Sokol William N, Sullivan James G, Acampora Matthew D, Busman Todd A, Notario Gerard F
Health Research Institute, Newport Beach, California 92660, USA.
Clin Ther. 2002 Apr;24(4):605-15. doi: 10.1016/s0149-2918(02)85136-0.
Treatment guidelines for community-acquired pneumonia (CAP) generally include use of a macrolide, a fluoroquinolone, or doxycycline, although there is some debate concerning the use of a fluoroquinolone.
The efficacy and tolerability of a new once-daily, extended-release (ER) formulation of clarithromycin were compared with those of a fluoroquinolone, trovafloxacin, in the treatment of patients with CAP.
This was a prospective, multicenter, double-blind, double-dummy, parallel-group trial in which outpatients were randomized to receive 7 days of once-daily treatment with either clarithromycin ER (two 500-mg tablets) or trovafloxacin (200 mg). Eligible patients were > or = 18 years old with signs and symptoms of pneumonia, radiologic evidence of an acute infiltrate, and mild to moderate infection, as classified by the investigator.
One hundred seventy-six patients were randomized to study treatment. They were primarily white (88%) and equally distributed between the sexes (52% female). Their mean (+/-SD) age was 47.5 +/- 16.2 years. Results were similar between treatment groups in rates of clinical cure, microbiologic cure, bacteriologic eradication, and radiologic success at the test-of-cure visit (14-21 days posttreatment) for both the per-protocol and intent-to-treat analyses. Among clinically evaluable patients, clinical cure rates for clarithromycin ER and trovafloxacin were 87% (74/85) and 95% (63/66), respectively, and radiologic success rates were 95% (80/84) and 95% (63/66), respectively. There were no statistically significant differences between groups. In clinically and microbiologically evaluable patients, overall bacteriologic eradication rates were 89% (85/95) for clarithromycin ER and 96% (64/67) for trovafloxacin, with no significant differences between groups. Both antibiotics demonstrated high eradication rates against target microorganisms. There were no clinically meaningful differences in the incidence of specific drug-related adverse events. The majority of drug-related adverse events (>90%) were considered mild or moderate and resolved without the need for additional treatment.
Although the study was prematurely terminated, resulting in inadequate power to demonstrate equivalence, once-daily clarithromycin ER was effective and well tolerated in the treatment of ambulatory adult (age > or = 18 years) outpatients with CAP.
社区获得性肺炎（CAP）的治疗指南通常包括使用大环内酯类药物、氟喹诺酮类药物或多西环素，尽管对于氟喹诺酮类药物的使用存在一些争议。
比较一种新的每日一次的克拉霉素缓释（ER）制剂与氟喹诺酮类药物曲伐沙星在治疗CAP患者中的疗效和耐受性。
这是一项前瞻性、多中心、双盲、双模拟、平行组试验，门诊患者被随机分配接受为期7天的每日一次治疗，分别使用克拉霉素ER（两片500毫克片剂）或曲伐沙星（200毫克）。符合条件的患者年龄≥18岁，有肺炎的体征和症状、急性浸润的影像学证据，且由研究者分类为轻度至中度感染。
176例患者被随机分配接受研究治疗。他们主要为白人（88%），男女分布均衡（女性占52%）。他们的平均（±标准差）年龄为47.5±16.2岁。在治疗结束访视（治疗后14 - 21天）时，在意向性分析和符合方案分析中，治疗组在临床治愈率、微生物学治愈率、细菌清除率和影像学改善率方面的结果相似。在可进行临床评估的患者中，克拉霉素ER和曲伐沙星的临床治愈率分别为87%（74/85）和95%（63/66），影像学改善率分别为95%（80/84）和95%（63/66）。两组之间无统计学显著差异。在可进行临床和微生物学评估的患者中，克拉霉素ER的总体细菌清除率为89%（85/95），曲伐沙星为96%（64/67），两组之间无显著差异。两种抗生素对目标微生物均显示出高清除率。在特定药物相关不良事件的发生率方面无临床意义上的差异。大多数药物相关不良事件（>90%）被认为是轻度或中度的，无需额外治疗即可缓解。
尽管该研究提前终止，导致证明等效性的效能不足，但每日一次的克拉霉素ER在治疗门诊成年（年龄≥18岁）CAP患者中有效且耐受性良好。
