Fructose 1,6-Diphosphate in Hypoxic lschemic Encephalopathy：A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

Liu Fang , Di SuoDi

Department of Pharmacy; Peking University Third Hospital; Beijing 100083; China;

Corresponding author：

Keywords：

Fructosediphosphate; Hypoxic ischemic encephalopathy; Systematic review

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Objective 　To assess the effectiveness and safety of fructose 1,6-diphosphate （FDP） in the treatment of hypoxic ischemic encephalopathy （HIE）patients.
Methods 　Biomedical databases, including MEDLINE （1977 -2004 ）, EMBASE（1989- 2004） ,Cochrane Injuries Group trials register, Cochrane Controlled Trials Register, CBMdisk and CNKI （1994- 2005 ）were searched. Chnical trials were collecte＆Quality assessments of chnical trials were carried out. Randomized controlled trials （RCTs） with mortality and the incidence of cerebral palsy, epilepsy and mental defect were selected for meta-analysis.
Results 　Nine RCTs were included, and all were done in China. None of the 9 RCTs described the method of randomization or allocation concealment. None of the 9 RCTs mentioned wether blindness was use＆ In Jadad score, 5 trials were scored by 2 and 4 trials were 1. Seven trials were included in the meta-analysis of death, which showed that the obsolute risk （OR） [95% confidence interval （CI）] of death following FDP administration was 0. 50 （95% CI 0. 21 to 1.16）. Five RCTs reported the results of follow-up. When intention to treat （ITT） analysis was adopted, the OR of FDP on cerebral palsy was 0. 36 （95% CI 0. 19 to 0. 89）, on epilepsy was 0.74 （95% CI 0. 29 to 1.88）, and on dementia was 0. 21 （95% CI 0. 06 to 0.70）. We didn＇t conduct sensitivity analysis because no RCTs were of high quality. We didn＇t identify clinical trials compared with adverse reactions between the two groups.
Conclusions 　The quality of RCTs on FDP for HIE is poor. Because there were no RCTs of high quality available, we can＇t draw a conlusion. Well-designed RCTs with economic evaluation are urgently needed to evaluate the value of FDP in the treatment of HIE.

Citation： Liu Fang,Di SuoDi. Fructose 1,6-Diphosphate in Hypoxic lschemic Encephalopathy：A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2005, 05(9): 696-701. doi: Copy

1.	高瑛. 新生儿缺氧缺血性脑病的治疗研究进展[J]. 临床儿科杂志, 2004; 22(8): 568～570.
2.	"九五"攻关项目HIE治疗协作组.新生儿缺氧缺血性脑病治疗方案(试行稿)[J]. 中国实用儿科杂志, 2000; 15(6): 381～382.
3.	李树青, 李乃琪, 李丽, 谭华清, 徐爱晶. 1,6-二磷酸果糖治疗新生儿缺氧缺血性脑病[J]. 实用儿科杂志, 1998; 13(1): 47.
4.	邵雷. 1,6-二磷酸果糖治疗新生儿缺氧缺血性脑病[J]. 脑与神经疾病杂志, 1998; 6(6): 335.
5.	叶斌. 1,6-二磷酸果糖治疗新生儿缺氧缺血性脑病疗效观察及预后探讨[J]. 新生儿科杂志, 2000; 15(3): 114～115.
6.	卓志强, 郑瑞霞, 施燕禧, 王素香. 果糖二磷酸钠治疗新生儿缺氧缺血性脑病疗效观察[J]. 中国医院药学杂志, 2000; 20(1): 19～20.
7.	况琦.1,6-二磷酸果糖治疗新生儿缺氧缺血性脑病观察[J]. 河南医药信息, 2001; 9(12): 10.
8.	杨康治, 陈正珊, 吴少华. 行为神经测定对1,6二磷酸果糖治疗新生儿缺氧缺血性脑病的疗效评价[J]. 实用医学杂志, 2001; 17(4): 363.
9.	杨秀芬, 于清, 张春跃. 1,6-二磷酸果糖治疗新生儿缺氧缺血性脑病疗效观察及预后探讨[J]. 中国优生与遗传杂志, 2001; 9(4): 76.
10.	王吉耀. 循证医学与临床实践[M]. 第1版. 北京: 科学出版社, 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, 刁建勋. 1,6二磷酸果糖佐治新生儿缺氧缺血性脑病106例[J]. 山东医药, 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, 刘鹏, 潘瑞超. 1,6-二磷酸果糖治疗新生儿缺氧缺血性脑病疗效观察[J]. 临床儿科杂志, 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. 高瑛. 新生儿缺氧缺血性脑病的治疗研究进展[J]. 临床儿科杂志, 2004; 22(8): 568～570.
2. "九五"攻关项目HIE治疗协作组.新生儿缺氧缺血性脑病治疗方案(试行稿)[J]. 中国实用儿科杂志, 2000; 15(6): 381～382.
3. 李树青, 李乃琪, 李丽, 谭华清, 徐爱晶. 1,6-二磷酸果糖治疗新生儿缺氧缺血性脑病[J]. 实用儿科杂志, 1998; 13(1): 47.
4. 邵雷. 1,6-二磷酸果糖治疗新生儿缺氧缺血性脑病[J]. 脑与神经疾病杂志, 1998; 6(6): 335.
5. 叶斌. 1,6-二磷酸果糖治疗新生儿缺氧缺血性脑病疗效观察及预后探讨[J]. 新生儿科杂志, 2000; 15(3): 114～115.
6. 卓志强, 郑瑞霞, 施燕禧, 王素香. 果糖二磷酸钠治疗新生儿缺氧缺血性脑病疗效观察[J]. 中国医院药学杂志, 2000; 20(1): 19～20.
7. 况琦.1,6-二磷酸果糖治疗新生儿缺氧缺血性脑病观察[J]. 河南医药信息, 2001; 9(12): 10.
8. 杨康治, 陈正珊, 吴少华. 行为神经测定对1,6二磷酸果糖治疗新生儿缺氧缺血性脑病的疗效评价[J]. 实用医学杂志, 2001; 17(4): 363.
9. 杨秀芬, 于清, 张春跃. 1,6-二磷酸果糖治疗新生儿缺氧缺血性脑病疗效观察及预后探讨[J]. 中国优生与遗传杂志, 2001; 9(4): 76.
10. 王吉耀. 循证医学与临床实践[M]. 第1版. 北京: 科学出版社, 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, 刁建勋. 1,6二磷酸果糖佐治新生儿缺氧缺血性脑病106例[J]. 山东医药, 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, 刘鹏, 潘瑞超. 1,6-二磷酸果糖治疗新生儿缺氧缺血性脑病疗效观察[J]. 临床儿科杂志, 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.

Chinese Journal of Evidence-Based Medicine

Fructose 1,6-Diphosphate in Hypoxic lschemic Encephalopathy：A Systematic Review

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