Abdul Kadir Noor Purdah, Ma Zheng Feei, Abdul Hafidz Muhammad Ilham, Annamalai Chandramouli, Jayaraman Thevaraajan, Hamid Nurhazwani, Norhasliza Siti, Abd Aziz Azliani, Yusof Zurkurnai, Lee Hady, Lee Yeong Yeh
School of Medical Sciences, Universiti Sains Malaysia, Kota Bharu, Malaysia.
Gastroenterology Unit, Faculty of Medicine, Universiti Teknologi MARA, Shah Alam, Malaysia.
Front Med (Lausanne). 2021 Feb 15;8:605647. doi: 10.3389/fmed.2021.605647. eCollection 2021.
Non-cardiac chest pain is common with two-thirds due to gastroesophageal reflux disease (GERD). To evaluate the effectiveness and safety of guided vs. empirical therapy in non-cardiac chest pain. Adults with normal angiogram or stress test were randomized into either a guided or empirical group. In the guided group, after the ambulatory pH-impedance test, if GERD then dexlansoprazole 30 mg/day for 8 weeks, but if functional or hypersensitive chest pain, then theophylline SR 250 mg/day for 4 weeks. In the empirical group, dexlansoprazole 60 mg/day was given for 2 weeks. The primary outcome was global chest pain visual analog score (VAS) and secondary outcomes were Quality of Life in Reflux and Dyspepsia (QOLRAD), GERD questionnaire (GERDQ), and pH parameters, all determined at baseline, 2nd and 8th weeks. Of 200 screened patients, 132 were excluded, and of 68 randomized per-protocol, 33 were in the guided group and 35 in the empirical group. For between-group analysis, mean global pain scores were better with guided vs. empirical group at 8th week ( = 0.005) but not GERDQ or QOLRAD or any of pH measures (all > 0.05). For within-group analysis, mean QOLRAD improved earliest at 8th week vs. baseline ( = 0.006) in the guided group and 2nd week vs. baseline ( = 0.011) in the empirical group but no differences were seen in other secondary outcomes ( > 0.05). No serious adverse events were reported. Guided approach may be preferred over short-term empirical therapy in symptom response, however QOLRAD, acid-related symptoms, or pH measures are not significantly different (trial registration ID no. NCT03319121).
非心源性胸痛很常见，其中三分之二归因于胃食管反流病（GERD）。为评估在非心源性胸痛中指导性治疗与经验性治疗的有效性和安全性。将血管造影或负荷试验正常的成年人随机分为指导性治疗组或经验性治疗组。在指导性治疗组中，动态pH阻抗测试后，若为GERD，则给予右兰索拉唑30毫克/天，持续8周；但若为功能性或高敏性胸痛，则给予缓释茶碱250毫克/天，持续4周。在经验性治疗组中，给予右兰索拉唑60毫克/天，持续2周。主要结局指标为总体胸痛视觉模拟评分（VAS），次要结局指标为反流和消化不良生活质量（QOLRAD）、GERD问卷（GERDQ）以及pH参数，均在基线、第2周和第8周测定。在200例筛查患者中，132例被排除，按方案分析的68例随机分组患者中，33例在指导性治疗组，35例在经验性治疗组。组间分析显示，第8周时指导性治疗组的总体疼痛评分均值优于经验性治疗组（P = 0.005），但GERDQ、QOLRAD或任何pH测量指标均无差异（均P > 0.05）。组内分析显示，指导性治疗组中，第8周时QOLRAD均值相对于基线最早改善（P = 0.006），经验性治疗组中第2周相对于基线改善（P = 0.011），但其他次要结局指标未见差异（P > 0.05）。未报告严重不良事件。在症状反应方面，指导性治疗方法可能优于短期经验性治疗，然而QOLRAD、酸相关症状或pH测量指标无显著差异（试验注册号：NCT03319121）。
