目的:探讨小剂量艾司氯胺酮对腹腔镜胆囊切除术(LC)患者全麻苏醒期躁动(EA)及炎症反应的影响。方法:选取110例行LC的患者为研究对象,按麻醉诱导前干预方式不同分为对照组与艾司氯胺酮组,每组各55例。艾司氯胺酮组患者麻醉诱导前给予小剂...目的:探讨小剂量艾司氯胺酮对腹腔镜胆囊切除术(LC)患者全麻苏醒期躁动(EA)及炎症反应的影响。方法:选取110例行LC的患者为研究对象,按麻醉诱导前干预方式不同分为对照组与艾司氯胺酮组,每组各55例。艾司氯胺酮组患者麻醉诱导前给予小剂量(0.25 mg/kg)艾司氯胺酮注射干预;对照组患者给予与艾司氯胺酮等量的生理盐水注射干预。比较两组患者EA发生情况;术中麻醉药物用量;镇静(苏醒期Ramsay镇静评分)及疼痛[视觉模拟评分(VAS)]情况;入室时(T0)、术毕(T1)、拔管即刻(T2)及拔管后15 min(T3)血清白细胞介素6(IL-6)和IL-8水平;术后住院时间及不良反应发生情况。结果:艾司氯胺酮组患者EA发生率低于对照组(P<0.05),且躁动程度低于对照组(P<0.05);术中瑞芬太尼用量少于对照组(P<0.05);苏醒期Ramsay评分高于对照组(P<0.05);拔管后10 min VAS评分低于对照组(P<0.05);在T1、T2和T3时血清IL-6及IL-8水平低于对照组(P<0.05);术后住院时间短于对照组(P<0.05)。两组患者术后不良反应率无统计学差异(P>0.05)。结论:小剂量艾司氯胺酮能有效预防LC患者EA的发生,原因可能与减轻术后疼痛和抑制炎症反应有关。展开更多
Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their rights.Methods The literature related to the participants’right t...Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their rights.Methods The literature related to the participants’right to compensation at home and abroad was searched to study the inadequacy of the compensation right for clinical trial participants in China from four aspects:insurance system,principle of attribution,legal relationship and compensation regulations.Then,some suggestions to improve the participants’right to compensation were proposed.Results and Conclusion China lacks clear legal norms for participants’right to compensation.There are problems such as unclear insurance rules and compensation rules,unclear contractual relationships between parties to clinical trials,and no laws and regulations to rely on for attribution and compensation.China should issue regulatory guidelines related to the right to compensation of participants in clinical trials,so that all parties in clinical trials can have rules to follow if there is the occurrence of injury,which can better protect the rights and interests of the participants.展开更多
文摘目的:探讨小剂量艾司氯胺酮对腹腔镜胆囊切除术(LC)患者全麻苏醒期躁动(EA)及炎症反应的影响。方法:选取110例行LC的患者为研究对象,按麻醉诱导前干预方式不同分为对照组与艾司氯胺酮组,每组各55例。艾司氯胺酮组患者麻醉诱导前给予小剂量(0.25 mg/kg)艾司氯胺酮注射干预;对照组患者给予与艾司氯胺酮等量的生理盐水注射干预。比较两组患者EA发生情况;术中麻醉药物用量;镇静(苏醒期Ramsay镇静评分)及疼痛[视觉模拟评分(VAS)]情况;入室时(T0)、术毕(T1)、拔管即刻(T2)及拔管后15 min(T3)血清白细胞介素6(IL-6)和IL-8水平;术后住院时间及不良反应发生情况。结果:艾司氯胺酮组患者EA发生率低于对照组(P<0.05),且躁动程度低于对照组(P<0.05);术中瑞芬太尼用量少于对照组(P<0.05);苏醒期Ramsay评分高于对照组(P<0.05);拔管后10 min VAS评分低于对照组(P<0.05);在T1、T2和T3时血清IL-6及IL-8水平低于对照组(P<0.05);术后住院时间短于对照组(P<0.05)。两组患者术后不良反应率无统计学差异(P>0.05)。结论:小剂量艾司氯胺酮能有效预防LC患者EA的发生,原因可能与减轻术后疼痛和抑制炎症反应有关。
基金Liaoning Pharmaceutical Industry Innovation and Development Strategy Research and Funding Project(2020lslktyb-095)National Medical Products Administration-Special Fund of Drug Regulatory Research Institute of Shenyang Pharmaceutical University(2021jgkx004)+1 种基金Shenzhen Maternity&Child Healthcare Hospital Science Foundation(2022(73))Shenzhen Health Economics Society Research Fund Project(202333).
文摘Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their rights.Methods The literature related to the participants’right to compensation at home and abroad was searched to study the inadequacy of the compensation right for clinical trial participants in China from four aspects:insurance system,principle of attribution,legal relationship and compensation regulations.Then,some suggestions to improve the participants’right to compensation were proposed.Results and Conclusion China lacks clear legal norms for participants’right to compensation.There are problems such as unclear insurance rules and compensation rules,unclear contractual relationships between parties to clinical trials,and no laws and regulations to rely on for attribution and compensation.China should issue regulatory guidelines related to the right to compensation of participants in clinical trials,so that all parties in clinical trials can have rules to follow if there is the occurrence of injury,which can better protect the rights and interests of the participants.