Endoscopic retrograde cholangiopancreatography (ERCP) is currently the first-line minimally invasive diagnosis and treatment of biliary and pancreatic diseases. With the increasing popularity of ERCP, ERCP-related adverse events which include post-ERCP pancreatitis, cholecystitis, cholangitis, bleeding, perforation, etc., have received more and more attention. In response to the controversy and problems in the management of these adverse events, the European Society of Gastrointestinal Endoscopy published the guidelines for ERCP-related adverse events in December 2019. The paper interprets the key points in the guideline to provide references for clinical practice.
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.
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 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 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.
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.
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.
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.
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.
