Between 50% and 86% of patients with autoimmune hepatitis (AIH) relapse after immunosuppression withdrawal; long‐term immunosuppression is associated with increased risk of neoplasias and infections. Chloroquine diphosphate (CQ) is an immunomodulatory drug that reduces the risk of flares in rheumatologic diseases. Our aims were to investigate the efficacy and safety of CQ for maintenance of biochemical remission of AIH in a double‐blind randomized trial and to define a subgroup that obtained a greater benefit from its use. A total of 61 patients with AIH in histologic remission (90.1% AIH type 1 [AIH‐1]) were randomized to receive CQ 250 mg/day or placebo for 36 months. Of the 61 patients, 31 received CQ and 30 placebo. At baseline, clinical, laboratory, histologic findings, and human leukocyte antigen (HLA) profile were similar between the two groups. Relapse‐free survival was significantly higher in the CQ group compared to the placebo group (59.3% and 19.9%, respectively P = 0.039). For those patients completing 3‐year treatment, relapse rates were 41.6% and 0% after CQ and placebo withdrawal, respectively. Factors associated with a higher risk of relapse in multiple Cox regression were placebo use (hazard ratio, 2.4; 95% confidence interval [CI], 1.055.5; P = 0.039) and anti‐soluble liver antigen/liver‐pancreas (anti‐SLA/LP) seropositivity (hazard ratio, 5.4; 95% CI, 1.91‐15.3; P = 0.002). Although it was not possible to define a subgroup that obtained a greater benefit from CQ according to anti‐SLA/LP reactivity or HLA profile, 100% of patients who were anti‐SLA/LP‐positive (+) relapsed with placebo compared to 50% with CQ (P = 0.055). In the CQ group, 54.8% had side effects and 19.3% interrupted the drug regimen. Conclusion: CQ safely reduced the risk of relapse of AIH, but it was not possible to define a subgroup that obtained a greater benefit with CQ use, probably because of sample size.
Introduction: Hepatitis B is an important public health problem in the world and one of the forms of contagion would be through vertical transmission. Precose diagnosis allows the adoption of prophylaxis measures, which results in prevention in more than 90% of cases. Objective: To describe the prevalences of vertical transmission and compare two generations (mother/patient and patient/child). Method: This was a cross-sectional study, which included 101 patients. The interviews were performed through the application of the instrument of data collection and information of the physical file before the medical consultation. Results: The mean ± SD of age was 50.9 ± 13.1 years, the male gender predominated, with 56.4% of the patients, and the predominance was white, with 43.6%. Vertical transmission between mother and patient occurred in 17.8% and between patient and child, in 7.9%. In all of the eight cases of vertical transmission, the diagnosis was after the birth of children infected with HBV, and in 3/8 (37.5%), there was more than one case of infection by this mechanism per patient, totaling 13 children with the disease. Conclusion: There was a reduction in vertical transmission, showing that preventive measures were effective.
Background Health care costs are growing faster than the rest of the global economy, according to the World Health Organization (WHO). Countries’ health expenditures include paying for general medicine, diagnostic procedures, hospitalizations and surgeries, as well as medications and prescribed treatment. Primary biliary cholangitis (PBC) is a rare autoimmune liver disease and the first line available treatment is ursodeoxycholic acid (UDCA), however, direct and indirect treatment costs are expensive. Main aim of this trial was to assess if the therapeutic efficacy of UDCA manufactured by the university hospital is equivalent to that of standard UDCA and treatment cost reduction in patients with PBC. Methods It is a prospective, interventional, randomized, and crossover study in patients diagnosed with PBC. UDCA 300 mg tablets and capsules were developed and manufactured by the university hospital. Thirty patients under treatment with standard UDCA, in stable doses were randomized in sequence A and B, 15 patients in each arm. The groups were treated for 12 weeks and after, the UDCA formulation was changed, following for another 12 weeks of continuous therapy (tablets and capsules / capsules and tablets). Laboratory tests were performed at time T0 (beginning of treatment), T1 (at the 12 week-therapy, before the crossing-over) and T2 (end of treatment). The evaluation was done by comparing the hepatic parameters ALP, GGT, ALT, AST and total bilirubin, also considering the adverse events. The comparison of costs was based on price of the manufactured UDCA and standard UDCA price of the hospital. Results Hospital reduced 66.1% the PBC treatment costs using manufactured UDCA. There were no differences in the biochemical parameters between sequence (A and B) and tablets or capsules of UDCA formulations applied in the treatment of PBC. Conclusions The study showed that there was no significant difference between manufactured UDCA (capsule and tablet) and standard UDCA. Hospital reduced the PBC treatment costs using the manufactured UDCA by the university hospital. Trial registration ClinicalTrials.gov: NCT03489889 retrospectively registered on January 12th, 2018; Ethics Committee approved the study (ID: 1.790.088) on October 25th, 2016.
Ao meu irmão Alexandre, meu companheiro desde sempre. À memória de Kunisigue e Kioko, queridos avós, sempre presentes, deixando recordações para toda vida. À Rafael, parceiro e companheiro de todas as horas. À memória de Ramon Silva Bispo, sua alegria e companheirismo permearam nossos caminhos. AGRADECIMENTOS Gratidão por ter chegado até aqui com força, saúde e coragem. Agradeço a todas as pessoas que fizeram parte desta etapa e que contribuíram de alguma forma para o sucesso deste trabalho. À minha família, Edson Toshio Nakano, Aparecida Namico Hirata Nakano, Alexandre Hideo Nakano e Rafael Vinicius da Cruz, pessoas muito especiais e fundamentais, meus sinceros agradecimentos pela torcida e apoio, sem os quais esse trabalho não seria possível. À Profa. Dra. Suzane Kioko Ono, agradeço por ter acreditado e me incentivado deste a residência. Obrigada a todos os ensinamentos e orientação, que contribuíram muito para o meu amadurecimento científico e pessoal. Ao Prof. Dr. Eduardo Luiz Rachid Cançado e Dr. Cleuber Esteves Chaves, agradeço pelos ensinamentos, dedicação e orientação. À Dra. Cleusa Martins, sempre disponível e acolhedora, desde o Aprimoramento e depois na Residência. Acompanhou todo meu crescimento profissional e pessoal, esteve sempre por perto para aconselhar e orientar. Agradeço por sempre me incentivar a trilhar por este caminho. À Jéssica Toshie Katayose, minha querida dupla durante a Residência e grande companheira. Este projeto só existe pela sua dedicação e empenho. Agradeço o apoio e a amizade. Admiração pela excelente pessoa e profissional. Obrigado por tudo. Ao Prof. Dr. Flair José Carrilho, um grande exemplo. Aos membros da banca do exame de qualificação, Dra. Márcia Marin, Dr. Andre Montagnini e Dr. Daniel Mazo pela leitura criteriosa, ensinamentos e sugestões.
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