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作 者:林航羽 徐玥 陈奕杰 王丽 刘梅青 李维镇 梁月琴 LIN Hangyu;XU Yue;CHEN Yijie;WANG Li;LIU Meiqing;LI Weizhen;LIANG Yueqin(Yan′an Hospital of Kunming City,Kunming,Yunnan,China 650000)
出 处:《中国药业》2023年第18期118-124,共7页China Pharmaceuticals
基 金:云南省昆明市卫生科技人才培养项目[2022-SW(后备)-77];云南省昆明市卫生健康委员会卫生科研课题项目[2022-13-01-011]。
摘 要:目的为临床围术期晶体液的选择提供循证依据。方法参照《药品临床综合评价管理指南(2021年版试行)》等相关指南,围绕药品的安全性、有效性、经济性、创新性、适宜性和可及性6个维度,采用德尔菲法,以问卷调查形式邀请医院13位专家构建完整临床综合评价指标体系;通过查阅相关药品说明书、国内外文献及相关官方网站,采用Meta分析、系统评价、成本-效果分析等方法,多维度收集、整合及分析评价证据,由专家对各项指标进行评分。结果共发放调查问卷13份,回收12份,均有效(有效回收率为92.31%)。评价体系最终纳入一级指标6个,二级指标18个,评分细则65条。评分由高到低依次为钠钾镁钙葡萄糖注射液(72.69分)、醋酸钠林格注射液(72.53分)、乳酸钠林格注射液(71.22分)。结论3种晶体液用于围术期补液临床效果相当。钠钾镁钙葡萄糖注射液成分齐全,安全性、有效性均较好,价格适中;醋酸钠林格注射液适宜人群广、安全性好,但价格高,并已退出医保;乳酸钠林格注射液适用范围窄,安全性、有效性均较低。Objective To provide a evidence-based basis for the selection of perioperative crystalloid solution in clinical practice.Methods According to relevant guidelines such as the Guidelines for the Management of Comprehensive Clinical Evaluation of Pharmaceutical Products(trial,2021 Version),13 experts in hospital were invited to construct a complete clinical comprehensive evaluation indicator system around six dimensions of drug safety,effectiveness,economy,innovation,suitability and accessibility by the Delphi method and questionnaire survey.Based on the drug instructions,domestic and foreign studies and relevant official websites,the evaluation evidence was collected,integrated and analyzed from multiple dimensions by the Meta-analysis,systematic review and cost-effectiveness analysis,and the experts were invited to score each indicator.Results A total of 13 survey questionnaires were distributed and 12 were effective,with an effective recovery rate of 92.31%.A total of six primary indicators,18 secondary indicators and 65 scoring rules were included in the evaluation system.Sodium Potassium Magnesium Calcium and Glucose Injection scored the highest(72.69 points),followed by Sodium Acetate Ringer's Injection(72.53 points),Sodium Lactate Ringer's Injection(71.22 points).Conclusion The clinical effects of three crystalloid solution for perioperative fluid supplement are similar.Sodium Potassium Magnesium Calcium and Glucose Injection is safe,effective,mid-priced,and has complete components.Sodium Acetate Ringer's Injection is safe and suitable for a wide range of people,but it is expensive and has quit medical insurance.Sodium Lactate Ringer's Injection has a narrow range of application due to low safety and effectiveness.
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