热毒宁注射液治疗儿童手足口病的随机对照研究

作者	单位
张爱军	浙江省慈溪市人民医院
汤伯宗	上海市(复旦大学附属)公共卫生临床中心
施莉萍	浙江省慈溪市人民医院
慕永平	上海市(复旦大学附属)公共卫生临床中心
卢亚君	浙江省慈溪市人民医院
卢申科	浙江省慈溪市人民医院
刘成	浙江省慈溪市人民医院
乐世锋	浙江省慈溪市人民医院
陈晓蓉	上海市(复旦大学附属)公共卫生临床中心

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中文摘要:

目的研究热毒宁注射液治疗儿童手足口病普通型伴发热的临床疗效。方法对76例临床诊断为手足口病患儿采用中央随机方法分为3组。西药组(24例)采用利巴韦林注射液或抗生素治疗;热毒宁注射液组(简称热毒宁组,26例)采用热毒宁注射液治疗;热毒宁注射液加西药组(简称结合组,26例)采用热毒宁注射液联合利巴韦林注射液或抗生素治疗,疗程3～7d,治疗结束后随访3d。观察3组患儿血常规,肝、肾功能,空腹血糖,退热起效时间,体温恢复正常时间以及皮疹消退时间。结果 (1)76例患儿脱落13例,最终有效病例为63例,其中西药组19例,热毒宁组22例,结合组22例。(2)与西药组比较,热毒宁组和结合组退热起效时间及体温恢复正常时间均显著缩短(P<0.05,P<0.01);(3)3组皮疹消退时间比较差异无统计学意义(P>0.05),但热毒宁组及结合组有缩短趋势;(4)热毒宁组1例患儿因出现轻度皮疹退出试验,其余2组患儿均未出现明显的药物不良反应事件。结论热毒宁注射液治疗儿童普通型手足口病具有退热起效迅速、体温恢复至正常所需时间短等优点,并在一定程度上可加速皮疹的消退。

英文摘要:

Objective To study the clinical effects of Reduning Injection on ordinary hand,foot and mouth disease(HFMD) in children.Methods 76 children with confirmed diagnosis of HFMD were randomly assigned to 3 groups by the center randomization method,i.e.,the Western medicine group(WM,24 cases,treated with Ribavirin Injection or antibiotics),the Reduning Injection group(RI,26 cases,treated with Reduning Injection),and the combination group(26 cases,treated with the combination of Reduning Injection with Ribavirin Injection or antibiotics).The therapeutic course lasted for 3 to 7 days.A 3-day follow-up study was performed by the end of the treatment.The blood routines,the liver function,the renal function,the fasting blood glucose,the pyretolysis effect initiating time,the time for the body temperature recovery,and the rash subside time were observed in the three groups.Results(1) Of 76 patients,13 dropped out,with the final effective case being 63.Of them,there were 19 cases in the WM group,22 in the RI group,and 22 in the combination group.(2) Compared with the WM group,the pyretolysis effect initiating time and the time for the body temperature recovery were both significantly shortened in the RI group and the combination group(P<0.05,P<0.01).(3) There was no significant difference in the rash subside time among the three groups(P>0.05).But there was shortening tendency in the RI group and the combination group.(4) One child in the RI group dropped out from this study due to a mild rash,and no adverse drug reaction occurred in the other two groups.Conclusions RI had some advantages in treatment of HFMD such as fasting pyretolysis effect initiating time,shorter time for the body temperature recovery,higher safety.Besides,it also could accelerate the subside of skin rashes to some extent.

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