CLINICAL TOLERATION AND SAFETY OF AZITHROMYCIN
CLINICAL TOLERATION AND SAFETY OF AZITHROMYCIN
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DOI：
10.1016/0002-9343(91)90401-i
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发表时间：
1991-09-12
影响因子：
5.9
通讯作者：
HOPKINS, S
中科院分区：
文献类型：
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作者：
HOPKINS, S
在3995例年龄在2-94岁（平均36岁）的患者（包括1644名女性和2351名男性）中，对氮唑类抗生素阿奇霉素的耐受性和安全性进行了评估。呼吸道或皮肤/皮肤结构感染患者5天内给予1.5 g阿奇霉素；衣原体引起的尿道炎/宫颈炎患者单次用药1 g。在治疗前和治疗开始后约7-14天和30天对副作用和实验室安全测试异常进行评估。使用了12种标准抗生素进行比较。总的来说，12.0%的患者出现了不良反应，显著低于比较药物的14.2% （p < 0.05）。最常见的副作用是腹泻（3.6%）、腹痛（2.5%）和其他胃肠道症状。93%的副作用被归类为轻度或中度，只有0.7%的患者退出治疗，显著低于比较药物（2.6%）。副作用发生的频率不受患者年龄的影响。阿奇霉素对实验室安全参数没有明显或一致的影响。治疗相关的实验室异常很少见，最常见的是短暂性ALT和AST升高，分别为1.7%和1.5%的患者。特异性检查未发现神经学、听力学或眼科异常，也无磷脂病的证据。没有观察到与茶碱、华法林、西咪替丁、卡马西平或甲基强的松龙的药代动力学相互作用，但与食物共给药改变了药物的吸收。与抗酸药共给药可降低阿奇霉素的血药峰浓度，但不影响其总吸收。阿奇霉素在多种并发疾病和药物的情况下具有良好的耐受性。
The toleration and safety profile of the azalide antibiotic, azithromycin, has been assessed in 3,995 patients aged 2-94 (mean, 36) years, comprising 1,644 females and 2,351 males. Patients with infections of the respiratory tract or skin/skin structure received 1.5 g azithromycin over 5 days; patients with urethritis/cervicitis caused by Chlamydia were treated with 1 g as a single dose. Assessments of side effects and laboratory safety test abnormalities were made pretreatment and approximately 7-14 and 30 days after the start of therapy. Twelve standard antibiotics have been used for comparison. Overall, side effects were recorded in 12.0% of patients, significantly less (p < 0.05) than with comparative drugs (14.2%). The most common side effects were diarrhea (3.6%), abdominal pain (2.5%), and other gastrointestinal symptoms. Ninety-three percent of side effects were classed as mild or moderate, and only 0.7% of patients withdrew from treatment, significantly less (p < 0.001) than with comparative agents (2.6%). The frequency of side effects was not affected by patient age. Azithromycin had no marked or consistent effect on laboratory safety parameters. Treatment-related laboratory abnormalities were rare, the most common being transient increases of ALT and AST in 1.7% and 1.5% of patients, respectively. Specific tests revealed no neurologic, audiometric, or ophthalmologic abnormalities, or evidence of phospholipidosis. There were no pharmacokinetic interactions observed with theophylline, warfarin, cimetidine, carbamazepine, or methylprednisolone, but coadministration with food altered the absorption of the drug. Coadministration with antacids decreased the peak serum concentration of azithromycin, but did not affect its overall absorption. Azithromycin was well tolerated in the presence of a wide variety of concurrent illnesses and medications.