• 1.廣州市腦科醫(yī)院神經(jīng)內(nèi)科（廣州 510370） 2.四川大學(xué)華西醫(yī)院神經(jīng)內(nèi)科（成都 610041）;

目的 　系統(tǒng)評(píng)價(jià)葛根素治療急性腦梗死的臨床療效和安全性。
方法 　運(yùn)用系統(tǒng)評(píng)價(jià)的方法，全面檢索2006年2月以前來自MEDLINE、EMBase、中國(guó)生物醫(yī)學(xué)文獻(xiàn)光盤數(shù)據(jù)庫、中國(guó)腦卒中臨床試驗(yàn)數(shù)據(jù)庫的相關(guān)文獻(xiàn)以及所獲文獻(xiàn)的參考文獻(xiàn)。按Cochrane標(biāo)準(zhǔn)，對(duì)納入研究逐個(gè)進(jìn)行質(zhì)量評(píng)價(jià)，而后采用RevMan 4.2軟件進(jìn)行Meta分析。
結(jié)果 　共14個(gè)研究（1 141例）符合納入標(biāo)準(zhǔn)。僅1個(gè)試驗(yàn)報(bào)告了6個(gè)月時(shí)的死亡或殘疾率，原試驗(yàn)結(jié)果顯示兩組差異無統(tǒng)計(jì)學(xué)意義。對(duì)提供神經(jīng)功能缺損改善率的11個(gè)研究進(jìn)行的Meta分析顯示，治療組有效率高于對(duì)照組，其差異有統(tǒng)計(jì)學(xué)意義 [OR 3.21, 95%CI (2.25,4.59)]。
結(jié)論 　本研究所納入試驗(yàn)的方法學(xué)質(zhì)量均較低，雖然葛根素可改善急性腦梗死近期神經(jīng)功能缺損，但評(píng)價(jià)遠(yuǎn)期功能性結(jié)局的研究?jī)H1個(gè)，且病例數(shù)（98例）太少，尚不能得出肯定結(jié)論。 因此進(jìn)行高質(zhì)量、大樣本的隨機(jī)對(duì)照試驗(yàn)非常必要。

引用本文： 譚 燕,劉 鳴,吳 波. 葛根素治療急性腦梗死的系統(tǒng)評(píng)價(jià). 中國(guó)循證醫(yī)學(xué)雜志, 2006, 06(7): 494-499. doi: 復(fù)制

1. 劉鳴, 張世洪. 臨床試驗(yàn)中的意向處理分析. 英國(guó)醫(yī)學(xué)雜志 (中文版), 2001; 4(4): 223-224.
2. 吳祖舜, 高俊鳳, 陳玉山, 等. 普潤(rùn) (葛根素) 葡萄糖注射液聯(lián)合低分子肝素 (海普甯) 治療急性腦梗死的療效觀察－附30例報(bào)告. 腦與神經(jīng)疾病雜志, 2004; 12(1): 53～54,58.
3. 巢建新, 葉明. 葛根素治療急性缺血性腦卒中的臨床研究. 廣東藥學(xué), 2004; 14(3): 38～39.
4. 宋春江, 李秋茹, 鐘曉閔, 等. 葛根素治療腦梗死40例療效觀察. 四川醫(yī)學(xué), 2005; 26(3): 306 ～307.
5. 石云, 馬湖蕊. 葛根素治療急性腦梗塞32例療效觀察. 云南中醫(yī)中藥雜志, 2005; 26(3): 7-8.
6. 榮培紅, 林海, 查鵬洲. 葛根素聯(lián)合降纖酶治療急性腦梗塞48例. 陜西中醫(yī), 2004; 25(2): 123～124.
7. 王吉, 管仁蓮. 葛根素與腦活素聯(lián)合治療急性腦梗塞的效果. 實(shí)用醫(yī)藥雜志, 2002; 19(7): 502.
8. 趙路清. 葛根素治療急性腦梗死的臨床觀察. 實(shí)用臨床醫(yī)藥雜志, 2004; 8(2): 76.
9. 吳新艷. 葛根素加川芎嗪治療急性腦梗死臨床療效觀察. 臨床急診雜志, 2003; 4(6): 26～27.
10. 龍明智, 王軍, 諶蓉, 等. 中西醫(yī)結(jié)合治療急性缺血性腦梗塞的臨床分析. 現(xiàn)代康復(fù), 2000; 4(5): 682~683.
11. 李賢昌, 黃靜波, 孫彥俊. 葛根素治療腦梗死64例臨床觀察. 浙江中西醫(yī)結(jié)合雜志, 2003; 13(9): 560.
12. 劉明龍. 葛根素氯化鈉注射液輔助治療急性腦梗死療效觀察. 現(xiàn)代中西醫(yī)結(jié)合雜志, 2005; 14(7): 872~873。.
13. 鄧娟, 周華東, 陳曼娥. 葛根素注射液對(duì)急性腦梗塞患者微循環(huán)保護(hù)機(jī)制的臨床研究. 微循環(huán)學(xué)雜志, 2001; 11(1): 14~15.
14. 曹大力, 許宏偉, 胡景云, 等. 葛根素注射液治療腦梗死的臨床療效. 湖南醫(yī)學(xué), 1999; 16(3): 191.
15. 張儉華. 葛根素治療急性缺血性腦梗塞32例療效觀察. 浙江中西醫(yī)結(jié)合雜志, 2002; 12(12): 731~732.
16. 賀卒英. 普樂林治療老年人腦梗塞臨床觀察. 現(xiàn)代康復(fù), 1998; 2(1): 44~45.
17. 應(yīng)衛(wèi)嬋. 葛根素注射液治療腦梗塞療效觀察. 浙江中西醫(yī)結(jié)合雜志, 2002; 12(11): 690。.
18. 王碧云, 張梅麗, 譚燕, 等. 葛根素注射液對(duì)缺血性腦卒中患者的臨床觀察及其對(duì)血漿ET及HCY、OX-LDL的影響. 海南醫(yī)學(xué), 2005; 16(5): 9~10.
19. 馬付堅(jiān). 葛根素對(duì)急性腦梗死纖溶及內(nèi)皮功能治療作用研究. 醫(yī)學(xué)文選, 2001; 20(6): 794~795.
20. 扈友莊, 楊彬, 劉東彪. 葛根素對(duì)急性腦梗死患者血清SICAM-1, TNF-α水平的影響. 中國(guó)醫(yī)師雜志, 2005; 7(8): 1135~1136.
21. 吳波, 劉鳴. 腦卒中臨床試驗(yàn)療效判定指標(biāo)現(xiàn)狀及趨勢(shì). 中華神經(jīng)科雜志, 2002; 35(3): 177~179.
22. International stroke trial collaborative group. The international stroke trial (IST): a randomized trial of aspirin, subcutaneous heparin, both, or neither among 19 345 patients with acute ischaemic stroke. Lancet, 1997; 349(9065): 1569-1581.
23. Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med, 1995; 333(24): 1581-1587.
24. Stroke--1989. Recommendations on stroke prevention, diagnosis, and therapy. Report of the WHO Task Force on Stroke and other Cerebrovascular Disorders. Stroke, 1989; 20(10): 1407-1431.
25. Mahoney FI, Barthel DW. Functional evaluation: the Barthel index. Md State Med J, 1965; 14: 61- 65.
26. Sulter G, Steen C, De Keyser J. Use of the Barthel index and modified Rankin scale in acute stroke scale in acute stroke trials. Stroke, 1999;30(8): 1538-1541.
27. Liu M, Zhang SH. Intention to treat analysis in clinical trials. BMJ (Chinese edition), 2001; 4(4): 223-224.
28. Wu ZS, Gao JF, Chen YS, et al. Observation of effect of pueraria injection and low molecular heparin on acute cerebral infarction. Journal of Brain and Neurology Disease, 2004; 12(1): 53-54, 58.
29. Chao JX, Ye M. Clinical study of pueraria for acute ischemic stroke. Pharmacy of Guangdong, 2004; 14(3): 38-39.
30. Song CJ, Li QR, Zhong XM, et al. Observation of effect of pueraria on cerebral infarction. Sichuan Medical Journal, 2005; 26(3): 306-307.
31. . Shi Y, Ma HR. Observation of effect of pueraria on acute cerebral infarction. Yunnan Journal of Traditional Chinese Medicine and Materia Medica, 2005; 26(3): 7-8.
32. Rong PH, Lin H, Cha PZ. 48 cases of pueraria and defibrase for acute cerebral infarction. Shaanxi Journal of Traditional Chinese Medicine, 2004; 25(2): 123-124.
33. Wang J, Guang RL. Effect of pueraria and cerebrolysis on acute cerebral infarction. Practical Journal of Medicine and Pharmacy, 2002; 19(7): 502.
34. Zhao LQ. Clinical observation on pueraria for acute ischemic stroke. Journal of Clinical Medicine in Practice, 2004; 8(2): 76.
35. Wu XY. Observation on effect of pueraria and chuanxiongzine on acute cerebral infarction. Journal of Clinical Emergency, 2003; 4(6): 26 -27.
36. Long MZ, Wang J, Shen R, et al. Observation on effect of gegen injection in treating patients of acute ischemic stroke. Modern Rehabilitation, 2000; 4(5): 682-683.
37. Li CX, Huang JB, Shun YB. Clinical observation on pueraria injection for cerebral infarction. Zhejiang Journal of Integrated Traditional Chinese and Western Medicine, 2003; 13(9): 560.
38. Liu ML. Observation on effect of pueraria injection on acute cerebral infarction. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2005; 14(7): 72-873.
39. Deng J, Zhou HD, Chen ME. Mechanism of Puerarin Induced Microcirculation Protection in Acute Cerebral Infarction. Chinese Journal of Microcirculation, 2001; 11(1): 14-15.
40. Cao DL, Xu HW, Hu JY, et al. Observation of effect of pueraria injection on cerebral infarction. Hunan Medical Journal, 1999; 16(3): 191.
41. Zhang JH. Observation of Therapeutic Efficacy in Treating Acute Cerebral Ischemia with Kankonein. Zhejiang Journal of Integrated Traditional Chinese and Western Medicine, 2002; 12(12): 731-732.
42. He ZY. Clinical observation of pueraria injection on cerebral infarction in the elder. Modern Rehabilitation, 1998; 2(1): 44- 45.
43. Ying WC. Observation of effect of pueraria injection on cerebral infarction. Zhejiang Journal of Integrated Traditional Chinese and Western Medicine, 2002; 12(11): 690.
44. Wang BY, Zhang ML, Tan Y, et al. Effects of puerarin injection treatment of cerebral ischemic stroke and its influence on plasma ET、HCY and OX-LDL. Hainan Medical Journal, 2005; 16(5): 9-10.
45. Ma FJ. Effects of puerarin in treatment of acute cerebral infarction and its influence on fibrolysis system and endothelium function. Anthology of Medicine, 2001; 20(6): 794-795.
46. Hu YZ, Yang B, Liu DB. Influence on plasma SICAM-1, TNF of puerarin for acute cerebral infarction. Journal of Chinese Physician, 2005; 7(8): 1135-1136.
47. Wu B, Liu M. Trends of outcome measurement in stroke trials. Chinese Journal of Neurology, 2002; 35(3): 177-179.
  1. 1. 劉鳴, 張世洪. 臨床試驗(yàn)中的意向處理分析. 英國(guó)醫(yī)學(xué)雜志 (中文版), 2001; 4(4): 223-224.
  2. 2. 吳祖舜, 高俊鳳, 陳玉山, 等. 普潤(rùn) (葛根素) 葡萄糖注射液聯(lián)合低分子肝素 (海普甯) 治療急性腦梗死的療效觀察－附30例報(bào)告. 腦與神經(jīng)疾病雜志, 2004; 12(1): 53～54,58.
  3. 3. 巢建新, 葉明. 葛根素治療急性缺血性腦卒中的臨床研究. 廣東藥學(xué), 2004; 14(3): 38～39.
  4. 4. 宋春江, 李秋茹, 鐘曉閔, 等. 葛根素治療腦梗死40例療效觀察. 四川醫(yī)學(xué), 2005; 26(3): 306 ～307.
  5. 5. 石云, 馬湖蕊. 葛根素治療急性腦梗塞32例療效觀察. 云南中醫(yī)中藥雜志, 2005; 26(3): 7-8.
  6. 6. 榮培紅, 林海, 查鵬洲. 葛根素聯(lián)合降纖酶治療急性腦梗塞48例. 陜西中醫(yī), 2004; 25(2): 123～124.
  7. 7. 王吉, 管仁蓮. 葛根素與腦活素聯(lián)合治療急性腦梗塞的效果. 實(shí)用醫(yī)藥雜志, 2002; 19(7): 502.
  8. 8. 趙路清. 葛根素治療急性腦梗死的臨床觀察. 實(shí)用臨床醫(yī)藥雜志, 2004; 8(2): 76.
  9. 9. 吳新艷. 葛根素加川芎嗪治療急性腦梗死臨床療效觀察. 臨床急診雜志, 2003; 4(6): 26～27.
  10. 10. 龍明智, 王軍, 諶蓉, 等. 中西醫(yī)結(jié)合治療急性缺血性腦梗塞的臨床分析. 現(xiàn)代康復(fù), 2000; 4(5): 682~683.
  11. 11. 李賢昌, 黃靜波, 孫彥俊. 葛根素治療腦梗死64例臨床觀察. 浙江中西醫(yī)結(jié)合雜志, 2003; 13(9): 560.
  12. 12. 劉明龍. 葛根素氯化鈉注射液輔助治療急性腦梗死療效觀察. 現(xiàn)代中西醫(yī)結(jié)合雜志, 2005; 14(7): 872~873。.
  13. 13. 鄧娟, 周華東, 陳曼娥. 葛根素注射液對(duì)急性腦梗塞患者微循環(huán)保護(hù)機(jī)制的臨床研究. 微循環(huán)學(xué)雜志, 2001; 11(1): 14~15.
  14. 14. 曹大力, 許宏偉, 胡景云, 等. 葛根素注射液治療腦梗死的臨床療效. 湖南醫(yī)學(xué), 1999; 16(3): 191.
  15. 15. 張儉華. 葛根素治療急性缺血性腦梗塞32例療效觀察. 浙江中西醫(yī)結(jié)合雜志, 2002; 12(12): 731~732.
  16. 16. 賀卒英. 普樂林治療老年人腦梗塞臨床觀察. 現(xiàn)代康復(fù), 1998; 2(1): 44~45.
  17. 17. 應(yīng)衛(wèi)嬋. 葛根素注射液治療腦梗塞療效觀察. 浙江中西醫(yī)結(jié)合雜志, 2002; 12(11): 690。.
  18. 18. 王碧云, 張梅麗, 譚燕, 等. 葛根素注射液對(duì)缺血性腦卒中患者的臨床觀察及其對(duì)血漿ET及HCY、OX-LDL的影響. 海南醫(yī)學(xué), 2005; 16(5): 9~10.
  19. 19. 馬付堅(jiān). 葛根素對(duì)急性腦梗死纖溶及內(nèi)皮功能治療作用研究. 醫(yī)學(xué)文選, 2001; 20(6): 794~795.
  20. 20. 扈友莊, 楊彬, 劉東彪. 葛根素對(duì)急性腦梗死患者血清SICAM-1, TNF-α水平的影響. 中國(guó)醫(yī)師雜志, 2005; 7(8): 1135~1136.
  21. 21. 吳波, 劉鳴. 腦卒中臨床試驗(yàn)療效判定指標(biāo)現(xiàn)狀及趨勢(shì). 中華神經(jīng)科雜志, 2002; 35(3): 177~179.
  22. 22. International stroke trial collaborative group. The international stroke trial (IST): a randomized trial of aspirin, subcutaneous heparin, both, or neither among 19 345 patients with acute ischaemic stroke. Lancet, 1997; 349(9065): 1569-1581.
  23. 23. Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med, 1995; 333(24): 1581-1587.
  24. 24. Stroke--1989. Recommendations on stroke prevention, diagnosis, and therapy. Report of the WHO Task Force on Stroke and other Cerebrovascular Disorders. Stroke, 1989; 20(10): 1407-1431.
  25. 25. Mahoney FI, Barthel DW. Functional evaluation: the Barthel index. Md State Med J, 1965; 14: 61- 65.
  26. 26. Sulter G, Steen C, De Keyser J. Use of the Barthel index and modified Rankin scale in acute stroke scale in acute stroke trials. Stroke, 1999;30(8): 1538-1541.
  27. 27. Liu M, Zhang SH. Intention to treat analysis in clinical trials. BMJ (Chinese edition), 2001; 4(4): 223-224.
  28. 28. Wu ZS, Gao JF, Chen YS, et al. Observation of effect of pueraria injection and low molecular heparin on acute cerebral infarction. Journal of Brain and Neurology Disease, 2004; 12(1): 53-54, 58.
  29. 29. Chao JX, Ye M. Clinical study of pueraria for acute ischemic stroke. Pharmacy of Guangdong, 2004; 14(3): 38-39.
  30. 30. Song CJ, Li QR, Zhong XM, et al. Observation of effect of pueraria on cerebral infarction. Sichuan Medical Journal, 2005; 26(3): 306-307.
  31. 31. . Shi Y, Ma HR. Observation of effect of pueraria on acute cerebral infarction. Yunnan Journal of Traditional Chinese Medicine and Materia Medica, 2005; 26(3): 7-8.
  32. 32. Rong PH, Lin H, Cha PZ. 48 cases of pueraria and defibrase for acute cerebral infarction. Shaanxi Journal of Traditional Chinese Medicine, 2004; 25(2): 123-124.
  33. 33. Wang J, Guang RL. Effect of pueraria and cerebrolysis on acute cerebral infarction. Practical Journal of Medicine and Pharmacy, 2002; 19(7): 502.
  34. 34. Zhao LQ. Clinical observation on pueraria for acute ischemic stroke. Journal of Clinical Medicine in Practice, 2004; 8(2): 76.
  35. 35. Wu XY. Observation on effect of pueraria and chuanxiongzine on acute cerebral infarction. Journal of Clinical Emergency, 2003; 4(6): 26 -27.
  36. 36. Long MZ, Wang J, Shen R, et al. Observation on effect of gegen injection in treating patients of acute ischemic stroke. Modern Rehabilitation, 2000; 4(5): 682-683.
  37. 37. Li CX, Huang JB, Shun YB. Clinical observation on pueraria injection for cerebral infarction. Zhejiang Journal of Integrated Traditional Chinese and Western Medicine, 2003; 13(9): 560.
  38. 38. Liu ML. Observation on effect of pueraria injection on acute cerebral infarction. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2005; 14(7): 72-873.
  39. 39. Deng J, Zhou HD, Chen ME. Mechanism of Puerarin Induced Microcirculation Protection in Acute Cerebral Infarction. Chinese Journal of Microcirculation, 2001; 11(1): 14-15.
  40. 40. Cao DL, Xu HW, Hu JY, et al. Observation of effect of pueraria injection on cerebral infarction. Hunan Medical Journal, 1999; 16(3): 191.
  41. 41. Zhang JH. Observation of Therapeutic Efficacy in Treating Acute Cerebral Ischemia with Kankonein. Zhejiang Journal of Integrated Traditional Chinese and Western Medicine, 2002; 12(12): 731-732.
  42. 42. He ZY. Clinical observation of pueraria injection on cerebral infarction in the elder. Modern Rehabilitation, 1998; 2(1): 44- 45.
  43. 43. Ying WC. Observation of effect of pueraria injection on cerebral infarction. Zhejiang Journal of Integrated Traditional Chinese and Western Medicine, 2002; 12(11): 690.
  44. 44. Wang BY, Zhang ML, Tan Y, et al. Effects of puerarin injection treatment of cerebral ischemic stroke and its influence on plasma ET、HCY and OX-LDL. Hainan Medical Journal, 2005; 16(5): 9-10.
  45. 45. Ma FJ. Effects of puerarin in treatment of acute cerebral infarction and its influence on fibrolysis system and endothelium function. Anthology of Medicine, 2001; 20(6): 794-795.
  46. 46. Hu YZ, Yang B, Liu DB. Influence on plasma SICAM-1, TNF of puerarin for acute cerebral infarction. Journal of Chinese Physician, 2005; 7(8): 1135-1136.
  47. 47. Wu B, Liu M. Trends of outcome measurement in stroke trials. Chinese Journal of Neurology, 2002; 35(3): 177-179.