Oldfield E C, Fessel W J, Dunne M W, Dickinson G, Wallace M R, Byrne W, Chung R, Wagner K F, Paparello S F, Craig D B, Melcher G, Zajdowicz M, Williams R F, Kelly J W, Zelasky M, Heifets L B, Berman J D
Naval Hospital, San Diego, California, USA.
Clin Infect Dis. 1998 Mar;26(3):611-9. doi: 10.1086/514566.
We conducted a randomized, double-blind, placebo-controlled multicenter trial of azithromycin (1,200 mg once weekly) for the prevention of Mycobacterium avium complex (MAC) infection in patients with AIDS and a CD4 cell count of < 100/mm3. In an intent-to-treat analysis through the end of therapy plus 30 days, nine (10.6%) of 85 azithromycin recipients and 22 (24.7%) of 89 placebo recipients developed MAC infection (hazard ratio, 0.34; P = .004). There was no difference in the ranges of minimal inhibitory concentrations of either clarithromycin or azithromycin for the five breakthrough (first) MAC isolates from the azithromycin group and the 18 breakthrough MAC isolates from the placebo group. Of the 76 patients who died during the study, four (10.5%) of 38 azithromycin recipients and 12 (31.6%) of 38 placebo recipients had a MAC infection followed by death (P = .025). For deaths due to all causes, there was no difference in time to death or number of deaths between the two groups. Episodes of non-MAC bacterial infection per 100 patient years occurred in 43 azithromycin recipients and 88 placebo recipients (relative risk, 0.49; 95% confidence interval, 0.33-0.73). The most common toxic effect noted during the study was gastrointestinal, reported by 78.9% of azithromycin recipients and 27.5% of placebo recipients. Azithromycin given once weekly is safe and effective in preventing disseminated MAC infection, death due to MAC infection, and respiratory tract infections in patients with AIDS and CD4 cell counts of < 100/mm3.
我们进行了一项随机、双盲、安慰剂对照的多中心试验，研究阿奇霉素（每周一次，1200毫克）对艾滋病患者且CD4细胞计数<100/mm³者预防鸟分枝杆菌复合体（MAC）感染的效果。在意向性分析中，至治疗结束加30天时，85名接受阿奇霉素治疗的患者中有9名（10.6%）发生MAC感染，89名接受安慰剂治疗的患者中有22名（24.7%）发生MAC感染（风险比，0.34；P = 0.004）。阿奇霉素组的5株突破性（首例）MAC分离株和安慰剂组的18株突破性MAC分离株，其克拉霉素或阿奇霉素的最低抑菌浓度范围无差异。在研究期间死亡的76例患者中，38名接受阿奇霉素治疗的患者中有4名（10.5%）发生MAC感染后死亡，38名接受安慰剂治疗的患者中有12名（31.6%）发生MAC感染后死亡（P = 0.025）。对于所有原因导致的死亡，两组之间的死亡时间或死亡人数无差异。每100患者年非MAC细菌感染发作次数，阿奇霉素治疗组有43例，安慰剂治疗组有88例（相对风险，0.49；95%置信区间，0.33 - 0.73）。研究期间观察到的最常见毒性反应为胃肠道反应，阿奇霉素治疗组78.9%的患者和安慰剂治疗组27.5%的患者报告有该反应。对于艾滋病患者且CD4细胞计数<100/mm³者，每周一次给予阿奇霉素在预防播散性MAC感染、MAC感染导致的死亡以及呼吸道感染方面安全有效。
