31724例灯盏细辛注射液安全性医院集中监测研究

A postmarketing surveillance study on 31 724 patients using Dengzhan Xixin injection in hospital

分析灯盏细辛注射液不良反应(ADR)发生特征和发生率。采用多中心、大样本、前瞻性医院集中监测方法,对2012年8月至2014年12月使用灯盏细辛注射液的住院及门诊31 724例患者进行监测,对出现ADR的患者临床表现进行详细记录。结果 31 724例患者中发生ADR 15例,占0.06%,主要表现为皮疹、皮肤瘙痒、头痛、面红、腹痛等,累及皮肤及其附件损害等6个系统,15例患者中男性8例,女性7例;1例有大黄黄芩过敏史;患者出现ADR距用药时间最短为5 min,大多数为用药0.5 h内;ADR患者均停药处理,其中2例使用异丙嗪,转归为痊愈及好转;有2例用药浓度超过正常范围。结果表明,灯盏细辛注射液ADR发生率属罕见,以中老年人为主,多在用药0.5 h内发生,临床应注意监测中老年人群用药及与其他药物联合使用情况。

Aim to explore the adverse drug reactions（ADR） characteristic and calculate the ADR incidence of Dengzhan Xixin injection（DZXX）. A muhicenter, large sample, and prospective cohort study was conducted from August 2012 to December 2014. A total of 31 724 patients using DZXX were observed. A total of 31 724 patients with 15 ADR cases among 31 724 patients, accounting for 0.06%, were reported. There were 8 male patients ADRs and 7 female patients with ADRs. ADRs included skin rashes, itching, headache, red face, ab- dominal pain, etc. 1 case with rhubarb radix seutellariac allergies. These ADRs happened from 5 rain to within 0.5 h after DZXX were used to treat patients. ADR patients discontinued treatment, of which 2 patients used promethazine for recovery and improvement. There were 2 cases with different DZXX concentration, out of the normal range. DZXX injection could cause some ADRs. Users must not ignore these and be careful of its related side effects. This study was a cohort with large sample, which should produce strong evidence for clinical practice. However, there was still weak evidence to conclude that it was a safe Chinese medicine injection in clinical practice.