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心脉隆注射液联合基础治疗方案治疗左心室射血分数降低型心力衰竭的药物经济学评价
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| 篇名： | 心脉隆注射液联合基础治疗方案治疗左心室射血分数降低型心力衰竭的药物经济学评价 |
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| 摘要： | 目的：探讨心脉隆注射液联合基础治疗方案在临床治疗左心室射血分数（LVEF）降低型心力衰竭的有效性和经济性。方法：采用前瞻性的中心区组随机、开放的实际临床试验，将2014年2月－2016年11月期间27家综合性医院收治的LVEF降低型心力衰竭患者按1 ∶ 3比例分为对照组（n＝253）和试验组（n＝872），对照组使用基础治疗，试验组在基础治疗上静脉注射至少1个疗程（5 d）的心脉隆注射液。以心功能分级总有效率、LVEF改善值、明尼苏达心衰生活质量量表（MLHFQ）总分改善值和再住院率等效果指标从全社会角度进行成本-效果分析。结果：对照组和试验组的3个月心功能分级总有效率分别为61.54％和81.06％，LVEF改善值分别约为3.05％和7.35％，MLHFQ总分改善值分别约为24.39和26.63，再住院率分别为19.43％和10.02％，两组比较差异均有统计学意义（P＜0.05），表明试验组临床疗效优于对照组。药物经济学结果显示，试验组的LVEF改善值、MLHFQ总分改善值等正向指标的成本-效果比均低于对照组（189.35 vs. 243.46，576.38 vs. 614.29）；再住院率等反向指标的成本-效果比均高于对照组（2 019.61 vs. 925.42）。结论：心脉隆注射液联合基础治疗方案治疗LVEF降低型心力衰竭的疗效优于单纯基础治疗方案，成本-效果分析表明该联合用药具有较好的经济性。 |
| ABSTRACT： | OBJECTIVE： To investigate the effectiveness and economy of Xinmailong injection combined with basic treatment plan in the treatment of heart failure with reduced left ventricular ejection fraction （HFREF）. METHODS： In prospective randomized central group and open programmatic clinical trials， HFREF patients enrolled in 27 general hospitals during Feb. 2014-Nov. 2016 were divided into control group （n＝253） and trial group （n＝872） according to 1 ∶ 3. Control group received basic treatment， while trial group was additionally given Xinmailong injection intravenously for a treatment course （5 d） at least. Cost-effectiveness analysis was conducted from the perspective of the whole society by using the total response rate of cardiac functional grading， left ventricular ejection fraction （LVEF） improved data， Minnesota heart failure quality scale （MLHFQ） improved data and re-hospitalization rate. RESULTS： Total response rates of cardiac functional grading in control group and trial group were 61.54％ and 81.06％ in 3 months. The improved data of LVEF were about 3.05％ and 7.35％； MLHFQ improved data were 24.39 and 26.63， and re-hospitalization rates were 19.43％ and 10.02％. There were statistical significance in 2 groups （P＜0.05）， which indicated that clinical efficacy of trial group was better than that of control group. Pharmacoeconomics results showed that cost-effectiveness ratio of positive indicators as the improved data of LVEF and chronic cardiac insufficiency QOL scale （MLHFQ） in trial group were lower than control group （189.35 vs. 243.46， 576.38 vs. 614.29）. The cost-effectiveness ratio of re-hospitalization rate and fatality rate in trial group were higher than control group （2 019.61 vs. 925.42）. CONCLUSIONS： Xinmailong injection combined with basic treatment plan is better than basic treatment plan in the treatment of HFREF， and shows a better economy in cost-effectiveness analysis. |
| 期刊： | 2018年第29卷第1期 |
| 作者： | 肖巍，张学斌，李磊，刘国恩，朱文涛，鲁卫星 |
| AUTHORS： | XIAO Wei，ZHANG Xuebin，LI Lei，LIU Guoen，ZHU Wentao，LU Weixing |
| 关键字： | 心脉隆注射液；左心室射血分数降低型心力衰竭；成本-效果；全社会角度 |
| KEYWORDS： | Xinmailong injection； Heart failure with reduced left ventricular ejection fraction； Cost-effectiveness； Perspective of the whole society |
| 阅读数： | 782 次 |
| 本月下载数： | 6 次 |
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