目的 系統(tǒng)評價葛根素治療急性腦梗死的臨床療效和安全性。
方法 運用系統(tǒng)評價的方法,全面檢索2006年2月以前來自MEDLINE、EMBase、中國生物醫(yī)學(xué)文獻光盤數(shù)據(jù)庫、中國腦卒中臨床試驗數(shù)據(jù)庫的相關(guān)文獻以及所獲文獻的參考文獻。按Cochrane標準,對納入研究逐個進行質(zhì)量評價,而后采用RevMan 4.2軟件進行Meta分析。
結(jié)果 共14個研究(1 141例)符合納入標準。僅1個試驗報告了6個月時的死亡或殘疾率,原試驗結(jié)果顯示兩組差異無統(tǒng)計學(xué)意義。對提供神經(jīng)功能缺損改善率的11個研究進行的Meta分析顯示,治療組有效率高于對照組,其差異有統(tǒng)計學(xué)意義 [OR 3.21, 95%CI (2.25,4.59)]。
結(jié)論 本研究所納入試驗的方法學(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,但評價遠期功能性結(jié)局的研究僅1個,且病例數(shù)(98例)太少,尚不能得出肯定結(jié)論。 因此進行高質(zhì)量、大樣本的隨機對照試驗非常必要。
引用本文: 譚 燕,劉 鳴,吳 波. 葛根素治療急性腦梗死的系統(tǒng)評價. 中國循證醫(yī)學(xué)雜志, 2006, 06(7): 494-499. doi: 復(fù)制
版權(quán)信息: ?四川大學(xué)華西醫(yī)院華西期刊社《中國循證醫(yī)學(xué)雜志》版權(quán)所有,未經(jīng)授權(quán)不得轉(zhuǎn)載、改編
1. | 劉鳴, 張世洪. 臨床試驗中的意向處理分析. 英國醫(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 (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. 葛根素注射液對急性腦梗塞患者微循環(huán)保護機制的臨床研究. 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. 葛根素注射液對缺血性腦卒中患者的臨床觀察及其對血漿ET及HCY、OX-LDL的影響. 海南醫(yī)學(xué), 2005; 16(5): 9~10. |
19. | 馬付堅. 葛根素對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. 葛根素對急性腦梗死患者血清SICAM-1, TNF-α水平的影響. 中國醫(yī)師雜志, 2005; 7(8): 1135~1136. |
21. | 吳波, 劉鳴. 腦卒中臨床試驗療效判定指標現(xiàn)狀及趨勢. 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. 劉鳴, 張世洪. 臨床試驗中的意向處理分析. 英國醫(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 (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. 葛根素注射液對急性腦梗塞患者微循環(huán)保護機制的臨床研究. 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. 葛根素注射液對缺血性腦卒中患者的臨床觀察及其對血漿ET及HCY、OX-LDL的影響. 海南醫(yī)學(xué), 2005; 16(5): 9~10.
- 19. 馬付堅. 葛根素對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. 葛根素對急性腦梗死患者血清SICAM-1, TNF-α水平的影響. 中國醫(yī)師雜志, 2005; 7(8): 1135~1136.
- 21. 吳波, 劉鳴. 腦卒中臨床試驗療效判定指標現(xiàn)狀及趨勢. 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.