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)的隨機對照試驗_《中國循證醫學雜志》

作者：

張穎 , 李廷謙 , 王剛 , 常靜 , 毛兵 , 王蕾 , 遲煥海 , 萬美華

四川大學華西醫院,國家藥品臨床研究基地,中藥,成都,610041;

關鍵詞：

痰熱清注射液慢性阻塞性肺疾病白介素-17 白介素-8 白三烯B4,中西醫結合治療隨機對照試驗

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目的　評價痰熱清注射液對慢性阻塞性肺疾病(COPD)急性加重期患者的臨床療效、安全性及其對血漿細胞因子白介素-17(IL-17)、白介素-8(IL-8)及白三烯B4表達的影響.
方法　按中華醫學會呼吸病學會2002年 lt;慢性阻塞性肺疾病診治指南 gt;和國家中醫藥管理局1994年發布的 lt;中醫病證診斷療效標準 gt;,將60例COPD急性加重期患者隨機分為治療組和對照組,每組各30例,進行隨機對照臨床試驗.中醫痰熱阻肺癥診斷標準為:咳嗽氣粗,痰多質粘厚或稠黃,咳吐不爽,或有身熱,口干欲飲,舌紅苔黃,脈滑數.治療組在基礎治療的基礎上,用痰熱清注射液20ml+5%糖水250 ml,iv gtt,q 24 h治療;對照組在基礎治療的基礎上,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計學意義(P＜0.05),且治療后治療組血漿細胞因子IL-17、IL-8水平明顯低于對照組(P＜0.05).
結論　痰熱清注射液治療COPD急性加重期患者的臨床療效明顯優于對照組,且未發現明顯毒副作用.其作用機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.

引用本文： 張穎,李廷謙,王剛,常靜,毛兵,王蕾,遲煥海,萬美華. 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)的隨機對照試驗. 中國循證醫學雜志, 2004, 04(5): 300-305. doi: 復制

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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.	［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］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. 中華醫學會呼吸病學分會慢性阻塞性肺疾病學組.慢性阻塞性肺疾病診治指南[J].中華結核和呼吸雜志,2002;25(8):453～460.
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. 鄭筱萸主編.中藥新藥臨床研究指導原則(試行)[M].第1版.北京:中國醫藥科技出版社,2002:54～58.
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. ［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. 鐘小寧,柳廣南.慢性阻塞性肺疾病氣道炎癥研究進展[J].國外醫學內科學分冊,2001;27:32～34.
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. ［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. ［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. ［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. ［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.

《中國循證醫學雜志》

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)的隨機對照試驗

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《中國循證醫學雜志》

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)的隨機對照試驗

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