ObjectiveZero-events studies frequently occur in systematic reviews of adverse events, which consist of an important source of evidence. We aimed to examine how evidence of zero-events studies was utilized in the meta-analyses of systematic reviews of adverse events.MethodsWe conducted a survey of systematic reviews published in two periods: January 1, 2015 to January 1, 2020 and January 1, 2008, to April 25, 2011. Databases were searched for systematic reviews that conducted at least one meta-analysis of any healthcare intervention and used adverse events as the exclusive outcome. An adverse event was defined as any untoward medical occurrence in a patient or subject in healthcare practice. We summarized the frequency of occurrence of zero-events studies in eligible systematic reviews and how these studies were dealt with in the meta-analyses of these systematic reviews.ResultsWe included 640 eligible systematic reviews. There were 406 (63.45%) systematic reviews involving zero-events studies in their meta-analyses, among which 389 (95.11%) involved single-arm-zero-events studies and 223 (54.93%) involved double-arm-zero-events studies. The majority (98.71%) of these systematic reviews incorporated single-arm-zero-events studies into the meta-analyses. On the other hand, the majority (76.23%) of them excluded double-arm-zero-events studies from the meta-analyses, of which the majority (87.06%) did not discuss the potential impact of excluding such studies. Systematic reviews published at present (2015-2020) tended to incorporate zero-events studies in meta-analyses than those published in the past (2008-2011), but the difference was not significant [proportion difference=–0.09, 95%CI (–0.21, 0.03), P=0.12].ConclusionSystematic review authors routinely treated studies with zero-events in both arms as "non-informative" carriers and excluded them from their reviews. Whether studies with no events are "informative" or not, largely depends on the methods and assumptions applied, thus sensitivity analyses using different methods should be considered in future meta-analyses.
Objective More and more women without child and female adolescents are undergoing medical abortion (MA), MA effect on subsequent pregnancy has been brought into focus. This research will evaluate the effect of MA on subsequent pregnancy. Methods To searched Medline, Embase, Cochrane Library, Chinese Biomed-database, correlative websites and nine Chinese medical journals. The studies that were included in the reference list were additionally searched. Only RCTs (randomized control trials), CCTs (clinical control trials) and prospective cohort studies were included. Two researchers evaluated the quality of the literature and combined the evidence independently. Revman 4.1 was used for meta-analysis. Results Eight prospective cohort studies with 2 934 cases were included. The incidences of miscarriage, postpartum hemorrhage and placental abnormality occurred in MA group were significantly lower than those occurred in SA group, and their OR (with 95%CI) were 0.42 (0.22 to 0.83), 0.58 (0.39 to 0.85) and 0.68 (0.54 to 0.87), respectively. No other significant differences were observed between the two artificial abortions groups. Though the tendency indicates that medical abortion has a probable influence on subsequent pregnancy, there was no significant difference about subsequent pregnancy between MA and first pregnancy. Conclusion Unnecessary abortion should be avoided. MA is safer than SA on subsequent pregnancy, so MA is the preferred option for women without child and female adolescent to terminate their unwilling pregnancy. However, as all the studies included were prospective cohort studies, further high-quality RCTs should be conducted.
In December 2019, an outbreak of pneumonia associated with the coronavirus disease 2019 (COVID-19) occurred in Wuhan, China. The lung imaging finding is like that of the lung cancer immune checkpoint inhibitors (ICI) associated pneumonia. Therefore, we speculated that they may have similar pathogenesis and treatment strategies, which is reviewed in this article in order to provide some reference to timely and effectively reduce the fatality rate of COVID-19.
ObjectiveTo explore the relationship between glycated hemoglobin (HbA1c) level and blood glucose fluctuations after coronary artery bypass grafting (CABG) and adverse events in non-diabetic patients, thus providing theoretical support for intensive preoperative blood glucose management in patients undergoing CABG surgery.MethodsA total of 304 patients undergoing CABG with or without valvular surgery from October 2013 to December 2017 were enrolled in this prospective, single-center, observational cohort study. We classified them into two different groups which were a low-level group and a high-level group according to the HbA1c level. There were 102 males and 37 females, aged 36–85 (61.5±9.5) years in the low-level group, and 118 males and 47 females aged 34–85 (63.1±9.4) years in the high-level group. The main results were different in hospital mortality and perioperative complications including in-hospital death, myocardial infarction, sternal incision infection, new stroke, new-onset renal failure and multiple organ failure. To assess the effects of confounding factors, multivariate logistic regression analysis was used.Results Postoperative blood glucose fluctuation was more pronounced in the high-level group than that in the low-level group before admission [0.8 (0.6, 1.2) mmol/L vs. 1.0 (0.8, 1.8) mmol/L, P<0.01]. This study also suggested that the incidence of major adverse events was significantly lower in the low-level group compared with the high-level group (P=0.001). Multivariate logistic regression analyses to correct the influence of other confounding factors showed that HbA1c (OR=2.773, P=0.002) and postoperative blood glucose fluctuations (OR=3.091, P<0.001) could still predict the occurrence of postoperative adverse events.ConclusionHbA1c on admission can effectively predict blood glucose fluctuations in 24 hours after surgery. Secondly, HbA1c on admission and postoperative blood glucose fluctuations can further predict postoperative adverse events. It is suggested that we control the patient's preoperative HbA1c at a low level, which is beneficial to control postoperative blood glucose fluctuation and postoperative adverse events.
Chemotherapy-induced mucositis, one of the most common complications of chemotherapy, can be subdivided in oral and gastrointestinal mucositis. The patients always suffer from oral pain and ulcers, nausea, vomiting, abdominal pain and diarrhea. 5-Fluorouracil- and irinotecan-based regimens are frequently associated with a higher risk and more severe grade of mucositis. The onset of mucositis is also influenced by the patient’s characteristics including age, sex, genetic polymorphisms, systemic comorbidities. At present, the diagnosis of chemotherapy-induced mucositis is mainly based on medical history, physical examination and gastroenteroscopy, lack of reliable biomarkers for early diagnosis. The principles of diagnosis and treatment mainly refer to the clinical practice guidelines issued. Therefore, this article will review the mechanism, diagnosis, latest preventive and treatment strategies of chemotherapy-induced mucositis for helping clinicians to further correctly understand and deal with the adverse reactions.
Lung cancer is the leading cause of cancer-related deaths worldwide. Although improvement has been achieved in platinum-based chemotherapy and tyrosine kinase inhibitors-based molecular targeted therapy, they still have limitations. Immunotherapy has recently emerged as a very effective new treatment, and there is now growing enthusiasm in cancer immunotherapy worldwide. We summarized the effects of immune checkpoint inhibitors in clinical trials, and the current status and progress of anti programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) agents in lung cancer treatment. Attention has been paid to finding out the factors which influence the therapeutic effect of anti-PD-1/PD-L1 therapy and reducing the occurrence of adverse events.
Tumor immunotherapy includes immune checkpoint inhibitor (ICI), tumor vaccines, and adoptive cell therapy. Immunotherapy, as the main systemic treatment for advanced malignant tumors, kills tumor cells by activating the immune system and prolongs the survival of patients. However, excessive immune responses can cause immune-related adverse events (irAE), causing damage to systemic tissues. ICI are the main tumor immunotherapy drugs that cause optic nerve irAE. The most common optic nerve irAE are optic neuritis, only a few patients appeared arteritic anterior ischemic optic neuropathy. Sudden painless loss of bilateral vision is the most common clinical manifestation. In severe cases, the vision decrease to no light perception. Early diagnosis and early adequate glucocorticoid treatment can improve the symptoms. Therefore, neuro-ophthalmologists and oncologists should know the clinical characteristics of optic nerve irAE, in order to diagnose and treat early and improve the prognosis.
The tyrosine kinase activity of epidermal growth factor receptor (EGFR) plays a key role in tumor cell proliferation, invasion, migration, and drug resistance. Studies have shown that non-small cell lung cancer patients with somatic driver gene EGFR mutations are sensitive to and can benefit from EGFR-tyrosine kinase inhibitors (EGFR-TKIs). Nevertheless, EGFR-TKIs-related adverse events should not be ignored. Common adverse events such as diarrhea, acne-like rash and paronychia are usually manageable; although the incidence of interstitial lung disease is low, once it occurs, it is a serious threat to patients' life, and its pathogenesis is still unclear. There is very limited animal experimental and clinical research evidence on the potential mechanism of EGFR-TKIs-related interstitial lung disease in the available literature. Based on this, this article reviews the association between EGFR-TKIs and interstitial lung disease, at the same time, also discusses the research progress of EGFR-TKIs-related interstitial lung disease in combination with cytotoxic drugs or immunotherapeutic drugs and EGFR-TKIs, in order to provide a reference for the prevention and treatment of EGFR-TKIs-related interstitial lung disease in clinical practice in the future.
ObjectiveTo investigate nurses' attitude on the reporting of clinical adverse events and analyze its correlated factors in the Emergency Department. MethodsA total of 130 nurses in a class-3 grade-A hospital were recruited in our study by convenience sampling method during November and December 2014. The Chinese version of Reporting of Clinical Adverse Events Scale was applied to assess nurses' attitude on reporting adverse events. ResultsThe nurses' willingness to report adverse events in the Emergency Department was generally low, and the attitude scores of nurses in the triage zone, rescue zone, monitoring zone and observation zone were respectively 65.62±1.16, 65.49±0.58, 65.06±0.80, and 63.20±0.86, without any significant difference among these zones (P>0.05). The attitude scores of nurses with a seniority of 1-2, 3-5, 6-9, and ≥ 10 years were respectively 67.37±3.27, 64.49±3.98, 63.77±4.82, and 64.30±4.52, with significant differences among these seniority groups (P＜0.05). The attitude scores of nurses with a rank of nurse-in-charge, primary nurse, and nurse were respectively 61.25±4.02, 63.97±4.52, and 65.92±4.02, also with significant differences among these groups (P＜0.05). ConclusionsThe willingness of reporting clinical adverse events in emergency nurses is not high. It is necessary to strengthen the training of nurses on their cognition of adverse events and encourage reporting, thus to create a non-punishment hospital security culture.
Objective To explore the predictive value of Composite Congestion Score (CCS) in predicting adverse events within 180 days in patients with acute heart failure (AHF) in emergency intensive care unit (EICU). Methods The patients with AHF who were admitted to EICU of Zigong Fourth People’s Hospital between January 1, 2018 and December 31, 2020 were included consecutively. The patients were followed up for 180 days, and were divided into poor prognosis group and good prognosis group according to whether there were adverse events. Logistic regression equation was used to screen independent risk factors for predicting adverse events in patients with AHF within 180 days after leaving EICU. To compare the discrimination, calibration and clinical usefulness of independent risk factors at EICU discharge and the Acute Physiology and Chronic Health Assessment SystemⅡ (APACHEⅡ) score at EICU admission to predict the occurrence of adverse events of AHF. Results A total of 71 patients were included, including 32 patients with good prognosis and 39 patients with poor prognosis. Except for age, APACHEⅡscore at EICU admission and CCS score at EICU discharge (P<0.05), there was no significant difference in other indicators between the two groups (P>0.05). Logistic regression analysis showed that CCS score at EICU discharge [odds ratio (OR)=2.806, 95% confidence interval (CI) (1.428, 5.512), P=0.003], age [OR=1.086, 95%CI (1.017, 1.159), P=0.013] were independent risk factors for predicting death or returning to hospital within 180 days. Among them, the CCS score at EICU discharge combining with age had a positive improvement ability compared with the CCS score at EICU discharge, the age, and the APACHE Ⅱ score at EICU admission. The calibration curves of the four scoring methods for predicting adverse events within 180 days showed that the CCS score at EICU discharge had the highest calibration and the calibration of age was the lowest. The decision curve showed that the clinical usefulness of age, the CCS score at EICU discharge and the CCS score at EICU discharge combining with age was better than the APACHE Ⅱ score at EICU admission. Conclusions The CCS score of patients with AHF at EICU discharge is closely related to adverse events within 180 days. The CCS score is designed based on clinical variables, simple and practical. The combination of age and the CCS score at EICU discharge will further enhance its clinical application value.