疏风解毒胶囊治疗小儿急性非化脓性中耳炎临床观察

Clinical investigation on Shufeng Jiedu Capsule in the treatment of children acute non-suppurative otitis media

目的:观察疏风解毒胶囊治疗小儿急性非化脓性中耳炎的临床效果及安全性。方法:将2015年2月-2016年8月本中心收治的90例急性非化脓性中耳炎患儿按照入院时间随机纳入对照组与治疗组,每组45例。对照组予抗感染等常规治疗,治疗组在对照组基础上加用疏风解毒胶囊,疗程5d。观察1个疗程后两组患儿耳痛、鼓膜红肿消退、听力恢复等指标变化情况,以及治疗前后主要证候积分变化情况,评价患儿的临床治疗效果。观察治疗期间患儿不良反应情况。结果:治疗组患儿耳痛、鼓膜红肿消退平均恢复时间低于对照组(P<0.05)。两组患儿治疗前主要证候积分比较差异无统计学意义;治疗5d后,两组患儿主要证候积分均降低,其中治疗组积分低于对照组(P<0.05);治疗组有效率为91.1%,对照组为75.6%,两组比较,差异有统计学意义(P<0.05)。治疗期间两组患儿均未见明显的药物不良反应,心电图、肝肾功能检查未见明显异常。结论:疏风解毒胶囊联合常规治疗可加快小儿急性非化脓性中耳炎耳痛、鼓膜红肿消退等好转,促进临床恢复。

Objective：To explore the clinical effect and security of Shufeng Jiedu Capsules in the treatment of children acute non-suppurative otitis media.Methods：Ninty children with acute non-suppurative otitis media were randomly divided into a treatment group and control group from February 2015 to Agust 2016,45 cases in each group.The control group was treated with conventional treatment,while the treatment group was treated with Shufeng Jiedu Capsules on the basis of control group,treatment caurse for 5 days.The change of symptoms and signs and scores of traditional Chinese medical syndrome of two groups were observed,and clinical effect was evaluated.Results：The average recovery time of otodynia and tympanic hyperemia in the treatment group was lower than that of the control group（P〈0.05）.The two groups before treatment with TCM syndrome integral without statistical significance;after treatment 5 days,the TCM syndrome integral in the treatment group was lower than that in the control group（P0.05）;the effective rate was 91.1%in the treatment group,and the control group was 75.6%,which had statistical significance between groups（P0.05）.There were no obvious drug reactions during the treatment in two groups.Conclusion：Shufeng Jiedu Capsules combined with routine treatment can accelerate the children acute non-suppurative otitis media recovery.