背景在成人哮喘研究中,沙美特罗/丙酸氟替卡松(FSC)联合用药已被证实较单用丙酸氟替卡松(FP)疗效更好且安全性相当,但在儿童哮喘人群中仍缺乏可靠的临床研究证据。目的对FSC组和单用FP组在哮喘患儿升阶梯治疗中的文献行系统评价/Meta分...背景在成人哮喘研究中,沙美特罗/丙酸氟替卡松(FSC)联合用药已被证实较单用丙酸氟替卡松(FP)疗效更好且安全性相当,但在儿童哮喘人群中仍缺乏可靠的临床研究证据。目的对FSC组和单用FP组在哮喘患儿升阶梯治疗中的文献行系统评价/Meta分析,探讨两组用药的有效性及安全性。设计系统评价/Meta分析。方法检索时间为数据库建库至2023年9月,在Cochrane、MEDLINE(通过PubMed)、Embase、Web of Science、中国生物医学文献数据库、中国知网数据库和万方数据库中检索以FSC和单用FP治疗哮喘患儿的RCT。2名研究者独立进行文献筛选、数据提取、偏倚风险评估和证据质量总结,通过R Studio1.4.1717进行数据分析。主要结局指标哮喘恶化、与吸入性糖皮质激素(ICS)和FSC相关的不良事件。结果共纳入11篇RCT中的9438例哮喘患儿。Meta分析结果显示,FSC组较FP组在治疗前后用力呼出50%肺活量时的瞬间流量(MEF50)MD=0.17(95%CI:0.16~0.18,P<0.0001)、晨间呼气峰流速(PEF)MD=4.84(95%CI:4.53~5.15,P<0.0001)、治疗前后无哮喘症状天数%MD=1.39(95%CI:1.36~1.41,P<0.05)、无沙丁胺醇使用天数%MD=1.09(95%CI:1.06~1.12,P<0.05)的改善情况差异均有统计学意义。在减少哮喘恶化发生RR=0.87(95%CI:0.70~1.09,P=0.22)、减少与ICS和FSC相关的不良事件RR=0.99(95%CI:0.61~1.60,P=0.95)和其他不良事件RR=0.98(95%CI:0.91~1.05,P=0.55)的发生率差异均无统计学意义。结论在儿童哮喘升阶梯治疗中,FSC组与FP组在减少哮喘恶化的发生率差异无统计学意义,两组用药安全性相当,没有因沙美特罗的添加而带来额外的药物相关不良事件,也没有增加其他不良事件;但FSC更能改善肺功能(MEF50、晨间PEF)和哮喘症状,并能减少治疗中沙丁胺醇的使用。展开更多
Background Evidence suggests that systemic inflammation may play an important role in the progression and morbidity of chronic obstructive pulmonary disease. It remains controversial whether inhaled corticosteroid in ...Background Evidence suggests that systemic inflammation may play an important role in the progression and morbidity of chronic obstructive pulmonary disease. It remains controversial whether inhaled corticosteroid in combination with a long-acting 132-adrenoceptor agonist can attenuate systemic inflammation. We evaluated the effect of salmeterol/fluticasone propionate on circulating C-reactive protein level in stable chronic obstructive pulmonary disease patients. Methods An open-label clinical trial was conducted to recruit 122 outpatients with stable moderate-to-severe chronic obstructive pulmonary disease from department of respiratory medicine in two teaching hospitals between June 2007 and March 2008. Patients were randomized into two groups (1:1) to receive either the combination of 50 μg salmeterol and 500 μg fluticasone twice daily (n=61), or the combination of 206 μg albuterol and 36 pg ipratropium q.i.d (n=61) over 6 months. Circulating C-reactive protein concentrations were measured before randomization and during the follow-up. The efficacy of treatment was also assessed by spirometry, as well as health status and dyspnea score at baseline and after 6-month treatment. Results Baseline characteristics of two groups were similar. Compared with ipratropium/albuterol, the combination of salmeterol/fluticasone significantly reduced circulating level of C-reactive protein (-1.73 vs. 0.08 mg/L, respectively, P 〈0.05) after 6-month treatment. Forced expiratory volume in one second (FEV1) and health status also improved significantly in salmeterol/fluticasone group compared with ipratropium/albuterol. Salmeterol/fluticasone treatment subjects who had a decrease of circulating C-reactive protein level had a significant improvement in FEV1 and St George's Respiratory Questionnaire total scores compared with those who did not (185 vs. 83 ml and -5.71 vs. -1.79 units, respectively, both P 〈0.01). Conclusion Salmeterol/fluticasone treatment reduced circulating C-reactive protein concentration in clinically stable moderate-to-severe chronic obstructive pulmonary disease patients after 6-month treatment.展开更多
文摘背景在成人哮喘研究中,沙美特罗/丙酸氟替卡松(FSC)联合用药已被证实较单用丙酸氟替卡松(FP)疗效更好且安全性相当,但在儿童哮喘人群中仍缺乏可靠的临床研究证据。目的对FSC组和单用FP组在哮喘患儿升阶梯治疗中的文献行系统评价/Meta分析,探讨两组用药的有效性及安全性。设计系统评价/Meta分析。方法检索时间为数据库建库至2023年9月,在Cochrane、MEDLINE(通过PubMed)、Embase、Web of Science、中国生物医学文献数据库、中国知网数据库和万方数据库中检索以FSC和单用FP治疗哮喘患儿的RCT。2名研究者独立进行文献筛选、数据提取、偏倚风险评估和证据质量总结,通过R Studio1.4.1717进行数据分析。主要结局指标哮喘恶化、与吸入性糖皮质激素(ICS)和FSC相关的不良事件。结果共纳入11篇RCT中的9438例哮喘患儿。Meta分析结果显示,FSC组较FP组在治疗前后用力呼出50%肺活量时的瞬间流量(MEF50)MD=0.17(95%CI:0.16~0.18,P<0.0001)、晨间呼气峰流速(PEF)MD=4.84(95%CI:4.53~5.15,P<0.0001)、治疗前后无哮喘症状天数%MD=1.39(95%CI:1.36~1.41,P<0.05)、无沙丁胺醇使用天数%MD=1.09(95%CI:1.06~1.12,P<0.05)的改善情况差异均有统计学意义。在减少哮喘恶化发生RR=0.87(95%CI:0.70~1.09,P=0.22)、减少与ICS和FSC相关的不良事件RR=0.99(95%CI:0.61~1.60,P=0.95)和其他不良事件RR=0.98(95%CI:0.91~1.05,P=0.55)的发生率差异均无统计学意义。结论在儿童哮喘升阶梯治疗中,FSC组与FP组在减少哮喘恶化的发生率差异无统计学意义,两组用药安全性相当,没有因沙美特罗的添加而带来额外的药物相关不良事件,也没有增加其他不良事件;但FSC更能改善肺功能(MEF50、晨间PEF)和哮喘症状,并能减少治疗中沙丁胺醇的使用。
文摘Background Evidence suggests that systemic inflammation may play an important role in the progression and morbidity of chronic obstructive pulmonary disease. It remains controversial whether inhaled corticosteroid in combination with a long-acting 132-adrenoceptor agonist can attenuate systemic inflammation. We evaluated the effect of salmeterol/fluticasone propionate on circulating C-reactive protein level in stable chronic obstructive pulmonary disease patients. Methods An open-label clinical trial was conducted to recruit 122 outpatients with stable moderate-to-severe chronic obstructive pulmonary disease from department of respiratory medicine in two teaching hospitals between June 2007 and March 2008. Patients were randomized into two groups (1:1) to receive either the combination of 50 μg salmeterol and 500 μg fluticasone twice daily (n=61), or the combination of 206 μg albuterol and 36 pg ipratropium q.i.d (n=61) over 6 months. Circulating C-reactive protein concentrations were measured before randomization and during the follow-up. The efficacy of treatment was also assessed by spirometry, as well as health status and dyspnea score at baseline and after 6-month treatment. Results Baseline characteristics of two groups were similar. Compared with ipratropium/albuterol, the combination of salmeterol/fluticasone significantly reduced circulating level of C-reactive protein (-1.73 vs. 0.08 mg/L, respectively, P 〈0.05) after 6-month treatment. Forced expiratory volume in one second (FEV1) and health status also improved significantly in salmeterol/fluticasone group compared with ipratropium/albuterol. Salmeterol/fluticasone treatment subjects who had a decrease of circulating C-reactive protein level had a significant improvement in FEV1 and St George's Respiratory Questionnaire total scores compared with those who did not (185 vs. 83 ml and -5.71 vs. -1.79 units, respectively, both P 〈0.01). Conclusion Salmeterol/fluticasone treatment reduced circulating C-reactive protein concentration in clinically stable moderate-to-severe chronic obstructive pulmonary disease patients after 6-month treatment.