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吉米沙星是一种广谱喹诺酮类抗菌药,它除了保持对革兰阴性菌(包括其他抗生素的耐药菌)的优秀活性外,对包括多重耐药性肺炎链球菌在内的革兰阳性菌也具有良好的活性。业已证明,本品对呼吸道感染和尿路感染特别有效。本文对临床试验中6775例患者口服吉米沙星(320mg/d)与5248名患者服用标准剂量的其他喹诺酮、大环内酯类抗生素或β-内酰胺类抗生素以及对在健康志愿者和特殊人群中的不良反应进行比较,以便对其安全性进行全面的评估。吉米沙星和对照药的不良事件发生率分别为44.7%和47.5%,主要表现为轻度胃肠道反应(其中腹泻5.1%,恶心3.9%)。本品的药疹的发生率为3.6%,其中在年轻女性中更高(>20%)。吉米沙星和对照药中出现可能与治疗相关的不良反应发生率分别为17.4%和20%,因出现不良反应而导致停止治疗的比例分别为2.2%和2.1%。本品可使QT间期轻微延长[2.56m s(SD±24.5)],但未见心率不齐。严重不良事件的总发生率分别为3.6%和4.3%,但其中与治疗相关者极少(二组均为0.4%)。本品与奥美拉唑、地高辛、茶碱、华法林无明显的药物相互作用。对老年肾或肝功能损伤患者而言,本品的耐受性良好。总之,与包括其他喹诺酮在内的抗生素对照药相似,口服吉米沙星(320mg/d)具有良好的安全性和耐受性。
Gemifloxacin is a broad-spectrum quinolone antibacterial drug that, in addition to its excellent activity against Gram-negative bacteria, including other antibiotic-resistant bacteria, is resistant to Gram-positive, including multiresistant Streptococcus pneumoniae The bacteria also have good activity. It has been proven that this product is particularly effective for respiratory infections and urinary tract infections. In this paper, 6775 patients in clinical trials of gemifloxacin (320mg / d) and 5248 patients taking standard doses of other quinolone, macrolide antibiotics or β-lactam antibiotics and in healthy volunteers and special populations In the adverse reactions were compared in order to conduct a comprehensive assessment of its safety. The incidence rates of adverse events of gemifloxacin and control drugs were 44.7% and 47.5%, respectively, which were mainly mild gastrointestinal reactions (diarrhea 5.1% and nausea 3.9%). The incidence of drug eruption of this product is 3.6%, of which higher in young women (> 20%). The incidence of possible treatment-related adverse events in gemifloxacin and control drugs were 17.4% and 20%, respectively, and 2.2% and 2.1%, respectively, of discontinuation of treatment due to adverse reactions. This product can make a slight extension of QT interval [2.56m s (SD ± 24.5)], but no arrhythmia. The overall incidence of serious adverse events were 3.6% and 4.3%, respectively, but very few were related to treatment (0.4% in both groups). This product and omeprazole, digoxin, theophylline, warfarin no obvious drug interactions. For elderly patients with renal or liver damage, the product is well tolerated. In conclusion, oral administration of gemifloxacin (320 mg / d) showed good safety and tolerability similar to the antibiotic control, including other quinolones.