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.
ObjectiveIn order to provide guidance for early interference of diabetic retinopathy (DR) in patients with diabetes mellitus (DM), we surveyed the prevalence and analysis the related factors of DR in Shanghai Songnan community. MethodsBased on an established resident health database, an epidemiology study was performed on the residents with DM in Shanghai Songnan community.1177 patients completed questionnaire survey, and received physical examination and laboratory tests. The diagnosis and grading of DR were established based on the ocular fundus images acquired by digital non-mydriasis fundus camera. Patients with incomplete questionnaires were excluded. ResultsThere were 1120 DM patients with valid questionnaires. DR was found in 264 (23.57%) patients. The prevalence of mild, moderate, severe non-proliferative DR and proliferative DR was 17.05%, 5.09%, 1.16% and 0.27% respectively. There was significant differences in age, disease course, systolic blood pressure, insulin usage between the DR group and NDR group(t=-2.647, 2.688, 2.204, 2.291;χ2=12.527;P=0.008, 0.007, 0.028, 0.022, 0.000). There was significant differences in fasting blood-glucose and insulin usage between the mild, the moderate and the severe DR group(t=21.964, χ2=14.996;P=0.000, 0.001). Stepwise logistic analysis identified that age, DM course, and insulin usage were the related factors of DR (OR=0.769, 1.239, 1.100, 1.071, 1.682;P=0.001, 0.043, 0.176, 0.097, 0.005). ConclusionThe age, DM course, and insulin usage were the related factors of DR. The high prevalence of DR indicated the importance of the management of diabetic patients.
Objective To investigate the clinical efficacy of minimally invasive mitral valvuloplasty (MVP) in the treatment of infective endocarditis (IE) with mitral regurgitation (MR). Methods A retrospective analysis was conducted on the clinical data of patients who underwent MVP for IE with MR in the Department of Cardiovascular Surgery at Zhongshan Hospital, Fudan University from January 2016 to December 2020. Patients were divided into two groups based on the surgical incision: those with a right mini-thoracotomy were classified as a minimally invasive surgery (MIS) group, and those with a median sternotomy were classified as a median sternotomy (MS) group. All patients had isolated mitral valve involvement. Perioperative data were analyzed, and mid- to long-term outcomes were compared between the two groups. Results A total of 86 patients were included, with 40 in the MIS group (22 males and 18 females, with a mean age of 39±15 years ranging from 8 to 71 years) and 46 in the MS group (27 males and 19 females, with a mean age of 49±16 years ranging from 14 to 71 years). The patients in the MIS group were relatively younger (P=0.004) with better preoperative cardiac function (P=0.004). There was no statistical difference in preoperative fever, gender, or comorbidities between the two groups (P>0.05). The MIS group had shorter postoperative ventilation times, less postoperative 24-hour drainage, less blood transfusion, and shorter total hospital stays compared to the MS group (P=0.001, 0.018, 0.005, 0.005). There was no statistical difference in cardiopulmonary bypass times or ICU stays between the two groups (P>0.05). The perioperative complication rates and mortality rates were not significantly different between the two groups (P>0.05). Follow-up was conducted for 11-92 months, with a mean duration of 49±19 months and an overall follow-up rate of 91.6%. During the follow-up, 3 patients in each group required reoperation for mitral valve issues, with no statistical difference in incidence (7.5% vs. 6.5%, P=0.691). There were no warfarin-related complications, recurrences, or deaths in either group during follow-up. Multivariate regression analysis identified age, preoperative cardiac function, and surgeon experience as influencing factors for the choice of surgical approach. Conclusion Minimally invasive MVP for IE with MR is relatively safe in the perioperative period and shows significant efficacy, with clear mid- to long-term outcomes. It is recommended for younger patients with better preoperative cardiac function and when performed by surgeons with extensive experience in mitral valvuloplasty.
Objective To investigate the risk factors associated with neovascular glaucoma (NVG) after pars plana vitrectomy (PPV) in eyes with proliferative diabetic retinopathy (PDR). Methods Retrospective study. One hundred and thirty-seven patients (137 eyes) with PDR who underwent PPV were recruited. There were 85 males and 52 females. The average age was (60.1±8.8) years old. The duration of diabetes was (10.2±3.6) years. There were 49 patients with ipsilateral carotid artery stenosis. Fifty-three eyes underwent intravitreal ranibizumab or conbercept injection before PPV. All eyes were treated with 23G standard three-port PPV. The average follow-up time after PPV was 11.5 months. Fundus fluorescein angiography (FFA) was conducted in postoperative 4-6 weeks to observe non-perfused retinal areas. Risk factors, such as ipsilateral carotid artery stenosis, the presence of non-perfusion in retina after PPV and the application of anti-vascular endothelial growth factor (VEGF) drugs before PPV, were identified by logistic regression. Results Twenty of 137 patients (14.6%) developed postoperative NVG after PPV. Ipsilateral carotid artery stenosis [odds ratio (OR) =5.048, 95% confidence interval (CI) 2.057-12.389,P=0.000] and the presence of non-perfusion in retina after PPV (OR=4.274, 95%CI 1.426-12.809,P=0.009) were significant risk factors for postoperative NVG, while the application of anti-VEGF drugs was not (OR=1.426, 95%CI 0.463-4.395,P=0.536). But the time from PPV to the onset of NVG varies significantly between the two groups of injection of anti-VEGF drugs or not (t=−4.370,P=0.000). Conclusions Risk factors associated with NVG after PPV in eyes with PDR included ipsilateral carotid artery stenosis and the presence of non-perfusion in retina after PPV. The application of anti-VEGF drugs before PPV can delay the onset of NVG in PDR eyes after vitrectomy.
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.
ObjectiveTo investigate the related factors of the retina1 hemorrhage in newborns. Methods9558 newborns included in this observation between March of 2012 and July of 2013 in our hospital. The fundus was examined by the fully-integrated wide-field digital imaging system RetCamⅢat 0-4 days after born. According to the literature, retinal hemorrhage was classified into degreeⅠ, ⅡandⅢ. The condition for baby and the mother during pregnancy were correlatively analyzed. The other factors were analyzed including twins, premature delivery, big baby, mode of delivery, fetal birth, forceps delivery, suction delivery, asphyxia, jaundice, ABO hemolytic, cranial hematoma, intracranial hemorrhage, maternal age, first-time mom, the maternal previous mode of production, emergency delivery, the first stage of labor prolonged, the second stage of labor prolonged, the third stage of labor prolonged, pregnancy-induced hypertension, gestational diabetes, oxytocin, prenatal body mass index (BMI). Multivariate logistic regression analysis was used. ResultsIn 9558 cases of newborns, retinal hemorrhages were found in 2753 infants (28.8%), including 1137 degreeⅠ(41.3%), 895 degreeⅡ(32.5%) and 721 degreeⅢ(26.2%). Multivariate logistic regression analysis showed that the mode of delivery, asphyxia, jaundice, advanced maternal age, maternal previous birth, prenatal BMI is a risk factor for neonatal values retinal hemorrhage (r=0.146, 5.841, 1.847, 0.071, 0.246, 0.965;P < 0.05). The degree of fundus hemorrhage was not related to birth weight and BMI (P > 0.05). ConclusionsThe neonatal retinal hemorrhage rate was 28.8%. Mode of delivery, asphyxia, neonatal jaundice, maternal age, the previous mode of delivery of mothers with more than one previous birth, prenatal BMI values may be risk factors lead to retinal hemorrhage.
Objective To observe the emulsification of silicone oil in eyes with rhegmatogenous retinal detachment (RRD) after silicone oil filling surgery, and to preliminarily analyze the possible clinical factors related to it. MethodsA cross-sectional clinical study. From January 2019 to April 2022, 50 eyes of 50 patients with RRD who underwent pans plana vitrectomy (PPV) combined with silicone oil filling surgery in Eye and ENT Hospital of Fudan University were included in the study. Among them, there were 25 males with 25 eyes and 25 females with 25 eyes; the age was 54.86±11.79 years old. The retina was in place 3 months after surgery. Before silicone oil removal surgery, intraocular pressure ＞21 mm Hg (1 mm Hg=0.133 kPa) or treated with≥1 anti-glaucoma drug (high intraocular pressure) in 20 eyes; intraocular pressure ≤21 mm Hg and no anti-glaucoma drug treatment in 30 eyes (normal intraocular pressure). During follow-up after surgery, silicone oil emulsification was found and those who met the indications for silicone oil removal were subjected to silicone oil removal surgery. The first 2 ml of lavage fluid was collected immediately after removal of the silicone oil, and the particle diameter and number of emulsified silicone oil were measured using a Multisizer® 3 particle/cell counter and particle size analyzer. The measuring range was 0.4-12.0 μm, and the diameter is accordingly divided into 0.4-＜1.0, 1.0-＜3.0, 3.0-＜5.0, 5.0-＜7.0, 7.0-12.0 μm. Each sample was measured 3 times and the average value was taken. Spearman correlation analysis and multiple linear regression analysis were used to analyze the correlation between the number of emulsified silicone oil particles and clinical factors. ResultsThe number of emulsified silicone oil particles was (1.74±2.94)×107/ml (0.96×107-14.11×107/ml), of which the diameter of 0.4-＜1.0 μm emulsified silicone oil particle was (1.25±2.41)×107/ml, accounted for (64.26±12.70)% [(1.25±2.41)×107/(1.74±2.94)×107]. The results of correlation analysis showed that there was no correlation between the total particle number of emulsified silicone oil and various clinical factors (P＞0.05). The number of emulsified silicone oil particles with a diameter of 7.0-12.0 μm was negatively correlated with age (r=－0.298, P=0.036), and positively correlated with axial length (r=0.325, P=0.021). There was no correlation between the previous ocular trauma, choroidal detachment and different lens states and the number of emulsified silicone oil particles (P＞0.05). Multiple linear regression analysis showed that eye axis (β=1 570.868, P=0.023) and age (β=－316.128, P=0.039) were the risk predictors of silicone oil emulsification into large diameter particles (7-＜12 μm). The number of emulsified silicone oil particles with a diameter of 7-12 μmin the patients with high intraocular pressure was significantly higher than that in the patients with normal intraocular pressure, and the difference was statistically significant (U=195.00, P=0.037). ConclusionsMost of the emulsified silicone oil particles in the eyes of RRD patients after silicone oil filling surgery are small-diameter particles; the silicone oil emulsification is more serious in young patients and patients with long ocular axis, and young patients are more prone to high intraocular pressure.
Objective To investigate the clinical efficacy and factors influencing treatment of pediatric noninfectious uveitis with Adalimumab (ADA). MethodsA retrospective clinical study. A total of 86 pediatric patients with non-infectious uveitis, diagnosed and treated with ADA at Department of Uveitis Specialist of Xi'an People's Hospital (Xi' an Fourth Hospital) from January 1, 2021 to December 31, 2023, were included in this study. The age of all patients was ≤16 years. Among them, 55 (63.95%, 55/86) patients received ADA combined with one immunosuppressive agent, 28 (32.56%, 28/86) patients received ADA combined with ≥2 immunosuppressive agents, and 3 (3.49%, 3/86) patients received ADA alone without any immunosuppressive agents. All patients underwent best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) examinations. The thickness of the retinal nerve fiber layer (RNFL) in the macular region was measured using an OCT device. The cumulative treatment effectiveness rate at 12 months post-treatment was evaluated using the Kaplan-Meier survival analysis. Multivariate analysis was performed using the Cox proportional hazards regression model, and the optimal predictive model was selected based on the Bayesian information criterion. The association between different treatment regimens and various clinical outcomes was assessed.ResultsAmong the 86 pediatric patients, 42 were male and 44 were female, with a mean age of (10.47±3.23) years. The distribution of uveitis types was as follows: anterior uveitis in 37 cases, intermediate uveitis in 15 cases, posterior uveitis in 10 cases, and panuveitis in 24 cases. Anterior chamber cells (ACC), keratic precipitates, and synechiae were present in 66, 55, and 38 cases, respectively. The cumulative treatment effectiveness at 12 months was 85.1% [95% confidence interval (CI) 71.9-92.2], with a median time to treatment effectiveness of 3 months. Compared with baseline, after 6 months of treatment, the BCVA, RNFL thickness (Z=−6.323, −8.017), and the grading of ACC and vitreous haze (χ2= −6.917, −5.027) showed significant improvement, with statistically significant differences (P＜0.05). Multivariate analysis revealed that ACC (hazard ratio=22.31, 95%CI 2.43-204.68) and anterior uveitis (hazard ratio=3.88, 95%CI 2.03-7.42) were significantly associated with treatment effectiveness (P＜0.05). Patients with ACC had a median time to treatment effectiveness of 2 months, with a 12-month cumulative treatment effectiveness of 95.5% (95%CI 86.3-98.5). Patients with anterior uveitis had a median time to treatment effectiveness of 2 months, with a 12-month cumulative treatment effectiveness of 97.3% (95%CI 81.3-99.6). Patients without anterior uveitis had a median time to treatment effectiveness of 5 months, with a 12-month cumulative treatment effectiveness of 76.7% (95%CI 54.1-88.2). The cumulative recurrence risk at 12 months was 15.6% (95%CI 6.2-24.1). ConclusionADA is safe and effective in treating pediatric non-infectious uveitis, and ACC and anterior uveitis are associated with response rate.