探讨中医药金莲清热泡腾片治疗儿童手足口病(HFMD)的临床疗效及可能机制。

选择2014年1月至2017年2月，在成都市妇女儿童中心医院临床诊断为普通型HFMD的790例门诊患儿为研究对象。采用随机数字表法，将790例患儿随机分为金莲清热泡腾片组(n＝390)与柴黄冲剂组(n＝400)。前者采用金莲清热泡腾片治疗，后者采用柴黄冲剂治疗，并均予以退热、抗感染等对症、支持治疗，进展为重症HFMD的患儿转入本院住院部治疗。2组患儿门诊治疗疗程均为5 d，治疗结束后均随访3 d。统计学比较2组患儿治愈率、重症HFMD发生率及临床症状消退所需时间等。2组患儿年龄、性别构成比等基本临床资料比较，差异均无统计学意义(P>0.05)。

①金莲清热泡腾片组与柴黄冲剂组患儿发热率分别为33.8%(132/390)与28.2%(113/400)，二者比较，差异无统计学意义(χ²＝2.890，P＝0.089)。2组继发细菌感染率分别为18.5%(72/390)与17.0%(68/400)，二者比较，差异亦无统计学意义(χ²＝0.289，P＝0.591)。②金莲清热泡腾片组重症HFMD发生率为0.5%(2/390)，较柴黄冲剂组的2.3%(9/400)低，并且差异有统计学意义(χ²＝4.340，P＝0.037)。金莲清热泡腾片组治疗3 d和5 d后的治愈率，均分别较柴黄冲剂组高，而下呼吸道感染率，以及体温恢复正常、口腔疱疹愈合及皮疹消退时间，均分别较柴黄冲剂组低或短，并且差异均有统计学意义(P<0.05)。

金莲清热泡腾片治疗普通型HFMD，较柴黄冲剂治疗疗效更佳，重症HFMD发生率更低。

To explore the clinical therapeutic efficacy and possible mechanism of Jinlianqingre effervescent tablets on children with hand, foot and mouth disease (HFMD).

A total of 790 outpatient children with common type HFMD who came to Chengdu Women & Children′s Central Hospital from January 2014 to February 2017, were chosen as study subjects. Random digits table was used to divide the 790 cases into Jinlianqingre effervescent tablets group (n=390) and Chaihuang granules group (n=400). The former was treated with Jinlianqingre effervescent tablets, and the latter was treated with Chaihuang granules, meanwhile, the two groups were given symptomatic and supportive treatments, such as defervesce and anti-infection, and so on. Progressive severe HFDM cases were admitted in inpatient department. All children were treated for 5 d in the outpatient department, and followed up for 3 d. The cure rates, incidence rates of severe HFDM cases and the time for clinical symptoms regression were compared between two groups statistically. There were no significant differences between two groups in general clinic data, such as age and gender constituent ratio.

①The fever rates of Jinlianqingre effervescent tablets group and Chaihuang granules group were 33.8% (132/390) and 28.2% (113/400) respectively, and there was no significant difference between two groups (χ²=2.890, P=0.089). The secondary bacterial infection rates of two groups were 18.5% (72/390) and 17.0% (68/400) respectively, and there was no significant difference between two groups (χ²=0.289, P=0.591). ②The incidence rate of severe HFDM cases in Jinlianqingre effervescent tablets group was 0.5% (2/390), it was lower than that of Chaihuang granules group, which was 2.3% (9/400), and the difference was statistically significant (χ²=4.340, P=0.037). The 3 d and 5 d cure rates of Jinlianqingre effervescent tablets group were both higher than those of Chaihuang granules group, while the lower respiratory tract infection rate, as well as temperatures normalization time, herpes of mouth healing time and deflorescence time were lower or shorter than those of Chaihuang granules group, and all the differences were statistically significant (P<0.05).

The therapeutic effect of Jinlianqingre effervescent tablets in chidren with common type HFMD is better than that of Chaihuang granules, and the incidence of severe HFMD cases is lower.