BackgroundsIntramuscular injection of the SARS-CoV-2 vaccine has raised concerns about its use in patients with neuromuscular disorders (NMDs). We evaluated the response of patients with NMDs to the BNT162b2 vaccine.MethodsHealthy subjects, patients with spinal muscular atrophy (SMA), and patients with Duchenne muscular dystrophy (DMD) were included. All participants received two BNT162b2 doses. SARS-CoV-2 antibody titers at baseline and 2 weeks after each vaccination were compared between groups. Residual muscle volume was evaluated in NMDs group. A questionnaire documented adverse reactions.ResultsEleven patients with NMDs (9 with SMA, 2 with DMD; 7 males; aged 32.7 ± 19.3 years) and 346 healthy subjects (60 males, aged 40.0 ± 12.4 years) were included. Antibody titers (U/mL) were similar between groups (baseline: <0.40 vs. <0.40, first vaccination, 145 ± 258 vs. 103 ± 1192, and second vaccination, 1528 ± 1265 vs. 1429 ± 944; p = 1.000, 0.909, and 0.736, respectively). A negative correlation was found between antibody titers and residual muscle volume but was not significant (Mercuri scale, r = −0.429, p = 0.249; fat infiltration rate, r = −0.194, p = 0.618). The adverse reactions were comparable between groups.ConclusionThe BNT162b2 vaccine is safe and effective in patients with NMDs.
BackgroundImmune checkpoint inhibitors (ICIs) sometimes cause immune-related adverse events (irAEs), the timing of occurrence of which is difficult to predict. We created a system to safely manage the patients treated with ICIs who visit hospital during an emergency.MethodsWe utilized the Plan-Do-Check-Act (PDCA) cycle method to improve the quality of countermeasures for irAEs in the emergency room. First, an icon showing the patients treated with ICIs was developed for inclusion in electronic medical records. Second, ICI-specified urgent sets of clinical laboratory tests were prepared to cover the spectrum of irAEs. Third, a direct call system to either the attending physician or the chemotherapy team was established. A flow chart for managing irAEs has been prepared since September 2018. We retrospectively analyzed the electronic medical records from September 2018 to December 2020 to determine the effectiveness of the developed system.ResultsIn the first cycle of PDCA, 24 patients administered ICIs were retrospectively surveyed and seven visited the emergency room. Six cases were examined according to the flow chart, whereas the other patient complaining of grade 2 diarrhea were not examined because of incomplete knowledge regarding ICIs and irAEs. As part of the “Act” step, we reminded the doctors of the flow chart and gave a lecture to the residents on how to manage irAEs. During the second and seventh cycle, no cases were observed without consulting the flow chart.ConclusionsQuality improvement activities for the management of irAEs were conducted using the PDCA cycle methodology. Patients on ICIs are now being continuously monitored to further improve management quality.
The reactivation of the hepatitis B virus (HBV) following systemic chemotherapy reportedly caused acute liver dysfunction as a fatal complication. HBV reactivation sometimes occurs even after the cessation of chemotherapy, especially in the patients with hematological malignancies. A retrospective survey of patients with hepatitis B surface (HBs) antigen-negative cancer with HBs and/or HBc antibodies was conducted by a multidisciplinary chemotherapy team to determine the examination rate of the HBV DNA test after the completion of chemotherapy. Among 83 patients with a resolved HBV infection, who were followed up for more than 3 months, only 17 patients underwent HBV DNA monitoring every 1-3 months (17/83; 20.5%). Since September, 2022, the chemotherapy team has informed the attending physician regarding the continuous HBV DNA monitoring in patients with cancer with a resolved HBV infection until 12 months after the cessation of chemotherapy.
Background: Remarkable progress in cancer genomic medicine (CGM) has been made with the advent of next-generation sequencing and advanced computational data analysis approaches. In Japan gene panel testing has been covered by the National Health Insurance System since June 2019. Although Nagoya Memorial Hospital has been designated as a regional medical support hospital, their medical staff are unfamiliar with CGM and generally experience difficulty in explaining the genetic testing to cancer patients. Methods: A multi-disciplinary CGM team was created in July 2019 to adapt to the clinical application of gene panel testing. Hospital functions were then maintained focusing on the following three aspects: a pathology system for handling genetic information, human resource development related to CGM, and a patient support system, including genetic counseling. Results: Third party ISO15189 (International Organization for Standardization) certification was acquired for the Department of Pathology to establish a quality-assured laboratory. Here, we report on 21 cancer patients who consulted and received information from the CGM outpatient department of our hospital. Among them 14 patients were introduced into a group of certified hospitals by the Japanese Ministry of Health, Labour, and Welfare and 10 patients underwent gene panel tests. Conclusions: As a regional medical support hospital dealing with many cancer patients, we will further improve hospital functions to match the progress in CGM.
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