匹多莫德辅助治疗手足口病合并细菌感染的疗效观察

Efficacy of pidotimod as an adjuvant treatment for hand-foot-and-mouth disease complicated with bacterial infection

目的探讨匹多莫德辅助治疗手足口病(HFMD)合并细菌感染的疗效。方法选取2012年6月-2015年5月湖北省某医院收治的84例HFMD患儿为研究对象。采用随机数字表法将患儿分为观察组和对照组,每组42例。对照组患儿采用常规治疗,观察组患儿在对照组治疗基础上加用匹多莫德口服溶液治疗。比较治疗前后2组患儿C反应蛋白(CRP)、肿瘤坏死因子-α(TNF-α)、白介素-6(IL-6)及白介素-10(IL-10)水平、T淋巴细胞亚群(CD3+,CD_4^+,CD_8^+细胞百分率及CD_4^+/CD_8^+比值)变化情况;比较2组患儿治疗期间不良反应发生情况、体温恢复正常时间、疱疹消退时间及住院时间。结果治疗前,2组患儿CRP,TNF-α,IL-6及IL-10水平比较,差异无统计学意义(P>0.05)。治疗后,2组患儿CRP,TNF-α,IL-6及IL-10水平均低于治疗前,且观察组患儿低于对照组,差异均有统计学意义(P<0.05)。治疗前,2组患儿CD3+,CD_4^+,CD_8^+细胞百分率及CD_4^+/CD_8^+比值比较,差异无统计学意义(P>0.05)。治疗后,观察组患儿CD_8^+细胞百分率低于治疗前,而CD3+,CD_4^+细胞百分率及CD_4^+/CD_8^+比值高于治疗前,差异均有统计学意义(P<0.05)。治疗后,观察组患儿CD_8^+细胞百分率低于对照组,而CD3+,CD_4^+细胞百分率及CD_4^+/CD_8^+比值高于对照组,差异均有统计学意义(P<0.05)。治疗前后,对照组患儿CD3+,CD_4^+,CD_8^+细胞百分率及CD_4^+/CD_8^+比值比较,差异无统计学意义(P>0.05)。观察组患儿治疗总有效率为92.86%,高于对照组的73.81%,差异有统计学意义(P<0.05)。观察组患儿体温恢复时间、疱疹消退时间、口腔溃疡消退时间及住院时间均短于对照组,差异均有统计学意义(P<0.05)。治疗期间,2组患儿均未发生任何不良反应。结论匹多莫德辅助治疗HFMD合并细菌感染,可改善患儿临床症状、提高患儿免疫功能,安全性高,疗效确切,值得临床推广应用。

Objective To assess the efficacy of pidotimod as an adjuvant treatment for hand-foot-and-mouth disease（HFMD）complicated with bacterial infection.Methods A total of 84 children with HFMD treated at a hospital in Hubei Province from June 2012 to May 2015 were included in this study.Using a random number table,children were divided into the trial group and the control group,42 children in each group.Children in the control group received conventional treatment,while those in the trial group received pidotimod oral solution in addition to conventional treatment.Both pre-and post-treatment levels of CRP,TNF-α,IL-6,and IL-10,as well as T cell subsets（proportions of CD3＋,CD_4~＋,CD_8~＋cells,and CD_4~＋/CD_8~＋ratio）were measured and compared between the two groups.Besides,the incidence of adverse events,time to normalization of body temperature,time to resolution of herpes,and length of hospital stay were also compared between the two groups.Results Before treatment,the CRP,TNF-α,IL-6,and IL-10 levels were comparable between the two groups（P〉0.05）.After treatment,the CRP,TNF-α,IL-6,and IL-10 levels were reduced in both groups compared with their pre-treatment levels;those in the trial group were significantly lower than those in the control group（P〈0.05）.Before treatment,the proportions of CD3＋,CD_4~＋,CD_8~＋cells,and CD_4~＋/CD_8~＋ratio were similar between the two groups（P〉0.05）.After treatment,the proportion of CD_8~＋cells was decreased and the proportions of CD3＋and CD_4~＋cells and the CD_4~＋/CD_8~＋ratio were increased in the trial group compared with their pre-treatment values and those in the control group（P〈0.05）.The proportions of CD3＋,CD_4~＋,CD_8~＋cells,and CD_4~＋/CD_8~＋ratio remained similar before and after treatment（P〉0.05）.The overall response rate in the trial group was significantly higher than that in the control group（92.86% vs 73.81%,P〈0.05）.Moreover,the time to normalization of body temperature,time to resolution of herpes,time to resolution of oral ulcers,and length of hospital stay were significantly shorter than those in the control group（P〈0.05）.No adverse events were reported during treatment in both groups.Conclusion As an adjuvant treatment for HFMD complicated with bacterial infection,pidotimod appears to be safe and effective in improving clinical symptoms and enhancing immunity,which deserves widespread clinical application.