Ⅰ期药物临床试验中静脉输液常见问题及对策

Common Problems and Countermeasures of Intravenous Infusion in PhaseⅠClinical Trials

目的为Ⅰ期药物临床试验中精准静脉输液提供对策。方法以注射用右旋兰索拉唑20 mg剂量的361次静脉输液为例,对Ⅰ期药物临床试验静脉输液中常见问题进行分析与总结。结果除1例受试者因在首次静脉输液时输液量偏差较大而退出试验外,其余360次输液量均在规定误差范围(-3.32%~5.57%)内;静脉输液中的常见问题包括药液外渗、输液泵故障、受试者晕针,对策为定期培训相关人员,精准配制药液,输液/采血时选择合适静脉,加强输液泵维护,做好对受试者的宣传教育和知情同意,增强医护人员的责任心。结论严格遵守临床试验方案和药物临床试验质量管理规范的规定,可确保Ⅰ期药物临床试验中的个体化精准静脉输液。

Objective To provide countermeasures of accurate and scientific intravenous infusion in phaseⅠclinical trials.Methods Taking 361 times of intravenous infusions in the 20 mg dose group of dexlansoprazole for injection as an example,the common problems of intravenous infusion in phaseⅠclinical trials were analyzed and summarized.Results Except for one subject who withdrew from the clinical trial due to a large deviation of infusion volume during the first intravenous infusion,the other 360 infusion volumes were all within the specified error range(-3.32%-5.57%).The common problems in intravenous infusion included liquid extravasation,failure of the infusion pump,and the subjects’needlesickness.The countermeasures were to regularly train relevant personnel,accurately dispense pharmaceutical liquids,select the appropriate vein during infusion/blood collection,strengthen infusion pump maintenance,do a good job of prmoting education and informed consent to the subjects,and enhance the sense of responsibility of medical staff.Conclusion Strict adherence to the protocol of clinical trials and GCP regulations can ensure individualized and accurate intravenous infusions in phaseⅠclinical trials.