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 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 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.
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.
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.
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.
Statistical graph is an indispensable part of scientific papers. It is helpful to promote the communication, dissemination, and application of academic achievements by presenting research results intuitively and accurately through standardized and beautiful visual graphs. The safety of a medical intervention is the basic premise of its clinical application, and randomized controlled trial (RCT) as an important design to determine the efficacy and safety of medical interventions, it is extremely important to accurately present the information on the safety outcomes of interventions found therein. However, the research found that the reports of RCTs didn’t adequately use visual graphs to present harms data. In order to promote clinical researchers to better use visual graphs to present harms data, international scholars recently published a consensus study in BMJ, which identified and recommended 10 statistical graphs for presenting harms data in RCTs. In order to facilitate domestic scholars to understand and apply the consensus, this article interprets the consensus and recommendations, and it is expected to provide help for improving the quality of harms visualization in domestic papers of RCTs.
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 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.
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.