四妙丸加减联合中药贴脐辅助治疗小儿盗汗(脾虚湿热证)的临床研究

Clinical Observation on Treating Night Sweating in Children(Syndrome of Spleen Deficiency and Dampness Heat)with Modified Simiao Pills and Umbilical Application of Chinese Medicine

目的 探究四妙丸加减联合中药贴脐辅助治疗小儿盗汗(脾虚湿热证)的临床疗效。方法 选取2019年1月—2021年12月于兰陵县人民医院就诊的小儿盗汗(脾虚湿热证)患儿共96例,按随机数字表法分成对照组(48例)和研究组(48例)。对照组采用常规西药治疗,观察组在对照组基础上采用四妙丸加减联合中药贴脐治疗,两组均持续治疗30 d。比较两组临床疗效,中医证候评分,夜卧不安消失时间和盗汗消失时间,不良反应发生率。结果 研究组治疗总有效率(93.75%)高于对照组(77.08%,P <0.05)。治疗30 d后,两组中医证候评分均较治疗前降低(P <0.05),且研究组均低于对照组(P <0.01);研究组夜卧不安消失时间和盗汗消失时间均短于对照组(P <0.01);研究组不良反应发生率(6.25%)与对照组(4.17%)比较,差异无统计学意义(P> 0.05)。结论 四妙丸加减联合中药贴脐辅助治疗小儿盗汗(脾虚湿热证)疗效确切,能促进临床症状改善,缩短康复进程,且安全性较高,可于临床推广。

Objective To observe the clinical effect of modified Simiao Pills plus umbilical application of Chinese medicine on night sweating in children(syndrome of spleen deficiency and dampness-heat).Methods A total of 96 children with night sweating(syndrome of spleen deficiency and dampness-heat)treated in Lanling People's Hospital from January 2019 to December 2021 were selected and randomized into a control group(n=48 cases)and an observation group(n=48 cases)with the random number table method.The control group was treated with Western medicine,while the observation group with modified Simiao Pills combined with umbilical application of Chinese medicine on the basis of the therapy in the control group.After 30 days of treatment,the clinical efficacy,traditional Chinese medicine(TCM)syndrome score,time to disappearance of restless sleep and night sweating,and incidence of adverse reactions were compared between the two groups.Results The total response rate in the observation group(93.75%)was higher than that in the control group(77.08%,P<0.05).After 30 days of treatment,the TCM syndrome scores of both groups decreased compared with that before treatment(P<0.05),and the decrease was more significant in the observation group(P<0.01).The time to disappearance of restless sleep and night sweating in the observation group was shorter than that in the control group(P<0.01).There was no statistically significant difference in the incidence of adverse reactions between the observation group(6.25%)and the control group(4.17%,P>0.05).Conclusion The combination of modified Simiao Pills and umbilical application of Chinese medicine has a definite therapeutic effect on night sweating in children(syndrome of spleen deficiency and dampness-heat).This therapy can mitigate clinical symptoms,shorten the rehabilitation process,and has high safety,being worthy of promotion in clinical practice.