中华结核和呼吸杂志
中華結覈和呼吸雜誌
중화결핵화호흡잡지
Chinese Journal of Tuberculosis and Respiratory Diseases
2010年
7期
519-523
,共5页
殷凯生%张德平%施毅%孙丽华%闵锐%肖永龙%夏锡荣%谭焰%傅完珍
慇凱生%張德平%施毅%孫麗華%閔銳%肖永龍%夏錫榮%譚燄%傅完珍
은개생%장덕평%시의%손려화%민예%초영룡%하석영%담염%부완진
肺疾病,慢性阻塞性%多中心研究%噻托溴铵
肺疾病,慢性阻塞性%多中心研究%噻託溴銨
폐질병,만성조새성%다중심연구%새탁추안
Pulmonary disease,chronic obstructive%Multicenter studies%Tiotropium
目的 评价国产噻托溴铵粉雾剂治疗COPD的临床疗效和安全性.方法 采用多中心、随机、双盲、安慰剂平行对照的研究方法,对205例筛选合格的I、Ⅱ级COPD稳定期患者,采用随机数字表法给予国产噻托溴铵粉雾剂18μg,每日1次,或用安慰剂治疗12周.在筛选期、用药后6和12周分别测定肺功能.结果 103例入选噻托溴铵组,用药后12周临床症状的控制率为25.2%(26/103),有效率为65.1%(67/103);102例入选对照组,用药后12周临床控制率为5.1%(5/99),有效率为30.3%(30/99).噻托溴铵组用药后12周FEV1增加值和增加率[(0.2±0.3)L和(19.2±29.1)%]明显高于对照组[(0.0±0.2)L和(0.8±18.2)%],FVC增加值和增加率(0.2 L和11.6%)明显高于对照组(0.0 L和2.2%).噻托溴铵组不良反应主要为口干和咽喉不适等,发生率(7.8%,8/103)略低于对照组(12.8%,13/102),差异无统计学意义(X2=1.381,P>0.05).结论 国产噻托溴铵粉雾剂可显著改善COPD患者的临床症状和肺功能,临床应用有效、安全.
目的 評價國產噻託溴銨粉霧劑治療COPD的臨床療效和安全性.方法 採用多中心、隨機、雙盲、安慰劑平行對照的研究方法,對205例篩選閤格的I、Ⅱ級COPD穩定期患者,採用隨機數字錶法給予國產噻託溴銨粉霧劑18μg,每日1次,或用安慰劑治療12週.在篩選期、用藥後6和12週分彆測定肺功能.結果 103例入選噻託溴銨組,用藥後12週臨床癥狀的控製率為25.2%(26/103),有效率為65.1%(67/103);102例入選對照組,用藥後12週臨床控製率為5.1%(5/99),有效率為30.3%(30/99).噻託溴銨組用藥後12週FEV1增加值和增加率[(0.2±0.3)L和(19.2±29.1)%]明顯高于對照組[(0.0±0.2)L和(0.8±18.2)%],FVC增加值和增加率(0.2 L和11.6%)明顯高于對照組(0.0 L和2.2%).噻託溴銨組不良反應主要為口榦和嚥喉不適等,髮生率(7.8%,8/103)略低于對照組(12.8%,13/102),差異無統計學意義(X2=1.381,P>0.05).結論 國產噻託溴銨粉霧劑可顯著改善COPD患者的臨床癥狀和肺功能,臨床應用有效、安全.
목적 평개국산새탁추안분무제치료COPD적림상료효화안전성.방법 채용다중심、수궤、쌍맹、안위제평행대조적연구방법,대205례사선합격적I、Ⅱ급COPD은정기환자,채용수궤수자표법급여국산새탁추안분무제18μg,매일1차,혹용안위제치료12주.재사선기、용약후6화12주분별측정폐공능.결과 103례입선새탁추안조,용약후12주림상증상적공제솔위25.2%(26/103),유효솔위65.1%(67/103);102례입선대조조,용약후12주림상공제솔위5.1%(5/99),유효솔위30.3%(30/99).새탁추안조용약후12주FEV1증가치화증가솔[(0.2±0.3)L화(19.2±29.1)%]명현고우대조조[(0.0±0.2)L화(0.8±18.2)%],FVC증가치화증가솔(0.2 L화11.6%)명현고우대조조(0.0 L화2.2%).새탁추안조불량반응주요위구간화인후불괄등,발생솔(7.8%,8/103)략저우대조조(12.8%,13/102),차이무통계학의의(X2=1.381,P>0.05).결론 국산새탁추안분무제가현저개선COPD환자적림상증상화폐공능,림상응용유효、안전.
Objective To compare the efficacy and safety between tiotropium capsule and placebo in a 12-week treatment in patients with chronic obstructive pulmonary disease (COPD). Methods A multi-center, randomized, double-blind, and placebo-control clinical trial was conducted in 205 patients with stable COPD. They were randomized into inhaled tiotropium 18 μg once daily or placebo, lasting for 12 weeks. The spiromentry was conducted at baseline, 6 and 12 weeks after treatment. Results A total of 205 patients with stable stage Ⅰ or Ⅱ COPD were randomized to tiotropium and placebo groups. The improvement rate of clinical symptom in the tiotropium group was 25. 2% (26/103 ) after a 12 week treatment, but that of the control group was 4. 9% (5/102). The forced expiratory volume in one second (FEV1 ) and forced vital capacity (FVC) in the tiotropium group increased (0. 2 ± 0. 3) L and (19. 2 ± 29. 1)% after the 12 week therapy, but only (0. 0 ±0. 2) L and (0. 8 ± 18. 2) % in the placebo group. The rate of adverse reaction in the tiotropium group was 7. 8% (8/103), but in the placebo group was 12. 8% (13/102). The difference between the 2 groups was not significant All adverse reactions were mild, including dry mouth and sore throat Conclusions This trial confirmed that tiotropium powder 18 μg once daily relieved dyspnea, prevented aggravation and improved pulmonary function, clinical symptoms and life quality. Tiotropium was a safe and effective once-daily anticholinergic bronchodilator as first-line maintenance therapy in COPD.
