Objective To investigate the association between environmental factors and nonsyndromic cleft lip and palate (NSCLP), and to explore the interaction of main risk factors in Chinese Guangdong population. Methods A hospital-based case-control study was used. NSCLP children were selected from Cleft Lip amp; Palate Treatment Centre of Second Affil iated Hospital of Medical College of Shantou University between September 2009 and March 2010 as cases. And controlswere chosen from other departments in the same hospital during the same period. The parents of cases and controls were inquired regarding the risk factors and the answers were filled in a unification questionnaire by physicians. These data were analysed with chi-square test and multivariate unconditional logistic regression analysis. Results A total of 105 cases and 110 controls with a mean age of 2.2 years and 3.0 years, respectively, were enrolled. Multivariate logistic regression analysis revealed that genetic family history (OR=4.210, P=0.039), mothers’ abnormal reproductive history (OR=2.494, P=0.033), early pregnancy medication (OR=3.488, P=0.000), and maternal stress (OR=3.416, P=0.011) were risk factors. There were positve interactions between genetic family history and mothers’ abnormal reproductive history as well as early pregnancy medication. Conclusion Certain influencing factors including genetic family history, mothers’ abnormal reproductive history, early pregnancy medication, and maternal stress are associated with NSCLP among Chinese Guangdong population. This study suggests that it may reduce the incidence rate of NSCLP through environmental intervention.
Objective To determine the extent of off-label drug use in pediatric outpatients of West China Second University Hospital in 2010, and to analyze its possible risk factors, so as to provide baseline data for getting acquainted with the extent of off-label drug use in pediatrics in China and developing policy of off-label drug use. Methods The stratified random sampling was conducted to select prescriptions of children aged 0 to 18 years in pediatric outpatients of the West China Second University Hospital in 2010. According to drug instructions, off-label drug use of prescriptions of all selected children was analyzed in the following aspects, the category of off-label drug use, age, category of drugs. In addition, an analysis was conducted to check the relationship between off-label use and following possible risk factors: age, sex, essential medicines and over-the-counter drugs. Results A total of 2 640 prescriptions with 8 588 medical advices involving 329 drugs were extracted and analyzed, with incidence rates of off-label drug use accounting for 76.59%, 40.88% and 83.89%, respectively. The main categories of off-label drug use were no pediatric information (35.57%), indication (25.44%), and dosage (25.31%). The top 2 age groups with highest incidence rate of off-label drug were neonates (54.35%) and adolescents (49.64%). The top 4 drugs with highest incidence rate of off-label drug were respiratory system medicines (48.12%), Chinese patent medicines (48.12%), digestive and metabolic system medicines (33.36%), and systemic anti-infectives (16.27%). The off-label use risks in all age groups in the hospital were indifferent, and the essential medicines and prescription medicines were likely to present higher risks of drug off-label. Conclusion Off-label drug use in pediatric outpatients is common with growth trend in pediatric outpatients of the West China Second University Hospital. On the one hand, drug instructions lack pediatric information, and on the other hand, it’s badly in need of developing relevant legislation, regulations or guidelines to regulate off-label drug use, providing more evidence by conducting clinical trials on pediatric drugs, encouraging the development and production of the applicable drugs and dosage forms for children, and establishing the children essential medicine list, so as to avoid doctor’s professional risk and ensure the safety of pediatric drug use.
ObjectiveTo understand the situation of off-label use of aspirin among outpatients in Sun Yatsen Memorial Hospital, so as to provide baseline data for developing off-label drug use policy. MethodsA stratified random sampling method was used to collected prescription data of aspirin among outpatients in 2013. The incidence rates between different types of off-label use of aspirin were determined by chi-square test, and the influence factors of off-label drug use were analyzed by logistic regression model. ResultsA total of 5 023 prescriptions with aspirin were collected and analyzed, with incidence rate of off-label use up to 17.7%. The major category of off-label use was no indication (94.38%). The top 3 no indications were recurrent abortion, infertility and systemic lupus erythematosus. Drug specification, gender, age and prescribed department were the risk factors of off-label use. ConclusionAspirin off-label use is common among outpatients in Sun Yat-sen Memorial Hospital in 2013, especially in obstetrics and gynecology department and assisted reproductive center. The results suggest that more clinical studies about aspirin for reproduction are needed to provide more evidence of drug use, so as to ensure the safety of drug use in special populations and avoid potential medical risk.