Objective To investigate safety of influenza A H1N1 vaccine vaccinations. Methods A total of 3 300 medical workers were vaccinated by batch of 200909012 influenza A H1N1 vaccine produced by Shanghai Biological Products Corporation Limited according to the principle of voluntary and concentration. The adverse reactions were observed within half an hour, three days and a week after vaccinations, respectively. Results The inoculators with local or systemic reaction reached 1.18% (39/3 300). There were 0.15% (5/3 300) of the inoculators with adverse reaction within half an hour; 0.70% (23/3 300) within 1 to 3 days after vaccination; and 0.33% (11/3 300) within 3 days to 1 week after vaccination. No severe adverse events were found. Conclusion Influenza A H1N1 vaccine vaccinations is an economic and effective way of influenza A H1N1 prevention with mild reactions.
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.
ObjectivesTo systematically review the risk of arterial ischemic and metabolic adverse events in chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs).MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and VIP databases were searched to collect clinical trials, observational studies and case reports of adverse events in CML patients treated with TKIs from inception to February 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using Stata 12.0 software.ResultsA total of 22 studies involving 4 223 patients were included. The incidence rates of ischemic heart disease in any grade were 2 per 100 patient-years (95%CI 2 to 3) for nilotinib, and 0 per 100 patient-years (95%CI 0 to 3) for imatinib. The incidence of ischemic heart disease in grade 3 or 4 was 1 per 100 patient-years (95%CI 0 to 2) for nilotinib. The incidence of peripheral arterial occlusive disease in any grade was 2 per 100 patient-years (95%CI 0 to 14) for nilotinib, and 0 per 100 patient-years (95%CI 0 to 2) for imatinib. The incidence of hypertension in any grade was 1 per 100 patient-years (95%CI 0 to 3) for nilotinib, and 44 per 100 patient-years (95%CI 27 to 71) for ponatinib. The incidence of hypertension in grade 3 or 4 was 2 per 100 patient-years (95%CI 0 to 15) for nilotinib, and 22 per 100 patient-years (95%CI 8 to 58) for ponatinib. The incidence of hyperlipidemia in any grade was 17 per 100 patient-years (95%CI 5 to 59) for nilotinib. The incidence of hyperglycemia in any grade was 11 per 100 patient-years (95%CI 9 to 15) for nilotinib, 2 per 100 patient-years (95%CI 1 to 4) for imatinib, 1 per 100 patient-years (95%CI 0 to 5) for dasatinib, and 19 per 100 patient-years (95%CI 19 to 20) for bosutinib. The incidence of hyperglycemia in grade 3 or 4 was 4 per 100 patient-years (95%CI 3 to 5) for nilotinib, and 1 per 100 patient-years (95%CI 1 to 2) for bosutinib.ConclusionsPatients treated with nilotinib have a greater possibility of ischemic heart and peripheral arterial occlusive disease compared with patients treated with imatinib. Patients treated with ponatinib have a high incidence rate of hypertension, and patients treated with nilotinib have a high incidence rate of hyperlipidemia. Patients treated with bosutinib and nilotinib have higher risk of hyperglycemia compared with patients treated with imatinib or dasatinib.
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.
Objective To explore the influence of dexmedetomidine on wake-up test during spinal orthopaedic surgery. Methods All 80 patients taking spinal orthopaedic surgery were randomly divided into the trial group and the control group, with 40 cases in each group. The endotracheal intubation anesthesia was adopted in both groups with same anesthesia induction. Additionally, dexmedetomidine 0.8 μg/ (kg·h) was infused within 10 min in the trial group before anesthesia induction, and then another 0.5 μg/ (kg·h) was also infused from the intraoperation to suture of incision. For the control group, the same amount of normal saline was infused, and all the narcotics were stopped pumping 15 min before the wake-up test, but then were continued pumping after the wake-up test. Finally, the following indexes were analyzed: wake-up time, wake-up quality, hemodynamic changes at the time of 15 min before wake-up (T1), recovery of spontaneous breathing (T2), wake-up (T3) and 15 min after wake-up (T4), dosage of narcotics, and the incidence of adverse events. Results There was no significant difference in the operation time before wake-up between the two groups (P=0.07). For the trial group, the dosage of sevoflurane (P=0.03) and sufentanil (P=0.00) used before wake-up was significantly lower, the wake-up time (P=0.04) and bleeding amount during wake-up (P=0.00) were significantly less, the wake-up quality (P=0.03) was significantly higher, the blood pressure (P=0.00) and heart rate (P=0.00) when wake-up were significantly lower, and the incidence of adverse events (P=0.04) was significantly lower, compared with the control group. Conclusion Dexmedetomidine adopted in spinal orthopaedic surgery can significantly improve patient’s wake-up quality, shorten wake-up time, reduce bleeding amount when wake-up and adverse events after wake-up, and maintain the hemodynamic stability, so it has better protective effects.
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 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.
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.
Radiation proctopathy, which can be categorized as acute and chronic, is defined as the radiation damage to the rectum caused by radiation therapy in patients with pelvic malignancies. Chronic radiation proctopathy can cause complications such as rectal bleeding, which severely affects patients’ quality of life. At present, endoscopic therapy has become the primary method for diagnosis and treatment of bleeding from chronic radiation proctopathy. In October 2019, the American Society for Gastrointestinal Endoscopy (ASGE) published "ASGE guideline on the role of endoscopy for bleeding from chronic radiation". The guideline described the effectiveness and safety of different endoscopic therapies such as argon plasma coagulation, bipolar electrocoagulation, heater probe, radiofrequency ablation, cryoablation, etc. in the treatment of bleeding from chronic radiation. This paper interprets it to provide references for clinicians in the treatment of bleeding from chronic radiation.
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.
