Clinical, epidemiological and therapeuthic study of 402 patients with American cutaneous leishmaniasis seen at University Hospital of Brasilia, DF, Brazil

FUNDAMENTOS – A leishmaniose tegumentar americana é doença em expansão no Brasil. A região Centro- Oeste é hoje a terceira em incidência e a primeira em crescimento da doença. OBJETIVOS – Avaliar pacientes com leishmaniose tegumentar americana atendidos no Hospital Universitário de Brasília, quanto a aspectos clinicoepidemiológicos e resposta ao tratamento com antimonial pentavalente. MÉTODOS – Estudo do tipo série de casos de 402 pacientes, segundo sexo, idade, ocupação, procedência, formas clínicas, métodos de diagnóstico, tratamento com antimonial pentavalente e efeitos colaterais, no período de 1/1/1994 a 28/2/2003. O acompanhamento foi de um ano pós-tratamento. RESULTADOS – Predomínio de homens, lavradores, de 20 a 39 anos, com a forma cutânea. A eficácia do antimonial foi maior em pacientes com forma cutânea tratados até seis meses depois do início dos sintomas, e em pacientes do sexo feminino (diferenças estatisticamente significativas na análise multivariada). O mesmo ocorreu para pacientes com forma mucocutânea, mas sem diferença estatística significante. Alterações eletrocardiográficas foram mais freqüentes no grupo tratado com 20mg SbV/kg/dia por 30 dias em relação ao tratado por 20 dias. Eosinofilia ocorreu em 17,5% dos casos. CONCLUSÕES – Tratamento precoce, sexo feminino e a forma cutânea apresentaram índices mais elevados de cura. Alterações do eletrocardiograma aumentaram com o tempo de tratamento com antimoniais. A eosinofilia como efeito colateral ao uso do antimonial merece maior investigação. _______________________________________________________________________________________ ABSTRACTBACKGROUND - American cutaneous leishmaniasis is a disease with high prevalence and incidence in Brazil. The Brazilian Central-Western Region currently holds the third largest incidence and the first growth rate of this disease in the country. OBJECTIVES - To evaluate clinical, epidemiological and treatment features of patients with American cutaneous leishmaniasis seen at the University Hospital of Brasília. METHOD - A case series study with 402 patients was carried out, spanning the period between January 1st, 1994 and February 28th, 2003. The following variables were studied: sex, age, occupation, state of origin, clinical features, diagnostic techniques, treatment with pentavalent antimony and side effects. Follow-up was one year after the end of treatment. RESULTS – The predominant group of patients was composed by male rural laborers who presented mainly the cutaneous form of the illness. The greatest efficacy of the antimony was observed in patients presenting the cutaneous form treated up to six months after the onset of symptoms, and in females in general (both differences were statistically significant in multivariate analysis). The early treatment of the mucocutaneous form also presented better results, although not statistically significant. Electrocardiographical alterations were more frequent in the group of patients receiving a 20mg SbV/Kg/day for a 30-day schedule than those with the same dosage for 20 days. Eosinophilia was found in 17.5%. CONCLUSIONS – Early treatment, female gender and cutaneous form presented higher levels of cure. Electrocardiographic changes rose as time of treatment was increased. The remarkable report of eosinophilia as a side effect of meglumine antimoniate deserves further investigation

Clinical, epidemiological and therapeuthic study of 402 patients with American cutaneous leishmaniasis seen at University Hospital of Brasilia, DF, Brazil

FUNDAMENTOS – A leishmaniose tegumentar americana é doença em expansão no Brasil. A região Centro- Oeste é hoje a terceira em incidência e a primeira em crescimento da doença. OBJETIVOS – Avaliar pacientes com leishmaniose tegumentar americana atendidos no Hospital Universitário de Brasília, quanto a aspectos clinicoepidemiológicos e resposta ao tratamento com antimonial pentavalente. MÉTODOS – Estudo do tipo série de casos de 402 pacientes, segundo sexo, idade, ocupação, procedência, formas clínicas, métodos de diagnóstico, tratamento com antimonial pentavalente e efeitos colaterais, no período de 1/1/1994 a 28/2/2003. O acompanhamento foi de um ano pós-tratamento. RESULTADOS – Predomínio de homens, lavradores, de 20 a 39 anos, com a forma cutânea. A eficácia do antimonial foi maior em pacientes com forma cutânea tratados até seis meses depois do início dos sintomas, e em pacientes do sexo feminino (diferenças estatisticamente significativas na análise multivariada). O mesmo ocorreu para pacientes com forma mucocutânea, mas sem diferença estatística significante. Alterações eletrocardiográficas foram mais freqüentes no grupo tratado com 20mg SbV/kg/dia por 30 dias em relação ao tratado por 20 dias. Eosinofilia ocorreu em 17,5% dos casos. CONCLUSÕES – Tratamento precoce, sexo feminino e a forma cutânea apresentaram índices mais elevados de cura. Alterações do eletrocardiograma aumentaram com o tempo de tratamento com antimoniais. A eosinofilia como efeito colateral ao uso do antimonial merece maior investigação. _______________________________________________________________________________________ ABSTRACTBACKGROUND - American cutaneous leishmaniasis is a disease with high prevalence and incidence in Brazil. The Brazilian Central-Western Region currently holds the third largest incidence and the first growth rate of this disease in the country. OBJECTIVES - To evaluate clinical, epidemiological and treatment features of patients with American cutaneous leishmaniasis seen at the University Hospital of Brasília. METHOD - A case series study with 402 patients was carried out, spanning the period between January 1st, 1994 and February 28th, 2003. The following variables were studied: sex, age, occupation, state of origin, clinical features, diagnostic techniques, treatment with pentavalent antimony and side effects. Follow-up was one year after the end of treatment. RESULTS – The predominant group of patients was composed by male rural laborers who presented mainly the cutaneous form of the illness. The greatest efficacy of the antimony was observed in patients presenting the cutaneous form treated up to six months after the onset of symptoms, and in females in general (both differences were statistically significant in multivariate analysis). The early treatment of the mucocutaneous form also presented better results, although not statistically significant. Electrocardiographical alterations were more frequent in the group of patients receiving a 20mg SbV/Kg/day for a 30-day schedule than those with the same dosage for 20 days. Eosinophilia was found in 17.5%. CONCLUSIONS – Early treatment, female gender and cutaneous form presented higher levels of cure. Electrocardiographic changes rose as time of treatment was increased. The remarkable report of eosinophilia as a side effect of meglumine antimoniate deserves further investigation

A comparative study between the efficacy of pentamidine isothionate given in three doses for one week and N-methil-glucamine in a dose of 20mgSbV/day for 20 days to treat cutaneous leishmaniasis

Setenta e nove pacientes com leishmaniose tegumentar americana, forma cutânea, foram divididos em dois grupos: o grupo experimental (I), formado por 38 pessoas que receberam isotionato de pentamidina, 4mg/kg/dia, três aplicações, IM, durante uma semana, e o grupo controle (II), formado por 41 doentes tratados com N-metilglucamina, 20mgSbV/kg/dia por 20 dias, EV. Foram identificados, por técnica de anticorpos monoclonais, 21 isolados com predominância de Leishmania (Viannia) braziliensis. Encontrou-se cura clínica em 71,05% do grupo experimental e 73,17% do grupo controle (p=0,47). Alterações de ECG foram mais freqüentes utilizando antimonial pentavalente, com significância (p<0,05). O tratamento com a pentamidina mostrou eficácia semelhante quando comparado ao antimonial e apresenta vantagens como duração reduzida de tratamento e baixa toxicidade cardiológica.Seventy-nine patients with cutaneous leishmaniasis were included in this study. The experimental group (n = 38) was treated with pentamidine isothionate in a dose of 4mg/kg/day on alternate days, for one week. The control group (n = 41) was treated with N-methylglucamine in a dose of 20mgSbV/kg/day for 20 days. Twenty-one isolates were identified using monoclonal antibody technique. We characterized Leishmania (Viannia) braziliensis, most frequently. There was a cure rate of 71.05% of the patients in the experimental group and 73.17% in the control group (p = 0.47).We found a statistical significance regarding frequency of ECG alterations between the experimental and control group (p<0.05). In our study pentamidine was as effective as antimonial for the treatment of american cutaneous leishmaniasis. It proved to be a safer drug considering heart toxicity. Moreover, it requires less time to complete the treatment

Estudo comparativo da eficácia de isotionato de pentamidina administrada em três doses durante uma semana e de N-metil-glucamina 20mgSbV/kg/dia durante 20 dias para o tratamento da forma cutânea da leishmaniose tegumentar americana A comparative study between the efficacy of pentamidine isothionate given in three doses for one week and N-methil-glucamine in a dose of 20mgSbV/day for 20 days to treat cutaneous leishmaniasis

Setenta e nove pacientes com leishmaniose tegumentar americana, forma cutânea, foram divididos em dois grupos: o grupo experimental (I), formado por 38 pessoas que receberam isotionato de pentamidina, 4mg/kg/dia, três aplicações, IM, durante uma semana, e o grupo controle (II), formado por 41 doentes tratados com N-metilglucamina, 20mgSbV/kg/dia por 20 dias, EV. Foram identificados, por técnica de anticorpos monoclonais, 21 isolados com predominância de Leishmania (Viannia) braziliensis. Encontrou-se cura clínica em 71,05% do grupo experimental e 73,17% do grupo controle (p=0,47). Alterações de ECG foram mais freqüentes utilizando antimonial pentavalente, com significância (p<0,05). O tratamento com a pentamidina mostrou eficácia semelhante quando comparado ao antimonial e apresenta vantagens como duração reduzida de tratamento e baixa toxicidade cardiológica.<br>Seventy-nine patients with cutaneous leishmaniasis were included in this study. The experimental group (n = 38) was treated with pentamidine isothionate in a dose of 4mg/kg/day on alternate days, for one week. The control group (n = 41) was treated with N-methylglucamine in a dose of 20mgSbV/kg/day for 20 days. Twenty-one isolates were identified using monoclonal antibody technique. We characterized Leishmania (Viannia) braziliensis, most frequently. There was a cure rate of 71.05% of the patients in the experimental group and 73.17% in the control group (p = 0.47).We found a statistical significance regarding frequency of ECG alterations between the experimental and control group (p<0.05). In our study pentamidine was as effective as antimonial for the treatment of american cutaneous leishmaniasis. It proved to be a safer drug considering heart toxicity. Moreover, it requires less time to complete the treatment

Effects of pre-operative isolation on postoperative pulmonary complications after elective surgery: an international prospective cohort study an international prospective cohort study

We aimed to determine the impact of pre-operative isolation on postoperative pulmonary complications after elective surgery during the global SARS-CoV-2 pandemic. We performed an international prospective cohort study including patients undergoing elective surgery in October 2020. Isolation was defined as the period before surgery during which patients did not leave their house or receive visitors from outside their household. The primary outcome was postoperative pulmonary complications, adjusted in multivariable models for measured confounders. Pre-defined sub-group analyses were performed for the primary outcome. A total of 96,454 patients from 114 countries were included and overall, 26,948 (27.9%) patients isolated before surgery. Postoperative pulmonary complications were recorded in 1947 (2.0%) patients of which 227 (11.7%) were associated with SARS-CoV-2 infection. Patients who isolated pre-operatively were older, had more respiratory comorbidities and were more commonly from areas of high SARS-CoV-2 incidence and high-income countries. Although the overall rates of postoperative pulmonary complications were similar in those that isolated and those that did not (2.1% vs 2.0%, respectively), isolation was associated with higher rates of postoperative pulmonary complications after adjustment (adjusted OR 1.20, 95%CI 1.05–1.36, p = 0.005). Sensitivity analyses revealed no further differences when patients were categorised by: pre-operative testing; use of COVID-19-free pathways; or community SARS-CoV-2 prevalence. The rate of postoperative pulmonary complications increased with periods of isolation longer than 3 days, with an OR (95%CI) at 4–7 days or ≥ 8 days of 1.25 (1.04–1.48), p = 0.015 and 1.31 (1.11–1.55), p = 0.001, respectively. Isolation before elective surgery might be associated with a small but clinically important increased risk of postoperative pulmonary complications. Longer periods of isolation showed no reduction in the risk of postoperative pulmonary complications. These findings have significant implications for global provision of elective surgical care. We aimed to determine the impact of pre-operative isolation on postoperative pulmonary complications after elective surgery during the global SARS-CoV-2 pandemic. We performed an international prospective cohort study including patients undergoing elective surgery in October 2020. Isolation was defined as the period before surgery during which patients did not leave their house or receive visitors from outside their household. The primary outcome was postoperative pulmonary complications, adjusted in multivariable models for measured confounders. Pre-defined sub-group analyses were performed for the primary outcome. A total of 96,454 patients from 114 countries were included and overall, 26,948 (27.9%) patients isolated before surgery. Postoperative pulmonary complications were recorded in 1947 (2.0%) patients of which 227 (11.7%) were associated with SARS-CoV-2 infection. Patients who isolated pre-operatively were older, had more respiratory comorbidities and were more commonly from areas of high SARS-CoV-2 incidence and high-income countries. Although the overall rates of postoperative pulmonary complications were similar in those that isolated and those that did not (2.1% vs 2.0%, respectively), isolation was associated with higher rates of postoperative pulmonary complications after adjustment (adjusted OR 1.20, 95%CI 1.05–1.36, p = 0.005). Sensitivity analyses revealed no further differences when patients were categorised by: pre-operative testing; use of COVID-19-free pathways; or community SARS-CoV-2 prevalence. The rate of postoperative pulmonary complications increased with periods of isolation longer than 3 days, with an OR (95%CI) at 4–7 days or ≥ 8 days of 1.25 (1.04–1.48), p = 0.015 and 1.31 (1.11–1.55), p = 0.001, respectively. Isolation before elective surgery might be associated with a small but clinically important increased risk of postoperative pulmonary complications. Longer periods of isolation showed no reduction in the risk of postoperative pulmonary complications. These findings have significant implications for global provision of elective surgical care

Global variation in postoperative mortality and complications after cancer surgery: a multicentre, prospective cohort study in 82 countries

© 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 licenseBackground: 80% of individuals with cancer will require a surgical procedure, yet little comparative data exist on early outcomes in low-income and middle-income countries (LMICs). We compared postoperative outcomes in breast, colorectal, and gastric cancer surgery in hospitals worldwide, focusing on the effect of disease stage and complications on postoperative mortality. Methods: This was a multicentre, international prospective cohort study of consecutive adult patients undergoing surgery for primary breast, colorectal, or gastric cancer requiring a skin incision done under general or neuraxial anaesthesia. The primary outcome was death or major complication within 30 days of surgery. Multilevel logistic regression determined relationships within three-level nested models of patients within hospitals and countries. Hospital-level infrastructure effects were explored with three-way mediation analyses. This study was registered with ClinicalTrials.gov, NCT03471494. Findings: Between April 1, 2018, and Jan 31, 2019, we enrolled 15 958 patients from 428 hospitals in 82 countries (high income 9106 patients, 31 countries; upper-middle income 2721 patients, 23 countries; or lower-middle income 4131 patients, 28 countries). Patients in LMICs presented with more advanced disease compared with patients in high-income countries. 30-day mortality was higher for gastric cancer in low-income or lower-middle-income countries (adjusted odds ratio 3·72, 95% CI 1·70–8·16) and for colorectal cancer in low-income or lower-middle-income countries (4·59, 2·39–8·80) and upper-middle-income countries (2·06, 1·11–3·83). No difference in 30-day mortality was seen in breast cancer. The proportion of patients who died after a major complication was greatest in low-income or lower-middle-income countries (6·15, 3·26–11·59) and upper-middle-income countries (3·89, 2·08–7·29). Postoperative death after complications was partly explained by patient factors (60%) and partly by hospital or country (40%). The absence of consistently available postoperative care facilities was associated with seven to 10 more deaths per 100 major complications in LMICs. Cancer stage alone explained little of the early variation in mortality or postoperative complications. Interpretation: Higher levels of mortality after cancer surgery in LMICs was not fully explained by later presentation of disease. The capacity to rescue patients from surgical complications is a tangible opportunity for meaningful intervention. Early death after cancer surgery might be reduced by policies focusing on strengthening perioperative care systems to detect and intervene in common complications. Funding: National Institute for Health Research Global Health Research Unit

Effects of hospital facilities on patient outcomes after cancer surgery: an international, prospective, observational study

© 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 licenseBackground: Early death after cancer surgery is higher in low-income and middle-income countries (LMICs) compared with in high-income countries, yet the impact of facility characteristics on early postoperative outcomes is unknown. The aim of this study was to examine the association between hospital infrastructure, resource availability, and processes on early outcomes after cancer surgery worldwide. Methods: A multimethods analysis was performed as part of the GlobalSurg 3 study—a multicentre, international, prospective cohort study of patients who had surgery for breast, colorectal, or gastric cancer. The primary outcomes were 30-day mortality and 30-day major complication rates. Potentially beneficial hospital facilities were identified by variable selection to select those associated with 30-day mortality. Adjusted outcomes were determined using generalised estimating equations to account for patient characteristics and country-income group, with population stratification by hospital. Findings: Between April 1, 2018, and April 23, 2019, facility-level data were collected for 9685 patients across 238 hospitals in 66 countries (91 hospitals in 20 high-income countries; 57 hospitals in 19 upper-middle-income countries; and 90 hospitals in 27 low-income to lower-middle-income countries). The availability of five hospital facilities was inversely associated with mortality: ultrasound, CT scanner, critical care unit, opioid analgesia, and oncologist. After adjustment for case-mix and country income group, hospitals with three or fewer of these facilities (62 hospitals, 1294 patients) had higher mortality compared with those with four or five (adjusted odds ratio [OR] 3·85 [95% CI 2·58–5·75]; p<0·0001), with excess mortality predominantly explained by a limited capacity to rescue following the development of major complications (63·0% vs 82·7%; OR 0·35 [0·23–0·53]; p<0·0001). Across LMICs, improvements in hospital facilities would prevent one to three deaths for every 100 patients undergoing surgery for cancer. Interpretation: Hospitals with higher levels of infrastructure and resources have better outcomes after cancer surgery, independent of country income. Without urgent strengthening of hospital infrastructure and resources, the reductions in cancer-associated mortality associated with improved access will not be realised. Funding: National Institute for Health and Care Research