Halkin H
Department of Medicine A, Chaim Sheba Medical Center, Tel Hashomer, Israel.
Rev Infect Dis. 1988 Jan-Feb;10 Suppl 1:S258-61. doi: 10.1093/clinids/10.supplement_1.s258.
Data on adverse reactions due to the quinolone antibacterial agents--ciprofloxacin, ofloxacin, pefloxacin, norfloxacin, and enoxacin--observed in a patient sample of approximately 30,000 are reviewed. Overall rates of adverse reactions were 4.0%-8.0%, and adverse reactions necessitated discontinuation of therapy in 1.0%-2.6% of patients. Patterns of organ-system involvement and of signs and symptoms were quite similar, with gastrointestinal effects predominating (nausea, vomiting, diarrhea, or abdominal pain in 1.0%-5.0% of the patients), followed by effects on the central nervous system (dizziness, headache, and/or insomnia in 0.1%-0.3% of the patients) and skin (0.5%-2.2% of the patients). Elevation in levels of hepatic enzymes occurred in 1.8%-2.5% of the patients, azotemia in 0.2%-1.3%, and eosinophilia in 0.2%-2.0%. These adverse effects were reversible after drug withdrawal and were generally not dose-dependent. Within the constraints of the relatively small number of well-documented patients and the unique mechanism of action of these antimicrobial agents, the safety profile of these drugs seems to make them acceptable for use when their administration is well directed and specific. In addition, close surveillance for new phenomena should be maintained.
回顾了在约30000例患者样本中观察到的喹诺酮类抗菌药物（环丙沙星、氧氟沙星、培氟沙星、诺氟沙星和依诺沙星）引起的不良反应数据。不良反应的总体发生率为4.0%-8.0%，1.0%-2.6%的患者因不良反应而需要停药。器官系统受累及体征和症状的模式非常相似，以胃肠道反应为主（1.0%-5.0%的患者出现恶心、呕吐、腹泻或腹痛），其次是对中枢神经系统的影响（0.1%-0.3%的患者出现头晕、头痛和/或失眠）和皮肤（0.5%-2.2%的患者）。1.8%-2.5%的患者出现肝酶水平升高，0.2%-1.3%出现氮质血症，0.2%-2.0%出现嗜酸性粒细胞增多。停药后这些不良反应是可逆的，且一般不依赖剂量。在记录充分的患者数量相对较少以及这些抗菌药物作用机制独特的限制条件下，当这些药物的使用得到良好指导且具有针对性时，其安全性似乎使其可以接受。此外，应持续密切监测新出现的现象。
