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社区获得性肺炎的治疗。一项比较克拉霉素与红霉素的多中心、双盲、随机研究。加拿大-瑞典克拉霉素-肺炎研究组。

Treatment of community-acquired pneumonia. A multicenter, double-blind, randomized study comparing clarithromycin with erythromycin. Canada-Sweden Clarithromycin-Pneumonia Study Group.

作者信息

Chien S M, Pichotta P, Siepman N, Chan C K

机构信息

Department of Medicine, University of Toronto, Ontario, Canada.

出版信息

Chest. 1993 Mar;103(3):697-701. doi: 10.1378/chest.103.3.697.

Abstract

The efficacy and safety of orally administered clarithromycin and erythromycin in the treatment of community-acquired pneumonia were assessed in a multicenter, double-blind, randomized study. Two hundred sixty-eight patients were randomized to receive either clarithromycin, 250 mg twice a day, or erythromycin stearate, 500 mg 4 times a day, for 7 to 14 days. Efficacy was evaluable in 173 patients (92 for clarithromycin, 81 for erythromycin). No statistically significant difference in clinical success rate (cure or improvement) was observed between the two groups (clarithromycin, 97 percent; erythromycin, 96 percent). Both groups had identical radiologic response (97 percent with resolution or improvement). Similarly, no statistically significant difference in bacteriologic response toward the target pathogens was observed among evaluable patients (clarithromycin, 23/26; erythromycin, 17/17; p value = 0.287). Clinical response toward Mycoplasma and Chlamydia pneumonia was comparable between the two groups (clarithromycin, 15/16; erythromycin, 10/11). However, patients receiving erythromycin had a twofold higher incidence of adverse events, mostly related to the gastrointestinal system, and were five times more likely to withdraw from therapy because of drug-related adverse events. These results show that clarithromycin is as effective as erythromycin in the outpatient treatment of community-acquired pneumonia. Furthermore, the lower incidence of adverse events associated with clarithromycin indicates that it is more acceptable to patients and, therefore, can enhance compliance.

摘要

在一项多中心、双盲、随机研究中,评估了口服克拉霉素和红霉素治疗社区获得性肺炎的疗效和安全性。268例患者被随机分为两组,一组接受克拉霉素治疗,每日2次,每次250mg;另一组接受硬脂酸红霉素治疗,每日4次,每次500mg,疗程7至14天。173例患者可进行疗效评估(克拉霉素组92例,红霉素组81例)。两组之间的临床成功率(治愈或改善)无统计学显著差异(克拉霉素组为97%,红霉素组为96%)。两组的放射学反应相同(97%患者病变消散或改善)。同样,在可评估患者中,对目标病原体的细菌学反应也无统计学显著差异(克拉霉素组23/26例,红霉素组17/17例;p值 = 0.287)。两组对支原体和衣原体肺炎的临床反应相当(克拉霉素组15/16例,红霉素组10/11例)。然而,接受红霉素治疗的患者不良事件发生率高出两倍,主要与胃肠道系统有关,因药物相关不良事件退出治疗的可能性高出五倍。这些结果表明,在社区获得性肺炎的门诊治疗中,克拉霉素与红霉素疗效相当。此外,克拉霉素相关不良事件发生率较低,表明患者对其接受度更高,因此可提高依从性。

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