儿泻康贴膜敷脐治疗小儿寒性泄泻的多中心随机对照临床研究

A multi⁃centre randomised controlled clinical study of pediatric cold diarrhoea treated with Erxiekang(儿泻康)plaster applied to the navel

目的观察儿泻康贴膜敷脐治疗小儿寒性泄泻的有效性及安全性。方法采用随机、平行对照、多中心临床研究的方法,将248例寒性泄泻患儿采用随机数字表法分为治疗组和对照组,各124例。治疗过程中治疗组脱落1例,对照组脱落3例,最终纳入治疗组123例,对照组121例。对照组予小儿暖脐膏加温水软化后贴于神阙穴,治疗组予儿泻康贴膜外敷神阙穴,2组均治疗5 d后统计临床疗效。结果对照组总有效率为90.91%(110/121),治疗组为96.75%(119/123),2组比较,差异有统计学意义(P<0.05)。治疗组的大便次数、大便性状、发热恶寒等症状前后积分差值均大于对照组,2组比较,差异有统计学意义(P<0.05)。治疗期间,治疗组3例、对照组1例患儿在贴药后出现脐部发红发痒,但不影响继续用药,且停药后1~2 d症状自行消失。结论儿泻康贴膜外敷神阙穴治疗小儿寒性泄泻,不仅疗效确切,而且安全性高,值得临床推广应用。

Objective To observe the effectiveness and safety of pediatric cold diarrhoea treated with Erxiek⁃ang(儿泻康)plaster applied to the navel.Methods Adopting the method of random,parallel control,multi⁃centre clinical research,248 children with cold diarrhea were divided into a treatment group and a control group by random number table method,each with 124 cases.In the course of treatment,1 case of the treatment group and 3 cases of the control group fell off,123 cases of the treatment group and 121 cases of the control group were finally included.The control group was given paediatric warming umbilical cord ointment with warm water to soften the paste on the Shenque(RN08),and the treatment group was given Erxiekang plaster to be applied externally on the Shenque(RN08),and the clinical efficacy of the two groups was counted after 5 days of treatment.Results The total effec⁃tive rate was 90.91%(110/121)in the control group and 96.75%(119/123)in the treatment group,and the difference between the two groups was statistically significant by Wilcoxon’s rank⁃sum test(P<0.05).The differ⁃ence between the pre⁃and post⁃score of the number of stools,faecal characteristics,fever and malignant cold in the treatment group was greater than that in the control group,and the difference was statistically significant by theχ2 test(P<0.05).During the treatment period,three cases in the treatment group and one case in the control group ap⁃peared red and itchy umbilicus after applying the medicine,but it did not affect the continuation of the medicine,and the symptoms disappeared on their own 1-2 days after stopping the medicine.Conclusion The treatment of cold diarrhoea in children by applying Erxiekang(儿泻康)plaster to the Shenque(RN08)is not only effective,but also safe,and is worthy of clinical popularization.