Sawaya George F, Chirenje Mike Zvavahera, Magure Mildred Tsitsi, Tuveson Jennifer L, Ma Yifei, Shiboski Stephen C, Da Costa Maria M, Palefsky Joel M, Moscicki Anna-Barbara, Mutasa Rudo Makunike, Chipato Tsungai, Smith-McCune Karen K
Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94118, USA.
Obstet Gynecol. 2008 Nov;112(5):990-7. doi: 10.1097/AOG.0b013e318189a8a4.
To estimate the effect of providing women with a latex diaphragm, lubricant gel, and male condoms (intervention) compared with condoms alone (control) on human papillomavirus (HPV) incidence and clearance.
Participants were 2,040 human immunodeficiency virus (HIV)-negative Zimbabwean women enrolled in a randomized trial estimating the effect of the intervention on HIV acquisition. Clinicians collected cervical samples for HPV testing at baseline, 12 months, and exit. L1 consensus polymerase chain reaction primers were used to determine HPV presence and type.
We found no differences in the following outcomes: HPV prevalence at the time of the first postenrollment HPV test (intention-to-treat analysis, relative risk [RR] 1.02, 95% confidence interval [CI] 0.90-1.16); HPV incidence at 12 months among women HPV-negative at baseline (RR 0.95, 95% CI 0.80-1.14); and HPV clearance at 12 months among women HPV-positive at baseline (RR 0.80, 95% CI 0.61-1.05). Clearance of HPV type 58 was lower in the intervention group at 12 months (RR 0.67, 95% CI 0.48-0.92), but not at exit (RR 0.93, 95% CI 0.75-1.16); clearance of HPV type 18 was lower in the intervention group at exit (RR 0.55, 95% CI 0.33-0.89), but not at 12 months (RR 0.55, 95% CI 0.29-1.05). Women reporting diaphragm/gel use at 100% of prior sex acts had a lower likelihood of having one or more new HPV types detected at 12 months (RR 0.75, 95% CI 0.58-0.96) and exit (RR 0.77, 95% CI 0.59-0.99).
Among women receiving risk reduction counseling and condoms in an HIV prevention program, diaphragm plus lubricant gel provision did not affect HPV incidence or clearance.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00121459
I.
评估为女性提供乳胶隔膜、润滑剂凝胶和男用避孕套（干预措施）与仅提供避孕套（对照）相比，对人乳头瘤病毒（HPV）感染率和清除率的影响。
参与者为2040名未感染人类免疫缺陷病毒（HIV）的津巴布韦女性，她们参与了一项随机试验，该试验旨在评估上述干预措施对HIV感染的影响。临床医生在基线、12个月和试验结束时采集宫颈样本进行HPV检测。使用L1共识聚合酶链反应引物来确定HPV的存在及类型。
我们发现以下结果无差异：首次入组后HPV检测时的HPV感染率（意向性分析，相对风险[RR]1.02，95%置信区间[CI]0.90 - 1.16）；基线时HPV阴性的女性在12个月时的HPV发病率（RR 0.95，95%CI 0.80 - 1.14）；以及基线时HPV阳性的女性在12个月时的HPV清除率（RR 0.80，95%CI 0.61 - 1.05）。干预组在12个月时HPV 58型的清除率较低（RR 0.67，95%CI 0.48 - 0.92），但在试验结束时无差异（RR 0.93，95%CI 0.75 - 1.16）；干预组在试验结束时HPV 18型的清除率较低（RR 0.55，95%CI 0.33 - 0.89），但在12个月时无差异（RR 0.55，95%CI 0.29 - 1.05）。报告在之前所有性行为中都使用隔膜/凝胶的女性在12个月（RR 0.75，95%CI 0.58 - 0.96）和试验结束时（RR 0.77，95%CI 0.59 - 0.99）检测到一种或多种新HPV类型的可能性较低。
在一个HIV预防项目中接受风险降低咨询和避孕套的女性中，提供隔膜加润滑剂凝胶并不影响HPV发病率或清除率。
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00121459
I级
