抗病毒合剂加通便合剂治疗小儿外感发热表里俱热证(急性上呼吸道感染)的临床观察

Clinical observation on antivirus mistura combined with purgation mistura in treating fever caused by exogenous pathogenic factor with interior and exterior heat syndrome in pediatirics (acute upper respiratory infection)

[目的]以黄栀花口服液为对照,评价抗病毒合剂加通便合剂治疗小儿外感发热表里俱热证(急性上呼吸道感染)的有效性和安全性。[方法]采用随机分组、阳性药平行对照的方法进行临床观察。[结果]试验组证候疗效的愈显率为82.2%,对照组为74.0%,两组比较,差异无显著性意义(P>0.05),非劣效检验结果显示,试验组疗效不劣于对照组(P<0.05);两药合用对发热、恶寒、鼻塞、流浊涕、咳嗽、咽红肿痛、口渴、烦躁、便秘等症状,以及异常舌脉等均有较高的治疗消失率,其中对发热、咽喉肿痛的治疗消失率,试验组明显高于对照组(P<0.05),且完全退热时间也短于对照组(P<0.05)。试验中,安全性观测未发现与试验药物有关的异常改变。[结论]抗病毒合剂加通便合剂治疗小儿急性上呼吸道感染表里俱热证具有较好疗效,具有退热快的优势,临床应用安全性好。

[Objective] Taking Huangzhihua oral solution as the control, the effectiveness and safety of the antivirus mistura combined with purgation mistura in treating fever caused by exogenous pathogenic factor with interior and exterior heat syndrome （acute upper respiratory infection） in pediatrics was observed. [Methods] Adopting randomly grouping, paralleled control with positive drug clinical ob- servation was performed. [Results] Compared with effectiveness rate of 74 percent in control group, the rate in treating group achieved to 82.2%. There was no statistic difference between two group （P〉0.05）. The result of Non-inferiority testing showed that the treating group was not women than the comparing group （P〈0.05）. The combined therapy with 2 misturas had a high disappearance rate towards to most symptoms, such as fever, aversion to cold, nasal obstruction, runny nose, cough, swollen and painful throat, thirst, vexation, constipation, abnormal tongue manifestations etc. Among them, the disappearance rate of fever, swollen and painful throat in treating group is higher than that in the comparing group with obvious statistic significance. At same time, the time of complete pyretolysis was shorter in treating group than that in control （P〈0.05）. There was no abnormal change induced by the test drugs in security observation. [Conclusion] The combined therapy （antivirus mistura and purgation formula） has a good effect in curing acute upper respiratory infection with both interior and exterior heat syndrome in pediatirics with an advantage of fast defervescence and satisfactory security clinically.