骨髓增殖性肿瘤患者NGAL、VEGF、PC及PS表达水平及意义研究

目的观察骨髓增殖性肿瘤(MPN)患者中性粒细胞明胶酶相关脂质运载蛋白(NGAL)、血管内皮生长因子(VEGF)、血浆蛋白C(PC)及血浆蛋白S(PS)表达水平,并分析其临床意义。方法回顾性选取2019年1月至2021年8月在沧州市中心医院初诊MPN患者40例、MPN治疗后患者40例,以及健康体检者40例为研究对象,分别作为初诊组、治疗后组、对照组。观察3组研究对象、不同临床特征MPN患者的NGAL、VEGF、PC及PS表达水平,分析影响MPN患者的NGAL、VEGF、PC及PS表达水平的因素。结果初诊组、治疗后组的NGAL[(18.34±2.11)、(10.49±1.87)ng/mL]、VEGF[(239.29±10.45)、(151.34±9.13) pg/mL]水平均显著高于对照组[(2.37±0.45) ng/mL、(78.66±8.35) pg/mL],初诊组、治疗后组的PC[(1 794.35±142.49)、(2 918.21±85.35) ng/mL]、PS[(43 424.64±102.41)、(63 467.47±125.48) ng/mL]水平均显著低于对照组[(3...     

Urine neutrophil gelatinase-associated lipocalin as a biomarker of adult pyelonephritis

BackgroundPyelonephritis is a common infection at any age. Urine neutrophil gelatinase-associated lipocalin (NGAL), a novel biomarker of acute renal failure, is related to pyelonephritis in pediatric patients, although the significance of this urine biomarker in adult patients are not clear. We investigated the relationship between urine NGAL of pyelonephritis and non-pyelonephritis.Patients and methodsWe prospectively enrolled adult patients who were hospitalized due to pyelonephritis or non-pyelonephritis. Pyelonephritis was diagnosed in patients with fever and bacteriuria, with no any other infection focuses. Non-pyelonephritis was diagnosed in patients who had fever and another infection focus without bacteriuria. Urine samples were collected on days 0, 3 and 7. Urine NGAL levels were measured by ELISA.ResultsThere were 35 patients in the pyelonephritis group and 19 patients in the non-pyelonephritis group. Urine NGAL level were significantly higher in the pyelonephritis group than the non-pyelonephritis group on day 0 (median 302 ng/mL vs 25 ng/mL, p = 0.006). The area under the receiver operating characteristic curve of NGAL was 0.78 (p = 0.006). Urine NGAL level had a specificity of 66.7% and sensitivity of 87.0% at the cut-off level of 250 ng/mL for diagnosing pyelonephritis.ConclusionsUrine NGAL level at the diagnosis of infection are elevated in adult patients with pyelonephritis, but not in those with non-pyelonephritis. Urine NGAL might be a supportive biomarker for the diagnosis of pyelonephritis.     

Development of a myelodysplastic/myeloproliferative neoplasm-unclassifiable in a patient with acute myeloid leukemia: a case report and literature review

Myelodysplastic/myeloproliferative neoplasms (MDS/MPNs) are a heterogeneous group of hematologic malignancies characterized by dysplastic and myeloproliferative overlapping features in the bone marrow and blood. The occurrence of the disease is related to age, prior history of MPN or MDS, and recent cytotoxic or growth factor therapy, but it rarely develops after acute myeloid leukemia (AML). We report a rare case of a patient diagnosed with AML with t(8; 21)(q22; q22) who received systematic chemotherapy. After 4 years of follow-up, MDS/MPN-unclassifiable occurred without signs of primary AML recurrence.     

Survivin、Bcl-2和VEGF在骨髓增生异常综合征中的表达及其相关性

本研究探讨存活蛋白（survivin）在骨髓增生异常综合征（MDS）发病中的可能作用及寻找凋亡和血管新生两种不同的机制在MDS中可能存在的联系。采用免疫细胞化学的方法检测survivin、Bcl-2和VEGF在MDS低危、高危患者和AML患者及对照者骨髓中的单个核细胞的表达情况，并分析三者间的关系。结果表明：survivin、Bcl-2和VEGF在MDS低危组、高危组和AML组的表达率和积分均逐渐增高，除Bcl-2在MDS低危组和对照组的差异无统计学意义外（P〉0．05），三者在各组间的表达差异均有统计学意义（P〈0．05），且三者间的表达率均呈正相关关系。结论：survivin、Bcl-2和VEGF参与了MDS的发病并与疾病病程进展有关，凋亡异常和血管新生可能通过以上3种蛋白的相互作用在MDS的发病中存在着某种联系。     

Neutrophil gelatinase-associated lipocalin levels during the first 48 hours of intensive care may indicate upcoming acute kidney injury

PurposeThe recognition of acute kidney injury (AKI) as early as possible is important in the intensive care unit. This study proposes that serum and urine levels of neutrophil gelatinase-associated lipocalin (NGAL) may be used for this purpose.MethodsOne hundred and seven critically ill adult patients with no previous renal failure were included. NGAL levels were measured during the first 48 hours after admission; NGAL levels were followed for 7 days and classified based on Risk, Injury, Failure, Loss, and End-Stage Renal Failure criteria.ResultsThe AKI incidence was 35.5%, and serum NGAL (sNGAL) and urinary NGAL (uNGAL) levels were higher in the AKI group. The area under the receiver operating characteristic curve was 0.76 (P < .001) for sNGAL and 0.75 (P < .001) for uNGAL. Seventy-one percent of AKI cases were observed within 48 hours, with 11 additional cases in the ensuing 7 days. The mean serum creatinine levels in the 11 patients were not different from non-AKI levels (P = .197), but the NGAL values were different, and the area under the receiver operating characteristic curve for sNGAL uNGAL was 1.00 (P = .014) and 0.93 (P = .02), respectively.ConclusionsMost AKI cases were diagnosed within the first 48 hours after admission, and NGAL was useful for predicting upcoming AKI.     

Soluble receptor for advanced glycation end products (sRAGE) in plasma and synovial fluid is inversely associated with disease severity of knee osteoarthritis

Objectives:The aim of this study was to measure soluble receptor for advanced glycation end products (sRAGE) in plasma and synovial fluid of knee osteoarthritis (OA) patients and to determine the correlation between sRAGE levels and disease severity.Design and methods:Thirty-six OA patients and 15 healthy controls were enrolled in this study. OA grading was performed using the Kellgren–Lawrence classification. sRAGE levels in plasma and synovial fluid were analyzed by enzyme-linked immunosorbent assay.Results:Plasma sRAGE levels were significantly lower in OA patients than in healthy controls (P = 0.01). sRAGE levels in plasma were remarkably higher with regard to paired synovial fluid (P = 0.001). Additionally, sRAGE concentrations in plasma and synovial fluid showed significant inverse correlation with disease severity (r = ?0.65, P < 0.001 and r = ?0.55, P = 0.001, respectively). Further analysis showed that there was a strong positive correlation between plasma and synovial sRAGE concentration (r = 0.81, P < 0.001).Conclusions:sRAGE levels were significantly lower in OA patients compared with controls, and sRAGE levels in plasma and synovial fluid also decreased significantly as the disease severity increased. Accordingly, sRAGE levels could be used as a biochemical marker for assessing the severity and progression of knee OA.     

骨髓异常增生综合征与急性髓性白血病的MRI表现

目的 通过比较骨髓异常增生综合征(MDS)、急性髓性白血病(AML)患者和健康成人骨髓的MRI表现,探讨应用MRI预测MDS转化为AML的可能性.方法 MDS和AML各25例(MDS组、AML组),另选25名健康志愿者作为对照组.采用SE T1WI及脂肪抑制序列T2WI,行腰椎矢状面、骨盆及股骨中上段骨髓正冠状面扫描,分析比较三组腰椎、髂骨和股骨近端的MRI表现差异.结果 MDS组、AML组患者骨髓MRI表现与对照组相比差异显著.MDS组与AML组腰椎、髂骨及股骨近端骨髓MRI表现差异无统计学意义.结论 骨髓MRI可明确区分对照组与MDS组、AML组.骨髓MRI对预测和诊断MDS是否已经转化为AML的价值有限.     

Pilates training improves aerobic capacity,but not lipid or lipoprotein levels in elderly women with dyslipidemia: A controlled trial

IntroductionThe aim of the present study was to verify the effects of a Pilates training on total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), glucose and C-reactive protein (CRP) levels, as well as on functionality of postmenopausal women with dyslipidemia.MethodThis randomized study involved 35 sedentary women with dyslipidemia, aged between 60 and 75 years. One group participated in a Pilates exercises training with two to four weekly sessions during 10 weeks (Pilates group, n = 20) and the other group did not perform any intervention (control group, n = 6). Biochemical analyses and functionality parameters were measured before and after the 10 weeks.ResultsNo significant differences were observed in TC, TG, LDL and HDL for both groups. Regarding glucose and CRP levels, significant reductions were observed in both groups after the intervention period. In functional parameters, both groups significantly increased their 30-s chair stand test values. On the other hand, only the Pilates group presented significant increments in the 6-min walk test (p < 0.05).ConclusionPilates training did not change lipid or lipoprotein levels, but improved cardiorespiratory fitness of elderly women with dyslipidemia.     

骨髓增生异常综合征患者骨髓VEGF和bFGF水平的变化及其意义

目的:探讨骨髓增生异常综合征(MDS)患者骨髓浆液中血管内皮细胞生长因子(VEGF)和碱性成纤维细胞生长因子(bFGF)水平变化及其临床意义。方法:采用酶联免疫吸附法(ELISA法)检测38例MDS、10例急性非淋巴细胞白血病(ANLL)患者和15例正常人骨髓浆液的VEGF和bFGF水平,用酶标仪测定VEGF及bFGF光密度平均值。结果:MDS组和ANLL组骨髓浆液VEGF和bFGF水平均显著高于正常对照组(P<0.05,P<0.01),而MDS组VEGF水平显著低于ANLL组(P<0.05),但MDS组bFGF水平与ANLL组之间差异无统计学意义(P>0.05)。骨髓浆液VEGF和bFGF表达与MDS患者性别、年龄、外周血中白细胞、血小板及血红蛋白含量及骨髓涂片中原始细胞百分比(高危组)均无相关(r分别为0.160、0.154、0.193、0.185、0.171、0.286;r分别为0.141、0.175、0.152、0.163、0.158、0.239,P均>0.05)。结论:MDS患者骨髓微环境中bFGF和VEGF表达水平均升高,可能在MDS骨髓血管新生及其病情发展过程中发挥了重要作用。     

Different profiles of circulating arginase 2 in subtypes of preeclampsia pregnant women

Background and aimsPreeclampsia (PE) is a gestational hypertensive disease responsible for high maternal and fetal morbidity and mortality. The increase in blood pressure is associated with a decrease in the bioavailability of nitric oxide (NO). Arginase interferes with NO production consuming L-arginine, a substrate required by endothelial NO synthase to NO formation. No previous study has quantified the circulating levels of the two arginase isoforms (arginase 1 and arginase 2) in the plasma of pregnant women with PE. Therefore, our objective is to evaluate these plasma levels in healthy pregnant women and PE with or without severe features and who respond or not to antihypertensive therapy.MethodsWe compared 29 healthy pregnant women with 56 pregnant women with PE, who were also divided into with severe features (n = 24) or without severe features (n = 32) and into responsive (n = 29) or nonresponsive to antihypertensive therapy (n = 27). We quantified the plasmatic expression of arginase 1 and arginase 2 by ELISA kits.ResultsWhile similar levels of arginase 1 were found among groups, lower arginase 2 plasma levels were found in PE without severe features and responsive to antihypertensive drugs when compared to healthy pregnant women. There was no difference between arginase 2 levels in PE with severe features and nonresponsive group when compared to healthy pregnant women.ConclusionThis shows different circulation profiles of arginase 2 among groups, suggesting the existence of mechanisms of arginase 2 modulation in pregnant women with PE associated with the severity of the disease and responsiveness to antihypertensive treatment.     

Minimal residual disease testing to predict relapse following transplant for AML and high-grade myelodysplastic syndromes

Evaluation of: Lange T, Hubmann M, Burkhardt R et al. Monitoring of WT1 expression in PB and CD34(+) donor chimerism of BM predicts early relapse in AML and MDS patients after hematopoietic cell transplantation with reduced-intensity conditioning. Leukemia 25, 498-505 (2011). Early detection of relapse is critical for patients who have undergone hematopoietic stem cell transplantation (HSCT) for acute myeloid leukemia (AML) or high-grade myelodysplastic syndromes (MDS), since therapy can be initiated while disease burden remains low. As these neoplasms represent a heterogeneous group of malignancies with distinct underlying mutations, no single genetic marker exists that both defines AML/MDS and can be exploited for sensitive detection of neoplastic cells prior to overt hematologic relapse. Conversely, the Wilms' tumor gene (WT1) expression level is increased in blasts of most AML/MDS patients, and quantitative analysis of WT1 expression has been used to predict relapse following myeloablative HSCT. In this article, we review a recently published study evaluating the usefulness of multiple markers, including WT1 expression, for predicting relapse in AML/MDS patients following reduced-intensity conditioning nonmyeloablative HSCT.     

Soluble receptor for advanced glycation end products in physiological and pathological pregnancy

ObjectiveThe receptor for advanced glycation end products, RAGE, has been implicated in pathogenesis of many diseases. Soluble RAGE, sRAGE, extracellular domain of RAGE, is new biomarker. The aim of the study was to determine sRAGE levels in physiological pregnancy and their changes in pregnancies complicated by preterm labor or preeclampsia.Design and methodsSerum levels of sRAGE were determined in 79 healthy pregnant women, 42 pregnant women in preterm labor or with preeclampsia and 24 non-pregnant controls.ResultssRAGE serum levels are decreased in physiological pregnancy compared to healthy non-pregnant controls (p < 0.001). Serum sRAGE concentrations are higher in the 2nd trimester of physiological pregnancy, compared to the 1st and 3rd trimesters of pregnancy (p < 0.001). sRAGE levels in women with preterm labor are decreased (p < 0.05) and correlate negatively with the leukocyte count (r = -0.47, p < 0.05). In women with preeclampsia, sRAGE is elevated (p < 0.05) and correlates with serum creatinine concentration (r = 0.54, p < 0.05) and with uric acid concentration (r = 0.51, p < 0.05).ConclusionOur results clearly demonstrate significant differences in serum sRAGE levels in physiological pregnancy and in pathological states in pregnancy, however, further studies are required demonstrate the usefulness and significance of sRAGE.     

Neutrophil to lymphocyte ratio is associated with in-hospital mortality in older adults admitted to the emergency department

BackgroundThe objective of this study was to test the hypothesis that an elevated neutrophil to lymphocyte ratio (NLR) at admission is associated with and increased risk of mortality in older patients admitted to the emergency department (ED).MethodsWe performed a retrospective analysis of patients admitted to the ED between November 2016 and February 2017. We included patients who were older than 65 years who visited the ED with any medical problem. We excluded patients with hematologic malignancy. Baseline NLR values were measured at the time of admission to the ED. The primary outcome was all-cause in-hospital mortality. A multivariate logistic analysis was performed.ResultsA total of 2777 patients were included in this study. The median age was 75 years (IQR 70–81), and 1359 (48.9%) patients were male. The in-hospital mortality rate was 5.0% (140 patients). The NLR value was higher in nonsurvivors (median, 8.08, IQR 4.29–15.25) than in survivors (median, 3.69, IQR 2.1–6.92, P < 0.001). In the multivariate logistic regression analysis, the NLR was associated with all cause in-hospital mortality after adjusting for confounding factors (OR = 1.03, 95% CI = 1.014–1.046).ConclusionsThese results show that the NLR at admission is associated with in-hospital mortality among patients older than 65 years without hematologic malignancy. Thus, NLR at admission may represent a surrogate marker of disease severity.     

Clinical value of serum miR‐320‐3p expression in predicting the prognosis of sepsis‐induced acute kidney injury

BackgroundFor investigating the expression of miR‐320‐3p in children with sepsis‐induced acute kidney injury (AKI) and its prognostic value.MethodsA total of 142 patients were grouped into a survival group (n = 95) and death group (n = 47), which was based on their 28‐day survival. Serum degrees of miR‐320‐3p, neutrophil gelatinase‐associated lipid carrier protein (NGAL) and kidney injury molecule‐1 (KIM‐1) were detected. The Acute Physiology and Chronic Health scoring system Ⅱ (APACHE Ⅱ) marks were recorded. Target gene forecast and functional enrichment discussion of miR‐320‐3p were performed, and a protein–protein interaction (PPI) network diagram was plotted by applying bioinformatics methods. Multivariate logistic regression, ROC curve and Pearson correlation analysis were applied.ResultsThe death group showed greatly higher serum levels of miR‐320‐3p, KIM‐1 and APACHE Ⅱ scores than the survival group (p < 0.01). Multivariate logistic regression analysis showed that levels of miR‐320‐3p, NGAL, KIM‐1 and APACHE Ⅱ scores were independent risk elements for death in sepsis children with AKI (p < 0.01). According to ROC curve analysis, the region under the curve (0.963, 95% CI: 0.908–0.996) of miR‐320‐3p, NGAL, KIM‐1 levels and APACHE Ⅱ scores combined to forecast the death of kids suffering from sepsis and AKI were the biggest. According to correlation analysis, the expression degree of serum miR‐320‐3p in the death group was positively correlated with NGAL, KIM‐1 and APACHE Ⅱ scores (all p < 0.01).ConclusionsThe expression level of serum miR‐320‐3p in children with sepsis‐induced AKI was significantly increased, and the combination of NGAL, KIM‐1 and APACHE Ⅱ scores has good value for prognosis prediction in children.     

骨髓增生异常综合征Cyr61和血管内皮细胞生长因子的表达及其相关性研究

目的 研究富半胱氨酸61(Cyt61)基因在骨髓增生异常综合征(MDS)不同亚型中的表达情况,探讨Cyr61基因在MDS发生、发展及向急性髓系白血病(AML)演变过程中的意义及其与血管内皮生长因子(VEGF)基因的关系.方法 采用RT-PCR和免疫组化SP法对28例MDS患者、12例AML(其中包括4例由MDS转变而来)患者和10例对照者骨髓单个核细胞(BMMNC)中Cyr61和VEGF mRNA和蛋白质水平进行检测.结果 Cyr61和VEGF mRNA在MDS组和AML组中的表达高于对照组,差异有统计学意义.Cyr61和VEGF mRNA在高危型MDS(RAEB-Ⅰ、RAEB-Ⅱ)(0.3998±0.2467,0.4775±0.1342)和AML患者中的表达(0.4594±0.1737,0.4967±0.2324)明显高于低危型MDS(RA、RARS、RCMD)患者中的表达(0.2213±0.1465,0.2872±0.2341)(P值均＜0.05).高危型MDS患者Cyt61和VEGF mRNA的表达水平和AML患者相比差异无统计学意义.MDS患者Cyr61和VEGF蛋白的表达水平高于对照组,差异有统计学意义.高危型MDS患者Cyr61和VEGF蛋白的表达水平[(38.7±2.9)%,(43.2±2.7)%]明显高于低危型MDS患者[(31.4±3.1)%,(33.5±3.4)%](P＜0.05).MDS患者Cyr61和VEGF的表达呈明显正相关关系(r=0.8762,P＜0.01).结论 Cyr61和VEGF可能在MDS骨髓血管生成及病情发展过程中发挥重要作用.     

Prognostic potential of morphological and cytogenetic indices in patients with myelodysplastic syndrome

AIM: To examine prognostic potential of the number of bone marrow (BM) blasts and cell karyotype as risk factors of transformation of myelodysplastic syndrome (MDS) in acute myeloblastic leukemia AML. MATERIAL AND METHOD: The analysis of examination was made for 72 patients with primary MDS in the groups formed by number of blasts in BM, karyotype and IPSS variant. MDS was diagnosed by WHO criteria. Transformation into AML was established in blastosis > 20% in peripheral blood and/or BM. The karyotype was studied according to GTG technique. RESULTS: More frequent progression of MDS was seen in patients with blastosis > 10%, unfavourable karyotype and high IPSS risk. The least number of leukemic transformations occurred in karyotype of intermediate prognosis while disease-free survival in patients with karyotype of good prognosis was similar to that of patients with unfavourable karyotype. The number of blasts in BM and IPSS variant appeared to be prognostic markers of duration of leukemia-free survival in one-factor analysis. The multifactorial analysis found out one factor of MDS transformation in AML: number of blasts in BM puncture biopsy. CONCLUSION: Prognostic priority of the number of BM blasts as a risk factor of MDS progression compared to karyotype is explained by biological heterogenicity of MDS.     

The Effects of Acupressure on Nausea,Vomiting, and Vital Signs in Patients Undergoing Gynecologic Surgery: A Randomized Controlled Trial

PurposeThis randomized controlled experimental study was conducted to determine the effect of acupressure on nausea, vomiting, and vital signs in patients undergoing gynecologic surgery.DesignA randomized controlled experimental study.MethodsStudy participants consisted of females aged 18 to 65 years who underwent surgery in the gynecology clinic of the related hospital between October 2016 and March 2017. The sample originally consisted of 111 patients: K-K9 group (n = 39), P6 group (n = 37), and control group (n = 35). The point P6 in both wrists was determined, and the patients in that group wore a wristband 1 hour before the operation. The point K-K9 in both hands was determined, and one Black Pepper Seed was fixed on the point with the help of a plaster almost 1 hour before the operation. Once the wristband and the seed were placed, they remained in place for 24 hours. The control group received routine care, with no application of acupressure devices.FindingsFinal sample number was 103 after six were lost to follow-up. Vital signs of the patients showed a difference between the intervention groups and control group after the surgical procedure. The pulse values varied at statistically significant levels according to groups in the first and second measurements. The respiratory values of the K-K9 and P6 groups were statistically lower than those in the control group in the first, second, fourth, and fifth measurements (P < .05). The first measurement of nausea scores varied statistically according to the groups. The K-K9 group nausea scores were statistically lower than those in the control group (P < .05). At the time of the first measurement, the number of those who retched in the P6 group was statistically higher than those in the K-K9 group (P < .05).ConclusionsWe examined the effect of two types of acupressure in the management of postoperative nausea and vomiting in the first 24 hours after gynecologic surgeries. Although some findings of ours did not show a statistically significant difference, these alternative therapies showed promise.     

Active and Passive Distraction Interventions in a Pediatric Emergency Department to Reduce the Pain and Anxiety During Venous Blood Sampling: A Randomized Clinical Trial

IntroductionDistraction is a method that is easy to use in emergency departments and effective in relieving procedural pain and anxiety. This study aimed to determine the effect of 2 new distraction methods—1 active distraction (rotatable wooden toy) and 1 passive distraction (toy wristband)—on procedural pain, fear, and anxiety in children during venous blood sampling.MethodsThis study was a randomized controlled experimental study. The sample consisted of 216 children aged 6 years to 12 years. They were divided into 3 groups using the block randomization procedure: active distraction group (n = 72); passive distraction group (n = 72); and control group (n = 72). The levels of pain and anxiety in the children were measured before and during the blood sampling by the children themselves, their parents, and the researcher using the Visual Analog Scale, the Wong-Baker FACES Pain Rating Scale, and the Children’s Fear Scale.ResultsThe children and their parents included in the control and experimental groups had similar sociodemographic characteristics. The active distraction group had lower levels of procedural pain, fear, and anxiety than the other groups (children’s visual analog scale score, F = 134.22; P < 0.05; Wong-Baker FACES Pain Rating Scale score, F = 137.54; P < 0.001; and Children’s Fear Scale score, F = 92.44; P < 0.001).DiscussionBoth the toy wristband and rotatable wooden toy interventions can be used to reduce procedural pain, fear, and anxiety in children during blood sampling in emergency departments.     

Mindfulness for stress and anxiety management in nursing students in a clinical simulation: A quasi-experimental study

AimTo determine the efficacy of an online mindfulness intervention in reducing anxiety and stress levels in nursing students during clinical simulations.BackgroundClinical simulation as a learning strategy has many benefits but the high levels of stress and anxiety it produces in participants can compromise learning, motivation or performance.DesignA quasi-experimental study with a non-equivalent control group design is presented. Forty-two undergraduate nursing students from a natural group were divided into: an experimental group (n = 21) and a control group (n = 21).MethodsBefore conducting a clinical simulation, the experimental group followed a 10-day intensive online mindfulness intervention. All students received the same information and training. Instruments used were: Self-administered Analogue Stress Scale, State-Trait Anxiety Inventory and Five Facet Mindfulness Questionnaire. In addition, physiological data (blood pressure and heart rate) were collected at baseline, pre-briefing and debriefing.ResultsPhysiological variables increased in the prebriefing phase but remained statistically significantly lower in the experimental group (diastolic blood pressure p = .032 and heart rate p = .048). Levels of stress (p = .029) and anxiety (p = .016) were also managed better. Both groups in the debriefing session showed a statistically significant decrease in the different physiological variables, stress and anxiety. No changes in mindfulness were observed.ConclusionsThe clinical simulation is indicated to generate stress and anxiety in nursing students. Therefore, measures must be adopted to control it. The intensive online mindfulness intervention proposed in this study reduced physiological parameters, stress and anxiety in the clinical simulation.     

Intra-Articular Injection of a Novel DVS Cross-Linked Hyaluronic Acid Manufactured by Biological Fermentation (YYD302) in Patients With Knee Osteoarthritis: A Double-Blind,Randomized, Multicenter,Noninferiority Study

PurposeThis double-blind, randomized, Phase III clinical trial was conducted to assess the efficacy andsafety of the novel divinyl sulfone cross-linked hyaluronate (YYD302) compared with the 1,4-butanediol diglycidyl ether cross-linked hyaluronate (Synovian) in patients with knee osteoarthritis.MethodsA total of 184 patients with osteoarthritis (Kellgren-Lawrence grade I–III) were randomized to 1 of 2 study groups (YYD302 group, n = 95; Synovian group, n = 89). A single injection of YYD302 or Synovian was given to both groups, and 182 participants completed the study (YYD302 group, n = 95; Synovian group, n = 87). The primary end point was the change in weight-bearing pain (WBP) at 12 weeks after the primary single injection. Secondary end points included the Knee Injury and Osteoarthritis Outcome Score; the Western Ontario and McMaster Universities Osteoarthritis Index score; the Patient Global Assessment and Investigator Global Assessment; the range of motion, swelling, and tenderness of the target knee; OMERACT-OARSI responder rate; WBP responder rate (the proportion of patients achieving at least 20 mm or 40% decrease in WBP); and rate of rescue medicine use and its total consumption at weeks 2, 4, and 12. Based on the efficacy results at week 12, the responders were administered an additional single injection of the same study drug at week 24, and safety and efficacy were additionally assessed at week 36.FindingsMean changes of WBP at 12 weeks after the primary injection were –31.76 mm with YYD302 and –29.74 mm with Synovian, proving noninferiority of the YYD302 group to the Synovian group as the lower bound of the 95% CI (–4.3 to 8.3) was well above the predefined margin (–10 mm). At week 2, the Knee Injury and Osteoarthritis Outcome Score (total, pain, activities of daily living, and sports/recreation) and Western Ontario and McMaster Universities Osteoarthritis Index scores (total, stiffness) were significantly better in the YYD302 group than in the Synovian group. There were no significant differences between the groups in all other end points. Local overall adverse events (pain, heat, erythema, or swelling) at the injection site were observed in 48.4% of the YYD302 group and in 47.7% of the Synovian group. No serious reactions were reported. There was no statistically significant difference between the 2 groups regarding re-injected patients (YYD302 group, n = 54; Synovian group, n = 46) in any of the efficacy outcomes at week 36.ImplicationsThe results of this study support that YYD302 is comparable to Synovian in terms of the efficacy and safety of the intra-articular injection treatment for osteoarthritis of the knee joint. Furthermore, YYD302 provided faster improvements in some efficacy assessments compared with Synovian. ClinicalTrials.gov identifier: NCT03561779.