Objective:
To investigate characteristics of multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients associated with drugs other than natalizumab since our experience in other ...disease-modifying drugs (DMD) is still limited.
Methods:
This is a descriptive observational study within the FAERS database, registered between July 2015 and June 2017.
Results:
The primary cohort for the analysis consisted of 100,921 MS patients (mean (standard deviation (sd)) age, 48.9 (12.8) years, 20.9% male). Among them 786 (0.78%) developed PML. The adjusted odds ratio of PML for each drug was as follows; natalizumab 115.72 (95% CI; 83.83, 159.74), fingolimod 4.98 (3.64, 6.81) followed by dimethyl fumarate 1.77 (1.2, 2.62) and rituximab 3.22 (1.07, 9.72). The median time from the start of suspected drugs to the onset of PML for natalizumab and other agents were 1463 and 178 days, respectively. The proportion of PML appeared higher in Japan (2.4%) compared to that in the United States (0.24%).
Conclusion:
The reporting proportion of PML was relatively higher in natalizumab followed by fingolimod, dimethyl fumarate and rituximab. Other characteristics of PML associated with DMDs, including the time to onset and differences in reporting among countries, are described.
The BioBank Japan (BBJ) Project was launched in 2003 with the aim of providing evidence for the implementation of personalized medicine by constructing a large, patient-based biobank (BBJ). This ...report describes the study design and profile of BBJ participants who were registered during the first 5-year period of the project.
The BBJ is a registry of patients diagnosed with any of 47 target common diseases. Patients were enrolled at 12 cooperative medical institutes all over Japan from June 2003 to March 2008. Clinical information was collected annually via interviews and medical record reviews until 2013. We collected DNA from all participants at baseline and collected annual serum samples until 2013. In addition, we followed patients who reported a history of 32 of the 47 target diseases to collect survival data, including cause of death.
During the 5-year period, 200,000 participants were registered in the study. The total number of cases was 291,274 at baseline. Baseline data for 199,982 participants (53.1% male) were available for analysis. The average age at entry was 62.7 years for men and 61.5 years for women. Follow-up surveys were performed for participants with any of 32 diseases, and survival time data for 141,612 participants were available for analysis.
The BBJ Project has constructed the infrastructure for genomic research for various common diseases. This clinical information, coupled with genomic data, will provide important clues for the implementation of personalized medicine.
•The BioBank Japan Project (BBJ) enrolled 200,000 patients with 47 target diseases.•The BBJ is one of the largest patient-based biobanks in the world.•The BBJ may allow for personalized medicine in the future.
To implement personalized medicine, we established a large-scale patient cohort, BioBank Japan, in 2003. BioBank Japan contains DNA, serum, and clinical information derived from approximately 200,000 ...patients with 47 diseases. Serum and clinical information were collected annually until 2012.
We analyzed clinical information of participants at enrollment, including age, sex, body mass index, hypertension, and smoking and drinking status, across 47 diseases, and compared the results with the Japanese database on Patient Survey and National Health and Nutrition Survey. We conducted multivariate logistic regression analysis, adjusting for sex and age, to assess the association between family history and disease development.
Distribution of age at enrollment reflected the typical age of disease onset. Analysis of the clinical information revealed strong associations between smoking and chronic obstructive pulmonary disease, drinking and esophageal cancer, high body mass index and metabolic disease, and hypertension and cardiovascular disease. Logistic regression analysis showed that individuals with a family history of keloid exhibited a higher odds ratio than those without a family history, highlighting the strong impact of host genetic factor(s) on disease onset.
Cross-sectional analysis of the clinical information of participants at enrollment revealed characteristics of the present cohort. Analysis of family history revealed the impact of host genetic factors on each disease. BioBank Japan, by publicly distributing DNA, serum, and clinical information, could be a fundamental infrastructure for the implementation of personalized medicine.
•The BioBank Japan Project (BBJ) annually collected clinical information.•Analysis of the clinical information at enrollment characterized the BBJ cohort.•Analysis of family history revealed impacts of host genetic factors on the diseases.
HPV vaccinations were recommended with the backing of a Japanese government subsidy program in 2010, and were included in the National Immunization Program in April 2013. However, the Ministry of ...Health, Labour, and Welfare withdrew the recommendation for the HPV vaccination in June 2013. We investigated HPV vaccine injury compensation programs for both the national and local governments. Approximately 3.38 million girls were vaccinated, and 2,584 complained of health problems. The majority of these received the vaccine shot as a non-routine vaccination. In total, 98 people developed health problems and applied for assistance from 2011 to 2014, but no cases have been processed since October 2014. Several local governments are providing their own compensation program for cases of vaccine adverse reactions, but the number is extremely low (16 of 1,741 municipalities and 1 of 47 prefectures). The local governments that are providing compensation are largely those where HPV vaccine victim support groups are prominent. The confusion regarding the national program for HPV vaccine injury was caused by the discrepancy between the compensation programs for those vaccinated under the immunization law and for those who received voluntary vaccinations. The establishment of a new compensation program might be key to finding a lasting resolution.
Aim
Malnutrition is associated with poor outcomes in cerebral infarction patients, with research indicating that early nutritional initiation may improve the short‐term prognosis of patients. ...However, evidence supported by big data is lacking. Here, to determine the effect of nutritional initiation during the first 3 days after hospital admission on home discharge rates, propensity score matching was conducted in patients with acute cerebral infarction.
Methods
This retrospective observational study, using the Diagnosis Procedure Combination anonymised database in Japan, included 41 477 ischaemic cerebral infarction patients hospitalised between 2016 and 2019. The patients were divided into two groups: those who received oral or enteral nutrition during the first 3 days of hospital admission (early nutrition group, n = 37 318) and those who did not (control group, n = 4159). One‐to‐one pair‐matching was performed using propensity scores calculated via extreme gradient boosting to limit the confounding variables of the two groups.
Results
After propensity score matching, 3541 pairs of patients were selected. The dependence of home discharge rates on early nutrition was significant (p < 0.05), and the effectiveness of early nutrition for home discharge showed an odds ratio of 1.79 (95% confidence interval of 1.59–2.03 in Fisher's exact test).
Conclusions
Our findings revealed that early nutritional initiation during the first 3 days of admission resulted in higher home discharge rates.
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