复方氨基酸注射液(18-B)治疗营养缺乏病的疗效观察

Clinical Observation of Compound Amino Acids Injection(18-B) for Treatment Nutritional Deficiencies

目的:评价复方氨基酸注射液(18-B)治疗营养缺乏病的疗效和安全性。方法:根据本研究的纳入与排除标准,选取营养缺乏病患者70例,按1:1随机分为治疗组和对照组各35例,进行单盲随机对照试验(RCT)。两组病例均每日治疗1次,疗程30天。结果:对总体疗效而言,意向性分析(intention-to-treat,ITT)显示两组总有效率分别为85.71%、71.43%,方案数据分析(per-protocol populatipn,PP)显示两组总有效率分别为90.63%、74.19%,疗效差异均具有显著性,P<0.05。PP分析显示治疗组在改善患者的营养状况方面优于对照组,P<0.05或<0.01。临床观察中未发现药物有任何明显毒副作用和不良反应。结论:复方氨基酸注射液(18-B)治疗营养缺乏病安全有效。

Objective：To assess the efficacy and safety of compound amino acids injection（18-B） in the treatment of nutritional deficiencies.Methods：According to the study inclusion and exclusion criteria,70 patients of nutritional deficiencies were randomly divided into treatment group and control group,69 patients in each group.Two groups of patients were treated 1 day,30-day course of treatment.Results：All the results were analyzed on the basis of intention-to-treat（ITT） and per-protocol population（PP）,the total effective rate was 85.71% or 90.63% in the treatment group and 71.43% or 74.19% in the control group with the significant difference between the two groups,P0.05.ITT and PP analysis revealed similar results.No adverse effect was found in the observation.Conclusion：Efficacy and safety of compound amino acids injection（18-B） for treatment nutritional deficiencies.