Research & Development, AstraZeneca K,K, 1-1-88 Ohyodo-naka, Kita-ku, Osaka 531-0076, Japan.
BMC Gastroenterol. 2011 Feb 28;11:15. doi: 10.1186/1471-230X-11-15.
For patients with reflux esophagitis (RE), endoscopic findings alone (without the frequency and severity of symptoms) may not fully reflect the associated impact on health-related quality of life (QOL). There is not enough data about symptoms and QOL of Japanese patients with RE. The present study therefore investigated the epidemiological characteristics of such patients, and evaluated the efficacy and safety of omeprazole (and other gastrointestinal drugs, except proton pump inhibitors [PPIs]) in terms of improving patients' symptoms and QOL.
In a large-scale, specific clinical experience investigation of Japanese patients with RE, epidemiological characteristics, QOL and symptoms of the disease in relation to treatment with omeprazole and other gastrointestinal drugs, except PPIs, and safety data of omeprazole were collected. The Quality Of Life in Reflux and Dyspepsia questionnaire (QOLRAD) was used for QOL assessment.
9967 patients were included in the analysis (omeprazole: 7888). At baseline, 75.2% of patients had three or more upper gastrointestinal symptoms, and 31.5% of patients had six or more upper gastrointestinal symptoms. The overall mean QOLRAD score at baseline was 5.14 (the best score is 7). In the omeprazole group, the rate of satisfactory improvement in subjective symptoms was 61.7% and 81.8% at Weeks 4 and 8, respectively, and these were both significantly higher than those of patients treated with other drugs. In both the omeprazole group and the other drugs group, the QOLRAD score at Week 4 improved significantly from baseline, and the degree of improvement was significantly greater in the omeprazole group than in the other drugs group. The favourable tolerability profile of omeprazole was confirmed.
In a large-scale survey, omeprazole improved symptoms and QOL more effectively in Japanese patients with RE than other investigated drugs, and had a good tolerability profile.
ClinicalTrials.gov identifier: NCT00859287.
对于反流性食管炎（RE）患者，内镜检查结果（不包括症状的频率和严重程度）可能无法充分反映其对健康相关生活质量（QOL）的影响。关于日本 RE 患者的症状和 QOL，尚无足够的数据。因此，本研究调查了此类患者的流行病学特征，并评估了奥美拉唑（和其他除质子泵抑制剂[PPIs]以外的胃肠道药物）在改善患者症状和 QOL 方面的疗效和安全性。
在一项针对日本 RE 患者的大规模、特定临床经验调查中，收集了奥美拉唑和其他除 PPIs 以外的胃肠道药物治疗患者的流行病学特征、疾病 QOL 和症状以及奥美拉唑安全性数据。采用反流和消化不良生活质量问卷（QOLRAD）评估 QOL。
共纳入 9967 例患者（奥美拉唑：7888 例）。基线时，75.2%的患者有三种或三种以上上消化道症状，31.5%的患者有六种或六种以上上消化道症状。基线时总体平均 QOLRAD 评分为 5.14（最佳评分为 7）。在奥美拉唑组中，主观症状的满意度改善率分别为第 4 周的 61.7%和第 8 周的 81.8%，均明显高于其他药物组。在奥美拉唑组和其他药物组中，第 4 周 QOLRAD 评分均较基线显著改善，且奥美拉唑组的改善程度明显大于其他药物组。证实了奥美拉唑良好的耐受性。
在一项大规模调查中，与其他研究药物相比，奥美拉唑更有效地改善了日本 RE 患者的症状和 QOL，且具有良好的耐受性。
ClinicalTrials.gov 标识符：NCT00859287。
