Wang Zhifei, Xie Yanming, Wang Yongyan
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Zhongguo Zhong Yao Za Zhi. 2011 Oct;36(20):2862-5.
Yuxingcao injection was suspended by China State Food and Drug Administration in 2006 for its severe adverse reaction in clinical practice. Althoug there are many real factors resulted in Yuxingcao injection's adverse reaction, some confounding factors should not be ignored. This study searched different kinds of related literatures and found out irregularity in defining dosage, disuses courses, indications and administration approach, which were the potential factors that caused the reported adverse drug reaction for Yuxingcao injection. And 97.8% adverse drug reaction in Yuxingcao injection happened 30 minutes after patients received administion, hence, observing patients'reaction in the first 30 minutes should be very important to prevent severe adverse drug reaction.
2006年,由于鱼腥草注射液在临床应用中出现严重不良反应,被国家食品药品监督管理局暂停使用。尽管导致鱼腥草注射液不良反应的有许多实际因素,但一些混杂因素也不容忽视。本研究检索了各类相关文献,发现其在剂量界定、用药疗程、适应证及给药途径等方面存在不规范之处,这些都是导致鱼腥草注射液不良反应报告的潜在因素。而且,97.8%的鱼腥草注射液不良反应发生在患者用药后30分钟内,因此,在用药后的前30分钟观察患者反应对于预防严重不良反应非常重要。