国医大师经验方清胃颗粒治疗难治性反流性食管炎的临床研究

Clinical trial of refractory reflux esophagitis treated with qingwei granules

目的观察雷贝拉唑胶囊比较评价联合使用清胃颗粒治疗难治性反流性食管炎的疗效及其安全性。方法符合入组标准的难治性反流性食管炎的患者120例,随机进入治疗组与对照组,两组均服用雷贝拉唑胶囊1粒/次,2次/d,治疗组同时加用清胃颗粒1袋/次,2次/d,共8周,治疗结束评价疗效和安全性。结果治疗组在胃食管反流病症状频率表评价中总有效率为81.67%,中医症状、证候量表评价中总有效率为78.33%,对照组分别为58.33%、66.67%,两组比较差异有统计学意义(P<0.05);其中吐酸、烧心、心下烦治疗前后比较差异有统计学意义(P<0.01),疗效显著,但两组比较差异无统计学意义(P>0.05)。停药率两组分别为治疗组56.67%,对照组38.33%,两组比较差异有统计学意义(P<0.05);复发率显示治疗组44.12%,对照组73.91%,差异有统计学意义(P<0.05);不良反应发生率分别是6.67%,8.33%,差异无统计学意义(P>0.05)。结论(1)雷贝拉唑胶囊联合使用清胃颗粒可显著降低难治性反流性食管炎症状分级量表等各项评分;(2)雷贝拉唑胶囊联合使用清胃颗粒,停药率及复发率有显著下降;(3)清胃颗粒与雷贝拉唑胶囊均为临床使用安全的药物。

Objective To observe and comparably evaluate the effects and the safety of rabeprazole capsules in combination with qingwei granules in the treatment of refractory reflux esophagitis. Methods A total of 120 patients of refractory reflux esophagitis,in compliance with the inclusion criteria were randomized into a treatment group and a control group. The rabeprazole capsules were taken orally,1 capsule each time,twice a day in the two groups. Additionally,qingwei granules were taken,one bag each time,twice a day in the treatment group. Totally,the treatment lasted 8 weeks. At the end of treatment,the effects and safety were evaluated. Results In the treatment group,the total effective rate was 81. 67% in the evaluation of frequency scale for the symptoms of gastroesophageal reflux disease（ FSSG）; the total effective rate was78. 33% in the evaluation of TCM symptom and syndrome scale. They were 58. 33% and 66. 67% respectively in the control group. The differences were significant in comparison of the two groups（ P〈0. 05）. The differences were significant in terms of acid reflux,burning sensation in the stomach and discomfort in the stomach before and after treatment（ P〈0. 01）.The therapeutic effects were significant,but without statistical difference between the two groups（ P〉0. 05）. The drug withdrawal rate was 56. 67% in the treatment group and was 38. 33% in the control group,indicating the significant difference（ P〈0. 05）. The recurrence rate was 44. 12% in the treatment group and was 73. 91% in the control group,indicating the significant difference（ P〈0. 05）. The incidence rate of the adverse reaction was 6. 67% in the treatment group and was8. 33% in the control group,without significant difference（ P〉0. 05）. Conclusion 1. The combined medication of rabeprazole capsules and qingwei granules significantly reduces the score of each item in the symptom scale of refractory reflux esophagitis. 2. The combined medication significantly reduces the drug withdrawal rate and the recurrence rate. 3. Both qingwei granules and rabeprazole capsules are safe in the clinical treatment.