疏肝和胃方联合伏诺拉生治疗气郁痰阻型难治性胃食管反流病的临床疗效

Clinical Effect of Shugan Hewei Prescription Combined with Vonoprazan on Refractory Gastroesophageal Reflux Disease Due to Qi Depression and Phlegm Obstruction

目的:评价“疏肝和胃方”联合伏诺拉生治疗气郁痰阻型难治性胃食管反流病(RGERD)的临床疗效与可能存在的不良反应。方法:将符合纳入标准的80例RGERD患者均进行24 h pH阻抗与高分辨率食管测压及电子胃镜检查;通过随机数字表将80例RGERD患者随机分配到观察组与对照组,观察组给予中药疏肝和胃方(1袋/次,2次/d)联合伏诺拉生片(20 mg/次,1次/d)治疗;对照组予伏诺拉生片(20 mg/次,1次/d)治疗,两组患者治疗周期均为4周。观察两组患者临床疗效,治疗前、治疗2周后、治疗后中医证候(咽部不适如有痰梗、胸骨后不适、嗳气等)积分、躯体症状、生活质量及胃镜下食管黏膜改善情况。结果:最终完成试验并纳入统计者75例,观察组38例,对照组37例。观察组临床总有效率为89.47%(34/38),对照组临床总有效率为62.16%(23/37);观察组总有效率显著高于对照组,差异有统计学意义(χ^(2)=13.014,P<0.01)。与本组治疗前比较,两组患者食管黏膜评分、反流性疾病问卷评分、中医主证咽部不适如有痰梗及胸膺部不适评分、胃食管反流病生活质量评价量表(GERD-HRQL)、躯体症状自评量表(SSS)评分均明显降低(P<0.05);与对照组治疗后比较,观察组在缓解气郁痰阻型RGERD患者烧心、反酸、咽喉不适如有痰梗、胸骨后不适、嗳气、半夜呛咳、恶心干呕、口黏腻、失眠效果等临床症状、躯体化症状及生活质量方面效果更优(P<0.05,P<0.01),但治疗后组间比较两组食管黏膜改善情况差异无统计学意义。结论:疏肝和胃方联合伏诺拉生治疗气郁痰阻型RGERD在临床症状、体征及生活质量、躯体化症状改善等方面效果更优,无明显不良反应。

Objective:To evaluate the clinical efficacy and adverse effects of Shugan Hewei prescription combined with vonoprazan in the treatment of refractory gastroesophageal reflux disease(RGERD)due to qi depression and phlegm obstruction.Method:Eighty RGERD patients who met the inclusion criteria underwent 24-hour pH impedance and high-resolution esophageal manometry and electronic gastroscopy.The 80 patients were randomly assigned to an observation group(Shugan Hewei prescription,one bag each time,twice a day+vonoprazan,20 mg each time,once a day)and a control group(vonoprazan,20 mg each time,once a day)by the random number table method.The treatment in both groups lasted for 4 weeks.The clinical efficacy was examined.The scores of TCM symptoms(pharyngeal discomforts such as phlegm obstruction,retrosternal discomfort,and belching),somatic symptoms,quality of life,and improvement of esophageal mucosa under gastroscopy were observed in both groups before treatment and after treatment for 2 and 4 weeks.Result:Seventy-five patients completed the trial were included in this study,including 38 patients in the observation group and 37 patients in the control group.The total response rate in the observation group was 89.47%(34/38),which was higher than that(62.16%,23/37)in the control group(χ^(2)=13.014,P<0.01).After treatment,the scores of esophageal mucous membrane,reflux disease symptoms,TCM symptoms,gastroesophageal reflux disease health-related quality of life scale(GERD-HRQL),and somatic self-rating scale(SSS)decreased in both groups(P<0.05).Moreover,the observation group outperformed the control group in alleviating heartburn,acid reflux,throat discomforts,midnight coughing,nausea and dry vomiting,mucousy mouth,and insomnia in the patients with GERD(P<0.05,P<0.01).However,the two groups showed no statistically significant differences in the improvement of esophageal mucosa after treatment.Conclusion:The combination of Shugan Hewei prescription with vonoprazan was superior to vonoprazan alone in treating RGERD regarding clinical symptoms,physical signs,quality of life,and somatic symptoms,without causing obvious adverse effects.