Objective To evaluate the adverse events following immunization (AEFI) of meningococcal vaccines, so as to provide references for the appraisal and treatment of AEFI. Methods The Chinese Bio-medicine Database (1978 to April, 2010), China Journal Full-text Database (1994 to April, 2010), VIP Database (1989 to April, 2010) and WangFang database (1988 to April, 2010) were fully searched, and the references listed in original studies were searched manually as well. Then two reviewers independently screened studies and abstracted relevant data.Results A total of 52 articles involving 61 cases were included. Among the AEFI cases, 72.13% were hypersensitive response, including henoch-schonlein purpura (accompanied with or without nephritis), anaphylactic shock, allergic eruption, angioedema, local allergic reaction and so on. Conclusion The results of this study show that meningococcal vaccines may result in AEFI. However, most AEFI are temporary and can be cured after treatment in time. In general, meningococcal vaccine is safe, but monitoring and treatment for AEFI are necessary.
Abstract： Objective To identify the risk factors for shortterm adverse events in infants with congenital heart diseases receiving open heart surgical correction with cardiopulmonary bypass (CPB), in order to improve the outcome by adopting appropriate treatment measures. Methods We retrospectively analyzed the clinical data of 98 consecutive children with congenital heart diseases who underwent surgical correction with CPB in Beijing Fu Wai Hospital from November 2009 to December 2009. The patients were divided into two groups according to the postoperative complications. Among the patients without complications（n=40）: there were 24 males and 16 females with an age of 7.60±0.40 months and a weight of 7.80±0.30 kg. In the patients with complications (n=58): there were 42 males and 16 females with an age of 6.20±0.40 months and a weight of 6.70±0.20 kg. In both groups, perioperative data were recorded, including preoperative fast blood glucose, creatinine, time of aortic crossclamp, modified or zerobalanced ultrafiltration, postoperative glucose level, concentration of lactate, notrope score and complications. Risk stratification was performed by Risk Adjusted Classification for Congenital Heart Surgery (RACHS-1). Univariate analysis and logistic regression analysis were used to identify the risk factors for shortterm adverse events. Results One patient(1.02%) died of circulatory failure during the perioperative period. Thirtyseven patients [CM(159mm]were supported by at least 2 vasoactive drugs for more than 48hours,29 by mechanical ventilation for more than 24 hours, 5 needed reintubation, 1 experienced tracheotomy, 31 suffered from noscomial infection, 4 had wound infection, 3 developed renal failure, and 1 developed hepatic dysfunction. By logistic regression analysis, age (OR=0.750, P=0.012), percutaneous oxygen saturation (OR=0.840,P=0.005), aortic crossclamp time (OR=1.040, P=0.008), postoperative glucose level (patients with a mean glucose level lower or equal to 8.33 mmol/L had a probability of developing adverse outcomes five times higher; OR=5.051, P=0.011) were found to be the risk factors for shortterm adverse outcomes. Conclusion Age, percutaneous oxygen saturation and aortic crossclamp time are associated with the shortterm adverse outcome of infants undergoing congenital heart disease correction with CPB. The present results do not support perioperative hyperglycemia as a risk factor for adverse outcome.
Objective To explore the relationship between macro-economic indicators and incidences of adverse events linked to intrauterine devices (IUDs). Methods Data on IUD-associated adverse events were collected from a cohort study conducted between September 2005 and December 2006. Regional economic data were from the 2006 National Economic and Social Development Statistical Bulletins and Statistical Yearbooks of various regions. A total of 20,220 IUD users in 236 towns in Jiangsu, Shanghai, Guangdong, Anhui, Sichuan, and Chongqing provinces in China were included in this study. Linear correlation and regression analyses were used to analyze the relationships between regional income and total incidences of adverse events, incidences of mild adverse events, and incidences of severe adverse events. Results Incidences of total adverse events and mild adverse events were positively correlated with regional economic level (rs=0.336, Plt;0.05; rs=0.272, Plt;0.05), while incidences of severe adverse events were not correlated with regional economic level. Conclusions The positive relationship between regional economic level and reported IUD-associated mild adverse events likely reflects income-related disparities in women seeking care and receiving treatment for mild adverse events. This points to a need to improve both public health education and the quality of health services, particularly in poorer areas.
Objective To evaluate the safety of intranasal use of beclomethasone dipropionate, budesonide, fluticasone propionate and mometasone for adults and children with chronic sinusitis/nasal polyps and allergic rhinitis. Methods Randomized controlled trials were located. Study quality was evaluated by two researchers independently. RevMan 4.2 was used for meta-analysis. Results Seven RCTs involving 826 patients were included. Compared with placebo, local use of fluticasone proprionate in adults showed no statistically significant trend to increase incidence of acute sinusitis (OR 16.87, 95% CI 0.87 to 301.62), but no significant difference was seen for epistaxis (OR 7.76, 95% CI 0.38 to 157.14): 1 trial, 60 patients. In another trial, no cases of nasal atrophy were reported in either fluticasone or placebo groups. No significant differences were seen between local use ofbudesonide and placebo in adults for dryness of nasal mucosa (OR 3.38, 95%CI 0.66 to 17.18) and epistaxis (OR 2.20, 95%CI 0.39 to 12.32): 1 trial, 193 participantions. No significant difference was seen between budesonide and pollinex for headache (OR 1.71, 95%CI 0.52 to 5.62). No differences were seen between placebo and fluticasone propionate in children for epistaxis (OR 0.85, 95%CI 0.20 to 3.66), headache (OR 0.25, 95%CI 0.02 to 2.83), plasma cortisol concentration (OR 1.56, 95%CI 0.06 to 38.69) and dryness of nasal mucosa (OR 4.76, 95%CI 0.25 to 89.54). Beclomethasone dipropionate in children showed no statistical differences for dryness of nasal mucosa (OR 0.51, 95%CI 0.14 to 1.87), epistaxis (OR 0.68, 95%CI 0.26 to 1.73) and rhinitis (OR 0.47, 95%CI 0.04 to 5.36). No decrease of plasma cortisol concentration was detected in either group. Mometasone and placebo showed no significant differences in children for epistaxis (OR 1.57, 95%CI 0.41 to 5.95), rhinitis (OR 0.33, 95%CI 0.01 to 8.22) or headache (OR 0.33, 95%CI 0.01 to 8.22). Decrease of plasma cortisol concentration was not detected. Conclusions According to this systematic review, long term intranasal use of steroid for adults and children may be safe based on the two high quality, four moderate quality trials and one with b bias. High quality studies with larger sample sizes and in other languages are needed to provide ber evidence.
ObjectiveTo reduce patients' adverse events caused by needle indwelling through quality control circle (QCC) activities, in order to ensure the effectiveness and safety of intravenous fluids. MethodsGuided by the QCC theory, we set up QCC, selected the topic related to reduction of patients' adverse events caused by needle indwelling, and worked out the plans from September 2012 to April 2013. Then, we adopted Plan-Do-Check-Act (PDCA) cycle method to set up goals, formulate measures, and inspect and improve the results. ResultsThe incidence of needle-related adverse events reduced from 44.8% to 9.8% by implementation of quality circle activities. There was a significant statistical difference between the two groups (χ2=148.16, P<0.05). ConclusionQCC activity can not only reduce the adverse events incidence of needle indwelling, but also improve the nurses' working enthusiasm and responsibility, problem-solving skills and accomplishment, and promote team cohesion.
ObjectiveTo explore low-seniority nurses' attitudes regarding adverse events reporting. MethodA total of 200 low-seniority nurses were investigated with the Chinese version of Reporting of Clinical Adverse Events Scale from October to December 2013. Epidata software was used to collect and manage data and SPSS 17.0 software was applied to analyze the collected data. ResultsThe nurses who once witnessed or experienced adverse events accounted for 76%, of whom 74.3% reported adverse events. The mean score of reporting of clinical adverse events among low-seniority nurses was 48.5±7.2. Age was positively associated with the global scores of reporting of clinical adverse events, when compared with other variables (r=0.20, P=0.01). ConclusionsOverall, low-seniority nurses' attitudes toward reporting adverse events are negative. Age is positively associated with attitudes toward reporting adverse events. Therefore, a non-punitive culture should be established and an efficient reporting system is good to enhance the quality of care.
ObjectiveTo explore the therapeutic efficacy of crizotinib for patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC). MethodsWe retrospectively analyzed the clinical data of 31 ALK-positive NSCLC patients who received crizotinib treatment between November 2012 and May 2014 in the Department of Thoracic Oncology of West China Hospital. The median age of the patients was 51 years old, and the percentage of male and female patients was 45.2% and 54.8%, respectively. Among them, 74.2% were non-smokers, 74.2% had an ECOG performance status of 0-2. Histologically, adenocarcinoma was the highest proportion of 96.8%, and one (3.2%) patient had large cell carcinoma. Fifteen (48.4%) ALK-positive patients were given crizotinib in the first-line setting, and 16 (51.6%) accepted crizotinib in the second-line and beyond. ResultsThe objective response rate (ORR) of the patients treated with crizotinib was 61.3%, and the disease control rate (DCR) was 90.3%. The median progression-free survival (time) was 10.0 months [(95% CI (2.9, 17.0) months]. The difference of ORR and DCR between the patients given crizotinib in the first-line setting and the patients given crizotinib in the second-line or beyond was not statistically significant (P=0.716 and P=0.600, respectively). The most frequent treatment-related adverse events were increased aspartate aminotransferase/alanine aminotransferase (64.5%), nausea and vomiting (35.5%), leukopenia (16.7%), vision disorder (16.1%), edema (12.9%), and diarrhea (12.9%), and most toxicities were grade 1 and 2. ConclusionThis study shows that crizotinib can increase the objective response rate and disease control rate, prolong progression-free survival time in patients with advanced ALK-positive non–small-cell lung cancer. Crizotinib has relative fewer side effects and can be tolerated by the patients.
Objective To explore the emergence agitation resulting from postoperative indwelling urethral catheters in patients of thoracic surgery. Methods In this prospective cohort study, we recruited 140 patients who were scheduled for thoracic surgery under general anesthesia in West China Hospital from January through April 2014. These patients were divided into two groups including a control group and a trial group with 70 patients in each group. The patients in the control group had indwelled urethral catheter routinely. The catheter removed after the surgery at operation room in the trial group. Intraoperative urinary volume, emergence agitation (EA) occurrence, postoperative urinary retention, and urethral irritation were recorded. Results There was no statistical difference in postoperative urinary retention rate between the control group and the trial group (1.43% vs. 2.86%, P=0.230). However, the urethral irritation rate in the control group was significantly higher than that in the trial group (12.86% vs. 0.00%, P=0.012) . And there was a statistical difference in adverse event rate (2.86% vs. 0.00%, P=0.039) between the two groups. There was a significantly higher incidence of urethral irritation in male patients (20.51%, 8/39) than female patients (3.23%, 1/31, P=0.033).The rate of EA in the control group was significantly higher than that in the trial group (28.57% vs. 12.86%, P=0.010). There was a significantly higher EA rate in the patients who had urethral irritation by postoperative indwelling catheters compared with those without indwelling catheters (45.00% vs. 12.86%, P=0.043). Conclusion This study suggests that postoperative EA is a result from urethral irritation than local pain, and the EA rate can be decreased by removal of catheter before anaesthetic recovery.
ObjectiveTo summarize the occurrence rules of adverse reactions/events of voriconazole, analyze the reasons of adverse reactions/events, and provide reference for clinical medication. MethodsUse China National Knowledge Infrastructure, Vip Journal Integration Platform and Wanfang Data Knowledge Service Platform to search the literatures published in 2015 and before with "voriconazole" "adverse reaction" and "adverse event", classify the adverse reactions/events according to gender, age, system-organs, drug combination, occurrence time, and outcome, and analyze the occurrence regularity and reasons of adverse reactions/events. ResultsA total of 29 literatures were searched, including 44 cases. In all the adverse reactions/events, elderly patients were the most (18 cases with the age of 61-80 years old, occupying 40.9%; 13 cases with >80 years old, occupying 29.5%). Adverse reactions/events mainly involved central nervous system (45 cases, 59.2%). Proton pump inhibitors (5 cases) were the more common drug combination in the 7 drug combination cases. Most adverse reactions/events occurred in 1-7 days after medication (35 cases, 79.5%). The outcome of adverse reactions/events included 39 improvement/recovery, 1 death, and 4 unknown. ConclusionUsing voriconazole should consider the drug characteristics. Choose the drug according to the specific condition of patients, at the same time pay attention to drug interactions, contraindications, and so on. If necessary, genetic testing and therapeutic drug monitoring can be done in order to reduce the occurrence of adverse drug reactions/events.
Objective To observe the incidence rate of cardiovascular adverse events and evaluate the safety of dexmedetomidine or midazolan sedation in patients with long-term mechanical ventilation in intensive care unit (ICU). Methods From January 2014 to December 2015, patients admitted to ICU aged ≥18 years with mechanical ventilation time ≥48 hours were randomly divided into dexmetomidine group (group D) and midazolam group (group M). Adverse events such as cardiovascular events during sedation were observed. Results There were 144 cases in group D and 143 cases in group M. Slow heart rate was the prominent manifestation in group D. The incidence of heart rate <50 beats per minute in group D (4.86%) was less than that in group M (6.29%), but there was no statistical difference ( P=0.681). Group D had lower blood pressure (40.28% vs. 72.73%), tachycardia (18.75% vs. 41.96%), arrhythmia (16.67% vs. 34.97%) and 28- day mortality (22.22% vs. 42.66%) than those in group M (P<0.01). No cardiac arrest, sinus arrest, hypertension, hyperglycemia, or hypoglycemia were found in the two groups. Conclusion The long-term sedation of dexmetidine in patients with mechanical ventilation is safe; in cardiovascular adverse events, the 28-day mortality is lower than that of traditional midazolam sedation, and the duration of mechanical ventilation is no longer than that of traditional midazolam sedation, with slightly longer ICU length of stay.