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 Risk factors for real-word immune checkpoint inhibitor-related pneumonitis in patients with lung cancer were analyzed by systematic analysis. Methods Computerized retrieval of PubMed, EMbase, Web of Science, the Cochrane Library , WanFang Data, CNKI and VIP databases was carried out. Studies were collected from the database establishment to March 2023. Three researchers independently screened the literature, extracted data, and evaluated the risk of bias in the included studies. Meta-analysis was performed using RevMan5.4.1software. Results A total of 18 studies were included with a total of 4 990 patients. The results of meta-analysis showed that, interstitial pneumonia [odds ratio (OR)=9.32, 95% confidence interval (CI) 4.66 - 18.67, P<0.01], smoking history (OR=2.39, 95%CI 1.29 - 4.45, P<0.01), chronic obstructive pulmonary disease (COPD) (OR=5.54, 95%CI 2.96 - 10.36, P<0.01), chest radiotherapy (OR=2.74, 95%CI 1.80 - 4.19, P<0.01), pulmonary fibrosis (OR=7.46, 95%CI 4.25 - 13.09, P<0.01), high programmed death ligand 1 (PD-L1) expression (OR=2.98, 95%CI 1.71 - 5.22, P<0.01), high absolute eosinophil count (AEC) (OR=3.92, 95%CI 2.17 - 7.08, P<0.01) and pembrolizumab (OR=2.90, 95%CI 1.56 - 5.37, P<0.01) were independent risk factors for immune checkpoint inhibitor-related pneumonitis in lung cancer patients. Conclusions Interstitial pneumonia, smoking history, COPD, Chest radiotherapy, pulmonary fibrosis, high PD-L1expression, high AEC and pembrolizumab are independent risk factors for immune checkpoint inhibitor-related pneumonitis in lung cancer patients. Due to insufficient evidence on the risk factors of low albumin, more studies are needed to further identify it.
Most immune-related adverse event (irAE) associated with immune checkpoint inhibitors (ICIs) resulted from excessive immune response against normal organs. The severity, timing, and organs affected by these events were often unpredictable. Adverse reactions could cause treatment delays or interruptions, in rare cases, pose a life-threatening risk. The mechanisms underlying irAE involved immune cell dysregulation, imbalances in inflammatory factor expression, alterations in autoantibodies and complement activation, even dysbiosis of intestinal microorganisms. However, the mechanisms of irAE occurrence might differ slightly among organs due to variations in their structures and the functions of resident immune cells. Future research should focus on the development of targeted drugs for the prevention or treatment of irAE based on the mechanisms by which irAE occurs in different organs. A deeper understanding of the mechanisms underlying irAE occurrence would aid clinicians in effectively utilizing ICIs and provide valuable guidance for their clinical application.
摘要:医院有效事前监测、管控医疗不良事件，是保障患者安全、提高医疗质量的管理措施之一。超大型医院对医疗不良事件管理的实战中，建立、实施医疗安全隐患事件关键监测指标、医疗安全隐患事件筛查程序指标，积极开展医疗不良事件后台监管工作，切断医疗安全隐患事件向医疗风险事件演变、医疗风险事件向医疗纠纷事件演变的环节，保障患者安全。Abstract: Effective supervision in advance to the medical adverse event, is one of measures which hospital adopt to guarantee patient safety and enhance medical quality. The actual combat of supervision to the medical adverse event in super sized hospital, set up and put in practice on the key target of supervising the medical adverse event and the key target of ridding procedure, remain in the background and work actively on supervision on the medical adverse event, shut off the road from the medical safety issue to the medical risk issue and the road from the medical risk issue to the medical dissension in order to guarantee the patient safety.
Objective To evaluate the prognostic value of several indexes of laboratory and ultrasonic cardiogram for adverse events in 3 months following the diagnosis of acute non-high-risk pulmonary embolism. Methods A total of 266 cases of acute non-high-risk pulmonary embolism patients diagnosed and treated in Beijing Anzhen Hospital during 2016 to 2017 were retrospectively analyzed. The patients were divided into a bad event group and a control group according to whether there was a bad event happened in 3 months following the diagnosis. The general data, indexes of laboratory and ultrasonic cardiogram were compared. Univariate and multivariate COX regression analysis were conducted to explore independent risk factors for 3 months’ poor prognosis. Results The bad outcome group had a significantly higher value of the proportion of suffering from connective disease and active cancer, C-reaction protein, monocyte/lymphocyte ratio (MLR) and urea while a significantly lower level of red blood cell count and hemoglobin compared with the control group (all P<0.05). Univariate and multivariate COX regression analysis showed that both the MLR (hazard ratio 14.59, 95% confidence interval 1.48 - 143.69, P=0.02) and suffering from connective disease (hazard ratio 5.85, 95% confidence interval 1.11 - 30.81, P=0.04) remain significantly different between the bad events group and the control group. Conclusion MLR at the admission may be related to the 3 months death of acute non-high-risk pulmonary embolism.
ObjectiveTo systematically evaluate the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors on the risk of cardiovascular events in type 2 diabetes mellitus (T2DM) patients. MethodsDatabases such as the Cochrane Library, PubMed, Elsevier ScienceDirect and EMbase were searched to collect randomized controlled trials (RCTs) about DPP-4 inhibitors for T2DM patients from inception to February 2014. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data and assessed the methodological quality of included studies. Then, meta-analysis was performed using RevMan5.2 software. ResultsA total of 20 RCTs involving 10 402 patients were included. The results of meta-analysis showed that:there were no significant differences between the DPP-4 inhibitors group and the control group in the cardiovascular adverse events (RR=0.86, 95%CI 0.62 to 1.20, P=0.38) and acute coronary syndrome (RR=0.66, 95%CI 0.37 to 1.17, P=0.15). Subgroup analyses by type of liptins and durations showed there were lower risks of adverse cardiovascular events in the DPP-4 inhibitors group of the sitagliptin subgroup (RR=0.49, 95%CI 0.29 to 0.82, P=0.007) and the duration of ≥52 weeks subgroup (RR=0.62, 95%CI 0.39 to 0.97, P=0.04). No significant difference was found between the two groups in hypertension events (RR=1.09, 95%CI 0.84 to 1.40, P=0.52). ConclusionThe DPP-4 inhibitors are relatively safe. In the long-term treatment of T2DM, the sitagliptin could not only effectively control the level of blood sugar but also might obtain benefits in cardiovascular aspects.
ObjectiveTo explore the risk factors and countermeasures of the perfusionist-related near-miss event (NME) in cardiopulmonary bypass (CPB). MethodsThe clinical data of the patients who underwent cardiac surgery in the Department of Cardiovascular Surgery, Nanfang Hospital, Southern Medical University from March 2020 to July 2021 were retrospectively analyzed. According to whether NME occurred during the operation, the patients were divided into an NME group and a non-NME group. The clinical data of the two groups were compared, and the risk factors for NME were analyzed. ResultsA total of 702 patients were enrolled, including 424 males and 278 females with a median age of 56.0 years. There were 125 patients in the NME group and 577 patients in the non-NME group. The occurrence rate of NME was 17.81%. Univariate analysis showed that there were statistical differences between the two groups in the gender, body surface area, CPB time, European system for cardiac operative risk evaluation score, emergency surgery, type of surgery, night CPB initiation, modified ultrafiltration use, multi-device control, average operation time, et al. (all P<0.05). The above variables were dimensionality reduction processed by least absolute shrinkage and selection operator regression, and the λ of minimum mean square error of 10-fold cross validation was 0.014. The variables of the corresponding model were selected as follows: multi-device control, night CPB initiation, minimum hematocrit, modified ultrafiltration use, CPB time. The results of multivariate logistic regression showed that night CPB initiation [OR=9.658, 95%CI (4.735. 19.701), P<0.01] and CPB time [OR=1.003, 95%CI (1.001, 1.006), P=0.014] were independent risk factors for NME. ConclusionNight CPB initiation and CPB time are independent risk factors for NME during CPB, which should be recognized and early warned in clinical work.
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.
Objective To investigate the association between D-dimer levels within 2 hours of admission and in-hospital major adverse events (MAEs) in patients with acute type A aortic dissection (ATAAD) who underwent total arch replacement combined with frozen elephant trunk (FET) implantation. Methods This retrospective study included patients with ATAAD who underwent total arch replacement with FET implantation at Fuwai Yunnan Cardiovascular Hospital from September 2017 to December 2022. Patients were divided into two groups based on the occurrence of in-hospital MAEs: a MAEs group and a non-MAEs group (control). Perioperative data were compared between the two groups. Univariate and multivariate logistic regression analyses were performed to identify risk factors for in-hospital MAEs, which included in-hospital death, gastrointestinal bleeding, paraplegia, acute kidney injury, low cardiac output syndrome, stroke, respiratory failure, multiple organ dysfunction syndrome, and severe infection. The predictive value of D-dimer was evaluated using the area under the receiver operating characteristic curve (AUC). Results A total of 218 patients were included (157 males, 61 females), with a mean age of (51.54±9.79) years. There were 152 patients in the non-MAEs group and 66 in the MAEs group. The overall incidence of in-hospital MAEs was 30.3%, and the in-hospital mortality rate was 2.8% (6/218). Compared to the non-MAEs group, the MAEs group had significantly higher levels of D-dimer and lactate, as well as longer cardiopulmonary bypass time, aortic cross-clamp time, and ICU length of stay (all P<0.05). Multivariate logistic regression analysis identified D-dimer as an independent risk factor for in-hospital MAEs [OR=1.077, 95%CI (1.020, 1.137), P=0.013]. The AUC for the D-dimer level within 2 hours of admission to predict in-hospital MAEs was 0.83 [95%CI (0.736, 0.870), P<0.001]. The optimal cutoff value was 2.2 μg/mL, with a sensitivity of 84.8% and a specificity of 73.0%. Conclusion The serum D-dimer level is an independent risk factor for in-hospital MAEs in patients with ATAAD following total arch replacement with FET implantation. D-dimer levels on admission can help clinicians optimize risk stratification and perioperative management, potentially reducing the incidence of early adverse events.
ObjectiveTo explore the common causes and the clinical pathological characteristics of infant death which occurred after vaccination. MethodsThe study retrospectively analyzed the data of 13 cases of infant death occurring after vaccination from January 2009 to September 2014 in West China Medico-legal Expertise Center. ResultsAmong the 13 cases of infant death, 12 were dead from lethal respiratory system and cardiovascular system diseases, 1 from mechanic asphyxia caused by milk intake. All cases were coupling disease death and had no direct correlation with vaccination. ConclusionSystematic and comprehensive forensic pathological examination is helpful to clarify the cause of death, reveal the relationship between vaccination and the cause of death, and contribute to proper processing of such incidents.