OBJECTIVE: To investigate the transfusion and infusion warmer manufacturers, combine the use failures to analyze adverse events, and provide support for enterprise risk management and clinical safe use. METHODS: The sentinels from 7 manufacturing enterprises and 11 medical institutions that participated in Shandong Province's key monitoring program during the "14th Five-Year Plan" period were targeted. This was done by understanding the equipment's principles, structures, and quality control. Additionally, real-world data from January 2019 to December 2023 were collected to count adverse events. RESULTS: During production, there are risks in switching power supply stability and solder joint firmness. Fifteen kinds of faults occurred during use, and common faults such as inability to heat, unable to turn on the machine, and bubbles in the infusion tube accounted for more than 80%. CONCLUSION There are many risk points and failures for transfusion and infusion warmers, so enterprises should improve processes and quality control to address risks, and medical institutions should formulate specifications and maintenance plans to provide targeted theoretical basis for supervision.
Blood Transfusion/instrumentation* ; Risk Factors ; Quality Control ; Humans ; Risk Management ; Equipment Failure

Objective:To evaluate the effect of umbilical cord milking (UCM) on neonatal outcomes after cesarean section.Methods:Chinese and English databases (including CNKI, Wanfang, China Biology Medicine Disc, VIP, Yiigle, PubMed, Embase, CINAHL, Web of Science, the Cochrane Library, and Google Scholar) and ClinicalTrials.gov were retrieved from the inception to July 2023. Randomized controlled trials regarding UCM in neonates from different races who were born by cesarean section were included. The outcomes were postnatal hemoglobin level, hematocrit value, peak serum bilirubin level, phototherapy, cord blood pH value, intraventricular hemorrhage, death, polycythemia, neonatal necrotizing enterocolitis, and Apgar score. The risk of bias among the included studies was confined to low or possible risk according to the Cochrane Risk of Bias Assessment Tool 2.0. RevMan5.3 was used for meta-analysis, and subgroup analysis was performed among neonates with different gestational ages. The certainty of evidence was evaluated using the grades of recommendations assessment, development, and evaluation (GRADE) framework.Results:A total of 11 articles involving 2 347 neonates (1 322 full-term and 1 025 preterm infants) were included. Meta-analysis results showed that: (1) Compared with the immediate cord clamping, UCM increased the hemoglobin level within 24 h and 48-72 h after birth ( MD=1.40, 95% CI: 1.11-1.70, Z=9.32; MD=0.86, 95% CI: 0.69-1.02, Z=10.02, both P<0.01), hematocrit value within 24 h and 48-72 h after birth ( MD=2.73, 95% CI: 0.18-5.29, Z=2.09, P=0.04; MD=3.57, 95% CI: 2.29-4.85, Z=5.46, P<0.01). However, no significant differences were found in the peak bilirubin level, phototherapy, cord blood pH, and Apgar score at 1 and 5 min (all P>0.05). (2) Compared with delayed cord clamping, UCM increased the hemoglobin level ( MD=0.83, 95% CI: 0.75-0.91, Z=20.11, P<0.01) and hematocrit value ( MD=2.34, 95% CI: 1.25-3.43, Z=4.20, P<0.01) within 24 h after birth, but not in the hematocrit value at 48-72 h after birth ( MD=－0.38, 95% CI:－2.27-1.52, Z=0.39, P=0.70) or the peak bilirubin level ( MD=－0.65, 95% CI:－2.16-1.04, Z=0.69, P=0.49). Sensitivity analysis showed that for full-term neonates born by cesarean section, the peak bilirubin level in the UCM group was significantly lower than that in the delayed cord clamping group ( MD=－1.30, 95% CI:－2.26-0.34, Z=2.66, P<0.01). Still, the incidence of phototherapy, intraventricular hemorrhage (grade Ⅰ-Ⅳ), death, polycythemia, neonatal necrotizing enterocolitis, and Apgar score at 1 min and 5 min showed no statistical differences (all P>0.05). Conclusions:UCM could increase the short-term postnatal hemoglobin and hematocrit levels in neonates born by cesarean section, which might prevent neonatal anemia in the short term without increasing the adverse neonatal outcomes. Little effects were observed on the peak bilirubin level, phototherapy, polycythemia, etc. More high-quality and large-sample randomized controlled trials are needed in the future.

Objective To investigate the relationship between interleukin-1β (IL-1β) and miR-185-5p in the process of joint injury in acute gouty arthritis (AGA). Methods The serum miR-185-5p levels of 89 AGA patients and 91 healthy volunteers were detected by real-time quantitative PCR. The correlation between miR-185-5p expression level and VAS score or IL-1β expression level was evaluated by Pearson correlation coefficient method. Receiver operating characteristic (ROC) curve was used to evaluate the diagnostic value of miR-185-5p in AGA. THP-1 cells were induced by sodium urate (MSU) to construct an in vitro acute gouty inflammatory cell model. After the expression level of miR-185-5p in THP-1 cells was upregulated or downregulated by transfection of miR-185-5p mimics or inhibitors in vitro, inflammatory cytokines of THP-1 cells, such as IL-1β, IL-8 and tumor necrosis factor α (TNF-α), were detected by ELISA. The luciferase reporter gene assay was used to determine the interaction between miR-185-5p and the 3'-UTR of IL-1β. Results Compared with the healthy control group, the expression level of serum miR-185-5p in AGA patients was significantly reduced. The level of serum miR-185-5p was negatively correlated with VAS score and IL-1β expression level. The area under the curve (AUC) was 0.905, the sensitivity was 80.17% and the specificity was 83.52%. Down-regulation of miR-185-5p significantly promoted the expression of IL-1β, IL-8 and tumor necrosis factor (TNF-α), while overexpression of miR-185-5p showed the opposite results. Luciferase reporter gene assay showed that IL-1β was the target gene of miR-185-5p, and miR-185-5p negatively regulated the expression of IL-1β. Conclusion miR-185-5p alleviates the inflammatory response in AGA by inhibiting IL-1β.
Humans ; 3' Untranslated Regions ; Arthritis, Gouty/genetics* ; Interleukin-1beta/genetics* ; Interleukin-8 ; Luciferases ; MicroRNAs/genetics* ; Tumor Necrosis Factor-alpha

Objective To explore the dyad coping experience of stress in pregnant women with undifferentiated connective tissue disease and their spouses,providing a basis for developing dyadic coping intervention measures.Methods By purposive sampling,15 pairs of pregnant women and their spouses who visited the outpatient clinic for pregnancy complicated with immune diseases in a matemity hospital in Jiangsu Province from April to August 2023 were selected as the research subjects for semi-structured interviews.Content analysis was conducted using the Colaizzi 7-step method,and an interview outline and integrated themes were developed based on the Developmental Contextual Coping Model.Results 3 themes(coexistence of positive and negative stress experiences;diverse approaches to dyadic coping with stress;growth and challenges following stress adaptation)and 11 subthemes were identified.Conclusion Healthcare professionals should attach importance to the stress coping issues of pregnant women with undifferentiated connective tissue disease and their spouses,take measures to regulate the negative emotions of couples,ensure multi-faceted support,help the couple adopt positive coping strategies,and promote good stress adaptation.

Purpose To evaluate the feasibility of droplet digital PCR(ddPCR)for gene fusion detection of neurotrophic receptor kinase(NTRK).Methods A total of 830 cases of primary colorectal adenocarcinoma(CRAC)and 560 cases of gastric adenocarcinoma(GAC)were retrospectively studied.Im-munohistochemistry(IHC)and fluorescence in situ hybridization(FISH)were used to detect pan-TRK protein expression and NTRK1/2/3 gene fracture in formalin-fixed paraffin-embedded(FFPE)tumor tissues,respectively.FISH or IHC positive sam-ples were further detected by next generation sequencing and ddPCR.Results All FFPE samples were tested successfully by IHC and FISH methods.A total of 26 samples with NTRK gene breaks or pan-TRK expression were detected by IHC,among these 26 cases,21 FISH were positive and 18 IHC positive.A total of 14 cases of NTRK fusion and 2 cases of amplification were detected by DNA sequencing.A total of 3 cases carrying NTRK gene fusion were detected by RNA sequencing,and the results of ddPCR were completely consistent with RNA sequen-cing.Conclusion ddPCR can effectively distinguish false posi-tive CRAC and GAC cases harboring NTRK fusion detected by FISH and DNA sequencing,which can be used as the effective method for screening NTRK gene fusion.

Objectives: To investigated the safety and efficacy of treating patients with acute non-ST-segment elevation myocardial infarction (NSTEMI) and elevated levels of N-terminal pro-hormone B-type natriuretic peptide (NT-proBNP) with levosimendan within 24 hours of first medical contact (FMC). Methods: This multicenter, open-label, block-randomized controlled trial (NCT03189901) investigated the safety and efficacy of levosimendan as an early management strategy of acute heart failure (EMS-AHF) for patients with NSTEMI and high NT-proBNP levels. This study included 255 patients with NSTEMI and elevated NT-proBNP levels, including 142 males and 113 females with a median age of 65 (58-70) years, and were admitted in the emergency or outpatient departments at 14 medical centers in China between October 2017 and October 2021. The patients were randomly divided into a levosimendan group (n=129) and a control group (n=126). The primary outcome measure was NT-proBNP levels on day 3 of treatment and changes in the NT-proBNP levels from baseline on day 5 after randomization. The secondary outcome measures included the proportion of patients with more than 30% reduction in NT-proBNP levels from baseline, major adverse cardiovascular events (MACE) during hospitalization and at 6 months after hospitalization, safety during the treatment, and health economics indices. The measurement data parameters between groups were compared using the t-test or the non-parametric test. The count data parameters were compared between groups using the χ² test. Results: On day 3, the NT-proBNP levels in the levosimendan group were lower than the control group but were statistically insignificant [866 (455, 1 960) vs. 1 118 (459, 2 417) ng/L, Z=-1.25,P=0.21]. However, on day 5, changes in the NT-proBNP levels from baseline in the levosimendan group were significantly higher than the control group [67.6% (33.8%,82.5%)vs.54.8% (7.3%,77.9%), Z=-2.14, P=0.03]. There were no significant differences in the proportion of patients with more than 30% reduction in the NT-proBNP levels on day 5 between the levosimendan and the control groups [77.5% (100/129) vs. 69.0% (87/126), χ²=2.34, P=0.13]. Furthermore, incidences of MACE did not show any significant differences between the two groups during hospitalization [4.7% (6/129) vs. 7.1% (9/126), χ²=0.72, P=0.40] and at 6 months [14.7% (19/129) vs. 12.7% (16/126), χ²=0.22, P=0.64]. Four cardiac deaths were reported in the control group during hospitalization [0 (0/129) vs. 3.2% (4/126), P=0.06]. However, 6-month survival rates were comparable between the two groups (log-rank test, P=0.18). Moreover, adverse events or serious adverse events such as shock, ventricular fibrillation, and ventricular tachycardia were not reported in both the groups during levosimendan treatment (days 0-1). The total cost of hospitalization [34 591.00(15 527.46,59 324.80) vs. 37 144.65(16 066.90,63 919.00)yuan, Z=-0.26, P=0.80] and the total length of hospitalization [9 (8, 12) vs. 10 (7, 13) days, Z=0.72, P=0.72] were lower for patients in the levosimendan group compared to those in the control group, but did not show statistically significant differences. Conclusions: Early administration of levosimendan reduced NT-proBNP levels in NSTEMI patients with elevated NT-proBNP and did not increase the total cost and length of hospitalization, but did not significantly improve MACE during hospitalization or at 6 months.
Male ; Female ; Humans ; Aged ; Natriuretic Peptide, Brain ; Simendan/therapeutic use* ; Non-ST Elevated Myocardial Infarction ; Heart Failure/drug therapy* ; Peptide Fragments ; Arrhythmias, Cardiac ; Biomarkers ; Prognosis

The evaluation of female fertility at first diagnosis is an important premise and basis for determining the treatment scheme of assisted reproduction. In this study, a survey was conducted among 13 assisted reproductive institutions in China to understand the evaluation indicators and detection methods of female fertility at first diagnosis in various institutions, and provide a basis for reasonable selection of indicators. The survey showed that the indicators of female fertility evaluation at first diagnosis among assisted reproductive institutions included general health indicators, ovarian reserve indicators, and uterine conditions, etc. The selection of indicators was considerably consistent, but the detection methods were quite different. Therefore, it is necessary to choose the detection method with better validity and less harm.

As a way of female fertility preservation, oocyte cryopreservation technology(OCT) has attracted more attention from the society. The health technology assessment (HTA) research progresses on OCT are important evidence basis for OCT clinical application promotion. Literatures on the maternal and offspring safety, efficacy and social ethics assessment of OCT were reviewed in this paper. Based on the current OCT evaluation evidence, short-term safety and effectiveness were confirmed, but long-term maternal and child safety should be testified in a large scale follow-up study. Social ethics evaluation methods of human assisted reproductive technology(ART) research were still in the exploratory stage. Therefore, it is necessary to establish the social ethics evaluation methods and system of human ART, including OCT, in China.

The evaluation of female fertility at first diagnosis is an important premise and basis for determining the treatment scheme of assisted reproduction. In this study, a survey was conducted among 13 assisted reproductive institutions in China to understand the evaluation indicators and detection methods of female fertility at first diagnosis in various institutions, and provide a basis for reasonable selection of indicators. The survey showed that the indicators of female fertility evaluation at first diagnosis among assisted reproductive institutions included general health indicators, ovarian reserve indicators, and uterine conditions, etc. The selection of indicators was considerably consistent, but the detection methods were quite different. Therefore, it is necessary to choose the detection method with better validity and less harm.

As a way of female fertility preservation, oocyte cryopreservation technology(OCT) has attracted more attention from the society. The health technology assessment (HTA) research progresses on OCT are important evidence basis for OCT clinical application promotion. Literatures on the maternal and offspring safety, efficacy and social ethics assessment of OCT were reviewed in this paper. Based on the current OCT evaluation evidence, short-term safety and effectiveness were confirmed, but long-term maternal and child safety should be testified in a large scale follow-up study. Social ethics evaluation methods of human assisted reproductive technology(ART) research were still in the exploratory stage. Therefore, it is necessary to establish the social ethics evaluation methods and system of human ART, including OCT, in China.