经Respimat吸入器给予不同剂量噻托溴铵干粉吸入剂在慢性阻塞性肺疾病维持治疗中的疗效及安全性研究
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摘要
目的探讨经Respimat吸入器给予不同剂量噻托溴铵干粉吸入剂在慢性阻塞性肺疾病维持治疗中的疗效及安全性。方法选取240例慢性阻塞性肺疾病患者作为研究对象,所有患者均经Respimat吸入器给予噻托溴铵干粉吸入剂连续治疗1年,随机将其分成高剂量组(5μg/d,n=120)和低剂量组(2.5μg/d,n=120),比较两组患者的临床疗效、血氧饱和度、血气分析、肺功能及呼吸肌功能指标水平、不良反应及死亡率。结果:两组患者治疗总有效率数据比较,差异无统计学意义(P>0.05);两组患者治疗前后血氧饱和度、血气分析、肺功能及呼吸肌功能指标水平数据比较差异均有统计学意义(P<0.05);低剂量组患者口干和胃肠道反应的发生率显著低于高剂量组,数据比较差异均有统计学意义(P<0.05);两组患者死亡率数据比较差异无统计学意义(P>0.05)。结论经Respimat吸入器给予低剂量的噻托溴铵干粉吸入剂可以用于慢性阻塞性肺疾病维持治疗,且不良反应低,值得临床进一步大数据分析。
Objective To investigate the efficacy and safety of different doses of tiotropium bromide dry powder by Respimat inhaler in the maintenance treatment of chronic obstructive pulmonary disease. Methods 240 patients with chronic obstructive pulmonary disease(COPD) were selected as subjects. All patients were treated with tiotropium bromide dry powderby Respimat inhaler for one year. They were randomly divided into the high dose group(5μg/d) and the low dose group(2.5μg/d). Their clinical efficacy, blood oxygen saturation, pulmonary function and respiratory muscle function were compared between the two groups. Results There was no significant difference in the total effective rate between the two groups(P>0.05). There were significant differences in pulmonary function and respiratory muscle function before and after treatment between the two groups(P<0.05), and the incidence of dry mouth and gastrointestinal tract reaction in the low dose group was significantly lower than that in the high dose group. There was no significant difference in mortality between the two groups(P>0.05). Conclusion Low dose tiotropium bromide dry powder by Respimat inhaler can be used in maintenance treatment of chronic obstructive pulmonary disease, and the adverse reaction is low, which is worthy of further clinical analysis.
Objective To investigate the efficacy and safety of different doses of tiotropium bromide dry powder by Respimat inhaler in the maintenance treatment of chronic obstructive pulmonary disease. Methods 240 patients with chronic obstructive pulmonary disease(COPD) were selected as subjects. All patients were treated with tiotropium bromide dry powderby Respimat inhaler for one year. They were randomly divided into the high dose group(5μg/d) and the low dose group(2.5μg/d). Their clinical efficacy, blood oxygen saturation, pulmonary function and respiratory muscle function were compared between the two groups. Results There was no significant difference in the total effective rate between the two groups(P>0.05). There were significant differences in pulmonary function and respiratory muscle function before and after treatment between the two groups(P<0.05), and the incidence of dry mouth and gastrointestinal tract reaction in the low dose group was significantly lower than that in the high dose group. There was no significant difference in mortality between the two groups(P>0.05). Conclusion Low dose tiotropium bromide dry powder by Respimat inhaler can be used in maintenance treatment of chronic obstructive pulmonary disease, and the adverse reaction is low, which is worthy of further clinical analysis.
引文
[1] 蔡华丹,侯均,吕永宁,等.噻托溴铵喷雾剂治疗慢性阻塞性肺疾病的有效性与安全性荟萃分析[J].中华结核和呼吸杂志, 2017, 40(8):596-603.
[2] 项艳,徐俊燕,孙亮.噻托溴铵粉吸入剂联合心理干预治疗慢性阻塞性肺疾病稳定期的效果观察[J].中国生化药物杂志, 2017,37(7):310-312.
[3] VOGELMEIER C,HEDERER B,GLAAB T,et al.Tiotropium versus salmeterol for the prevention of exacerbations of COPD[J].N Engl J Med,2011,364(12):1093-1103.
[4] ICHINOSE M,FUJIMOTO T,FUKUCHI Y.Tiotropium 5microg via Respimat and 18microg via HandiHaler;efficacy and safety in Japanese COPD patients[J]. Respir Med,2010,104(2):228-236.
[5] 姜锋,郑洪飞,柳雅军,等.噻托溴铵粉吸入剂联合茶碱缓释片治疗稳定期慢性阻塞性肺疾病的临床研究[J].中国临床药理学杂志,2017,33(22):2233-2235,2238.
[6] AALBERS R,MALEKI-YAZDI M R,HAMILTON A,et al.Dose-finding study for tiotropium and olodaterol when administered in combination via the Respimat inhaler in patients with COPD[J].Eur Respir J,2012,40(S56):2882-2885.
[7] WISE R A,ANZUETO A,COTTON D,et al.Tiotropium Respimat inhaler and the risk of death in COPD[J].N Engl J Med,2013,369(16):1491-1501.
[8] 王培颖,田增莲,王培慧.吸入噻托嗅铵对慢性阻塞性肺疾病合并肺动脉高压患者的治疗作用[J].中华全科医师杂志,2012,11(11):833-835.
[9] MATHIOUDAKIS A G,CHATZIMAVRIDOU-GRIGORIADOU V,EVANGELOPOULOU E,et al.Comparative mortality risk of tiotropium administered via handihaler or respimat in COPD patients:are they equivalent[J].Pulm Pharmacol Ther,2014,28(2):91-97.
[10] 马锦芳,周志敏,汤彦,等.经Respimat(R)吸入小剂量噻托溴铵溶液治疗慢性阻塞性肺疾病的有效性与安全性[J].中华内科杂志, 2014,53(12):964-968.
[11] HALPIN D M,DAHL R,HALLMANN C,et al.Tiotropium HandiHaler and Respimat in COPD:a pooled safety analysis[J].Int J Chron Obstruct Pulmon Dis,2015,10(S2):239-259.
[12] RICK H,DEMETRI P,ANGELA L,et al.Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat Soft Mist Inhaler in COPD[J].Int J Chron Obstruct Pulmon Dis,2011,6:245-251.
[13] MASAKAZU I,HIROYUKI T,AYAKO T,et al.The efficacy and safety of combined tiotropium and olodaterol via the Respimat inhaler in patients with COPD:results from the Japanese sub-population of the Tonado studies[J].Int J Chron Obstruct Pulmon Dis,2016,11(1):2017-2027.
[14] CICILIANI A M,LANGGUTH P,WACHTEL H.In vitro dose comparison of Respimat inhaler with dry powder inhalers for COPD maintenance therapy[J].Int J Chron Obstruct Pulmon Dis,2017,12(S1):1565-1577.
[2] 项艳,徐俊燕,孙亮.噻托溴铵粉吸入剂联合心理干预治疗慢性阻塞性肺疾病稳定期的效果观察[J].中国生化药物杂志, 2017,37(7):310-312.
[3] VOGELMEIER C,HEDERER B,GLAAB T,et al.Tiotropium versus salmeterol for the prevention of exacerbations of COPD[J].N Engl J Med,2011,364(12):1093-1103.
[4] ICHINOSE M,FUJIMOTO T,FUKUCHI Y.Tiotropium 5microg via Respimat and 18microg via HandiHaler;efficacy and safety in Japanese COPD patients[J]. Respir Med,2010,104(2):228-236.
[5] 姜锋,郑洪飞,柳雅军,等.噻托溴铵粉吸入剂联合茶碱缓释片治疗稳定期慢性阻塞性肺疾病的临床研究[J].中国临床药理学杂志,2017,33(22):2233-2235,2238.
[6] AALBERS R,MALEKI-YAZDI M R,HAMILTON A,et al.Dose-finding study for tiotropium and olodaterol when administered in combination via the Respimat inhaler in patients with COPD[J].Eur Respir J,2012,40(S56):2882-2885.
[7] WISE R A,ANZUETO A,COTTON D,et al.Tiotropium Respimat inhaler and the risk of death in COPD[J].N Engl J Med,2013,369(16):1491-1501.
[8] 王培颖,田增莲,王培慧.吸入噻托嗅铵对慢性阻塞性肺疾病合并肺动脉高压患者的治疗作用[J].中华全科医师杂志,2012,11(11):833-835.
[9] MATHIOUDAKIS A G,CHATZIMAVRIDOU-GRIGORIADOU V,EVANGELOPOULOU E,et al.Comparative mortality risk of tiotropium administered via handihaler or respimat in COPD patients:are they equivalent[J].Pulm Pharmacol Ther,2014,28(2):91-97.
[10] 马锦芳,周志敏,汤彦,等.经Respimat(R)吸入小剂量噻托溴铵溶液治疗慢性阻塞性肺疾病的有效性与安全性[J].中华内科杂志, 2014,53(12):964-968.
[11] HALPIN D M,DAHL R,HALLMANN C,et al.Tiotropium HandiHaler and Respimat in COPD:a pooled safety analysis[J].Int J Chron Obstruct Pulmon Dis,2015,10(S2):239-259.
[12] RICK H,DEMETRI P,ANGELA L,et al.Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat Soft Mist Inhaler in COPD[J].Int J Chron Obstruct Pulmon Dis,2011,6:245-251.
[13] MASAKAZU I,HIROYUKI T,AYAKO T,et al.The efficacy and safety of combined tiotropium and olodaterol via the Respimat inhaler in patients with COPD:results from the Japanese sub-population of the Tonado studies[J].Int J Chron Obstruct Pulmon Dis,2016,11(1):2017-2027.
[14] CICILIANI A M,LANGGUTH P,WACHTEL H.In vitro dose comparison of Respimat inhaler with dry powder inhalers for COPD maintenance therapy[J].Int J Chron Obstruct Pulmon Dis,2017,12(S1):1565-1577.