参麦注射液辅助治疗休克的文献计量及HIS真实世界研究

Literature review and hospital information system data real world clinical outcome analysis of role of parenterally administered Shenmai in treatment of shock

参麦注射液具有益气固脱,养阴生津,生脉的功效。现代药理研究证明,其中含有的人参皂苷和麦冬皂苷等成分具有改善心脏泵血功能、提高心肌耐缺氧能力和机体免疫力、改善微循环、清除自由基等作用,适用于休克的辅助治疗。文献计量分析与HIS真实世界研究是2种常用的研究方法,是前瞻性研究的基础,该文将二者相结合,从参麦注射液辅助治疗休克的类型、常用剂量、合并用药等方面进行分析,2种方法所得到的结果基本一致,进而为了解参麦注射液辅助治疗休克的临床特征,以及进一步开展前瞻性研究提供方法与思路。但是由于参麦注射液辅助治疗休克的临床有效性文献质量并不是很高,为上市后临床疗效评价提供的证据级别不够,同时HIS所提供的数据信息属性为回顾性数据,信息缺失现象也较为常见,因而2种方法得到的结果虽可作为参麦注射液上市后临床再评价的基础和支撑,但仍要结合前瞻性的研究才可得出最终的结论。

Parenterally administered Shenmai has the functions of benefiting vital energy, nourishing Yin, generating body fluids, and activating the pulse. Modern pharmacological studies have shown that constituents of parenterally administered Shenmai such as ginsenosides and ophiopogonin can improve hypoxia tolerance, immunity, function, and microcirculation of the heart, and free radi- cal scavenging. Therefore, parenterally administered Shenmai is a suitable treatment for shock. Literature review and analysis of HIS data outcomes, are the two methods used to study the type of shock treated, dose and combinations of other medications used with par- enterally administered Shenmai. The results of the two methods are consistent in understanding the clinical features of shock therapy with parenterally administered Shenmai which thereby provides information for the design of prospective studies. However, the results of the two methods are limited by the poor quality of the literature and the low level of evidence for clinical evaluation after the registration of Shenmai. Nevertheless, HIS data provides retrospective data although some information is missing. Thus, although the results of the two methods can be used as the foundation to support the clinical evaluation of post-marketing parenterally administered Shenmai, final conclusions can only be drawn based on prospective studies.