| 胡义亭,赵娜,白万军,邱博,吴茵,宋浩静,张建,董占军.基于医疗机构的治疗慢性乙型肝炎的核苷(酸)类似物的卫生技术评估[J].中国药事,2023,(9):1033-1046 |
| 基于医疗机构的治疗慢性乙型肝炎的核苷(酸)类似物的卫生技术评估 |
| Health Technology Assessment of Nucleos(t)ide Analogues for the Treatment of Chronic Hepatitis B Based on Medical Institutions |
| 投稿时间：2023-02-01 |
| DOI：10.16153/j.1002-7777.2023.09.008 |
| 中文关键词: 医院卫生技术评估 核苷(酸)类似物 药品安全性 药品有效性 |
| 英文关键词: hospital-based health technology assessment nucleos(t)ide analogues safety eff ectiveness |
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| 摘要点击次数: 428 |
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| 中文摘要: |
| 目的：按照《中国医疗机构药品评价与遴选快速指南》中的量化评分细则，为当前医院决策层药物遴选、规范使用核苷（酸）类似物提供循证依据。方法：依照药品量化评分体系，参考最新版临床应用指南、国内外文献和现行药品说明书，从安全性、有效性、经济性、药学特性及其他属性5个方面分别对河北省人民医院口服核苷（酸）类似物进行医院卫生技术评估。结果：富马酸丙酚替诺福韦片、 富马酸替诺福韦二吡夫酯片、恩替卡韦分散片、恩替卡韦片、阿德福韦酯片及替比夫定片最终分值分别为80.5、86.1、90.5、82、59.8、72.7分。富马酸丙酚替诺福韦、富马酸替诺福韦酯、恩替卡韦为强效低耐药核苷类似物，为诊疗规范及指南首选推荐，阿德福韦不推荐应用；富马酸丙酚替诺福韦不良反应发生率最低；富马酸替诺福韦酯、替比夫定阻断母婴传播有优势，均为国家医保乙类药物；富马酸丙酚替诺福韦片、恩替卡韦片、替比夫定片为原研品种；富马酸替诺福韦二吡夫酯片、恩替卡韦分散片、阿德福韦酯片均通过一致性评价；恩替卡韦分散片经济性最优。结论：卫生技术评估可指导医院合理遴选及使用核苷（酸）类似物，并提供循证依据。临床医师可根据专科特点、患者的病情及自身需求合理选择用药。 |
| 英文摘要: |
| Objective: According to the quantitative scoring rules in th Rapid Guide for Drug Evaluation and Selection of Medical Institutions in China, to provide evidence-based basis for hospital decision makers to drug selection and standardized use of nucleos(t)ide analogues in clinical rationality. Methods: According to the drug quantitative scoring system and refer to the latest version of clinical application guidelines, domestic and foreign literature and current drug instruction, the hospital tase health technology assessment of oral nucleos(t) ide analogues in Hebei General Hospital was carried out from five aspects: safety, effiectiveness, economy, pharmaceutical properties, other attributes. Results: The fi nal scores of tenofovir alafenamide fumarate tablets, tenofovir disoproxil fumarate tablets, entecavir dispersible tablets, entecavirt ablets, adefovir dipivoxil tablets and telbivudine tablets were 80.5 points, 86.1 points, 90.5 points,82 points, 59.8 points and 72.7 points, respectively. Tenofovir alafenamide fumarate, tenofovir disoproxil fumarate and entecavir were highly potent nucleos(t)ide analogues with low drug resistance, and they were recommended as the fi rst choice for diagnosis and treatment standards and guidelines. Adefovir was not recommended for use. The incidence of adverse reactions to tenofovir alafenamide fumarate was the lowest. Tenofovir disoproxil fumarate and telbivudine had advantages in blocking mother-to-child transmission. They all were class B drugs of national medical insurance. Tenofovir alafenamide fumarate tablets, entecavir tablets and telbivudine tablets were the original varieties. Tenofovir disoproxil fumarate, entecavir dispersible tablets and adefovirdipivoxil tablets all passed the consistency evaluation. The economy of entecavir dispersible tablets was the best. Conclusion: The health technology assessment can guide the rational selection and use of nucleos(t)ide analogues, and provide evidence-based basis for hospital. Clinicians can reasonably choose the drugs based on the specialty characteristics, the patient's conditions and own needs. |
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