A Clinical Study of Vonoprazan Fumarate Tablets for the Treatment of Non-erosive Reflux Disease
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摘要:
目的 研究富马酸伏诺拉生片与艾司奥美拉唑镁肠溶片在治疗非糜烂性反流病（non-erosive reflux disease，NERD）中的效果及不良反应对比。 方法 选取124例NERD患者，采用随机数字表法分为观察组62例和对照组62例。观察组给予富马酸伏诺拉生片，对照组给予艾司奥美拉唑镁肠溶片，疗程均为4周。对幽门螺旋杆菌（helicobacter pylori，HP）阳性的患者进一步根除HP。比较2组患者的临床疗效、反流性疾病问卷量表（reflux disease questionnaire，RDQ）评分、匹兹堡睡眠质量指数（pittsburgh sleep quality index，PSQI） 评分、治疗前后食管pH值变化、HP根除率及不良反应发生率。 结果 观察组总有效率高于对照组（P < 0.05），观察组治疗后RDQ评分低于对照组（P < 0.05），观察组治疗后PSQI评分低于对照组（P < 0.05），观察组治疗后pH < 4反流次数、> 5 min反流次数和pH < 4总时间低于对照组（P < 0.05），观察组HP根除率高于对照组（P < 0.05）。观察组和对照组比较，总不良反应率无明显差异（P > 0.05）。 结论 在治疗非糜烂性反流病方面，富马酸伏诺拉生片与艾司奥美拉唑镁肠溶片对比，疗效显著，可改善睡眠质量，抑酸更强，提高HP根除率，并不增加不良反应。 -
关键词:
- 富马酸伏诺拉生片 /
- 艾司奥美拉唑镁肠溶片 /
- 非糜烂性反流病
Abstract:Objective To study the efficacy and adverse reactions of vonoprazan fumarate tablets and esomeprazole magnesium enteric-coated tablets in the treatment of non-erosive reflux disease（NERD）. Methods A total of 124 patients with NERD were selected and divided into treatment group（62 cases） and control group（62 cases） by random number table method. Treatment group received vohoprazan fumarate tablet, while control group received esomeprazole magnesium enteric-coated tablet, and the course of treatment was 4 weeks. HP was eradicated in helicobacter pylori（HP）-positive patients. The clinical efficacy, reflux disease questionnaire（RDQ ）score, pittsburgh sleep quality index score, changes of esophageal pH before and after treatment、HP eradication rate and incidence of adverse reactions were compared between the two groups. Results The treatment group showed a higher overall effectiveness compared to the control group（P < 0.05）. After treatment, the RDQ scores in the treatment group were lower than those in the control group（P < 0.05）. Similarly, the PSQI scores in the treatment group were lower than those in the control group（P < 0.05）. Additionally, the treatment group exhibited fewer reflux episodes with pH < 4, reflux episodes lasting > 5 minutes, and a lower total time with pH < 4 compared to the control group（P < 0.05）. The eradication rate of HP in the treatment group was higher than that in the control group（P < 0.05）. There was no significant difference in the overall rate of adverse reactions between the treatment group and the control group（P > 0.05）. Conclusion In the treatment of non-erosive reflux disease, compared to esomeprazole magnesium enteric-coated tablets, vonoprazan fumarate tablets show significant efficacy, improve sleep quality, provide stronger acid suppression, increase the eradication rate of Helicobacter pylori（HP）, and do not increase adverse reactions. -
表 1 观察组和对照组一般资料比较[$\bar x \pm s$/n（%）]
Table 1. Comparison of general data between treatment group and control group[$ \bar x \pm s $/n（%）]
组别 性别
（男/女）年龄
（岁）BMI
（kg/m2）吸烟 饮酒 HP感染 观察组 27/35 57.74±12.81 23.86±2.58 10（16.13） 12（19.35） 34（54.84） 对照组 24/38 56.79±11.29 23.12±2.27 9（14.52） 13（20.97） 32（51.61） t/χ2 0.300 0.439 1.689 0.062 0.050 0.130 P 0.584 0.662 0.094 0.803 0.823 0.719 
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表 2 2组患者治疗后临床疗效[n（%）]
Table 2. Clinical efficacy of two groups of patients after treatment [n（%）]
组别 n 显效 有效 无效 总有效率 观察组 62 34（54.84） 24（38.71） 4（6.45） 58（93.55） 对照组 62 29（46.77） 18（29.03） 15（24.19） 47（75.81） χ2 / / / / 7.521 P / / / / 0.006* *P < 0.05。
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表 3 2组患者治疗前后RDQ评分[（$\bar x \pm s$），分]
Table 3. RDQ scores before and after treatment in the two groups [（$\bar x \pm s$），points]
组别 n 治疗前 治疗后 观察组 62 17.13±6.11 9.03±3.28 对照组 62 16.81±5.59 10.48±2.86 t / 0.307 −2.624 P / 0.760 0.010* *P < 0.05。
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表 4 2组患者治疗前后PSQI评分[（$\bar x \pm s$），分]
Table 4. PSQI score before and after treatment in the two groups [（$\bar x \pm s$），points]
组别 n 治疗前 治疗后 观察组 62 7.90±2.51 4.76±1.89 对照组 62 7.85±1.57 5.95±1.74 t / 0.129 −3.660 P / 0.898 < 0.001* *P < 0.05。
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表 5 2组患者治疗前后食管pH检测变化（$\bar x \pm s$）
Table 5. The changes of esophageal pH before and after treatment in the two groups of patients（$\bar x \pm s$）
组别 n pH < 4反流次数（次） > 5 min反流次数（次） pH < 4总时间（min） 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 观察组 62 28.37±8.71 11.16±2.57 5.76±2.41 1.69±0.86 74.84±12.30 16.81±5.02 对照组 62 28.05±8.15 13.02±5.36 5.42±2.27 2.87±1.15 71.77±11.23 23.97±6.17 t / −0.213 2.457 0.804 −6.447 1.449 −7.115 P / 0.832 0.015 0.423 < 0.001* 0.150 < 0.001* *P < 0.05。
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表 6 2组患者HP感染者根除率（%）
Table 6. The eradication rate of HP infection in the two groups of patients （%）
组别 n 根除率（%） 根除前HP阳性 根除后HP阴性 观察组 34 31 31/34（91.2） 对照组 32 20 20/32（62.5） χ2 / / 4.030 P / / 0.045* *P < 0.05。
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