埃索美拉唑对胃食管反流病患者症状和生活质量的影响

Effect of esomeprazole on symptom relief and improvement of quality of life in gastroesophageal reflux disease patients

目的:探讨埃索美拉唑对胃食管反流病(GERD)患者症状和生活质量的影响.方法:采用前瞻、随机、阳性对照研究,将经内镜或24 h食管pH监测明确诊断的78例GERD患者随机分为标准剂量的埃索美拉唑(20 mg,2次/d,po)组和加倍剂量的奥美拉唑(20 mg,2次/d,po)组,每组39例.2组分别治疗8 wk,比较2组症状控制、RE内镜下有效率和愈合率、生活质量等区别.结果:共76例患者完成试验.埃索美拉唑组和奥美拉唑组各有1例RE因违反试验方案退出.4 wk和8 wk两组症状总积分治疗后均明显下降,但两组间差异无统计学意义.埃索美拉唑组和奥关拉唑组使NERD症状积分下降程度不如RE患者,但埃索美拉唑组使NERD患者症状积分下降优于奥美拉唑组(P<0.01);两组在烧心和胸痛缓解率上差异明显(78.3%vs 45.5%,64.3%vs 37.5%,均P<0.05),在反酸、咽下困难上无明显差异:4 wk和8 wk对RE内镜有效率和愈合率差异明显(4 wk:88.8%vs 59.3%,80.0%vs 51.9%;8 wk:96.0%vs 70.4%,88.0%vs 63.1%,均P<0.05),埃索美拉唑组患者活力和社会功能疗效明显(92.5±5.7 vs 85.3±7.1,85.2±4.6 vs 76.8±6.5,均P<0.05).结论:标准剂量的埃索美拉唑较加倍剂量的奥美拉唑更有效的控制GERD患者(尤其是RE患者)的临床症状,改善活力和社会功能相关的生活质量.

AIM： To compare the efficacy and safety of esomeprazole with omeprazole on symptom relief and improvement of quality of life in gastroesophageal reflux disease （GERD） patients. METHODS： A prospective, randomized controlled study was designed. A total of 78 GERD patients diagnosed with endoscope and/or their 24 h esophageal pH monitored were randomized into esomeprazole treatment group and omeprazole treatment group （39 patients each group）. Patients in the two groups received standard doses of esomeprazole （20 mg, twice a day, po） or double doses of omeprazole （20 mg, twice a day, po） for cure rate and 8 wk. Sympto0a relief, efficiency, quality of life were compared between the two groups. RESULTS： Seven-six patients completed the 8-week therapy. One patient in each group was dropped out because of running counter to the RE testing procedure. Symptoms of the two groups at weeks 4 and 8 were significantly improved. Symptoms of patients in the esomeprazole group were much better improved than those in the omeprazole group （P 〈 0.01）. There was a significant difference in remission of heartburn and chest pain between the two groups （78.3% vs 45.5%, 64.3% vs 37.5%, P 〈 0.05）. However, there was no significant difference in remission of acid regurgitation and dysphagia between the two groups. There was a significant difference in the efficiency and cure rate at weeks 4 and 8 between the two groups （4 wk： 88.8% vs 59.3%, 80.0% vs 51.9%, P 〈 0.05; 8 wk： 96.0% vs 70.4%, 88.0% vs 63.1%, P 〈 0.05）. The quality of life, cure rate, vitality （VT） and social function （SF） were much better improved in the esomeprazole group than in the omeprazole group （92.5 ±5.7 vs 85.3 ± 7.1, 85.2 ± 4.6 vs 76.8 ± 6.5, P 〈 0.05）. CONCLUSION： Standard doses of esomeprazole have better effects on improving heartburn and chest pain, cure rate, VT and SF in GERD patients than double doses of omeprazole.