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Safety and efficacy of gefapixant, a novel drug for the treatment of chronic cough: A systematic review and meta-analysis of randomized controlled trials.
Annals of Thoracic Medicine ( IF 2.3 ) Pub Date : 2021-04-17 , DOI: 10.4103/atm.atm_417_20
Ahmed Abu-Zaid 1, 2 , Aseel Khalid Aljaili 1 , Amnah Althaqib 1 , Fatima Adem 1 , Doaa Ali Alhalal 1 , Amena Faiq Almubarak 3 , Saud Musaab Aldughaither 1 , Sarah Ali Alghabban 1 , Ghaidaa Alfaraj 1 , Ahmed Taher Masoud 4 , Nujud Abdullah Alsuhaibani 1
Affiliation  

AIM We conducted this systematic review and meta-analysis to investigate the efficacy and safety of gefapixant, a novel P2X3 receptor antagonist, in patients with chronic cough. METHODS We searched four databases for randomized controlled trials (RCTs). We assessed the cough frequency, severity, total Leicester cough questionnaire (LCQ) score, and adverse events. We analyzed the data using Open Meta-Analyst and Review Manager Software. RESULTS We included four unique studies (comprising five stand-alone RCTs) with 439 patients. Compared to placebo, gefapixant had positive anti-tussive effects by improving awake cough frequency (mean difference [MD] = -5.27, 95% confidence interval [CI] [-6.12, -4.42], P < 0.00001), night cough frequency (MD = -3.71, 95% CI [-6.57, -0.85], P = 0. 01), 24 h cough frequency (MD = -4.18, 95% CI [-5.01, -3.36], P < 0.00001), cough severity using the Visual Analog Scale (MD = -13.36, 95% CI [-17.80, -8.92], P < 0.00001), cough severity diary (MD = -0.88, 95% CI [-1.25, -0.51], P < 0.00001), and total LCQ score (MD = 2.00, 95% CI [1.15, 2.86], P = 0. 00001). Meta-regression analyses showed a positive correlation between the gefapixant dose and the incidence of any adverse event (relative risk [RR] = 0.239, 95% CI [0.093, 1.839], P = 0.001) and incidence of adverse event related to treatment (RR = 0.520, 95% CI [0.117, 0.922], P = 0.011). CONCLUSIONS In patient with chronic cough, gefapixant exhibits favorable anti-tussive outcomes by improving the cough frequency, severity, and quality of life. While gefapixant is largely tolerable, its side effects (notably taste alteration) are dose dependent.

中文翻译:

治疗慢性咳嗽的新药吉法匹克的安全性和有效性:随机对照试验的系统评价和荟萃分析。

目的 我们进行了这项系统评价和荟萃分析,以研究吉法匹克特(一种新型 P2X3 受体拮抗剂)对慢性咳嗽患者的疗效和安全性。方法 我们检索了四个数据库中的随机对照试验 (RCT)。我们评估了咳嗽频率、严重程度、莱斯特咳嗽问卷 (LCQ) 总分和不良事件。我们使用 Open Meta-Analyst 和 Review Manager 软件分析了数据。结果 我们纳入了四项独特的研究(包括五项独立的随机对照试验),涉及 439 名患者。与安慰剂相比,吉法匹克通过改善清醒咳嗽频率(平均差 [MD] = -5.27,95% 置信区间 [CI] [-6.12, -4.42],P < 0.00001)、夜间咳嗽频率( MD = -3.71, 95% CI [-6.57, -0.85], P = 0. 01), 24 小时咳嗽频率 (MD = -4.18, 95% CI [-5.01, -3.36], P < 0.00001), 咳嗽使用视觉模拟量表评估严重程度(MD = -13.36,95% CI [-17.80,-8.92],P < 0.00001),咳嗽严重程度日记(MD = -0.88,95% CI [-1.25,-0.51],P < 0.00001) 和 LCQ 总分 (MD = 2.00, 95% CI [1.15, 2.86], P = 0. 00001)。荟萃回归分析显示,吉法匹克剂量与任何不良事件发生率(相对风险 [RR] = 0.239,95% CI [0.093, 1.839],P = 0.001)以及与治疗相关的不良事件发生率呈正相关( RR = 0.520,95% CI [0.117,0.922],P = 0.011)。结论 对于慢性咳嗽患者,吉法匹克通过改善咳嗽频率、严重程度和生活质量而表现出良好的镇咳效果。虽然吉法匹克在很大程度上是可以耐受的,但其副作用(特别是味道改变)是剂量依赖性的。
更新日期:2021-04-17
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