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·循证药学·
司来帕格治疗肺动脉高压的快速卫生技术评估 Δ
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董文星 ,张 喆 ,王 江 ,许汝福 ,楚明明 ,张 蓉 (1.陆军军医大学第二附属医院药剂科,重庆 400037;
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2.陆军军医大学第二附属医院心内科,重庆 400037)
中图分类号 R956 文献标志码 A 文章编号 1001-0408(2022)20-2524-05
DOI 10.6039/j.issn.1001-0408.2022.20.18
摘 要 目的 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 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 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。
关键词 司来帕格;肺动脉高压;快速卫生技术评估
Rapid health technology assessment of selexipag in the treatment of pulmonary arterial hypertension
DONG Wenxing ,ZHANG Zhe ,WANG Jiang ,XU Rufu ,CHU Mingming ,ZHANG Rong (1. Dept. of
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Pharmacy,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China;2. Dept. of
Cardiology,the Second Affiliated Hospital of Army Medical University,Chongqing 400037,China)
ABSTRACT OBJECTIVE To evaluate the efficacy,safety,and economy of selexipag in the treatment of pulmonary arterial
hypertension(PAH). METHODS 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 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.
KEYWORDS selexipag;pulmonary arterial hypertension;rapid health technology assessment
肺动脉高压(pulmonary arterial hypertension,PAH)
Δ 基金项目“十三五”双重学科项目;重庆市临床药学重点专科
被称为“心肺血管领域的癌症”,患者主要表现为呼吸困
(心血管专科)建设项目 [1]
难、疲劳、头晕和胸痛,最终可发展为右心衰竭甚至死亡 。
*第一作者 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 《中国肺动脉高压诊断与治疗指南(2021版)》指出,全球成
# 通信作者 主任药师,博士生导师,博士。研究方向:医院药事管 人PAH的发病率约为2.4/百万,患病率约为15/百万,但我
[1]
理。电话:023-68755580。E-mail:xqpharmacylab@126.com 国PAH的流行病学数据尚不清楚 。
·2524· China Pharmacy 2022 Vol. 33 No. 20 中国药房 2022年第33卷第20期