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高血脂患者口服甲硝唑的药物不良反应监测
The ADRs Monitoring of Metronidazole in Paients with Hyperlipidemia
【摘要】 为了探讨甲硝唑治疗高血脂症的安全性,68例高血脂患者口服10d甲硝唑,分三种日剂量给药[Ⅰ.0,6g/d,38例;Ⅱ.1.2g/d,20例;Ⅲ.1.8g/d,10例)系统监测甲硝唑药物不良反应(ADRs).68例出现ADRs者42例,72例次,ADRs发生率为61.8%.消化系ADRs例次最多(45例次),恶心多见;其次为神经系统(23例次),多见头痛乏力;皮肤最少(4例次).ADRs出现日多在第2d及第3d,程度轻度最多(61.1%).三种方案ADRs发生率比较,方案Ⅲ(90%)及方案Ⅱ(80.0%)均较方案Ⅰ(44.7%)高,差异显著P<O.05.结果表明高血脂患者口服甲硝唑,ADRs发生率较高,日剂量大者(1.8g/d)尤高而严重,多不易耐受,甲硝唑治疗高血压脂症新用途的安全性不佳.
【Abstract】 In order to investigate the safety of metronidazole (MTZ) therapy in patients with hyperlipidemia, the ADRs of MTZ were monitored. 68 patients with hyperlipidemia were given MTZ orally for 10 days by three regimens: 1) 0. 6 g/d, 38 patients; 2) 1.2 g/d, 20 patients; 3) 1. 8 g/d, 10 patients. 42 patients developed ADRs of MTZ with the rate being 61.8%. 72 case-times of ARDs were found in 42 patients. The ADRs of digestive system was on the top of the list (45 case-time), with the nausea being the most commonly seen adverse effect, followed by adverse effects in nerve system (23 case-times), manifested by headache and fatigue. Skin ADRs were the least. Most ADRs were found on day 2 and day 3 and most of them were mild (61. 1%). The comparison among 3 regimes showed that ADRs of regime 3 (90%) and regime 2 (80%) were higher than those of regime 1(44.7%). Their differences were all statistically significant (P< 0. 05). The results showed that the ADRs rate of MTZ in patients with hyperlipidemia was high, especially in patients receiving high dose (1.8 g/d). The high dose group had a high rate of ADRs, which were usually more serious. Most patients could not tolerate the dosage, indicating that the safety of MTZ therapy is poor in patients with hyperlipidemia.
- 【文献出处】 药物流行病学杂志 ,Chinese Journal of Pharmaco Epidemiology , 编辑部邮箱 ,1996年04期
- 【分类号】R181.35
- 【被引频次】16
- 【下载频次】40