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1.陆军军医大学第二附属医院药剂科,重庆 400037
2.陆军军医大学第二附属医院心内科,重庆 400037
主管药师,硕士研究生。研究方向:临床药学、药物经济学。电话:023-68755401。E-mail:dong15696963253@163.com
主任药师,博士生导师,博士。研究方向:医院药事管理。电话:023-68755580。E-mail:xqpharmacylab@126.com
收稿:2022-03-22,
修回:2022-09-17,
纸质出版:2022-10-30
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董文星,张喆,王江,等.司来帕格治疗肺动脉高压的快速卫生技术评估[J].中国药房,2022,33(20):2524-2528.
DONG Wenxing,ZHANG Zhe,WANG Jiang,et al.Rapid health technology assessment of selexipag in the treatment of pulmonary arterial hypertension[J].ZHONGGUO YAOFANG,2022,33(20):2524-2528.
董文星,张喆,王江,等.司来帕格治疗肺动脉高压的快速卫生技术评估[J].中国药房,2022,33(20):2524-2528. DOI: 10.6039/j.issn.1001-0408.2022.20.18.
DONG Wenxing,ZHANG Zhe,WANG Jiang,et al.Rapid health technology assessment of selexipag in the treatment of pulmonary arterial hypertension[J].ZHONGGUO YAOFANG,2022,33(20):2524-2528. DOI: 10.6039/j.issn.1001-0408.2022.20.18.
目的
2
评价司来帕格治疗肺动脉高压(PAH)的有效性、安全性和经济性。
方法
2
计算机检索PubMed、Embase、Web of Science、Cochrane Library、Epistemonikos、SinoMed、中国知网、维普网、万方数据、中国生物医学文献数据库、国内外卫生技术评估机构官方网站及相关数据库,经文献筛选、资料提取、质量评价后,对纳入研究的结果进行描述性分析。
结果与结论
2
共纳入7篇文献,包括6篇Meta分析和1篇药物经济学研究。有效性方面,司来帕格可改善患
者运动耐量、血流动力学指标,并可降低临床恶化事件发生率和住院治疗率,但静脉/皮下途径的前列环素类似物在改善WHO心功能分级和降低全因死亡率方面的效果更佳(
P
<0.05)。司来帕格与其他靶向药物对各项结局指标影响的差异均无统计学意义(
P
>0.05)。安全性方面,司来帕格可增加一般不良反应事件的发生率和因无法耐受不良反应停药的发生率(
P
<0.05),而与各类靶向药物比较的差异均无统计学意义(
P
>0.05)。经济性方面,基于加拿大卫生体系背景,司来帕格治疗PAH不具有经济性;目前缺少基于我国国情的经济学研究。尚需进一步开展司来帕格和前列环素类药物在真实世界中疗效和经济性的对比研究。
OBJECTIVE
2
To evaluate the efficacy, safety, and economy of selexipag in the treatment of pulmonary arterial hypertension (PAH).
METHODS
2
After literature screening, data extraction and quality evaluation, the results of included studies were analyzed descriptively by retrieving PubMed, Embase, Web of Science, Cochrane Library, Epistemonikos, SinoMed, CNKI, VIP, Wanfang data, CBM, official websites of domestic and foreign health technology assessment institutions and relevant database.
RESULTS &CONCLUSIONS
2
A total of 7 literature were included, involving 6 meta-analysis and 1 pharmacoeconomic study. In terms of efficacy, selexipag could improve patients’ exercise tolerance and hemodynamic indexes, and reduced the incidence of clinical worsening events and hospitalization. However, intravenous/subcutaneous administration of prostacyclin analog had better effects in improving WHO functional class and reducing all-cause mortality (
P
<0.05). There were no statistically significant differences in the impact on outcome indexes between selexipag and other targeted agents (
P
>0.05). In terms of safety, the incidence of adverse drug events and drug withdrawal due to adverse reactions was increased by selexipag (
P
<0.05), but there were no significant differences between the effects of selexipag and other targeted drugs on adverse events, serious adverse events and drug withdrawal due to adverse reactions (
P
>0.05). In terms of economy, based on
the background of Canada’s health system, it was not economical for selexipag to treat PAH, and there was a lack of economic research based on China’s national conditions. Further comparative studies on the efficacy and economics of selexipag and prostacyclins in the real world are needed.
中华医学会呼吸病学分会肺栓塞与肺血管病学组 , 中国医师协会呼吸医师分会肺栓塞与肺血管病工作委员会 , 全国肺栓塞与肺血管病防治协作组 , 等 . 中国肺动脉高压诊断与治疗指南: 2021版 [J ] . 中华医学杂志 , 2021 , 101 ( 1 ): 11 - 51 .
ZHANG R , DAI L Z , XIE W P , et al . Survival of Chinese patients with pulmonary arterial hypertension in the modern treatment era [J ] . Chest , 2011 , 140 ( 2 ): 301 - 309 .
CHIN K M , RUBIN L J . Pulmonary arterial hypertension [J ] . J Am Coll Cardiol , 2008 , 51 ( 16 ): 1527 - 1538 .
RUOPP N F , COCKRILL B A . Diagnosis and treatment of pulmonary arterial hypertension:a review [J ] . JAMA , 2022 , 327 ( 14 ): 1379 - 1391 .
PANAGIOTIDOU E , BOUTOU A , PITSIOU G . An eva-luation of selexipag for the treatment of pulmonary hypertension [J ] . Expert Opin Pharmacother , 2021 , 22 ( 1 ): 29 - 36 .
王冉冉 , 郑英丽 , 顾智淳 , 等 . 选择性前列环素受体激动剂selexipag:一种治疗肺动脉高压的口服新药 [J ] . 中国新药与临床杂志 , 2016 , 35 ( 6 ): 405 - 408 .
HUMBERT M , KOVACS G , HOEPER M M , et al . 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension [J ] . Eur Respir J , 2022 : 2200879 .
HAILEY D . Toward transparency in health technology assessment:a checklist for HTA reports [J ] . Int J Technol Assess Health Care , 2003 , 19 ( 1 ): 1 - 7 .
SHEA B J , REEVES B C , WELLS G , et al . AMSTAR 2:a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions,or both [J ] . BMJ , 2017 , 358 : j4008 .
HUSEREAU D , DRUMMOND M , PETROU S , et al . Consolidated health economic evaluation reporting standards(CHEERS)statement [J ] . BMC Med , 2013 , 11 : 80 .
JAIN S , KHERA R , GIROTRA S , et al . Comparative effectiveness of pharmacologic interventions for pulmonary arterial hypertension:a systematic review and network meta-analysis [J ] . Chest , 2017 , 151 ( 1 ): 90 - 105 .
WANG S M , YU M , ZHENG X C , et al . A Bayesian network meta-analysis on the efficacy and safety of eighteen targeted drugs or drug combinations for pulmonary arterial hypertension [J ] . Drug Deliv , 2018 , 25 ( 1 ): 1898 - 1909 .
ZHENG Y G , MA H , CHEN L , et al . Efficacy and safety of oral targeted therapies in pulmonary arterial hypertension:a meta-analysis of randomized clinical trials [J ] . Pulm Circ , 2018 , 8 ( 4 ): 2045894018798183 .
PICKEN C , FRAGKOS K C , EDDAMA M , et al . Adverse events of prostacyclin mimetics in pulmonary arterial hypertension:a systematic review and meta-analysis [J ] . J Clin Med , 2019 , 8 ( 4 ): E481 .
PETROVIČ M , LOCATELLI I . A Bayesian network meta-analysis of add-on drug therapies specific for pulmonary arterial hypertension [J ] . Ann Pharmacother , 2020 , 54 ( 5 ): 423 - 433 .
FU W H , HE W J , LI Y X , et al . Efficacy and safety of novel-targeted drugs in the treatment of pulmonary arterial hypertension:a Bayesian network meta-analysis [J ] . Drug Deliv , 2021 , 28 ( 1 ): 1007 - 1019 .
Canadian Agency for Drugs and Technologies ih Health . Pharmacoeconomic review report:selexipag(uptravi) [EB/OL ] .[ 2022-03-04 ] . http://www.ncbi.nlm.nih.gov/books/NBK533876 http://www.ncbi.nlm.nih.gov/books/NBK533876 .
SIMONNEAU G , TORBICKI A , HOEPER M M , et al . Selexipag:an oral,selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension [J ] . Eur Respir J , 2012 , 40 ( 4 ): 874 - 880 .
SITBON O , CHANNICK R , CHIN K M , et al . Selexipag for the treatment of pulmonary arterial hypertension [J ] . N Engl J Med , 2015 , 373 ( 26 ): 2522 - 2533 .
CHIN K M , SITBON O , DOELBERG M , et al . Three- versus two-drug therapy for patients with newly diagnosed pulmonary arterial hypertension [J ] . J Am Coll Cardiol , 2021 , 78 ( 14 ): 1393 - 1403 .
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