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.
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.
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.
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.
ObjectiveTo investigate nurses' attitude on the reporting of clinical adverse events and analyze its correlated factors in the Emergency Department.
MethodsA total of 130 nurses in a class-3 grade-A hospital were recruited in our study by convenience sampling method during November and December 2014. The Chinese version of Reporting of Clinical Adverse Events Scale was applied to assess nurses' attitude on reporting adverse events.
ResultsThe nurses' willingness to report adverse events in the Emergency Department was generally low, and the attitude scores of nurses in the triage zone, rescue zone, monitoring zone and observation zone were respectively 65.62±1.16, 65.49±0.58, 65.06±0.80, and 63.20±0.86, without any significant difference among these zones (P>0.05). The attitude scores of nurses with a seniority of 1-2, 3-5, 6-9, and ≥ 10 years were respectively 67.37±3.27, 64.49±3.98, 63.77±4.82, and 64.30±4.52, with significant differences among these seniority groups (P＜0.05). The attitude scores of nurses with a rank of nurse-in-charge, primary nurse, and nurse were respectively 61.25±4.02, 63.97±4.52, and 65.92±4.02, also with significant differences among these groups (P＜0.05).
ConclusionsThe willingness of reporting clinical adverse events in emergency nurses is not high. It is necessary to strengthen the training of nurses on their cognition of adverse events and encourage reporting, thus to create a non-punishment hospital security culture.
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.
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.
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.
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.
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.
