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目的探讨不同剂量柴黄颗粒治疗小儿急性上呼吸道感染风热证退热效果。方法 2011年3月至2011年12月四川大学华西二院儿科采用随机双盲对照方法收集200例急性上呼吸道感染风热证患儿,随机分配到柴黄颗粒高剂量组(A组)、中剂量组(B组)、低剂量组(C组)、阳性对照组和安慰剂组,各40例。按照<3岁、3～5岁、>5岁,3次/d分别给予不同剂量。阳性对照组给与抗感颗粒治疗,10g/次,1日3次;安慰剂组给予外观相似的淀粉颗粒。疗程均为3d。结合总疗效、中医症候疗效和人群统计进行分析。结果最终全分析集(FAS)190例,符合方案集(PPS)183例。本研究中,总疗效判定(基于FAS数据集):A组愈显率为86.84%,有效率为97.4%;B组愈显率为86.8%,有效率为94.7%;C组愈显率为65.8%,有效率为71.1%;阳性对照组愈显率为75.0%,有效率95.0%;安慰剂组愈显率为21.6%,有效率为40.5%。A组、B组和阳性对照组间疗效差异无统计学意义(P>0.05),且均优于C组和安慰剂组(P<0.05)。PPS统计结果与FAS结果一致。结论柴黄颗粒中剂量治疗效果比较理想,且没有毒副反应,推荐在临床应用。

A study of antipyretic effect of ChaiHuang Keli with different doses on children with acute upper respiratorytract infection

Objective To Find the best dose of ChaiHuang Keli in clinical treatment of children with acute upper respiratory infection. Methods Clinical randomized controlled trial was carried out for this research.Totally 200 patients were chosen based on the inclusion criteria , and they were divided into five groups:positive control group , high , middle , and low dose of ChaiHuang Keli treatment group and placebo group.The patients were divided by age into three levels: below three years old , between 3 and 5 , and beyond six ; different treatments were given respectively as designed.The control group ( Kanggan Keli , 10 g each time , three times a day , tid ); treatment group A ( ChaiHuang Keli , 6-10g , tid ); placebo group ( placebo , 10 g , tid ) .All patients had the same three-day course of treatment and the effects were compared among the groups. Results Effect ratio ( FAS ) of the control group , three treatment groups and placebo group were re spectively 98.00% , 93.17% , 97.37% , 73.68% and 40.54%.According to the comparison among groups , the effect of group B was nearly the same as group A and the positive control group , while it was better than group C ; all treatment groups had quite statistical significance compared with the placebo group in this research.There was no significance among group A 、 B and C (P> 0.05 ), but there was statistical significance between treatment group and the placebo group (P< 0.05 ) .The statistical result t of FAS and PPS analysis was nearly the same.No adverse effects were observed in this research. Conclusion The middle dose group of ChaiHuang Keli in this research shows the best effect in curing children with acute upper respiratory infection ( wind-heat syndrome ), and can be recommended in clinical areas.