无菌医疗器械生产企业在实施GMP中存在的问题和建议

对无菌医疗器械生产企业在实施GMP过程中存在的普遍问题进行阐述,并对目前企业实施GMP的薄弱环节提出一些建议,使无菌医疗器械生产企业能更好地实施GMP,切实将无菌医疗器械生产管理水平提升到新的高度.     

Does a dedicated program for young breast cancer patients affect the likelihood of fertility preservation discussion and referral?

PurposeTo assess whether a dedicated program for young breast cancer patients, including a nurse navigator, improves the frequency of: a) fertility discussion documentation and b) fertility preservation (FP) referrals.MethodsA retrospective chart review and prospective survey were undertaken of breast cancer patients diagnosed at age 40 or younger between 2011 and 2013 who received adjuvant or neo-adjuvant chemotherapy at two academic cancer centers in Toronto, Canada. The Odette Cancer Centre (OCC) has a dedicated program for young breast cancer patients while Princess Margaret Cancer Centre (PM) does not. Patient demographics, tumor pathology, treatment and fertility discussion documentation prior to systemic chemotherapy administration were extracted from patient records. Prospective surveys were administered to the same cohort to corroborate data collected.ResultsEighty-one patient charts were reviewed at both OCC and PM. Forty-seven and 49 at OCC and PM returned surveys for a response rate of 58% and 60% respectively. Chart reviews demonstrated no difference in the frequency of fertility discussion documentation (78% versus 75% for OCC and PM, p = 0.71); however, surveys demonstrated higher rates of recall of fertility discussion at OCC (96% versus 80%, p = 0.02). A greater proportion of women were offered FP referrals at OCC, as observed in chart reviews (56% versus 41%, p = 0.09), and surveys (73% versus 51%, p = 0.04). Time to initiation of chemotherapy did not differ between women who underwent FP and those who did not.ConclusionA dedicated program for young breast cancer patients is associated with a higher frequency of FP referrals without delaying systemic therapy.     

Effects of Vehicles and Pressure Sensitive Adhesives on the Penetration of Isosorbide Dinitrate Across the Hairless Mouse Skin

The effects of various vehicles and adhesives on the percutaneous absorption of isosorbide dinitrate (ISDN) were evaluated. Lauroglycol ® FCC showed the highest flux among vehicles tested. The flux of ISDN from silicone and acrylic adhesive matrices was found to be higher than that from other types of adhesive matrices. No statistically significant relationship between the flux from acrylic PSA and the flux from a solution formulation was observed. A highly cross-linked acrylic adhesive gave higher permeation rates than the other acrylic adhesives examined. N-decylmethyl sulfoxide showed the highest enhancing effect on the flux of ISDN from acrylic adhesive. The relationship between the HLB values of vehicles and the measured flux showed a decrease of flux at HLB values greater than 12.     

The effect of variable heart rate decelerations on intraventricular hemorrhage and other perinatal outcomes in preterm infants

Objective: We investigated the hypothesis that repetitive variable heart rate decelerations in labor are associated with an increased incidence of neonatal complications in premature infants. Methods: This was a retrospective case-control study. Singleton fetuses weighing between 750 and 2500 g at 25-35 weeks' gestation were considered for the study. Fetuses delivered by Cesarean section prior to labor were excluded. Heart rate traces were retrieved from an electronic archive and were assessed for the presence of variable decelerations. Cases had at least three variable decelerations in the hour prior to delivery and were matched 1 : 1 with controls for gestation, sex and birth weight. Results: A review of 6500 deliveries yielded 41 matched pairs. The groups were compared for the following outcomes. Measures of acute morbidity were cord pH at delivery, 5-min Apgar score and resuscitation; measures of chronic morbidity were intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis and death. There was no difference in measures of acute morbidity between the groups. The incidence of chronic morbid outcome measures in the cases was six (15%) vs. one (2.5%) in controls ( p = 0.01). Conclusions: This study suggests that variable decelerations in preterm infants are associated with chronic morbidity, particularly intraventricular hemorrhage through a mechanism independent of fetal acidemia. Further study is required to determine whether these infants would benefit from early Cesarean section.