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玛巴洛沙韦治疗流行性感冒的快速卫生技术评估
Rapid health technology assessment of baloxavir marboxil in the treatment of influenza
- 中国药房 2023年34卷第19期 页码：2402-2408
- 作者机构：
1.深圳市儿童医院药剂科，广东 深圳 518038
2.深圳市第二人民医院中西医结合科，广东 深圳 518035
- 作者简介：
副主任药师，硕士。研究方向：临床药学。电话：0755-83008256。E-mail：wuyue161@163.com
主任药师，硕士。研究方向：临床药学。电话：0755-83008255。E-mail：szchenzb@126.com
- 基金信息：广东省医学科研基金项目(A2022432);深圳三名工程项目(SZSM201612049)
DOI：10.6039/j.issn.1001-0408.2023.19.17
中图分类号： R978.7;R956纸质出版日期：2023-10-15，
收稿日期：2023-03-17，
修回日期：2023-08-18，
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吴越,陈启庭,陈芳昭等.玛巴洛沙韦治疗流行性感冒的快速卫生技术评估 Δ[J].中国药房,2023,34(19):2402-2408.
WU Yue,CHEN Qiting,CHEN Fangzhao,et al.Rapid health technology assessment of baloxavir marboxil in the treatment of influenza[J].ZHONGGUO YAOFANG,2023,34(19):2402-2408.
吴越,陈启庭,陈芳昭等.玛巴洛沙韦治疗流行性感冒的快速卫生技术评估 Δ[J].中国药房,2023,34(19):2402-2408. DOI： 10.6039/j.issn.1001-0408.2023.19.17.
WU Yue,CHEN Qiting,CHEN Fangzhao,et al.Rapid health technology assessment of baloxavir marboxil in the treatment of influenza[J].ZHONGGUO YAOFANG,2023,34(19):2402-2408. DOI： 10.6039/j.issn.1001-0408.2023.19.17.
摘要
目的
2
评价玛巴洛沙韦治疗流行性感冒（以下简称“流感”）的有效性、安全性和经济性，以期为医院新药引进和临床用药决策提供循证参考。
方法
2
检索PubMed、Embase、Web of Science、Cochrane Library、Epistemonikos、中国生物医学文献数据库、中国知网、维普网、万方数据库及卫生技术评估（HTA）相关学术机构官方网站及数据库，经文献筛选、资料提取、质量评价后，对研究结果进行描述性分析。
结果
2
共纳入11篇文献，包括6篇系统评价（SR）/Meta分析、5篇经济学研究。与安慰剂相比，玛巴洛沙韦在缩短流感患者症状缓解时间（TTAS）和退热时间（TTRF）、降低治疗后24 h和48 h病毒滴度相对于基线的变化水平、降低支气管炎发生率等方面差异有统计学意义（
P
＜0.05）。与神经氨酸酶抑制剂（NAIs）相比，玛巴洛沙韦在缩短流感患者TTRF，降低流感并发症、肺炎、支气管炎发生率等方面差异无统计学意义（
P
＞0.05）；多数研究认为玛巴洛沙韦在缩短TTAS方面差异无统计学意义（
P
＞0.05）；仅有极低质量文献认为玛巴洛沙韦可显著降低患者治疗后24 h和48 h病毒滴度相对于基线的变化水平。安全性方面，玛巴洛沙韦与帕拉米韦、扎那米韦相比，不良事件（AEs）发生率和药物相关不良事件（DRAEs）发生率差异无统计学意义（
P
＞0.05）。部分研究认为玛巴洛沙韦AEs和DRAEs发生率较安慰剂、奥司他韦、拉尼米韦更低。现有经济学研究显示，在中国与奥司他韦相比、在日本与拉尼米韦相比，玛巴洛沙韦均更具有成本-效果优势。
结论
2
与安慰剂相比，玛巴洛沙韦治疗流感具有良好的有效性、安全性和经济性。与NAIs（奥司他韦）相比，玛巴洛沙韦在中国有良好的经济学优势，但在安全性和有效性方面尚需开展更多高质量研究。
Abstract
OBJECTIVE
2
To evaluate the effectiveness， safety and economy of baloxavir marboxil in the treatment of influenza， and to provide evidence-based reference for the introduction of new drugs in hospitals and clinical medication decisions.
METHODS
2
Retrieved from PubMed， Embase， Web of Science， Cochrane Library， Epistemonikos， CBM， CNKI， VIP， Wanfang database， official websites and relevant databases of health technology assessment （HTA） institutions， the results of the included studies were descriptively analyzed after literature screening， data extraction and quality evaluation.
RESULTS
2
A total of 11 studies were included， involving 6 systematic reviews/meta-analyses and 5 pharmacoeconomic studies. Compared with placebo， baloxavir marboxil significantly shortened the time to alleviation of symptoms （TTAS） and time to resolution of fever （TTRF）， reduced the virus titer change from baseline at 24 h and 48 h after treatment and the incidence of bronchitis， with statistical significance （
P
＜0.05）. Compared with neuraminidase inhibitors （NAIs）， there were no significant differences in shortening TTRF and reducing the incidence of complications， pneumonia and bronchitis （
P
＞0.05）. The majority of studies suggested that there were no significant differences in shortening TTAS （
P
＞0.05）. Only very low-quality literature suggested that baloxavir marboxil could significantly reduce the virus titer change from baseline at 24 h and 48 h after treatment. In terms of safety， the incidences of adverse events （AEs） and drug-related adverse events （DRAEs） induced by baloxavir marboxil showed no significant differences， compared with peramivir and zanamivir （
P
＞0.05）. Some studies considered that the incidences of AEs and DRAEs with baloxavir marboxil were lower than placebo， oseltamivir and laninamivir. Compared with oseltamivir in China and laninamivir in Japan， baloxavir marboxil showed cost-effectiveness advantages.
CONCLUSIONS
2
Compared with placebo， baloxavir marboxil has good efficacy， safety and economy. Compared with NAIs （oseltamivir）， baloxavir marboxil has good economic advantages in China， but further high-quality studies are still needed regarding its safety and efficacy.
关键词
玛巴洛沙韦流行性感冒快速卫生技术评估有效性安全性经济性
Keywords
influenzarapid health technology assessmenteffectivenesssafetyeconomy
references
KRAMMER F，SMITH G J D，FOUCHIER R A M，et al. Influenza[J]. Nat Rev Dis Primers，2018，4（1）：3.
HOOKER K L，GANUSOV V V. Impact of oseltamivir treatment on influenza A and B virus dynamics in human volunteers[J]. Front Microbiol，2021，12：631211.
朱爱琴，郑亚明，秦颖，等. 中国流感经济负担研究系统综述[J]. 中华预防医学杂志，2019，53（10）：1043-1048.
ZHU A Q，ZHENG Y M，QIN Y，et al. A systematic review of the economic burden of influenza in China[J]. Chin J Prev Med，2019，53（10）：1043-1048.
TANI N，KAWAI N，CHONG Y，et al. Susceptibility of epidemic viruses to neuraminidase inhibitors and treatment- emergent resistance in the Japanese 2019-20 influenza season[J]. J Infect，2022，84（2）：151-157.
ISON M G，PORTSMOUTH S，YOSHIDA Y，et al. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza （CAPSTONE-2）：a randomised，placebo-controlled，phase 3 trial[J]. Lancet Infect Dis，2020，20（10）：1204-1214.
ZHANG W X，XU H F，GUAN S X，et al. Frequency and distribution of H1N1 influenza A viruses with oseltamivir-resistant mutations worldwide before and after the 2009 pandemic[J]. J Med Virol，2022，94（9）：4406-4416.
YANG T R. Baloxavir marboxil：the first cap-dependent endonuclease inhibitor for the treatment of influenza[J]. Ann Pharmacother，2019，53（7）：754-759.
YOSHINO Y，KITAZAWA T，OTA Y. Clinical efficacy of baloxavir marboxil in the treatment of seasonal influenza in adult patients：a prospective observational study[J]. Int J Gen Med，2020，13：735-741.
TAIEB V，IKEOKA H，MA F，et al. A network meta-analysis of the efficacy and safety of baloxavir marboxil versus neuraminidase inhibitors for the treatment of influen- za in otherwise healthy patients[J]. Curr Med Res Opin，2019，35（8）：1355-1364.
KUO Y C，LAI C C，WANG Y H，et al. Clinical efficacy and safety of baloxavir marboxil in the treatment of influenza：a systematic review and meta-analysis of randomized controlled trials[J]. J Microbiol Immunol Infect，2021，54（5）：865-875.
LIU J W，LIN S H，WANG L C，et al. Comparison of antiviral agents for seasonal influenza outcomes in healthy adults and children：a systematic review and network meta-analysis[J]. JAMA Netw Open，2021，4（8）：e2119151.
TAIEB V，IKEOKA H，WOJCIECHOWSKI P，et al. Efficacy and safety of baloxavir marboxil versus neuraminidase inhibitors in the treatment of influenza virus infection in high-risk and uncomplicated patients：a Bayesian network meta-analysis[J]. Curr Med Res Opin，2021，37（2）：225-244.
TEJADA S，TEJO A M，PEÑA-LÓPEZ Y，et al. Neura- minidase inhibitors and single dose baloxavir are effective and safe in uncomplicated influenza：a meta-analysis of randomized controlled trials[J]. Expert Rev Clin Pharmacol，2021，14（7）：901-918.
ZHAO Y H，HUANG G L，HE W J，et al. Efficacy and safety of single-dose antiviral drugs for influenza treatment：a systematic review and network meta-analysis[J]. J Med Virol，2022，94（7）：3270-3302.
International Society for Pharmacoeconomics and Outcomes Research. Cost-effectiveness analysis of baloxavir marboxil as seasonal influenza treatment compared to oseltamivir in China[EB/OL]. [2022-12-31]. https：//www.ispor.org/docs/default-source/euro2021/ispor-poster-1108-pdfhttps://www.ispor.org/docs/default-source/euro2021/ispor-poster-1108-pdf.
International Society for Pharmacoeconomics and Outcomes Research. A cost-effectiveness analysis for in- fluenza virus infection with oseltamivir or baloxavir in Japan[EB/OL]. [2022-12-31]. https：//www.ispor.org/docs/default-source/intl2019/poster_naoto-nakagawa-pdfhttps://www.ispor.org/docs/default-source/intl2019/poster_naoto-nakagawa-pdf.
International Society for Pharmacoeconomics and Outcomes Research. Cost-effectiveness and budget impact of baloxavir marboxil in the netherlands based on post-covid influenza season scenario[EB/OL]. [2022-12-31]. https：//www.ispor.org/docs/default-source/euro2022/isporxoflu- zadef-pdfhttps://www.ispor.org/docs/default-source/euro2022/isporxoflu-zadef-pdf.
SKRZECZEK A，IKEOKA H，HIROTSU N，et al. Cost-effectiveness of baloxavir marboxil compared to lanina- mivir for the treatment of influenza in Japan[J]. J Infect Chemother，2021，27（2）：296-305.
DRONOVA M，IKEOKA H，ITSUMURA N，et al. Cost-effectiveness of baloxavir marboxil compared with laninamivir for the treatment of influenza in patients at high risk for complications in Japan[J]. Curr Med Res Opin，2021，37（7）：1135-1148.
成人流行性感冒抗病毒治疗共识专家组. 成人流行性感冒抗病毒治疗专家共识[J]. 中华传染病杂志，2022，40（11）：641-655.
Expert Group on Consensus for Antiviral Treatment of Influenza in Adults. Expert consensus on antiviral treatment of influenza in adults[J]. Chin J Infect Dis，2022，40（11）：641-655.
UYEKI T M，BERNSTEIN H H，BRADLEY J S，et al. Clinical practice guidelines by the Infectious Diseases Society of America：2018 update on diagnosis，treatment，chemoprophylaxis，and institutional outbreak management of seasonal influenza A[J]. Clin Infect Dis，2019，68（6）：895-902.
Committee on Infectious Diseases. Recommendations for prevention and control of influenza in children，2021-2022[J]. Pediatrics，2021，148（4）：e2021053745.
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