From April 2012, Japanese Adverse Drug Event Report database (JADER) has become downloadable for utilization in the public, under the specified acceptable use policy. Given the situation, we focused on the severe eruptions which cases are increased in the public Relief System for Sufferers from Adverse Drug Reactions, for the purpose to analyze the characteristics of typical severe eruptions and a trend or a commonality in the corresponding reported drugs, by utilizing JADER. Disproportionate reporting obtained with ROR (Reporting Odds Ratio) and distribution parameter estimations obtained with Weibull distribution fit for the onset time of drug adverse reactions, were applied for the analysis in addition to the summary of frequency. We obtained 10,171 cases of severe eruptions from JADER, after exclusion of duplicated reports. In the Drug Induced Hypersensitivity Syndrome (DIHS), which has characteristics in clinical time course and causal drugs, we confirmed that typical causal drugs such as anti-epilepsy are frequently reported in JADER. On the other hand, drugs other than typical causal drugs also showed high ROR signal values. In the estimation of Weibull distribution shape parameter fit for drug adverse reaction onset time, DIHS gave estimation apparently different from other severe eruptions. Coincide with the estimation, histogram of onset time for DIHS showed the peak at around 20 days after drug administration, which is later than other severe eruptions. We conclude that analytical approach to obtaining information from multiple aspects of JADER data should be a useful effort for the persons who are engaged in preventive action for drug adverse reactions.

We investigated whether TEAS affected intellect in the elderly, prevented the decline of daily activity and/or improved HDS-R and elderly activity valuation scale in 93 aged patients over 70.
As a result, HDS-R and the elderly activity valuation scale increased after 8 weeks, in the physical exercise group that also received TEAS treatment, indicating a tendency to improve. Improved intellect was measured by asking subject to guess the time and date, recollect some words, and remember five items in HDS-R. All items on the elderly activity valuation scale were improved except for hearing and appetite. Many patients showed increased scores in combination with TEAS. Before treatment, patients in both groups were divided into 4 subgroups by HDS-R score and change in HDS-R was investigated after treatment for 8 weeks. Those scoring 16 points or more on the initial test tended to show an increased score in both groups, those showing 11-15 points initially demonstrated an increased score only in exercise in the combined group, and those showing 10 points or less did not demonstrate any change in either group.
Based on these results, physical therapy combined with TEAS appeared to accelerate daily activity and promote intellect and cognition in the elderly.

INTRODUCTION: The introduction of the mass screening (MS) program measuring urinary catecholamine metabolites at six-months of age for detecting neuroblastoma has resulted in the increase in both number and incidence of patients detected less than one year of age in Japan. The prognosis for infantile neuroblastoma is well known to surpass that for older patients. The prognosis of patients detected by MS has been outstanding. However, in Japan, there has been no consentient guideline of optimal therapeutic management for infants with favorable prognosis. There has been a continuing controversy on the selection of appropriate therapy for neuroblastoma infants, especially those detected by MS. In Japan, based on prognostic factors including N-myc amplification as well as clinical stage, patients with advanced disease receive a consistent therapeutic regimen. In contrast, neuroblastoma infants with favorable biological characteristics and clinical outcome have received variable therapeutic regimens at individual institutions. Resulting from an urgency to assess the status and enforce a consentient as well as an optimal management plan for neuroblastoma infants, the survey and the analysis on a total of 537 cases, including 355 cases detected by the MS program, were conducted and led us to the conclusion that neuroblastoma infants in Japan had been treated comparatively intensive despite excellent prognosis, and further that adjuvant chemotherapy should be avoidable or minimized for patients with such excellent outcomes. Finally, a nationwide prospective study (#9405) has been commenced in Japan to standardize and to optimize therapy for neuroblastoma infants. In the present paper, retrospective considerations and current stategy for neuroblastoma infants in Japan will be discussed.
Chemotherapy, Adjuvant ; Humans ; Incidence ; Infant* ; Japan* ; Mass Screening ; Neuroblastoma* ; Population Characteristics ; Prognosis ; Retrospective Studies

[Objective] We studied the relationship between circadian blood pressure variations and oriental medical observations in the elderly.
[Methods] Subjects in the present study were 39 elderly patients who were aged 65 or older. For measurement of circadian blood pressure variations, ambulatory blood pressure monitoring (ABPM) was used. Meiji Oriental Medical Score (MOS) and Qi, Blood, Body Fluids Score (developed by Terasawa et al.) were used to evaluate Oriental Medical Status of the subjects.
[Results and Discussion] In the subjects who showed abnormality in circadian blood pressure variations, symptoms of Lung, Kidney and Qi deficiency were identified using MOS, blood deficiency and Qi stagnation were identified using Qi, Blood, Body Fluids Score. The number of the oriental medical symptoms were significantly greater in the subjects who showed abnormalities in circadian blood pressure variations compared with the other subjects. We concluded that oriental medical observations would be helpful to suggest existence of abnormalities in circadian blood pressure variations in elderly with hypertension

OBJECTIVE: To investigate the utility of serum squamous cell carcinoma antigen (SCC-Ag) levels upon the diagnosis of recurrent cervical cancer for decision making in patient management. METHODS: Clinical records from 167 cervical cancer patients who developed recurrence between April 1996 and September 2010 were reviewed. A Cox proportional hazards regression model was used to investigate the prognostic significance of serum SCC-Ag levels at the time of recurrence. The effects of various salvage treatments on survival outcomes of recurrent cervical cancer were examined with respect to serum SCC-Ag levels. RESULTS: Serum SCC-Ag levels were elevated (>2.0 ng/mL) in 125 patients (75%) when recurrence was diagnosed. These patients exhibited significantly shorter postrecurrence survival than those with normal SCC-Ag levels (log-rank; p=0.033). Multivariate analyses revealed that an elevated serum SCC-Ag level was an independent prognostic factor for poor postrecurrence survival. In patients with SCC-Ag levels <14.0 ng/mL, radiotherapy or surgery resulted in improved survival compared with chemotherapy or supportive care. In contrast, in patients with SCC-Ag levels of > or =14.0 ng/mL, salvage treatment with radiotherapy had only a minimal impact on postrecurrence survival. CONCLUSION: The serum SCC-Ag level measured when cervical cancer recurrence is diagnosed can be useful for deciding upon the appropriate salvage treatment.
Antigens, Neoplasm ; Carcinoma, Squamous Cell ; Decision Making ; Humans ; Multivariate Analysis ; Recurrence ; Serpins ; Uterine Cervical Neoplasms

Background/Aims: Covered self-expandable metallic stents (CMSs) are widely used for malignant distal biliary obstructions (MDBOs) caused by pancreatic carcinoma. This study compared the efficacy and safety of the laser-cut-type and braided-type CMSs. Methods: To palliate MDBOs caused by pancreatic carcinoma, the laser-cut-type CMSs was used from April 2014 to March 2017, and the braided-type CMSs was used from April 2017 to March 2019. The tested self-expandable metallic stents were equipped with different anti-migration systems. Results: In total, 47 patients received CMSs for MDBOs (24 laser-cut type, 23 braided-type). The time to recurrent biliary obstruction (TRBO) was significantly longer in the braided-type CMSs (p=0.0008), and the median time to stent dysfunction or patient death was 141 and 265 days in the laser-cut-type CMSs and braided-type CMSs, respectively (p=0.0023). Stent migration was the major cause of stent dysfunction in both groups, which occurred in 37.5% of the laser-cut-type CMSs and 13.0% of the braidedtype CMSs. There were no differences in the survival duration between the groups. Conclusions The TRBO was significantly longer for the braided-type CMSs with an anti-migration system than for the laser-cuttype. Stent migration tended to be less frequent with the braided-type CMSs than with the laser-cut-type CMSs.

Background/Aims: Endoscopic resection (ER) for superficial non-ampullary duodenal epithelial tumors (SNADETs) is challenging. Conventional endoscopic mucosal resection (CEMR) is also problematic due to the anatomical features of the duodenum. We compared the safety and efficacy of underwater endoscopic mucosal resection (UEMR) with those of CEMR through a retrospective analysis. Methods: Altogether, 44 consecutive patients with 46 SNADETs underwent ER (18 CEMR cases and 28 UEMR cases) between January 2016 and October 2019. We investigated the proportions of en bloc resection, R0 resection, complications, resection time, and total procedure time and compared the outcomes of patients from the CEMR group with those of patients from the UEMR group. Results: The median tumor size was 8.0 mm (range, 2.0–20.0 mm). The UEMR group showed a higher proportion of en bloc resection (96.4% vs. 72.2%, p<0.05) and significantly lower median resection time and total procedure time (4 min vs. 9.5 min, p<0.05 and 13 min vs. 19 min, p<0.05; respectively) than the CEMR group. No complications were observed. However, two patients treated with piecemeal resection in the CEMR group had residual tumors. Conclusions UEMR is a feasible therapeutic option for SNADETs. It can be recommended as a standard treatment.

BACKGROUND/AIMS: L-carnitine not only alleviates hyperammonemia and reduces muscle cramps in patients with liver cirrhosis, but also improves anemia in patients with chronic hepatitis and renal dysfunction. This study prospectively evaluated the preventative efficacy of L-carnitine supplementation against hemolytic anemia during antiviral treatment using ribavirin in patients with hepatitis C virus (HCV)-related chronic liver disease. METHODS: A total of 41 patients with chronic hepatitis were consecutively enrolled in this study. Group A (n=22) received sofosbuvir plus ribavirin for 3 months, whereas group B (n=19) was treated with sofosbuvir, ribavirin, and L-carnitine. Hemoglobin concentration changes, the effects of antiviral treatment, and the health status of patients were analyzed using short form-8 questionnaires. RESULTS: A significantly smaller decrease in hemoglobin concentration was observed in group B compared to group A at every time point. Moreover, the prescribed dose intensity of ribavirin in group B was higher than that of group A, resulting in a higher ratio of sustained virological response (SVR) 24 in group B compared with group A. The physical function of patients in group B was also significantly improved compared to group A at the end of antiviral treatment. CONCLUSIONS: L-carnitine supplementation alleviates ribavirin-induced hemolytic anemia in patients with HCV and helps relieve the physical burden of treatment with ribavirin-containing regimens. These advantages significantly increase the likelihood of achieving SVR.
Anemia ; Anemia, Hemolytic ; Carnitine ; Drug Therapy ; Hepacivirus ; Hepatitis C ; Hepatitis C, Chronic ; Hepatitis ; Hepatitis, Chronic ; Humans ; Hyperammonemia ; Liver Cirrhosis ; Liver Diseases ; Muscle Cramp ; Prospective Studies ; Ribavirin ; Sofosbuvir

BACKGROUND AND AIMS: We previously reported the comparable efficacy of bi-monthly hepatic arterial infusion chemotherapy (B-HAIC) to that of sorafenib chemotherapy for the treatment of advanced hepatocellular carcinoma (aHCC) in patients with compensated cirrhosis. In this study, we demonstrate the efficacy of B-HAIC in patients with decompensated cirrhosis.METHODS: Forty-five patients with aHCC refractory to transcatheter arterial chemo-embolization (TACE) were treated with B-HAIC and were divided into two groups according to hepatic functional reserve (Child-Pugh grade). Overall survival period, treatment response, and adverse events in each group were analyzed.RESULTS: Efficacy and disease control rates in the Child-Pugh B group (n=24; 21% and 71%, respectively) were not significantly impaired compared the Child-Pugh A group (n=21; 38% and 67%, respectively). Median survival time and survival rate at 12 months in the Child-Pugh B group were 422 days and 58.3%, respectively, whereas those in the Child-Pugh A group were 567 days and 70.8%, respectively. Importantly, the hepatic functional reserve of patients did not worsen in either group during the treatment period. Furthermore, the occurrence rate of adverse events leading to discontinuation of anti-tumor treatment was not significantly increased in the Child-Pugh B group.CONCLUSIONS: Given the preservation of hepatic functional reserve afforded by B-HAIC chemotherapy in patients with decompensated cirrhosis, B-HAIC might be an acceptable alternative strategy for aHCC patients who do not respond to TACE.
Carcinoma, Hepatocellular ; Cisplatin ; Drug Therapy ; Fibrosis ; Humans ; Liver Cirrhosis ; Survival Rate

Background/Aims: Endoscopic resection (ER) for superficial non-ampullary duodenal epithelial tumors (SNADETs) is challenging. Conventional endoscopic mucosal resection (CEMR) is also problematic due to the anatomical features of the duodenum. We compared the safety and efficacy of underwater endoscopic mucosal resection (UEMR) with those of CEMR through a retrospective analysis. Methods: Altogether, 44 consecutive patients with 46 SNADETs underwent ER (18 CEMR cases and 28 UEMR cases) between January 2016 and October 2019. We investigated the proportions of en bloc resection, R0 resection, complications, resection time, and total procedure time and compared the outcomes of patients from the CEMR group with those of patients from the UEMR group. Results: The median tumor size was 8.0 mm (range, 2.0–20.0 mm). The UEMR group showed a higher proportion of en bloc resection (96.4% vs. 72.2%, p<0.05) and significantly lower median resection time and total procedure time (4 min vs. 9.5 min, p<0.05 and 13 min vs. 19 min, p<0.05; respectively) than the CEMR group. No complications were observed. However, two patients treated with piecemeal resection in the CEMR group had residual tumors. Conclusions UEMR is a feasible therapeutic option for SNADETs. It can be recommended as a standard treatment.