中药敷脐治疗儿童轮状病毒腹泻湿热证多中心临床对照研究  

Multicenter clinical trial on umbilical application with traditional Chinese medicine in treating children rotavirus diarrhea with damp-heat syndrome

作　　者：叶青艳[1] 沈健[1] 杨巧芝[2] 谢绍华 陈黎 姚俊丽 周华[1] 赵鋆[1] YE Qingyan;SHEN Jian;YANG Qiaozhi;XIE Shaohua;CHEN Li;YAO Junli;ZHOU Hua;ZHAO Jun(Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Liaocheng People’s Hosptial,Liaocheng 252000,China;Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai 201999,China)

机构地区：[1]上海中医药大学附属曙光医院,上海201203 [2]聊城市人民医院,聊城252000 [3]上海市宝山区中西医结合医院,上海201999

出　　处：《中华中医药杂志》2023年第9期4492-4496,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家自然科学基金项目(No.81804141),“十三五”国家科技重大专项(No.2017ZX10305501-007);上海市进一步加快中医药传承创新发展三年行动计划项目[No.ZY(2021-2023)-0101-02,No.ZY(2021-2023)-0206-02];上海市中医药管理局传染病中医药防治能力建设项目(No.ZYYB-FRMZ-02)。

摘　　要：目的:观察中药敷脐治疗儿童轮状病毒腹泻湿热证的临床疗效及安全性。方法:采用多中心、随机双盲、安慰剂对照的研究设计,将160例辨证为湿热证的轮状病毒腹泻患儿随机分为治疗组、对照组,各80例。两组均予西医基础治疗,治疗组加用黄连五倍子散贴敷神阙穴,对照组予黄连五倍子散安慰剂贴敷。均治疗3 d,随访4 d。观察两组患儿治疗后临床疗效、止泻时间、伴随症状积分、轮状病毒转阴率及安全性指标。结果:160例患儿进入全分析数据集,134例进入符合方案数据集,160例进入安全性数据集。治疗后,治疗组总有效率[95.59%(65/68)]优于对照组[84.85%(56/66)](P<0.05)。治疗组止泻时间短于对照组(P<0.01)。治疗组患儿治疗3 d、随访4 d后伴随症状总分均显著低于同期对照组(P<0.01)。治疗组轮状病毒转阴率[75.00%(54/72)]高于对照组[64.94%,(50/77)],但差异无统计学意义。治疗期间两组均无严重不良事件发生。结论:中药敷脐联合西医基础治疗儿童轮状病毒腹泻湿热证临床疗效好,安全性好,且患儿治疗依从性高,值得临床推广应用。Objective:To observe the clinical efficacy and safety of umbilical application with traditional Chinese medicine in treating children rotavirus diarrhea with damp-heat syndrome.Methods:A randomized multi-center double-blind placebo-controlled clinical study was undertaken.A total of 160 rotavirus diarrhea with damp-heat syndrome children were randomly divided into treatment group and control group,80 patients in each group.The two groups’patients were treated with conventional treatment of the western medicine.The patients in the treatment group were given umbilical application with Huanglian Wubeizi Powder,while the patients in the control group were treated with placebo powder.Both groups were treated 3 days,and 4 days after the treatment were recorded.The effec rate,the time of relieving diarrhe,accompanied symptoms score,positive stool culture and safety indicators were observed.Results:A total of 160 patients were included,of which 160 entered the full analysis set,134 entered the per-protocol set,and 160 entered the safety set.The treatment group overall clinical efficiency was 95.59%(65/68),that in the control group was 84.85%(56/66),the statistical outcomes were distinct between the two groups(P<0.05).The time of stopping diarrhea of the treatment group was shoter than that of the control group(P<0.01).The accompanied symptoms score in the treatment group was lower than that in the control group after 3 days of treatment and 4 days of follow-up(P<0.01).The seroconversion rates of rotavirus in the treatment group were 75.00%(54/72),which were higher than that in the control group[64.94%(50/77)],but there were no significant difference between the two groups.There were no serious adverse events in the two groups.Conclusion:Umbilical application with traditional Chinese medicine plus conventional treatment with western medicine has obvious clinical efficacy and safety in treating children rotavirus diarrhea with damp-heat syndrome,and children have high compliance and are worthy of clinical application.

关 键 词：轮状病毒 感染性腹泻 湿热证 敷脐 儿童 临床研究 黄连五倍子散 疗效 

分 类 号：R272[医药卫生—中医儿科学]