参附注射液治疗重型颅脑损伤随机对照试验meta分析

A meta-analysis of randomized controlled trials of Shenfu injection in the treatment of severe head injury

目的运用meta分析研究参附注射液治疗重型颅脑损伤临床疗效。方法计算机数据库检索以“参附注射液”和“重型颅脑损伤”为主题词及其自由词的国内外公开发表的随机对照试验文献,检索时限为建库至2020年12月。使用Cochrane量表对文献进行评价,运用Review Manger 5.3及STATA软件进行meta分析。结果共纳入8篇文献,共524例患者,Cochrane量表评分在中度偏倚风险以下。meta分析表明,相比单纯常规或亚低温治疗,加用参附注射液可明显降低重型颅脑损伤患者急性期颅内压(SMD=-2.82,95%CI-3.19~-2.45,P<0.05);有效改善急性期患者格拉斯哥昏迷评分(GCS)(SMD=0.67,95%CI 0.41~0.94,P<0.05),提高治疗30 d的格拉斯哥预后评分(GOS)(OR=2.55,95%CI 1.57~4.41,P<0.05)。结论重型颅脑损伤患者加用参附注射液可有效降低急性期颅内压,减轻患者颅内血流循环障碍,显著改善急性期患者昏迷程度,提高预后。

Objective To systematically evaluate the clinical efficacy of Shenfu injection in the treatment of severe head injury.Methods Databases including PubMed,Medline,The Cochrane Library,Elsevier,VIP,WanFang Data,CNKI,and CMB were searched from inception to December,2020 to collect literature on the“Shenfu injection”“severe head injury”.The Cochrane scale was used to evaluate the literature,and the Review Manger 5.3 software and STATA were used for meta-analysis.Results A total of 8 articles were included,and the Cochrane scale score was below the moderate risk of bias.A total of 524 patients were included.Meta analysis showed that compared with simple conventional or mild hypothermia treatment,the addition of Shenfu injection can reduce acute intracranial pressure in patients with severe head injury(SMD=-2.82,95%CI-3.19--2.45,P<0.05),and effectively improve the Glasgow coma score(GCS)(SMD=0.67,95%CI 0.41-0.94,P<0.05)in acute stage patients and the prognosis of Glasgow after 30 days of treatment score(GOS)(OR=2.55,95%CI 1.57-4.41,P<0.05).Conclusion The addition of Shenfu injection in patients with severe head injury can effectively reduce the intracranial pressure in the acute phase,relieve the patient's intracranial blood circulation disorder,significantly improve the degree of coma in the acute phase,and improve the prognosis.