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外科手术中应用注射用血凝酶安全性多中心大样本回顾性调查 被引量:30

Safety of hemocoagulase atrox for injection in patients undergoing surgery:a multicenter,large sample retrospective study
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摘要 目的回顾性研究注射用血凝酶用于外科手术预防和治疗出血的安全性。方法收集2008年1月至2010年9月全国203家医院手术过程中使用注射用血凝酶预防和治疗出血的16 053例病例资料,统计过敏反应、深静脉血栓形成及其他不良事件的发生率,分析用药前后凝血检查数据。结果全部病例共发生不良事件39例,发生率为0.243%,其中不良反应28例,发生率为0.174%。不良事件以轻度为主(29/39),无深静脉血栓和重度不良事件报告。手术和药物的应用对凝血4项指标有轻度影响,且和手术部位有关。结论外科手术使用注射用血凝酶预防和治疗出血,不良反应发生率低、程度轻,无深静脉血栓发生,对凝血功能影响不大。临床使用注射用血凝酶预防和治疗外科手术出血比较安全。 AIM To investigate the bioequivalence of two compound chlorzoxazone tablets in healthy volunteers.METHODS Single oral doses of two compound chlorzoxazone tablets(chlorzoxazone 250 mg and paracetamol 300 mg) were given to 20 healthy male volunteers in an open,randomized and crossover study. The plasma concentrations of chlorzoxazone and paracetamol were determined by HPLC-MS method with glipizide and acetophenetidin employed as the internal standard,and the pharmacokinetic parameters were calculated with BAPP2.2.RESULTS The major pharmacokinetic parameters of test and reference tablets in the singledose study were as follows;for paracetamol,ρ_(max) were(5.1±1.5) vs.(5.2±1.7) mg·L^(-1);t_(max) were(0.6±0.4) vs.(0.6±0.4) h;t_(1/2)were(3.0±0.4) vs.(3.0±0.5) h;AUC_(0-12)were(16.4±4.7) vs.(17.0±5.5) mg·h·L^(-1);AUC_(0-∞) were(17.6±5.1) vs.(18.2±6.0) mg·h·L^(-1),respectively.In the case of chlorzoxazone,ρ_(max) were(7.0±1.3) vs.(7.0±1.3) mgΛL^(-1);t_(max)were(0.9±0.6) vs.(1.0±0.5) h;t_(1/2) were(0.9±0.1) vs. (0.9±0.1) h,AUC_(0-∞)were(16.6±3.5) vs.(17.0±4.1) mg·h·L^(-1),AUC_90-∞) were(16.7±3.5) vs.(17.0±4.1) mg ? h ? L^(-1),respectively.There were no significant differences in pharmacokinetic parameters between two compound chlorzoxazone tablets(P0.05).The relative bioavalibility of paracetamol and chlorzoxazone in compound chlorzoxazone tablets were(99.3±14.3)%and(99.5±14.8)%,respectively.CONCLUSION The test tablet is bioequivalent to the reference tablet for chlorzoxazone and paracetamol in healthy volunteers.
出处 《中国新药与临床杂志》 CAS CSCD 北大核心 2011年第12期942-946,共5页 Chinese Journal of New Drugs and Clinical Remedies
关键词 外科手术 注射用血凝酶 止血 血栓形成 药物不良反应 chlorzoxazone paracetamol bioequivalence chromatography high pressure liquid tandem mass spectrometry pharmacokinetics
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