[Show abstract][Hide abstract] ABSTRACT: We evaluate the benefits of clinical research carried out in Costa Rica from the published results and a sample of informed consent forms of approved protocols. We found 30 studies on 28 pharmaceuticals and 23 published scientific papers. Results: Of surveyed medical conditions, 19% are directly related to the main causes of mortality and morbidity in our country. Of the drugs tested, 50% are available in Costa Rica, but these investigations that were developed in the country does not seem to have been necessary for drug registration. A placebo as control was used in 27% of investigations; of all studies with results, 30% had not published results, 37% published positive results, 17% ambiguous or contradictory results and 13% ended prematurely. Out of the major authors responsible for the publications, 91% were affiliated with research centers abroad. Conclusions: We conclude that there is insufficient evidence to claim that analyzed clinical research has provided a significant benefit to the health of Costa Ricans, represents a significant therapeutic option, or has been a significant contribution to scientific research in Costa Rica.
[Show abstract][Hide abstract] ABSTRACT: Renal transplantations (RTs) are performed routinely in many countries. After RT, the administration of lifelong immunosuppressive therapy is required. As a consequence, renal transplant recipients (RTRs) have a high risk to develop virus-associated (pre)malignancies, such as Human papillomavirus (HPV) related anogenital (pre)malignancies. It is known that the majority of the RTRs are infected with HPV and that these women have a 14-fold increased risk of cervical cancer, up to 50-fold of vulvar cancer and up to 100-fold of anal cancer. Often, treatment of these lesions requires concessions and may be suboptimal as radiation therapy and extensive surgery may damage the renal transplant. Therefore, prognosis may be compromised due to inadequately treated malignancies. Especially for these immunocompromised patients prevention is of utmost importance. Yearly cervical cancer screening for RTRs is advised, but appears to be executed poorly. For the future, optimizing screening and prevention of anogenital (pre)malignancies is an important issue for women after RT. This review gives a broad overview of all aspects regarding HPV-related (pre)malignancies of the female anogenital tract in RTRs.
[Show abstract][Hide abstract] ABSTRACT: The human papilloma virus (HPV) vaccines were introduced to reduce the incidence of cervical cancer. The bivalent vaccine is effective against HPV-16, -18, -31, -33 and -45 while the quadrivalent vaccine is effective against HPV-16, 18, 31, 6 and 11 types. The immunisation, recommended for adolescent females, has led to high vaccine coverage in many countries. Along with the introduction of the HPV vaccines, several cases of onset or exacerbations of autoimmune diseases following the vaccine shot have been reported in the literature and pharmacovigilance databases, triggering concerns about its safety. This vaccination programme, however, has been introduced in a population that is at high risk for the onset of autoimmune diseases, making it difficult to assess the role of HPV vaccine in these cases and no conclusive studies have been reported thus far. We have thus analysed and reviewed comprehensively all case reports and studies dealing with either the onset of an autoimmune disease in vaccinated subject or the safety in patients with autoimmune diseases to define the role of the HPV vaccines in these diseases and hence its safety. A solid evidence of causal relationship was provided in few cases in the examined studies, and the risk vs. benefit of vaccination is still to be solved. The on-going vigilance for the safety of this vaccine remains thus of paramount importance.
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