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肉毒毒素注射治疗帕金森病患者运动障碍的有效性和安全性:一项随机对照试验的荟萃分析。

The effectiveness and safety of botulinum toxin injections for managing motor disorders of patients with Parkinson's disease: A meta-analysis of randomized controlled trials.

机构信息

Department of Rehabilitation Medicine, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.

Department of Cardiothoracic Surgery, Yantai Municipal Laiyang Central Hospital, Yantai, Shandong, China.

出版信息

Basic Clin Pharmacol Toxicol. 2024 Nov;135(5):655-663. doi: 10.1111/bcpt.14082. Epub 2024 Sep 19.

Abstract

This study aimed to assess the effectiveness and safety of botulinum toxin (BTX) injections for managing motor disorders in patients with Parkinson's disease (PD). An electronic search was conducted based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data from available randomized controlled trials (RCTs) assessing BTX injections for motor disorders in PD patients were extracted for meta-analysis. Ultimately, 215 patients from eight RCTs were enrolled. Pooled analyses indicated that BTX was more effective than placebo in improving tremor (standardized mean difference [SMD] = 0.96, 95% CI [0.34, 1.58], p < 0.01), whereas no notable differences were observed between BTX and placebo regarding freezing of gait (SMD = 0.66, 95% CI [-0.26, 1.58], p = 0.162), United Parkinson's Disease Rate Scale (UPDRS) III score (SMD = -0.20, 95% CI [-1.17, 0.76], p = 0.68) and clinical global impression (CGI) score (SMD = 0.84, 95% CI [-0.74, 2.42], p = 0.298). Adverse events related to BTX injections were comparable to placebo (OR = 1.74, 95% CI [0.59, 5.14], p = 0.32). The current evidence suggests that BTX is effective and safe in treating PD tremor but fails to provide therapeutic benefits for freezing of gait and motor functional scores in PD patients. Furthermore, the limited number of included studies and heterogeneity in BTX intervention protocols suggest more research is needed, with additional standardized RCTs, to better understand and optimize BTX injections for motor disorders in PD.

摘要

本研究旨在评估肉毒毒素(BTX)注射治疗帕金森病(PD)患者运动障碍的有效性和安全性。我们按照系统评价和荟萃分析的首选报告项目(PRISMA)指南进行了电子检索。对评估 BTX 注射治疗 PD 患者运动障碍的随机对照试验(RCT)的数据进行了荟萃分析。最终,纳入了 8 项 RCT 的 215 名患者。汇总分析表明,BTX 治疗震颤的效果优于安慰剂(标准化均数差 [SMD] = 0.96,95%置信区间 [0.34, 1.58],p < 0.01),但 BTX 与安慰剂在改善冻结步态(SMD = 0.66,95%置信区间 [-0.26, 1.58],p = 0.162)、帕金森病评定量表(UPDRS)第三部分评分(SMD = -0.20,95%置信区间 [-1.17, 0.76],p = 0.68)和临床总体印象(CGI)评分(SMD = 0.84,95%置信区间 [-0.74, 2.42],p = 0.298)方面无显著差异。BTX 注射相关的不良反应与安慰剂相当(比值比 [OR] = 1.74,95%置信区间 [0.59, 5.14],p = 0.32)。现有证据表明,BTX 治疗 PD 震颤有效且安全,但对 PD 患者的冻结步态和运动功能评分无治疗益处。此外,纳入研究数量有限,BTX 干预方案存在异质性,这表明需要开展更多研究,包括更多标准化 RCT,以更好地了解和优化 BTX 注射治疗 PD 运动障碍。

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