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 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.
Objectives We conducted a literature review of 33 kinds of Traditional Chinese medicine injections (CMIs) on the national essential medicine list (2004 edition) of China in ADR articles to retrieve basic ADR information and research trends related to CMIs and to provide evidence for the research and development as well as the rational use of CMIs, particularly pharmacovigilance and risk management of CMIs. Methods We electronically searched Chinese Biomedical Literature Database (CBM, Jan. 1978-April 2009), the China National Knowledge Infrastructure Database (CNKI, Jan. 1979-April 2009), Chinese Science and Technology Periodical Database (VIP, Jan. 1989-April 2009) and the Traditional Chinese Medicine Database (Jan. 1984 April 2009). We also retrieved the websites of Ministry of Health and State Food and Drug Administration, to collect data about CMIs ADRs reports and regulations from “Newsletter of Adverse Drug Reactions” (Issue 1 to 22). Then we descriptively analyzed all the results on the year published, periodicals and types of study design of included ADR literatures, the major CMIs as well as the regulations about their ADRs. Results (1) There were 5 405 citations found in total and 2160 were removed because of duplication. After screening the title, abstract and full text of the selected papers, 1 010 studies finally met the eligible criteria. (2) The total and cumulative amount of research articles published about CMIs ADRs significantly increases over time. (3) The included 1,010 articles were scattered among 297 periodicals. A total of 55 journals on pharmaceutical medicine, containing 399 articles, accounted for 39.50% of total; 64 journals on traditional Chinese medicine and pharmaceutical medicine, containing only 197 articles, amounted for 19.50% of total. Only 22 periodicals were included on the core journals of the Beijing University List (2008 edition) (8.94% of the total journals in the list), which published 129 articles (12.77% of the total articles published). (4) We categorized the articles included into eight categories based on their content and study methodology. There were: 348 case reports and 254 case series which accounted for 34.46% and 25.15% of the total articles, 119 overviews (11.78%), 116 randomized controlled trials (11.49%), 78 cross-sectional studies (7.72%), 61 ADR literature analyses (6.04%), and 28 non-randomized controlled clinical studies (2.77%). (5) In the three of top ten journals, "Adverse Drug Reactions Journal", "China Medical Herald", and "Chinese Pharmaceuticals" published literature accounted for 5.84%, 3.76% and 2.67% of the total respectively. (6) The reports of ADRs to Shuanghuanglian, Qingkailing and Yuxingcao injections were the most in all reports for CMIs (All the three injections had more than 200 articles, accounting for 41.95% of the total). The Ministry of Health and the State Food and Drug Administration took measures to supervise them. (7) The four kinds of CMIs (Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang injections) among the top 5 reported ADR literatures were removed from the market or were suspended for sale. The varieties and numbers of reports for CMIs ADRs have relationship with the supervision to them. Conclusions (1) Articles published on CMIs ADRs increased year by year, but overall the research is of low quality and is scattered in a large number of sources. (2) It is very urgent to create a clear standard to grade ADRs of CMIs for the risk management. (3) It is necessary to enforce safety re-evaluation work for CMIs and to promote the clinical rational use.
Objective While reporting of adverse drug reactions (ADR) and adverse drug events (AE) following Chinese medicine injection (CMI) is becoming more common, the reporting quality is of concern. Methods A checklist about the reporting quality of ADR/AE was set up, and the ADR/AE reporting of Herba Houttuyniae injection was chosen as an example. Electronic databases Chinese Journal Net (CJN) (1994-2009) and Chinese Science and Technological Journal Net (VIP) (1989-2009) were searched for target literature. Results Based on our search strategy, 210 articles were included, with 175 articles reporting single or several cases of ADR/AE following Herba Houttuyniae injection (type I report). There were 7 reports from regional or national ADR monitoring centers (type II report), and 28 summary reports from a single hospital or medical center (type III report). All 210 papers mentioned ‘adverse effect,’ ‘safety’ or related meaning words in their titles, but 199 articles did not have abstract. Patient demographic characteristics were not fully reported in these articles. In type I articles, only 97 cases (43.11%) mentioned whether patients had or did not have a history of allergies, while 128 cases (56.89%) in Type II papers and Fourteen (50%) type III papers, did not mention allergic history of patients. Only three articles (3/210, 1.43%), all of them type I, mentioned the syndrome type in Chinese medicine. None of the papers gave clear indications of the type and grade of ADR/AE of patients. Most papers did not report details of the CMI procedure, such as the drug company, product serial number, or the drug’s validity period. Data about the occurrence time and management of ADR/AE was also inadequately reported. Conclusion and recommendations The current reporting format of ADR/AE in clinical CMIs is not standardized. Much fundamental information of ADR/AE following CMI is therefore missing. A standard reporting format for ADR should be developed, and should include the following: 1) a title mentioning adverse effects and safety; 2) a structured abstract including adequate information about the patient and the disease treated, the drug used, the specific ADR/AE, physician response to the ADR/AE, and result of management; 3) demographic characteristic of the patients (gender, age, etc.); 4) clinical characteristics of patients (disease, syndrome, etc); 5) allergic history of patients; 6) diagnosis and syndrome based on Chinese medicine theory; 7) detailed information about the Chinese materia medica intervention (the manufacturer of the drug, series number, valid dates, dosage, route of administration, menstruum, dripping speed, etc.); 8) concomitant drug use; 9) time and symptoms of ADR/AE; 10) type and grading of ADR/AE; 11) physiological systems affected by ADR/AE; 12) specific treatment and prognosis for ADR/AE; 13) evidence of the cause and effect of ADR/AE; 14) any other possibility of ADR/AE. Also, a ADR/AE registration system should be established.
Objective Qin Kai Ling injection (QKL) is made upon traditional Chinese medicine formulation “An Gong Niu Huang Wan”, is widely used to treatment a lot of diseases. This review aims to assess the safety of QKL. Methods We searched Chinese databases CNKI, VIP from 1987 to April 2009. Two authors extracted the data. Results Totally 1 486 cases were included in this review. We unable to answer the question about the incidence of adverse drug reaction/adverse event (ADR/AE) induced by QKL due to absence of total numbers of producing and market information. It was estimated based on the limited data that the possibility of ADR/AE by using QKL should be low. We found some ADR/AE may induced by incorrect use of QKL, such as used in infants, and some incompatibility drugs were used together with QKL, four patients died in private clinics or patient’s home. We unable to distinguish the ADR or AE based on the poor reported data. Conclusion Current weak evidence shows that QKL has a low risk of ADR/AE. The use of QKL in some ADR/AE cases may be questionable. The reporting of ADR/AE needs to be much improved based on “Recommendation for reporting traditional Chinese medicine adverse drug reaction”.
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 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.