A questionnaire survey of risk management systems for medical products was conducted with the cooperation of domestic and foreign pharmaceutical companies. As for the foreign companies, it was revealed that specialized safety management teams and data-management committees are established to formulate risk management plans in order to create systems that assure consistent risk management for each company. In addition, it was revealed that toxicologists are incorporated in the central decision making organization. As for domestic companies, it turned out that no less than half of the respondents pay attention to consistent risk management from the development stage through the post marketing stage. From now on, it will be essential to consolidate safety data, improve the accessibility of centralized safety data from the relevant departments, and establish systems to provide consistent risk management from the development stage to the post marketing stage.

Congenital heart disease of partial anomalous pulmonary venous drainage of entire left lung without other cardiac anomaly was very rare. 21-year-old man, who was pointed out heart disease 6 months ago, was diagnosed as partial anomalous pulmonary venous drainage of entire left lung without other cardiac anomaly by cardiac catheterization and angiography. The patient underwent surgery through the left forth intercostal incision without cardiopulmonary bypass. The end-to-side anastomosis was made between the vertical vein and the left atrial appendage following ligation of the vertical vein near the innominate vein. Surgical treatment was satisfactory in the postoperative angiography which was shown widely patent anastomosis. He was discharged with uneventful postoperative course and returned to full activity.

From March 1981 to March 1990, 61 patients with Stanford type B acute aortic dissection were initially treated by conservative therapy. Among these 61 patients, the dissected lumen became occluded due to thrombosis early after diagnosis in 25 patients (Group T) and remained patent in 36 patients (Group P). Twentythree patients in Group T (92%) and 22 patients in Group P (61%) were discharged without major complications related to acute aortic dissection. However, 2 patients in Group T (8%) and 14 patients in Group P (39%) required additional surgical therapy or died during hospitalization. The mean aortic diameter at the time of admission in Group T was smaller than that of Group P (38±3mm vs 43±7mm, p<0.05). During the observation period, there was a tendency for the diameter of the dissected aorta in Group T to decrease, but to increase in Group P. Long-term survival appeared to be better in Group T than in Group P, but there was no significant difference in the overall survival curve. Large aortic diameter at the time of admission and the presence of a true thoracic aortic aneurysm were major contributing factors influencing the prognosis. A long-term follow-up study showed that the dissected lumen reduced or disappeared in 14 of 23 patients in Group T (61%) but only 2 of 16 patients in Group P (12.5%). We concluded that the patients with small dissected aortas and thrombosed dissected lumens (Group T) can recuperate only with conservative therapy. However, patients with large dissected aortas and patent dissected lumen (Group P) may require surgical therapy even in Stanford type B aortic dissection.

Pyogenic liver abscess in patients with malignant disease is a fatal state and is easily diagnosed. We presented a rare case of sudden fatal septicemia following anticancer treatment for recurred gastric cancer due to multiple liver abscesses which could not be diagnosed. A 72-year-old male with recurred gastric cancer received anticancer agents. He had a history of distal gastrectomy with right hepatic lobectomy for hepatic metastasis. He received anticancer treatment in the outpatient's service center periodically, and his performance status was preserved with nothing in particular. After administrating docetaxel, he suddenly developed septicemia and multiple organ failure and died 5 days after strong medical supports. Pathological autopsy revealed that multiple minute abscesses of the liver which could not be detected macroscopically were the causes of fatal septicemia. The etiology, therapies and prognosis of rare entity are being discussed.
Abscess ; Antineoplastic Agents ; Autopsy ; Gastrectomy ; Hepatectomy ; Humans ; Liver ; Liver Abscess ; Liver Abscess, Pyogenic ; Male ; Multiple Organ Failure ; Neoplasm Metastasis ; Prognosis ; Sepsis ; Stomach Neoplasms ; Taxoids

BACKGROUND: Pruritis caused by atopic dermatitis (AD) is not always well controlled by topical corticosteroid therapy, but use of tacrolimus often helps to soothe such intractable pruritis in clinical settings. OBJECTIVE: To determine the anti-pruritic efficacy of topical tacrolimus in treating AD in induction and maintenance therapy. METHODS: Prior to the study, patients were randomly allocated into two groups, induction therapy followed by tacrolimus monotherapy maintenance, and induction therapy followed by emollient-only maintenance. In the induction therapy, the patients were allowed to use topical tacrolimus and emollients in addition to a low dose (<10 g/week) of topical steroids. Patients showing relief from pruritis were allowed to proceed to maintenance therapy. Recurrence of pruritis in maintenance therapy was examined as a major endpoint. RESULTS: Two-thirds of patients (44/68; 64.7%) showed relief from pruritis after induction therapy. Pruritis recurred in 23.8% (5/21) of the tacrolimus monotherapy group and in 100% (21/21) of the emollient group during maintenance period, a difference that was statistically significant. CONCLUSION: Use of topical tacrolimus is effective in controlling pruritis of AD compared to emollient.
Dermatitis, Atopic ; Emollients ; Humans ; Pruritus ; Recurrence ; Steroids ; Tacrolimus

BACKGROUND: A variety of dietary supplements are commercially available. However, the efficacy and safety of dietary supplement use in children are not well established. Understanding dietary supplement use is important for developing public health policy regarding dietary supplements. This study aimed to investigate the types of dietary supplements used and characteristics of dietary supplement users among Japanese elementary school children. METHOD: We conducted a cross-sectional web-based questionnaire study. Dietary supplement use, socio-demographics, and health-related behaviors were assessed through mother-reported questionnaire. Types of dietary supplements were identified based on ingredient using product barcodes and brand names. Multivariate logistic regression analysis was conducted to investigate the socio-demographics and health-related behaviors associated with supplement use. RESULTS: Among 4933 children, 333 (6.8%) were identified as dietary supplement users. The most common supplement was amino acids or protein (1.4%), followed by n-3 fatty acids or fish oil (1.0%), probiotics (1.0%), multivitamins (0.9%), multivitamin-minerals (0.8%), and botanicals (0.8%). Overall, any dietary supplement use was significantly associated with the highest frequency of sports participation (odds ratio [OR], 2.58; 95% confidence interval [CI], 1.65-4.02), highest household income (OR, 1.87; 95% CI, 1.13-3.10), highest maternal educational level (OR, 1.82; 95% CI, 1.31-2.52), and male sex (OR, 1.38; 95% CI, 1.09-1.75). The highest frequency of sports participation was significantly associated with higher odds of use of amino acids or protein (OR, 6.06; 95% CI, 1.78-20.6) and multivitamins (OR, 3.56; 95% CI, 1.11-11.5), compared to the lowest frequency of sports participation. CONCLUSION This study showed that Japanese children primarily use non-vitamin, non-mineral supplements. Non-vitamin, non-mineral supplements should thus be included in future studies aimed at monitoring dietary supplement use. We also found that dietary supplement use in children was associated with sports participation. Guidelines for dietary supplement use for children, in particular sport participants, are needed.