Clinical therapeutics最新文献

Chest pain is one of the most common reasons for emergency department visits in the United States. Common etiologies of chest pain include both anxiety and myocardial infarction (MI); furthermore, anxiety and stress may contribute to the development of MI, particularly MI with non-obstructed coronary arteries (MINOCA). We present the cases of two women with acute chest pain in the setting of acute life stressors who were found to have MINOCA. We discuss the relationship between acute stress, chest pain, and MINOCA, as well as the importance of considering a broad differential diagnosis in women with acute chest pain.

Purpose: To identify clinical characteristics predictive of failure or success of the INtubation-SURfactant-Extubation (INSURE) strategy, to distinguish infants who could be managed using this strategy to prevent mechanical ventilation (MV).

Methods: Infants with a gestational age <32 weeks were classified into two groups according to whether they required reintubation and MV within 72 h after birth. The clinical characteristics of the two groups were subsequently analyzed.

Results: INSURE was unsuccessful in 77 infants (20.7%). Infants in the INSURE failure group had a higher incidence of severe respiratory distress syndrome, as evidenced by radiological grade; lower blood pH, partial oxygen pressure, and base excess (BE) levels; higher partial carbon dioxide pressure levels at the first arterial blood gas analysis; lower Apgar scores at 1 and 5 min; lower use of antenatal steroids; and higher occurrence of gestational diabetes mellitus, versus those in the INSURE success group. Multiple regression analysis confirmed severe radiological grade, lower BE levels at the first arterial blood gas analysis, and decreased use of antenatal steroids as independent risk factors for INSURE failure. Compared with infants in the INSURE success group, those in the INSURE failure group also had higher mortality.

Conclusions: We successfully identified specific predictors of an unsuccessful INSURE strategy. Maintaining high-risk preterm infants with one or several predictors intubated and treated with MV after surfactant administration can prevent reintubation and reduce mortality.

Background: Precision medicine utilizes individual patient data to guide decision making. Sex and gender medicine is likewise focused on individual patients' biological sex or sociocultural gender as determinants of disease. How these two fields intersect with one another and with acute care medicine is unclear.

Methods: We conducted a scoping literature review utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews to evaluate the primary research in three related areas: sex & gender medicine, emergency medicine, and precision medicine. We searched six databases and screened eligible studies for inclusion. Included studies were reviewed in full, and study characteristics were compiled using a standardized data extraction form. Research questions were drafted by workgroup members and ranked by all participants of the consensus conference.

Results: A total of 401 studies were screened for inclusion. Of these, 70 met inclusion criteria and were evaluated in full text. The majority (84%, 59/70) reported evaluating sex, whereas only 16% (11/70) reported evaluating gender. The most common clinical topics were cardiovascular diseases and trauma/injury prevention, comprising 50% (35/70) of the included manuscripts. Cumulatively, 77% (54/70) of the manuscripts reviewed cited at least one funding source. The vast majority (66/70, 94%) of studies were included because their statistical analysis accounted for sex or gender, and very few studies (4/70, 6%) were included due to their use of biomarker or genomic data.

Conclusions: Sex- and gender-based medicine and research commonly employ precision medicine concepts to evaluate the effects of sex and gender in a variety of clinical topic areas, but much of this literature is not commonly described as precision medicine. We propose a hierarchy to categorize, label, and advance sex and gender precision medicine research. Fundamental to this advancement are implementation of guidelines regarding the correct use of sex and gender and continued research funding for sex and gender precision EM research.

Background: Women undergo diagnostic testing for pulmonary embolism (PE) in greater numbers than men, despite the disease incidence being higher in men overall. It is unknown if testing for PE varies based on patient chief complaint.

Methods: This retrospective cohort study was conducted at two academic tertiary care hospitals. Nonpregnant adult patients (aged 18-49 years) were included if they presented to the ED between 1/1/2016 and 12/31/2018 with nontraumatic mechanisms and any of the following chief complaints: chest pain, shortness of breath, hemoptysis, or syncope AND had objective testing for PE. Data were obtained from the electronic medical record and analyzed descriptively. Four outcome variables were assessed: receipt of D-dimer testing, D-dimer positivity, receipt of pulmonary vascular imaging, and diagnosis of PE.

Results: We studied 1,991 unique patient encounters, most of whom (63%; 1,256/1,991) were female. Overall, female patients had higher odds of receiving D-dimer testing than male patients (OR 1.30, CI 1.06-1.59, P = 0.015), while they had lower odds of being diagnosed with PE (OR 0.57, CI 0.36-0.90, P = 0.019). However, this trend varied by chief complaint. Among patients with chest pain, females had higher odds of having a D-dimer performed (OR 1.35, CI 1.01-1.80, P = 0.049) and lower odds of being diagnosed with PE (OR 0.36, CI 0.18-0.70, P = 0.003) than males.

Conclusions: Both patient sex and chief complaint were associated with trends in diagnostic testing for PE. Among patients with chest pain, females are significantly more likely to be tested with a D-dimer and less likely to be diagnosed with PE.

Purpose: Docetaxel-based chemotherapy regimens (DBRs) are commonly used in the treatment of early-stage breast cancer (EBC). The prophylactic use of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) has been shown to reduce the incidence of neutropenia induced by DBRs. However, the clinical usage of PEG-rhG-CSF in EBC patients undergoing DBRs in China remains unclear.

Methods: This retrospective study was conducted in 137 EBC patients receiving DBRs from September 2022 to February 2024. We compared the incidence of chemotherapy-induced neutropenia (CIN) between patients who was treated with prophylactic PEG-rhG-CSF or not by complete blood counts, evaluating the effectiveness of PEG-rhG-CSF in preventing CIN. Prophylactic PEG-rhG-CSF was given at 100 μg/kg body weight (maximum total dosage of 6 mg) once 24-48 h following chemotherapy. Meanwhile, we also collected basic patient information, the area under time-concentration curve of docetaxel, and liver and kidney function indicators. Multivariate logistic regression and Receiver operating characteristic (ROC) curve analysis were employed to explore independent factors influencing neutropenia.

Findings: In this study, 87 of 137 EBC patients were administrated with prophylactic PEG-rhG-CSF, while 50 were not. Compared to patients who did not receive PEG-rhG-CSF, those who received prophylactic injections had a significantly lower incidence of grade 3-4 CIN (20% vs. 4.6%, P < 0.05). Higher body surface area (BSA), lower body mass index (BMI), elevated alanine aminotransferase (ALT), and nonprophylactic use of PEG-rhG-CSF were found to be positively correlated with CIN occurrence. ROC curve analysis indicated an area under the curve of 0.756 for predicting CIN in EBC patients when BSA was 1.66 m², BMI was 24.8 kg/m², and ALT was 41 U/L, with a sensitivity of 73.08% and specificity of 73.87%.

Implications: Prophylactic use of PEG-rhG-CSF significantly reduces the incidence of CIN, particularly grades 3 and 4. BSA, BMI, ALT, and PEG-rhG-CSF prophylaxis are independent influencing factors for the occurrence of neutropenia.

Background: Increasing medical device usage raises concerns regarding unexpected, potentially life-threatening events that pose public health risks. Such events are reported to the Food and Drug Administration (FDA), and cataloged in the Manufacturer and User Facility Device Experience (MAUDE) database, a vital tool for post market surveillance that requires information of high quality and integrity, particularly concerning reporting sources.

Purpose: To analyze reporting behavior among different reporters, including manufacturers, distributors, and user facilities, by examining differences in reported factors, namely: (1) device types, (2) product problem attribution, and (3) selection of Device Problem Codes (DPCs) associated with the root causes of events.

Methods: Data spanning from 2005 to 2022 was retrieved from the MAUDE database using Python. Reports were grouped by reporter type and divided according to device type, and the reporter's indication of association with a product problem. Furthermore, events were classified by their respective DPCs, which were manually grouped into four categories: device issues, user issues, clinical issues, or unknown.

Findings: The analysis revealed significant variations among reporters across all examined aspects (P < 0.00001 in all comparisons according to the proportion test). Manufacturers predominantly focused on infusion pumps (10.1%) and Implant, Endosseous, Root-Form (IER) devices (7.6%), with a product problem indication rate of 29.2% in their reports. Device issues codes were the most frequently observed category in their reports, comprising 36.3%, followed by unknown codes (32%) and clinical codes (19.3%). Distributors, on the other hand, primarily reported on IER devices (89%) and exhibited the lowest product problem indication rate at 2.7%. Clinical issues codes predominated in their reports, constituting 85.7%, followed by unknown codes (6.7%). User facilities concentrated on intravascular sets (4.7%), Electrosurgical, Cutting & Coagulation & Accessories (4.2%), and Ventricular (Assist) Bypass (4.1%). Remarkably, their product problem indication rate was the highest at 56.7%. They predominantly reported device issues codes (54.3%), followed by use codes (30.8%), and unknown codes (11.4%) IMPLICATIONS: The notable variation among different reporters underscores the importance of incorporating diverse sources when analyzing the database, particularly in cases where majority of reports originate from manufacturers. Decision-makers must approach database information comprehensively, considering data sources and diverse perspectives to inform regulatory decisions effectively. Developing strategies that encourage various reporters to contribute their unique and complementary viewpoints is advisable.

Purpose: Chronic obstructive pulmonary disease (COPD) will become the fourth largest cause of death of chronic diseases in the world in 2030. The incidence of COPD ranked top among chronic diseases in the world. At present, there is a lack of simple and effective drugs for the treatment of COPD and for slowing the progression of the disease. The application of vitamin D as a drug in clinical treatment has been a research hotspot. In this study, we investigated the correlation between serum 25-hydroxyvitamin D (25(OH)D), inflammatory markers, and T lymphocytes with the severity of COPD and its effect on the risk of acute exacerbation.

Methods: In this study, we recruited hospital inpatients and outpatient clinic patients with COPD. Their levels of 25(OH)D, inflammatory markers, and T lymphocytes were assessed. We built a nomogram model to evaluate the risk of acute exacerbation of COPD.

Findings: The inflammatory mediators were higher in patients with acute exacerbation of COPD (AECOPD) than those in patients with COPD, but 25(OH)D showed the opposite phenomenon. In logistic regression analysis, high levels of neutrophil-lymphocyte ratio, C-reactive protein, and partial pressure of carbon dioxide and low levels of vitamin D, partial pressure of oxygen, and forced expiratory volume in the first as a percentage of predicted were regarded as independent risk factors for AECOPD. These variables were used for the construction of the nomogram model. The AUCs of the model were 0.971 (95% CI, 0.952-0.989), and 0.981 (95% CI, 0.959-1.000) in the training and testing set respectively, demonstrating that the model exhibited high accuracy for the prediction of the risk of acute exacerbation of COPD. The calibration curve of the nomogram found a high degree of consistency between the expected and actual values. The decision curve analysis and clinical impact curve indicated that the nomogram has clinical applicable for patients with COPD.

Implications: A considerable percentage of patients with COPD were found to have insufficient vitamin D levels. Patients with AECOPD reported more symptoms than those with COPD. The variables neutrophil-lymphocyte ratio, C-reactive protein, partial pressure of carbon dioxide, 25(OH)D, partial pressure of oxygen, and forced expiratory volume in the first as a percentage of predicted can be used for the prediction of AECOPD. Accordingly, this study provided experimental rationales for the role of 25(OH)D in the prevention and the potential anti-inflammatory mechanisms involved in the control of the COPD process.