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目的:观察中药止泻汤辅助治疗小儿急性腹泻的疗效及安全性。方法:选取180例脾虚型急性腹泻患儿作为研究对象,随机分为观察组和对照组各90例。对照组采用常规治疗,观察组在对照组治疗基础上加用中药止泻汤进行治疗。观察比较2组患儿的症状评分改善情况、治愈时间和药物不良反应情况。结果:观察组症状积分低于对照组(P<0.01),不同时点症状积分差异有统计学意义(P<0.01),组别与时间存在交互作用(P<0.01)。单独效应分析,在固定分组条件下,随着治疗时间延长,2组的症状积分逐渐下降;在固定时间条件下,观察组治疗3、5、7天后,症状积分均低于对照组(P<0.01)。观察组平均治愈时间短于对照组,差异有统计学意义(P<0.05)。治疗过程中2组患儿均未观察到明显的药物不良反应。结论:在常规西药治疗基础上加用中药止泻汤对脾虚型急性腹泻患儿进行治疗,可以有效改善患儿的临床症状,缩短治愈时间,同时无明显不良反应,是一种安全有效的治疗方法。
Objective: To observe the efficacy and safety of traditional Chinese medicine Zhixie Decoction in adjuvant treatment of children with acute diarrhea. Methods: A total of 180 children with spleen deficiency acute diarrhea were randomly divided into observation group (n = 90) and control group (n = 90). The control group was treated by conventional treatment. The observation group was treated with Zhixie Decoction on the basis of the control group. The improvement of symptom score, healing time and adverse drug reactions were observed and compared in two groups. Results: The symptom scores in the observation group were lower than those in the control group (P <0.01). There were significant differences in symptom scores at different time points (P <0.01). There was interaction between the two groups (P <0.01). Independent effect analysis showed that symptom scores of two groups decreased gradually with the prolongation of treatment time under the condition of fixed grouping. Symptom scores of observation group were lower than those of control group at fixed time (P < 0.01). The average healing time in the observation group was shorter than that in the control group, with significant difference (P <0.05). No significant adverse drug reactions were observed in both groups during treatment. Conclusion: It is a safe and effective treatment to treat children with acute diarrhea due to spleen deficiency by adding traditional Chinese medicine Zhixie Decoction on the basis of conventional western medicine, which can effectively improve the clinical symptoms and shorten the cure time of children with no obvious adverse reactions method.