生脉注射液治疗新生儿缺氧缺血性脑病疗效的系统评价

目的系统评价生脉注射液治疗新生儿缺氧缺血性脑病(HIE)的疗效和安全性。方法计算机检索MEDLINE(1966～2007.2)、EMbase(1980～2007.2)、CBM(1978～2006年)、CNKI(1979～2007.2)、VIP(1989～2007.2),手工检索5种中文儿科杂志,纳入生脉注射液治疗新生儿HIE的随机和半随机对照试验,并对其进行质量评价。用RevMan4.2.8软件进行统计分析。结果共纳入7个随机对照试验。Meta分析结果显示,常规治疗下,加用生脉注射液组的5天治愈率高于未用组RR1.55,95%CI(1.25,1.93)],10天治愈情况相似RR0.74,95%C(I0.43,1.29)];生脉注射液组与纳洛酮组5天及10天疗效均相似RR(95%CI)分别为1.55(1.25,1.93);0.88(0.53,1.46)]。加用生脉注射液组病死率、致残率与对照组相比无明显差异RR(95%CI)分别为0.44(0.16,1.19)和0.58(0.21,1.56)]。对于HIE合并心肌损害的患儿,加用生脉注射液后,心电图恢复情况也优于对照组WMD=-2.02,95%CI(-2.76,-1.28)];CK-MB、CK-BB的恢复优于对照组WMD(95%CI)分别为-4.78(-6.77,-2.79)和-2.68(-4.58,-0.78)]。加用生脉注射液后进行NBNA评分,5天与10天疗效治疗组均优于对照组WMD(95%CI)分别为4.05(2.47,5.63)和3.50(2.26,4.74)]。现有资料未提示有不良反应发生。结论生脉注射液对于新生儿HIE的治疗有一定价值。常规治疗加用生脉注射液可以明显加快HIE患儿临床症状恢复。对于HIE合并心肌损害的患儿,还能促进其心电图、CK-MB和CK-BB的恢复。但由于本次评价纳入的研究质量不高,存在选择性偏倚、实施偏倚、测量性偏倚的高度可能性,尚需要更多的高质量研究提供可靠的证据对其疗效及安全性做进一步评价。

Shengmai Injection for Hypoxic-ischemic Encephalopathy: A Systematic Review

Objective To evaluate the efficacy and safety of Shengmai injection for hypoxic-ischemic encephalopathy(HIE).Methods We searched MEDLINE(1966 to February 2007),EMBASE(1980 to February 2007),CBM(1978 to 2006),CNKI(1979 to February 2007),VIP(1989 to February 2007),and handsearched five Journals on Pediatrics.We evaluated features of quality of included studies,including randomization,blinding,allocation concealment and loss of follow-up.Meta-analyses were performed using The Cochrane Collaboration's RevMan 4.2.8.Results Seven randomized controlled trials were included.The cure rate on day 5 in the Shengmai injection group was higher than in the control group(RR 1.55,95%CI 1.25 to 1.93),but this rate was similar on day 10(RR 0.74,95%CI 0.43 to 1.29).No significant difference in cure rate was noted between the Shengmai injection group and naloxone group(RR 0.88,95%CI 0.53 to 1.46).No significant differences were observed in mortality(RR0.44,95%CI 0.16 to 1.19) and mutilation rate(RR 0.58,95%CI 0.21 to 1.56) between the Shengmai injection group and the control group.For those babies suffering from HIE combined with myocardial damage,Shengmai injection could speed up the recovery of ECG(WMD=-2.02,95%CI-2.76 to-1.28) and myocardial enzymogram(CK-MB:WMD=-4.78,95%CI-6.77 to-2.79;CK-BB:WMD=-2.68,95%CI-4.58 to-0.78).Significant differences in NBNA score were noted between the Shengmai injection group and the control group on day 5(WMD=4.05,95%CI 2.47 to 5.63) and day 10(WMD=3.50,95%CI 2.26 to 4.74).No fatal side effects were reported.Conclusions Shengmai injection has certain therapeutic values in treating HIE.Shengmai injection can speed up the recovery ECG,CK-BM and CK-BB of HIE patients,especially in those who have myocardial damage.Shengmai injection can also improve the NBNA score.However,because of the low statistical powerand high risks for selection bias,performance bias and measurement bias in the included trials,these conclusions need to be interpreted cautiously.