Eduardo Motti

To assess the mechanisms related to tetanus-induced acute renal failure (ARF), 30 patients with tetanus had their renal function prospectively studied and factors possibly related to renal changes were evaluated during four weeks of hospitalization. Fifty percent of these patients had a glomerular filtration rate (GFR) < or = 50 ml/min in the first or second week of hospitalization (Group I) and 50% had a GFR > 50 ml/min throughout the entire hospitalization period (Group II). Age, gender, tetanus incubation time and tetanus onset time, hospitalization time, use of nephrotoxic drugs, need for mechanical ventilation with intermittent positive pressure, and presence of systemic infection were similar in both groups. None of the patients presented with oliguria. Autonomic nervous system (ANS) overactivity, characterized by intense variations in systolic and diastolic blood pressure, by increased heart rate and elevated urinary metanephrine excretion, was higher in Group I compared with Group II. Plasma renin activity, serum creatinephosphokinase levels, and myoglobinuria were not significantly different between the two groups. These results strongly suggest that tetanus-induced ARF has a high prevalence, is characterized by early onset, and is probably related to ANS overactivity.

L atin American (LA) countries operate increasingly in accordance with international standards and guidelines. This has been a major driver for increasing interest and placement of clinical studies in the region. Even though LA countries are considered to have many similarities, it is important to keep in mind that, in reality, they are 20 different countries, with different cultures, regulatory requirements, pathologies, incidence rates, standards of care, etc. For this reason, it is fundamental to have local knowledge to accommodate diversity while leveraging shared characteristics. This paper will provide a quick overview of LA's current clinical research environment, summarize its challenges and opportunities, vis-à-vis successful stories of other countries out of LA, in the competitive scenario of global clinical trial placement. Brief Overview on Latin America Latin America expands across two hemispheres and consists of 569 million people [1]. Nearly half of them concentra...

T he theme of outsourcing in clinical development seems to be a never ending story, a field of constant and passionate debates, perhaps more similar to the ones of soccer team fans, than of executives over a business decision. And there may not be more diverse opinions than when headquarters and field managers get together to discuss over the best service provider. This article will try to expose some of the arguments both sides present to defend their positions, with an emphasis on the Latin American arena, and dare to propose some common ground. One recent issue of ACRP´s The Monitor [1] was named, "Outsourcing and Partnerships – Finding the Right Fit." In the editor´s message, Bouchard and Jones-Wright conclude that "outsourcing is no longer an option, it is a necessity." Interestingly, one of the invited authors named his article: "When will outsourcing mature ?" It provides the reader with a realistic view of the field, and provides a concise defin...

The Implications of Good Clinical Practice T he current boom in clinical studies conducted in South America might give the impression that clinical research was introduced in the conti-nent recently by the pharmaceutical industry and contract research orga-nizations (CROs). In reality, interesting research started to be performed in South America in the initial decades of the 20th century. Researchers were mainly European scientists who came as visitors or immigrants and decided to dedicate themselves to the study of endemic diseases; local experts also participated in those pioneer endeavors. 1 As a result, considerable progress was made in the knowledge of yellow fever, leishmaniasis, and Chagas dis-ease, among others. Governments had an interest in controlling the diseases that impaired eco-nomic growth, and sponsored much of the work, directly or through public research institutes. The involvement of private entrepreneurs was not com-mon. The local pharmaceutical industry advanc...

We conducted a survey with 41 Brazilian clinical research professionals who worked abroad, to know more about their experiences. Most of them (68%) were female, mean age was 37.5 years, and they left Brazil on average 9 years after university graduation. The most frequent background education was in Pharmacy (58%), followed by Medicine (14%). The USA was the most frequent destination country, followed by Australia (14%). Two worked at research sites, 19 in service companies (CROs) and 19 in industries. Fifty-eight percent were in leadership positions, and 90% were satisfied or very satisfied with their professional activity. All the participants encouraged other professionals who want to work abroad. Overall, one may conclude that those professionals adapted very fast to the new environment and have experienced a successful career.

A atividade de pesquisa clínica apresentou um crescimento muito intenso nos últimos anos. Esse crescimento pode ser verificado através uma variedade de indicadores: volume de investimentos, de recursos humanos dedicados, de projetos, de pacientes envolvidos, até de espaço na imprensa leiga e médica. No Brasil, apenas em números de pedidos de aprovação na ANVISA, o crescimento foi de cerca de 1000% na década de 1995 a 2004 1 . Fora do Brasil, o crescimento também foi vigoroso, embora em ritmo não tão acentuado 2 . Essa expansão, entretanto, não tem acontecido de forma planejada ou equilibrada. A pesquisa ligada ao desenvolvimento de novos recursos terapêuticos, em sua grande maioria patrocinada por empresas privadas do setor, tem sido a grande responsável pelo "boom". Esse viés faz parecer que a indústria é a única financiadora de pesquisa no Brasil, isso embaralha as expectativas da indústria em relação à pesquisa clínica brasileira e da comunidade científica em relação à ...

Minimal inhibitory concentration test with 16 antibiotics was performed for 435 stains of Gram negative bacilli, isolated from patients in intensive care units of five large hospitals. The results were analysed as to provide in vitro sensitivity patterns, as well as cross resistance between the tested drugs. The most frequent species were Pseudomonas aeruginosa, E. coli, Klebsiella spp., Enterobacter ssp., and Acinetobacter calcoaceticu, accounting for more than 80% of all isolates. Best figures were seen with ciprofloxacin and imipenem, with 805 of sensitive strains or more; third generation cephalosporins, aminoglycosides and aztreonam had overall sensitivity rates ranging from 58 to 73%. There was marked cross resistance between ceftazidime and other beta-lactam antibiotics, except for imipenem. These results bear implications regarding the establishment of empirical therapy in critical patients.

We describe a case of a patient presenting tetanus after mastectomy with postoperative complications. Risk factors and prophylaxis of this disease after surgery are discussed, emphasizing the need for vaccine protection and evaluation of all patients before any kind of surgical procedure.

Treatment with indinavir has been shown to result in marked decreases in viral load and increases in CD4 cell counts in HIV-infected individuals. A randomized double-blind study to evaluate the efficacy of indinavir alone (800 mg q8h), zidovidine alone (200 mg q8h) or the combination was performed to evaluate progression to AIDS. 996 antiretroviral therapy-naive patients with CD4 cell counts of 50-250/mm3 were allocated to treatment. During the trial the protocol was amended to add lamivudine to the zidovudine-containing arms. The primary endpoint was time to development of an AIDS-defining illness or death. The study was terminated after a protocol-defined interim analysis demonstrated highly significant reductions in progression to a clinical event in the indinavir-containing arms, compared to the zidovudine arm (p<0.0001). Over a median follow-up of 52 weeks (up to 99 weeks), percent reductions in hazards for the indinavir plus zidovudine and indinavir groups compared to the z...

A 15 year old male patient was diagnosed as being infected with the nematode Lagochilascaris minor, presenting as abscesses over the left mastoid region, and invading the temporal bone, mastoid sinuses and possibly the CNS. Surgical drainage and administration of cambendazole and levamisole led to improvement, followed by an early relapse and poor tolerance to the antihelminthic drugs. Repeated doses of ivermectin (an animal preparation) were used for the first time to treat this condition and resulted in complete remission of signs of infection, maintained for 15 months after the end of drug therapy, indicating cure of the disease.

... Tristan Gorrindo, MD tristan.gorrindo@mgh.harvard.edu James E. Groves, MD Department of Psychiatry Harvard Medical School Boston ... 2 Charles A. Pilcher, MD chuck@pilchermd.com Emergency Department Evergreen Hospital Medical Center Kirkland, Washington Financial ...

... cepa. A cepa KMcC também foi isolada a partir das lesões cutâneas de uma criançasadia e submetida a sucessivas passagens em cultura de células WI-38. Ensaios ... assays. Pediatrcs 72: 291,1983. 6 - BABA, K. et al. - Seroepidemiologíc ...

Breast cancer is the most prevalent type of tumor and a major leading cause of cancer mortality. Triple-negative breast cancer (TNBC) has the worst prognosis due to its malignant characteristics and the absence of efficacious treatments. Crotoxin, a protein in Crotalus genus snake venom, has proven antitumor activity against aggressive solid tumors, but marked toxicity in humans. Crotoxin B-derived peptides were synthesized and evaluated in vitro for their antitumor activity, which resulted in the discovery of 3-NAntC. 3-NAntC (1µg/mL) treatment for 72 hours decreased the MDA-MB-231 cells viability to 49.0%±17.5% (p < 0.0001), while the same condition resulted in the viability of HMEC cells at 98.2%±13.8%. 3-NAntC exhibited higher antitumoral activity in vitro than cisplatin and similar effect of doxorubicin. 3-NAntC reduced MDA-MB-231 cell proliferation and caused a G2/M arrest. 3-NAntC primarily induced apoptosis, with a lower necrosis occurrence compared with doxorubicin. 3-NA...