• 1.四川大學(xué)華西醫(yī)院中西醫(yī)結(jié)合科（成都 610041）2.四川大學(xué)華西醫(yī)院國(guó)家藥品臨床研究基地（中藥）3.湖南醫(yī)科大學(xué)附屬第一醫(yī)院（長(zhǎng)沙 410008）4.湖南醫(yī)科大學(xué)附屬第二醫(yī)院（長(zhǎng)沙 410011） 5.貴陽(yáng)中醫(yī)學(xué)院附屬醫(yī)院（貴陽(yáng) 550002）6.海南省中醫(yī)院（海口 570203）;

目的 　觀察雙解膠囊（片劑）治療急性上呼吸道感染（風(fēng)溫病熱在肺衛(wèi)證）的療效，并對(duì)其安全性作出評(píng)價(jià)。
方法 　采用多中心隨機(jī)雙盲雙模擬陽(yáng)性藥物平行對(duì)照臨床試驗(yàn)方法，對(duì)急性上呼吸道感染（風(fēng)溫病熱在肺衛(wèi)證）患者770例，按3∶3∶1比例隨機(jī)分為雙解膠囊組（膠囊組）330例，雙解片劑組（片劑組）330例，及柴黃片組（對(duì)照組）110例。膠囊組給予雙解膠囊，片劑組給予雙解片，對(duì)照組給予柴黃片，均每次3粒（片），每日3次。療程均為5天。
結(jié)果 　納入患者770例，隨機(jī)化763例，剔除28例，脫落17例，最終進(jìn)入意向治療（ITT）分析724例，符合方案集分析（PPS）718例。其中上呼吸道感染療效：ITT分析顯示膠囊組愈顯率83.60%，總有效率98.39%；片劑組分別為83.28％，99.04%；對(duì)照組分別為68.62%，98.04%。PPS分析顯示膠囊組愈顯率84.69%，總有效率99.02%；片劑組分別為83.22%，99.03%；對(duì)照組分別為69.30%，99.01%。試驗(yàn)組（膠囊、片劑）疾病療效優(yōu)于對(duì)照組（P lt;0.05），ITT分析與PPS分析結(jié)果一致。中醫(yī)證候療效：ITT分析顯示膠囊組愈顯率83.92%，總有效率98.07%；片劑組分別為83.92％，99.36%；對(duì)照組分別為74.51%，98.04%。PPS分析顯示膠囊組愈顯率85.02%，總有效率98.70%；片劑組分別為83.87%，99.35%；對(duì)照組分別為75.24%，98.02%。試驗(yàn)組（膠囊、片劑）中醫(yī)證候療效優(yōu)于對(duì)照組（P lt;0.05），ITT分析與PPS分析結(jié)果一致。觀察中未發(fā)現(xiàn)明顯不良反應(yīng)。
結(jié)論 　雙解膠囊（片劑）治療急性上呼吸道感染（風(fēng)溫病熱在肺衛(wèi)證）的療效確切，未發(fā)現(xiàn)明顯毒副作用。

引用本文： 王 蕾,張瑞明,趙艷玲,馮國(guó)湘,潘定舉,黃西園,毛 兵,王 剛,常 靜,張 穎,萬(wàn)美華,郭 佳,陳 雁,李廷謙. 雙解膠囊（片劑）治療急性上呼吸道感染（風(fēng)溫病熱在肺衛(wèi)證）的多中心雙盲雙模擬隨機(jī)對(duì)照臨床試驗(yàn). 中國(guó)循證醫(yī)學(xué)雜志, 2006, 06(3): 162-170. doi: 復(fù)制

1. 四川大學(xué)華西醫(yī)院國(guó)家藥品臨床研究基地 (中藥). 雙解膠囊Ⅱ期臨床試驗(yàn)總結(jié)報(bào)告 (內(nèi)部資料), 2004; 5.
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5. 國(guó)家食品藥品監(jiān)督管理局. 中藥新藥研究的技術(shù)要求; 34-37.
6. 孫麗霞, 黃敬孚. 呼吸道病毒檢測(cè)與臨床意義. 中國(guó)醫(yī)學(xué)工程, 2005; 13(3): 325-326.
7. 化學(xué)藥物和生物制品臨床試驗(yàn)的生物統(tǒng)計(jì)學(xué)技術(shù)指導(dǎo)原則 (第二稿). 2004; 21.
8. 李芳, 李建北, 張東明. 柴胡的藥理研究進(jìn)展. 時(shí)珍國(guó)醫(yī)國(guó)藥, 2004;15(2): 120-121.
9. 葉曉平, 宋純清. 柴胡皂苷藥理研究進(jìn)展. 中草藥, 2004; 35(12): 1434-1435.
10. 遲戈夫, 丁麗, 常麗敏. 國(guó)內(nèi)黃芩藥理研究進(jìn)展. 內(nèi)蒙古民族大學(xué)學(xué)報(bào)(自然科學(xué)版), 2005; 20(2): 207-209.
11. 李霞, 于慶海, 艾明, 等. 人工培植牛黃抗炎作用及其機(jī)制的初步探討. 沈陽(yáng)藥科大學(xué)學(xué)報(bào), 2000; 17(6): 431-433.
12. 顧克顯, 鄭家潤(rùn), 高紀(jì)偉, 等. 雷醇內(nèi)酯的抗炎作用. 中國(guó)藥理學(xué)通報(bào), 1994; 10(1): 54-57.
13. 宋民憲, 郭維加, 主編. 新編國(guó)家中成藥. 北京: 人民衛(wèi)生出版社, 2002; 74.
14. Kirkpatrick GL. The common cold. Prim Care. 1996; 23: 657-675.
15. Mossad SB. Treatment of the common cold. BMJ. 1998; 317: 33-36.
16. National Base for Drug Clinical Trials (traditional Chinese medicine) in west china hospital of Sichuan University. The report of phase Ⅱclinical trial of Shuangjie Capsule (internal data), 2004; 5.
17. Moher D, Schulz KF, Altman D, et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA, 2001; 285(15): 1987-1991.
18. Ye RG, edit. Internal Medicine. 5th eds. Beijing: People’s Medical Publishing House; 11-13.
19. Zheng XY, Edit. The principle of clinical research for new drug of traditional Chinese medicine; 58-60.
20. Liu YX, Yao C, Chen F, et al. Statistical methods of noninferiority/equivalence trials. Chin J Clin Pharmacol Ther, 2000; 5(4): 344-349.
21. State Drug and Food Administration. Technology rules about new drug of traditional Chinese medicine; 34-37.
22. Sun LX, Huang JF. The detection of virus in respiratory tract. China medical engineering, 2005; 13(3): 325-326.
23. The principle of statistical technology about chemical drugs and biologic drugs. 2004; 21.
24. Tyrrell DA, Cohen S, Schlarb JE. Signs and symptoms in common colds. Epidemiol Infect, 1993; 111: 143-156.
25. Gwaltney JM Jr. Rhinovirus infection of the normal human airway. Am J Respir Crit Care Med. 1995; 152(pt 2): S36-S39.
26. Li F, Li JB, Zhang DM. The pharmacological advance about Chaihu. Lishizhen Medical and Material Medical Research, 2004; 15(2): 120-121.
27. Ye XP, Song CQ. The pharmacological advance about Chaihu saponins. Chinese Traditional and Herb Drugs, 2004; 35(12): 1434-1435.
28. Chi GF, Ding L, Chang LM. The Present Domestic Pharmacological Advance on Scutellaria Baicalensis. Journal of Inner Mongolia University for Nationalities, 2005; 20(2): 207-209.
29. Li X, Yu QH, Ai M, et al. The primary research on pathology of anti-inflammation of artificial cultivated Calcul bovi. Journal of Shenyang Pharmaceutical University, 2000; 17(6): 431-433.
30. Gu KX, Zheng JR, GAO JW, et al. The antiinflammatory of triptolidenol activities. Chinese Pharmacological Bulletin, 1994; 10(1): 54-57.
31. Song MX, Guo WJ, Edit. State Chinese Traditional Patent Medicine. Beijing: People’s Medical Publishing House, 2002; 74.
  1. 1. 四川大學(xué)華西醫(yī)院國(guó)家藥品臨床研究基地 (中藥). 雙解膠囊Ⅱ期臨床試驗(yàn)總結(jié)報(bào)告 (內(nèi)部資料), 2004; 5.
  2. 2. 葉任高, 主編. 內(nèi)科學(xué). 第5版. 北京: 人民衛(wèi)生出版社; 11-13.
  3. 3. 鄭筱萸 主編 .中藥新藥臨床研究指導(dǎo)原則 (試行); 58-60.
  4. 4. 劉玉秀, 姚晨, 陳峰, 等. 臨床非劣效性/等效性評(píng)價(jià)的統(tǒng)計(jì)學(xué)方法. 中國(guó)臨床藥理學(xué)與治療學(xué), 2000; 5(4): 344-349.
  5. 5. 國(guó)家食品藥品監(jiān)督管理局. 中藥新藥研究的技術(shù)要求; 34-37.
  6. 6. 孫麗霞, 黃敬孚. 呼吸道病毒檢測(cè)與臨床意義. 中國(guó)醫(yī)學(xué)工程, 2005; 13(3): 325-326.
  7. 7. 化學(xué)藥物和生物制品臨床試驗(yàn)的生物統(tǒng)計(jì)學(xué)技術(shù)指導(dǎo)原則 (第二稿). 2004; 21.
  8. 8. 李芳, 李建北, 張東明. 柴胡的藥理研究進(jìn)展. 時(shí)珍國(guó)醫(yī)國(guó)藥, 2004;15(2): 120-121.
  9. 9. 葉曉平, 宋純清. 柴胡皂苷藥理研究進(jìn)展. 中草藥, 2004; 35(12): 1434-1435.
  10. 10. 遲戈夫, 丁麗, 常麗敏. 國(guó)內(nèi)黃芩藥理研究進(jìn)展. 內(nèi)蒙古民族大學(xué)學(xué)報(bào)(自然科學(xué)版), 2005; 20(2): 207-209.
  11. 11. 李霞, 于慶海, 艾明, 等. 人工培植牛黃抗炎作用及其機(jī)制的初步探討. 沈陽(yáng)藥科大學(xué)學(xué)報(bào), 2000; 17(6): 431-433.
  12. 12. 顧克顯, 鄭家潤(rùn), 高紀(jì)偉, 等. 雷醇內(nèi)酯的抗炎作用. 中國(guó)藥理學(xué)通報(bào), 1994; 10(1): 54-57.
  13. 13. 宋民憲, 郭維加, 主編. 新編國(guó)家中成藥. 北京: 人民衛(wèi)生出版社, 2002; 74.
  14. 14. Kirkpatrick GL. The common cold. Prim Care. 1996; 23: 657-675.
  15. 15. Mossad SB. Treatment of the common cold. BMJ. 1998; 317: 33-36.
  16. 16. National Base for Drug Clinical Trials (traditional Chinese medicine) in west china hospital of Sichuan University. The report of phase Ⅱclinical trial of Shuangjie Capsule (internal data), 2004; 5.
  17. 17. Moher D, Schulz KF, Altman D, et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA, 2001; 285(15): 1987-1991.
  18. 18. Ye RG, edit. Internal Medicine. 5th eds. Beijing: People’s Medical Publishing House; 11-13.
  19. 19. Zheng XY, Edit. The principle of clinical research for new drug of traditional Chinese medicine; 58-60.
  20. 20. Liu YX, Yao C, Chen F, et al. Statistical methods of noninferiority/equivalence trials. Chin J Clin Pharmacol Ther, 2000; 5(4): 344-349.
  21. 21. State Drug and Food Administration. Technology rules about new drug of traditional Chinese medicine; 34-37.
  22. 22. Sun LX, Huang JF. The detection of virus in respiratory tract. China medical engineering, 2005; 13(3): 325-326.
  23. 23. The principle of statistical technology about chemical drugs and biologic drugs. 2004; 21.
  24. 24. Tyrrell DA, Cohen S, Schlarb JE. Signs and symptoms in common colds. Epidemiol Infect, 1993; 111: 143-156.
  25. 25. Gwaltney JM Jr. Rhinovirus infection of the normal human airway. Am J Respir Crit Care Med. 1995; 152(pt 2): S36-S39.
  26. 26. Li F, Li JB, Zhang DM. The pharmacological advance about Chaihu. Lishizhen Medical and Material Medical Research, 2004; 15(2): 120-121.
  27. 27. Ye XP, Song CQ. The pharmacological advance about Chaihu saponins. Chinese Traditional and Herb Drugs, 2004; 35(12): 1434-1435.
  28. 28. Chi GF, Ding L, Chang LM. The Present Domestic Pharmacological Advance on Scutellaria Baicalensis. Journal of Inner Mongolia University for Nationalities, 2005; 20(2): 207-209.
  29. 29. Li X, Yu QH, Ai M, et al. The primary research on pathology of anti-inflammation of artificial cultivated Calcul bovi. Journal of Shenyang Pharmaceutical University, 2000; 17(6): 431-433.
  30. 30. Gu KX, Zheng JR, GAO JW, et al. The antiinflammatory of triptolidenol activities. Chinese Pharmacological Bulletin, 1994; 10(1): 54-57.
  31. 31. Song MX, Guo WJ, Edit. State Chinese Traditional Patent Medicine. Beijing: People’s Medical Publishing House, 2002; 74.