Impact of an HPV6/11/16/18 L1 virus-like particle vaccine on progression to cervical intraepithelial neoplasia in seropositive women with HPV16/18 infection.

The impact of a human papillomavirus (HPV) vaccine on development of cervical intraepithelial neoplasia grade 2-3 or adenocarcinoma in situ (CIN2-3/AIS) in women with ongoing HPV16 or 18 infections prevaccination is reported. Seventeen thousand six-hundred and twenty-two women aged 16-26 were enrolled in 1 of 2 randomized, placebo-controlled, efficacy trials (Protocols 013 and 015). Vaccine or placebo was given at day 1, month 2 and 6. Women were tested for HPV6/11/16/18 DNA and antibodies at day 1. We focus on the subset of women who were seropositive and DNA positive to HPV16 or HPV18 prevaccination. Incidence is expressed as the number of women with an endpoint per 100 person-years-at-risk. In total, 419 vaccine and 446 placebo recipients were both seropositive and DNA positive to HPV16 or HPV18 prevaccination and had at least one follow-up visit. In Protocol 013, the incidence of HPV16/18-related CIN2-3/AIS among these women was 10.9 in the vaccine arm and 7.0 in the placebo arm (vaccine efficacy = -54.9; 95% CI: -181.7, 13.0). In Protocol 015, the incidence of HPV16/18-related CIN2-3/AIS was 5.5 in the vaccine arm and 6.2 in the placebo arm (vaccine efficacy = 12.2%; 95% CI: -29.8, 40.9). These data suggest HPV vaccination neither reduces nor enhances progression to HPV16/18-related high grade cervical lesions, and cervical cytology screening and corresponding management should continue as per local recommendations. Ultimately, population-based surveillance of vaccinated individuals beyond these clinical trials will be required to further address questions regarding the impact of vaccination in women exposed to vaccine HPV types before vaccination.

Effect of hysterectomy or LNG-IUS on serum inhibin B levels and ovarian blood flow.

OBJECTIVES: Nearly one third of women complain of heavy menstrual bleeding during their reproductive years. Hysterectomy and levonorgestrel-releasing intrauterine system (LNG-IUS) are effective treatment options for menorrhagia. However, the influence of these two treatment modalities on ovarian function remains unclear. The aim of the study was to evaluate the effect of hysterectomy or LNG-IUS on ovarian function. METHODS: Of 107 women, aged 35-49 years, referred for menorrhagia to the University of Helsinki, Finland, 54 were randomised to hysterectomy group and 53 to LNG-IUS group. Serum concentrations of inhibin B were measured at baseline, at 6-month, and at 12-month follow-up visits. The pulsatility indeces (PI) of ovarian and intraovarian arteries were measured by transvaginal ultrasound on the same visits. Changes in outcome measures between the groups were tested by Student's t-test for independent samples and within the group by Wilcoxon signed rank test. To test association between outcome variables and explaining factors a multiple linear regression model was used. RESULTS: Serum inhibin B concentrations decreased after the first 6 months in both groups (P<0.05). No change was observed in PI of the ovarian arteries in either group. PI of the intraovarian arteries decreased at 6 and 12 months (P<0.05) in the hysterectomy group, which was not seen among LNG-IUS users. Change in PIs between the treatment arms was also significant (P<0.05). In multiple linear regression model treatment modality explained the change in serum inhibin B concentration and the change in PI of intraovarian artery (P<0.05). CONCLUSIONS: Hysterectomy but not LNG-IUS alters intraovarian blood flow and may impair ovarian function.

Endometritis: the clinical-pathologic syndrome.

OBJECTIVE: The purpose of this study was to evaluate histologically proved endometritis as a clinical syndrome that is distinct from laparoscopically confirmed salpingitis. STUDY DESIGN: This was a cross-sectional study of 152 women in an urban hospital with a suspected pelvic inflammatory disease. All women provided a standardized medical history and underwent physical examination, endometrial biopsy, and laparoscopy. We defined endometritis by the presence of plasma cells in endometrial stroma and neutrophils in the endometrial epithelium. RESULTS: Of 152 women who were enrolled, 43 women had neither endometritis nor salpingitis; 26 women had endometritis alone without salpingitis, and 83 women had salpingitis. Those women with endometritis alone more often had douched recently, had a current intrauterine device, and were in menstrual cycle day 1 to 7, compared with women with no endometritis or salpingitis (P =.007,.04,.005, respectively) or women with acute salpingitis (P =.03,.01,.02, respectively). Infection with Neisseria gonorrhoeae and/or Chlamydia trachomatis was found more frequently in women with endometritis alone than in women with no endometritis or salpingitis (P <.001) and less frequently than in women with salpingitis (P =.05). Lower quadrant, adnexal, cervical motion, rebound tenderness, peritonitis, tenderness score, fever, and laboratory abnormalities that indicated inflammation and detection of gonorrheal or chlamydial infection were significantly less common in women with endometritis alone than in women with salpingitis but were somewhat more common in women with endometritis alone than among women with no salpingitis or endometritis. CONCLUSION: Among women with suspected pelvic inflammatory disease, the histopathologic manifestations of endometritis were associated with clinical manifestations, infection, and specific risk factors that were intermediate in frequency between women with salpingitis and women with neither endometritis nor salpingitis.