Kao Ai-Wen, Sheu Bor-Shyang, Sheu Ming-Jen, Chang Ye-Mei, Huang Shu-Feng, Chuang Chiao-Hsiung, Lai Yung-Ling, Kao Yeh-Heuy
Department of Internal Medicine, National Cheng Kung University, Medical College, Tainan, Taiwan.
J Formos Med Assoc. 2003 Sep;102(9):607-12.
Reflux esophagitis of Los Angeles grade A or B is more common than grades C and D disease among Taiwanese. This study compared the efficacy of esomeprazole 40 mg and omeprazole 20 mg for starting on-demand therapy for grade A and B reflux esophagitis.
100 patients with grade A and B reflux esophagitis were randomized to receive either esomeprazole 40 mg once daily (n = 50) or omeprazole 20 mg once daily (n = 50) for the first 4 weeks. Sustained symptomatic response (SSR) was defined as freedom from symptoms for the last 7 days of the 4-week treatment duration. On-demand therapy was used for the next 4 weeks in patients with SSR; patients without SSR continued with the same proton pump inhibitor regimen. Patients were asked to record their daily severity of acid regurgitation (AR) and heartburn (HB). Medication usage during on-demand therapy was recorded.
Forty six patients in the esomeprazole group and 45 patients in the omeprazole group completed the study protocol. The rate of SSR was higher in the esomeprazole group than in the omeprazole group (per-protocol: 73.9% vs 51.1%, p < 0.05; intent-to-treat: 68% vs 46%, p < 0.05). The symptomatic scores for AR and HB were similar between patients taking medication continuously and those taking medication on-demand with both esomeprazole and omeprazole. For patients starting on-demand therapy, the total number of tablets used during 4 weeks was lower in the esomeprazole group than in the omeprazole group (13.5 vs 18.5, p < 0.05).
In patients with grade A and B reflux esophagitis, esomeprazole 40 mg was more effective than omeprazole 20 mg for the initiation of on-demand therapy.
在台湾地区，洛杉矶分级为A或B级的反流性食管炎比C级和D级疾病更为常见。本研究比较了埃索美拉唑40mg和奥美拉唑20mg起始按需治疗A级和B级反流性食管炎的疗效。
100例A级和B级反流性食管炎患者被随机分为两组，在最初4周内，一组每日一次服用埃索美拉唑40mg（n = 50），另一组每日一次服用奥美拉唑20mg（n = 50）。持续症状缓解（SSR）定义为在4周治疗期的最后7天无症状。有SSR的患者在接下来4周采用按需治疗；无SSR的患者继续使用相同的质子泵抑制剂方案。患者被要求记录每日反酸（AR）和烧心（HB）的严重程度。记录按需治疗期间的药物使用情况。
埃索美拉唑组46例患者和奥美拉唑组45例患者完成了研究方案。埃索美拉唑组的SSR率高于奥美拉唑组（符合方案分析：73.9%对51.1%，p < 0.05；意向性分析：68%对46%，p < 0.05）。服用埃索美拉唑和奥美拉唑持续用药的患者与按需用药的患者之间，AR和HB的症状评分相似。对于开始按需治疗的患者，埃索美拉唑组4周内使用的总片数低于奥美拉唑组（13.5对18.5，p < 0.05）。
在A级和B级反流性食管炎患者中，起始按需治疗时埃索美拉唑40mg比奥美拉唑20mg更有效。
