To study the bioequivalence of Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets, a randomized cross over study was conducted in 18 healthy volunteers. A single oral dose of 1000 mg Clav ulanate Pot...To study the bioequivalence of Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets, a randomized cross over study was conducted in 18 healthy volunteers. A single oral dose of 1000 mg Clav ulanate Potassium and Amoxicillin (1:7) dispersible tablets (Tested formulation, T) or Augmentin syrup (Reference formulation, R). Concentrations in plasma were determined with high performance liquid chromatography. The main paramaters of T were: for Clavulanate Potassium and Amoxicillin, C max : 2.46±1.11 μg/m l and 18.81±7.26 μg/ml, T max : 1.12±0.23h and 1.30±0.34h, AUC (0 - 6 h) : 5.18±2.24 μg·h/ml and 45.09±14.53 μg·h/ml, t 1/2 : 1.43±0.44 h and 1.09±0.22 h., respectively. The relative bioavailability of T to R were 9 6.5±19.2 % and 98.4±26.1 % , respectively. Statistical analysis showed that th e two formulations were bioequivalent.展开更多
目的:探究阿莫西林克拉维酸钾和布地奈德雾化吸入联合治疗小儿喘息性肺炎的效果及对患儿肺功能、血清高迁移率族蛋白B1(Serum high mobility group protein B1,HM GB1)、降钙素原(Procalcitonin,PCT)的影响。方法:选取2021年1月至2023年...目的:探究阿莫西林克拉维酸钾和布地奈德雾化吸入联合治疗小儿喘息性肺炎的效果及对患儿肺功能、血清高迁移率族蛋白B1(Serum high mobility group protein B1,HM GB1)、降钙素原(Procalcitonin,PCT)的影响。方法:选取2021年1月至2023年5月我院收治的66例小儿喘息性肺炎患者作为研究对象,采用随机信封法分为雾化组和联用组,各33例。雾化组吸入雾化的布地奈德治疗,联用组在雾化组的基础上加用阿莫西林克拉维酸钾治疗。治疗10 d后,比较两组疗效、症状缓解时间、住院时间、炎症指标(HMGB1、PCT)、肺功能指标[潮气量与体重之比(Ratio of tidal volume to body weight,VT/kg)、呼气流量峰值时间与总呼气时间之比(Ratio of time to peak tidal expiratory flow to total expiratory time,TPTEF/TE)、呼气流量峰值与总呼气流量之比(Ratio of volume to peak expiratory flow to total expiratory volume,VPEF/VE)]和不良反应情况。结果:治疗10 d后,联用组总有效率明显高于雾化组(P<0.05);联用组患儿气促缓解时间、咳嗽消失时间、啰音消失时间以及住院时长均短于雾化组(P<0.05);两组患儿治疗后的血清HMGB1与PCT水平均较前降低,且联用组均低于雾化组(P<0.05);两组患儿治疗后的VT/kg、TPTEF/TE、VPEF/VE水平均较前升高,且联用组均高于雾化组(P<0.05);两组不良反应发生率无明显差异(P>0.05)。结论:阿莫西林克拉维酸钾和布地奈德雾化吸入联合治疗小儿喘息性肺炎效果显著,能缩短症状缓解时间和住院时间,改善炎症因子水平和肺功能,且不会加重不良反应,安全性高。展开更多
文摘To study the bioequivalence of Clavulanate Potassium and Amoxicillin (1:7) dispersible tablets, a randomized cross over study was conducted in 18 healthy volunteers. A single oral dose of 1000 mg Clav ulanate Potassium and Amoxicillin (1:7) dispersible tablets (Tested formulation, T) or Augmentin syrup (Reference formulation, R). Concentrations in plasma were determined with high performance liquid chromatography. The main paramaters of T were: for Clavulanate Potassium and Amoxicillin, C max : 2.46±1.11 μg/m l and 18.81±7.26 μg/ml, T max : 1.12±0.23h and 1.30±0.34h, AUC (0 - 6 h) : 5.18±2.24 μg·h/ml and 45.09±14.53 μg·h/ml, t 1/2 : 1.43±0.44 h and 1.09±0.22 h., respectively. The relative bioavailability of T to R were 9 6.5±19.2 % and 98.4±26.1 % , respectively. Statistical analysis showed that th e two formulations were bioequivalent.
文摘目的:探究阿莫西林克拉维酸钾和布地奈德雾化吸入联合治疗小儿喘息性肺炎的效果及对患儿肺功能、血清高迁移率族蛋白B1(Serum high mobility group protein B1,HM GB1)、降钙素原(Procalcitonin,PCT)的影响。方法:选取2021年1月至2023年5月我院收治的66例小儿喘息性肺炎患者作为研究对象,采用随机信封法分为雾化组和联用组,各33例。雾化组吸入雾化的布地奈德治疗,联用组在雾化组的基础上加用阿莫西林克拉维酸钾治疗。治疗10 d后,比较两组疗效、症状缓解时间、住院时间、炎症指标(HMGB1、PCT)、肺功能指标[潮气量与体重之比(Ratio of tidal volume to body weight,VT/kg)、呼气流量峰值时间与总呼气时间之比(Ratio of time to peak tidal expiratory flow to total expiratory time,TPTEF/TE)、呼气流量峰值与总呼气流量之比(Ratio of volume to peak expiratory flow to total expiratory volume,VPEF/VE)]和不良反应情况。结果:治疗10 d后,联用组总有效率明显高于雾化组(P<0.05);联用组患儿气促缓解时间、咳嗽消失时间、啰音消失时间以及住院时长均短于雾化组(P<0.05);两组患儿治疗后的血清HMGB1与PCT水平均较前降低,且联用组均低于雾化组(P<0.05);两组患儿治疗后的VT/kg、TPTEF/TE、VPEF/VE水平均较前升高,且联用组均高于雾化组(P<0.05);两组不良反应发生率无明显差异(P>0.05)。结论:阿莫西林克拉维酸钾和布地奈德雾化吸入联合治疗小儿喘息性肺炎效果显著,能缩短症状缓解时间和住院时间,改善炎症因子水平和肺功能,且不会加重不良反应,安全性高。