医院卫生技术评估在大环内酯类抗菌药物遴选评价中的应用

Application of Hospital-based Health Technology Assessment in the Assessment and Selection of Macrolides

关键词:  医院卫生技术评估  医疗机构药品遴选  大环内酯类药物  药品安全性  药品有效性

Key words:  hospital-based health technology assessment  drug selection in medical institutions  macrolides  drug safety  drug effectiveness

摘要:

目的 贯彻落实河北省卫生健康委《河北省公立医疗机构用药目录遴选评价管理指南》的要求，为医院决策者遴选、临床合理使用大环内酯类抗菌药物提供循证依据。方法 依照百分制评分体系，参考药品说明书、临床指南和文献，从安全性、有效性、经济性、创新性、适宜性和可及性等6个方面分别对河北省人民医院口服大环内酯类抗菌药物进行医院卫生技术评估。结果 红霉素肠溶胶囊、阿奇霉素干混悬剂、阿奇霉素片和克拉霉素片最终分值分别为71，78，83和68.5分。阿奇霉素被多个指南和专家共识推荐，在治疗社区获得性肺炎和支原体肺炎方面有一定的优势。阿奇霉素干混悬剂和阿奇霉素片均为原研品种，经济优势小，但在全球范围广泛使用，安全性较高。红霉素肠溶胶囊在衣原体感染方面有优势，价格较低，但该药为国产品种且未通过一致性评价，临床应用较少。克拉霉素片对单纯性阻塞性肺疾病和慢性鼻窦炎效果好，克拉霉素是抗幽门螺杆菌的四联方案中的药物之一，为国产品种，已通过一致性评价，但克拉霉素安全性较其他大环内酯类药物差，临床应用不广。此外，多种肝药酶诱导剂或抑制剂均可与大环内酯类药物产生相互作用，医务人员应用过程中应注意药物相互作用的影响。结论 本次卫生技术评估可为医院遴选及合理使用大环内酯类抗菌药物提供循证依据。临床医师可结合患者自身条件及需求合理选择使用药品，与其他药物合用时需关注药物相互作用，防止不良事件的发生。

Abstract:

OBJECTIVE To implement the requirements of Hebei Provincial Health Commission “Guidelines for the Selection, Evaluation and Management of Drug Catalogue in Public Medical Institutions in Hebei Province”, and provide evidence-based evidence for hospital decision makers to select and use Macrolide antimicrobials in clinical rationality.METHODS According to the 100-point scoring system and referring to the drug instructions, clinical guidelines and literature, the hospital health technology of oral macrolides antibacterial drugs in Hebei General Hospital was evaluated from six aspects, including safety, efficacy, economy, innovation, suitability and accessibility.RESULTS The final scores of erythromycin enteric-coated capsules, azithromycin suspension, azithromycin tablets and clarithromycin tablets were 71, 78, 83 and 68.5, respectively.Azithromycin was recommended by multiple guidelines and expert consensus, and has certain advantages in the treatment of community-acquired pneumonia and mycoplasma pneumonia.Both azithromycin suspension and azithromycin tablets were original varieties with small economic advantages, but they are widely used worldwide and have high safety.Erythromycin enteric-coated capsules had advantages in terms of chlamydia infection, and the price was relatively low.However, the drug was a domestic product and has not passed the consistency evaluation, and has less clinical application.Clarithromycin tablets had a good effect on simple obstructive pulmonary disease and chronic sinusitis.In addition, clarithromycin has a place in the quadruple regimen against Helicobacter pylori.This variety was a domestic variety and has passed the consistency evaluation.But the safety of clarithromycin was no better than other macrolide drugs, and its clinical application was limited.In addition, a variety of hepatic microsomal enzyme inducers or inhibitors could interact with macrolide drugs, and medical staff should pay attention to the impact of drug interactions during application.CONCLUSION The health technology assessment provides an evidence-based basis for hospital selection and rational use of macrolides.Clinicians can reasonably choose the drugs based on the patient’s conditions and needs.Attention should be paid to drug interactions to prevent adverse events when combined with other drugs.