疏肝胃安方辅助治疗胃食管反流病的临床效果及安全性研究

Clinical effect and safety of Shugan Weian Recipe in adjuvant treatment of gastro esophageal reflux disease

目的探究疏肝胃安方辅助治疗胃食管反流病(GERD)的临床效果及安全性。方法选取2017年3月~2019年3月在南京中医药大学附属南京市中西医结合医院门诊接受治疗的GERD患者120例作为研究对象,采用随机数字表法将其分为对照组和观察组,每组60例,对照组采用常规西药治疗,观察组采用常规西药联合疏肝胃安方治疗。治疗前后两组分别进行反流性疾病问卷(RDQ)调查、24 h食管pH检测,比较两组胃镜疗效、RDQ总分、pH检测结果及不良反应。结果观察组治疗总有效率明显高于对照组,但差异无统计学意义(P> 0.05);治疗后,两组RDQ总分均明显低于治疗前(P <0.05),且观察组RDQ总分明显低于对照组(P <0.05);治疗后,两组pH<4总时间百分比、反流持续≥5 min次数、最长反流持续时间及DeMeester得分均明显低于治疗前(P <0.05),且观察组最长反流持续时间及DeMeester得分均明显低于对照组(P <0.05)。治疗后,两组不良反应比较,差异无统计学意义(P> 0.05)。结论疏肝胃安方联合西药在治疗GERD方面有较好的临床效果,不仅可以缓解GERD患者的临床症状、改善患者的生活质量,且具有一定的安全性。

Objective To explore the clinical effect and safety of Shugan Weian Recipe in the adjuvant treatment of gastro esophageal reflux disease(GERD). Methods A total of 120 patients GERD who were treated in the Outpatient Service of Nanjing Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Nanjing University of Chinese Medicine from March 2017 to March 2019 were selected as the research objects. They were divided into control group and the observation group by random number table method, with 60 cases in each group. The control group was treated with routine western medicine, while the observation group was treated with routine western medicine combined with Shugan Weian Recipe. Before and after treatment, the reflux disease questionnaire(RDQ) and 24-hour esophageal pH of two groups were surveyed. After treatment, gastroscopic efficacy, total RDQ score, pH test results and adverse reactions were compared between the two groups. Results The total effective rate of the observation group was significantly higher than that of the control group, but the difference was not statistically significant(P > 0.05);after treatment, the total RDQ score of the two groups was significantly lower than that before treatment(P < 0.05), and the total RDQ score of the observation group was significantly lower than that of the control group(P < 0.05);after treatment, the percentage of total time of pH<4, times of reflux duration ≥ 5 minutes, longest reflux duration and DeMeester score in both groups were significantly lower than those before treatment(P < 0.05), and the longest reflux duration and DeMeester score in the observation group were significantly lower than those in the control group(P < 0.05). After treatment, the difference in the rate of adverse reactions between the two groups was not statistically significant(P > 0.05).Conclusion Shugan Weian Decoction combined with Western medicine has a good clinical effect in the treatment of GERD. It can not only alleviate the clinical symptoms of GERD patients, improve the quality of life of patients, but also has certain safety.