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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
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| 篇名： | 玛巴洛沙韦治疗流行性感冒的快速卫生技术评估 |
| TITLE： | Rapid health technology assessment of baloxavir marboxil in the treatment of influenza |
| 摘要： | 目的 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。方法检索PubMed、Embase、WebofScience、CochraneLibrary、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24h和48h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24h和48h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 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 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 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 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. |
| 期刊： | 2023年第34卷第19期 |
| 作者： | 吴越；陈启庭；陈芳昭；卓超林；刘微；李学娟；陈泽彬 |
| AUTHORS： | WU Yue，CHEN Qiting，CHEN Fangzhao，ZHUO Chaolin，LIU Wei，LI Xuejuan，CHEN Zebin |
| 关键字： | 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： | baloxavir marboxil； influenza； rapid health technology assessment； effectiveness； safety； economy |
| 阅读数： | 208 次 |
| 本月下载数： | 12 次 |
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