Le-Qing You, Jing Liu, Lin Jia, Department of Gastroenterology, Guangzhou First People's Hospital, Guangzhou Medical University, Guangzhou 510180, Guangdong Province, China.
World J Gastroenterol. 2013 Nov 14;19(42):7455-60. doi: 10.3748/wjg.v19.i42.7455.
To compare the efficacy and side effects of low-dose amitriptyline (AMT) with proton pump inhibitor treatment in patients with globus pharyngeus.
Thirty-four patients who fulfilled the Rome III criteria for functional esophageal disorders were included in this study. Patients were randomly assigned to receive either 25 mg AMT before bedtime (AMT group) or 40 mg Pantoprazole once daily for 4 wk (conventional group). The main efficacy endpoint was assessed using the Glasgow Edinburgh Throat Scale (GETS). The secondary efficacy endpoints included the Medical Outcomes Study 36-item short form health survey [social functioning (SF)-36] and the Pittsburgh Sleep Quality Index. Treatment response was defined as a > 50% reduction in GETS scores. All patients entering this study recorded side effects at days 1, 8, 15, 22 and 29 using a visual analogue scale.
Thirty patients completed the study. After 4 wk of treatment, the AMT group had a greater response than the conventional group (75% vs 35.7%, P = 0.004). At day 3, the AMT group showed significantly more improvement than the Conventional group in GETS score (3.69 ± 1.14 vs 5.64 ± 1.28, P = 0.000). After 4 wk of treatment, the AMT group showed significantly greater improvement in GETS score and sleep quality than the Conventional group (1.25 ± 1.84 vs 3.79 ± 2.33, 4.19 ± 2.07 vs 8.5 ± 4.97; P < 0.01 for both). Additionally, the AMT group was more likely than the Conventional group to experience improvement in the SF-36, including general health, vitality, social functioning and mental health (P = 0.044, 0.024, 0.049 and 0.005). Dry mouth, sleepiness, dizziness and constipation were the most common side effects.
Low-dose AMT is well tolerated and can significantly improve patient symptoms, sleep and quality of life. Thus, low-dose AMT may be an effective treatment for globus pharyngeus.
比较低剂量阿米替林（AMT）与质子泵抑制剂治疗对咽球综合征患者的疗效和副作用。
本研究纳入了 34 名符合罗马 III 功能性食管疾病标准的患者。患者被随机分配接受睡前 25mg AMT（AMT 组）或 40mg 泮托拉唑每日一次治疗 4 周（常规组）。主要疗效终点采用格拉斯哥-爱丁堡咽喉量表（GETS）评估。次要疗效终点包括健康研究 36 项简明健康调查问卷[社会功能（SF）-36]和匹兹堡睡眠质量指数。治疗反应定义为 GETS 评分降低>50%。所有入组患者在第 1、8、15、22 和 29 天使用视觉模拟量表记录副作用。
30 名患者完成了研究。治疗 4 周后，AMT 组的反应率高于常规组（75% vs 35.7%，P=0.004）。第 3 天，AMT 组 GETS 评分的改善明显优于常规组（3.69±1.14 vs 5.64±1.28，P=0.000）。治疗 4 周后，AMT 组在 GETS 评分和睡眠质量方面的改善明显优于常规组（1.25±1.84 vs 3.79±2.33，4.19±2.07 vs 8.5±4.97；均 P<0.01）。此外，与常规组相比，AMT 组更有可能改善 SF-36，包括一般健康、活力、社会功能和心理健康（P=0.044、0.024、0.049 和 0.005）。口干、嗜睡、头晕和便秘是最常见的副作用。
低剂量 AMT 耐受性良好，可显著改善患者症状、睡眠和生活质量。因此，低剂量 AMT 可能是咽球综合征的有效治疗方法。
