• 北京大學(xué)第三醫(yī)院藥劑科（北京 100083）;

目的 　評(píng)價(jià)果糖二磷酸鈉（fructose-1,6 diphosphate, FDP）治療急性腦梗死的療效與安全性。
方法 　檢索MEDLINE、EMbase、Cochrane系統(tǒng)評(píng)價(jià)和臨床試驗(yàn)數(shù)據(jù)庫、中國生物醫(yī)學(xué)文獻(xiàn)光盤數(shù)據(jù)庫、中國期刊全文數(shù)據(jù)庫，收集FDP治療急性腦梗死的隨機(jī)或半隨機(jī)對(duì)照試驗(yàn)。所有檢索均截至2006年。對(duì)納入研究進(jìn)行質(zhì)量評(píng)價(jià)，并用RevMan 4.2軟件進(jìn)行Meta分析。
結(jié)果 　共納入10個(gè)隨機(jī)對(duì)照試驗(yàn)，均為中文，其中9個(gè)試驗(yàn)質(zhì)量評(píng)分為C級(jí)，1個(gè)試驗(yàn)質(zhì)量評(píng)分為A級(jí)。所有研究均未對(duì)遠(yuǎn)期效果進(jìn)行評(píng)價(jià)。在近期療效上，8個(gè)研究的合并分析顯示，F(xiàn)DP可明顯改善急性腦梗死患者的神經(jīng)功能缺損 [OR 2.55，95%CI (1.74, 3.74)]。在治療期間的病死率方面，7個(gè)研究的Meta分析顯示，F(xiàn)DP組與對(duì)照組差異無統(tǒng)計(jì)學(xué)意義 [RD –0.01，95%CI (–0.03, 0.01)]。1個(gè)研究評(píng)價(jià)了肌力改善的情況，結(jié)果顯示FDP組患者肌力改善的比例高于對(duì)照組 [OR 4.69，95%CI (1.55, 14.24)]。1個(gè)研究結(jié)局指標(biāo)為歐洲卒中量表評(píng)分，經(jīng)治療后FDP組評(píng)分高于對(duì)照組 [WMD 10.23，95%CI (4.13, 16.33)]。1個(gè)研究發(fā)現(xiàn)FDP組和對(duì)照組的安全性差異無統(tǒng)計(jì)學(xué)意義 [OR 1.24，95%CI (0.32, 4.75)]。未檢索到評(píng)價(jià)FDP用于急性腦梗死的經(jīng)濟(jì)學(xué)研究。
結(jié)論 　FDP在短期內(nèi)可能有助于改善急性腦梗死患者的神經(jīng)功能缺損，但對(duì)近期病死率的影響與對(duì)照組無差異，對(duì)遠(yuǎn)期生存率、依賴率和神經(jīng)功能缺損的影響尚不清楚。因此FDP在急性腦梗死中的應(yīng)用仍需要進(jìn)行大規(guī)模、高質(zhì)量、隨訪時(shí)間足夠的隨機(jī)對(duì)照研究提供證據(jù)。

引用本文： 劉芳,翟所迪,趙蕊,舒展. 果糖二磷酸鈉治療急性腦梗死的系統(tǒng)評(píng)價(jià). 中國循證醫(yī)學(xué)雜志, 2007, 07(4): 283-288. doi: 復(fù)制

1. The 4th National Conference on Cardiovascular Disease. Neuro-function deficit score for stroke. Chinese Journal of Neurology, 1996, 29(6): 381–382.
2. Wang YM, Kong YQ. Clinical effect of 1,6-fructose diphosphate in patients with acute cerebral infarction. The Journal of Practical Medicine, 1997, 13(12): 845.
3. Wang DC. Effect of Fructose-1,6-Diphosphate in treating acute cerebral infarction. Journal of Youjiang Medical College for Nationalities, 1999, 21(4): 572.
4. Wang S, Zong BY, Li L. Therapeutic effects of 1,6-fructose diphosphate on cerebral infarction. Shanghai Medical & Pharmaceutical Journal, 1999, 20(2): 22–23.
5. Ding J, Sun XF. 1,6-fructose diphosphate for acute cerebral infarction. Chinese Journal of Coal Industry Medicine, 2000, 3(2): 161.
6. Xu P. Fructose 1,6-diphosphate for stroke and brain injury. Clinical Medical Journal of China, 2001, (3): 282.
7. Peng XX, Hu XH, Deng XR, et al. 1, 6-diphosphate fructose in the treatment of diabetes combined with cerebral infarction. Journal of Clinical Internal Medicine, 2002, 19(2): 152–153.
8. Fang N, Zhang YM, Xu Z, et al. Clinical observation of 1,6-diphosphate fructose in the treatment of cerebral infarction: 30 cases. Shandong Medical Journal, 2003, 43(16): 63.
9. Liu XQ, Cui LY, Wang YJ, et al. The clinical efficacy and safety of fructose-1,6-diphosphate (Ruianji) in treating acute cerebral infarction. Chin J Mult Organ Dis Elderly, 2005, 4(2): 201–204.
10. Sun LY, Wang Y, Zang FC, et al. Effect of 1,6-fructose diphosphate in 119 cases of cerebral infarction. Journal of Postgraduates of Medicine, 2005, 28(7): 49–51.
11. Yang JZ, Zeng YM, Xiong HS, et al. Clinical observation of fructosediphosephate in the treatment of acute cerebral infarction. Chongqing Medical Journal, 2005, 34(8): 1121–1122.
12. Li PP, Deng CH. FDP in severe cerebral infarction: 30 cases. Central Plains Medical Journal, 1998, 25(11): 24.
13. Wang WH, Zhang SG, Xu Li. Clinical effect of 1,6-diphosphate Fructose for cerebral infarction. Journal of Binzhou Medical College, 1999, 22(1): 26.
14. Sang LL. Use of 1,6-fructose diphosphate in the treatment of 103 stroke cases. Shandong Medical Journal, 2000, 40(10): 59.
15. Wang XM, Wei JC, Zhang WD. Clinical observation of Ruianji in treating acute cerebral infarction. Chinese New Medicine, 2002, 3(10): 887–888.
16. 全國第四屆腦血管病學(xué)術(shù)會(huì)議. 腦卒中患者神經(jīng)功能缺損評(píng)分標(biāo)準(zhǔn). 中華神經(jīng)科雜志, 1996, 29(6): 381~382.
17. Juni P, Altman DG, Eger M. Assessing the quality of controlled clinical trails. BMJ, 2001, 323(7303): 4246.
18. 王允明, 孔永奇. 1,6-二磷酸果糖治療急性腦梗塞臨床觀察. 實(shí)用醫(yī)學(xué)雜志, 1997, 13(12): 845.
19. 王大成. 1,6-二磷酸果糖治療急性腦梗塞效果觀察. 右江民族醫(yī)學(xué)院學(xué)報(bào), 1999, 21(4): 572.
20. 王松, 宗碧云, 李麗. 1,6-二磷酸果糖治療腦梗塞的臨床療效觀察. 上海醫(yī)藥, 1999, 20(2): 22~23.
21. 丁靖, 孫新芳. 1,6-二磷酸果糖治療急性腦梗死. 中國煤炭工業(yè)醫(yī)學(xué)雜志, 2000, 3(2): 161.
22. 許萍. 1,6-二磷酸果糖治療腦卒中和顱腦損傷的作用. 中國臨床醫(yī)學(xué), 2001, (3): 282.
23. 彭小祥, 胡小紅, 鄧小容, 等. 1,6-二磷酸果糖治療糖尿病合并腦梗死療效觀察. 臨床內(nèi)科雜志, 2002, 19(2): 152~153.
24. 房娜, 張玉梅, 徐贊, 等. 果糖二磷酸治療腦梗死30例臨床觀察. 山東醫(yī)藥, 2003, 43(16): 63.
25. 劉秀琴, 崔麗英, 王擁軍, 等. 1,6二磷酸果糖注射液 (瑞安吉) 治療急性腦梗死的多中心、隨機(jī)、雙盲、安慰劑對(duì)照臨床研究. 中華老年多器官疾病雜志, 2005, 4(2): 201~204.
26. 孫麗艷, 王怡, 臧福才, 等. 1,6-二磷酸果糖治療119例腦梗死患者的療效觀察. 醫(yī)師進(jìn)修雜志, 2005, 28(7): 49~51.
27. 楊建中, 曾詠梅, 熊慧生, 等. 果糖二磷酸鈉治療急性腦梗死的臨床觀察. 重慶醫(yī)學(xué), 2005, 34(8): 1121~1122.
28. 李平平, 鄧昌華. 用FDP治療重癥腦梗塞30例療效觀察. 中原醫(yī)刊, 1998, 25(11): 24.
29. 王維和, 張曙光, 徐麗. 1,6-二磷酸果糖治療腦梗塞臨床觀察. 濱州醫(yī)學(xué)院學(xué)報(bào), 1999, 22(1): 26.
30. 桑琳麗. 佐用1,6-二磷酸果糖治療腦卒中103例. 山東醫(yī)藥, 2000, 40(10): 59.
31. 王雪梅, 魏建朝, 張偉東. 瑞安吉治療急性腦梗塞臨床觀察. 中華新醫(yī)學(xué), 2002, 3(10): 887~888.
32. Vickers A, Goyal N, Harland R, et al. Do certain countries produce only positive results? A systematic review of controlled trials. Control Clin Trials, 1998, 19(2): 159–166.
  1. 1. The 4th National Conference on Cardiovascular Disease. Neuro-function deficit score for stroke. Chinese Journal of Neurology, 1996, 29(6): 381–382.
  2. 2. Wang YM, Kong YQ. Clinical effect of 1,6-fructose diphosphate in patients with acute cerebral infarction. The Journal of Practical Medicine, 1997, 13(12): 845.
  3. 3. Wang DC. Effect of Fructose-1,6-Diphosphate in treating acute cerebral infarction. Journal of Youjiang Medical College for Nationalities, 1999, 21(4): 572.
  4. 4. Wang S, Zong BY, Li L. Therapeutic effects of 1,6-fructose diphosphate on cerebral infarction. Shanghai Medical & Pharmaceutical Journal, 1999, 20(2): 22–23.
  5. 5. Ding J, Sun XF. 1,6-fructose diphosphate for acute cerebral infarction. Chinese Journal of Coal Industry Medicine, 2000, 3(2): 161.
  6. 6. Xu P. Fructose 1,6-diphosphate for stroke and brain injury. Clinical Medical Journal of China, 2001, (3): 282.
  7. 7. Peng XX, Hu XH, Deng XR, et al. 1, 6-diphosphate fructose in the treatment of diabetes combined with cerebral infarction. Journal of Clinical Internal Medicine, 2002, 19(2): 152–153.
  8. 8. Fang N, Zhang YM, Xu Z, et al. Clinical observation of 1,6-diphosphate fructose in the treatment of cerebral infarction: 30 cases. Shandong Medical Journal, 2003, 43(16): 63.
  9. 9. Liu XQ, Cui LY, Wang YJ, et al. The clinical efficacy and safety of fructose-1,6-diphosphate (Ruianji) in treating acute cerebral infarction. Chin J Mult Organ Dis Elderly, 2005, 4(2): 201–204.
  10. 10. Sun LY, Wang Y, Zang FC, et al. Effect of 1,6-fructose diphosphate in 119 cases of cerebral infarction. Journal of Postgraduates of Medicine, 2005, 28(7): 49–51.
  11. 11. Yang JZ, Zeng YM, Xiong HS, et al. Clinical observation of fructosediphosephate in the treatment of acute cerebral infarction. Chongqing Medical Journal, 2005, 34(8): 1121–1122.
  12. 12. Li PP, Deng CH. FDP in severe cerebral infarction: 30 cases. Central Plains Medical Journal, 1998, 25(11): 24.
  13. 13. Wang WH, Zhang SG, Xu Li. Clinical effect of 1,6-diphosphate Fructose for cerebral infarction. Journal of Binzhou Medical College, 1999, 22(1): 26.
  14. 14. Sang LL. Use of 1,6-fructose diphosphate in the treatment of 103 stroke cases. Shandong Medical Journal, 2000, 40(10): 59.
  15. 15. Wang XM, Wei JC, Zhang WD. Clinical observation of Ruianji in treating acute cerebral infarction. Chinese New Medicine, 2002, 3(10): 887–888.
  16. 16. 全國第四屆腦血管病學(xué)術(shù)會(huì)議. 腦卒中患者神經(jīng)功能缺損評(píng)分標(biāo)準(zhǔn). 中華神經(jīng)科雜志, 1996, 29(6): 381~382.
  17. 17. Juni P, Altman DG, Eger M. Assessing the quality of controlled clinical trails. BMJ, 2001, 323(7303): 4246.
  18. 18. 王允明, 孔永奇. 1,6-二磷酸果糖治療急性腦梗塞臨床觀察. 實(shí)用醫(yī)學(xué)雜志, 1997, 13(12): 845.
  19. 19. 王大成. 1,6-二磷酸果糖治療急性腦梗塞效果觀察. 右江民族醫(yī)學(xué)院學(xué)報(bào), 1999, 21(4): 572.
  20. 20. 王松, 宗碧云, 李麗. 1,6-二磷酸果糖治療腦梗塞的臨床療效觀察. 上海醫(yī)藥, 1999, 20(2): 22~23.
  21. 21. 丁靖, 孫新芳. 1,6-二磷酸果糖治療急性腦梗死. 中國煤炭工業(yè)醫(yī)學(xué)雜志, 2000, 3(2): 161.
  22. 22. 許萍. 1,6-二磷酸果糖治療腦卒中和顱腦損傷的作用. 中國臨床醫(yī)學(xué), 2001, (3): 282.
  23. 23. 彭小祥, 胡小紅, 鄧小容, 等. 1,6-二磷酸果糖治療糖尿病合并腦梗死療效觀察. 臨床內(nèi)科雜志, 2002, 19(2): 152~153.
  24. 24. 房娜, 張玉梅, 徐贊, 等. 果糖二磷酸治療腦梗死30例臨床觀察. 山東醫(yī)藥, 2003, 43(16): 63.
  25. 25. 劉秀琴, 崔麗英, 王擁軍, 等. 1,6二磷酸果糖注射液 (瑞安吉) 治療急性腦梗死的多中心、隨機(jī)、雙盲、安慰劑對(duì)照臨床研究. 中華老年多器官疾病雜志, 2005, 4(2): 201~204.
  26. 26. 孫麗艷, 王怡, 臧福才, 等. 1,6-二磷酸果糖治療119例腦梗死患者的療效觀察. 醫(yī)師進(jìn)修雜志, 2005, 28(7): 49~51.
  27. 27. 楊建中, 曾詠梅, 熊慧生, 等. 果糖二磷酸鈉治療急性腦梗死的臨床觀察. 重慶醫(yī)學(xué), 2005, 34(8): 1121~1122.
  28. 28. 李平平, 鄧昌華. 用FDP治療重癥腦梗塞30例療效觀察. 中原醫(yī)刊, 1998, 25(11): 24.
  29. 29. 王維和, 張曙光, 徐麗. 1,6-二磷酸果糖治療腦梗塞臨床觀察. 濱州醫(yī)學(xué)院學(xué)報(bào), 1999, 22(1): 26.
  30. 30. 桑琳麗. 佐用1,6-二磷酸果糖治療腦卒中103例. 山東醫(yī)藥, 2000, 40(10): 59.
  31. 31. 王雪梅, 魏建朝, 張偉東. 瑞安吉治療急性腦梗塞臨床觀察. 中華新醫(yī)學(xué), 2002, 3(10): 887~888.
  32. 32. Vickers A, Goyal N, Harland R, et al. Do certain countries produce only positive results? A systematic review of controlled trials. Control Clin Trials, 1998, 19(2): 159–166.