PURPOSE: Hemodynamically significant patent ductus arteriosus (PDA) may increase the mortality of premature infants who received ventilator care by aggravating hypoxia, acidosis, pulmonary edema and hypotension. The risk factors for PDA in premature infants are low gestational age, infusion of excessive fluid, and severity of neonatal respiratory distress syndrome. We studied the risk factors of PDA in very low birth weight infants (VLBW) to establish a guideline for the treatment. METHODS: VLBW infants who were born at Severance Hospital, Yonsei Medical Center from January, 1989 through December, 1995 and survived for at least 5 days with ventilator care were recruited for this study. Patent ductus arteriosus was diagnosed according to the clinical diagnostic criteria of Yeh (Yeh et al, 1981b). Thirty six infants had diagnosed as PDA (PDA group), and thirty seven infants who had not PDA were selected as control. Both groups of infants received restrictive fluid therapy. RESULTS: 1) Gestational age, sex, Apgar score, administration of surfactant, mode of delivery, toxemia and use of antenatal dexamethasone were similar between PDA and control infants. 2) In PDA group, ventilatory index and duration of vetilator care were significantly greater (P<0.05), and a/ApO2 was significantly lower than control group (P<0.05). There was no difference in peak inspiratory pressure at initial setting, the highest peak inspiratory pressure and mean airway pressure during ventilator care. 3) During the first 3 days of life, the urine output was similar between groups. On the 4th and 5th days of life, PDA group had significantly reduced urine ouput compared with control (on day 4; 2.6+/-1.1 ml/kg/h vs. 3.2+/-1.2ml/kg/h, P<0.05; on day 5, 2.9+/-1.4ml/kg/h vs. 3.6+/-1.6ml/kg/h, P<0.05) . 4) The percent weight loss compared to birth weight was siginificantly lower in PDA group (12.5% vs. 15.1%, P<0.05). 5) The PDA group had higher incidences of bronchpulmonary dysplasia and intraventricular hemorrhage (P<0.05). CONCLUSION: Among Vlnfants who received restrictive fluid therapy during the first 5 days of life, infants with PDA had reduced urine output and percent weight loss than control group.
Acidosis ; Anoxia ; Apgar Score ; Birth Weight ; Dexamethasone ; Ductus Arteriosus* ; Ductus Arteriosus, Patent ; Fluid Therapy ; Gestational Age ; Hemorrhage ; Humans ; Hypotension ; Incidence ; Infant* ; Infant, Newborn ; Infant, Premature ; Infant, Very Low Birth Weight* ; Mortality ; Pulmonary Edema ; Respiratory Distress Syndrome, Newborn ; Risk Factors* ; Toxemia ; Ventilators, Mechanical ; Weight Loss

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.
Australia ; Canada ; Delivery of Health Care ; Drug and Narcotic Control ; Drug Approval ; European Union ; Health Expenditures ; Japan ; Korea ; Nonprescription Drugs*

BACKGROUND AND OBJECTIVES: It has been reported that intracoronary radiation therapy (ICRT) using a Ho-166 coated balloon inhibits restenosis of porcine coronary arteries. However, the consequences of ICRT on coronary artery endothelial function are unknown. The aim of this study is to investigate the effects of ICRT using a Ho-166 balloon on coronary artery endothelial function and vasomotor reactivity. MATERIALS AND METHODS: Female pigs (25-35 kg) were orally premedicated daily with aspirin (100 mg) and ticlopidine (250 mg) for the duration of the study. Under sterile conditions with local anesthesia of the skin provided by 2% lidocaine, an arteriotomy of the left carotid artery was performed, an 8 Fr sheath was inserted, and intraarterial heparin sodium (10,000 IU) was injected. Under fluoroscopic guidance, the coronary artery main branch was selected through an 8 Fr guiding catheter for coronary artery overdilation injury (balloon to artery ratio, 1.3:1) and ICRT. A Ho-166 coated balloon prepared to deliver 20 Gy at a depth of 2 mm from the balloon surface was used for ICRT. The coronary artery main branch in each pig was randomly assigned to either balloon injury (Group I) or balloon injury plus ICRT (Group II). Coronary artery segments were taken from the animals at 0 week (n=8), 4 weeks (n=6) and 8 weeks (n=8) after the intervention. Data in each group denote the relative ratio compared to non-injured coronary artery and are expressed as mean +/- standard error of mean. RESULTS: The degree of KCl-induced contractile response (g) was not different between the two groups at 0 and 4 weeks, but was significantly decreased in group II compared to group I at 8 weeks (I:1.04+/-0.06, II:0.79+/-0.07, p=0.014). In rings precontracted with prostaglandin F 2alpha (PGF 2alpha), the degree of NO-dependent relaxation (%) induced with substance P was significantly decreased in group II compared to group I at 0 week (I:0.93+/-0.33, II:0.47+/-0.31, p=0.03), but the difference between the two groups was not significant at 4 and 8 weeks. In rings precontracted with PGF 2alpha and LAME in the presence of indomethacin, the degree of EDHF-induced relaxation (%) using substance P was not different between the two groups at 0, 4 and 8 weeks; nor was the degree of sodium nitroprusside-induced endothelium independent relaxation (%) in depolarized conditions with PGF 2alpha. CONCLUSION: Endothelial function of the porcine coronary artery is only transiently impaired after ICRT using a Ho-166 coated balloon. Therefore this therapy can be used as an effective method to prevent restenosis after percutaneous coronary intervention.
Anesthesia, Local ; Angioplasty ; Animals ; Arteries ; Aspirin ; Carotid Arteries ; Catheters ; Coronary Restenosis ; Coronary Vessels ; Endothelium ; Female ; Heparin ; Humans ; Indomethacin ; Lidocaine ; Percutaneous Coronary Intervention ; Prostaglandins F ; Relaxation ; Skin ; Sodium ; Substance P ; Swine ; Ticlopidine