Colli E, Landoni M, Parazzini F
Medical Department, Upjohn SpA, Caponago-Milan, Italy.
Genitourin Med. 1997 Aug;73(4):267-70. doi: 10.1136/sti.73.4.267.
To test the efficacy of treatment with clindamycin of a partner on the recurrence rate of bacterial vaginosis in women within 3 months from diagnosis.
Eligible for the study were sexually active women with one current sexual partner, who were aged 18-45 years, with a clinical diagnosis of bacterial vaginosis and whose partner agreed to be treated.
A double blind, randomised, controlled trial was conducted comparing the effect of treating the partner with either clindamycin capsules or placebo on the reduction of the recurrence rate of bacterial vaginosis. Women were treated with clindamycin 2% vaginal cream, administered intravaginally once daily at bedtime for 7 consecutive days. The partners were randomly allocated to clindamycin hydrochloride capsules, 150 g by mouth four times daily for 7 consecutive days, or a placebo. A total of 139 couples were randomised--69 were treated with clindamycin vaginal cream group and 70 with placebo. One, 4, and 12 weeks after the end of treatment the patients and their partners were examined; vaginal discharges were examined to check for clue cells, vaginal pH was determined, and a KOH test carried out.
Overall, 131 women out of the 139 who entered the study were cured (94.2%, lower 95% confidence interval 79.8, based on Poisson's approximation). There was no difference in the cure rate among women whose partner received clindamycin or placebo (chi(2) p = not significant). A total of 55 couples (26 in the clindamycin and 29 in the placebo group) withdrew from the study during the follow up period. Of the 69 women whose partner received clindamycin, 22 (31.9%) reported "recurrence" or persistence. The corresponding number was 21 (30%) of the 70 women whose partner received placebo (chi(2) p = not significant). Of the 84 couples in which the woman was cured by the first week's visit and who completed the study; there were five recurrences (11.6%) among the 43 women whose partner received clindamycin and nine (22.0%) of the 41 whose partner received placebo (chi(2) p = not significant).
This study indicates that vaginal clindamycin is effective and safe in the treatment of bacterial vaginosis, but it does not support the suggestion that male treatment markedly reduces the short term recurrence rate.
检测性伴侣使用克林霉素治疗对女性细菌性阴道病诊断后3个月内复发率的影响。
符合研究条件的为18 - 45岁、有一个固定性伴侣、临床诊断为细菌性阴道病且其伴侣同意接受治疗的性活跃女性。
进行一项双盲、随机、对照试验，比较性伴侣使用克林霉素胶囊或安慰剂治疗对降低细菌性阴道病复发率的效果。女性使用2%克林霉素阴道乳膏治疗，每天睡前阴道内给药一次，连续7天。性伴侣被随机分配接受盐酸克林霉素胶囊，口服150mg，每日4次，连续7天，或接受安慰剂。共有139对夫妇被随机分组——69对在克林霉素阴道乳膏组治疗，70对在安慰剂组治疗。治疗结束后1周、4周和12周对患者及其伴侣进行检查；检查阴道分泌物以查找线索细胞，测定阴道pH值，并进行氢氧化钾试验。
总体而言，参与研究的139名女性中有131名治愈（94.2%，基于泊松近似法的95%置信区间下限为79.8）。伴侣接受克林霉素或安慰剂治疗的女性治愈率无差异（卡方检验p值不显著）。在随访期间共有55对夫妇（克林霉素组26对，安慰剂组29对）退出研究。伴侣接受克林霉素治疗的69名女性中，22名（31.9%）报告“复发”或病情持续。伴侣接受安慰剂治疗的70名女性中相应数字为21名（30%）（卡方检验p值不显著）。在女性在首次就诊时治愈且完成研究的84对夫妇中；伴侣接受克林霉素治疗的43名女性中有5名复发（11.6%），伴侣接受安慰剂治疗的41名女性中有9名复发（22.0%）（卡方检验p值不显著）。
本研究表明阴道用克林霉素治疗细菌性阴道病有效且安全，但不支持男性治疗能显著降低短期复发率这一观点。
