| 魏春燕,罗琼,胡明,梁伟春,周乃彤.基于Meta分析的肾衰宁胶囊治疗慢性肾功能衰竭的药物经济学评价[J].中国药事,2022,36(8):852-861 |
| 基于Meta分析的肾衰宁胶囊治疗慢性肾功能衰竭的药物经济学评价 |
| Pharmacoeconomic Evaluation of Shenshuaining Capsule in the Treatment of Chronic Renal Failure Based on Meta-Analysis |
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| DOI：10.16153/j.1002-7777.2022.08.002 |
| 中文关键词: 肾衰宁胶囊 慢性肾功能衰竭 药物经济学 成本-效果分析 Meta分析 |
| 英文关键词: Shenshuaining capsule chronic renal failure pharmacoeconomic cost-effectiveness analysis Meta-analysis |
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| 中文摘要: |
| 目的：评价肾衰宁胶囊联合常规治疗对比常规治疗用于慢性肾功能衰竭的有效性、安全性以及经济性。方法：检索中国知网、万方、维普、PubMed、Embase数据库(各数据库建库-2021年7月)， 以肾衰宁胶囊联合常规治疗为试验组，常规治疗作为对照组的随机对照试验，以临床有效率、血肌酐、 尿素氮作为疗效指标，不良反应发生率作为安全性指标，用Review Manage5.2软件进行Meta分析。在此基础上从卫生体系角度，以门诊费用、检查费用及药品费用为成本指标，以血肌酐、尿素氮及有效率变化为效果指标，进行短期经济学评价。以慢性肾脏病各期治疗费用除以各期血肌酐及尿素氮的变化幅度，获得慢性肾脏病各期每单位血肌酐、尿素氮改变所需的治疗费用，取其中最小值作为阈值。结果：Meta分析结果显示，试验组临床有效率、血肌酐、尿素氮指标均明显优于对照组[RR=1.50，95%CI (1.32，1.71)，P＜0.05]、[MD=-50.27，95%CI(-62.07，-38.47)，P＜0.05]、[MD=-3.62，95%CI (-4.35，-2.89)，P＜0.05]。进行成本-效果分析，以慢性肾脏病各期治疗费用除以各期血肌酐及尿素氮变化幅度，取最小值作为阈值。得到血肌酐指标支付阈值为302.37元/μmol·L-1，尿素氮指标支付阈值为13916.42元/mmol·L-1。试验组和对照组相比，血肌酐、尿素氮指标的增量成本-效果比值分别为 38.47元/μmol·L-1，534.17元/mmol·L-1，小于研究设定阈值，在常规治疗的基础上加用肾衰宁胶囊治疗具有经济性。敏感性分析结果表明，药品价格及Meta分析结果的改变不影响经济学结论。结论：对于慢性肾功能衰竭的治疗，在常规治疗基础上联合肾衰宁胶囊与常规治疗相比，临床疗效更佳，安全性相当，具有一定的经济性。 |
| 英文摘要: |
| To evaluate the eff ectiveness, safety and economy of Shenshuaining capsule combined with conventional treatment compared with conventional treatment of chronic renal failure (CRF). Methods: By retrieving CNKI, Wanfang, VIP, Pubmed, Embase from the inception to July 1st, 2021, Shenshuining capsule combined with conventional treatment was used as the experimental group, and conventional treatment was used as the control group in the randomized controlled trials (RCTs). The clinical eff ective rate, serum creatinine and urea nitrogen were used as effi cacy indexes, and the incidence of adverse reactions was used as safety indexes. Meta-analysis was performed using Review Manager 5.2. On this basis, from the perspective of health system, the short-term economic evaluation was carried out by taking the cost of outpatient service, examination and medicine as the cost indexes, and the changes of serum creatinine, urea nitrogen and eff ective rate as the eff ect indexes. The treatment cost per unit of changes in serum creatinine and urea nitrogen at each stage of CKD was obtained by dividing the treatment cost at each stage by the change range of serum creatinine and urea nitrogen at each stage of CKD, and the minimum value was taken as the threshold. Results: Meta-analysis shows that the clinical eff ective rate, serum creatinine and urea nitrogen in treatment group were signifi cantly higher than those in control group [RR=1.50, 95%CI (1.32,1.71), P＜0.00001], [MD=-50.27, 95%CI (-62.07, -38.47), P＜0.00001], [MD=-3.62, 95%CI (-4.35, -2.89), P＜0.00001]. Cost-effectiveness analysis was performed. The treatment cost of CKD at each stage was divided by the variation range of serum creatinine and urea nitrogen at each stage, and the minimum value was taken as the threshold. The thresholds of serum creatinine and urea nitrogen of the experimental group were 302.37 yuan/μmol·L-1 and 13916.42 yuan/mol·L-1, respectively. Compared with the control group, the incremental cost-eff ectiveness ratio of serum creatinine and urea nitrogen of the experimental group were 38.47 yuan/μmol·L-1 and 534.17 yuan/mmol·L-1, respectively, which were lower than thethreshold value set in this study. It was economical to use Shenshuaining capsule in addition to conventional treatment. The result of sensitivity analysis shows that changes in drug prices and metaanalysis results did not aff ect the economic conclusions. Conclusion: For the treatment of chronic renal failure, the combination of Shenshuaining capsule on the basis of conventional treatment has better clinical effi cacy and comparable safety compared with conventional treatment, which has certain economic effi ciency. |
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