Ipratropium bromide （IB） is an effective treatment for reversible bronchospasm associated with COPD. Cipla Ltd. hasdeveloped a formulation of lpratropium bromide pMDI （Test IB） which is designed to be equivalent t...Ipratropium bromide （IB） is an effective treatment for reversible bronchospasm associated with COPD. Cipla Ltd. hasdeveloped a formulation of lpratropium bromide pMDI （Test IB） which is designed to be equivalent to the originator product Atrovent HFA pMDI （Reference IB） as a cost effective alternative for the treatment of COPD. The objective of the study was to establishnon-inferiority of the Test 1B to Reference 1B in patients with stable COPD. In this multicenter, randomized, double-blind, doubledummy, parallel group study, patients aged 〉 40 years were randomized to receive 2 puffs three times daily （TID） of either the Test IBor Reference IB for 12 weeks. The primary endpoint was the change from pre dose to post dose FEVj at 90 min at the end of 12 weeks.Secondary endpoints included FVC, symptom score, rescue medication use and St. George＇s Respiratory Questionnaire （SGRQ）.Safety and tolerability included evaluation of adverse events （AEs）, vital signs assessments, physical examination and any change inconcomitant medications. A total of 395 patients were randomized to either the Test IB （n = 199） or the Reference IB （n = 196）; themajority of patients were male with a mean pre-bronchodilator FEV1 （% predicted） of 60%. The per protocol set comprised of 258patients （n = 129 in each treatment group）. The mean treatment difference between the Test IB and Reference 1B for the primaryendpoint （mean change in FEV1 from pre-dose to 90 rain post dose at 12 weeks） was -0.003 L and the lower limit of the 95% confidenceinterval （CI） for the difference between the two products was -0.041 Lwhich is greater than the predefined non inferiority limit of-0.100 L. No significant difference was seen between the Test IB and Reference IB for any secondary efficacy variables. The AEprofile was also comparable between the two treatments. The results indicate that the Test 1B （Ipratropium Bromide HFA pMD1, CiplaLtd.） is non inferior to the Reference lB.展开更多
目的探讨重组α干扰素-2b和异丙托溴铵雾化吸入在小儿毛细支气管炎治疗中的临床效果。方法选取2020年4月至2022年8月湖州市中心医院诊治的112例毛细支气管炎患儿,根据信封法将其分为对照组和观察组,每组各56例。对照组患儿给予异丙托溴...目的探讨重组α干扰素-2b和异丙托溴铵雾化吸入在小儿毛细支气管炎治疗中的临床效果。方法选取2020年4月至2022年8月湖州市中心医院诊治的112例毛细支气管炎患儿,根据信封法将其分为对照组和观察组,每组各56例。对照组患儿给予异丙托溴铵雾化吸入,观察组患儿给予重组α干扰素-2b雾化吸入,两组患儿均连续治疗7d。比较两组患儿的肺功能、γ干扰素(interferon-γ,IFN-γ)、白细胞介素-10(interleukin-10,IL-10)、免疫功能及不良反应。结果干预7d后,观察组患儿的喘息、咳嗽、肺部湿啰音及痰鸣音消失时间均显著短于对照组(P<0.05);两组患儿的潮气量(tidal volume,TV)、潮气呼气峰流量(peak tidal expiratory flow,PTEF)及达峰时间比(ratio of time to peak tidal expiratory flow to total expiratory time,TPTEF/TE)、IFN-γ及IL-10均显著高于本组干预前(P<0.05),观察组患儿的TV、PTEF、TPTEF/TE、IFN-γ及IL-10水平均显著高于对照组(P<0.05);两组患儿的CD3^(+)、CD4^(+)及CD4^(+)/CD8^(+)均显著高于本组干预前,CD8^(+)显著低于本组干预前(P<0.05);观察组患儿的CD3^(+)、CD4^(+)及CD4^(+)/CD8^(+)均显著高于对照组,CD8^(+)显著低于对照组(P<0.05);两组患儿的不良反应发生率比较差异无统计学意义(χ^(2)=0.704,P=0.401)。结论毛细支气管炎患儿采用重组α干扰素-2b和异丙托溴铵雾化吸入均可获得良好的治疗效果,但前者有助于缩短症状消失时间,提高患儿免疫水平,值得临床推广应用。展开更多
文摘Ipratropium bromide （IB） is an effective treatment for reversible bronchospasm associated with COPD. Cipla Ltd. hasdeveloped a formulation of lpratropium bromide pMDI （Test IB） which is designed to be equivalent to the originator product Atrovent HFA pMDI （Reference IB） as a cost effective alternative for the treatment of COPD. The objective of the study was to establishnon-inferiority of the Test 1B to Reference 1B in patients with stable COPD. In this multicenter, randomized, double-blind, doubledummy, parallel group study, patients aged 〉 40 years were randomized to receive 2 puffs three times daily （TID） of either the Test IBor Reference IB for 12 weeks. The primary endpoint was the change from pre dose to post dose FEVj at 90 min at the end of 12 weeks.Secondary endpoints included FVC, symptom score, rescue medication use and St. George＇s Respiratory Questionnaire （SGRQ）.Safety and tolerability included evaluation of adverse events （AEs）, vital signs assessments, physical examination and any change inconcomitant medications. A total of 395 patients were randomized to either the Test IB （n = 199） or the Reference IB （n = 196）; themajority of patients were male with a mean pre-bronchodilator FEV1 （% predicted） of 60%. The per protocol set comprised of 258patients （n = 129 in each treatment group）. The mean treatment difference between the Test IB and Reference 1B for the primaryendpoint （mean change in FEV1 from pre-dose to 90 rain post dose at 12 weeks） was -0.003 L and the lower limit of the 95% confidenceinterval （CI） for the difference between the two products was -0.041 Lwhich is greater than the predefined non inferiority limit of-0.100 L. No significant difference was seen between the Test IB and Reference IB for any secondary efficacy variables. The AEprofile was also comparable between the two treatments. The results indicate that the Test 1B （Ipratropium Bromide HFA pMD1, CiplaLtd.） is non inferior to the Reference lB.
文摘目的探讨重组α干扰素-2b和异丙托溴铵雾化吸入在小儿毛细支气管炎治疗中的临床效果。方法选取2020年4月至2022年8月湖州市中心医院诊治的112例毛细支气管炎患儿,根据信封法将其分为对照组和观察组,每组各56例。对照组患儿给予异丙托溴铵雾化吸入,观察组患儿给予重组α干扰素-2b雾化吸入,两组患儿均连续治疗7d。比较两组患儿的肺功能、γ干扰素(interferon-γ,IFN-γ)、白细胞介素-10(interleukin-10,IL-10)、免疫功能及不良反应。结果干预7d后,观察组患儿的喘息、咳嗽、肺部湿啰音及痰鸣音消失时间均显著短于对照组(P<0.05);两组患儿的潮气量(tidal volume,TV)、潮气呼气峰流量(peak tidal expiratory flow,PTEF)及达峰时间比(ratio of time to peak tidal expiratory flow to total expiratory time,TPTEF/TE)、IFN-γ及IL-10均显著高于本组干预前(P<0.05),观察组患儿的TV、PTEF、TPTEF/TE、IFN-γ及IL-10水平均显著高于对照组(P<0.05);两组患儿的CD3^(+)、CD4^(+)及CD4^(+)/CD8^(+)均显著高于本组干预前,CD8^(+)显著低于本组干预前(P<0.05);观察组患儿的CD3^(+)、CD4^(+)及CD4^(+)/CD8^(+)均显著高于对照组,CD8^(+)显著低于对照组(P<0.05);两组患儿的不良反应发生率比较差异无统计学意义(χ^(2)=0.704,P=0.401)。结论毛细支气管炎患儿采用重组α干扰素-2b和异丙托溴铵雾化吸入均可获得良好的治疗效果,但前者有助于缩短症状消失时间,提高患儿免疫水平,值得临床推广应用。
