Objective: Currently, Risk Management Plans (RMPs), plan that provide new risk information about drugs, are published on the Pharmaceutical and Medical Devices Agency (PMDA) website.  The aim of this study was to compare enumerated risks in RMPs to the product labeling (PL) of the drug package insert.
Methods: The risks listed in RMPs on the PMDA website were assessed on February 10, 2014.  We investigated the documentation of these risks on the PL.
Results: Seven-hundred and eighty-five risks were enumerated in the RMPs of 77 drugs.  The enumerated risks were classified as “important identified risks” (66%), “important potential risks” (22%), and “important missing information” (12%).  Ninety-four percent of risks listed in RMPs were documented on the PL.  A portion of both the “important identified risks” and “important potential risks” groups were not documented on the PL.
Conclusion: This study was clearly the relation between risks listed in RMPs and documents on the PL.  Because a portion of the risks listed in RMPs was not documented on the PL, RMPs provide more safety information.  It is necessary to better understanding their characteristics, considering RMPs are a new source of drug information.

A lower abdominal tumor with thrill and bruit was pointed out in a 59-year-old female. Angiography showed a pelvic arteriovenous malformation (AVM) with remarkably dilated vessels resembling an aneurysm. Feeding arteries for this AVM originated from the right internal iliac artery, right lumbar artery and right renal artery, and drainage blood flowed into the inferior vena cava from the dilated vessel via a large vein. At operation the right internal iliac artery and right lumbar artery were ligated and the dilated vessel with AVM, which connected with the right renal artery, was resected. An angiography 16 days after the operation revealed the normal arteries without AVM and the right internaal iliac artery filled through collateral arteries. Recently catheter embolization in frequently the first choice for treatment of AVM. However, in the case of AVM with aneurysmal dilated vessels, surgical resection should be selected.

The liver mitochondrial redox state (the liver mitochondrial free NAD+/NADH ratio), which indicates hepatic energy charge, is known to parallel the ketone body ratio (acetoacetate/3-hydroxybutyrate) in liver tissue. Since the ketone body ratio in arterial blood was reported to correlate with that in liver tissue; the arterial ketone body ratio (AKBR) has been widely accepted as a useful measure of the liver function reserve. The liver mitochondrial redox state is known to decrease with the oxidation of ethanol in alcohol abusers. To evaluate whether AKBR reflected the effect of alcohol intake on the liver, AKBR was measured in normal controls (n=8), and patients with alcoholic liver injuries (n=14) and chronic active hepatitis (n=15). The mean AKBRs in the normal control subjects, in patients with chronic active viral hepatitis, and in those with alcoholic liver disease were 1.68±0.77, 2.22±1.02, and 1.55±0.79, respectively. Though the AKBR in patients with alcoholic liver disease tended to be lower than the other groups, there was no significant difference in AKBR among those three groups. In conclusion, this study demonstrated that AKBR was doubtful as an accurate parameter to estimate the changes in the liver mitochondrial redox state by alcoholic intake.

Purpose: To identify the nature of personal growth of family primary caregivers after bereavement and to explore the association between such growth and the experience of caring for a terminally ill cancer patient at home. Methods: A self-administered questionnaire survey was mailed to 112 bereaved family primary caregivers who, with assistance from a palliative care service, had cared for a terminally ill cancer patient at home. The main outcomes were measured using the After Bereavement Growth Inventory, previously developed. Results: Responses from 73 questionnaires were analyzed (effective response rate, 66%). The post-bereavement growth score was significantly higher among the study group than among the general population who had experienced bereavement due to illness-related death. Multiple regression analysis revealed that post-bereavement growth was more likely to occur among those family members who, "at the time they chose to provide home palliative care, intended to care for a patient at home until the time of death" and when "the patient desired home palliative care", those who "felt a deepening of their bond with the patient", and those who "felt the death was peaceful". Conclusion: Our findings suggest that for primary family caregiver's to experience personal growth after bereavement, medical professionals should support patients' preference of place at the end of life and caregivers' preparation for the expected home death, respect the family's bond with the patient, and through appropriate symptom management in home palliative care to maintain the patient's sense of peacefulness until the end of life.

BACKGROUND: physicians' awareness regarding evidence-based medicine (EBM), clinical practice guidelines, and clinical information resources were rarely examined in Japan. We need to know them prior to the initiation of the Medical Information Network Distribution Service (Minds) by the Japan Council for Quality Health Care (JCQHC) .
METHODS: A total of 10, 000 directors/owners of private clinics (CDs: clinic physicians) affiliated with the Japan Medical Association (JMA) and 8682 physicians working for hospitals certified by the JCQHC (HDs: hospital physicians) were randomly selected and surveyed by a mailed questionnaire.
RESULTS: The response rate to the questionnaire was 18.7% (n=1865) among CDs and 67.8% (n=5885) among HDs. The percentage of respondents who uses internet was 39.9% among CDs and 69.3% among HDs. The information resource most commonly used by all respondents was medical journals, followed by textbooks. The percentage of respondents who used medical literature database was 10.8% among CDs and 49.7% among HDs, respectively. Approximately 80% of all respondents approved implementing EBM in daily practice. Fifty percent of all respondents indicated to have used clinical practice guidelines, and 90% of all the guideline users replied that clinical practice guidelines are useful tools for clinical decision-making. Over half of HDs required to access to the abstracts of the literature cited in the guidelines.
CONCLUSIONS: Many physicians who responded to the survey acknowledged that EBM will contribute to improving the quality of medical services. They are positive in using clinical practice guidelines that include a series of recommendations proposed by specialists in the relevant field (s) in accordance to the reviewed evidence.

BACKGROUND: The purpose of our study was to compare the characteristics of medical practitioners who prefer using the Internet as their information resource and those who prefer using printed materials.
METHODS: From December 2002 to January 2003, a non-anonymous questionnaire was sent out by post to members of the Japanese Medical Association (JMA) and physicians working in hospitals. Contributing factors were examined by using logistic regression analysis.
RESULTS: The response rates for the questionnaires were 18.7% (n=1868) for JMA physicians and 68.0% (n=5901) for hospital physicians. Factors associated with the preference for using the Internet were: ‘younger age’; ‘use of the Internet to solve clinical problems and uncertainties’; ‘use of personal computers at work’; and, ‘use of personal computers at home’.
CONCLUSION: The results of this study show that, although some younger physicians prefer printed materials, providing medical information via the Internet is better suited for younger physicians who are making full use of computers. In contrast, older physicians prefer printed materials because they tend to be less familiar with using computers and may have limited accessibility to the Internet. Therefore, using both the Internet and printed materials to provide medical information is necessary to meet the needs of the larger physician population.

The role of nodal station No. 14v (along the superior mesenteric vein) in lymphadenectomy for distal gastric cancer remains elusive. A 73-year-old woman underwent endoscopic submucosal dissection for gastric cancer, and was referred to our division for additional surgery because of pathologically non-curative resection. A laparoscopic distal gastrectomy with D1+ dissection was performed, with a final diagnosis of pT1bN1M0, Stage IB (2 nodal metastases to No. 6). Four months post-surgery, abdominal computed tomography revealed a 14-mm solitary nodule along the superior mesenteric vein. The lesion was excised and pathologically identified as a lymph node metastasis. Adjuvant chemotherapy with tegafur-gimeracil-oteracil potassium (S-1) was administered for the metastasis. Presently the patient survives without recurrence, 5.5 years after the second operation. Our findings suggest that there is lymphatic flow from the No. 6 to the No. 14v nodal station. Some patients with a No. 6 metastasis may benefit from a No. 14v lymphadenectomy, even in early-staged disease.
Aged ; Chemotherapy, Adjuvant ; Diagnosis ; Early Detection of Cancer ; Female ; Gastrectomy ; Humans ; Lymph Node Excision ; Lymph Nodes ; Mesenteric Veins ; Neoplasm Metastasis ; Potassium ; Recurrence* ; Stomach Neoplasms*

PURPOSE: High tibial valgus osteotomy (HTO) is a well-established surgical procedure for patients with medial compartment osteoarthritis (OA) of the knee. The hybrid closed-wedge HTO (CWHTO) procedure permits extensive correction in patients with severe deformities or patellofemoral joint OA. The aim of this study was to report the short-term results in a consecutive series of patients treated with hybrid CWHTO. MATERIALS AND METHODS: We retrospectively evaluated the clinical outcomes and radiographic parameters in 29 consecutive knees that underwent hybrid CWTHO to correct medial compartment OA at an average follow-up of 52.6 months. Clinical outcomes were assessed using the Lysholm score and knee scoring system of the Japanese Orthopedic Association (JOA). The Kellgren-Lawrence grading system and pre- and postoperative mechanical axis (MA), femorotibial angle (FTA), posterior tibial slope, and patella height were assessed. RESULTS: The FTA and MA significantly changed from 180.7° to 170.4° and from 22.0° to 60.2°, respectively. No significant differences were observed between the mean pre- and postoperative posterior tibial slope, Insall-Salvati ratio, or Caton-Deschamps index. The postoperative JOA and Lysholm scores significantly improved from 76.7 to 95.8 and from 58.8 to 90.2, respectively. CONCLUSIONS: Satisfactory outcomes can be achieved with hybrid CWHTO in patients with medial OA.
Asian Continental Ancestry Group ; Congenital Abnormalities ; Follow-Up Studies ; Humans ; Knee ; Orthopedics ; Osteoarthritis ; Osteotomy ; Patella ; Patellofemoral Joint ; Retrospective Studies

A 3-month alcoholism rehabilitation program at psychiatric hospitals is common in Japan for patients with alcohol use disorder (AUD). However, many AUD patients are often hospitalized for the treatment of digestive disorders due to alcohol-related liver diseases and pancreatitis. In this sense, AUD patients need to be better supported by professionals and departments in general hospitals. Here we analyzed the problems in alcohol-related medical care in Japan and examined the measures to be taken at general hospitals.

Background/Aims: Magnifying endoscopic classification systems, such as the Japan narrow-band imaging (NBI) Expert Team (JNET) classification, have been widely used for predicting the histologic diagnosis and invasion depth of colorectal epithelial tumors. However, disagreement exists among observers regarding magnifying endoscopic diagnosis, because these classification systems are subjective. We herein investigated the utility of endoscopic microvascular density (eMVD) calculated from magnifying NBI endoscopic images in colorectal tumors. Methods: We reviewed magnifying NBI endoscopic images from 169 colorectal epithelial tumors (97 adenomas, 72 carcinomas/high-grade dysplasias) resected endoscopically or surgically. The eMVD on magnifying NBI endoscopic images was evaluated using image-editing software, and relationships between eMVD and clinical, endoscopic, and pathological findings were retrospectively analyzed. Results: The eMVD in carcinomas (0.152 ± 0.079) was significantly higher than that in adenomas (0.119 ± 0.059, P< 0.05). The best cutoff value for distinguishing carcinoma from adenoma was 0.133. Sensitivity, specificity, and accuracy were 56.9%, 67.0%, and 62.7%, respectively. In addition, JNET type 2B tumors showed significantly higher eMVD (0.162 ± 0.079) compared to type 2A tumors (0.111 ± 0.050, P< 0.05). Conclusions The eMVD as determined by magnifying NBI endoscopy is considered to be a possible objective indicator for differentiating colorectal carcinomas from adenomas.