目的 評價抗病毒口服液治療普通型小兒手足口病肺脾濕熱證的有效性及安全性。方法 采用隨機、雙盲、安慰劑平行對照、多中心臨床試驗方法，計劃納入288例患兒，按1：1的比例隨機分為試驗組和對照組。試驗組服用抗病毒口服液，對照組服用安慰劑，劑量均為1~2歲5 mL/次、3~6歲10 mL/次，3次/d，療程5 d。以完全退熱時間為主要有效性指標。結(jié)果 實際入組287例，其中試驗組144例、對照組143例。試驗組完全退熱中位時間為24 h （PPS數(shù)據(jù)集，下同），對照組為48 h，兩組比較差異有顯著性（P<0.05）；試驗組皮疹/皰疹開始消退中位時間為24 h、對照組為40 h，試驗組皮疹/皰疹完全消退中位時間為96 h、對照組為112 h，試驗組中醫(yī)證候療效總愈顯率為92.62%、對照組為72.32%，兩組比較，差異均有統(tǒng)計學意義（P<0.05）。試驗組與對照組不良事件發(fā)生率分別為4.35%和2.99%，組間比較，差異無統(tǒng)計學意義。結(jié)論 抗病毒口服液治療小兒手足口病普通型肺脾濕熱證，可以縮短退熱時間、皮疹/皰疹消退時間，促進口腔黏膜皰疹/潰瘍愈合，改善中醫(yī)證候，臨床使用有效、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 involve 288 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.