Bowie W R, Willetts V, Binns B A, Brunham R C
Division of Infectious Disease, Department of Medicine, University of British Columbia, Vancouver, British Columbia; and the Departments of Obstetrics and Gynecology, Medicine, and Microbiology and Infectious Diseases, University of Manitoba, Winnipeg, Manitoba.
Can J Infect Dis. 1993 Mar;4(2):95-100. doi: 10.1155/1993/209218.
To evaluate the etiology of cervicitis using the recommended Canadian definition, and to evaluate the efficacy and tolerability of seven days of minocycline treatment, 100 versus 200 mg at bedtime.
Randomized double-blind study with initial microbiological evaluation, and intended follow-up through 12 weeks.
Women attending the major sexually transmitted disease clinic in Vancouver and the major teaching hospital in Winnipeg.
Women with cervicitis (inclusion criteria were an off-white or yellow colour of cervical mucus when viewed on a white-tipped swab, and a mean of 10 or more polymorphonuclear leukocytes per oil immersion [× 1000] field on Gram stain of cervical mucus). Fourty-four women were enrolled but two were excluded because of contaminated cultures.
Treatment with two identical appearing capsules of 50 mg (100 mg dose) or 100 mg (200 mg dose) of minocycline taken at bedtime with water for seven days.
Of the 42 evaluable women, Chlamydia trachomatis was initially isolated from 19 (45%) and Neisseria gonorrhoeae from four (10%). The study was prematurely terminated because of an unacceptable and significantly higher frequency of adverse reactions on the higher dose regimen of minocycline - severe reactions in one (4%) on 100 mg compared with six (30%) on 200 mg (P=0.05). Major reactions were dizziness, mood alterations and nausea. Clinical parameters, but not numbers of polymorphonuclear leukocytes, improved significantly irrespective of initial microbiology or the regimen received. Cultures became and stayed negative for C trachomatis in seven of eight on minocycline 100 mg and five of six on minocycline 200 mg. Both 'failures' had an intervening negative culture and were re-exposed to untreated sexual partners.
Although not a definitive study in terms of proving efficacy of lower dose regimens, the results are consistent with efficacy and demonstrate the significant advantage of the lower dose regimen in terms of adverse reactions.
采用推荐的加拿大宫颈炎定义评估宫颈炎病因,并评估米诺环素治疗7天(睡前服用100mg或200mg)的疗效和耐受性。
随机双盲研究,初始进行微生物学评估,计划随访12周。
温哥华主要性传播疾病诊所及温尼伯主要教学医院就诊的女性。
宫颈炎女性(纳入标准为用白色头拭子观察时宫颈黏液呈灰白色或黄色,且宫颈黏液革兰氏染色每油镜视野[×1000]平均有10个或更多多形核白细胞)。44名女性入组,但2名因培养物污染被排除。
睡前用水服用两粒外观相同的胶囊,分别含50mg(100mg剂量)或100mg(200mg剂量)米诺环素,共7天。
42名可评估女性中,最初从19名(45%)分离出沙眼衣原体,4名(10%)分离出淋病奈瑟菌。由于米诺环素高剂量方案不良反应发生率不可接受且显著更高,该研究提前终止——100mg组1名(4%)出现严重反应,200mg组6名(30%)出现严重反应(P=0.05)。主要反应为头晕、情绪改变和恶心。无论初始微生物学情况或接受的治疗方案如何,临床参数均显著改善,但多形核白细胞数量未改善。米诺环素100mg组8名中的7名及200mg组6名中的5名沙眼衣原体培养转为阴性并持续阴性。两名“治疗失败”患者中间培养结果为阴性,并再次接触未治疗的性伴侣。
尽管就证明低剂量方案疗效而言并非确定性研究,但结果与疗效相符,并显示出低剂量方案在不良反应方面的显著优势。