英国纽卡斯尔弗里曼医院James O’Hara团队研究了质子泵抑制剂治疗持续性咽喉症状的疗效。2021年1月7日，该研究发表在《英国医学杂志》上。

为了探讨质子泵抑制剂（PPIs）治疗持续性咽喉症状的疗效，研究组在英国的8个耳鼻喉科门诊进行了一项实用、双盲、安慰剂对照的随机试验。共招募了346名年龄在18岁及以上、有持续性咽喉症状的患者，根据招募中心和基线症状严重程度（轻度或重度）随机分组，其中172名服用兰索拉唑，174名服用安慰剂，为期16周。主要观察指标为16周时的症状反应，采用总反流症状指数（RSI）评分。次要结局包括12个月时的症状反应、生活质量和咽喉症状。

346名参与者的平均年龄为52.2岁，其中196名（57%）为女性，162名（47%）患者有严重症状，两组间的临床特征保持平衡。对220名在14-20周内完成主要结果评估的患者进行初步分析。基线检查时，兰索拉唑组的平均RSI得分为22.0分，安慰剂组为21.7分，组间差异不大。

治疗16周后，两组患者的RSI评分均有所改善，其中兰索拉唑组为17.4分，安慰剂组为15.6分，两组间差异无统计学意义。兰索拉唑在任何次要结局指标中均未显示出优于安慰剂的益处，包括12个月时的RSI评分，其中兰索拉唑组为16.0分，安慰剂为13.6分。

综上，没有证据表明PPI治疗对持续性咽喉症状患者有益。兰索拉唑组和安慰剂组在治疗16周后和12个月随访时的RSI评分相似。

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