雷尼替丁联合艾司奥美拉唑镁治疗咽喉反流性疾病患者的临床研究

Clinical trial of ranitidine combined with esomeprazole magnesium in the treatment of patients with laryngopharyngeal reflux disease

目的 观察盐酸雷尼替丁胶囊联合艾司奥美拉唑镁肠溶片治疗咽喉反流性疾病(LPRD)患者的临床疗效及安全性。方法 将LPRD患者随机分为对照组和试验组。2组患者在常规治疗的基础上,对照组联合口服艾司奥美拉唑镁肠溶片每次20 mg,qd;试验组在对照组治疗的基础上,联合口服盐酸雷尼替丁胶囊每次0.15 g,bid。2组患者均治疗8周。比较2组患者的临床疗效、咽喉反流情况、炎症因子、食管动力学,以及药物不良反应的发生情况。结果 试验组入组50例,脱落3例,最终有47例纳入统计分析;对照组因入组51例,脱落5例,最终有46例纳入统计分析。治疗后,试验组和对照组的总有效率分别为95.74%(45例/47例)和78.26%(36例/46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症状指数量表评分分别为(12.01±2.14)和(15.81±3.02)分,反流体征指数量表评分分别为(5.89±1.06)和(8.20±1.45)分,核因子-κB p65 mRNA相对表达水平分别为0.97±0.18和1.13±0.21,高敏-C反应蛋白分别为(20.01±3.52)和(32.01±5.29)mg·L^(-1),食管下括约肌静息压分别为(28.49±4.01)和(24.68±3.58)mmHg,食管上括约肌静息压分别为(72.01±8.69)和(65.58±7.14)mmHg,食管远端收缩积分分别为(1 584.19±258.67)和(1 348.67±226.35)mmHg·cm^(-1)·s^(-1),远端潜伏期分别为(2.92±0.49)和(3.62±0.63)s,差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以便秘、口干、恶心为主。试验组和对照组的总药物不良反应发生率分别为10.64%和8.70%,差异无统计学意义(P>0.05)。结论 盐酸雷尼替丁胶囊联合艾司奥美拉唑镁肠溶片治疗LPRD患者的临床疗效确切,其能显著降低患者的炎症因子水平,改善咽喉反流情况、体征和食管动力学,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of ranitidine hydrochloride capsules combined with esomeprazole magnesium enteric-coated tablets in the treatment of patients with laryngopharyngeal reflux disease (LPRD).Methods LPRD patients were randomly divided into control group and treatment group.On the basis of conventional treatment,the control group was combined with esomeprazole magnesium enteric-coated tablet 20 mg each time,qd;on the basis of the control group,the treatment group was combined with oral ranitidine hydrochloride capsule 0.15 g each time,bid.Two groups were treated for 8 weeks.The clinical efficacy,laryngeal reflux,inflammatory factors,esophageal dynamics and the occurrence of adverse drug reactions were compared between the two groups.Results In the treatment group,50 cases were enrolled,3 cases fell off,and 47 cases were included in the statistical analysis.In the control group,51 cases were enrolled,5 cases fell off,and 46 cases were finally included in the statistical analysis.After treatment,the total effective rates of treatment group and control group was 95.74%(45 cases/47 cases) and 78.26%(36 cases/46cases),and the difference was statistically significant (P0.05).After treatment,the reflux symptom index scores of the treatment group and the control group were (12.01±2.14) and (15.81±3.02) points,the reflux finding scores were (5.89±1.06) and (8.20±1.45) points,relative expression levels of nuclear factor-κB p65 mRNA were0.97±0.18 and 1.13±0.21,high sensitivity-C reactive protein levels were (20.01±3.52) and (32.01±5.29)mg·L^(-1),lower esophageal sphincter resting pressure was (28.49±4.01) and (24.68±3.58) mm Hg,the upper esophageal sphincter resting pressure was (72.01±8.69) and (65.58±7.14) mm Hg,distal esophageal systolic scores were(1 584.19±258.67) and (1 348.67±226.35) mm Hg·cm^(-1)·s^(-1),and distal latency were (2.92±0.49) and(3.62±0.63) s,the differences were statistically significant (all P0.05).The adverse drug reactions of 2 groups were mainly constipation,dry mouth and nausea.The total incidences of adverse drug reactions in treatment group and control group were 10.64%and 8.70%,without significant difference (P0.05).Conclusion Ranitidine hydrochloride capsules combined with esomeprazole magnesium enteric-coated tablets have definite clinical efficacy in the treatment of LPRD patients,which can significantly reduce the level of inflammatory factors,improve the status of pharyngeal reflux,physical signs and esophageal dynamics,and does not increase the incidence of adverse drug reactions.