Pace F, Negrini C, Wiklund I, Rossi C, Savarino V
UO Gastroenterologia Ospedale Sacco, Milano, Italy.
Aliment Pharmacol Ther. 2005 Aug 15;22(4):349-56. doi: 10.1111/j.1365-2036.2005.02558.x.
Quality of life has been assessed in a large, multicentre randomized, open label study.
To evaluate the economic and clinical consequences of two different maintenance treatment modalities, administered to 6017 gastro-oesophageal reflux disease patients at 451 gastroenterological centres in Italy.
Adult gastro-oesophageal reflux disease patients received, at enrolment, an acute treatment of esomeprazole 40 mg/day for 4 weeks and, if successfully treated, were randomized into two maintenance treatment strategies: esomeprazole 20 mg/day or esomeprazole on demand for 6 months. A baseline endoscopy allowed the exclusion of grade II-IV oesophagitis according to Savary-Miller's classification. Burden of gastro-oesophageal reflux disease was measured at baseline by the generic questionnaire Short-Form 36 and by a disease specific instrument, quality of life in reflux and dyspepsia (QOLRAD), also administered at start and conclusion of maintenance period. Investigators were required to collect patient judgement about the degree of satisfaction with treatment effect on heartburn, with a 7-point scale.
A comparison between Short-Form 36 scores and the normative source of the Italian general population suggested that symptomatic gastro-oesophageal reflux disease patients experience a worse quality of life than the general population. At the end of the 4-week treatment with esomeprazole 40 mg all (QOLRAD) dimensions showed a statistically significant (P < 0.0001) and clinically meaningful improvement. Satisfaction level towards treatment was reported high in the total enrolled population after acute treatment with esomeprazole 40 mg/day (96.2% satisfied and 64.4% very satisfied). A statistically significant difference in (QOLRAD) scores was registered at the end of maintenance phase in favour of the continuous regimen, nevertheless the size of this difference was very small in all dimensions; similarly, the proportion of patients very satisfied was slightly higher in the continuous treatment arm (64.5%) than in the on-demand arm (59.7%).
Gastro-oesophageal reflux disease can significantly impair health-related quality of life and esomeprazole therapy allows immediate relief in the acute phase of the disease. Quality of life improvement was maintained during the 6-month follow-up with a slight difference in term of quality of life in reflux and dyspepsia scores and patients' satisfaction in favour of the continuous treatment strategy.
在一项大型多中心随机开放标签研究中对生活质量进行了评估。
评估两种不同维持治疗方式对意大利451个胃肠病中心的6017例胃食管反流病患者的经济和临床后果。
成年胃食管反流病患者在入组时接受埃索美拉唑40mg/天的急性治疗，为期4周，若治疗成功，则随机分为两种维持治疗策略：埃索美拉唑20mg/天或按需服用埃索美拉唑，为期6个月。基线内镜检查可根据Savary-Miller分类排除II-IV级食管炎。胃食管反流病的负担在基线时通过通用问卷简明健康状况调查简表36以及一种疾病特异性工具反流和消化不良生活质量量表（QOLRAD）进行测量，该量表在维持期开始和结束时也进行了测评。研究人员被要求用7分制收集患者对烧心治疗效果满意度的判断。
简明健康状况调查简表36评分与意大利普通人群的标准来源之间的比较表明，有症状的胃食管反流病患者的生活质量比普通人群差。在使用40mg埃索美拉唑进行4周治疗结束时，（QOLRAD）的所有维度均显示出具有统计学意义（P<0.0001）且具有临床意义的改善。在用40mg/天埃索美拉唑进行急性治疗后，总入组人群对治疗的满意度较高（96.2%满意，64.4%非常满意）。在维持期结束时，（QOLRAD）评分存在统计学意义上的差异，有利于持续治疗方案，不过在所有维度上这种差异的幅度都非常小；同样，持续治疗组中非常满意的患者比例（64.5%）略高于按需治疗组（59.7%）。
胃食管反流病可显著损害健康相关生活质量，埃索美拉唑治疗可在疾病急性期立即缓解症状。在6个月的随访期间，生活质量得到改善，在反流和消化不良评分以及患者满意度方面，持续治疗策略略有优势。
