Wang Zhi-Fei, Yu Jin-Yang, Xie Yan-Ming
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Center for ADR Monitoring of Guangdong, Guangzhou 510080, China.
Zhongguo Zhong Yao Za Zhi. 2017 Aug;42(15):2871-2876. doi: 10.19540/j.cnki.cjcmm.20170705.008.
This paper is to report the implementation and results of safety monitoring of Shenfu injection. Prospective, multicenter, large sample, registry-type centralized hospital monitoring mode was used, and the three-level quality control and anti-omissive mechanisms were used strictly. In the monitoring was carried out in 28 hospitals and lasted for 4 years. 30 106 patients were registered; ADE occurred in 114 patients, and ADR was identified in 23 patients with an incidence rate of 0.076% for ADR [95% confidence interval (0.045%,0.108%), which was in a rare level. The main ADRs included rash, pruritus, discomfort at the site of the infusion, nausea, vomiting, abdominal pain, dizziness, chest tightness, heart palpitations, chills, fever and dyspnea. No severe ADRs were found in the monitoring. This paper also fund that history of allergy, methods of administration, dosage, solvent, concentration, and combined medication may affect the incidence of ADR in the use of Shenfu injection.
本文旨在报道参附注射液安全性监测的实施情况及结果。采用前瞻性、多中心、大样本、登记型集中医院监测模式，并严格运用三级质量控制及防漏机制。监测在28家医院开展，持续4年。共登记30106例患者；114例患者出现药品不良事件（ADE），23例患者被认定为发生药品不良反应（ADR），ADR发生率为0.076%[95%置信区间（0.045%，0.108%）]，处于罕见水平。主要的ADR包括皮疹、瘙痒、输液部位不适、恶心、呕吐、腹痛、头晕、胸闷、心悸、寒战、发热及呼吸困难。监测中未发现严重ADR。本文还发现过敏史、给药方式、剂量、溶剂、浓度及联合用药可能影响参附注射液使用中ADR的发生率。
