Combined administration of fluticasone propionate and salmeterol xinofoate has been widely used for the treatment of asthma in recent decades. In this investigation, we developed and validated a novel and sensitive ul...Combined administration of fluticasone propionate and salmeterol xinofoate has been widely used for the treatment of asthma in recent decades. In this investigation, we developed and validated a novel and sensitive ultra performance liquid chromatography-tandem mass spectrometry （UPLC-MS/MS） method for simultaneous determination of fluticasone propionate and salmeterol xinofoate in human plasma. Following a simple SPE sample extraction in 96-well plate format, chromatography was performed on a Waters ACQUITY UPLC BEH C 18 column （1.7 μm, 50 min×2.1 mm） with mobile phase consisting of 100% MeOH and 0.1% NH4OH in water on a gradient program at flow rate of 0.5 mL/min. Detection of analytes and internal standards was accomplished using multiple reaction monitoring （MRM） of precursor〉product ion pairs of m/z 501.4〉313.2 （fluticasone propionate）, 506.4〉293.3 （fluticasone propionate-d5）, 416.4〉232.1 （salmeterol xinofoate） and 419.3〉235.2 （salmeterol-d3）. The assay range was 2.50-500 pg/mL for both analytes, and a 1/x2 weighted linear regression model was used. The inter-assay accuracy and precision of the method were within ±8.6%. The recoveries from 0.30 mL of plasma were greater than 51.0% and 54.6% for fluticasone propionate and salmeterol, respectively, and the results were consistent across low, middle and high concentration levels. The method was validated following FDA, EMA and CFDA （China Food and Drug Administration）＇s guidance on bioanalysis and then successfully applied to support a clinical study in healthy Chinese subjects following inhaled administration of a single combination of fluticasone propionate/salmeterol （250 μg/50 μg）.展开更多
目的:观察麻黄附子细辛汤联合沙美特罗替卡松粉吸入剂治疗老年慢性支气管哮喘的临床疗效。方法:将98例老年慢性支气管哮喘患者按照随机数字表法分为对照组47例和治疗组51例。对照组给予沙美特罗替卡松粉吸入剂经口吸入,治疗组在对照组...目的:观察麻黄附子细辛汤联合沙美特罗替卡松粉吸入剂治疗老年慢性支气管哮喘的临床疗效。方法:将98例老年慢性支气管哮喘患者按照随机数字表法分为对照组47例和治疗组51例。对照组给予沙美特罗替卡松粉吸入剂经口吸入,治疗组在对照组治疗的基础上联合麻黄附子细辛汤。比较两组患者的临床疗效、不良反应发生率及治疗前后中医证候积分、哮喘控制测试(asthma control test,ACT)评分、肺功能[用力呼气流量峰值(forced expiratory peak,PEF)、用力肺活量(forced vital capacity,FVC)、一秒用力呼气容积(forced expiratory volume in one second,FEV_(1))]、细胞因子水平[白细胞介素-4(interleukin-4,IL-4)、干扰素-γ(interferon-γ,IFN-γ)、转化生长因子-β1(transforming growth factor-β1,TGF-β1)]变化情况。结果:对照组有效率为87.23%,治疗组有效率为98.04%,两组患者有效率比较,差异具有统计学意义(P<0.05)。两组治疗后中医证候积分低于本组治疗前,ACT评分高于本组治疗前,且治疗后组间比较,差异具有统计学意义(P<0.05)。两组治疗后PEF、FVC及FEV_(1)高于本组治疗前,且治疗后治疗组高于对对照组,差异具有统计学意义(P<0.05)。两组患者治疗后IFN-γ高于本组治疗前,IL-4及TGF-β1低于本组治疗前,且治疗后组间比较,差异具有统计学意义(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:麻黄附子细辛汤联合沙美特罗替卡松粉吸入剂治疗老年慢性支气管哮喘,可明显改善患者的临床症状及肺功能,有效拮抗炎性细胞因子及转化生长因子表达,减轻呼吸道炎症反应,阻止气道重塑发生。展开更多
文摘Combined administration of fluticasone propionate and salmeterol xinofoate has been widely used for the treatment of asthma in recent decades. In this investigation, we developed and validated a novel and sensitive ultra performance liquid chromatography-tandem mass spectrometry （UPLC-MS/MS） method for simultaneous determination of fluticasone propionate and salmeterol xinofoate in human plasma. Following a simple SPE sample extraction in 96-well plate format, chromatography was performed on a Waters ACQUITY UPLC BEH C 18 column （1.7 μm, 50 min×2.1 mm） with mobile phase consisting of 100% MeOH and 0.1% NH4OH in water on a gradient program at flow rate of 0.5 mL/min. Detection of analytes and internal standards was accomplished using multiple reaction monitoring （MRM） of precursor〉product ion pairs of m/z 501.4〉313.2 （fluticasone propionate）, 506.4〉293.3 （fluticasone propionate-d5）, 416.4〉232.1 （salmeterol xinofoate） and 419.3〉235.2 （salmeterol-d3）. The assay range was 2.50-500 pg/mL for both analytes, and a 1/x2 weighted linear regression model was used. The inter-assay accuracy and precision of the method were within ±8.6%. The recoveries from 0.30 mL of plasma were greater than 51.0% and 54.6% for fluticasone propionate and salmeterol, respectively, and the results were consistent across low, middle and high concentration levels. The method was validated following FDA, EMA and CFDA （China Food and Drug Administration）＇s guidance on bioanalysis and then successfully applied to support a clinical study in healthy Chinese subjects following inhaled administration of a single combination of fluticasone propionate/salmeterol （250 μg/50 μg）.
文摘目的:观察麻黄附子细辛汤联合沙美特罗替卡松粉吸入剂治疗老年慢性支气管哮喘的临床疗效。方法:将98例老年慢性支气管哮喘患者按照随机数字表法分为对照组47例和治疗组51例。对照组给予沙美特罗替卡松粉吸入剂经口吸入,治疗组在对照组治疗的基础上联合麻黄附子细辛汤。比较两组患者的临床疗效、不良反应发生率及治疗前后中医证候积分、哮喘控制测试(asthma control test,ACT)评分、肺功能[用力呼气流量峰值(forced expiratory peak,PEF)、用力肺活量(forced vital capacity,FVC)、一秒用力呼气容积(forced expiratory volume in one second,FEV_(1))]、细胞因子水平[白细胞介素-4(interleukin-4,IL-4)、干扰素-γ(interferon-γ,IFN-γ)、转化生长因子-β1(transforming growth factor-β1,TGF-β1)]变化情况。结果:对照组有效率为87.23%,治疗组有效率为98.04%,两组患者有效率比较,差异具有统计学意义(P<0.05)。两组治疗后中医证候积分低于本组治疗前,ACT评分高于本组治疗前,且治疗后组间比较,差异具有统计学意义(P<0.05)。两组治疗后PEF、FVC及FEV_(1)高于本组治疗前,且治疗后治疗组高于对对照组,差异具有统计学意义(P<0.05)。两组患者治疗后IFN-γ高于本组治疗前,IL-4及TGF-β1低于本组治疗前,且治疗后组间比较,差异具有统计学意义(P<0.05)。两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:麻黄附子细辛汤联合沙美特罗替卡松粉吸入剂治疗老年慢性支气管哮喘,可明显改善患者的临床症状及肺功能,有效拮抗炎性细胞因子及转化生长因子表达,减轻呼吸道炎症反应,阻止气道重塑发生。
