质子泵抑制剂治疗持续性咽喉症状的多中心、双盲、随机、安慰剂对照试验。
Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial.
机构信息
Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne NE7 7DN, UK James.O'
Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.
出版信息
BMJ. 2021 Jan 7;372:m4903. doi: 10.1136/bmj.m4903.
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.
TRIAL REGISTRATION
ISRCTN Registry ISRCTN38578686 and EudraCT 2013-004249-17.
目的
评估质子泵抑制剂（PPIs）治疗持续性咽喉症状的效果。
设计
实用、双盲、安慰剂对照、随机试验。
地点
英国 8 家耳鼻喉科门诊诊所。
参与者
346 名年龄在 18 岁及以上、持续性咽喉症状的患者，按招募中心和症状严重程度（轻度或重度）进行随机分组：172 名患者接受兰索拉唑治疗，174 名患者接受安慰剂治疗。
干预
根据 1:1 比例随机分配接受兰索拉唑（30mg，每日 2 次）或匹配安慰剂（每日 2 次）治疗 16 周。
主要观察指标
主要结局是在 16 周时使用反流症状指数（RSI）总分评估的症状反应。次要结局包括 12 个月时的症状反应、生活质量和咽喉外观。
结果
在最初筛选的 1427 名符合条件的患者中，有 346 名患者被招募。研究样本的平均年龄为 52.2（标准差 13.7）岁，196 名（57%）为女性，162 名（47%）在就诊时症状严重；这些特征在治疗组之间是均衡的。主要分析在 220 名在 14-20 周内完成主要结局测量的患者中进行。治疗组基线时的 RSI 评分相似：兰索拉唑组为 22.0（95%置信区间 20.4 至 23.6），安慰剂组为 21.7（20.5 至 23.0）。两组均观察到（RSI 评分降低）症状改善：兰索拉唑组在 16 周时为 17.4（15.5 至 19.4），安慰剂组为 15.6（13.8 至 17.3）。治疗组之间无统计学显著差异：估计差值为 1.9 分（95%置信区间 -0.3 至 4.2 分；P=0.096），校正了地点和基线症状严重程度的影响。兰索拉唑在任何次要结局测量上均未显示优于安慰剂的效果，包括 12 个月时的 RSI 评分：兰索拉唑组为 16.0（13.6 至 18.4），安慰剂组为 13.6（11.7 至 15.5）：估计差值为 2.4 分（-0.6 至 5.4 分）。
结论
在持续性咽喉症状患者中，未发现质子泵抑制剂治疗有获益的证据。治疗 16 周后和 12 个月随访时，兰索拉唑组和安慰剂组的 RSI 评分相似。
试验注册
ISRCTN 注册 ISRCTN38578686 和 EudraCT 2013-004249-17。
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