加味半夏泻心汤联合质子泵抑制剂降阶梯式撤药治疗非糜烂性反流病寒热错杂证

Modified Banxia Xiexin Decoction Combined with Proton Pump Inhibitor for Stepwise Withdrawal in Treatment of Non-erosive Reflux Disease with Cold-Heat Mixed Syndrome

目的:观察加味半夏泻心汤联合质子泵抑制剂降阶梯式撤药治疗非糜烂性反流病寒热错杂证的临床疗效。方法:选择2020年10月至2021年9月武汉市中西医结合医院就诊的长期使用质子泵抑制剂的88例非糜烂性反流病寒热错杂证患者为研究对象,随机分为观察组46例与对照组42例。对照组给予5%加味半夏泻心汤模拟剂联合质子泵抑制剂降阶梯式撤药治疗,观察组给予加味半夏泻心汤联合质子泵抑制剂降阶梯式撤药治疗。两组患者均治疗6周。治疗后,比较两组患者临床疗效、质子泵抑制剂停药率、复发率以及不良反应发生情况,治疗前后症状总积分、中医证候总积分、主要中医证候评分。结果:治疗后,观察组有效率为84.8%(39/46),对照组有效率为64.3%(27/42),两组有效率比较,差异有统计学意义(P<0.05)。治疗2周、4周、6周,两组患者症状总积分均显著降低,观察组治疗6周低于同期对照组,差异均有统计学意义(P<0.05)。治疗2周、4周、6周,两组患者中医证候总积分均显著降低,观察组治疗6周低于同期对照组,差异均有统计学意义(P<0.05)。治疗2周、4周、6周,两组患者主要中医证候评分均显著降低,观察组治疗4周胸骨后或胃脘部烧灼感评分低于同期对照组,观察组治疗6周主要中医证候评分均低于同期对照组,差异均有统计学意义(P<0.05)。观察组质子泵抑制剂停药率为82.6%(38/46),对照组为31.0%(13/42),两组停药率比较,差异有统计学意义(P<0.05)。观察组复发率为19.6%(38/46),对照组为40.5%(17/42),两组复发率比较,差异有统计学意义(P<0.05)。两组均未出现严重不良反应。结论:加味半夏泻心汤联合质子泵抑制剂降阶梯式撤药治疗非糜烂性反流病寒热错杂证疗效确切,能够有效改善患者症状、降低质子泵抑制剂的停药率以及复发率。

Objective:To observe the clinical efficacy of Jiawei Banxia Xiexin Decoction combined with step-by-step withdrawal of proton pump inhibitor in treatment of Cold-Heat mixed syndrome of non-erosive reflux disease.Methods:From October 2020 to September 2021 in Wuhan Hospital of Integrated Traditional Chinese and Western Medicine,88 patients with Cold-Heat mixed syndrome of non-erosive reflux disease who used proton pump inhibitors for a long time were selected as the research object and randomly divided into observation group(46 cases)and control group(42 cases).The control group was treated with 5%Jiawei Banxia Xiexin Decoction simulant combined with proton pump inhibitor,while the observation group was treated with Jiawei Banxia Xiexin Decoction combined with proton pump inhibitor.Both groups were treated for 6 weeks.After treatment,the clinical efficacy,the withdrawal rate of proton pump inhibitors,the recurrence rate and the occurrence of adverse reactions,the total score of symptoms,the total score of TCM syndromes and the scores of main TCM syndromes before and after treatment were compared between the two groups.Results:After treatment,the effective rate of the observation group was 84.8%(39/46),and that of the control group was 64.3%(27/42).The difference between the two groups was statistically significant(P<0.05).After 2 weeks,4 weeks and 6 weeks of treatment,the total symptom score of patients in both groups decreased significantly,and the observation group was lower than the control group after 6 weeks of treatment,with statistical significance(P<0.05).After 2 weeks,4 weeks and 6 weeks of treatment,the total scores of TCM syndromes in the two groups were significantly reduced,and the observation group was lower than the control group after 6 weeks of treatment,with statistical significance(P<0.05).After 2 weeks,4 weeks and 6 weeks of treatment,the scores of main TCM syndromes in the two groups were significantly reduced,and the scores of burning sensation behind sternum or epigastrium in the observation group were lower than those in the control group at the same period,while the scores of main TCM syndromes in the observation group were lower than those in the control group at the same period after treatment for 6 weeks,with statistical significance(P<0.05).The withdrawal rate of proton pump inhibitors was 82.6%(38/46)in the observation group and 31.0%(13/42)in the control group.The difference between the two groups was statistically significant(P<0.05).The recurrence rate of the observation group was 19.6%(38/46),while that of the control group was 40.5%(17/42).The difference was statistically significant(P<0.05).No serious adverse reactions occurred in both groups.Conclusion:Modified Banxia Xiexin Decoction combined with step-by-step withdrawal of proton pump inhibitors is effective in treating Cold-Heat syndrome of non-erosive reflux disease,which can effectively improve patients′symptoms and reduce the withdrawal rate and recurrence rate of proton pump inhibitors.