摘要:醫院有效事前監測、管控醫療不良事件，是保障患者安全、提高醫療質量的管理措施之一。超大型醫院對醫療不良事件管理的實戰中，建立、實施醫療安全隱患事件關鍵監測指標、醫療安全隱患事件篩查程序指標，積極開展醫療不良事件后臺監管工作，切斷醫療安全隱患事件向醫療風險事件演變、醫療風險事件向醫療糾紛事件演變的環節，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.
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 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.
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.
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.
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.
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 develop and validate a Nomogram for predicting severe immune-related adverse events (irAEs) in patients with advanced non-small cell lung cancer (NSCLC) undergoing immunotherapy based on clinical features and inflammatory indicators. MethodsA total of 423 patients with advanced NSCLC treated with immunotherapy between January 2023 and January 2025 at Tianjin Fourth Center Hospital and Tianjin Cancer Hospital Airport Hospital were enrolled. Patients were divided into a severe irAEs group (≥grade 3, n=76) and a non-severe irAEs group (n=347), then randomly allocated into training and validation cohorts (7:3 ratio) . Clinical data, neutrophil-to-lymphocyte ratio (NLR), and interleukin-6/C-reactive protein (IL-6/CRP) levels were collected. Independent risk factors for severe irAEs during immunotherapy in advanced NSCLC were identified through logistic regression analysis, and a nomogram model was constructed accordingly. The discriminative ability, accuracy, and clinical utility of the model were evaluated using receiver operating characteristic (ROC) curves, calibration curves, and decision curve analysis (DCA). ResultsAmong the 423 included patients [274 males, 149 females, aged 44-78 (60.77±5.91) years], the overall incidence of irAEs was 57.92% (245/423), with severe irAEs occurring in 17.97% (76/423). Multivariate analysis revealed that Eastern Cooperative Oncology Group (ECOG) performance score ≥2, programmed death-ligand 1 (PD-L1) expression [tumor proportion score (TPS) ≥50%], combination therapy regimen, low NLR values, and high IL-6/CRP ratio were independent risk factors for severe irAEs during immunotherapy in advanced NSCLC (P<0.05). The area under the ROC curve (AUC) was 0.948 [95%CI (0.912, 0.985)] in the training cohort and 0.946 [95%CI (0.917, 0.976)] in the validation cohort. Calibration curves and DCA demonstrated good consistency and clinical net benefit of the model. ConclusionThe nomogram integrating clinical features and inflammatory markers effectively predicts the risk of severe irAEs in advanced NSCLC patients receiving immunotherapy, exhibiting excellent discrimination, calibration, and clinical practicality.
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.
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.
