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.

Postoperative cardiac function and the occurrence of arrythmia depend upon myocardial protection during open heart surgery in severe concentric hypertrophy. The effect of myocardial protection was evaluated in terms of several released cardiac enzymes before and after reperfusion, and postoperative left ventricular (LV) cardiac function from cardiac pool scintigram in 21 cases with aortic stenosis (AS Group). These data were compared with 20 cases with aortic regurgitation (AR Group). Heart weight and aortic cross-clamping time were not significantly different in these two groups. The enzymatic values in peak total creatine-kinase (CK) and peak CK-MB fraction were higher in the AS group than in the AR group, and peak GOT was significantly elevated in the AS group (peak GOT: 93±32 in AS group, 64±17IU/l in the AR group, p<0.01). Among the cases in the AS group, six cases with LV small cavity (LVDd<4cm) and severe concentric hypertrophy were associated with high values of released enzyme and the occurrence of ventricular arrythmia. Postoperative cardiac function was estimated from both systolic parameters such as LV ejection fraction (LVEF) or peak ejection rate (PER) and diastolic parameters such as peak filling rate (PFR) or early diastolic filling rate (1/3PFR). Postoperative LVEF and PER improved to normal control levels in the AS group with preoperatively depressed systolic function, although values were decreased in the AR group with impaired systolic function. The postoperative early diastolic peak filling rate did not recover to control levels in the AS group as well as the AR group, and was impaired in the AS group with severe concentric hypertrophy due to elevated chamber stiffness and the delay of time to peak filling rate. In severe concentric hypertrophy, we used several techniques for myocardial protection of terminal blood cardioplegia, and gradually increased reperfusion pressure and LV venting after reperfusion. Late results revealed a good clinical course in all 21 cases except for the occurrence of arrythmia in three.

We present three cases of injured iliac arteries due to blunt abdominal trauma in traffic accidents. We performed emergency operations on these patients. Two of them received interposition of artificial prosthesis, and one received extraanatomical bypass. Fasciotomy was needed for compartment syndrome in 2 cases and one of them suffered a fractured pelvis with rupture of the ipsilateral femoral vein. One case was complicated with laceration of the mesentery. The postoperative course was almost uneventful in 2 cases but one died 8 days after operation because of subsequent multiple organ failure due to renal failure with necrosis of the small intestine of unknown cause. The diagnostic difficulties in such injuries depend on the existence of complications and different obstructive mechanisms from the penetrating injuries. Adequate and prompt diagnosis based on the clinically suspicious signs including weakness and discrepancy of the pulse are required.

BACKGROUND: Leukotriene receptor antagonists have been used to prevent virus-induced asthma exacerbations in autumn. Its efficacy, however, might differ with age and sex. OBJECTIVE: This study aimed to investigate whether pranlukast added to usual asthma therapy in Japanese children during autumn, season associated with the peak of asthma, reduces asthma exacerbations. It was also evaluated the effect of age and sex on pranlukast's efficacy. METHODS: A total of 121 asthmatic children aged 1 to 14 years were randomly assigned to receive regular pranlukast or not according to sex, and were divided in 2 age groups, 1–5 years and 6–14 years. The primary outcome was total asthma score calculated during 8 weeks by using a sticker calendar related to the days in which a child experienced a worsening of asthma symptoms. This open study lasted 60 days from September 15 to November 14, 2007. RESULTS: Significant differences in pranlukast efficacy were observed between sex and age groups. Boys aged 1 to 5 years had the lower total asthma score at 8 weeks (p = 0.002), and experienced fewer cold episodes (p = 0.007). There were no significant differences between pranlukast and control group in total asthma score at 8 weeks (p = 0.35), and in the days in which a child experienced a worsening of asthma symptoms (p = 0.67). CONCLUSION: There was a substantial benefit of adding pranlukast to usual therapy in asthmatic children, especially in boys aged 1 to 5 years, during autumn season.
Asian Continental Ancestry Group ; Asthma ; Child ; Child, Preschool ; Humans ; Leukotriene Antagonists ; Seasons