質子泵抑制劑無益於治療持續性咽喉症狀
作者：
小柯機器人發布時間：2021/1/9 21:07:34
英國紐卡斯爾弗裡曼醫院James O』Hara團隊研究了質子泵抑制劑治療持續性咽喉症狀的療效。2021年1月7日，該研究發表在《英國醫學雜誌》上。
為了探討質子泵抑制劑（PPIs）治療持續性咽喉症狀的療效，研究組在英國的8個耳鼻喉科門診進行了一項實用、雙盲、安慰劑對照的隨機試驗。共招募了346名年齡在18歲及以上、有持續性咽喉症狀的患者，根據招募中心和基線症狀嚴重程度（輕度或重度）隨機分組，其中172名服用蘭索拉唑，174名服用安慰劑，為期16周。主要觀察指標為16周時的症狀反應，採用總反流症狀指數（RSI）評分。次要結局包括12個月時的症狀反應、生活質量和咽喉症狀。
346名參與者的平均年齡為52.2歲，其中196名（57%）為女性，162名（47%）患者有嚴重症狀，兩組間的臨床特徵保持平衡。對220名在14-20周內完成主要結果評估的患者進行初步分析。基線檢查時，蘭索拉唑組的平均RSI得分為22.0分，安慰劑組為21.7分，組間差異不大。
治療16周後，兩組患者的RSI評分均有所改善，其中蘭索拉唑組為17.4分，安慰劑組為15.6分，兩組間差異無統計學意義。蘭索拉唑在任何次要結局指標中均未顯示出優於安慰劑的益處，包括12個月時的RSI評分，其中蘭索拉唑組為16.0分，安慰劑為13.6分。
綜上，沒有證據表明PPI治療對持續性咽喉症狀患者有益。蘭索拉唑組和安慰劑組在治療16周後和12個月隨訪時的RSI評分相似。
附：英文原文
Title: Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial
Author: James O』Hara, Deborah D Stocken, Gillian C Watson, Tony Fouweather, Julian McGlashan, Kenneth MacKenzie, Paul Carding, Yakubu Karagama, Ruth Wood, Janet A Wilson
Issue&Volume: 2021/01/07
Abstract:
Objective To assess the use of proton pump inhibitors (PPIs) to treat persistent throat symptoms.
Design Pragmatic, double blind, placebo controlled, randomised trial.
Setting Eight ear, nose, and throat outpatient clinics, United Kingdom.
Participants 346 patients aged 18 years or older with persistent throat symptoms who were randomised according to recruiting centre and baseline severity of symptoms (mild or severe): 172 to lansoprazole and 174 to placebo.
Intervention Random blinded allocation (1:1) to either 30 mg lansoprazole twice daily or matched placebo twice daily for 16 weeks.
Main outcome measures Primary outcome was symptomatic response at 16 weeks measured using the total reflux symptom index (RSI) score. Secondary outcomes included symptom response at 12 months, quality of life, and throat appearances.
Results Of 1427 patients initially screened for eligibility, 346 were recruited. The mean age of the study sample was 52.2 (SD 13.7) years, 196 (57%) were women, and 162 (47%) had severe symptoms at presentation; these characteristics were balanced across treatment arms. The primary analysis was performed on 220 patients who completed the primary outcome measure within a window of 14-20 weeks. Mean RSI scores were similar between treatment arms at baseline: lansoprazole 22.0 (95% confidence interval 20.4 to 23.6) and placebo 21.7 (20.5 to 23.0). Improvements (reduction in RSI score) were observed in both groups—score at 16 weeks: lansoprazole 17.4 (15.5 to19.4) and placebo 15.6 (13.8 to 17.3). No statistically significant difference was found between the treatment arms: estimated difference 1.9 points (95% confidence interval 0.3 to 4.2 points; P=0.096) adjusted for site and baseline symptom severity. Lansoprazole showed no benefits over placebo for any secondary outcome measure, including RSI scores at 12 months: lansoprazole 16.0 (13.6 to 18.4) and placebo 13.6 (11.7 to 15.5): estimated difference 2.4 points (0.6 to 5.4 points).
Conclusions No evidence was found of benefit from PPI treatment in patients with persistent throat symptoms. RSI scores were similar between the lansoprazole and placebo groups after 16 weeks of treatment and at the 12 month follow-up.
DOI: 10.1136/bmj.m4903
Source: https://www.bmj.com/content/372/bmj.m4903