• 北京大學(xué)第三醫(yī)院藥劑科,北京100083;

目的 　評(píng)價(jià)1,6-二磷酸果糖(FDP)治療新生兒缺氧缺血性腦病(HIE)的療效與安全性.
方法 　計(jì)算機(jī)檢索MEDLINE(1977～2004年)、EMBASE(1989～2004年)、Cochrane圖書(shū)館(2004年第4期)、CBM(1978～2004年)和CNKI(1994～2005年)等文獻(xiàn)數(shù)據(jù)庫(kù),收集FDP治療HIE的臨床研究和系統(tǒng)評(píng)價(jià),進(jìn)行質(zhì)量評(píng)價(jià),并對(duì)符合納入標(biāo)準(zhǔn)的臨床研究進(jìn)行Meta分析.
結(jié)果 　共納入9項(xiàng)隨機(jī)對(duì)照研究,全部為中文.5項(xiàng)研究的JADAD評(píng)分為2分,4項(xiàng)研究為1分.各研究均未描述具體的隨機(jī)方法,未進(jìn)行分配方案的隱藏.所有研究均未使用盲法.7項(xiàng)研究報(bào)道了治療過(guò)程中的死亡例數(shù), 5項(xiàng)研究進(jìn)行了隨訪.與安慰劑或空白對(duì)照比較,FDP組死亡的OR(95%CI)為0.50(0.21,1.16),腦癱的OR(95%CI) 0.36(0.19,0.89),癲癇的OR(95%CI)為0.74(0.29,1.88),智力低下的OR(95%CI)為0.21(0.06,0.70).由于缺乏高質(zhì)量的臨床研究,上述Meta分析中未進(jìn)行敏感性分析.未檢索到評(píng)價(jià)FDP用于HIE安全性的評(píng)價(jià)研究.
結(jié)論 　目前FDP用于HIE的臨床研究普遍質(zhì)量較低.由于缺乏高質(zhì)量的臨床研究,FDP用于治療HIE的有效性缺乏證據(jù).

引用本文： 劉 芳,翟所迪. 1,6-二磷酸果糖治療新生兒缺氧缺血性腦病的系統(tǒng)評(píng)價(jià). 中國(guó)循證醫(yī)學(xué)雜志, 2005, 05(9): 696-701. doi: 復(fù)制

1. 高瑛. 新生兒缺氧缺血性腦病的治療研究進(jìn)展[J]. 臨床兒科雜志, 2004; 22(8): 568～570.
2. "九五"攻關(guān)項(xiàng)目HIE治療協(xié)作組.新生兒缺氧缺血性腦病治療方案(試行稿)[J]. 中國(guó)實(shí)用兒科雜志, 2000; 15(6): 381～382.
3. 李樹(shù)青, 李乃琪, 李麗, 譚華清, 徐愛(ài)晶. 1,6-二磷酸果糖治療新生兒缺氧缺血性腦病[J]. 實(shí)用兒科雜志, 1998; 13(1): 47.
4. 邵雷. 1,6-二磷酸果糖治療新生兒缺氧缺血性腦病[J]. 腦與神經(jīng)疾病雜志, 1998; 6(6): 335.
5. 葉斌. 1,6-二磷酸果糖治療新生兒缺氧缺血性腦病療效觀察及預(yù)后探討[J]. 新生兒科雜志, 2000; 15(3): 114～115.
6. 卓志強(qiáng), 鄭瑞霞, 施燕禧, 王素香. 果糖二磷酸鈉治療新生兒缺氧缺血性腦病療效觀察[J]. 中國(guó)醫(yī)院藥學(xué)雜志, 2000; 20(1): 19～20.
7. 況琦.1,6-二磷酸果糖治療新生兒缺氧缺血性腦病觀察[J]. 河南醫(yī)藥信息, 2001; 9(12): 10.
8. 楊康治, 陳正珊, 吳少華. 行為神經(jīng)測(cè)定對(duì)1,6二磷酸果糖治療新生兒缺氧缺血性腦病的療效評(píng)價(jià)[J]. 實(shí)用醫(yī)學(xué)雜志, 2001; 17(4): 363.
9. 楊秀芬, 于清, 張春躍. 1,6-二磷酸果糖治療新生兒缺氧缺血性腦病療效觀察及預(yù)后探討[J]. 中國(guó)優(yōu)生與遺傳雜志, 2001; 9(4): 76.
10. 王吉耀. 循證醫(yī)學(xué)與臨床實(shí)踐[M]. 第1版. 北京: 科學(xué)出版社, 2002. p. 59.
11. Gao Y. Progress in the research of Hypoxic Ischemic Encephalopathy treatment[J]. Journal of Clinical Pediatrics, 2004; 22(8): 568-570.
12. Ferriero, Donna M. Medical Progress: Neonatal Brain Injury[J]. New England Journal of Medicine, 2004; 351(19): 1985-1995.
13. National key scientific and technological project-Cooperation Group of HIE treatment. Pilot plan for the treatment of Hypoxic Ischemic Encephalopathy[J]. Chinese Journal of Practical Pediatrics, 2000; 15(6): 381-382.
14. Jadad AR, Moore A, Carroll D, Jenkinson C, Reynolds JM, Gavaghan DJ. Assessing the quality of reports of randomized clinical trials: Is blinding necessary[J]. Control Clin Trials, 1996; 17(1): 1-12.
15. Li SQ, Li NQ, Li L, Tan HQ, Xu AJ. 1,6-fructose diphosphate in treating of Hypoxic Ischemic Encephalopathy[J]. Journal of Practical Pediatrics, 1998; 13(1): 47.
16. Shao L. 1,6-fructose diphosphate for treatment of Hypoxic Ischemic Encephalopathy[J]. Journal of Brain and Nervous Disease, 1998; 6(6): 335.
17. Ye B. Therapeutic effects and prognosis of fructose 1,6-diphosphate in treating Hypoxic Ischemic Encephalopathy[J]. Journal of Neonatolog, 2000; 15(3): 114-115.
18. Zhuo ZQ, Zheng RX, Shi YX, Wang SX. Observation of curative effect of Fructose-1,6-Diphosphate in treating Hypoxic Ischemic Encephalopathy[J]. Journal of Hospital Pharmacy, 2000; 20(1): 19-20.
19. Kuang Q. Study of fructose-1,6-diphosphate on the treatment of Hypoxic Ischemic Encephalopathy[J]. He Nan Medical Information, 2001; 9(12): 10.
20. Yang KZ, Chen ZS, Wu SH. Evaluation the efficacy of Fructose-1,6-Diphosphate for Hypoxic Ischemic Encephalopathy with neonatal behavior neurologic assessment[J]. The Journal of Practical Medicine, 2001; 17(4): 363.
21. Yang XF, Yu Q, Zhang CY. Efficacy and prognosis of Fructose-1,6-Diphosphate on Hypoxic Ischemic Encephalopathy[J]. Chinese Journal of Birth Health and Heredity, 2001; 9(4): 76.
22. Hao YZ, Diao JX. Effect of fructose 1,6-diphosphate administration in 106 cases of Hypoxic Ischemic Encephalopathy [J]. Shandong Medical Journal, 2002; 42(6): 46.郝玉芝, 刁建勛. 1,6二磷酸果糖佐治新生兒缺氧缺血性腦病106例[J]. 山東醫(yī)藥, 2002; 42(6): 46.
23. Li XL, Liu P, Pan RC. Clinical effect of fructose diphosphate on patients with Hypoxic Ischemic Encephalopathy[J]. Journal of Clinical Pediatrics, 2002; 20(8): 471-472.李秀玲, 劉鵬, 潘瑞超. 1,6-二磷酸果糖治療新生兒缺氧缺血性腦病療效觀察[J]. 臨床兒科雜志, 2002; 20(8): 471～472.
24. Wang JY. Evidence-Based Medicine and Clinical Practice[M]. 1sd edition. Beijing: Scientific Publication, 2002. 59.
25. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in Meta-analyses[J]. Lancet, 1998; 352: 609-613.
26. Vickers A, Goyal N, Harland R, Rees R. Do certain countries produce only positive results? A systematic review of controlled trials[J]. Control clin trials, 1998; 19(2): 159-166.
27. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J]. JAMA, 1995; 273(5): 408-412.
  1. 1. 高瑛. 新生兒缺氧缺血性腦病的治療研究進(jìn)展[J]. 臨床兒科雜志, 2004; 22(8): 568～570.
  2. 2. "九五"攻關(guān)項(xiàng)目HIE治療協(xié)作組.新生兒缺氧缺血性腦病治療方案(試行稿)[J]. 中國(guó)實(shí)用兒科雜志, 2000; 15(6): 381～382.
  3. 3. 李樹(shù)青, 李乃琪, 李麗, 譚華清, 徐愛(ài)晶. 1,6-二磷酸果糖治療新生兒缺氧缺血性腦病[J]. 實(shí)用兒科雜志, 1998; 13(1): 47.
  4. 4. 邵雷. 1,6-二磷酸果糖治療新生兒缺氧缺血性腦病[J]. 腦與神經(jīng)疾病雜志, 1998; 6(6): 335.
  5. 5. 葉斌. 1,6-二磷酸果糖治療新生兒缺氧缺血性腦病療效觀察及預(yù)后探討[J]. 新生兒科雜志, 2000; 15(3): 114～115.
  6. 6. 卓志強(qiáng), 鄭瑞霞, 施燕禧, 王素香. 果糖二磷酸鈉治療新生兒缺氧缺血性腦病療效觀察[J]. 中國(guó)醫(yī)院藥學(xué)雜志, 2000; 20(1): 19～20.
  7. 7. 況琦.1,6-二磷酸果糖治療新生兒缺氧缺血性腦病觀察[J]. 河南醫(yī)藥信息, 2001; 9(12): 10.
  8. 8. 楊康治, 陳正珊, 吳少華. 行為神經(jīng)測(cè)定對(duì)1,6二磷酸果糖治療新生兒缺氧缺血性腦病的療效評(píng)價(jià)[J]. 實(shí)用醫(yī)學(xué)雜志, 2001; 17(4): 363.
  9. 9. 楊秀芬, 于清, 張春躍. 1,6-二磷酸果糖治療新生兒缺氧缺血性腦病療效觀察及預(yù)后探討[J]. 中國(guó)優(yōu)生與遺傳雜志, 2001; 9(4): 76.
  10. 10. 王吉耀. 循證醫(yī)學(xué)與臨床實(shí)踐[M]. 第1版. 北京: 科學(xué)出版社, 2002. p. 59.
  11. 11. Gao Y. Progress in the research of Hypoxic Ischemic Encephalopathy treatment[J]. Journal of Clinical Pediatrics, 2004; 22(8): 568-570.
  12. 12. Ferriero, Donna M. Medical Progress: Neonatal Brain Injury[J]. New England Journal of Medicine, 2004; 351(19): 1985-1995.
  13. 13. National key scientific and technological project-Cooperation Group of HIE treatment. Pilot plan for the treatment of Hypoxic Ischemic Encephalopathy[J]. Chinese Journal of Practical Pediatrics, 2000; 15(6): 381-382.
  14. 14. Jadad AR, Moore A, Carroll D, Jenkinson C, Reynolds JM, Gavaghan DJ. Assessing the quality of reports of randomized clinical trials: Is blinding necessary[J]. Control Clin Trials, 1996; 17(1): 1-12.
  15. 15. Li SQ, Li NQ, Li L, Tan HQ, Xu AJ. 1,6-fructose diphosphate in treating of Hypoxic Ischemic Encephalopathy[J]. Journal of Practical Pediatrics, 1998; 13(1): 47.
  16. 16. Shao L. 1,6-fructose diphosphate for treatment of Hypoxic Ischemic Encephalopathy[J]. Journal of Brain and Nervous Disease, 1998; 6(6): 335.
  17. 17. Ye B. Therapeutic effects and prognosis of fructose 1,6-diphosphate in treating Hypoxic Ischemic Encephalopathy[J]. Journal of Neonatolog, 2000; 15(3): 114-115.
  18. 18. Zhuo ZQ, Zheng RX, Shi YX, Wang SX. Observation of curative effect of Fructose-1,6-Diphosphate in treating Hypoxic Ischemic Encephalopathy[J]. Journal of Hospital Pharmacy, 2000; 20(1): 19-20.
  19. 19. Kuang Q. Study of fructose-1,6-diphosphate on the treatment of Hypoxic Ischemic Encephalopathy[J]. He Nan Medical Information, 2001; 9(12): 10.
  20. 20. Yang KZ, Chen ZS, Wu SH. Evaluation the efficacy of Fructose-1,6-Diphosphate for Hypoxic Ischemic Encephalopathy with neonatal behavior neurologic assessment[J]. The Journal of Practical Medicine, 2001; 17(4): 363.
  21. 21. Yang XF, Yu Q, Zhang CY. Efficacy and prognosis of Fructose-1,6-Diphosphate on Hypoxic Ischemic Encephalopathy[J]. Chinese Journal of Birth Health and Heredity, 2001; 9(4): 76.
  22. 22. Hao YZ, Diao JX. Effect of fructose 1,6-diphosphate administration in 106 cases of Hypoxic Ischemic Encephalopathy [J]. Shandong Medical Journal, 2002; 42(6): 46.郝玉芝, 刁建勛. 1,6二磷酸果糖佐治新生兒缺氧缺血性腦病106例[J]. 山東醫(yī)藥, 2002; 42(6): 46.
  23. 23. Li XL, Liu P, Pan RC. Clinical effect of fructose diphosphate on patients with Hypoxic Ischemic Encephalopathy[J]. Journal of Clinical Pediatrics, 2002; 20(8): 471-472.李秀玲, 劉鵬, 潘瑞超. 1,6-二磷酸果糖治療新生兒缺氧缺血性腦病療效觀察[J]. 臨床兒科雜志, 2002; 20(8): 471～472.
  24. 24. Wang JY. Evidence-Based Medicine and Clinical Practice[M]. 1sd edition. Beijing: Scientific Publication, 2002. 59.
  25. 25. Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in Meta-analyses[J]. Lancet, 1998; 352: 609-613.
  26. 26. Vickers A, Goyal N, Harland R, Rees R. Do certain countries produce only positive results? A systematic review of controlled trials[J]. Control clin trials, 1998; 19(2): 159-166.
  27. 27. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J]. JAMA, 1995; 273(5): 408-412.