富马酸伏诺拉生片治疗复发性反流性食管炎患者的临床研究

Clinical trial of vonoprazan fumarate tablets in the treatment of patients with recurrent reflux esophagitis

目的 观察富马酸伏诺拉生片治疗复发性反流性食管炎患者的临床疗效及安全性。方法 将132例复发性反流性食管炎患者随机分为对照组66例和试验组66例。对照组给予奥美拉唑钠肠溶胶囊每次20 mg,口服,每日2次;试验组给予富马酸伏诺拉生片每次20 mg,口服,每日1次。2组患者均治疗8周。比较2组患者的临床疗效、反流时间≥5 min次数、pH<4时间占比、血清肿瘤坏死因子-α(TNF-α)水平,以及药物不良反应的发生情况。结果 试验过程中共脱落8例。治疗后,试验组和对照组的总有效率分别为93.75%(60例/64例)和80.00%(48例/60例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的反流时间≥5 min次数分别为(1.04±0.67)和(3.12±1.69)次,pH<4时间占比分别为(2.17±0.70)%和(4.75±0.99)%,血清TNF-α水平分别为(6.31±2.49)和(9.02±2.86)mg·L^(-1),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有腹泻和便秘,对照组的药物不良反应主要有轻度恶心和腹胀。试验组和对照组的总药物不良反应发生率分别为4.68%和6.67%,差异无统计学意义(P>0.05)。结论 富马酸伏诺拉生片治疗复发性反流性食管炎患者的临床疗效显著,其能显著改善24 h食管pH,降低炎症因子水平,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of vonoprazan fumarate tablets in the treatment of patients with recurrent reflux esophagitis. Methods A total of 132 patients with recurrent reflux esophagitis were randomly divided into control and treatment groups with 66 cases per group. The control group was treated with omeprazole enteric-coated capsules 20 mg per time, twice a day, orally. The treatment group was treated with vonoprazan fumarate tablets 20 mg per time, once a day, orally. Two groups were treated for 8 weeks. The times of reflux time ≥ 5 min, time of PH<4, serum levels of tumor necrosis factor-α(TNF-α) and adverse drug reactions were compared between two groups. Results A total of 8 cases were dropped off during the trial. After treatment, the total effective rates of treatment and control groups were 93.75%(60 cases/64 cases) and 80.00%(48 cases/60 cases) with significant difference(P<0.05). After treatment, the times of reflux time ≥ 5 min were( 1. 04 ± 0. 67) and( 3. 12 ± 1. 69) times,the time of PH < 4 was( 2. 17 ± 0. 70) % and( 4. 75 ± 0. 99) %,serum levels of TNF-α were( 6. 31 ± 2. 49) and( 9. 02 ± 2. 86) mg·L^(-1),the differences were statistically significant( all P < 0. 05). The adverse drug reactions of treatment group were diarrhea and constipation,which in the control group were mild nausea and abdominal distention. The total incidences of adverse drug reactions in the treatment and control groups were 4. 68% and 6. 67% without significant difference( P > 0. 05). Conclusion Vonoprazan fumarate tablets has a definitive clinical efficacy in the treatment of patients with recurrent reflux esophagitis,which can improve 24-hour esophageal pH and reduce inflammatory factors,without increasing the incidences of adverse drug reactions.