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- Villa, Luisa L., et al.
(författare)
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Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
- 2007
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Ingår i: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 356:19, s. 1915-1927
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18. METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18. RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31). CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group.
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| 3. |
- Gustavsson, M. T., et al.
(författare)
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Modification of cellulose fiber surfaces by use of a lipase and a xyloglucan endotransglycosylase
- 2005
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Ingår i: Biomacromolecules. - : American Chemical Society (ACS). - 1525-7797 .- 1526-4602. ; 6:1, s. 196-203
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Tidskriftsartikel (refereegranskat)abstract
- A strategy for the modification of cellulose fiber surfaces was developed that used the ability of Candida antarctica lipase B (CALB) to acylate carbohydrates with high regioselectivity, combined with the transglycosylating activity of the Populus tremula x P. tremuloides xyloglucan endotransglycosylase 16A (PttXET16A). Xyloglucan oligosaccharides (XGOs) prepared from tamarind xyloglucan were acylated with CALB as a catalyst and vinyl stearate or gamma-thiobutyrolactone as acyl donors to produce carbohydrate molecules with hydrophobic alkyl chains or reactive sulfhydryl groups, respectively. The modified XGOs were shown to act as glycosyl acceptors in the transglycosylation reaction catalyzed by PttXET16A and could therefore be incorporated into high M-r xyloglucan chains. The resulting xyloglucan molecules exhibited a high affinity for cellulose surfaces, which enabled the essentially irreversible introduction of fatty acid esters or thiol groups to cellulose fibers.
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| 6. |
- Pedersen, A. T., et al.
(författare)
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Impact of recent studies on attitudes and use of hormone therapy among Scandinavian gynaecologists
- 2007
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Ingår i: Acta Obstet Gynecol Scand. - 1600-0412. ; 86:12, s. 1490-5
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Climacteric medicine has been in focus during the last 2 decades, and an intensive debate has been ongoing regarding the positive and negative aspects of postmenopausal hormone therapy (HT). Recent randomised controlled studies have been unable to confirm data from observational studies of primary or secondary preventive effects of HT on coronary heart disease, and other studies have indicated an increased risk of breast cancer, stroke and venous thromboembolism among HT users. In 2001, we reported on knowledge, attitudes, management strategies and use of HT among Scandinavian gynaecologists. The aim of the present study was to re-assess the same parameters concerning HT among Scandinavian gynaecologists in 2002-2003, and compare the results with the data collected in 1995-1997. METHODS: All practicing gynaecologists in Denmark, Sweden and Norway were invited by letter to complete and return a questionnaire regarding their knowledge, attitudes and management strategies concerning HT. Female gynaecologists were questioned if they were currently using HT, and the same question was posed concerning spouses of male gynaecologists. RESULTS: The questionnaire was completed and returned by 60, 76 and 72%, respectively of gynaecologists in Denmark, Sweden and Norway. Of the 1,591 physicians who responded, 13% thought that all women should be offered HT provided there were no contraindications, while 86% recommended HT only to selected women after considering the individual advantages and disadvantages of the treatment. Of the gynaecologists, 37% considered HT to be without relevance in the primary prevention of osteoporosis in healthy women. As for duration of the treatment, 40% of the gynaecologists would recommend HT for <5 years for the treatment of climacteric complaints, and only 8% would recommend HT for >10 years. The prevalence of HT use among the menopausal female gynaecologists varied between 71 and 74%. Among the menopausal spouses of male gynaecologists, 68-72% were current users of HT. CONCLUSION: During the last years of ongoing debate, gynaecologists from Denmark, Sweden and Norway have become more modest in their recommendations of postmenopausal HT. Scandinavian specialists are more cautious in prescribing hormones for women with symptomatic CVD or previously treated for breast cancer, however, their personal use of HT has not changed dramatically and still reflects a positive attitude.
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| 10. |
- Majewski, S., et al.
(författare)
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The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24
- 2009
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Ingår i: Journal of the European Academy of Dermatology and Venereology. - : Wiley. - 1468-3083 .- 0926-9959. ; 23:10, s. 1147-1155
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Tidskriftsartikel (refereegranskat)abstract
- Background Quadrivalent human papillomavirus (HPV types 6/11/16/18) L1 VLP vaccine is highly effective in preventing HPV 6/11/16/18-related cervical and external genital disease. Herein, we evaluated the impact of the quadrivalent HPV 6/11/16/18 L1 VLP vaccine on prevention of HPV-associated cervico-genital lesions in a broad population of sexually active European women. Methods Female subjects (N = 9265) aged 16-24 with four or fewer lifetime sexual partners were enrolled and randomized to quadrivalent HPV vaccine or placebo. Subjects underwent cervicovaginal sampling for HPV DNA detection. Papanicolaou testing and anti-HPV 6/11/16/18 serology testing was also performed. Results Vaccine efficacy against lesions representing immediate cervical cancer precursors (cervical intraepithelial neoplasia grade 2/3 or adenocarcinoma in situ) related to HPV 6/11/16/18 in the per-protocol population was 100.0%[95% confidence interval (95% CI), 89.8-100.0]. Efficacy against external genital lesions (vulvar or vaginal intraepithelial neoplasia, condyloma, vulvar or vaginal cancer) related to vaccine HPV types in the per-protocol European population was 99.0% (95% CI, 94.4-100.0). Conclusion These data demonstrate that quadrivalent HPV 6/11/16/18 vaccination programs in 16- to 24-year-old European women can be beneficial. NCT0009252, NCT00092534, NCT00092495.
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| 12. |
- Nygren, Mats, et al.
(författare)
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The effect of Mg doping on the thermoelectric performance of Zn4Sb3 : International Conference on Thermoelectrics
- 2008
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Ingår i: Institute of Electrical and Electronics Engineers. - 1094-2734. ; , s. 382-385
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Tidskriftsartikel (refereegranskat)abstract
- The effect of Mg doping of Zn4Sb3 on thermal and thermoelec. properties has been studied on 4 samples with a doping degree ranging from 0.1 to 2 at.% Mg, and compared to a pure, undoped sample. Lab. X-ray powder diffraction shows that all samples are pure single phase materials as further evidenced with higher confidence by Rietveld refinement of high resoln. synchrotron powder diffraction of the as synthesized 1 at.% and 2 at.% Mg doped samples. Zn4Sb3 undergoes a transition from the room temp. disordered phase to an ordered ' phase, going over an intermediate phase; differential scanning calorimetry show only small effects of doping on the phase transition temp. Phys. properties have been evaluated from 2-400 K for all samples. Some phys. property parameters are affected by doping, but no immediate improvement of ZT was achieved by the doping procedure. The reason for this is discussed in relation to differences in sample compaction.
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| 14. |
- Paavonen, J, et al.
(författare)
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Baseline demographic characteristics of subjects enrolled in international quadrivalent HPV (types 6/11/16/18) vaccine clinical trials
- 2008
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Ingår i: Current Medical Research and Opinion. - : Informa Healthcare. - 1473-4877 .- 0300-7995. ; 24:6, s. 1623-1634
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: In Phase II/III trials, administration of quadrivalent human papillomavirus (HPV) (types 6/11/16/18) L1 virus-like-particle vaccine was highly effective in preventing HPV6/11/16/18-related cervical intraepithelial neoplasia and non-invasive cervical cancer in women aged 16-26 years who were naïve to these HPV types at enrollment. However, the makeup and extent of catch-up vaccination programs among young women is unclear, because a proportion of this population will likely already have been exposed to one or more vaccine-HPV-types. OBJECTIVE: Herein we analyze baseline data from the quadrivalent HPV vaccine clinical trial program to investigate variables which may help shape catch-up vaccine implementation policies. METHODS: Female adolescents and young adults aged 16-26 years were randomized into five clinical trials. Baseline data regarding demographics, sexual history, pregnancy history, and other characteristics were collected at enrollment. At the baseline gynecological examination during enrollment, specimens were obtained for Pap testing. Swabs of external genital, lateral vaginal, and cervical sites for HPV polymerase chain reaction (PCR) testing were taken, and serum samples were obtained for HPV serology testing. Regional analyses of data were conducted. RESULTS: Overall, 72% of subjects enrolled worldwide were naïve by both serology and PCR to all four vaccine HPV types. Few subjects were seropositive and/or PCR positive for more than two vaccine-related HPV types. Of all subjects with HSIL at enrollment, 78% were positive to at least one vaccine-related HPV type at enrollment. Regional differences in HPV and STD prevalence were evident. Study limitations included under-representation of women with >/=4 sexual partners and possible underestimation of prior HPV exposure. CONCLUSIONS: Our findings demonstrate that sexually active 16-26 year-old women with
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| 15. |
- Stranne, Johan, 1970, et al.
(författare)
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Inguinal hernia in stage M0 prostate cancer: a comparison of incidence in men treated with and without radical retropubic prostatectomy--an analysis of 1105 patients
- 2005
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Ingår i: Urology. - : Elsevier BV. - 0090-4295. ; 65:5, s. 847-851
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Tidskriftsartikel (refereegranskat)abstract
- Objectives To analyze the incidence of inguinal hernia (IH) in a large group of patients with nonmetastatic prostate cancer who were treated nonoperatively, and to compare it with the incidence in a subset of patients who had undergone radical retropubic prostatectomy (RRP). IH has been reported in 12% to 21% of men at a mean period of 6 to 10 months after RRP. However, whether IH truly represents a complication after RRP has been somewhat debatable owing to the lack of proper control groups. Methods A total of 953 patients treated without surgery (nonoperative group) and 152 patients who underwent RRP (operative group) were selected from the Scandinavian Prostate Cancer Group Study No. 6 database consisting of 1218 patients with nonmetastatic prostate cancer. Radiotherapy, cryotherapy, and a follow-up duration of less than 3 months were exclusion criteria. Patients were followed up for any new medical condition at 12-week intervals for a mean period of 39 months (nonoperative group) and 50 months (operative group). Results Of the 953 patients in the nonoperative group, 23 (2.4%) developed IH versus 13 (8.6%) of 152 in the operative group (log-rank [Mantel-Cox] P = 0.010). Conclusions Within comparable age groups, the incidence of IH in men with prostate cancer treated without surgery was significantly lower than that after RRP. This phenomenon seems to be causally related to the surgical procedure. The increased risk of IH after RRP deserves further recognition and should be included in the preoperative information given to patients. Studies are warranted to define the causal mechanisms, as well as possible preventive measures. Article Outline Material and methods Results Comment Conclusions Acknowledgements References Display Full Size version of this image (56K) FIGURE 1. Cumulative hernia-free survival time in operative and nonoperative patient groups. TABLE I. Follow-up and patient age Group -------------------------------------------------------------------------------- Follow-up (mo) -------------------------------------------------------------------------------- Age at Beginning of Follow-up (yr) -------------------------------------------------------------------------------- Mean (Median) Range Mean (Median) Range Nonoperative (n = 953) 39 (42) 3–72 69 (70) 53–75 Operative (n = 152) 50 (47) 5–155 63 (64) 45–74 All (n = 1105) 41 (43) 3–155 68 (70)
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| 16. |
- Villa, L., et al.
(författare)
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Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials
- 2007
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Ingår i: The Lancet. - 1474-547X. ; 369:9576, s. 1861-1868
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Tidskriftsartikel (refereegranskat)abstract
- Background Cervical cancer and its obligate precursors, cervical intraepithelial neoplasia grades 2 and 3 (CIN2/3), and adenocarcinona in situ (AIS), are caused by oncogenic human papillomavirus (HPV). In this combined analysis of four clinical trials we assessed the effect of prophylactic HPV vaccination on these diseases. Methods 20 583 women aged 16-26 years were randomised to receive quadrivalent HPV6/11/16/18 vaccine (n=9087), its HPV16 vaccine component (n=1204), or placebo (n=10292). They underwent periodic Papanicolaou testing, with colposcopy or biopsy for detected abnormalities. The primary composite endpoint was the combined incidence of HPV16/18-related CIN2/3, AIS, or cervical cancer. These trials are registered at ClinicalTrials.gov, numbers NCT00365378, NCT00365716, NCT00092521, and NCT00092534. Findings Mean follow-up was 3.0 years (SD 0.66) after first dose. In women negative for HPV16 or HPV18 infection during the vaccination regimen (n=17129, per protocol), vaccine efficacy was 99% for the primary endpoint (95% Cl 93-100), meeting the statistical criterion for success. In an intention-to-treat analysis of all randomised women (including those who were HPV16/18 naive or HPV16/18-infected at day 1), efficacy was 44% (95% Cl 31-55); all but one case in vaccine recipients occurred in women infected with HPV16 or HPV18 before vaccination. In a second intention-to-treat analysis we noted an 18% reduction (95% CI 7-29) in the overall rate of CIN2/3 or AIS due to any HPV type. Interpretation Administration of HPV vaccine to HPV-naive women, and women who are already sexually active, could substantially reduce the incidence of HPV16/18-related cervical precancers and cervical cancer.
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| 18. |
- Villa, Luisa L., et al.
(författare)
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Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection
- 2007
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Ingår i: Journal of Infectious Diseases. - : Oxford University Press (OUP). - 1537-6613 .- 0022-1899. ; 196:10, s. 1438-1446
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Tidskriftsartikel (refereegranskat)abstract
- Background. A quadrivalent (types 6, 11, 16, and 18) human papillomavirus (HPV) L1 virus-like-particle (VLP) vaccine has been shown to be 95%-100% effective in preventing cervical and genital disease related to HPV-6,-11,-16, and-18 in 16-26-year-old women naive for HPV vaccine types. Because most women in the general population are sexually active, some will have already been infected with >= 1 HPV vaccine types at the time vaccination is offered. Here, we assessed whether such infected women are protected against disease caused by the remaining HPV vaccine types. Methods. Two randomized, placebo-controlled trials of the quadrivalent (types 6, 11, 16, and 18) HPV vaccine enrolled 17,622 women without consideration of baseline HPV status. Among women infected with 1-3 HPV vaccine types at enrollment, efficacy against genital disease related to the HPV vaccine type or types for which subjects were naive was assessed. Results. Vaccination was 100% effective (95% confidence interval [CI], 79%-100%) in preventing incident cervical intraepithelial neoplasia 2 or 3 or cervical adenocarcinoma in situ caused by the HPV type or types for which the women were negative at enrollment. Efficacy for preventing vulvar or vaginal HPV-related lesions was 94% (95% CI, 81%-99%). Conclusions. Among women positive for 1-3 HPV vaccine types before vaccination, the quadrivalent HPV vaccine protected against neoplasia caused by the remaining types. These results support vaccination of the general population without prescreening.
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