Shengmai Injection for Hypoxic-ischemic Encephalopathy: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

WU Ming ¹ , LI Gang ² , SHEN Qi ³

1. Department of Pediatrics, The Affiliated Hospital of Xuzhou Medical College, Xuzhou 221002, China2. Department of Stomatology, The Affiliated Hospital of Xuzhou Medical College, Xuzhou 221002, China3. Department of Pediatrics, Liuzhou People’s Hospital, Liuzhou 545001, China;

Corresponding author：

Keywords：

Shengmai injection; Hypoxic-ischemic encephalopathy; Neonate; Systematic review

DOI：

10.7507/1672-2531.20080042

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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 power and high risks for selection bias, performance bias and measurement bias in the included trials, these conclusions need to be interpreted cautiously.

Citation： WU Ming,LI Gang,SHEN Qi. Shengmai Injection for Hypoxic-ischemic Encephalopathy: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2008, 08(3): 190-195. doi: 10.7507/1672-2531.20080042 Copy

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5.	李宁, 高惠萍, 张峰刚, 等. 生脉注射液与纳洛酮治疗新生儿缺氧缺血性脑病疗效观察. 实用心脑肺血管病杂志, 2006, 14(3): 220-221.
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9.	王兆领, 李艳. 生脉注射液治疗新生儿缺氧缺血性脑病的观察. 医药产业资讯, 2005, 2(15): 62-63.
10.	张青. 生脉注射液治疗新生儿缺氧缺血性脑病合并心肌损害临床研究. 山西医药杂志, 2001, 30(2): 113-115.
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1. 胡亚美, 江载芳, 主编. 诸福堂实用儿科学. 第7版. 北京: 人民卫生出版社, 2003. 450-451.
2. 李勤, 刘宏. 生脉注射液的药理作用及临床应用. 医学综述, 2005, 11(10): 950-952.
3. 中华医学会儿科学分会新生儿学组. 新生儿缺氧缺血性脑病诊断依据和临床分度. 中华儿科杂志, 1997, 35(2): 99.
4. 史长宏, 刘忠平, 王晓燕. 生脉注射液辅助治疗新生儿缺氧缺血性脑病合并心肌损害36例. 中国中西医结合杂志, 2005, 25(3): 268-269.
5. 李宁, 高惠萍, 张峰刚, 等. 生脉注射液与纳洛酮治疗新生儿缺氧缺血性脑病疗效观察. 实用心脑肺血管病杂志, 2006, 14(3): 220-221.
6. 汤钟娟, 江咏梅. 生脉注射液治疗新生儿缺氧缺血性脑病48例. 北京中医药大学学报 (中医临床版), 2003, 10(2): 27-28.
7. 江咏梅, 汤钟娟. 生脉注射液治疗新生儿缺氧缺血性脑病48例疗效观察. 山东医药, 2002, 42(30): 51-52.
8. 朱华玉, 王维照, 张立萍. 生脉注射液治疗新生儿缺氧缺血性脑病的临床应用. 山东医药, 2001, 41(5): 72.
9. 王兆领, 李艳. 生脉注射液治疗新生儿缺氧缺血性脑病的观察. 医药产业资讯, 2005, 2(15): 62-63.
10. 张青. 生脉注射液治疗新生儿缺氧缺血性脑病合并心肌损害临床研究. 山西医药杂志, 2001, 30(2): 113-115.
11. 鲍秀兰. 新生儿行为和0～3岁教育. 北京: 中国少年儿童出版社,1997, 120-140.

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Chinese Journal of Evidence-Based Medicine

Shengmai Injection for Hypoxic-ischemic Encephalopathy: A Systematic Review

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