Abnormal Laboratory Test Results Research Articles

Establishing reference intervals for common hematology test parameters from apparently healthy geriatrics in Asella town, Southeast Ethiopia, 2020: a community-based cross-sectional study

BackgroundReference intervals are an important method tool for identifying abnormal laboratory test results. Complete blood count reference values are useful to interpret complete blood count (CBC) results and make clinical decisions, but these values have not been established for geriatrics in Asella town. Therefore, this study aimed to establish reference intervals (RIs) for complete blood count (CBC) parameters from geriatric participants/subjects in Asella town, Southeast Ethiopia.MethodsA community-based cross-sectional study was conducted from December 2019 to May 2020. An interviewer-administered questionnaire was used to collect data on sociodemography and other characteristics from 342 eligible geriatric participants. Weight, height, and vital signs were measured, and 8 mL of blood sample was collected. Screening tests such as HIV, HBsAg, HCV, syphilis, stool examination, and urinalysis were performed. The hematological parameter was measured using a Sysmex kx-21 hematology analyzer. The data were analyzed using SPSS version 21 software. The non-parametric independent Kruskal–Wallis test and Wilcoxon rank-sum test (Mann–Whitney U test) were used to compare the parameters between age groups and genders. The 97.5 and 2.5th percentile were the upper and lower reference limit for the population.ResultsAccording to the study’s findings, the reference intervals of red blood cell, white blood cell, platelet count, hemoglobin (HGB), and hematocrit (HCT) in male geriatrics were 3.8–5.85 × 1012/L, 3.1–9.66 × 109/L, 115.8–353 × 109/L, 12.4–17.76 g/dL, and 35.06–50.2%, respectively. The respective values for women were 3.94–5.48 × 1012/L, 3.13–8.4 × 109/L, 137.5–406 × 109/L, 12.5–16.4 g/dL, and 36.09–48.2%. Most of the hematological parameters showed significant differences between the two genders (p value <0.05).ConclusionAccurate gender and age-specific reference intervals are crucial in managing patient health. The current study offers essential CBC hematological parameters that can assist clinicians in interpreting laboratory results and can improve healthcare quality in the geriatric population. Therefore, it is more relevant to use the current RIs in the geriatric set-up.

Thirteen-year viral suppression and immunologic recovery of LPV/r-based regimens in pediatric HIV treatment: a multicenter cohort study in resource-constrained settings of China.

Antiretroviral Therapy (ART) in children remains challenging due to resource-constrained settings. We conducted a 13-year, prospective, multicenter cohort study on the effectiveness and safety of LPV/r-based regimens in ART-naive and ART-experienced children. From January 2008 to May 2021, children living with HIV-1 were recruited with LPV/r-based regimens from 8 clinical research sites in 6 provinces in China. Effectiveness outcomes were virologic failure (defined as at least two consecutive measurements of VL > 200 copies/mL after 6 months of ART) and immune response (defined as CD4% recovered to more than 25% after 12 months of treatment). The safety outcomes were treatment-related grade 2-4 adverse events and abnormal laboratory test results. A total of 345 ART-naïve children and 113 ART-experienced children were included in this cohort study. The median follow-up time was 7.3 (IQR 5.5-10.5) years. The incidence density of virologic failure was 4.1 (95% CI 3.3-4.9) per 100 person-years in ART-naïve children and 5.0 (95% CI 3.5-6.5) per 100 person-years in ART-experienced children. Kaplan Meyer (KM) curve analysis showed children with ART experience were at a higher risk of virologic failure (p < 0.05). The risk factors of virologic failure in ART-naïve children were clinic setting in rural hospitals (aHR = 2.251, 1.108-4.575), annual missed dose times >5 days of LPV intake (aHR = 1.889, 1.004-3.554); The risk factor of virologic failure in ART-experienced children was missed dose times >5 days (aHR = 2.689, 1.299-5.604) and mother as caregivers for ART administration (aHR = 0.475, 0.238-0.948). However, during long-term treatment, viral suppression rates between ART-naïve and ART-experienced children remained similar. No significant differences were observed in the immune response, treatment-related grade 2-4 events, and abnormal laboratory test results between ART-naïve children and ART-experienced children. Our research underscores that with consistent, long-term treatment of LPV/r-based regimens, ART-experienced children can achieve therapeutic outcomes comparable to ART-naïve children. It provides crucial insights on LPV/r-based regimens in pediatric HIV treatment, especially in resource-limited settings where high-cost Integrase Strand Transfer Inhibitors (INSTs) are inaccessible. This evidence-based understanding provides an essential addition to the global therapeutic strategies for pediatric HIV treatment.

Real-world predictors of survival in patients with extensive-stage small-cell lung cancer in Manitoba, Canada: a retrospective cohort study.

Extensive-stage small-cell lung cancer (ES-SCLC) is an incurable cancer with poor prognosis in which characteristics predictive of long-term survival are debated. The utility of agents such as immune checkpoint inhibitors highlights the importance of identifying key characteristics and treatment strategies that contribute to long-term survival and could help guide therapeutic decisions. This real-world analysis examines the characteristics, treatment patterns, and clinical outcomes of patients receiving chemotherapy without immunotherapy for ES-SCLC in Manitoba, Canada. A retrospective cohort study assessed patient characteristics, treatment, and survival duration (short: <6 months; medium: 6-24 months; long: >24 months) using the Manitoba Cancer Registry and CancerCare Manitoba records. Eligible patients were aged >18 years with cytologically confirmed ES-SCLC diagnosed between January 1, 2004, and December 31, 2018, and received cytotoxic chemotherapy (CT). The one-, two-, and five-year probabilities of overall survival (OS) were assessed relative to patient, disease, and treatment characteristics using Kaplan-Meier methods and Cox proportional hazards models. This analysis included 537 patients. Cisplatin was used in 56.1% of patients, 45.6% received thoracic radiotherapy (RT), and few received prophylactic cranial irradiation (PCI). In the overall cohort, one-, two- and five-year OS rates were 26%, 8%, and 3%, respectively. For patients with Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, OS rates at one, two, and five years were 43%, 17%, and 10%, respectively, vs. 27%, 8%, and 2% for those with ECOG PS 1-2, and 16%, 3%, and 3% for those with ECOG PS 3-4. In long-term survivors, ECOG PS scores were lower and abnormal laboratory test results were less frequent. Overall, 74.4% of long-term survivors received thoracic RT and 53.5% received PCI. Known poor prognostic factors - including brain/liver metastases, high lactate dehydrogenase (LDH), abnormal sodium, and low hemoglobin levels - were less common but still seen in long-term survivors. Although rare, patients with ES-SCLC may experience long-term survival with CT ± thoracic RT ± PCI. Factors predicting long-term survival include traditional prognostic factors such as ECOG PS, LDH level, and receipt of thoracic RT or PCI. These findings support current treatment algorithms for ES-SCLC and provide baseline survival estimates to assess the real-world impact of adding immune checkpoint inhibitors in the future.

A phase I/IIa study to assess the safety, tolerability, PK, and PD of T3011, a genetically modified oncolytic virus (OVs) administered intravenously (IV) in patients with advanced solid tumors.

2640 Background: T3011 is a genetically modified, next-generation oncolytic HSV-1 with 2 exogenous genes encoding the active heterodimer human IL-12 and the Fab fragment of an anti-human PD-1 antibody. T3011 intratumoral injection (IT) was reported to be well tolerated in patients (pts). IV therapy of OVs is rare and provides an attractive option to many pts with advanced cancers that are not candidates for IT therapy. Methods: It is a phase I/IIa multi-center, open label, single ascending dose (SAD) /multiple ascending dose (MAD) study to evaluate T3011 IV therapy. The primary objective is to evaluate the safety and tolerability. Dose cohort and regimen are shown in Table. PK and PD profiles are tested in samples of blood, saliva, urine, and tumor tissue. Results: As of 16 Dec 2022, 15 pts with stage IV disease were enrolled, 9 pts had received at least 3 lines of prior therapy. The median follow-up time is 1.58 months. Treatment-emergent adverse event (TEAE) occurred in 15 (100%) pts and treatment-related adverse event (TRAE) occurred in 10 (66.7%) pts. G3 TEAE in 3 (20%) pts (hypertriglyceridemia, dyspnea, lymphopenia) and G3 TRAE in 1 (6.7%) pt (lymphopenia), no≥ G4 AE reported. Dyspnea, the only reported SAE (1, 6.7%), is drug-unrelated. TRAEs were lymphopenia (5, 33.3%), anemia (1, 6.7%), diarrhea (1, 6.7%), malaise (1, 6.7%), urticaria (1,6.7%), rash (1, 6.7%), constipation (1, 6.7%), flu like symptoms (1, 6.7%), headache (1, 6.7%) and abnormal laboratory test results (incidence were all 6.7%), most of them are mild and manageable. No AEs led to drug withdrawal. No DLT occurred; MTD was not reached. 11/15 pts achieved stable disease (SD) by RECIST v 1.1. DCR was 73.3%. 1 pt with colorectal cancer who experienced irinotecan-based chemotherapy, anti-VEGF and radiotherapy in Cohort 1 had a long-term SD for over 4 months. In SAD part, T3011 DNA in blood at 2 hours post-dose was detected in 0% (0/3), 0% (0/4), 66.7% (2/3) and 100% (2/2) pts in Cohort 1, 2, 3 and 4 respectively. The DNA copies in pts of Cohort 4 are significantly higher than those of Cohort 3 (Mean viral DNA copies/ul 49.6 vs. 5.7). In cohort 2 of MAD part, T3011 DNA in blood at 2 hours post-dose was detected in 0% (0/3), 66.7% (2/3) and 100% (3/3) pts at C1D1, C1D4 and C1D8 respectively. T3011 DNA was not detected in saliva or urine samples. Pre-existing HSV-1 IgG was shown to hardly affect T3011 activity. Conclusions: T3011 IV is safe and well tolerated, and unlikely to spread to close contacts. Preliminary efficacy is encouraging. T3011 DNA in blood is in a dose-dependent manner with additive effect from repeated doses supporting continued recruitment of pts to higher dose cohorts. Clinical trial information: NCT05598268 . [Table: see text]

Safety of butylphthalide and edaravone in patients with ischemic stroke: a multicenter real-world study.

Butylphthalide (NBP) and edaravone (EDV) injection are common acute ischemic stroke medications in China, but there is a lack of large real-world safety studies on them. This study aimed to determine the incidence of adverse events, detect relevant safety signals, and assess the risk factors associated with these medications in real-world populations. In this study, data of acute ischemic stroke patients were extracted from the electronic medical record database of six tertiary hospitals between January 2019 and August 2021. Baseline confounders were eliminated using propensity score matching. The drugs' safety was estimated by comparing the results of 24 laboratory tests standards on liver function, kidney function, lipid level, and coagulation function. The drugs' relative risk was estimated by logistic regression. A third group with patients who did not receive NBP or EDV was constructed as a reference. Prescription sequence symmetry analysis was used to evaluate the associations between adverse events and NBP and EDV, respectively. 81,292 patients were included in this study. After propensity score matching, the NBP, EDV, and third groups with 727 patients in each group. Among the 15 test items, the incidence of adverse events was lower in the NBP group than in the EDV group, and the differences were statistically significant. The multivariate logistic regression equation revealed that NBP injection was not a promoting factor for abnormal laboratory test results, whereas EDV had statistically significant effects on aspartate transaminase, low-density lipoprotein cholesterol and total cholesterol. Prescription sequence symmetry analysis showed that NBP had a weak correlation with abnormal platelet count. EDV had a positive signal associated with abnormal results in gamma-glutamyl transferase, alanine aminotransferase, aspartate aminotransferase, prothrombin time, and platelet count. In a large real-world population, NBP has a lower incidence of adverse events and a better safety profile than EDV or other usual medications.

Preeclampsia

(N Engl J Med. 2022;386:1817–1832. doi: 10.1056/NEJMra2109523) Preeclampsia affects 2% to 4% of global pregnancies, targeting low- and middle-income countries specifically, and it results in serious complications for 5% to 20% of women. Preeclampsia often causes or contributes to endothelial damage, increased peripheral vascular resistance, hypertension, pulmonary edema, hemorrhagic stroke, ischemic encephalopathy, kidney, liver, hematologic, and perinatal injury. Demographic characteristics, medical history, current pregnancy characteristics, physiological abnormalities, abnormal laboratory test results, and ultrasonography abnormalities are risk factors for preeclampsia. These risk factors play a critical role in early identification and treatment during pregnancy.

Reference intervals for common clinical chemistry parameters in healthy adults of Northeast Ethiopia.

Clinical chemistry reference intervals are important tools for health evaluation, diagnosis, prognosis and monitoring adverse events. Currently used reference intervals in most African countries including Ethiopia are mainly derived from Western populations, despite studies reporting differences that could lead to incorrect clinical decisions. The aim of this study was to establish reference intervals for commonly used clinical chemistry parameters for healthy adults in Northeast Ethiopia. A community based cross-sectional study was conducted among 328 apparently healthy adults between the ages of 18 and 57 years. Blood samples were collected for clinical chemistry analysis using Dirui CS-T240 auto-analyzer and serological testing to screen the population. Medians and 95% reference intervals were computed using non-parametric method according to the Clinical and Laboratory Standards Institute guideline. The Mann-Whitney U test was used to compare reference values between males and females. Reference intervals established were: ALT 11.2-48.0 U/L, AST 16-60 U/L, ALP 53-342.3 U/L, total protein 5.4-8.9 mg/dL, total bilirubin 0.1-1.23 mg/dL, glucose 65-125 mg/dL, total cholesterol 69-213 mg/dL, triglycerides 46-207 mg/dL, creatinine 0.3-1.2 mg/dL and urea 9.5-46.3 mg/dL. Significant sex-differences were observed for ALT, AST, ALP, total cholesterol, triglycerides, creatinine and urea. We found that the established reference intervals substantially differ from the reference ranges currently in use. Up to 43.1% of apparently healthy adults are considered as having abnormal test values on the bases of the currently in use reference ranges. If the reference values from the United States based intervals were applied to the study population, 81.8% would have been classified as having abnormal laboratory test results. Local population-specific reference intervals were established for commonly used clinical chemistry parameters in adult population of Northeast Ethiopia. Although further study is needed, these reference intervals may have the potential to facility the decision-making process based on laboratory test results in this population.

Challenging surgical dogma: are routine postoperative day 1 laboratory tests necessary after bariatric operations?

Postoperative day (POD) 1 laboratory tests are routinely ordered after bariatric operations. Determine how often these laboratory tests are abnormal and whether they represent value-added care. Academic medical center, United States. Patients undergoing bariatric operations for obesity and complications from prior bariatric surgery from 1 January 2011 to 12 December 2020 at a single institution were identified. Patients with POD 1 hemoglobin, potassium, creatinine, or glucose serum laboratory tests obtained before 08:00 on POD 1 were reviewed. Laboratory-specific exclusion criteria were applied. Abnormal laboratory test results were a hemoglobin < 8.0 g/dL or a hemoglobin drop of > 3.0 g/dL; a potassium < 3.5 mmol/L (hypokalemia), 5.5-5.9 mmol/L (mild hyperkalemia), or ≥ 6.0 mmol/L (severe hyperkalemia); a creatinine increase of 0.3 g/dL or 1.5X the preoperative value (acute kidney injury); and a glucose > 180 mg/dL (hyperglycemia). Intervention for abnormal hemoglobin, potassium, and glucose was also assessed. Of 2090 patients who underwent bariatric operations, 1969 met inclusion criteria for hemoglobin analysis, 1223 for potassium analysis, 1446 for creatinine analysis, and 563 for glucose analysis. Only 0.2% (n = 4) of patients had a hemoglobin < 8.0 g/dL< and only 3.1% (n = 62) had a > 3.0 g/dL hemoglobin drop. Potassium was abnormal in 2.8% of patients (n = 34 total). An acute kidney injury was diagnosed in 1.8% (n = 26) of patients. Hyperglycemia was identified in 2.1% (n = 12) of patients. Of 5227 laboratory test values, only 1.5% were abnormal. Further, of laboratory tests analyzed for intervention (n = 3781), only 14 (0.4%) were actively acted upon. Routine POD 1 laboratory tests after bariatric operations seem to be a continuation of a surgical tradition rather than a clinically valuable tool. POD 1 laboratory tests should be ordered based on specific patient co-morbidities and clinical criteria.

Extensive Bowel Necrosis in a Case of COVID-19 Disease Despite Warfarin Toxicity: A Paradoxical Event

Background: Coronavirus disease 2019 (COVID-19) involves multiple organs, including the gastrointestinal tract. It also causes frequent thromboembolic events because of its thrombogenicity. This study reports a COVID-19 case of extensive bowel necrosis despite using warfarin. Case Presentation: A 52-year-old homeless addict male was brought via Emergency Medical Services with a chief complaint of abdominal pain for two days and loss of consciousness since the day before. He had a history of cough and dyspnea for seven days and had been using warfarin after mitral valve replacement three years earlier. On admission, he had low oxygen saturation, tachycardia, and fever. Because of his respiratory signs and symptoms, a chest CT scan was performed, and evidence of COVID-19 infection was detected. He had nausea, and on abdominal examination, there was generalized tenderness, rebound tenderness, and guarding. Following physical examination and abnormal laboratory test results, he underwent an emergent laparotomy. Extensive necrosis made surgical intervention impossible, and he died shortly after the surgery. Conclusion: COVID-19-associated coagulopathy raises many challenges nowadays, and according to the present case, even using anticoagulants may not prevent it.

Predicting Abnormal Laboratory Blood Test Results in the Intensive Care Unit Using Novel Features Based on Information Theory and Historical Conditional Probability: Observational Study.

BackgroundRedundancy in laboratory blood tests is common in intensive care units (ICUs), affecting patients’ health and increasing health care expenses. Medical communities have made recommendations to order laboratory tests more judiciously. Wise selection can rely on modern data-driven approaches that have been shown to help identify low-yield laboratory blood tests in ICUs. However, although conditional entropy and conditional probability distribution have shown the potential to measure the uncertainty of yielding an abnormal test, no previous studies have adapted these techniques to include them in machine learning models for predicting abnormal laboratory test results.ObjectiveThis study aimed to address the limitations of previous reports by adapting conditional entropy and conditional probability to extract features for predicting abnormal laboratory blood test results.MethodsWe used an ICU data set collected across Alberta, Canada, which included 55,689 ICU admissions from 48,672 patients. We investigated the features of conditional entropy and conditional probability by comparing the performances of 2 machine learning approaches for predicting normal and abnormal results for 18 blood laboratory tests. Approach 1 used patients’ vitals, age, sex, and admission diagnosis as features. Approach 2 used the same features plus the new conditional entropy–based and conditional probability–based features. Both approaches used 4 different machine learning models (fuzzy model, logistic regression, random forest, and gradient boosting trees) and 10 metrics (sensitivity, specificity, accuracy, precision, negative predictive value [NPV], F1 score, area under the curve [AUC], precision-recall AUC, mean G, and index balanced accuracy) to assess the performance of the approaches.ResultsApproach 1 achieved an average AUC of 0.86 for all 18 laboratory tests across the 4 models (sensitivity 78%, specificity 84%, precision 82%, NPV 75%, F1 score 79%, and mean G 81%), whereas approach 2 achieved an average AUC of 0.89 (sensitivity 84%, specificity 84%, precision 83%, NPV 81%, F1 score 83%, and mean G 84%). We found that the inclusion of the new features resulted in significant differences for most of the metrics in favor of approach 2. Sensitivity significantly improved for 8 and 15 laboratory tests across the different classifiers (minimum P<.001 and maximum P=.04). Mean G and index balanced accuracy, which are balanced performance metrics, also improved significantly across the classifiers for 6 to 10 and 6 to 11 laboratory tests. The most relevant feature was the pretest probability feature, which is the probability that a test result was normal when a certain number of consecutive prior tests was already normal.ConclusionsThe findings suggest that conditional entropy–based features and pretest probability improve the capacity to discriminate between normal and abnormal laboratory test results. Detecting the next laboratory test result is an intermediate step toward developing guidelines for reducing overtesting in the ICU.

The Value of Preoperative Laboratory Investigations in Healthy Individuals Undergoing Elective Cataract Surgeries.

PurposeTo evaluate the number of patients with abnormal preoperative laboratory test results and determine the benefits of these tests in healthy individuals scheduled for elective cataract surgeries.Patients and MethodsThis study was conducted at Songklanagarind Hospital, Thailand. The data were collected from January 1, 2020, to August 31, 2021. The results of laboratory investigations, consisting of a complete blood count (CBC), including hemoglobin (Hb), hematocrit (Hct), and platelet count; chest X-ray (CXR); electrocardiography (EKG); and anti-human immunodeficiency virus (anti-HIV), were evaluated and analyzed. Additional management actions and rates of postponement or cancellation of surgeries were also evaluated.ResultsIn total, 401 participants were enrolled in this study. The rates of abnormal investigation results were 40.2% for EKG, 15.5% for CXR, 12.7% for Hb, 11.7% for Hct, 2.0% for platelet count, and 0.2% for anti-HIV. The preoperative tests that required additional management and postponement/cancellation of surgeries were CXR (5.5% and 1.7%, respectively), EKG (2.5% and 0.5%, respectively), and anti-HIV (0.2% and 0%, respectively). Moreover, age ≥60 years was associated with a significantly higher rate of positive preoperative EKG findings (relative risk, 4.64; p = 0.017).ConclusionThe CBC test was not beneficial as a preoperative laboratory investigation for healthy individuals in any age group who were scheduled for elective cataract surgery. However, EKG, CXR, and anti-HIV test results were valuable. Patients aged ≥60 years were at risk of having positive EKG results that could result in cancellation or postponement of surgery.

Effect of Food Intake on Pharmacokinetics of Oral Almonertinib: A Randomized Crossover Trial in Healthy Chinese Participants.

The third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) almonertinib (HS-10296) targets both EGFR-sensitizing and T790M resistance mutations. This randomized, open-label, two-period crossover trial investigated the effect of food intake on the single-dose pharmacokinetic properties of almonertinib and its metabolite HAS-719. Twenty healthy adults received a single dose of almonertinib tablets (110mg) on days 1 and 22 under overnight fasting or fed conditions, respectively. Plasma samples were collected 216hours post-dosing and almonertinib and HAS-719 concentrations were determined using liquid chromatography-tandem mass spectrometry. For almonertinib, the geometric mean ratio (GMR, fed/fasting) and 90% confidence interval (CI) for the area under the curve (AUC) from time 0 to 216hours and apparent oral clearance (CLz /F) were 119.9 (110.0-130.7) and 83.5 (76.6-90.9), respectively. Fasting and fed groups showed significant differences in these parameters, but not for maximum concentration (Cmax ) and time to Cmax (Tmax ). The Cmax GMR of HAS-719 was 81.7 (75.8-88.0), which decreased significantly in the fed group. The drug-related adverse reaction (AR) incidence was similar in the two groups, 50% in the fasting group and 52.6% in the fed group. ARs were mainly gastrointestinal diseases and abnormal laboratory test results, and all participants fully recovered. In conclusion, a high-fat diet slightly affected the pharmacokinetic profile of almonertinib in healthy participants, but not the safety tolerance. Therefore, almonertinib is suitable for administration under fasting or fed conditions.

Prevalence of primary eosinophilic colitis in patients with chronic diarrhea and diarrhea-predominant irritable bowel syndrome.

Primary eosinophilic colitis (PEC) is an inflammatory disease caused by the infiltration of eosinophils into the mucosa of the colon, determined after having ruled out other possible causes. It is characterized by abdominal pain and diarrhea and its prevalence is unknown. To know the prevalence of PEC in patients with chronic diarrhea and in those with clinical criteria for diarrhea-predominant irritable bowel syndrome (IBS-D). All patients with chronic noninflammatory diarrhea that were consecutively seen over a decade were studied through colonoscopy, with systematic biopsy. Patients with a known or decompensated organic disease, alarm features, abnormal minimal laboratory test results, and factors associated with eosinophilia were excluded. Patients with the clinical criteria for IBS-D (Rome III) were selected from the general group. Eosinophilic colitis was defined as the presence of>35eosinophils/100 epithelial cells per field in any of the segments. From the 683 patients seen, a total of 545 patients (361 women) were included in the study. Twenty-two cases of PEC were detected, resulting in a prevalence of 4.0%. A total of 343 patients had IBS-D criteria (223 women), with 16 cases of PEC detected, for a prevalence of 4.7%. Colonoscopy was normal, or almost normal, in all the PEC cases detected. The prevalence of PEC was 4.0% in the patients with chronic diarrhea and 4.7% in the patients with IBS-D. Peripheral eosinophilia appeared to be the main distinctive clinical characteristic, but systematic biopsy was essential for making the diagnosis.

Can cell salvage be used for resuscitation in a patient with amniotic fluid embolism and hepatic laceration? A case report

BackgroundAmniotic fluid embolism (AFE) is a rare disease that can lead to profound coagulopathy and hemorrhage, especially when combined with the laceration and bleeding of other organs. Intraoperative cell salvage (ICS) has been widely used for treating obstetric hemorrhage, but it remains unclear whether ICS can be used in the treatment of AFE.Case presentationWe report the case of a 27-year-old woman at 39 weeks’ gestation who suddenly developed severe abdominal pain, convulsions, loss of consciousness, and decreased vital signs during labor. Despite an emergency cesarean section being performed, the parturient experienced sudden cardiac arrest. Fortunately, the heart rate spontaneously recovered after effective cardiopulmonary resuscitation (CPR). Further abdominal exploration revealed right hepatic laceration with active bleeding. ICS was performed and the salvaged blood was promptly transfused back to the patient. Subsequently, the patient was diagnosed with AFE based on hypotension, hypoxia, coagulopathy, and cardiac arrest. The patient was transfused with 2899 mL salvaged blood during surgery with no adverse effects. At 60- and 90-day follow-ups, no complaints of discomfort or abnormal laboratory test results were observed in the mother or the baby.ConclusionICS was used to rescue patient with AFE, and ICS did not worsen the condition of patients with AFE. For pregnant women who received CPR, clinicians should explore the presence of hepatic laceration which can be fatal to patients.

Analysis of the reasons for screening failure in phase I clinical trials in China: a retrospective study of the clinical trials screening process.

BackgroundTo analyze the main reasons for screening failure in the screening process of healthy subjects in phase I clinical trials and coping strategies.MethodsWe retrospectively collected data from the screening process of 1,640 healthy subjects in 12 phase I clinical trials conducted between April 2019 and July 2020 at the First Affiliated Hospital of Bengbu Medical College. The reasons for screening failure were statistically analyzed (χ2 test), and correlation studies were conducted to explore the main factors associated with screening failure.ResultsAmong the 1,640 healthy subjects, 632 (38.5%) successfully passed screening, and 1,008 (61.5%) failed screening. Abnormal laboratory test results (43.25%), abnormal vital sign examination results (11.81%), withdrawal of informed consent (10.02%), abnormal height/weight examination results (8.33%), and abnormal electrocardiogram (ECG) examination results (5.66%) accounted for 79.07% of the screening failures. Subjects aged 46–57 years were more likely to fail screening than those aged 18–30 or 31–45 years (158/220 vs. 541/893 vs. 309/527, respectively, P=0.002), and males were more likely than females to fail screening (721/1, 133 vs. 287/507, respectively, P=0.007). However, the distance between the subject’s residence and clinical trial institution (P=0.491) was not significantly correlated with screening failure.ConclusionsBefore trial screening, healthy subjects should be informed of the clinical trial risks and have sufficient time to consider or discuss participation with their family members. In addition, subjects should be informed that they should eat lightly, have adequate rest, and maintain a relaxed state of mind prior to screening. Regarding fluctuations in the normal range of laboratory indicators and ECG examination reports during the screening process, clinicians should determine the medical decision level (MDL) for each indicator. If no clinical significance is identified, then the subject can be included. In terms of sex and age, this study provides reasonable suggestions to further improve project protocols and improve the healthy subject screening success rate.

Prevalence of primary eosinophilic colitis in patients with chronic diarrhea and diarrhea-predominant irritable bowel syndrome

IntroductionPrimary eosinophilic colitis (PEC) is an inflammatory disease caused by the infiltration of eosinophils into the mucosa of the colon, determined after having ruled out other possible causes. It is characterized by abdominal pain and diarrhea and its prevalence is unknown. AimsTo know the prevalence of PEC in patients with chronic diarrhea and in those with clinical criteria for diarrhea-predominant irritable bowel syndrome (IBS-D). Patients and methodsAll patients with chronic noninflammatory diarrhea that were consecutively seen over a decade were studied through colonoscopy, with systematic biopsy. Patients with a known or decompensated organic disease, alarm features, abnormal minimal laboratory test results, and factors associated with eosinophilia were excluded. Patients with the clinical criteria for IBS-D (Rome III) were selected from the general group. Eosinophilic colitis was defined as the presence of > 35 eosinophils/100 epithelial cells per field in any of the segments. ResultsFrom the 683 patients seen, a total of 545 patients (361 women) were included in the study. Twenty-two cases of PEC were detected, resulting in a prevalence of 4.0%. A total of 343 patients had IBS-D criteria (223 women), with 16 cases of PEC detected, for a prevalence of 4.7%. Colonoscopy was normal, or almost normal, in all the PEC cases detected. ConclusionsThe prevalence of PEC was 4.0% in the patients with chronic diarrhea and 4.7% in the patients with IBS-D. Peripheral eosinophilia appeared to be the main distinctive clinical characteristic, but systematic biopsy was essential for making the diagnosis.

Malignant hyperthermia when dantrolene is not readily available

BackgroundMalignant hyperthermia is a rare but life-threatening pharmacogenetic muscle disorder characterized by abnormal hypermetabolic reactions and commonly triggered in susceptible individuals by volatile anesthetics or succinylcholine, or both. Unfortunately, the specific medicine dantrolene is not readily available in many countries including China. The aim of this study was to find the characteristics of malignant hyperthermia under the situation that dantrolene is not readily available.MethodsThe cases of malignant hyperthermia reported on the most commonly used databases in China from 1985 to 2020 were analyzed. The inclusion criteria were the MH episodes only related to anesthesia. The exclusion criteria were dubious MH episodes only caused by Ketamine administration or MH episodes irrelevant to anesthesia. Independent samples t-test and Pearson’s chi-squared test were applied to assess the difference between the survived and death cases.ResultsNinety-two cases of malignant hyperthermia reported on the most commonly used databases in China from 1985 to 2020 were analyzed. Median (IQR [range]) age was 18.5 (11.8–37.0 [0–70.0]) years. Compared with the survived cases, the death cases had higher maximum end-tidal partial pressure of CO2 (P = 0.033), the maximum arterial partial pressure of CO2 (P = 0.006), temperature first measured when the patient was first discovered abnormal (P = 0.012), and maximum temperature (P < 0.001). Besides, the death cases had less minimum pH (P < 0.001) and higher potassium (P < 0.001) and were more likely to have coagulation disorders (p = 0.018). Concerning treatment, cases used furosemide (P = 0.024), mannitol (P = 0.029), blood purification treatment (P = 0.017) had the advantage on the outcome. Creatine phosphokinase, myoglobin, and MB isoenzyme of creatine phosphokinase differed greatly among cases during the first week. 43 (46.7%) cases had congenital diseases. 12 (13.0%) cases were reported with abnormal laboratory test results or abnormal signs that are possibly relevant before anesthesia.ConclusionsIn countries that dantrolene is not readily available, early warning, diagnosis, and prompt effective therapies are crucial for MH patients to survive.

Sex differences in clinical characteristics and risk factors for disease severity of hospitalized patients with COVID-19.

Recent studies reported sex differences in patients with coronavirus disease‐2019 (COVID‐19). We aim to analyze sex differences in clinical characteristics and risk factors for disease severity of hospitalized patients with COVID‐19 in Beijing. All adults (185 cases) diagnosed with COVID‐19 and admitted to Beijing Ditan Hospital, Capital Medical University were included in samples. The median age of all patients was 41 years. The mean body mass index (BMI) of males was relatively higher compared to females (p < 0.001). The proportion of male patients with coronary heart disease (CHD), nonalcoholic fatty liver disease (NAFLD), history of smoking and drinking was higher than females. Male patients developed more clinical symptoms, obtained more abnormal laboratory test results, while they were less aware of care‐seeking than female patients. There were no significant differences in clinical complications and outcomes between two groups. Age (odds ratio [OR]: 1.082; 95% confidence interval [CI]: 1.034–1.132; p = 0.001) and BMI (OR: 1.237; 95% CI: 1.041–1.47; p = 0.016) were considered risk factors for refractory pneumonia in multivariate regression analysis. The findings of the current study showed that SARS‐CoV‐2 was more likely to affect older males with comorbidities. Further researches into factors underlying obesity and disease severity may provide mechanistic insight into COVID‐19 development.

Early onset of neurological features differentiates two outbreaks of Lassa fever in Ebonyi state, Nigeria during 2017-2018.

Lassa fever (LF) is an acute viral haemorrhagic illness with various non-specific clinical manifestations. Neurological symptoms are rare at the early stage of the disease, but may be seen in late stages, in severely ill patients.The aim of this study was to describe the epidemiological evolution, socio-demographic profiles, clinical characteristics, and outcomes of patients seen during two Lassa fever outbreaks in Ebonyi State, between December 2017 and December 2018. Routinely collected clinical data from all patients admitted to the Virology Centre of the hospital during the period were analysed retrospectively. Out of a total of 83 cases, 70(84.3%) were RT-PCR confirmed while 13 (15.7%) were probable cases. Sixty-nine (83.1%) patients were seen in outbreak 1 of whom 53.6% were urban residents, while 19%, 15%, and 10% were farmers, students and health workers respectively. There were 14 (16.8%) patients, seen in second outbreak with 92.9% rural residents. There were differences in clinical symptoms, signs and laboratory findings between the two outbreaks. The case fatality rates were 29.9% in outbreak 1 and 85.7% for outbreak 2. Neurological features and abnormal laboratory test results were associated with higher mortality rate, seen in outbreak 2. This study revealed significant differences between the two outbreaks. Of particular concern was the higher case fatality during the outbreak 2 which may be from a more virulent strain of the Lassa virus. This has important public health implications and further molecular studies are needed to better define its characteristics.

Retrospective analysis of abnormal laboratory test results in pediatric patients prescribed terbinafine for superficial fungal infections

To the Editor: Superficial fungal infections in children are common, with significant impact on quality of life.1,2 Terbinafine is frequently prescribed for its antifungal coverage and high cure rates.3 It is well tolerated in adults, with low rates of abnormal laboratory test results and adverse events and few drug-drug interactions.4 There are no guidelines for laboratory monitoring in children prescribed systemic terbinafine.3 Our objectives were to investigate the prevalence of abnormal laboratory test results in children prescribed systemic terbinafine for superficial fungal infections.