Zheng Rui, Wang Hui, Liu Zhi, Wang Xiaohui, Li Jing, Lei Xiang, Fan Yilin, Liu Si, Feng Zhiqiao, Shang Hongcai
Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.
Evidence-based Medicine Center, Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.
Ann Transl Med. 2019 Mar;7(6):117. doi: 10.21037/atm.2018.09.26.
Although we have made tremendous medical advances in recent decades in modern antibiotics and supportive therapies, the treatment of sepsis has not experienced such rapid advancement. Xuebijing injection (XBJ) is a Chinese prescription consisting of rubra, and . Clinical experience suggests that XBJ may provide a solution in the management of sepsis. However, the safety of this treatment is still controversial. This study aims to detect the occurrence of XBJ-related adverse drug reactions (ADRs) among individuals in clinical practice.
From the clinical application of XBJ in a real-world setting, patients in 93 hospitals using XBJ were monitored between August 2013 and August 2016. There was no limit on the treatment course and dosage. From data obtained in interviews or telephone follow-ups with hospitalized patients, the circumstances of patients' adverse events (AEs) during the course of drug treatment and during the 7 days after drug withdrawal were recorded and encoded by MedDRA18.0. The likelihood of ADRs was determined by the criteria of the Uppsala Monitoring Centre. Statistical analyses were performed by SAS9.2 software.
In total, 31,913 participants enrolled, and none were lost to follow-up. AEs (suspected ADRs) occurred in 234 participants. ADRs occurred in 96 participants, and the incidence was 0.3%. The ADRs with the top three frequencies were skin pruritus (0.116%), erythra (0.066%) and chest tightness (0.044%). There was no significant relationship between ADRs and solvents (P=0.149), route of administration (P=0.640), unhealthy addiction (P=0.069), allergy (P=0.535), first use of XBJ (P=0.161) or dosage (P=0.743). There was a significant relationship between ADRs and irrigating syringe (P<0.0001) and fluid dripping too quickly (P=0.019).
This large-scale survey of hospitalized patients found that the incidence of ADRs was occasional (0.3%), while most of the ADRs were relatively mild or non-serious. XBJ should be administered rationally and according to its instructions to prevent the occurrence of ADRs.
尽管近几十年来我们在现代抗生素和支持性治疗方面取得了巨大的医学进步，但脓毒症的治疗并未取得如此迅速的进展。血必净注射液（XBJ）是一种由[具体成分1]、[具体成分2]等组成的中药制剂。临床经验表明，血必净可能为脓毒症的治疗提供一种解决方案。然而，这种治疗方法的安全性仍存在争议。本研究旨在检测临床实践中使用血必净的个体中与血必净相关的药物不良反应（ADR）的发生情况。
从血必净在实际临床环境中的应用情况来看，对2013年8月至2016年8月期间使用血必净的93家医院的患者进行了监测。治疗疗程和剂量均无限制。根据对住院患者的访谈或电话随访所获得的数据，记录患者在药物治疗期间及停药后7天内不良事件（AE）的情况，并按照MedDRA18.0进行编码。根据乌普萨拉监测中心的标准确定药物不良反应的可能性。使用SAS9.2软件进行统计分析。
总共纳入了31913名参与者，无一例失访。234名参与者发生了不良事件（疑似药物不良反应）。96名参与者发生了药物不良反应，发生率为0.3%。发生率最高的前三种药物不良反应分别是皮肤瘙痒（0.116%）、皮疹（0.066%）和胸闷（0.044%）。药物不良反应与溶媒（P = 0.149）、给药途径（P = 0.640）、不良嗜好（P = 0.069）、过敏（P = 0.535）、首次使用血必净（P = 0.161）或剂量（P = 0.743）之间均无显著关系。药物不良反应与冲洗注射器（P < 0.0001）和滴注速度过快（P = 0.019）之间存在显著关系。
这项对住院患者的大规模调查发现，药物不良反应的发生率较低（0.3%），且大多数药物不良反应相对较轻或不严重。应合理使用血必净并按照说明书用药，以预防药物不良反应的发生。
