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.
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.
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.
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.
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.
ObjectiveTo explore the psychological process and needs of the second victims of medical adverse events after the occurrence of adverse events, so as to provide reference for the psychological intervention strategies of medical institutions for the second victims of medical adverse events.MethodsThe second victims of medical adverse events in the First People’s Hospital of Ziyang were selected from April to July 2019. Qualitative research method was used to conduct semi-structured in-depth interviews with the second victims. Colaizzi method was used to analyze the transcripts through reading and rereading, coding, and thematizing. ResultsA total of 22 second victims of medical adverse events were interviewed. The second victims of medical adverse events experienced negative emotional experience, and the desire to seek emotional support was urgent. The psychological process of the second victims of medical adverse events mainly involved five stages: fear, anxiety, depression, guilt and recovery. Emotional support hada positive effect on regression. Conversely, negative or lack of emotional support had a negative effect on regression. ConclusionsThe emotional experience of the second victims of medical adverse events is relatively staged, and the recovery and regression are greatly affected by internal and external factors. Hospital administrators should take active measures and establish an emotional support mechanism for adverse events in order to reduce psychosomatic injuries and improve medical quality and efficiency.
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 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.