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.
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.
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.
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.
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.
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.
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 Anterior cruciate ligament (ACL) reconstruction using a new generation of artificial ligaments (NGAL) gained popularity in China owing to its good effectiveness and early functional recovery, but iatrogenic surgical failures and preconceived misconceptions have seriously affected its standardized clinical application. A specialist consensus is now developed to provide guidance and reference for orthopaedic sports medicine doctors when adopting or considering the NGAL for ACL reconstruction. Methods The consensus on the core techniques and adverse events in ACL reconstruction using the NGAL was developed by a modified Delphi method, referring exclusively to the NGAL for ACL reconstruction approved by the National Medical Products Administration (NMPA). Consensus specialists were selected from the members of the Chinese Association of Orthopaedic Surgeons (CAOS) and the Chinese Society of Sports Medicine (CSSM). The drafting team summarized the draft consensus terms based on medical evidence and organized rounds of investigation: two rounds of online questionnaire investigation and the final round of face-to-face meeting. After discussion, revision, and voting, a consensus on the draft consensus term was reached when the agreement rate exceeded 85%. The consensus terms were categorized as “strong” (agreement rate: 95.0%-100%), “moderate” (agreement rate: 90.0%-94.9%), and “basic” (agreement rate: 85.0%-89.9%). ResultsThirty-one specialists completed the questionnaire investigation. They all practiced in university teaching hospitals (Grade-A tertiary hospitals) from 16 provinces, autonomous regions, and municipalities in China. Among them, 28 were chief physicians and 3 were associate chief physicians; 22 were professors and 7 were associate professors; the average seniority in orthopedic sports medicine was 25.2 years (range, 12-40 years); the average seniority in performing ACL reconstruction procedures was 13.2 years (range, 7-23 years); in terms of the number of ACL reconstruction using the NGAL, 18 completed more than 100 cases, of which 6 had more than 300 cases; in terms of research, 28 had published more than 1 related paper in the past 5 years, of which 13 had published more than 3 related papers. Twenty-six specialists attended the face-to-face meeting and reached a consensus on 9 terms, including 8 strong terms and 1 moderate term. Conclusion ACL reconstruction using the NGAL must deploy “isometric” or “near-isometric” reconstruction and should preserve the natural ACL remnants as much as possible. Bone tunnel positioning can be performed using intraoperative radiographic measurements or the lateral femoral intercondylar ridge as reference marks. Incorrect positioning of the bone tunnel is the main reason of surgical failure, and there is a lack of consensus on handling interference screws during revision. Bone tunnel enlargement exists after reconstruction but rarely causes related symptoms. Synovitis and infection are uncommon complications. The aging effect of polyethylene terephthalate fiber on the long-term clinical outcomes is unknown and deserves attention.
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.
Video-electroencephalogram (VEEG) monitoring is a valuable tool for diagnosing recurrent partial epilepsy, classification of intractable epilepsy, and evaluation of epilepsy surgery. The role of video EEG in identifying and determining the type of epilepsy and determining the location of seizures has been widely demonstrated, but there is There is a lack of uniform standards for adverse events and management methods during monitoring. In order to improve the quality of long-range video EEG monitoring and reduce the possible impact on patients during monitoring, it is necessary to summarize the possible adverse reactions during monitoring.