| BackgroundHypoxic ischemic encephalopathy(HIE) in newboms is a kind of cerebral lesion caused by prenatal anoxia neonatorum and ischemia. The main causes are intrauterine distress and asphyxia neonatorum, which are also the common factors leading to the prenatal full-term deaths or brain injury .HIE patients may have good prognosis if not serious, but it may lead to feeblemindedness, brain paralysis or epilepsy if serious, which might not only affect the quality of population, but also exert heavy load on family or society. No standards of diagnosis, curative effect or clinical norms have been set and the study of HIE has become one of the most important clinical fields. reports on the use of cerebrolysin in treating HIE have increased a lot, but great controversy still exists because no clinical experiments of large samples, multiple centers or random double-blind contrast have been conducted and no comprehensive evaluation on the quality or curative effect of these clinical trials have been made, therefore, scientific evidence is still unavailable to confirm the curative effect of cerebrolysin on HIE.Objectivesthis literature is use EBM systematic evaluation methods to analyze and appraise the clinical effects, cautions, side effects and contraindication for the curative effects of cerebrolysin on HIE.MethodsAccording to the standard of the Cochrane Collaboration, electronic and manual searches were conducted to collect the clinical trials of the accessory treatment of HIE in newborns with cerebrolysin and the data were then evaluated systematically. No language limitations were applied in this process. The quality of trials was evaluated based on the Jadad evaluation scale. In the quantitative comprehensive evaluation, Fixed or random potency model was chosen according to the heterogeneity between the studies.Results1.Data gathered in this studyUp to 85 articles were got through research, of which 9 conformed to the standard of application, all in Chinese. In the 9 trials, there were 726 cases of HIE, including 466 males and 260 female.366 cases in the treatment group were treated with cerebrolysin, which the other 360cases formed the contrast group. The mean samples were 81 cases (48～169 cases).All the 9 trials were confirmed to be of poor quality. Funnel plot analyses showed uneven distribution of scatter diagram, which might indicate the possibility of deviation or the poor quality of experimental methods.2.Results of Meta analyses(1)The short-term curative effects: according to the results of the 9 trials, the total effective rates were 87.43%(320/366) in the treatment group and 69.72%(251/360) in the contrast group respectively. The pooled OR=3.38;95%CI:1.54～7.42.The integral effects: Z=3.03;P=0.002.the short-term clinical effect was higher in the treatment group than in the contrast group.(2)The long-term effects:①In the 9 trials, 152 cases missed follow-up surveys(including 76 cases in the treatment group and 76 cases in the contrast group)with the rate of missed follow-up surveys being 21%,290 cases in the treatment group received follow-up surveys and 248 cases were found to be effective with the effective rate being 85.52%,while 284 cases in the contrast group received follow-up surveys and 198 cases were found to be effective with the effective rate being 69.72% (pooled OR=2.63;95%CI:1.36～5.07) ,The integral effects:Z=2.88;P=0.004.Cerebrolysin was found to have higher effective rate in the treatment group than in the contrast group in the long term.②Of the 9 trials,4 of them were excluded because there was a high percentage of missed follow-up surveys, and the other 5 trials had 20 cases of missed follow-up surveys consisting of 8 cases in the treatment group and 12 cases in the contrast group with the rate of missed follow-up surveys being 5.6%.if the cases of missed follow-up surveys in the treatment group were regarded as invalid but those in the contrast group as valid, the effective rate in the treatment group was 83.52%(147/176),and in the contrast group was 70.39%.pooled OR=2.11;95%CI:1.26～3.52;The integraleffects:Z=2.86;P=0.004.according to this analysis, the long-term curative rate can be believed to be higher in the treatment group than in the contrast group after statistical treatment.3. Results of qualitative comprehensive analyses(1)Neonatal behavioral neurological assessment (NBNA):Two trials analyzed the NBNA values. One trials found no statistical significance (t =1.23,P >0.05) in the NBNA values on the third day, but statistical significance(t=2.78,3.54;P<0.01) was found on the 7th and 14th day, with the value being higher in the treatment group .the other study found the statistical significance in the NBNA values from the 5th to 7th day and from the 10th to 14th day (t =5.13,4.20;P <0.01),but not on the 1st day (t =0.11 ,P >0.05),with the value being lower in the cerebrolysin group.(2) Time of the disappearance of nervous disease symptoms:One study indicated that the mean time of the disappearance time of nervous disease symptoms were (4.0±2.4) d in the treatment group and (5.4±2.0) d in the contrast group.the time being less in the treatment group (t =3.654,P<0.01).(3)The mean hospitalization time: One study showed that the mean hospitalization time were ( 12.8±1.78 ) d in the treatment group and (15.5±2.07) d in the contrast group. the mean time being less in the treatment group(t=6.097,P<0.01).(4)The time of recovery of consciousness:One study indicates that the time of recovery of consciousness were (9.41±1.27) d in the treatment group and (5.11±1.06) d in the contrast group, the time being more in the treatment group(t =16.68,P<0.01).(5)Side effects: Of the 9 studies, 8 revealed no obvious side effects, and the other one did not mention them.ConclusionsThis study reveals that cerebrosylin can have short-term and long-term curative effect in helping to treat HIE without causing obvious side effects.
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