我国部分地区国家基本药物基础大输液包装形式适宜性研究

Research of Suitable Package of Basic Infusions Product of Essential Drugs in Some Regions of China

目的比较国家基本药物基础大输液各种包装材料和包装形式在我国不同自然环境、不同地域及不同经济条件的各级医疗机构临床使用适宜特性。方法以问卷调查的形式调查全国7省市、35家医疗机构的护士、药师、医师对国家基本药物基本大输液包装的各项评价指标的满意程度。评价通过安全与质量、使用便捷性两个维度,19项指标(安全与质量指标:抗冲击力、耐低温、耐高温、稳定性、异物率、密封程度、胶塞脱屑率、输液反应、空气栓塞风险、残液量;便捷性指标:透明度、加药、悬挂、标记、输液、存放、重量、生物安全柜、加压输液),每项指标采取11级评分制并由14名相关领域专家论证确认并赋予权重。并针对患者进行价格接受程度调研。最后召开专家论证会推荐最适宜的基础大输液包装。结果收回有效问卷539份。尽管玻璃瓶的澄明度和耐高温项评分较高,但其余各项得分均低于其他输液包装;软袋加药便捷性、密封程度等指标得分较低。各种输液包装的综合评分结果:直立式软袋>单阀软袋=塑料瓶>双阀软袋>玻璃瓶患者对玻璃瓶价格接受程度最高,99.3%完全接受,63.6%的被调查患者对各种输液价格都可以接受。大部分专家推荐直立式软袋推荐为最适宜的基础大输液包装。结论直立式软袋可能是未来输液包装的发展方向之一,但目前市场供应厂商有限;塑料瓶可获得性高,综合评分较高,价格较为适宜,成为目前输液包装的主流;非PVC软袋虽具有较多优势,使用量呈上升趋势,但操作便捷性有待改善,尤其双管易发生漏液等问题;玻璃瓶作为基础大输液包装临床选择倾向性减弱。未来应该建立以临床为中心的包材设计理念,既要考虑药物安全性,也应关注临床应用的便捷性。

OBJECTIVE To compare the security, convenience and price of the package of basic infusions in different regions, different economic conditions and different natural environment in medical institutions at all levels in our country. METHODS A questionnaire survey was carried among medical personnel of 35 medical institutions in seven provinces and cities on evaluation of satis- faction on safety, quality and convenience of various package of basic infusions, questionnaires are respectively for nurses, pharma- cists, and physicians with two dimensions of ＂safety and quality＂ and ＂convenience＂ and 19 questions（ ＂safety and quality＂ with im- pact resistance, low temperature resistance, high temperature resistance, stability, foreign body, sealing, rubber plug desquamation rate, transfusion reaction, air embolism risk,and infusion residue, ＂convenience＂ with transparency, admixture, hanging, marking, transfusion, placing, weight, operation in biosafety cabinet and pressure transfusion）rated by 11 grades weighted by 14 experts in dif- ferent relevant fields, the acceptance of patients about the prices of infusions of different packages were also surveyed by question- naires ; Finally, the results were confirmed by 11 experts. RESULTS Altogether 539 effective questionaire were received. Except for transparency and high temperature resistance, the scores of glass bottles were lower than other packages, the scores of sealing and con- venience of admixture were low. The total scores of various infusion packages were vertical pouch 〉 single tube soft bag = plastic bottles 〉 double-barreled soft bag 〉 glass bottles, most experts would recommend vertical pouch as the most appropriate basic infusion pack- age. The price of infusion of bottle glass were most accepted by patients, although 63.6% patients pronounced that they could accept the prices of infusion of all packages. Most experts would recommend vertical pouch as the most appropriate package of basic infusion of essential drugs. CONCLUSION Vertical pouch could be respected as one of future directions of development of basic infusion pack- age, but there are limited market suppliers, plastic bottles have highest availability, good comprehensive score and more suitable price, so become the mainstream of the current infusion packaging. Non-PVC soft bags need to improve ease of operation （ in particular doub- le-barreled soft bag） and solve the problems such as leakage and large residual liquid volume. Tendency of glass bottles as package of basic infusions has greatly weakened.