{"title":"肉毒杆菌毒素注射治疗帕金森病患者运动障碍的有效性和安全性:随机对照试验荟萃分析","authors":"Fang Gao, Jinpeng Zhao, Chen Wang, Luoman Hu, Chengfei Gao","doi":"10.1111/bcpt.14082","DOIUrl":null,"url":null,"abstract":"<p>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], <i>p</i> < 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], <i>p</i> = 0.162), United Parkinson's Disease Rate Scale (UPDRS) III score (SMD = −0.20, 95% CI [−1.17, 0.76], <i>p</i> = 0.68) and clinical global impression (CGI) score (SMD = 0.84, 95% CI [−0.74, 2.42], <i>p</i> = 0.298). Adverse events related to BTX injections were comparable to placebo (OR = 1.74, 95% CI [0.59, 5.14], <i>p</i> = 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.</p>","PeriodicalId":8733,"journal":{"name":"Basic & Clinical Pharmacology & Toxicology","volume":"135 5","pages":"655-663"},"PeriodicalIF":2.7000,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"Fang Gao, Jinpeng Zhao, Chen Wang, Luoman Hu, Chengfei Gao\",\"doi\":\"10.1111/bcpt.14082\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>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], <i>p</i> < 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], <i>p</i> = 0.162), United Parkinson's Disease Rate Scale (UPDRS) III score (SMD = −0.20, 95% CI [−1.17, 0.76], <i>p</i> = 0.68) and clinical global impression (CGI) score (SMD = 0.84, 95% CI [−0.74, 2.42], <i>p</i> = 0.298). Adverse events related to BTX injections were comparable to placebo (OR = 1.74, 95% CI [0.59, 5.14], <i>p</i> = 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.</p>\",\"PeriodicalId\":8733,\"journal\":{\"name\":\"Basic & Clinical Pharmacology & Toxicology\",\"volume\":\"135 5\",\"pages\":\"655-663\"},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2024-09-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Basic & Clinical Pharmacology & Toxicology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1111/bcpt.14082\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Basic & Clinical Pharmacology & Toxicology","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1111/bcpt.14082","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
摘要
本研究旨在评估肉毒杆菌毒素(BTX)注射治疗帕金森病(PD)患者运动障碍的有效性和安全性。根据系统综述和荟萃分析首选报告项目(PRISMA)指南进行了电子检索。从现有的随机对照试验(RCT)中提取了评估 BTX 注射治疗帕金森病患者运动障碍的数据进行荟萃分析。最终,8项随机对照试验中的215名患者被纳入研究。汇总分析表明,在改善震颤方面,BTX 比安慰剂更有效(标准化平均差 [SMD] = 0.96,95% CI [0.34,1.58],p < 0.01),而在步态冻结方面,BTX 和安慰剂之间没有观察到明显差异(SMD = 0.66,95% CI [-0.26,1.58],p = 0.162)、联合帕金森病评分量表(UPDRS)III 评分(SMD = -0.20,95% CI [-1.17,0.76],p = 0.68)和临床总体印象(CGI)评分(SMD = 0.84,95% CI [-0.74,2.42],p = 0.298)。与 BTX 注射相关的不良事件与安慰剂相当(OR = 1.74,95% CI [0.59,5.14],p = 0.32)。目前的证据表明,BTX 对治疗帕金森病震颤有效且安全,但未能为帕金森病患者的步态冻结和运动功能评分带来治疗益处。此外,由于纳入的研究数量有限,且 BTX 干预方案存在异质性,因此需要进行更多研究,并开展更多标准化 RCT,以更好地了解和优化 BTX 注射治疗 PD 运动障碍的效果。
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
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.
期刊介绍:
Basic & Clinical Pharmacology and Toxicology is an independent journal, publishing original scientific research in all fields of toxicology, basic and clinical pharmacology. This includes experimental animal pharmacology and toxicology and molecular (-genetic), biochemical and cellular pharmacology and toxicology. It also includes all aspects of clinical pharmacology: pharmacokinetics, pharmacodynamics, therapeutic drug monitoring, drug/drug interactions, pharmacogenetics/-genomics, pharmacoepidemiology, pharmacovigilance, pharmacoeconomics, randomized controlled clinical trials and rational pharmacotherapy. For all compounds used in the studies, the chemical constitution and composition should be known, also for natural compounds.