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喜炎平注射液治疗儿童手足口病的随机对照试验
A randomized control trial of Xiyanping injection in treatment of children with hand,foot and mouth disease
【摘要】 目的观察喜炎平注射液治疗儿童手足口病的疗效及其不良反应。方法入选符合手足口病诊断标准Ⅰ期和Ⅱ期病例的住院患儿200例,随机分为2组:喜炎平注射液试验组(喜炎平组)100例,男性56例,女性44例,年龄(30.2±10.7)mo,给予喜炎平0.2 mL.kg-1.次-1+氯化钠注射液50 mL稀释静滴,bid×3 d;利巴韦林对照组(利巴韦林组)100例,男性55例,女性45例,年龄(29.2±9.7)mo,给予利巴韦林7.5 mg.kg-1.次-1+5%葡萄糖注射液50 mL稀释静滴,bid×3 d。观察2组24、48、72 h的体温、口腔疱疹、皮疹情况,治疗过程中观察有无过敏、腹泻、呕吐等不良反应,喜炎平组治疗72 h前后检测静脉血尿素氮(BUN)、肌酐(Cr)、外周血白细胞、血小板、血红蛋白。结果喜炎平组95例、利巴韦林组94例完成研究,治疗24、48、72 h后2组患儿皮疹减少、口腔疱疹减少例数均无显著差异(P>0.05),但治疗72 h后喜炎平组体温正常例数明显多于利巴韦林组(P<0.01);喜炎平注射液治疗72 h前后ALT、BUN、Cr无明显变化(P>0.05),AST平均值明显低于治疗前(P=0.04),外周血白细胞明显减少(P<0.01),血小板计数明显升高(P<0.01),血红蛋白无明显变化(P>0.05),2组患儿均未见药物性皮疹、过敏性休克、腹泻、呕吐等严重的不良反应。结论喜炎平注射液治疗儿童手足口病72 h的退热效果好于利巴韦林,用于治疗儿童手足口病是安全的。
【Abstract】 AIM To study the efficacy and safety of Xiyanping injection in children with hand,foot and mouth disease(HFMD).METHODS A total of 200 children in stage Ⅰ or Ⅱ of the HFMD classification were randomly divided into treatment group(n = 100)and control group(n = 100),and were administered with Xiyanping injection 0.4 mL·kg-1·d-1 and ribavirin for injection 15 mg·kg-1·d-1,respectively.In the treatment group,there were 56 boys and 44 girls,and mean age was(30.2 ± 10.7)mo.In the control group,there were 55 boys and 45 girls,and mean age was(29.2 ± 9.7)mo.The changes of temperature,rashes and herpes in the mouth of two groups were investigated 24,48 and 72 hours after the administration.Peripheral blood leukocyte,platelet and haemoglobin,and ALT,AST,BUN and Cr in venous blood of treatment group were measured before and 72 hours after the administration.The adverse reaction was observed.RESULTS There was no significant difference between two groups in rashes and herpes of mouth 24,48 and 72 hours after the administration(P > 0.05).The patients with normal temperature in the treatment group was more than that of the control group(P < 0.01).Compared with before the treatment,AST and WBC decreased significantly(P < 0.05,P < 0.01),PLT increased significantly(P < 0.01)and there were no significant changes in Hb,ALT,BUN and Cr(P > 0.05)after treatment in the treatment group.No severe adverse reaction occurred in any patient.CONCLUSION Xiyanping injection is more effective in antipyretic impact than ribavirin for injection,and is safe in children with HFMD.
【Key words】 Xiyanping injection; hand,foot and mouth disease; therapy; randomized controlled trials; child;
- 【文献出处】 中国新药与临床杂志 ,Chinese Journal of New Drugs and Clinical Remedies , 编辑部邮箱 ,2012年02期
- 【分类号】R272
- 【被引频次】24
- 【下载频次】546