The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, People's Republic of China.
Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, 300000, People's Republic of China.
BMC Complement Altern Med. 2018 Oct 16;18(1):277. doi: 10.1186/s12906-018-2329-z.
Traditional Chinese medicine injections (TCMIs) have been widely used to treat severe and acute diseases due to their high bioavailability, accurate curative effect, and rapid effect. However, incidence rates of adverse drug reactions (ADRs) of TCMIs have also increased in recent years. Xueshuantong injection (XSTI) is a commonly-used TCMI comprised of Panax notoginseng total sapiens for the treatment of stroke hemiplegia, chest pain, and central retinal vein occlusion. Its safety remains uncelar. Therefore, post-marketing safety of XSTI was studied in this research.
In present study, post-marketing safety surveillance and re-evaluation of XSTI were reported. Thirty thousand eight hundred eighty-four patients in 33 hospitals from 7 provinces participated in this study. Incidence rate, most common clinical manifestations, types, severity, occurrence time, and disposal of ADRs were calculated.
Incidence rate of ADR of XSTI was 4.14‰ and the most common clinical manifestations were skin and its appendages damage. Type A accounts for 95.49% of ADRs of XSTI and most of them (41.41%) were occurred within 24 h after receiving XSTI treatment. Severities of most ADRs of XSTI were moderate reactions (86.72%). Main disposition of ADRs of XSTI was drug withdrawal and symptomatic treatment (54.69%).
Our data provide basis for improvement of instructions of XSTI and clinical safety of XSTI. Post-marketing surveillance of TCMIs in this study is a powerful tool to identify types and manifestations of ADRs to improve safety and effectiveness of drugs in clinical applications.
This protocol has international registration in China clinical trial registration center ( ChiCTROPC 14,005,718 ) at December 22, 2014.
由于中药注射液（TCMIs）具有生物利用度高、疗效确切、起效快等特点，已广泛用于治疗重症、急症。但近年来中药注射液不良反应（ADRs）的发生率也有所增加。血塞通注射液（XSTI）是一种常用的中药注射液，由三七总皂苷组成，用于治疗中风偏瘫、胸痛、视网膜中央静脉阻塞等。其安全性仍不清楚。因此，本研究对 XSTI 进行了上市后安全性研究。
本研究报告了 XSTI 的上市后安全性监测和再评价。来自 7 个省 33 家医院的 3884 名患者参与了这项研究。计算了不良反应的发生率、最常见的临床表现、类型、严重程度、发生时间和处理方法。
XSTI 的不良反应发生率为 4.14‰，最常见的临床表现为皮肤及其附件损害。A型不良反应占 XSTI 不良反应的 95.49%，其中大部分（41.41%）发生在接受 XSTI 治疗后 24 小时内。XSTI 大多数不良反应的严重程度为中度反应（86.72%）。XSTI 不良反应的主要处理方法是停药和对症治疗（54.69%）。
我们的数据为改进 XSTI 的说明书和 XSTI 的临床安全性提供了依据。本研究对中药注射液的上市后监测是一种识别 ADR 类型和表现的有力工具，可提高药物在临床应用中的安全性和有效性。
本方案于 2014 年 12 月 22 日在中国临床试验注册中心（ChiCTR-OPC-14005718）进行了国际注册。
