• 四川大學(xué)華西醫(yī)院,國(guó)家藥品臨床研究基地,中藥,成都,610041;

目的 　評(píng)價(jià)痰熱清注射液對(duì)慢性阻塞性肺疾病(COPD)急性加重期患者的臨床療效、安全性及其對(duì)血漿細(xì)胞因子白介素-17(IL-17)、白介素-8(IL-8)及白三烯B4表達(dá)的影響.
方法 　按中華醫(yī)學(xué)會(huì)呼吸病學(xué)會(huì)2002年 lt;慢性阻塞性肺疾病診治指南 gt;和國(guó)家中醫(yī)藥管理局1994年發(fā)布的 lt;中醫(yī)病證診斷療效標(biāo)準(zhǔn) gt;,將60例COPD急性加重期患者隨機(jī)分為治療組和對(duì)照組,每組各30例,進(jìn)行隨機(jī)對(duì)照臨床試驗(yàn).中醫(yī)痰熱阻肺癥診斷標(biāo)準(zhǔn)為:咳嗽氣粗,痰多質(zhì)粘厚或稠黃,咳吐不爽,或有身熱,口干欲飲,舌紅苔黃,脈滑數(shù).治療組在基礎(chǔ)治療的基礎(chǔ)上,用痰熱清注射液20ml+5%糖水250 ml,iv gtt,q 24 h治療;對(duì)照組在基礎(chǔ)治療的基礎(chǔ)上,給予生理鹽水20 ml+5%糖水250 ml,iv gtt,q 24 h治療,兩組療程均為12 d.
結(jié)果 　ITT和PP分析,治療組總有效率分別為96.67%和96.55%,總顯效率分別為70.00%和72.41%;對(duì)照組總有效率分別為86.67%和89.65%,總顯效率分別為46.67%和48.28%,兩組間療效比效有統(tǒng)計(jì)學(xué)意義(P＜0.05),且治療后治療組血漿細(xì)胞因子IL-17、IL-8水平明顯低于對(duì)照組(P＜0.05).
結(jié)論 　痰熱清注射液治療COPD急性加重期患者的臨床療效明顯優(yōu)于對(duì)照組,且未發(fā)現(xiàn)明顯毒副作用.其作用機(jī)理可能與痰熱清注射液能有效降低COPD急性加重期患者血漿IL-17和IL-8的水平有關(guān).

引用本文： 張穎,李廷謙,王剛,常靜,毛兵,王蕾,遲煥海,萬(wàn)美華. 痰熱清注射液治療慢性阻塞性肺疾病急性加重期(痰熱阻肺證)的隨機(jī)對(duì)照試驗(yàn). 中國(guó)循證醫(yī)學(xué)雜志, 2004, 04(5): 300-305. doi: 復(fù)制

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2. 中華醫(yī)學(xué)會(huì)呼吸病學(xué)分會(huì)慢性阻塞性肺疾病學(xué)組.慢性阻塞性肺疾病診治指南[J].中華結(jié)核和呼吸雜志,2002;25(8):453～460.
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10. ［7］Laan M, Cui ZH, Hoshino H, Lotvall J, Sjosrtand M, Gruenert DC, Skoogh BE, Linden A. Neutrophil recruitment by human IL -17 via C -X -C chemokine release in the airways[J]. J Immunol, 1999; 162(4):2 347 -2 352.
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12. ［9］Riise GC,Ahlstedt S,Larsson S, Enander I, Jones I, Larsson P, Andersson B. Bronchial inflammation in chronic bronchitis assessed by measurement of cell products in bronchial lavage fluid[J]. Thorax, 1995; 50:360 -365.
13. ［10］Pesei A, Balbi B,Majori M. Inflammatory cells and mediators in bronchial lavage of patients with chronic obstructive pulmonary disease[J]. Eur Respir J, 1998; 12:380 -386.
14. ［11］Balbi B, Majori M,Bertacco S, Convertino G, Cuomo A,Donner CF, Pesci A. Inhaled corticosteroids in stable COPD patients:do they have effects on cells and molecular mediators of airway inflammation [ J ] ? Chest, 2000; 117 ( 6 ): 1 633 -1 637.
15. ［12］Tanino M,Betsuyaku T, Takeyabu K, Tanino Y, Yamaguchi E, Miyamoto K, Nishimura M. Increased levels of intefieukin -8 in BAL fluid from smokers susceptible to pulmonary emphysema[J]. Thorax, 2002; 57(5) :405 -411.
16. ［13］Keatings VM, Collin PD, Scott DM, Barnes PJ. Differences in intefieukin -8 and tumor necrosis factor -alpha in induced sputum from patients with chronic obstructive pulmonary disease or asthma[J]. Am J Respir Cdt Care Med,1996; 153:530- 534.
17. ［14］Mikami M, Llewellyn -Jones CG, Bayley D,Hill SL,Stockley RA. The Chemotacfic Activity of Sputum from Patients with Bronchiectasis [ J ]. Am J Respir Crit Care Med,1998; 157:723 -728.
18. ［15］Seggev JS, Thomton WH Jr,Edes TE. Serum leukotriene B4 levels in patient with obstructive pulmonary disease[J]. Chest,1991; 99:289 -291.
19. ［16］Beeh KM, Korumann O,Buhl R,Culpitt SV, Giembycz MA, Bame PJ. Neutrophil Chemntachc Activity of Sputum From Patients With COPD: Role of Intedeukin 8 and Leukotriene B4[J]. Chest, 2003; 123(4) :1 240 -1 247.
  1. 1. ［1］Chronic obstructive pulmonary disease research group of chinese society for respiratory disease. Guideline for diagnosis and management of chronic obstructive pulmonary disease [ J ].Chinese Journal of Tuberculosis and Respiratory Diseases, 2002;25(8) :453-460.
  2. 2. 中華醫(yī)學(xué)會(huì)呼吸病學(xué)分會(huì)慢性阻塞性肺疾病學(xué)組.慢性阻塞性肺疾病診治指南[J].中華結(jié)核和呼吸雜志,2002;25(8):453～460.
  3. 3. ［2］Zheng XY. Principle of clinical research for new traditional herbs [ M ]. First Edition. Chinese medical pharmacological science publishing house, 2002; 54-58.
  4. 4. 鄭筱萸主編.中藥新藥臨床研究指導(dǎo)原則(試行)[M].第1版.北京:中國(guó)醫(yī)藥科技出版社,2002:54～58.
  5. 5. ［3］De Boer WI, Sont JK, Van Schadewijk A, Stolk J, van Krieken JH, Hiemstra PS. Monocyte chemoattractant protein 1 ,interleukin 8, and chronic airways inflammation in COPD [J ].Journal of Pathol, 2000; 190 ( 5 ) :619 - 626.
  6. 6. ［4］Zhong XN, Liu GN. New research for airway inflammation of chronic obstructive pulmonary disease [ J ]. Foreign Medical Sciences ( Section of Internal Medicine ), 2001; 27:32 - 34.
  7. 7. 鐘小寧,柳廣南.慢性阻塞性肺疾病氣道炎癥研究進(jìn)展[J].國(guó)外醫(yī)學(xué)內(nèi)科學(xué)分冊(cè),2001;27:32～34.
  8. 8. ［5］Rutgers SR, Postma DS, ten Hacken NH, Kauffman HF,van Der Mark TW, Koeter GH,Timens W. Ongoing airway inflammation in patients with COPD who do not currently smoke[J]. Chest, 2000; 117(5 Suppl 1):262.
  9. 9. ［6］Turato G, Zuin R, Monti S. Cellular and structural changes in peripheral airways of subjects with severe COPD[J]. Eur Respir J, 2001; 91: 662.
  10. 10. ［7］Laan M, Cui ZH, Hoshino H, Lotvall J, Sjosrtand M, Gruenert DC, Skoogh BE, Linden A. Neutrophil recruitment by human IL -17 via C -X -C chemokine release in the airways[J]. J Immunol, 1999; 162(4):2 347 -2 352.
  11. 11. ［8］Barczyk A, Pierzchala W, Sozanska E. Interleukin-17 in sputum correlates with airway hyperresponsiveness to methacholine[J]. Respir Med, 2003; 97(6):726-733.
  12. 12. ［9］Riise GC,Ahlstedt S,Larsson S, Enander I, Jones I, Larsson P, Andersson B. Bronchial inflammation in chronic bronchitis assessed by measurement of cell products in bronchial lavage fluid[J]. Thorax, 1995; 50:360 -365.
  13. 13. ［10］Pesei A, Balbi B,Majori M. Inflammatory cells and mediators in bronchial lavage of patients with chronic obstructive pulmonary disease[J]. Eur Respir J, 1998; 12:380 -386.
  14. 14. ［11］Balbi B, Majori M,Bertacco S, Convertino G, Cuomo A,Donner CF, Pesci A. Inhaled corticosteroids in stable COPD patients:do they have effects on cells and molecular mediators of airway inflammation [ J ] ? Chest, 2000; 117 ( 6 ): 1 633 -1 637.
  15. 15. ［12］Tanino M,Betsuyaku T, Takeyabu K, Tanino Y, Yamaguchi E, Miyamoto K, Nishimura M. Increased levels of intefieukin -8 in BAL fluid from smokers susceptible to pulmonary emphysema[J]. Thorax, 2002; 57(5) :405 -411.
  16. 16. ［13］Keatings VM, Collin PD, Scott DM, Barnes PJ. Differences in intefieukin -8 and tumor necrosis factor -alpha in induced sputum from patients with chronic obstructive pulmonary disease or asthma[J]. Am J Respir Cdt Care Med,1996; 153:530- 534.
  17. 17. ［14］Mikami M, Llewellyn -Jones CG, Bayley D,Hill SL,Stockley RA. The Chemotacfic Activity of Sputum from Patients with Bronchiectasis [ J ]. Am J Respir Crit Care Med,1998; 157:723 -728.
  18. 18. ［15］Seggev JS, Thomton WH Jr,Edes TE. Serum leukotriene B4 levels in patient with obstructive pulmonary disease[J]. Chest,1991; 99:289 -291.
  19. 19. ［16］Beeh KM, Korumann O,Buhl R,Culpitt SV, Giembycz MA, Bame PJ. Neutrophil Chemntachc Activity of Sputum From Patients With COPD: Role of Intedeukin 8 and Leukotriene B4[J]. Chest, 2003; 123(4) :1 240 -1 247.