| 中医运动疗法对帕金森病临床效果随机对照试验的质量评价 |
| 投稿时间：2025-01-01 修订日期：2025-02-05 点此下载全文 |
| 引用本文：章伟丽,杨静,蔡祎晴,赵安妮,赵国桢,刘新.中医运动疗法对帕金森病临床效果随机对照试验的质量评价[J].医学研究杂志,2025,54(5):158-165 |
| DOI：
10.11969/j.issn.1673-548X.2025.05.028 |
| 摘要点击次数: 3 |
| 全文下载次数: 4 |
|
| 基金项目:北京中医药大学高层次人才科研启动项目(90011451310034) |
|
| 中文摘要:目的 评价中医运动疗法对帕金森病(Parkinson′s disease,PD)临床效果的随机对照试验(randomized controlled trial,RCT)的方法学和报告质量,了解其质量现况和存在的问题,为今后临床实践的改进提供参考。方法 计算机检索中英文数据库后,依据Cochrane偏倚风险评估工具(ROB 1.0)与CONSORT 2010声明,对纳入的RCT的方法学和报告质量进行评价,并统计结局指标报告情况。结果 共纳入54项研究,其中57.4%的研究采用太极拳干预。在纳入的研究中,随机分配方法与分配方案隐藏、结局评价者盲法、其他偏倚来源未能充分报告。这些研究中96.3%(52篇)在受试者及干预者盲法方面为高风险,仅14.8%(8篇)采用且描述了随机分配方案隐藏、38.9%(21篇)报告使用了结局评价者盲法。CONSORT评价显示,总的37个小项中,有5个小项(13.5%)报告率为0。有超过一半的小项(67.6%)报告率小于50%,其中有分配方案的隐藏(14.8%)、盲法的实施情况(38.9%)、样本量估算(16.7%)、意向性治疗分析(20.4%)及研究方案注册(22.2%)等。结论 中医运动疗法对PD临床疗效的RCT整体方法学质量、报告质量偏低,研究者未来开展临床研究时,要严格遵循CONSORT声明来规范RCT的设计、实施和报告,减小偏倚风险和提高非运动症状及安全性指标的关注度,提高原始研究质量,以便于研究更好地被转化和利用,促进中医运动疗法在PD管理中的应用与推广。 |
| 中文关键词:帕金森病 中医运动疗法 随机对照试验 质量评价 CONSORT |
| |
| Quality Evaluation of Randomized Controlled Trials of Exercise Therapy of Traditional Chinese Medicine for Parkinson′s Disease. |
|
|
| Abstract:Objective To evaluate the methodological and report quality of the randomized controlled trials (RCT) of Traditional Chinese Medicine (TCM) exercise in patients with Parkinson′s disease (PD). Know the current quality status and existing problems, and provide reference for future clinical practice. Methods After Chinese and English databases were searched by computer. We referred to Cochrane 5.1.0 Bias Risk Assessment Tool and the CONSORT 2010 Statement, evaluated the methodology and report quality of the included RCT. Results 54studies were included, 57.4% were Tai chi intervention, the concealment of randomization and allocation schemes, blinding of outcome assessors, and other sources of bias were not adequately reported. 96.3% (52studies) had a high risk of blinding subjects and intervenors, only 14.8% (8studies) used and described the concealment of randomization, and 38.9% (21studies) reported the use of blinding of outcome assessors. The evaluation results of CONSORT statement showed that in total 37subitems, 5subitems (13.5%) had a report rate of 0. More than half of the subitems (67.6%) had a report rate of less than 50%, including concealment of allocation (14.8%), implementation of blinding (38.9%), sample-size estimation (16.7%), intention-to-treat analysis (20.4%), and protocol registration (22.2%), etc. Conclusion The methodological and report quality of RCT were low. In the future, researchers should strictly follow the CONSORT statement to standardize the design, implementation and reporting of RCT, improve the higher methodological quality and pay more attention to outcomes in non-motor function and safety outcomes, then provide original studies with better quality for PD management and promote them to be transformed and utilized. Finally, promote exercise therapy of traditional Chinese medicine in PD management. |
| keywords:Parkinson′s disease Exercise therapy of traditional Chinese medicine RCT Quality evaluation CONSORT |
| 查看全文 查看/发表评论 下载PDF阅读器 |
|
|
|
