Efficacy of carboxymethyl beta-glucan in cervical intraepithelial neoplasia: a retrospective, case-control study.

BACKGROUND: Persistent human papillomavirus (HPV) infection constitutes the principal risk factor for the development of cervical intraepithelial neoplasia (CIN) and cervical cancer. For this reason, new drugs have been studied to support the host immune system against the HPV infection. The aim of this retrospective, case-control study was to detect the efficacy and safety of carboxymethyl ß-glucan (Colpofix®) gel as adjuvant therapy in HPV infection. METHODS: The medical records of patients attending the Colposcopy Service of four hospitals in Rome from 2011 to 2013 were collected. Case arm consisted of patients submitted to local therapy with Colpofix®. Control arm comprised patients who did not receive this therapy. A total of 999 patients were included, divided into four groups, according to their cytological and histological specimens, colposcopy and subsequent management. RESULTS: Local therapy with Colpofix® gel resulted effective with respect to no therapy for the regression of low-grade CIN (CIN1) in patients submitted to follow up (P=0.0204), while it was no effective for the regression of CIN1 submitted to ablative therapy and high-grade CIN (CIN 2+) (P value not significant). CONCLUSIONS: In conclusion, Colpofix® gel represents a valid alternative to "wait and see" strategy in patients affected by CIN1. Further prospective studies are warranted to confirm these results.

Multiple intraepithelial neoplasias of the lower female genital tract: the reliability of HPV mRNA test.

OBJECTIVE: Human papillomavirus (HPV) is the most important pathogenetic factor of intraepithelial neoplasias of the lower genital tract. HPV-DNA and mRNA tests are applied for the management of epithelial dysplasias. The aims of this multicentric retrospective study were to compare the 2 molecular tests before the onset of metachronous intraepithelial lesions and to analyze the different characteristics between synchronous and metachronous lesions and their relationship to the pathologic mechanisms. MATERIALS AND METHODS: The study concerns 55 cases of multiple intraepithelial neoplasias of the lower genital tract. Clinical features of patients with synchronous and metachronous lesions were analyzed. During a 3-year follow-up, HPV-DNA and mRNA tests were performed every 6 months after treatment of the initial lesion. HPV-DNA and mRNA results were analyzed 12 and 6 months before, at time of the onset of the metachronous lesion, and 6 months after its treatment. RESULTS: We observed 31 synchronous lesions and 24 metachronous lesions. Immunodeficiency and multiple genotypes were associated with the synchronous lesions (p = .04 and p = .02, respectively). During the follow-up, positive DNA and mRNA tests increased before the appearance of the metachronous lesion and decreased 6 months after; mRNA test was significantly better than the DNA test 6 months before the appearance of the lesion (p = .04) and at the time of its appearance (p = .02). CONCLUSIONS: Our results support the hypothesis that a positive HPV-mRNA test could be a marker of persistent infection and a risk factor for the onset of metachronous lesions.

Pregnancy outcome after loop electrosurgical excision procedure for cervical intraepithelial neoplasia.

OBJECTIVE: To determine pregnancy outcomes among women who underwent loop electrosurgical excision procedure (LEEP). METHODS: In a case-control study in Italy, 475 pregnant women who underwent LEEP and 441 untreated pregnant women were enrolled between January 2003 and January 2007. Outcome measures were spontaneous abortion, preterm delivery, and at-term delivery rates. Continuous and discrete variables were analyzed via t, χ(2), and Fisher exact tests. Groups were compared by analysis of variance and Tukey HSD test. RESULTS: The spontaneous abortion rate was 14.5% and 14.1% in the LEEP and untreated groups, respectively. The preterm delivery rate was 6.4% and 5.0% in the LEEP and untreated groups, respectively. The number of women with a cervical length of less than 30mm was higher in the LEEP group, but this did not influence preterm delivery rate (odds ratio [OR], 1.01; 95% confidence interval [CI], 0.53-1.95). Among women with a cervical length of less than 15mm, those treated with a wider removal of cervical tissue showed increased risk of preterm delivery (OR, 5.31; 95% CI, 1.01-28.07). CONCLUSION: The preterm delivery rate was not higher among women who underwent LEEP than among untreated women. Preterm delivery was associated with cone size and cervical length in the second trimester.

The re-infection rate of high-risk HPV and the recurrence rate of vulvar intraepithelial neoplasia (VIN) usual type after surgical treatment.

BACKGROUND: VIN usual type appears to be related to the HPV's oncogenic types. The aim of this prospective multicenter study was to evaluate the re-infection rate of high-risk HPV and the recurrence rate of VIN usual type after surgical treatment. MATERIAL/METHODS: The study enrolled 103 women affected by VIN usual type. They underwent wide local excision by CO2 laser. The patients were investigated by clinical evaluation and HPV DNA test 6 months after surgical treatment, and then were followed-up at 12, 18, 24, and 36 months. The recurrences were treated with re-excision. RESULTS: The rate of HPV infection after surgical treatment was 34% at 6 months, 36.9% at 12 months, 40% at 18 months, 41.7% at 24 months and 44.7% at 36 months. The mean time from HPV infection to the development of VIN was 18.8 months. CONCLUSIONS: HPV testing in the follow-up of VIN usual type patients might be useful for identifying those patients with a higher risk of recurrence after surgical treatment, although more studies are needed. These preliminary data suggest that the test, in addition to clinical examination, can improve the efficacy of the follow-up.

Impact of human papillomavirus infection on the neovaginal and vulval tissues of women who underwent surgical treatment for Mayer-Rokitansky-Kuster-Hauser syndrome.

OBJECTIVE: To evaluate the impact of human papillomavirus (HPV) infections on the neovaginal and vulval tissues of women who underwent surgical treatment for Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome. DESIGN: Multicenter observational study. SETTING: University and community hospitals. PATIENT(S): Thirty-three women who had previously undergone neovagina reconstruction due to MRKH and who were referred to our centers for the evaluation and treatment of HPV neovaginal/vulval-related lesions. INTERVENTION(S): HPV infections were confirmed by polymerase chain reaction analysis or hybrid capture 2 tests; the patients underwent vaginoscopy, pap smear, and biopsy of the lesion and were treated by laser vaporization. Follow-up was conducted for 5 years. MAIN OUTCOME MEASURE(S): HPV-related neovaginal/vulval lesions, HPV testing, follow-up, recurrence rate. RESULT(S): Seventeen patients showed vulval lesions, and 16 patients neovaginal lesions. HPV testing results were positive for low-risk HPVs in 27 patients and high-risk HPVs in six patients. All the vulval lesions were condylomata, whereas 10 neovaginal lesions were condylomata, three were vaginal intraepithelial neoplasia (VAIN) degree 1, two were VAIN degree 2, and one was an adenocarcinoma. Eight patients were lost to follow-up. Twenty patients tested positive for an HPV infection, and seven patients (28%) had a recurrence of the lesion in the follow-up time. CONCLUSION(S): Patients who underwent neovagina reconstruction have sexual relationships and are HPV exposed. These patients should be evaluated after surgery for HPV infections to prevent HPV-related diseases and cancers.

Prevalence of acetowhite areas in male partners of women affected by HPV and squamous intra-epithelial lesions (SIL) and their prognostic significance. A multicenter study.

BACKGROUND: Estimates for the prevalence of cervical HPV infection vary and are only available for a few populations with regard to male partners. Attention has been drawn to the male role in cancer progression from cervical intra-epithelial neoplasia, but most of the male lesions are subclinical and only visible after acetowhite staining. The prognostic significance of acetowhite areas, of male partners of women affected by HPV and preneoplastic lesions, was evaluated. MATERIALS AND METHODS: A cohort of 3210 male partners of women affected by HPV infection and/or preneoplastic lesion of the lower genital tract was observed from 1987 to 2001. Acetowhite changes were assessed 5 min after the application of 5% solution of acetic acid and biopsies were tested for HPV-DNA by PCR. Patients with HPV lesions underwent CO2 laser surgery and follow-up. RESULTS: Of the 3210 male partners, 39.12% exhibited clinical HPV lesions and 3.64% subclinical lesions identified as acetowhite areas. In the group of 117 male partners with acetowhite areas, the HPV-DNA test was positive (HPV 6-11) in 36.75% and negative in 63.24% (p<0.001). No statistical differences were observed between HPV+/- groups regarding their sexual habits. The HPV-positive infection group compared to the HPV-negative group showed a statistically significant difference for CO2 laser surgery (p<0.001). CONCLUSION: The acetic acid test can give false-positives and is not a specific indicator of HPV infection, and thus the limited efficacy of tests for acetowhite areas was confirmed. The treatment of clinical lesions is necessary. Follow-up represents the major route to the diagnosis of preneoplastic lesions in men and for the prevention of cervical carcinoma in their female partners.

Follow-up of high-grade squamous intra-epithelial lesions (H-SIls) in human immunodeficiency virus (HIV)-positive and human papillomavirus (HPV)-positive women. analysis of risk factors.

BACKGROUND: Human immunodeficiency virus (HIV)-positive women are at high risk of co-infection from human papillomavirus (HPV) and of developing squamous intraepithelial lesions of the cervix. MATERIALS AND METHODS: From April 1997 to March 1999, 86 women, affected by high-grade squamous intra-epithelial lesions (H-SILs), were enrolled: 41 were HIV+ (CD4+ count >500/ml) and 45 were HIV-. The diagnosis of high-grade squamous intra-epithelial lesion (H-SIL) was established for each patient by Pap test, colposcopy and guided biopsy. For all samples, the HPV/DNA test was also performed by PCR. The patients' lesions and recurrence were treated by cone biopsy or large loop excision (LEEP). Annual controls were performed for 5 years. RESULTS: A high rate of alcohol and drug use (60.7% vs. 31.4%; p=0.004; 80% vs. 27.5%; p<0.001, respectively) and number of male partners (4.5 vs. 3.0; p<0.001) were found in the HIV+ patients, compared to the HIV- patients. Both groups were HPV+ for high-risk types. No difference was found in the percentage of patients who had received a second LEEP. CONCLUSION: Our findings suggest the treatment of H-SIL in HIV-positive women, for a longer disease-free survival, or a lower risk of developing cervical cancer.