贝母枳术方治疗胃食管反流性咳嗽的回顾性队列研究  

Treatment of Gastroesophageal Reflux Cough with Beimu ZhizhuPrescription:A Retrospective Cohort Study

作　　者：王海强 马纪长 高峰[1] 吴蔚[1] 胡雪冰 王彬[1] WANG Hai-Qiang;MA Ji-Zhang;GAO Feng;WU Wei;HU Xue-Bing;WANG Bin(Wangjing Hospital of China Academy of Chinese Medical Sciences,Beijing 100102,China)

机构地区：[1]中国中医科学院望京医院,北京100102

出　　处：《广州中医药大学学报》2024年第9期2333-2339,共7页Journal of Guangzhou University of Traditional Chinese Medicine

基　　金：2024年首都卫生发展科研专项自主创新项目(编号:首发2024-2-4167);中国中医科学院望京医院自主选题专项课题(编号:WJYY-ZZXT-2022-07);中国中医科学院望京医院“加强医疗机构制剂研究与新药转化”专项课题(编号:WJZJ-202317)。

摘　　要：【目的】回顾性分析297例胃食管反流性咳嗽(gastroesophageal reflux cough,GERC)患者临床资料,探讨贝母枳术方(枳术丸加味)治疗GERC的临床疗效和安全性。【方法】采用回顾性队列研究,共计纳入2021年7月至2023年7月就诊于中国中医科学院望京医院门诊的297例胃气上逆型GERC患者,根据是否应用贝母枳术方分为暴露组136例和非暴露组161例,暴露组应用贝母枳术方治疗,非暴露组应用质子泵抑制剂(艾司奥美拉唑镁肠溶片)治疗,并经1∶1倾向性评分匹配(PSM)得到119对病例,观察匹配后2组患者治疗前后唾液胃蛋白酶水平的变化情况,比较匹配后2组患者治疗2周、8周后的咳嗽缓解总有效率和反流相关症状缓解率(包括反酸、烧心、嗳气、胃胀缓解率),并记录不良反应发生情况。【结果】(1)症状缓解率方面,匹配后,暴露组治疗2周后的咳嗽缓解总有效率及反酸、烧心、嗳气、胃胀等反流相关症状缓解率分别为84.87%(101/119)、80.77%(84/104)、82.61%(76/92)、82.5%(66/80)、84.42%(65/77),非暴露组分别为73.95%(88/119)、72.90%(78/107)、70.41%(69/98)、65.38%(51/78)、64.38%(47/73),组间比较,暴露组除反酸缓解率外的其他症状缓解率均明显优于非暴露组(P<0.05或P<0.01);暴露组治疗8周后的咳嗽缓解总有效率及反酸、烧心、嗳气、胃胀等反流相关症状缓解率分别为94.74%(36/38)、91.67%(33/36)、91.43%(32/35)、93.75%(30/32)、94.12%(32/34),非暴露组分别为77.78%(35/45)、74.42%(32/43)、71.43%(30/42)、68.42%(26/38)、66.67%(24/36),组间比较,暴露组的各项症状缓解率均明显优于非暴露组(P<0.05或P<0.01)。(2)唾液胃蛋白酶水平方面,匹配后,暴露组治疗2周后的唾液胃蛋白酶水平较治疗前明显下降(P<0.01),非暴露组的唾液胃蛋白酶水平未见明显下降(P>0.05),暴露组对唾液胃蛋白酶水平的下降作用明显优于非暴露组,组间治疗2周后及治疗前后差值比较,差异均有统Objective To explore the clinical efficacy and safety of Beimu Zhizhu Prescription(derived from the modification of Zhizhu Pills)in the treatment of GERC by retrospectively analyzing the clinical data of 297 patients with gastroesophageal reflux cough(GERC).Methods A retrospective cohort study was conducted in a total of 297 patients with GERC of rebellious stomach qi type who were admitted to the Outpatient Department of Wangjing Hospital of China Academy of Chinese Medical Sciences from July 2021 to July 2023.The patients were divided into an exposure group(136 cases)and a non-exposure group(161 cases)according to the medication of Beimu Zhizhu Prescription or not.The exposure group was treated with Beimu Zhizhu Decoction,and the non-exposure group was treated with proton pump inhibitor of Esomeprazole Magnesium Enteric-coated Tablets.A total of 119 pairs of cases were obtained after propensity score matching(PSM)at the ratio of 1 to 1.The changes of salivary pepsin level before and after treatment in the two groups were observed.After two weeks and eight weeks of treatment,the cough response rate and the remission rates for reflux-related symptoms of acid reflux,heartburn,belching and gastric distension were compared between the two groups,and the incidence of adverse reactions was recorded.Results(1)After two weeks of treatment,the comparison of symptom remission rate after PSM showed that the cough response rate and the remission rates for reflux-related symptoms of acid reflux,heartburn,belching and gastric distension in the exposure group were 84.87%(101/119),80.77%(84/104),82.61%(76/92),82.5%(66/80),84.42%(65/77),respectively,and those in the non-exposure group were 73.95%(88/119),72.90%(78/107),70.41%(69/98),65.38%(51/78),64.38%(47/73),respectively.The intergroup comparison showed that the remission rates for all of the symptoms except for acid reflux in the exposure group was significantly superior to that in the non-exposure group(P<0.05 or P<0.01).After eight weeks of treatment,the cough response rate

关 键 词：贝母枳术方 枳术丸 胃食管反流性咳嗽 胃气上逆 临床疗效 唾液胃蛋白酶 安全性 回顾性队列研究 

分 类 号：R256.11[医药卫生—中医内科学]