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.
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.
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 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.
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.
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.
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.
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.
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.
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.