粉-液双室袋产品的综合评价
投稿时间:2023-12-05  修订日期:2024-03-21  点此下载全文
引用本文:舒飞,孙蕊,宋凯,张元林,闫家铭,舒丽芯.粉-液双室袋产品的综合评价[J].药学实践杂志,2025,43(2):92~96
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作者单位E-mail
舒飞 海军军医大学药学系军队药材保障论证中心, 上海 200433  
孙蕊 海军军医大学药学系军队药材保障论证中心, 上海 200433
武警甘肃省总队医院, 甘肃 兰州 730050 
 
宋凯 海军军医大学药学系军队药材保障论证中心, 上海 200433
中国人民解放军32106部队, 内蒙古 锡盟 026000 
 
张元林 海军军医大学药学系军队药材保障论证中心, 上海 200433
中国人民解放军77570部队, 西藏 昌都 854000 
 
闫家铭 海军军医大学药学系军队药材保障论证中心, 上海 200433  
舒丽芯 海军军医大学药学系军队药材保障论证中心, 上海 200433 lucy_shu@sina.com 
中文摘要:目的 以传统粉针剂为对照,对粉-液双室袋产品进行综合评估。方法 采用系统综述法,收集粉-液双室袋文献资料,提取常用评价指标,评估粉-液双室袋产品的使用价值,与传统粉针剂产品进行综合比较。结果 共纳入文献23篇,评估使用的有效性指标为药液稳定性、配制浓度准确性、药液残留量;安全性指标为不溶性微粒、刺伤划伤发生率;经济性指标为配制成本、废弃物重量、住院成本、血液感染发生率;适用性指标为配制时间、平均医护人员人力占用、包装重量和储运体积、环境适应性、废弃物处理难易程度;可及性指标为生产厂家数量、原料供应能力、患者可承担性。通过文献证据对其评估,表明粉-液双室袋稳定性、浓度准确性高于传统粉针剂,并已实现国产供应。双室袋法配制药液可减少输液反应,能缩短药液配制时间。结论 相比于传统粉针产品,粉-液双室袋在有效性、安全性、经济性、适宜性、创新性维度均具备优势,可及性维度符合要求。
中文关键词:粉-液双室袋  综合评估  注射液
 
Comprehensive evaluation of powder-liquid double-chamber bag products: a systematic review
Abstract:Objective To evaluate the advantages of powder-liquid double-chamber bag products compared with traditional powder injection. Methods The systematic review method was used to collect the literature on powder-liquid double-chamber bag, extract common evaluation indicators, evaluate the use value of powder-liquid double-chamber bag products, and conduct a comprehensive comparison with traditional powder injection products. Results A total of 23 articles were included in the literature. The effectiveness indicators used for evaluation were the stability of the liquid medicine, the accuracy of the preparation concentration, and the residual amount of the liquid medicine; the safety indicators were the incidence of insoluble particles and the incidence of punctures and scratches. The economic indicators were preparation cost, occupied volume of preparation supplies, waste weight, hospitalization cost and incidence of blood infection. The applicability indicators were preparation time, average occupation of medical staff, packaging weight and storage and transportation volume, environmental adaptability, and ease of waste disposal. Accessibility indicators are the number of manufacturers, raw material supply capacity, and patient affordability. Through the evaluation of literature evidence, it was found that the stability and concentration accuracy of the powder-liquid double-chamber bag were higher than those of the traditional powder injection, and the domestic supply had been achieved. The double-chamber bag method can reduce the infusion reaction and shorten the preparation time of the liquid medicine.Conclusion Compared with traditional powder injectabler products, powder-liquid double-chamber bags have advantages in the dimensions of effectiveness, safety, economy, suitability and innovation, and the accessibility dimension meets the requirements.
keywords:powder-liquid double chamber bag  comprehensive evaluation  injection
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