RESUMO
Inflammatory bowel disease (IBD) is now recognised as a global disease, with incidence rapidly increasing in newly industrialised countries in South America, Asia, and Africa. Trials in IBD, therefore, should adequately represent diverse groups with respect to gender, age, place of residence, race, and ethnicity to ensure the global applicability and generalisability of their findings. In this systematic review, we searched PubMed and Embase for randomised controlled trials (RCTs) published in English from Jan 1, 1995, to Jan 13, 2023, evaluating the efficacy of any pharmacological intervention in patients with IBD. Of 7543 records yielded in the search, we included 617 records reporting data from 627 RCTs and 108 986 participants. The results show a paucity of adequate representation of diverse groups in these RCTs. This finding was true for various groups, including racially and ethnically diverse populations, older (aged >65 years) and younger (aged <18 years) populations, those who identify outside of the gender binary, and people from South America and Africa. Also, some regions had an apparent scarcity of funding sources for trials. Pharmaceutical companies and clinical trial organisations should aim to ensure adequate representation of such under-represented groups in future IBD trials.
Assuntos
Doenças Inflamatórias Intestinais , Humanos , Doenças Inflamatórias Intestinais/tratamento farmacológico , América do Sul/epidemiologia , África , Ásia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Acute cholangitis (AC) is a gastro-intestinal emergency associated with significant mortality. Role of change in the levels of inflammatory markers post drainage in predicting outcome in acute cholangitis is uncertain. OBJECTIVE: To evaluate the predictive value of changes in C-reactive protein (CRP) and procalcitonin levels after biliary drainage in relation to outcomes (survival or mortality) at 1 month. METHODS: A prospective observational study of consecutive adults presenting with AC was performed. At admission and at 48 hours post biliary drainage, procalcitonin and CRP were sent. RESULTS: Between August 2020 till December 2020 we recruited 72 consecutive patients of AC. The median age of the patients was 55 years (range 43-62 years) and 42 (58.33%) were females. Although the delta change in serum procalcitonin (P value<0.001) and CRP (P value<0.001) was significant, it had no bearing on the outcome. Altered sensorium and INR were independently associated with mortality at 1 month. The 30-day mortality prediction of day 0 procalcitonin was measured by receiver operating characteristic analysis which resulted in an area under the curve of 0.697 with a 95% confidence interval (95%CI) of 0.545-0.849. The optimal cut-off of procalcitonin would be 0.57ng/mL with a sensitivity and specificity of 80% and 60% respectively to predict mortality. CONCLUSION: Change in serum procalcitonin and CRP levels at 48 hours post drainage although significant, had no impact on the outcome of acute cholangitis.
Assuntos
Calcitonina , Colangite , Adulto , Biomarcadores , Proteína C-Reativa/análise , Colangite/diagnóstico , Drenagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pró-Calcitonina , Curva ROCRESUMO
ABSTRACT Background: Acute cholangitis (AC) is a gastro-intestinal emergency associated with significant mortality. Role of change in the levels of inflammatory markers post drainage in predicting outcome in acute cholangitis is uncertain. Objective: To evaluate the predictive value of changes in C-reactive protein (CRP) and procalcitonin levels after biliary drainage in relation to outcomes (survival or mortality) at 1 month. Methods A prospective observational study of consecutive adults presenting with AC was performed. At admission and at 48 hours post biliary drainage, procalcitonin and CRP were sent. Results: Between August 2020 till December 2020 we recruited 72 consecutive patients of AC. The median age of the patients was 55 years (range 43-62 years) and 42 (58.33%) were females. Although the delta change in serum procalcitonin (P value<0.001) and CRP (P value<0.001) was significant, it had no bearing on the outcome. Altered sensorium and INR were independently associated with mortality at 1 month. The 30-day mortality prediction of day 0 procalcitonin was measured by receiver operating characteristic analysis which resulted in an area under the curve of 0.697 with a 95% confidence interval (95%CI) of 0.545-0.849. The optimal cut-off of procalcitonin would be 0.57ng/mL with a sensitivity and specificity of 80% and 60% respectively to predict mortality. Conclusion: Change in serum procalcitonin and CRP levels at 48 hours post drainage although significant, had no impact on the outcome of acute cholangitis.
RESUMO Contexto: A colangite aguda (CA) é uma emergência gastro-intestinal associada à significativa mortalidade. O papel da mudança nos níveis de marcadores inflamatórios pós drenagem na previsão do desfecho em CA é incerto. Objetivo: Avaliar o valor preditivo das alterações nos níveis de proteína reativa C (PCR) e procalcitonina após drenagem biliar em relação aos desfechos (sobrevida ou mortalidade) em um mês. Métodos Realizou-se estudo observacional prospectivo de adultos consecutivos que apresentam CA. Na admissão e após 48 horas de drenagem biliar, foram analisadas a procalcitonina e a PCR. Resultados Entre agosto de 2020 e dezembro de 2020, foram recrutados 72 pacientes consecutivos de CA. A idade mediana dos pacientes foi de 55 anos (faixa de 43 a 62 anos) e 42 (58,33%) do sexo feminino. Embora a variação delta no soro procalcitonina (valor P<0,001) e PCR (valor P<0,001) tenha sido significativa, não houve influência sobre o resultado. Sensório alterado e INR foram independentemente associados à mortalidade em 1 mês. A previsão de mortalidade de 30 dias no dia 0 da procalcitonina foi medida pela análise característica operacional receptora que resultou em uma área sob a curva de 0,697 com intervalo de confiança de 95% (IC95%) de 0,545-0,849. O corte ideal de procalcitonina seria de 0,57ng/mL com sensibilidade e especificidade de 80% e 60% respectivamente para prever a mortalidade. Conclusão: A mudança nos níveis de procalcitonina sérica e PCR em 48 horas após a drenagem, embora significativa, não teve impacto no resultado da colangite aguda.