Gump D W, Ashikaga T, Fink T J, Radin A M
Antimicrob Agents Chemother. 1977 Nov;12(5):642-6. doi: 10.1128/AAC.12.5.642.
The incidence of side effects due to two dosage regimens of minocycline was examined over a 5-day period. A total of 60 normal women volunteers were randomly assigned in a double-blind manner to either a group who took 100 mg of minocycline twice a day or a group who took 75 mg of minocycline twice a day for 5 days. Both groups were comparable from the standpoints of age, size, race, and the use of oral contraception, nicotine, and ethanol. They were seen on a daily basis, and symptoms were evaluated by both volunteers (from diaries) and physicians. Minocycline serum concentrations were determined on blood samples taken 2 h after the a.m. dose. Volunteers taking 150 mg of minocycline per day had significantly lower serum antibiotic concentrations than those taking 200 mg per day. However, both low- and high-dose groups exhibited similar incidence and prevalence of recorded symptoms, with the single exception of nausea, where the low-dose group had fewer symptoms than the high-dose group (P = 0.035). Symptomatic volunteers did not have higher serum concentrations of minocycline than their asymptomatic counterparts. When either weight or surface area was examined with antibiotic serum concentration there was a significant inverse correlation between the two on day 2 for both groups and also on day 4 for the low-dose group. It is concluded that, in women, a dose of 150 mg of minocycline per day is associated with the same degree of side effects as a dose of 200 mg per day.
在5天的时间里,对两种米诺环素给药方案的副作用发生率进行了检查。总共60名正常女性志愿者以双盲方式被随机分配到两组,一组每天服用100毫克米诺环素两次,另一组每天服用75毫克米诺环素两次,持续5天。从年龄、体型、种族以及口服避孕药、尼古丁和乙醇的使用情况来看,两组具有可比性。每天对她们进行检查,由志愿者(通过日记)和医生对症状进行评估。在上午服药后2小时采集血样测定米诺环素血清浓度。每天服用150毫克米诺环素的志愿者血清抗生素浓度显著低于每天服用200毫克的志愿者。然而,低剂量组和高剂量组记录症状的发生率和流行率相似,唯一的例外是恶心,低剂量组的症状比高剂量组少(P = 0.035)。有症状的志愿者米诺环素血清浓度并不高于无症状的志愿者。当将体重或体表面积与抗生素血清浓度进行对照检查时,两组在第2天以及低剂量组在第4天,二者之间均存在显著的负相关。得出的结论是,在女性中,每天150毫克米诺环素的剂量与每天200毫克的剂量产生的副作用程度相同。