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评估巴氯芬治疗恶性肿瘤化疗所致顽固性呃逆疗效和安全性的单臂试验。

Single-arm trial to evaluate the efficacy and safety of baclofen in treatment of intractable hiccup caused by malignant tumor chemotherapy.

作者信息

Mei Mengxue, Fang Ming, Mao Ye, Chen He, Huang Long

机构信息

Department of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi, China.

JiangXi Key Laboratory of Clinical and Translational Cancer Research, Nanchang 330006, Jiangxi, China.

出版信息

Open Med (Wars). 2023 Mar 8;18(1):20230664. doi: 10.1515/med-2023-0664. eCollection 2023.

DOI:10.1515/med-2023-0664
PMID:36910849
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9999114/
Abstract

Previous studies suggest that baclofen may be useful in the treatment of intractable hiccup caused by chemotherapy. This study was aimed to assess the possible efficacy and safety of baclofen. In total, 65 patients with intractable hiccup caused by chemotherapy were screened. 45 patients with intractable hiccup caused by chemotherapy were finally recruited. Participants in the trial received 10 mg baclofen three times daily for 3 days. The primary outcome measure was cessation of hiccups. Secondary outcome measures included efficacy and adverse events. All 45 patients completed the study. Among them, 41 cases were cured (91.11%, 41/45), 4 cases were relieved (8.89%, 4/45), and the overall effective rate was 100% (45/45). Furthermore, the median remission time was 2(1, 9) times, the median cure time was 2(1, 9) times, the remission rate of one-time was 13.33% (6/45), the remission rate of two-time was 53.33% (24/45), and 2 cases (4.44%, 2/45) relapsed after drug withdrawal. No serious adverse events were documented. Only 1 case (2.22%) had grade 2 fatigue and 2 cases (4.44%) had grade 1 sleepiness. Baclofen is safe and effective in the treatment of intractable hiccup caused by chemotherapy of malignant tumor.

摘要

先前的研究表明,巴氯芬可能对治疗化疗引起的顽固性呃逆有用。本研究旨在评估巴氯芬可能的疗效和安全性。总共筛选了65例化疗引起的顽固性呃逆患者。最终招募了45例化疗引起的顽固性呃逆患者。试验参与者接受每日3次、每次10毫克巴氯芬,共治疗3天。主要结局指标是呃逆停止。次要结局指标包括疗效和不良事件。所有45例患者均完成了研究。其中,41例治愈(91.11%,41/45),4例缓解(8.89%,4/45),总有效率为100%(45/45)。此外,中位缓解次数为2(1,9)次,中位治愈次数为2(1,9)次,一次缓解率为13.33%(6/45),二次缓解率为53.33%(24/45),2例(4.44%,2/45)停药后复发。未记录到严重不良事件。仅1例(2.22%)出现2级疲劳,2例(4.44%)出现1级嗜睡。巴氯芬治疗恶性肿瘤化疗引起的顽固性呃逆安全有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63b3/9999114/2cd2c06a9366/j_med-2023-0664-fig001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63b3/9999114/2cd2c06a9366/j_med-2023-0664-fig001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63b3/9999114/2cd2c06a9366/j_med-2023-0664-fig001.jpg

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