抗病毒口服液治疗小儿手足口病肺脾湿热证的随机对照、多中心临床研究

Antiviral Oral Liquid in treatment of lung and spleen damp-heat syndrome in children with hand-foot-mouth disease: A randomized controlled, multicenter clinical study

目的评价抗病毒口服液治疗普通型小儿手足口病肺脾湿热证的有效性及安全性。方法采用随机、双盲、安慰剂平行对照、多中心临床试验方法,计划纳入288例患儿,按1∶1的比例随机分为试验组和对照组。试验组服用抗病毒口服液,对照组服用安慰剂,剂量均为1～2岁5 mL/次、3～6岁10 mL/次,3次/d,疗程5 d。以完全退热时间为主要有效性指标。结果实际入组287例,其中试验组144例、对照组143例。试验组完全退热中位时间为24 h(PPS数据集,下同),对照组为48 h,两组比较差异有显著性(P<0.05);试验组皮疹/疱疹开始消退中位时间为24 h、对照组为40 h,试验组皮疹/疱疹完全消退中位时间为96 h、对照组为112 h,试验组中医证候疗效总愈显率为92.62%、对照组为72.32%,两组比较,差异均有统计学意义(P<0.05)。试验组与对照组不良事件发生率分别为4.35%和2.99%,组间比较,差异无统计学意义。结论抗病毒口服液治疗小儿手足口病普通型肺脾湿热证,可以缩短退热时间、皮疹/疱疹消退时间,促进口腔黏膜疱疹/溃疡愈合,改善中医证候,临床使用有效、安全。

Objective To evaluate the efficacy and safety of Antiviral Oral Liquid in the treatment of children with hand-foot-mouth disease(HFMD).Methods This was a randomized,double-blind,placebo-controlled,multicenter clinical trial intending to involve288 children.They were randomly divided into two groups:trail group received Antiviral Oral Liquid and control group received placebo for 5 d,1—2 years old,5 mL/time;3—6 years old,10 mL/time,3 times a day,and the usage and dosage of the control group was the same as the experimental group.Taking complete antipyretic time as the main effective index.Results A total of 287 cases were enrolled,144 in the treatment group and 143 in the control group.The median time of complete antipyretic was 24 h in the trail group(PPS,the same below),and 48 h in the control group.There were statistically significant differences between the two groups(P<0.05).The median time of beginning rash/herpes regression was 24 h in the experimental group and 40 h in the control group,the median time of complete regression of rash/herpes was 96 h in the experimental group and 112 h in the control group,and the total effective rate of TCM syndromes in the trail group and the control group was 92.62%and 72.32%,respectively.There also were statistically significant differences between the two groups(P<0.05).The incidence of adverse events in the trail group and the control group was 4.35%and 2.99%,respectively.There was no statistically significant difference between the two groups.Conclusion Antiviral Oral Liquid can shorten the time of antipyretic and the time of rash/herpes regression,promote the healing of herpes/ulcer in oral mucosa,and improve the TCM syndromes,so it is effective and safe in clinic.