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A型肉毒毒素治疗手部震颤:随机对照试验的荟萃分析。

Botulinum toxin type A for hand tremor: a meta-analysis of randomised controlled trials.

机构信息

Guangzhou University of Traditonal Chinese Medicine, No 12,Baiyun District, 510000 Guangzhou, China.

出版信息

Neurol Neurochir Pol. 2020;54(6):561-567. doi: 10.5603/PJNNS.a2020.0079. Epub 2020 Oct 13.

DOI:10.5603/PJNNS.a2020.0079
PMID:33047784
Abstract

BACKGROUND

Tremor is one of the most common movement disorders. It does not usually respond to first-line drug treatments (e.g. propranolol, primidone, anticholinergics, gabapentin and clonazepam) due to side effects and frequent dose limitations. Botulinum toxin type A (BoNT-A) has been widely used to treat tremor, but its efficacy and safety are uncertain.

AIMS

To evaluate the efficacy and safety of BoNT-A in the treatment of hand tremor.

METHODS

We searched the MEDLINE, EMBASE, PsycINFO and Cochrane Library databases for relevant randomised controlled trials of the effects of BoNT-A injections on tremors, up to 20 February 2020. A meta-analysis of comparative effects was performed using R studio software, and publication bias was examined using Egger's test.

RESULTS

Six studies examining a total of 245 participants with tremor were included in the meta-analysis. The primary outcome of meta-analysis showed no difference in clinical tremor scale scores between the BoNT-A group versus the placebo group (standardised mean difference (SMD): -0.42, 95% confidence interval (CI): -1.94 to 1.10; I2 = 96%). For clinical tremor scale scores, subgroup analyses suggested that the BoNT-A group may differ in terms of multiple sclerosis (MS) related tremor (SMD: -1.10; 95% CI: -2.17 to -0.04; I2 = 79%) compared to a placebo, but the difference did not exist in the outcome of essential tremor (ET) or hand tremor (MD: -1.31; 95% CI: -3.39; 1.31; I2 = 97%). Grip strength (MD: -1.25, 95% CI: -5.99 to 3.50, I2 = 97%) was slightly lower in the BoNT-A group, but the difference was not significant. The incidence of adverse events (AEs), including hand weakness (RR: 2.96, 95% CI: 1.40 to 6.24, I2 = 37%), was significantly greater in the BoNT-A group than in the placebo group. Two studies were assessed as having an overall low risk of bias.

CONCLUSIONS

Our study confirms that BoNT-A injections are unlikely to have an impact on patients with hand tremors. However, subgroup analysis suggested that BoNT-A injections could have possible benefits in MS-related tremor. While moderate to severe hand weakness AEs often limits their use in clinical practice, additional well-designed double-blind, placebo-controlled trials are needed to provide more robust conclusions.

摘要

背景

震颤是最常见的运动障碍之一。由于副作用和频繁的剂量限制,它通常不会对一线药物治疗(例如普萘洛尔、丙戊酸钠、抗胆碱能药物、加巴喷丁和氯硝西泮)产生反应。A型肉毒毒素(BoNT-A)已被广泛用于治疗震颤,但疗效和安全性尚不确定。

目的

评估 BoNT-A 治疗手部震颤的疗效和安全性。

方法

我们检索了 MEDLINE、EMBASE、PsycINFO 和 Cochrane 图书馆数据库,以获取截至 2020 年 2 月 20 日 BoNT-A 注射治疗震颤效果的相关随机对照试验。使用 R 工作室软件对比较效果进行了荟萃分析,并使用 Egger 检验检查了发表偏倚。

结果

荟萃分析纳入了 6 项共 245 名震颤患者的研究。主要结局的荟萃分析显示,BoNT-A 组与安慰剂组的临床震颤量表评分无差异(标准化均数差(SMD):-0.42,95%置信区间(CI):-1.94 至 1.10;I2=96%)。对于临床震颤量表评分,亚组分析表明,BoNT-A 组可能在多发性硬化症(MS)相关震颤方面与安慰剂有所不同(SMD:-1.10;95%CI:-2.17 至-0.04;I2=79%),但在特发性震颤(ET)或手部震颤(MD:-1.31;95%CI:-3.39;1.31;I2=97%)方面没有差异。BoNT-A 组握力(MD:-1.25,95%CI:-5.99 至 3.50,I2=97%)略有下降,但差异无统计学意义。不良事件(AE)的发生率,包括手部无力(RR:2.96,95%CI:1.40 至 6.24,I2=37%),BoNT-A 组明显高于安慰剂组。两项研究被评估为总体低偏倚风险。

结论

我们的研究证实,BoNT-A 注射不太可能对手部震颤患者产生影响。然而,亚组分析表明,BoNT-A 注射可能对 MS 相关震颤有潜在益处。虽然中重度手部无力的 AE 常限制其在临床实践中的应用,但需要更多设计良好的双盲、安慰剂对照试验来提供更有力的结论。

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