吸入制剂治疗慢性阻塞性肺疾病的经济学系统评价
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摘要
目的:采用系统评价方法评价吸入制剂治疗慢性阻塞性肺疾病稳定期的经济性。方法:计算机检索PubMed、Cochrane Library、Embase、SinoMed、CNKI、WanFang Data、VIP数据库,搜集相关吸入制剂治疗慢性阻塞性肺疾病的经济学评价研究,检索年限均为建库至2018年12月。由两名评价员独立进行文献筛选、资料提取、方法学质量评价,对疗效、成本及成本效果数据进行综合分析。结果:共纳入9篇文献,大部分研究的方法学质量较高。在降低急性加重发生率及改善肺功能指标上,复方吸入制剂或联合吸入方案基本上优于单药吸入方案,但同时治疗成本增加。吸入沙美特罗(SALM)/氟替卡松(FUT)对比单方SALM,增量成本效果(ICER)为$(美元)13 000～46 300/质量调整生命年(QALY)<3倍人均国内生产总值(GDP),增加的成本在可接受范围内。吸入布地奈德(BUD)/氟莫特罗(FORM)+噻托溴铵(TIO)对比单用TIO治疗12周,ICER为■(欧元)149/避免一次严重急性加重。SALM/FUT+TIO较单用TIO治疗1年,ICER为CAN$(加元)145 756/QALY>$50 000/QALY阈值。结论:国产TIO与进口品种疗效相似,但具价格优势;吸入沙美特罗(SALM)/氟替卡松(FUT)与布地奈德(BUD)/氟莫特罗(FORM)均较口服班布特罗具有较好的经济性。受纳入研究数量和质量限制,上述结论尚需开展更多高质量研究予以验证。多项研究均为国外研究,受不同卫生体系及国情限制,研究方法虽有借鉴价值,但结果外在适用性受限。
Objective:A systematic review method was used to evaluate the economics of inhaled preparations therapy in stable phase of chronic obstructive pulmonary disease. Methods:PubMed, the Cochrane Library, Embase, SinoMed, CNKI, WanFang Data and VIP database were electronically searched to collect economic evaluation of inhaled preparations in the treatment of chronic obstructive pulmonary diseasefrom inception to December 2018. Two reviewers independently screened literatures, extracted data and assessed methodological quality. Finally, we comprehensively analyzed the efficacy, cost and cost-effectiveness data. Results:9 studies were included in our research, and majority of which had high quality in methodology. In reducing the incidence of acute exacerbations and improving FEV_1, the inhalation of compound preparation or combined inhalation regimen was substantially better than the monotherapy inhalation regimen, but at the same time, the cost of treatment increases. Inhaling Salmeterol/Fluticasone(SALM/FUT) vs. SALM alone, ICER was $13 000 to 46 300/QALY <3 times per capita GDP, and the added cost was acceptable. Inhalation of Budesonide/Flumotorol(BUD/FORM)+ Tiotropium bromide(TIO) compared to TIO alone, for 12 weeks of treatment, ICER was ■149 to avoid a severe acute exacerbation. Giving SALM/FUT+TIO for a year compared with TIO alone, ICER was CAN $145 756/QALY > $50 000/QALY threshold. Conclusion:The imitation TIO has similar efficacy to the original research variety, but it has a price advantage. Inhalation of SALM/FUT and BUD/FORM are more economical than oral bambuterol. Due to the small number of included studies and the low quality, the above conclusions need to be verified by more high-quality studies. Many studies are foreign studies. Due to the different health systems and national conditions, although the research methods have reference value, the external applicability of the results is limited.
Objective:A systematic review method was used to evaluate the economics of inhaled preparations therapy in stable phase of chronic obstructive pulmonary disease. Methods:PubMed, the Cochrane Library, Embase, SinoMed, CNKI, WanFang Data and VIP database were electronically searched to collect economic evaluation of inhaled preparations in the treatment of chronic obstructive pulmonary diseasefrom inception to December 2018. Two reviewers independently screened literatures, extracted data and assessed methodological quality. Finally, we comprehensively analyzed the efficacy, cost and cost-effectiveness data. Results:9 studies were included in our research, and majority of which had high quality in methodology. In reducing the incidence of acute exacerbations and improving FEV_1, the inhalation of compound preparation or combined inhalation regimen was substantially better than the monotherapy inhalation regimen, but at the same time, the cost of treatment increases. Inhaling Salmeterol/Fluticasone(SALM/FUT) vs. SALM alone, ICER was $13 000 to 46 300/QALY <3 times per capita GDP, and the added cost was acceptable. Inhalation of Budesonide/Flumotorol(BUD/FORM)+ Tiotropium bromide(TIO) compared to TIO alone, for 12 weeks of treatment, ICER was ■149 to avoid a severe acute exacerbation. Giving SALM/FUT+TIO for a year compared with TIO alone, ICER was CAN $145 756/QALY > $50 000/QALY threshold. Conclusion:The imitation TIO has similar efficacy to the original research variety, but it has a price advantage. Inhalation of SALM/FUT and BUD/FORM are more economical than oral bambuterol. Due to the small number of included studies and the low quality, the above conclusions need to be verified by more high-quality studies. Many studies are foreign studies. Due to the different health systems and national conditions, although the research methods have reference value, the external applicability of the results is limited.
引文
1 中华医学会呼吸病学分会慢性阻塞性肺疾病学组.慢性阻塞性肺疾病诊治指南(2013年修订版)[J].中华结核和呼吸杂志,2013,36(4):1-10
2 Global initiative for chronic obstructive lung disease.Global strategy for the diagnosis,management,and prevention of chronic obstructive pulmonary disease 2018 report[EB/OL].(2017-12) [2017-12- 05]http://www.goldcopd.org
3 Ofman JJ,Sullivan SD,Neumann PJ,et al.Examining the Value and Quality of Health Economic Analyses:Implications of Utilizing the QHES[J].J Manag Care Spec Pharm,2003,9(1):53-61
4 孔彩,付希婧,孙茂,等.国外药物经济学研究质量评估的经验及对我国的启示[J].中国卫生经济,2014,9:62-65
5 Briggs AH,Glick HA,Lozano-Ortega G,et al.Is treatment with ICS and LABA cost-effective for COPD?Multinational economic analysis of the TORCH study[J].Eur Respir J,2010,35(3) :532-539
6 L?fdahl CG,Ericsson A,Svensson K,et al.Cost effectiveness of budesonide/ formoterol in a single inhaler for COPD compared with each monocomponent used alone[J].Pharmacoeconomics,2005,23(4):365-375
7 Mittmann N,Hernandez P,Mellstr?m C,et al.Cost effectiveness of budesonide/ formoterol added to tiotropium bromide versus placebo added to tiotropium bromide in patients with chronic obstructive pulmonary disease:Australian,Canadian and Swedish healthcare perspectives[J].Pharmaco Economics,2011,29(5):403-414
8 Najafzadeh M,Marra CA,Sadatsafavi M,et al.Cost effectiveness of therapy with combinations of long acting bronchodilators and inhaled steroids for treatment of COPD[J].Thorax,2008,63(11):962-967
9 Nielsen R,Kankaanranta H,Bjermer L,et al.Cost effectiveness of adding budesonide/formoterol to tiotropium in COPD in four Nordic countries[J].Respir Med,2013,107(11):1709-1721
10 Oostenbrink JB,Rutten-van M?lken MP,Al MJ,et al.One-year cost-effectiveness of tiotropium versus ipratopium to treat chronic obstructive pulmonary disease[J].Eur Respir J,2004,23(2):241-249
11 Zalis'ka O,Tolubaiev V,Bocharova V.Cost-benefit analysis of tiotropium and salmeterol treatment compare to usual practice on sample of employed economicaly active copd patients in Ukraine[J].Value Health,2012,15(7):A562
12 颜小艳,周贤刚,周弋特,等.国产噻托溴铵粉雾剂治疗慢性阻塞性肺疾病的临床疗效和成本分析[J].四川医学,2016,37(4):426-429
13 卓广英,何庆.2011GOLD推荐3种方案治疗慢性阻塞性肺疾病稳定期的药物经济学分析[J].四川医学,2013,34(1):28-30
14 慢性阻塞性肺疾病急性加重(AECOPD)诊治专家组.慢性阻塞性肺疾病急性加重(AECOPD)诊治中国专家共识(2017年更新版) [J].国际呼吸杂志,2017,37(14):1041-1057
15 Villoro R,Merino M,Carmona C,et al.The economic burden of chronic obstructive pulmonary disease in china:A systematic literature review[J].Value Health,2016,19(7):A877
16 李建,冯芮华,崔月颖,等.我国三级医院药物治疗慢阻肺患者的经济负担分析[J].中国卫生经济,2015,34(9):66-68
17 安晓红,娄培安,余加席,等.徐州市社区慢性阻塞性肺疾病患者直接经济负担研究[J].中国校医,2009,23(5):505-507
18 徐东波,李洪超,马爱霞.慢性阻塞性肺炎疾病成本研究[J].中国药物经济学,2011,11:18-27
19 谢兴悦,江兵,缪李丽.芜地溴铵/维兰特罗治疗慢性阻塞性肺疾病有效性和安全性的 Meta 分析[J].中国循证医学杂志,2017,17(12):1404-1412
20 Zhong N,Wang C,Zhou X,et al.Efficacy and Safety of Indacaterol/ Glycopyrronium (IND/GLY) Versus Salmeterol/Fluticasone in Chinese Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease:The Chinese Cohort from the LANTERN Study[J].COPD,2016,13(6):686-692
21 Bai C,Ichinose M,Lee SH,et al.Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease[J].Int J Chron Obstruct Pulmon Dis,2017,12:3329-3339
22 D'Urzo A,Rennard S,Kerwin E,et al.A randomised double-blind,placebo-controlled,long-term extension study of the efficacy,safety and tolerability of fixed-dose combinations of aclidinium/formoterol or monotherapy in the treatment of chronic obstructive pulmonary disease[J].Respir Med,2017,125:39-48
23 Reisner C,Fabbri LM,Kerwin EM,et al.A randomized,seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease[J].Respir Res,2017,18(1):8
24 Schlueter M,Gonzalez-Rojas N,Baldwin M,et al.Comparative efficacy of fixed-dose combinations of long-acting muscarinic antagonists and long-acting β2-agonists:a systematic review and network meta-analysis[J].Ther Adv Respir Dis,2016,10(2):89-104
25 宗欣,孙利华.从多国视角看成本效果阈值的应用现状[J].中国药事,2011,25(8):768-771
26 刘国恩.中国药物经济学评价指南及导读[M].2015版.北京:科学出版社,2015:33
2 Global initiative for chronic obstructive lung disease.Global strategy for the diagnosis,management,and prevention of chronic obstructive pulmonary disease 2018 report[EB/OL].(2017-12) [2017-12- 05]http://www.goldcopd.org
3 Ofman JJ,Sullivan SD,Neumann PJ,et al.Examining the Value and Quality of Health Economic Analyses:Implications of Utilizing the QHES[J].J Manag Care Spec Pharm,2003,9(1):53-61
4 孔彩,付希婧,孙茂,等.国外药物经济学研究质量评估的经验及对我国的启示[J].中国卫生经济,2014,9:62-65
5 Briggs AH,Glick HA,Lozano-Ortega G,et al.Is treatment with ICS and LABA cost-effective for COPD?Multinational economic analysis of the TORCH study[J].Eur Respir J,2010,35(3) :532-539
6 L?fdahl CG,Ericsson A,Svensson K,et al.Cost effectiveness of budesonide/ formoterol in a single inhaler for COPD compared with each monocomponent used alone[J].Pharmacoeconomics,2005,23(4):365-375
7 Mittmann N,Hernandez P,Mellstr?m C,et al.Cost effectiveness of budesonide/ formoterol added to tiotropium bromide versus placebo added to tiotropium bromide in patients with chronic obstructive pulmonary disease:Australian,Canadian and Swedish healthcare perspectives[J].Pharmaco Economics,2011,29(5):403-414
8 Najafzadeh M,Marra CA,Sadatsafavi M,et al.Cost effectiveness of therapy with combinations of long acting bronchodilators and inhaled steroids for treatment of COPD[J].Thorax,2008,63(11):962-967
9 Nielsen R,Kankaanranta H,Bjermer L,et al.Cost effectiveness of adding budesonide/formoterol to tiotropium in COPD in four Nordic countries[J].Respir Med,2013,107(11):1709-1721
10 Oostenbrink JB,Rutten-van M?lken MP,Al MJ,et al.One-year cost-effectiveness of tiotropium versus ipratopium to treat chronic obstructive pulmonary disease[J].Eur Respir J,2004,23(2):241-249
11 Zalis'ka O,Tolubaiev V,Bocharova V.Cost-benefit analysis of tiotropium and salmeterol treatment compare to usual practice on sample of employed economicaly active copd patients in Ukraine[J].Value Health,2012,15(7):A562
12 颜小艳,周贤刚,周弋特,等.国产噻托溴铵粉雾剂治疗慢性阻塞性肺疾病的临床疗效和成本分析[J].四川医学,2016,37(4):426-429
13 卓广英,何庆.2011GOLD推荐3种方案治疗慢性阻塞性肺疾病稳定期的药物经济学分析[J].四川医学,2013,34(1):28-30
14 慢性阻塞性肺疾病急性加重(AECOPD)诊治专家组.慢性阻塞性肺疾病急性加重(AECOPD)诊治中国专家共识(2017年更新版) [J].国际呼吸杂志,2017,37(14):1041-1057
15 Villoro R,Merino M,Carmona C,et al.The economic burden of chronic obstructive pulmonary disease in china:A systematic literature review[J].Value Health,2016,19(7):A877
16 李建,冯芮华,崔月颖,等.我国三级医院药物治疗慢阻肺患者的经济负担分析[J].中国卫生经济,2015,34(9):66-68
17 安晓红,娄培安,余加席,等.徐州市社区慢性阻塞性肺疾病患者直接经济负担研究[J].中国校医,2009,23(5):505-507
18 徐东波,李洪超,马爱霞.慢性阻塞性肺炎疾病成本研究[J].中国药物经济学,2011,11:18-27
19 谢兴悦,江兵,缪李丽.芜地溴铵/维兰特罗治疗慢性阻塞性肺疾病有效性和安全性的 Meta 分析[J].中国循证医学杂志,2017,17(12):1404-1412
20 Zhong N,Wang C,Zhou X,et al.Efficacy and Safety of Indacaterol/ Glycopyrronium (IND/GLY) Versus Salmeterol/Fluticasone in Chinese Patients with Moderate-to-Severe Chronic Obstructive Pulmonary Disease:The Chinese Cohort from the LANTERN Study[J].COPD,2016,13(6):686-692
21 Bai C,Ichinose M,Lee SH,et al.Lung function and long-term safety of tiotropium/olodaterol in East Asian patients with chronic obstructive pulmonary disease[J].Int J Chron Obstruct Pulmon Dis,2017,12:3329-3339
22 D'Urzo A,Rennard S,Kerwin E,et al.A randomised double-blind,placebo-controlled,long-term extension study of the efficacy,safety and tolerability of fixed-dose combinations of aclidinium/formoterol or monotherapy in the treatment of chronic obstructive pulmonary disease[J].Respir Med,2017,125:39-48
23 Reisner C,Fabbri LM,Kerwin EM,et al.A randomized,seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease[J].Respir Res,2017,18(1):8
24 Schlueter M,Gonzalez-Rojas N,Baldwin M,et al.Comparative efficacy of fixed-dose combinations of long-acting muscarinic antagonists and long-acting β2-agonists:a systematic review and network meta-analysis[J].Ther Adv Respir Dis,2016,10(2):89-104
25 宗欣,孙利华.从多国视角看成本效果阈值的应用现状[J].中国药事,2011,25(8):768-771
26 刘国恩.中国药物经济学评价指南及导读[M].2015版.北京:科学出版社,2015:33