两种中药注射液治疗儿童手足口病的疗效、安全性及经济学评价

发布时间：2018-04-29 11:47

本文选题：喜炎平注射液 + 热毒宁注射液　；参考：《广州中医药大学》2017年硕士论文

【摘要】：目的:(1)对喜炎平注射液与热毒宁注射液治疗儿童手足口病进行临床疗效及安全性评价,促进临床合理用药,为手足口病的临床诊治、药品说明书的补充与修订提供循证依据。(2)通过构建决策树模型和采用成本-效果分析方法对使用喜炎平注射液、热毒宁注射液治疗儿童手足口病进行药物经济学评价,控制药品费用,提高医药卫生资源利用率,为药品定价与医疗保险目录的选择提供科学依据。方法:(1)计算机检索中国知网、维普、万方、Cochrane Library、PubMed数据库自建库至2015年8月关于喜炎平注射液或热毒宁注射液治疗儿童手足口病的随机对照试验和半随机对照试验;通过文献管理软件EndNote X7进行文献筛选;对纳入文献进行数据提取及文献质量评价;并采用Review Manager5.3对退热时间、退疹时间、口腔溃疡/疱疹消退时间、总有效率、住院时间、总病程、不良反应发生率进行meta分析。(2)成本的计算包括直接成本、间接成本和隐性成本。在现有循证资料的基础上,运用TreeAge Pro 2011构建决策树模型,进行成本-效果分析;对所有变量进行Tornado Diagram分析,并进行单因素和双因素敏感度分析。结果:(1)共纳入喜炎平注射液治疗儿童手足口病的文献18篇,其中干预措施为喜炎平注射液对比利巴韦林注射液的文献6篇,干预措施为喜炎平注射液联合利巴韦林注射液对比利巴韦林注射液的文献12篇。退热时间的meta分析结果显示:单用组的退热时间比对照组短,差异具有统计学意义[WMD=-1.41,95%CI(-2.60,-0.22),P=0.020.05];联用组的退热时间比对照组短,差异具有统计学意义[WMD=-1.58,95%CI(-1.95,-1.21),P0.00001]。退疹时间的meta分析结果显示:单用组的退疹时间比对照组短,差异具有统计学意义[WMD=-1.58,95%CI(-2.42,-0.74),P=0.00020.01];联用组的退疹时间比对照组短,差异具有统计学意义[WMD=-1.54,95%CI(-1.91,-1.17),P0.00001]。口腔溃疡/疱疹消退时间的meta分析结果显示:1篇文献报道了喜炎平注射液对比利巴韦林注射液治疗儿童手足口病的口腔溃疡/疱疹消退时间,不能进行meta分析;联用组的口腔溃疡/疱疹消退时间比对照组短,差异具有统计学意义[WMD=-1.22,95%CI(-1.75,-0.69),P0.00001]。总有效率的meta分析结果显示:单用组优于对照组,结论具有统计学意义[OR=3.51,95%CI(2.08,5.92),P0.00001];联用组优于单用组,结论具有统计学意义[OR=3.83,95%CI(2.68,5.46),P0.00001]。住院时间的meta分析结果显示..单用组的住院时间比对照组短,差异具有统计学意义[WMD=-1.87,95%CI(-3.16,-0.58),P=0.0040.05];联用组的住院时间比对照组短,差异具有统计学意义[WMD=-2.01,95%CI(-2.71,-1.31),P0.00001]。不良反应发生率的meta分析结果显示:2篇文献报道了喜炎平注射液对比利巴韦林注射液治疗儿童手足口病未出现不良反应;联用组的不良反应发生率与对照组相同[OR=5.05,95%CI(0.58,43.57),P=0.140.05]。(2)共纳入热毒宁注射液治疗儿童手足口病的文献15篇,其中干预措施为热毒宁注射液对比利巴韦林注射液的文献10篇,干预措施为热毒宁注射液联合利巴韦林注射液对比利巴韦林注射液的文献5篇。退热时间的meta分析结果显示:单用组的退热时间比对照组短,差异具有统计学意义[WMD=-0.96,95%CI(-1.09,-0.82),P0.00001];联用组的退热时间比对照组短,差异具有统计学意义[WMD=-1.45,95%CI(-2.33,-0.56),P=0.0010.01]。退疹时间的meta分析结果显示:单用组的退疹时间比对照组短,差异具有统计学意义[WMD=-1.57,95%CI(-1.73,-1.42),P0.00001];联用组的退疹时间比对照组短,差异具有统计学意义[WMD=-1.46,95%CI(-1.68,-1.25),P0.00001]。口腔溃疡/疱疹消退时间的meta分析结果显示:单用组的口腔溃疡/疱疹消退时间比对照组短,差异具有统计学意义[WMD=-1.75,95%CI(-2.12,-1.38),P0.00001];联用组的口腔溃疡/疱疹消退时间比对照组短,差异具有统计学意义[WMD=-1.77,95%CI(-2.05,-1.48),P0.00001]。总有效率的meta分析结果显示:单用组优于对照组,结论具有统计学意义[OR=5.16,95%CI(3.49,7.64),P0.00001];联用组优于对照组,结论具有统计学意义[OR=4.73,95%CI(2.47,9.03),P0.00001]。总病程的meta分析结果显示:单用组的总病程比对照组短,差异具有统计学意义[WMD=-2.22,95%CI(-3.40,-1.05),P=0.00020.01];联用组的总病程比对照组短,差异具有统计学意义[WMD=-2.14,95%CI(-2.54,-1.74),P0.00001]。不良反应发生率的meta分析结果显示:单用组的不良反应发生率低于对照组,结论具有统计学意义[OR=0.45,95%CI(0.21,0.97),P=0.040.05];联用组的不良反应发生率与对照组相等[OR=0.97,95%CI(0.31,3.05),P=0.960.05]。(3)喜炎平注射液经济学评价结果:实验组和对照组的总成本分别为2887.53元、3058.72元,总有效率分别为92.49%、78.12%。敏感度分析结果显示:实验组疗程对结果影响最大,其次是实验组住院时间、对照组住院时间、对照组疗程和对照组总有效率。在实验组疗程小于6.9天时,结局稳定;实验组住院时间小于5.9天或对照组住院时间大于6.1天时,结局稳定;在对照组疗程波动范围内,结局都是稳定的。(4)热毒宁注射液经济学评价结果:实验组和对照组的总成本分别为2769.35元、3062.98元,总有效率分别为95.00%、78.70%。敏感度分析结果显示:对照组的总有效率对结果影响最大,其次是实验组住院时间、对照组住院时间、实验组疗程,其他因素影响较小。当对照组的总有效率、实验组住院时间和实验组疗程波动变化时,结局仍稳定;当对照组的住院时间大于5.49天时,结局稳定。结论:在疗效方面,喜炎平注射液和热毒宁注射液治疗儿童手足口病优于利巴韦林注射液;在安全性方面,喜炎平注射液治疗儿童手足口病的安全性与利巴韦林注射液相当,而热毒宁注射液的安全性比利巴韦林注射液高;在经济性方面,喜炎平注射液和热毒宁注射液比利巴韦林注射液更具有成本-效果。
[Abstract]:Objective: (1) to evaluate the clinical efficacy and safety of Xi Yanping injection and hining injection in the treatment of hand foot and mouth disease (HFMD) for children, promote clinical rational use of drugs, provide evidence-based evidence for the clinical diagnosis and treatment of hand foot and mouth disease, supplement and revision of drug instructions. (2) the use of decision tree model and cost effect analysis method are used in the use of the evidence. In the treatment of children's hand foot and mouth disease (HFMD), the pharmacoeconomic evaluation of the treatment of children's hand foot and mouth disease (HFMD), the control of drug cost, the utilization of medical and health resources, and the scientific basis for the selection of drug pricing and medical insurance catalogues are provided. Methods: (1) the computer retrieval of Chinese knowledge net, VIP, Wanfang, Cochrane Library, PubMed database In August 2015, the randomized controlled trial and semi randomized controlled trial of yanyanping injection or hot toxic Ning Injection in the treatment of hand foot and mouth disease in children were carried out by literature management software EndNote X7; data extraction and literature quality evaluation were carried out in the included literature, and Review Manager5.3 was used for antipyretic time, time of retreating and oral ulceration. Meta analysis of total efficiency, total efficiency, time of hospitalization, total duration of hospitalization, the incidence of adverse reactions. (2) the cost calculation included direct cost, indirect cost and recessive cost. Based on the existing evidence-based data, the decision tree model was constructed with TreeAge Pro 2011, and the cost effect analysis was carried out, and Tornado Diag for all variables was carried out. Ram analysis, and analysis of single factor and double factor sensitivity. Results: (1) 18 articles were included in the treatment of children's hand foot and mouth disease with yanyanping injection. The intervention measures were 6 articles of yanyanping injection compared with Ribavirin Injection, and the intervention measures were the combination of yanyanping injection and Ribavirin Injection contrast Ribavirin Injection. The meta analysis of the antipyretic time showed that the antipyretic time of the single use group was shorter than the control group, and the difference was statistically significant [WMD=-1.41,95%CI (-2.60, -0.22), P=0.020.05], and the time of heat removal in the combined group was shorter than that of the control group, and the difference was statistically significant [WMD= -1.58,95%CI (-1.95, -1.21), and meta analysis of P0.00001]. rash time The results showed that the time of rash withdrawal in the single group was shorter than the control group, the difference was statistically significant [WMD=-1.58,95%CI (-2.42, -0.74), P=0.00020.01]. The time of retreating in the combined group was shorter than the control group, and the difference was statistically significant [WMD=-1.54,95%CI (-1.91, -1.17). The meta analysis of the time of P0.00001]. oral cavity ulcer / herpes regression showed that 1 papers were reported. The time of oral ulcer / herpes regression in children's hand foot and mouth disease treated with Ribavirin Injection injection was compared with that of Ribavirin Injection. The time of oral ulcer / herpes regression in the combined group was shorter than that of the control group, the difference was statistically significant [WMD=-1.22,95%CI (-1.75, -0.69), and the meta analysis of the total effective rate of P0.00001]. showed that: The single use group was better than the control group, the conclusion was statistically significant [OR=3.51,95%CI (2.08,5.92), P0.00001]. The combined group was better than the single use group, and the conclusion had statistical significance [OR=3.83,95%CI (2.68,5.46). The result of meta analysis of the time of hospitalization of P0.00001]. showed that the hospitalization time between the single use group was shorter than the control group, and the difference was statistically significant [WMD=-1.87,95%CI (the difference was statistically significant). -3.16, -0.58), P=0.0040.05]; the hospitalization time of the combined group was shorter than the control group, and the difference was statistically significant [WMD=-2.01,95%CI (-2.71, -1.31). The meta analysis of the incidence of P0.00001]. ADR showed that the 2 papers reported that the yanyanping injection did not have adverse reactions to Ribavirin Injection in the treatment of children's hand foot and mouth disease. The incidence of adverse reactions was the same as that of the control group ([OR=5.05,95%CI (0.58,43.57)), and P=0.140.05]. (2) included 15 literature for the treatment of hand foot and mouth disease in children by P=0.140.05]. (2), and the intervention measures were 10 articles compared with the literature of hot toxic Ning injection compared to the combination of hot toxic Ning Injection and Ribavirin Injection. 5 articles from Ribavirin Injection. The results of meta analysis of antipyretic time showed that the antipyretic time of the single group was shorter than that of the control group, and the difference was statistically significant [WMD=-0.96,95%CI (-1.09, -0.82), P0.00001], the time of heat removal in the combined group was shorter than that of the control group, and the difference was statistically significant [WMD=-1.45,95%CI (-2.33, -0.56), and P=0.0010.01]. regression time. The results of meta analysis showed that the time of rash withdrawal from the single group was shorter than the control group, the difference was statistically significant [WMD=-1.57,95%CI (-1.73, -1.42), P0.00001], the time of retreating in the combined group was shorter than the control group, the difference was statistically significant [WMD=-1.46,95%CI (-1.68, -1.25), and the meta analysis of the P0.00001]. oral ulcer / herpes regression time showed that the meta analysis results showed The time of oral ulcer / herpes regression in single use group was shorter than that of the control group, the difference was statistically significant [WMD=-1.75,95%CI (-2.12, -1.38), P0.00001]. The time of oral ulcer / herpes regression in the combined group was shorter than that of the control group, the difference was statistically significant [WMD=-1.77,95%CI (-2.05, -1.48), and the meta analysis results of P0.00001]. total effective rate showed: single use The group was better than the control group, the conclusion was statistically significant [OR=5.16,95%CI (3.49,7.64), P0.00001], and the combined group was superior to the control group. The conclusion was statistically significant [OR=4.73,95%CI (2.47,9.03). The results of meta analysis of the total course of P0.00001]. showed that the total course of disease in the single use group was shorter than the control group, and the difference was statistically significant [WMD=-2.22,95%CI (-3.40, -1.05). P=0.00020.01], the total course of disease in the combined group was shorter than the control group, and the difference was statistically significant [WMD=-2.14,95%CI (-2.54, -1.74). The meta analysis of the incidence of P0.00001]. ADR showed that the incidence of adverse reactions in the single use group was lower than that of the control group, and the conclusion had statistical meaning [OR=0.45,95%CI (0.21,0.97), P=0.040.05], and the adverse effect of the combination group. The incidence of the reaction was equal to that of the control group [OR=0.97,95%CI (0.31,3.05), P=0.960.05]. (3) the economic evaluation results of the yanyanping injection: the total cost of the experimental group and the control group was 2887.53 yuan, 3058.72 yuan, and the total effective rate was 92.49% respectively. The results of the 78.12%. sensitivity analysis showed that the experimental group had the most effect on the result, followed by the experimental group. Hospital time, control group time, control group and control group were effective. The outcome was stable when the course of treatment was less than 6.9 days. The outcome of the experimental group was less than 5.9 days or the control group was more than 6.1 days. The outcome was stable. (4) the economic evaluation of the injection of hot toxic Ning Injection. Results: the total cost of the experimental group and the control group was 2769.35 yuan, 3062.98 yuan, and the total effective rate was 95% respectively. The 78.70%. sensitivity analysis showed that the total effective rate of the control group had the greatest impact on the results, followed by the time of hospitalization in the experimental group, the time of the control group, the course of treatment in the experimental group, and the other factors. Rate, the outcome of the time of hospitalization in the experimental group and the fluctuation of the experimental group was still stable, and the outcome was stable when the time of hospitalization of the control group was greater than 5.49 days. Conclusion: in the effect, the treatment of hand foot and mouth disease in children is better than that of Ribavirin Injection. The safety of foot and mouth disease is equal to that of Ribavirin Injection, and the safety of the injection is higher than that of Ribavirin Injection. In the economic aspect, the injection and the hot poison Ning injection are more cost effective than that of Ribavirin Injection.

【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R725.1

【相似文献】