Luis Arredondo J, Higuera F, Narcio M L, Casanova G, Beltrán M
Departamento de Infectología e Inmunología, Instituto Nacional de Perinatología, México, D.F.
Ginecol Obstet Mex. 1994 Aug;62:226-34.
Efficiency and security clindamycin vaginal cream (2%) were compared to oral metronidazole's for the treatment of 184 women with symptomatic bacterial vaginosis in a multicentric, randomized, double-blind, controlled study. The treatment was of 7 days duration, using placebo capsules for the clindamycin group and placebo cream for the metronidazole group. Patients were observed during a follow up (4-13 and 20-43 days after completion of therapy). Global results of this treatment indicated that clindamycin vaginal cream offers a similar efficiency than oral metronidazole. Improvement or total healing was 87% for clindamycin and 79% for metronidazole, with no significant differences (p > 0.22). No relapses were observed in the clindamycin group, and 7% in the metronidazole group. The clindamycin group had a failure rate of 3% compared to 15% in the oral metronidazole group. Both drugs were well tolerated. Side effects more frequently reported were vulvovaginal irritation and cervicitis/vaginitis. The only side effect that could have been classified as serious was a generalized rash in a patient receiving metronidazole. It was concluded that clindamycin vaginal cream (2%) is an efficient and secure alternative to oral metronidazole for the treatment of bacterial vaginosis being the elective therapy for pregnant women in their first gestational trimester.
在一项多中心、随机、双盲、对照研究中,对184例有症状的细菌性阴道病女性患者,比较了2%克林霉素阴道乳膏与口服甲硝唑的疗效和安全性。治疗为期7天,克林霉素组使用安慰剂胶囊,甲硝唑组使用安慰剂乳膏。在随访期间(治疗完成后4 - 13天和20 - 43天)观察患者。该治疗的总体结果表明,克林霉素阴道乳膏的疗效与口服甲硝唑相似。克林霉素组的改善或完全治愈率为87%,甲硝唑组为79%,无显著差异(p>0.22)。克林霉素组未观察到复发,甲硝唑组为7%。克林霉素组的失败率为3%,口服甲硝唑组为15%。两种药物耐受性均良好。更常报告的副作用是外阴阴道刺激和宫颈炎/阴道炎。唯一可被归类为严重的副作用是一名接受甲硝唑治疗的患者出现全身性皮疹。结论是,2%克林霉素阴道乳膏是治疗细菌性阴道病的一种有效且安全的替代口服甲硝唑的药物,是孕早期孕妇的首选治疗方法。