目的观察喜炎平注射液治疗普通型手足口病(HFMD)的疗效及不良反应。方法符合纳入标准并自愿参加的87例普通型HFMD患儿进入试验,其中脱落5例,1例并发脑炎转为重症,1例误入,有效观察病例80例,随机分为西医组24例、中医组27例和中西医结合组29例。西医组予西医对症治疗;中医组予喜炎平注射液5～10 mg·kg-1.d-1,静脉滴注,每日1次;中西医结合组在西医组基础上加用喜炎平注射液。观察3组病例退热起效时间、体温恢复正常时间及皮疹消退时间。结果退热起效时间:中医组[(5.95±5.75)h]与中西医结合组[(5.95±7.25)h]均短于西医组[(12.44±11.10)h],差异均有统计学意义(P=0.015,0.016);体温恢复正常时间:中医组[(26.14±17.83)h]与中西医结合组[(27.14±19.49)h]均短于西医组[(43.67±32.20)h],差异均有统计学意义(P=0.022,0.032);皮疹消退时间:中医组[(121.41±22.98)h]与中西医结合组[(127.79±25.98)h]均短于西医组[(162.67±36.69)h],差异均有统计学意义(Pa=0.000)。中医组与中西医结合组间3个指标比较差异均无统计学意义。结论喜炎平注射液治疗HFMD普通型病例能显著缩短退热起效时间、体温恢复正常时间及皮疹消退时间,无不良反应。 Objective To observe the efficacy and adverse reactions of Xiyanping Injection in the treatment of common hand-foot-mouth disease (HFMD). Methods Eighty-seven children with HFMD who were enrolled and voluntarily participated in the trial were enrolled in this study. Among them, 5 cases were exfoliated, 1 case complicated by encephalitis was severe, 1 case was mistakenly admitted and 80 cases were effectively observed. , Chinese medicine group of 27 cases and Integrative Medicine group of 29 cases. Western medicine group to Western symptomatic treatment; Chinese medicine group Xiyanping injection 5 ~ 10 mg · kg-1.d-1, intravenous drip once a day; Integrative Medicine group on the basis of Western medicine group with Xi Yan Flat injection. The onset time of fever, onset of normal body temperature and rash subsidence were observed in 3 groups. Results The onset time of fever was (5.95 ± 5.75) h in TCM group and (5.95 ± 7.25) h in Integrative Medicine group were shorter than that in Western medicine group (12.44 ± 11.10 h), respectively, with significant difference (P = 0.015,0.016); body temperature returned to normal time: the Chinese medicine group [(26.14 ± 17.83) h] and the integrated traditional Chinese and Western medicine group (27.14 ± 19.49 h) were shorter than the western medicine group (43.67 ± 32.20 h) (121.41 ± 22.98) h and Integrative Medicine group [(127.79 ± 25.98) h] were shorter than Western medicine group [(162.67 ± 36.69) h], the differences were statistically significant (Pa = 0.000). There was no significant difference in the three indexes between TCM group and TCM-WM group. Conclusion Xiyanping injection in the treatment of HFMD common type cases can significantly reduce the onset of fever, body temperature and rash subsided normal time, no adverse reactions.