运和饮治疗儿童幽门螺杆菌相关再发性腹痛湿阻中焦证的随机对照试验

Yunhe Decoction on Helicobacter pylori-associated recurrent abdominal pain in children with syndrome of dampness in middle-jiao:A randomized controlled trial

目的:观察运和饮治疗儿童幽门螺杆菌(Hp)相关再发性腹痛(RAP)湿阻中焦证的临床疗效和安全性。方法:将2019年4月—2021年12月于南京中医药大学附属医院儿科就诊的65例Hp相关RAP湿阻中焦证患儿随机分为试验组40例,对照组25例。试验组采用运和饮口服;对照组采用标准三联疗法(奥美拉唑+克拉霉素+阿莫西林)口服,疗程均为2周。结果:与治疗前比较,治疗1、2周后两组腹痛频率积分、腹痛持续时间积分、腹痛影响学习生活程度积分均显著下降(P<0.05,P<0.01);试验组治疗1、2周后腹痛频率积分、腹痛持续时间积分、腹痛影响学习生活程度积分显著低于对照组(P<0.05,P<0.01);试验组Hp转阴率47.5%(19/40)显著低于对照组的72.0%(18/25)(P<0.01)。试验组中医证候疗效总显效率82.5%(33/40)、痊愈率52.5%(21/40)均显著高于对照组的总显效率36.0%(9/25)、痊愈率16.0%(4/25)(P<0.01)。两组患儿均未见明显不良反应发生。结论:运和饮治疗儿童Hp相关RAP湿阻中焦证安全有效。

Objective:To observe the efficacy and safety of Yunhe Decoction on Helicobacter pylori(Hp)-associated recurrent abdominal pain(RAP)children with syndrome of dampness in middle-jiao.Methods:A total of 65 cases of Hpassociated RAP children with syndrome of dampness in middle-jiao treated in the Department of Pediatrics,Affiliated Hospital of Nanjing University of Chinese Medicine,from April 2019 to December 2021 were randomly divided into observation group(40 cases)and control group(25 cases).Children were treated with orally Yunhe Decoction in observation group and standard triple therapy(omeprazole+Amoxicillin/Clavulanate potassium+clarithromycin)in control group,the treating period was 2 weeks.Results:Compared to before the treatment,the frequency scores of abdominal pain,the duration scores of abdominal pain and influence on study and life scores of abdominal pain were significantly reduced after the treatment of one and two weeks in both groups(P<0.05,P<0.01).The frequency scores of abdominal pain,the duration scores of abdominal pain and influence on study and life scores of abdominal pain were significant in observation group lower than control group(P<0.05,P<0.01);After treatment,the negative conversion rate of Hp was 47.5%(19/40)in the observation group which significantly lowered than that of the control group 72.0%(18/25)(P<0.01).Total apparent rate of TCM syndromes therapeutic effect 82.5%(33/40),total cure rate 52.5%(21/40)in the observation group,were significantly highered than total apparent rate 36.0%(9/25),total cure rate 16.0%(4/25)in the control group(P<0.01).In the course of treatment had not found any marked adverse reactions in both groups.Conclusion:The treatment of oral administration Yunhe Decoction on Hp-associated RAP with dampness in middle-jiao is effective and safety.