摘要
目的 观察酒石酸西尼必利片联合艾司奥美拉唑镁肠溶片治疗胃食管反流病患者的临床疗效及安全性。方法 将183例胃食管反流病患者随机分为对照组92例和试验组91例。对照组给予艾司奥美拉唑镁肠溶片每次20 mg,bid,口服;试验组在对照组治疗的基础上,给予酒石酸西尼必利片每次1 mg,tid,餐前15 min口服。2组患者均治疗8周。比较2组患者的临床疗效、反流总次数、酸反流>5 min次数、总pH<4百分比,以及药物不良反应的发生情况。结果 试验过程中共脱落7例。治疗后,试验组和对照组的总有效率分别为93.18%(82例/88例)和77.27%(68例/88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总次数分别为(71.34±8.03)和(78.63±8.24)次,酸反流>5 min次数分别为(8.61±1.07)和(9.81±1.24)次,总pH<4百分比分别为(6.23±1.44)%和(7.32±1.50)%,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面色潮红和皮肤瘙痒,对照组的药物不良反应主要有胃肠道不适。试验组和对照组的总药物不良反应发生率分别为9.09%和5.68%,差异无统计学意义(P>0.05)。结论 酒石酸西尼必利片联合艾司奥美拉唑镁肠溶片治疗胃食管反流病患者的临床疗效显著,可减少反流次数,降低食管pH,安全性较高。
Objective To investigate the effect of cinitapride hydrogen tartrate tablets combined with esomeprazole magnesium enteric coated tablets in the treatment of patients with gastroesophageal reflux disease. Methods A total of 183 patients with gastroesophageal reflux disease were randomly divided into control group with 92 cases and treatment groups with 91 cases. The control group was given esomeprazole magnesium enteric coated tablets 20 mg per time, bid, orally. On the basis of the control group, the treatment group was given cinitapride hydrogen tartrate tablets1 mg per time, tid, orally 15 min before meals. Two groups were treated for 8 weeks. The clinical efficacy, total frequency of reflux, the frequency of acid reflux > 5 min, the percentage of total pH<4 and adverse drug reactions were compared between two groups. Results A total of 7 cases were dropped off during the trial. After treatment, the total effective rates of treatment and control groups were 93. 18%(82 cases/88 cases) and 77. 27%(68 cases/88 cases) with significant difference(P < 0. 05).After treatment,the total frequencies of reflux were(71. 34 ± 8. 03) and(78. 63 ± 8. 24) times,the frequencies of acid reflux > 5 min were(8. 61 ± 1. 07) and(9. 81 ± 1. 24) times,the percentages of total pH < 4 were(6. 23 ± 1. 44) %and(7. 32 ± 1. 50) %,the differences were all statistically significant(all P < 0. 05). The adverse drug reactions of treatment group were flush and itchy skin,which in the control group were gastrointestinal discomfort. The total incidences of adverse drug reactions in the treatment and control groups were 9. 09% and 5. 68% without significant difference(P > 0. 05). Conclusion Cinitapride hydrogen tartrate tablets combined with esomeprazole magnesium enteric-coated tablets have a definitive clinical efficacy and safety in the treatment of patients with gastroesophageal reflux disease,which can reduce the number of reflux and reduce esophageal pH,with high safety.
作者
高媛
王爽
王鸿婵
赵砚宁
张琳
GAO Yuan;WANG Shuang;WANG Hong-chan;ZHAO Yan-ning;ZHANG Lin(Department of Gastroenterology,Shengjing Hospital Afflitated to China Medical University,Shenyang 11000,Liaoning Province,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2022年第15期1731-1734,共4页
The Chinese Journal of Clinical Pharmacology
基金
辽宁省自然科学基金资助项目(20170540627)。
关键词
酒石酸西尼必利片
艾司奥美拉唑镁肠溶片
胃食管反流病
安全性评价
cinitapride hydrogen tartrate tablet
esomeprazole magnesium enteric-coated tablet
gastroesophageal reflux disease
safety evaluation
