Wilson Robert, Schentag Jerome J, Ball Peter, Mandell Lionel
Royal Brompton Hospital, London, England.
Clin Ther. 2002 Apr;24(4):639-52. doi: 10.1016/s0149-2918(02)85139-6.
Gemifloxacin is an enhanced-affinity quinolone with potent activity against lower respiratory tract pathogens.
The efficacy and safety of a 5-day course of gemifloxacin were compared with those of a standard 7-day regimen of clarithromycin in patients with an acute exacerbation of chronic bronchitis (AECB). The impact of treatment on the long-term (26 weeks) clinical outcome was also assessed.
The acute phase of this randomized, double-blind study was performed in 93 centers in 7 countries. Adult patients (age >40 years) with a history of chronic bronchitis and an Anthonisen type 1 acute exacerbation (increased dyspnea, cough, and sputum purulence) were eligible. Patients receiving systemic steroids at a dose of >10 mg prednisone or the equivalent were excluded. Patients were randomized to receive gemifloxacin 320 mg once daily for 5 days or clarithromycin 500 mg twice daily for 7 days. Clinical and bacteriologic response rates were assessed at the end-of-therapy visit (days 8-12), the week 2-3 follow-up visit (days 13-24), and the week 4-5 follow-up visit (days 25-38). The long-term phase (26 weeks), which included US and Canadian participants only, evaluated the proportion of patients who remained free of a recurrence of AECB requiring additional antimicrobial therapy after resolution of the initial episode.
Seven hundred twelve patients were randomized to treatment, 351 to gemifloxacin and 361 to clarithromycin. The long-term study included 438 patients, 214 receiving gemifloxacin and 224 receiving clarithromycin. Clinical success rates at the 2-3 week follow-up visit were 85.4% for gemifloxacin and 84.6% for clarithromycin. Bacteriologic success rates were 86.7% for gemifloxacin and 73.1% for clarithromycin. Significantly more patients receiving gemifloxacin than clarithromycin remained free of AECB recurrences (71.0% vs 58.5%, respectively; P = 0.016). Both treatments were well tolerated.
In the acute treatment of Anthonisen type 1 AECB, a 5-day course of gemifloxacin was at least as effective as a 7-day regimen of clarithromycin. In this population, significantly more patients receiving gemifloxacin remained free of AECB recurrence after 26 weeks compared with those receiving clarithromycin.
吉米沙星是一种亲和力增强的喹诺酮类药物，对下呼吸道病原体具有强效活性。
比较吉米沙星5天疗程与标准7天克拉霉素疗程治疗慢性支气管炎急性加重期（AECB）患者的疗效和安全性。还评估了治疗对长期（26周）临床结局的影响。
这项随机、双盲研究的急性期在7个国家的93个中心进行。入选患者为有慢性支气管炎病史且符合安东尼森1型急性加重（呼吸困难、咳嗽和痰液脓性增加）的成年患者（年龄>40岁）。排除接受剂量>10mg泼尼松或等效剂量全身用类固醇的患者。患者被随机分配接受吉米沙星320mg每日一次，共5天，或克拉霉素500mg每日两次，共7天。在治疗结束访视（第8 - 12天）、第2 - 3周随访访视（第13 - 24天）和第4 - 5周随访访视（第25 - 38天）时评估临床和细菌学反应率。长期阶段（26周）仅包括美国和加拿大的参与者，评估在初始发作缓解后无需额外抗菌治疗的AECB复发患者比例。
712例患者被随机分配接受治疗，351例接受吉米沙星治疗，361例接受克拉霉素治疗。长期研究包括438例患者，214例接受吉米沙星治疗，224例接受克拉霉素治疗。吉米沙星组在第2 - 3周随访时的临床成功率为85.4%，克拉霉素组为84.6%。吉米沙星组的细菌学成功率为86.7%，克拉霉素组为73.1%。接受吉米沙星治疗且无AECB复发的患者明显多于接受克拉霉素治疗的患者（分别为71.0%和58.5%；P = 0.016）。两种治疗耐受性均良好。
在安东尼森1型AECB的急性治疗中，吉米沙星5天疗程至少与克拉霉素7天疗程一样有效。在该人群中，与接受克拉霉素治疗的患者相比，接受吉米沙星治疗的患者在26周后无AECB复发的明显更多。
