丹红注射液和银杏达莫注射液治疗心脑血管疾病的系统评价及药物经济学对比分析
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摘要
目的比较丹红注射液与银杏达莫注射液治疗脑梗死、冠心病心绞痛和血管性痴呆的有效性、安全性、经济性,以期为临床选药提供依据。方法检索2000年1月1日至2017年11月10日中国知网(CNKI)、中文科技期刊数据库(VIP)、万方数据资源系统数据库、Pubmed、Corchrane Library、Springer,收集丹红注射液与银杏达莫注射液治疗脑梗死、冠心病心绞痛和血管性痴呆的随机对照试验文献,采用Revman5.3软件对符合纳入与排除标准的研究进行统计分析,并进行药物经济学评价。结果共纳入16个研究,其中脑梗死9篇,冠心病心绞痛3篇,血管性痴呆4篇。Meta分析结果显示:1)丹红注射液在脑梗死临床疗效、NIHSS评分、血浆黏度、全血黏度高切、全血黏度低切、红细胞比容、红细胞变形指数方面均优于银杏达莫注射液,差异有统计学意义(P <0.05);2)在冠心病心绞痛临床疗效方面,丹红注射液与银杏达莫注射液相比差异无统计学意义(P> 0.05),在心电图疗效方面,丹红注射液优于银杏达莫注射液(P <0.05);3)丹红注射液在治疗血管性痴呆的临床疗效和ADL评分上中均优于银杏达莫注射液(P <0.05)。在不良反应方面,丹红注射液与银杏达莫注射液均无相关病例。药物经济学分析结果显示:与银杏达莫注射液相比,在治疗脑梗死疗效、冠心病心绞痛的心电图疗效及血管性痴呆疗效中,丹红注射液每增加1个疗效,分别需多花0.56、1.32、5.67元。根据WHO关于药物经济学评价的推荐意见,丹红注射液更具成本-效果优势。结论丹红注射液在脑梗死、冠心病心绞痛、血管性痴呆的治疗中较银杏达莫注射液具有良好的临床效果和经济性。
Objective: To compare the cost-effectiveness of Danhong Injection(DI) versus Ginkgo Dipyridamole Injection(GDI) in the treatment of cerebral infarction,angina pectoris and vascular dementia. Methods:Chinese and English databases from Jan. 1 st,2000 to Nov. 10 th,2017 were retrieved to collect the randomized controlled trials of DI and GDI in the treatment of cerebral infarction,angina pectoris and vascular dementia.Revman5. 0 software was used to make statistical analysis on the compliance of the patients with the standard.The outcome index was evaluated by pharmacoeconomics. Results: 16 studies were included,including 9 cerebral infarction,3 coronary heart disease and 4 vascular dementia. The results of Meta analysis showed that : 1)The clinical efficacy,NIHSS score,plasma viscosity,whole blood viscosity,low blood viscosity,erythrocyte specific volume and erythrocyte deformability index of DI were superior to that of GDI. The difference was statistically significant(P < 0.05). 2)The clinical efficacy and electrocardiogram effect of DI in treating coronary heart disease was not significantly different from those of GDI(P > 0.05),but in angina pectoris were significantly different from those of GDI(P < 0.05). 3)There were significant difference in the clinical efficacy and ADL score of DI in the treatment of vascular dementia compared with GDI(all P < 0.05). In terms of side effects,DI and GDI had no related cases. Pharmacoeconomic analysis showed that DI cost 0.56 yuan,1.32 yuan and 5.67 yuan more than GDI in the treatment of cerebral infarction,angina pectoris and vascular dementia respectively. According to WHO′ s recommendation on pharmacoeconomics evaluation,the cost of DI was worth increasing and cost effectiveness advantage. Conclusion: DI has a better clinical effect and more economy than GDI on cerebral infarction,angina pectoris and vascular dementia.
Objective: To compare the cost-effectiveness of Danhong Injection(DI) versus Ginkgo Dipyridamole Injection(GDI) in the treatment of cerebral infarction,angina pectoris and vascular dementia. Methods:Chinese and English databases from Jan. 1 st,2000 to Nov. 10 th,2017 were retrieved to collect the randomized controlled trials of DI and GDI in the treatment of cerebral infarction,angina pectoris and vascular dementia.Revman5. 0 software was used to make statistical analysis on the compliance of the patients with the standard.The outcome index was evaluated by pharmacoeconomics. Results: 16 studies were included,including 9 cerebral infarction,3 coronary heart disease and 4 vascular dementia. The results of Meta analysis showed that : 1)The clinical efficacy,NIHSS score,plasma viscosity,whole blood viscosity,low blood viscosity,erythrocyte specific volume and erythrocyte deformability index of DI were superior to that of GDI. The difference was statistically significant(P < 0.05). 2)The clinical efficacy and electrocardiogram effect of DI in treating coronary heart disease was not significantly different from those of GDI(P > 0.05),but in angina pectoris were significantly different from those of GDI(P < 0.05). 3)There were significant difference in the clinical efficacy and ADL score of DI in the treatment of vascular dementia compared with GDI(all P < 0.05). In terms of side effects,DI and GDI had no related cases. Pharmacoeconomic analysis showed that DI cost 0.56 yuan,1.32 yuan and 5.67 yuan more than GDI in the treatment of cerebral infarction,angina pectoris and vascular dementia respectively. According to WHO′ s recommendation on pharmacoeconomics evaluation,the cost of DI was worth increasing and cost effectiveness advantage. Conclusion: DI has a better clinical effect and more economy than GDI on cerebral infarction,angina pectoris and vascular dementia.
引文
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[10]于艳辉,王彦超.丹红注射液对首发急性脑梗死患者的临床疗效[J].辽宁中医杂志,2015,42(10):1936-1937.
[11]袁加文,王枫,孙晓江.丹红注射液治疗急性缺血性脑卒中的临床研究[J].中国老年学,2011,31(1):41-42.
[12]崔艳丽.脑心通联合丹红注射液治疗老年慢性脑供血不足疗效分析[J].北方药学,2017,14(2):83-84.
[13]赵惠琴.银杏达莫注射液与丹红注射液治疗脑梗死临床疗效比较[J].亚太传统医药,2014,10(16):121-122.
[14]周宗水.银杏达莫注射液治疗急性脑梗死[J].中国实验方剂学杂志,2012,18(2):239-241.
[15]黄岭晖.银杏达莫注射液治疗急性脑梗死40例临床观察[J].中国民族民间医药, 2016, 25(13):76-77.
[16]陈芳.银杏达莫注射液治疗急性脑梗死的临床效果[J].中药药理与临床,2015,31(1):313-314.
[17]彭燕,王凯.丹红注射液和银杏达莫注射液治疗冠心病心绞痛疗效观察[J].现代临床医学,2010,36(5):346-347.
[18]雍玉琴.银杏达莫注射液合生脉注射液治疗气虚血瘀型胸痹(冠心病心绞痛)临床试验总结[C].甘肃省中医药学会2010年会员代表大会暨学术年会论文汇编,2010.
[19]杨蔚,顾家富.中成药注射液治疗冠心病心绞痛的等效性比较[J].中国医学创新,2010,7(28):153-154.
[20]金杰,贾敬选,郭智宽.丹红注射液治疗血管性痴呆的临床研究及对β-Ap、Apo B的影响[J].中医学报,2010,25(2):271-273.
[21]金杰,于浩,陈海燕.丹红注射液治疗血管性痴呆40例[J].中国实验方剂学杂志,2010,16(8):198-200.
[22]贾敬选.丹红注射液治疗血管性痴呆的临床研究及对β-Ap、ApoB的影响[D].郑州:河南中医药大学,2009.
[23]于浩.丹红注射液治疗血管性痴呆的临床观察及其对ET-1、NO的影响[D].郑州:河南中医药大学,2009.
[24]王文文,卢颖,张昱,等.基于荟萃分析的参仙升脉口服液治疗缓慢性心律失常药物经济学研究[J].中国循证心血管医学杂志,2017,9(10):1165-1168.
[25]黄智然,刘诗洋,魏晓晶,等.北京市85家二、三级公立医院心血管类原研药与仿制药利用分析[J].药物流行病学杂志,2017,26(7):490-495.
[26]李岩,张毓辉,万泉,等. 2016年中国卫生总费用核算结果与分析[J].中国卫生经济,2018,37(5):5-8.
[27]付长庚,刘龙涛,王跃飞,等.丹红注射液临床应用中国专家共识[J].中国中西医结合杂志,2018,38(4):389-397.
[28]马西凡.银杏达莫注射液对急性脑梗死患者血清MMP-9和hs-CRP的影响[J].中国实用神经疾病杂志,2017,20(11):121-123.
[2]中华人民共和国卫生部.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002.
[3]国际心脏病学会和协会及WHO临床命名标准化联合专题组.缺血性心脏病的命名及诊断标准[J].中华心血管病杂志,1981,20(4):254.
[4]佚名.冠心病心绞痛及心电图疗效评定标准(中西医结合治疗冠心病心绞痛及心律失常座谈会,1979,上海)[J].中国药事,1987,1(2):71.
[5]美国精神医学学会.精神疾病诊断与统计手册[M].北京:北京大学出版社,2014.
[6]中华医学会神经病学分会.血管性痴呆诊断标准草案[J].中华神经科杂志,2002,35(4):246.
[7]田金州,韩明向,涂晋文,等.血管性痴呆诊断、辨证及疗效评定标准(研究用)[J].中国老年学杂志,2002,22(5):329-331.
[8]丁宁,易征,赫留党.丹红注射液治疗急性缺血性脑卒中的疗效观察[J].中医药导报,2014,20(8):62-65.
[9]王淑贞.丹红注射液治疗急性脑梗死临床疗效观察[C].山东省第3次中西医结合神经内科学术研讨会论文汇编,2011:100-101.
[10]于艳辉,王彦超.丹红注射液对首发急性脑梗死患者的临床疗效[J].辽宁中医杂志,2015,42(10):1936-1937.
[11]袁加文,王枫,孙晓江.丹红注射液治疗急性缺血性脑卒中的临床研究[J].中国老年学,2011,31(1):41-42.
[12]崔艳丽.脑心通联合丹红注射液治疗老年慢性脑供血不足疗效分析[J].北方药学,2017,14(2):83-84.
[13]赵惠琴.银杏达莫注射液与丹红注射液治疗脑梗死临床疗效比较[J].亚太传统医药,2014,10(16):121-122.
[14]周宗水.银杏达莫注射液治疗急性脑梗死[J].中国实验方剂学杂志,2012,18(2):239-241.
[15]黄岭晖.银杏达莫注射液治疗急性脑梗死40例临床观察[J].中国民族民间医药, 2016, 25(13):76-77.
[16]陈芳.银杏达莫注射液治疗急性脑梗死的临床效果[J].中药药理与临床,2015,31(1):313-314.
[17]彭燕,王凯.丹红注射液和银杏达莫注射液治疗冠心病心绞痛疗效观察[J].现代临床医学,2010,36(5):346-347.
[18]雍玉琴.银杏达莫注射液合生脉注射液治疗气虚血瘀型胸痹(冠心病心绞痛)临床试验总结[C].甘肃省中医药学会2010年会员代表大会暨学术年会论文汇编,2010.
[19]杨蔚,顾家富.中成药注射液治疗冠心病心绞痛的等效性比较[J].中国医学创新,2010,7(28):153-154.
[20]金杰,贾敬选,郭智宽.丹红注射液治疗血管性痴呆的临床研究及对β-Ap、Apo B的影响[J].中医学报,2010,25(2):271-273.
[21]金杰,于浩,陈海燕.丹红注射液治疗血管性痴呆40例[J].中国实验方剂学杂志,2010,16(8):198-200.
[22]贾敬选.丹红注射液治疗血管性痴呆的临床研究及对β-Ap、ApoB的影响[D].郑州:河南中医药大学,2009.
[23]于浩.丹红注射液治疗血管性痴呆的临床观察及其对ET-1、NO的影响[D].郑州:河南中医药大学,2009.
[24]王文文,卢颖,张昱,等.基于荟萃分析的参仙升脉口服液治疗缓慢性心律失常药物经济学研究[J].中国循证心血管医学杂志,2017,9(10):1165-1168.
[25]黄智然,刘诗洋,魏晓晶,等.北京市85家二、三级公立医院心血管类原研药与仿制药利用分析[J].药物流行病学杂志,2017,26(7):490-495.
[26]李岩,张毓辉,万泉,等. 2016年中国卫生总费用核算结果与分析[J].中国卫生经济,2018,37(5):5-8.
[27]付长庚,刘龙涛,王跃飞,等.丹红注射液临床应用中国专家共识[J].中国中西医结合杂志,2018,38(4):389-397.
[28]马西凡.银杏达莫注射液对急性脑梗死患者血清MMP-9和hs-CRP的影响[J].中国实用神经疾病杂志,2017,20(11):121-123.