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随机临床试验:加巴喷丁与巴氯芬治疗疑似难治性胃食管反流相关性慢性咳嗽。

Randomised clinical trial: gabapentin vs baclofen in the treatment of suspected refractory gastro-oesophageal reflux-induced chronic cough.

机构信息

Department of Pulmonary and Critical Care Medicine, Tongji Hospital, Tongji University School of Medicine, Shanghai, China.

Department of Respiratory Medicine, Tongren Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

出版信息

Aliment Pharmacol Ther. 2019 Mar;49(6):714-722. doi: 10.1111/apt.15169. Epub 2019 Feb 10.

Abstract

BACKGROUND

Neuromodulators are considered potential therapeutic options for refractory gastro-oesophageal reflux-induced chronic cough.

AIM

To compare the efficacy of gabapentin and baclofen in patients with suspected refractory gastro-oesophageal reflux-induced chronic cough.

METHODS

Two hundred and thirty-four patients with suspected refractory gastro-oesophageal reflux-induced chronic cough, who failed an 8-week course of omeprazole and domperidone, were recruited into the open-labelled study and randomly assigned to receive either gabapentin (maximum daily dose of 900 mg) or baclofen (maximum daily dose of 60 mg) for 8 weeks as add-on therapy to the previous treatment. The primary end point was the successful rate of cough resolution; and the secondary end-points included cough sensitivity to capsaicin and gastro-oesophageal reflux disease questionnaire score and reported side effects.

RESULTS

One hundred and eleven patients in the gabapentin group and 106 in the baclofen group completed the study. The overall success rate for cough resolution was comparable (57.3% vs 53.0%, χ  = 0.357, P = 0.550) between the two groups. In parallel, cough sensitivity to capsaicin and gastro-oesophageal reflux disease questionnaire score decreased after treatment with either gabapentin or baclofen. However, gabapentin was associated with less frequent somnolence (20.5% vs 35.0%, χ = 6.156, P = 0.013) and dizziness (11.1% vs 23.9%, χ = 6.654, P = 0.010) than baclofen.

CONCLUSIONS

Gabapentin and baclofen have similar therapeutic efficacy for suspected refractory gastro-oesophageal reflux-induced chronic cough. However, gabapentin may be preferable because of fewer side effects. Trial Register: http://www.chictr.org/; No.: ChiCTR-ONC-13003066.

摘要

背景

神经调节剂被认为是治疗难治性胃食管反流引起的慢性咳嗽的潜在治疗选择。

目的

比较加巴喷丁和巴氯芬治疗疑似难治性胃食管反流引起的慢性咳嗽患者的疗效。

方法

234 例疑似难治性胃食管反流引起的慢性咳嗽患者,在接受 8 周奥美拉唑和多潘立酮治疗后失败,纳入开放性研究,并随机分为加巴喷丁组(最大日剂量 900mg)或巴氯芬组(最大日剂量 60mg),作为先前治疗的附加治疗,疗程为 8 周。主要终点是咳嗽缓解的成功率;次要终点包括辣椒素咳嗽敏感性和胃食管反流病问卷评分以及报告的副作用。

结果

加巴喷丁组 111 例和巴氯芬组 106 例患者完成了研究。两组咳嗽缓解的总体成功率相当(57.3%vs53.0%,χ²=0.357,P=0.550)。同时,加巴喷丁或巴氯芬治疗后辣椒素咳嗽敏感性和胃食管反流病问卷评分均降低。然而,加巴喷丁的嗜睡(20.5%vs35.0%,χ²=6.156,P=0.013)和头晕(11.1%vs23.9%,χ²=6.654,P=0.010)发生率低于巴氯芬。

结论

加巴喷丁和巴氯芬治疗疑似难治性胃食管反流引起的慢性咳嗽疗效相似。然而,由于副作用较少,加巴喷丁可能更可取。

试验注册

http://www.chictr.org/;注册号:ChiCTR-ONC-13003066。

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