的RCT，以文字和图表相结合的方式呈现证据的分布情况。[结果] 共纳入230项RCTs，发表文献量呈波动式上升，近3年有下降趋势；涉及157种中药外用制剂，以奇正消痛贴膏、海桐皮汤熏洗、消瘀接骨散、青鹏软膏等研究较多，对照组干预方式以外用或口服非甾体抗炎药（NSAIDs）为主，干预时长以2～4周为主，随访时长多为3个月；多数研究方法学质量较低；结局指标以疼痛/功能主观评分指标、临床疗效类指标为主，对疼痛/功能客观评价指标、中医证候疗效评价指标、安全性指标关注较少。[结论] 当前中药外用制剂治疗KOA的临床研究存在样本规模小、周期短、方法学质量低、结局指标不规范等问题，在今后研究中应做好顶层设计，规范研究过程，提高研究质量，从而挖掘并验证中药外用制剂治疗KOA的独特优势。

Abstract:

[Objective] To systematically search and screen the clinical randomized controlled trial（RCT） of topical preparations of traditional Chinese medicine（TCM） in the treatment of knee osteoarthritis（KOA），use the evidence graph to sort out the evidence distribution characteristics，and find the existing problems and possible improvement direction. [Methods] The Chinese and English databases of China National Knowledge Infrastructure（CNKI），China Biology Medicine（CBM），Wanfang Database，VIP Information Chinese Science and Technology Journal Database（VIP），PubMed，Embase，Cochrane library，and Web of Science were comprehensively searched from the establishment of the database to July 2024. According to the inclusion and exclusion criteria，RCTs of traditional Chinese medicine topical preparations in the treatment of KOA were screened，and the distribution of evidence was presented in the form of text and charts. [Results] A total of 230 RCTs were included. The number of articles published increased fluctuantly and decreased in recent 3 years. There were 157 kinds of traditional Chinese medicine topical preparations involved，including Qizheng Xiaotong Plaster，Haitongpi Decoction fumigation and washing，Xiaoyu Jiegu Powder，Qingpeng Ointment，etc. The intervention methods of the control group were mainly external or oral non-steroidal anti-inflammatory drugs（NSAIDs），the intervention duration was mainly 2 to 4 weeks，and the follow-up duration was mostly 3 months. The methodological quality of most studies was low. The outcome indicators were mainly pain/function subjective scoring indicators and clinical efficacy indicators，and less attention was paid to pain/function objective evaluation indicators，TCM syndrome efficacy evaluation indicators and safety indicators. [Conclusion] At present，there are some problems in the clinical studies of TCM topical preparations for the treatment of KOA，such as small sample size，short period，low methodological quality，and non-standard outcome indicators. In the future research，we should do a good top-level design，standardize the research process，and improve the research quality，so as to explore and verify the unique advantages of TCM topical preparations for the treatment of KOA.