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硫酸奎宁治疗肌萎缩侧索硬化症肌肉痉挛:一项随机双盲交叉试验

Quinine Sulfate for Muscle Cramps in Amyotrophic Lateral Sclerosis: A Randomized, Double-Blind Crossover Trial.

作者信息

Vogt Charlotte, Weber Markus, Schneider Ursula, Neuwirth Christoph

机构信息

Neuromuscular Diseases Unit/ALS Clinic, Kantonsspital St Gallen, St Gallen, Gallen, Switzerland.

出版信息

Muscle Nerve. 2025 Aug;72(2):267-273. doi: 10.1002/mus.28440. Epub 2025 May 19.

Abstract

INTRODUCTION/AIMS: Many patients with amyotrophic lateral sclerosis (ALS) experience muscle cramps during the course of the disease. This study aimed to evaluate the efficacy of orally administered quinine sulfate for muscle cramps in ALS patients.

METHODS

We conducted a randomized, double-blind, placebo-controlled crossover trial in ALS patients experiencing daily muscle cramps. After a two-week run-in period, patients were assigned to receive 250 mg quinine sulfate once daily, followed by a placebo or vice versa. Each treatment period lasted 2 weeks and was followed by a 4-week washout period. Patients used a daily diary to rate muscle cramp intensity on the numeric rating scale (NRS) and record muscle cramp frequency. The primary outcome measure was change in cramp intensity; coprimary outcome measures were number of muscle cramps during daytime and nighttime.

RESULTS

Data from four women and three men were included in the analysis, all of whom reported a notable reduction in cramp intensity and frequency, leading them to continue the medication. Quinine sulfate was well-tolerated, with two patients reporting mild tinnitus. Cramp intensity was significantly reduced by 48% (p = 0.042). Further, the number of daytime muscle cramps declined significantly (p = 0.024).

DISCUSSION

Our findings suggest the potential efficacy of quinine sulfate in reducing muscle cramp intensity and frequency in ALS patients. However, the small sample size (n = 7) limits generalizability. Larger, multicenter studies are needed to confirm these results and fully assess its safety, serious adverse events, and therapeutic potential.

摘要

引言/目的:许多肌萎缩侧索硬化症(ALS)患者在疾病过程中会出现肌肉痉挛。本研究旨在评估口服硫酸奎宁对ALS患者肌肉痉挛的疗效。

方法

我们对每日经历肌肉痉挛的ALS患者进行了一项随机、双盲、安慰剂对照的交叉试验。在为期两周的导入期后,患者被分配接受每日一次250毫克硫酸奎宁治疗,随后接受安慰剂治疗,或反之。每个治疗期持续2周,之后是4周的洗脱期。患者使用每日日记以数字评分量表(NRS)对肌肉痉挛强度进行评分,并记录肌肉痉挛频率。主要结局指标是痉挛强度的变化;共同主要结局指标是白天和夜间的肌肉痉挛次数。

结果

分析纳入了4名女性和3名男性的数据,他们均报告痉挛强度和频率显著降低,因此继续用药。硫酸奎宁耐受性良好,有两名患者报告有轻度耳鸣。痉挛强度显著降低了48%(p = 0.042)。此外,白天肌肉痉挛次数显著减少(p = 0.024)。

讨论

我们的研究结果表明硫酸奎宁在降低ALS患者肌肉痉挛强度和频率方面具有潜在疗效。然而,样本量较小(n = 7)限制了结果的普遍性。需要开展更大规模的多中心研究来证实这些结果,并全面评估其安全性、严重不良事件和治疗潜力。

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