Jain Suresh, Shamrao Kulkarni Sandeep, Mahapatra Jyoti R, Todi Dilip, Petare Anup U, Banerjee Ritwik, Rathod Rahul, Naqvi Syed, Mane Amey, Dhanaki Gauri, Kotak Bhavesh P
Department of Gastroenterology, Digestive Endoscopy Clinic, Pune, IND.
Department of Gastroenterology, Sahyadri Super Speciality Hospital, Pune, IND.
Cureus. 2023 Jul 17;15(7):e41994. doi: 10.7759/cureus.41994. eCollection 2023 Jul.
Objectives This prospective study assessed the effectiveness and patient satisfaction of four-week omeprazole therapy in acid peptic disease (APD). Methods This was an observational, post-marketing, real-world evidence, patient-reported outcome (PRO) measures study. Patients visiting the five study sites across India with symptoms of APD, and who were prescribed oral omeprazole (20/40 mg per day) for at least four weeks were enrolled after obtaining informed consent. Study assessments included frequency and severity of symptoms and overall satisfaction reported by the patients using the Patient Assessment of Gastrointestinal Disorder Symptom Severity Index (PAGI-SYM) questionnaire. The satisfaction with therapy was reported by the patients using the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire. Both PAGI-SYM and TSQM were reported by patients on days 14 and 28. Omeprazole safety was assessed based on the adverse events reported by the patients. Results A total of 96 (62 males and 34 females) patients were included in the study, of which 38.54% had significant findings related to APD at baseline. The proportion of patients with symptoms reduced to 16.67% on day 14 and 8.33% on day 28 with omeprazole therapy. The PAGI-SYM total scores at baseline were 41.32 (15.487), which reduced to 20.86 (11.620) on day 14 (p < 0.0001), and to 8.93 (8.361) on day 28 (p < 0.0001). Significant reductions were also seen in individual symptom scores. The TSQM total scores increased to 36.67 (range: 13 to 63) on day 28 from 34.69 (range: 12 to 58) on day 14. Improvement in scores for all domains of TSQM (effectiveness, convenience, and global satisfaction) was seen on day 28. Improvement in reflux symptoms was reported by 46.74% and 68.48% of patients on day 14 and day 28, respectively. Four (4.17%) patients reported adverse events, which were of mild severity and were unrelated to omeprazole. Conclusions Omeprazole provides significant improvement in PAGI-SYM and TSQM questionnaires on day 14 and day 28. Patients reported the omeprazole-based therapy as effective, convenient, and satisfactory. Omeprazole therapy is safe and effective for the treatment of APD and shows good improvement in APD in patients suffering from duodenal ulcers, gastric ulcers, and reflux oesophagitis.
目的 本前瞻性研究评估了为期四周的奥美拉唑治疗酸相关性疾病（APD）的有效性和患者满意度。方法 这是一项观察性、上市后、基于真实世界证据的患者报告结局（PRO）指标研究。在印度各地五个研究地点就诊且有APD症状、被处方口服奥美拉唑（每日20/40毫克）至少四周的患者，在获得知情同意后入组。研究评估包括使用胃肠道疾病症状严重程度患者评估指数（PAGI-SYM）问卷报告的患者症状频率和严重程度以及总体满意度。患者使用药物治疗满意度问卷（TSQM）报告对治疗的满意度。PAGI-SYM和TSQM均由患者在第14天和第28天报告。根据患者报告的不良事件评估奥美拉唑的安全性。结果 共有96例（62例男性和34例女性）患者纳入研究，其中38.54%在基线时有与APD相关的显著发现。接受奥美拉唑治疗的患者中，症状比例在第14天降至16.67%，在第28天降至8.33%。基线时PAGI-SYM总分是41.32（15.487），在第14天降至20.86（11.620）（p<0.0001），在第28天降至8.93（8.361）（p<0.0001）。各单项症状评分也有显著降低。TSQM总分从第14天的34.69（范围：12至58）增至第28天的36.67（范围：13至63）。在第28天，TSQM所有领域（有效性、便利性和总体满意度）的评分均有改善。分别有46.74%和68.48%的患者报告在第14天和第28天反流症状有所改善。4例（4.17%）患者报告了不良事件，其严重程度为轻度且与奥美拉唑无关。结论 奥美拉唑在第14天和第28天使PAGI-SYM和TSQM问卷有显著改善。患者报告基于奥美拉唑的治疗有效、方便且令人满意。奥美拉唑治疗APD安全有效，对患有十二指肠溃疡、胃溃疡和反流性食管炎的患者的APD有良好改善。
