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A randomized trial of immunotherapy for persistent genital warts. Human Vaccines & Immunotherapeutics 8:5, 623–629; May 2012. Genital warts are caused by infection with human papillomavirus type 6 (HPV6) or less commonly the closely related HPV 11.
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Human Vaccines & Immunotherapeutics 8:5, 623–629; May 2012
Genital warts are caused by infection with human papillomavirus type 6 (HPV6) or less commonly the closely related HPV 11.
Therefore a randomized placebo controlled trial was undertaken to establish whether VLP immunotherapy could educe the recurrence of genital warts following locally destructive therapy
Randomization and masking. Consecutive patients attending the participating clinics for treatment of genital warts were offered participation if they fulfilled the wart related entry criteria, and were then screened for disqualifying conditions including abnormal hematology or biochemistry, a recent vaccination or evidence of immunosuppression.
Procedures. The immunotherapy consisted of 1, 5 or 25 µg of HPV6b VLPs suspended in 1 ml of 0.9% NaCl without adjuvant or preservative.
Warts were assessed at each visit by magnification assisted visual inspection and recurrence assessed with reference to photographs and chart drawings
VLP immunotherapy at the two higher doses (5 µg and 25 µg) was associated with less disease recurrence two months after treatment for patients recruited to the Australian trial site, as assessed by number of responding subjects ,and by percentage reduction in disease from pre-treatment. No significant effect of any dose of VLP immunotherapy was observed at the Chinese site.
The extent of presenting disease was significantly less at the Chinese site.
Primary destructive therapy at the Chinese site was exclusively cautery, whereas other options were also used at the Australian site.
Recipients of 5 µg or more of VLP immunotherapy and treated with other than trichloroacetic acid (TCA) or cautery, had significantly shorter duration of disease when compared with similarly treated patients receiving lower VLP immunotherapy doses.
This study demonstrates that administration of two doses of 5 µg or more of a VLP immunotherapy based on the L1 capsid protein of HPV6 was associated with a significantly reduced rate of recurrence of genital warts after conventional destructive therapy, and reduced burden of wart disease.
Analysis of the results suggested that the benefit of VLP immunotherapy was not uniformly observed, but rather was restricted to patients treated with cryotherapy or podophyllotoxin, which on their own were relatively ineffective.
The current study failed to observe an association of recurrence with subject age or gender, or with the extent of disease at presentation, as has been observed in previous studies.
نرسد هیچ مصیبتی در زمین و نه در نفس های شما مگر آنکه در لوح ثبت است پیش از آنکه پدید آوریم آنرا، بدرستیکه آن بر خدا آسان است تا غمگین نشوید بر آنچه فوت شد از شا و شاد نشوید به آنچه داد شما را، وخدا
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