Bergmann J F, Hamelin B, Barbier J P
Service de Médecine A, Hôpital Lariboisière, Paris.
Gastroenterol Clin Biol. 1995 May;19(5):482-6.
The objective of this study was to compare the cost of achieving a unit of clinical success for treatment of reflux oesophagitis with either ranitidine or omeprazole.
After randomisation 430 patients with reflux oesophagitis (grade 2 or 3) were assigned to receive omeprazole 20 mg or ranitidine 150 b.i.d. for 8 weeks. Patients were given diary cards to assess their symptoms every day, and record every two weeks a life satisfaction index. Patients were seen after 4 and 8 weeks for symptoms assessment and repeat endoscopy at 8 weeks. The perspective of the analysis was that of the payer. The costs of medical care were based in French drug costs currently advertised, payment for physician and actual mean payment for upper GI endoscopy.
The healing rates at 8 weeks in the omeprazole group and the ranitidine group were 93 and 67.5% respectively. After 8 weeks of treatment, life satisfaction was good in 81 and 53.6% and the relief of pain was 86,6 and 69,5% respectively. For each effectiveness criteria, omeprazole was more cost effective than ranitidine: cost per healed patient (2,338 F vs 2,744 F), cost per asymptomatic patient (2,510 F vs 2,964 F), cost per patient with a good or very good life satisfaction index (2,687 F vs 3,456 F). This advantage remained independent of the oesophagitis initial severity. The sensitivity analysis showed that the results were unsensitive to the variations of the efficacy variables in their confidence interval.
This cost-effectiveness analysis suggests that in the treatment of reflux oesophagitis, the strategy with the more effective treatment is more cost-effective.
本研究旨在比较使用雷尼替丁或奥美拉唑治疗反流性食管炎达到单位临床成功的成本。
随机分组后，430例反流性食管炎（2级或3级）患者被分配接受20mg奥美拉唑或150mg雷尼替丁，每日两次，共8周。患者每天使用日记卡评估症状，并每两周记录一次生活满意度指数。在4周和8周时对患者进行症状评估，并在8周时重复进行内镜检查。分析的视角是付款方。医疗费用基于目前公布的法国药品成本、医生诊疗费用以及上消化道内镜检查的实际平均费用。
奥美拉唑组和雷尼替丁组8周时的愈合率分别为93%和67.5%。治疗8周后，生活满意度良好的患者分别为81%和53.6%，疼痛缓解率分别为86.6%和69.5%。对于各项有效性标准，奥美拉唑比雷尼替丁更具成本效益：每治愈一名患者的成本（2338法郎对2744法郎）、每无症状患者的成本（2510法郎对2964法郎）、每生活满意度指数良好或非常良好患者的成本（2687法郎对3456法郎）。这一优势与食管炎的初始严重程度无关。敏感性分析表明，结果对疗效变量在其置信区间内的变化不敏感。
这项成本效益分析表明在反流性食管炎的治疗中，更有效的治疗策略更具成本效益。
