三仁汤合旋覆代赭汤治疗胃食管反流病72例临床研究

Clinical study of Sanren decoction combined with Xuanfu Daizhe decoction in treating 72 cases of gastroesophageal reflux disease

目的:探讨三仁汤合旋覆代赭汤加减治疗胃食管反流病(Gastroesophageal Reflux Disease,GERD)的临床疗效及对中医证候积分、GERD主要症状积分、不良反应、复发率及患者满意度等的影响。方法:研究对象选取2022年1月―2023年1月福建中医药大学附属第三人民医院脾胃病科及脾胃科门诊收治的GERD患者72例,根据随机数字表法分成治疗组(36例)和对照组(36例)。其中对照组给予富马酸伏诺拉生片方案治疗,治疗组在对照组基础上给予口服中药三仁汤合旋覆代赭汤加减治疗,两组均持续治疗4周。比较治疗前后两组中医证候积分、主要症状积分、复发率、患者满意度等,并对其疗效及安全性进行记录。结果:治疗前两组中医证候积分、主要临床症状积分(反酸、烧心)比较,差异无统计学意义(P>0.05),治疗后两组中医证候积分均有改善(P<0.05),且治疗组改善效果优于对照组(P<0.05);两组治疗后在GERD的主要症状反酸、烧心方面均有显著改善作用,且治疗组在改善烧心症状方面优于对照组(P<0.05);临床总有效率方面,治疗组优于对照组,差异有统计学意义(P<0.05);不良反应发生率方面,治疗组低于对照组,但差异无统计学意义(P>0.05);疾病复发率上,随访调查治疗后3个月患者,显示治疗组复发率低于对照组,差异有统计学意义(P<0.05);治疗组患者满意度优于对照组,差异有统计学意义(P<0.05)。结论:三仁汤合旋覆代赭汤加减治疗GERD,能有效缓解其症状,尤其在烧心主要症状方面更加显著,调节胃肠功能作用,减少复发,提高生活质量,相比常规治疗临床疗效更显著,安全性也更好。

Objective:To investigate the clinical effects of Modified Sanren decoction(三仁汤)combined with Xuanfu Daizhe decoction(旋覆代赭汤)in the treatment of gastroesophageal reflux disease(GERD),TCM syndrome score,main symptom score,adverse reactions,recurrence rate and patient satisfaction.Methods:Seventy-two patients with gastroesophageal reflux disease admitted to the Department of Spleen and Stomach Diseases and the Outpatient Department of Spleen and Stomach Diseases in the Third People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine from January 2022 to January 2023 were selected and divided into the treatment group(36 cases)and the control group(36 cases)according to random number table method.The control group was given the regimen of fumarate,and the treatment group was given the oral traditional Chinese medicine Modified Sanren decoction combined with Xuanfu Daizhe decoction on the basis of the treatment of the control group.Both groups were treated continuously for 4 weeks.The TCM syndrome score,main symptom score,patient recurrence rate,patient satisfaction and other aspects of the two groups before and after treatment were compared,and the efficacy and safety were recorded.Results:There was no significant difference in TCM syndrome score and main clinical symptom score(acid reflux and heartburn)between the two groups before treatment(P>0.05).After treatment,TCM syndrome score of the two groups was improved compared with that before treatment(P<0.05),the improvement effect of the treatment group was better than that of the control group(P<0.05),and the two groups had significant effects on acid reflux and heartburn,the main symptoms of gastroesophageal reflux disease.However,the treatment group was better than the control group in improving heartburn symptoms(P<0.05).The total effective rate of the treatment group(91.6%)was better than that of the control group(75.0%),and the difference was statistically significant(P<0.05).The incidence of adverse reactions in the treatment group was lower than that in the control group,but there was no significant difference(P>0.05).In terms of disease recurrence rate,the follow-up survey of patients 3 months after treatment showed that the recurrence rate of the treatment group was lower than that of the control group,the difference was statistically significant(P<0.05),and the satisfaction of the treatment group was better than that of the control group,the difference was statistically significant.Conclusion:In the treatment of gastroesophageal reflux disease,Modified Sanren decoction combined with Xuanfu Daizhe decoction can not only effectively relieve the symptoms,especially in the main symptoms of heartburn,but also regulate gastrointestinal function,reduce recurrence,and play an important role in improving the quality of life,which has more significant clinical efficacy and better safety thanc onventional treatment.