J Antimicrob Chemother. 1993 Jun;31(6):949-61. doi: 10.1093/jac/31.6.949.
In a double-blind, multicentre study, 662 patients with acute maxillary sinusitis were randomly assigned to receive either loracarbef 400 mg bd (332 patients) or doxycycline, 200 mg for the first dose followed by 100 mg od, (330 patients) for ten days. One hundred and sixty-eight patients in the loracarbef group and 164 in the doxycycline group were evaluable for efficacy. Streptococcus pneumoniae and/or Haemophilus influenzae were isolated from approximately 75% of patients. The clinical response rate (cure or improvement) was significantly higher for patients receiving loracarbef (98.2%) than for those who received doxycycline (92.2%). There was no significant difference between the two groups with respect to bacteriological outcome, although more of the pre-treatment isolates were resistant to doxycycline (35 strains) than to loracarbef (five strains). Adverse events related to the gastrointestinal tract occurred in 11.7% and 10.6% of loracarbef- and doxycycline-treated patients respectively; therapy was terminated prematurely in ten patients in the loracarbef group and in nine in the doxycycline group. The results indicate that loracarbef is effective and safe treatment for acute maxillary sinusitis.
在一项双盲、多中心研究中,662例急性上颌窦炎患者被随机分配,分别接受氯碳头孢400毫克,每日两次(332例患者)或强力霉素治疗,首剂200毫克,随后每日100毫克(330例患者),疗程均为10天。氯碳头孢组有168例患者、强力霉素组有164例患者可进行疗效评估。约75%的患者分离出肺炎链球菌和/或流感嗜血杆菌。接受氯碳头孢治疗的患者临床有效率(治愈或改善)显著高于接受强力霉素治疗的患者(分别为98.2%和92.2%)。两组在细菌学结果方面无显著差异,尽管治疗前分离出的菌株中对强力霉素耐药的(35株)多于对氯碳头孢耐药的(5株)。氯碳头孢治疗组和强力霉素治疗组分别有11.7%和10.6%的患者发生与胃肠道相关的不良事件;氯碳头孢组有10例患者、强力霉素组有9例患者提前终止治疗。结果表明,氯碳头孢是治疗急性上颌窦炎的有效且安全的药物。