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目的:观察并对比双金连合剂不同给药途径治疗小儿外感发热的临床疗效及不良反应,以选择最佳给药途径。方法:将122例外感发热患儿随机分成灌肠组和口服组。在常规对症治疗的基础上,灌肠组62例采用双金连合剂灌肠治疗,口服组60例采用双金连合剂口服治疗。观察2组患儿退热起效时间、解热时间及完全退热时间,检测治疗前后血清炎性应激因子白细胞介素(IL)-1β,干扰素(IFN)-γ及肿瘤坏死因子(TNF)-α水平,患儿中医证候积分变化、临床疗效及不良反应情况。结果:灌肠组患儿退热起效时间、解热时间、完全退热时间均短于口服组(P<0.05);与治疗前比较,治疗后2组患儿IL-1β,IFN-γ及TNF-α水平均明显下降(P<0.05),与口服组比较,治疗后灌肠组IL-1β,IFN-γ及TNF-α水平下降更快(P<0.05);治疗后2组患儿中医证候积分均较治疗前下降(P<0.05),且灌肠组下降程度较口服组更明显(P<0.05);总有效率灌肠组为96.78%,口服组为86.66%,灌肠组优于口服组(P<0.05);口服组有3例发生不良反应,灌肠组无不良反应事件发生。结论:应用双金连合剂治疗小儿外感发热,口服和灌肠两种给药途径均取得满意疗效,灌肠给药方法疗效明显优于口服治疗,而且不良反应更少,更易被患儿和家属接受,可作为首选给药途径。
OBJECTIVE: To observe and compare the clinical efficacy and side effects of different routes of administration of Shuangjin Lian Mixture in treating pediatric exogenous fever, in order to select the best route of administration. Methods: 122 children with exogenous fever were randomly divided into enema group and oral group. On the basis of routine symptomatic treatment, 62 patients in the enema group were treated with bimetallic enema, and 60 patients in the oral group were treated with bingjin oral agent. The onset time, the antipyretic time and the complete antipyretic time of the two groups were observed, and the levels of serum inflammatory stress factors such as interleukin (IL) -1β, interferon (IFN) -γ and tumor necrosis factor (TNF) TNF) -α levels, changes in children’s TCM syndrome scores, clinical efficacy and adverse reactions. Results: The onset time of antipyretic effect, antipyretic time and complete antipyretic time were shorter in the enema group than in the oral group (P <0.05). Compared with those before treatment, the levels of IL-1β, IFN-γ and IFN- (P <0.05). Compared with the oral group, the levels of IL-1β, IFN-γ and TNF-α in the enema group decreased more rapidly after treatment (P <0.05). After treatment, the levels of TNF- (P <0.05), and the decrease in enema group was more obvious than that in oral group (P <0.05). The total effective rate was 96.78% in enema group and 86.66% in oral group, which was better than that in oral group (P <0.05). There were 3 adverse reactions in the oral group and no adverse reactions in the enema group. Conclusion: The treatment of exogenous fever in children with double gold Lian Ji, oral administration and enema have achieved satisfactory results, the efficacy of enema was significantly better than oral administration, and less adverse reactions, more susceptible to children and their families to accept, Can be used as the preferred route of administration.