Objective To mine and analyze the adverse event data of polatuzumab vedotin(Pola)and fam-trastuzumab deruxtecan-nxki(T-Dxd),so as to provide reference for clinical medication safety.Methods The adverse events reported from January 1,2004 to June 7,2023 were extracted based on openFDA database.The suspicious risk signals were screened by the Open Vigil 2.1 data platform and ranked by signal strength and frequency of occurrence;then ADEs were classified by reference to the MedDRA 26.0.Results A total of 7 164 and 22 870 ADE reports related to Pola and T-Dxd were obtained,and 104 and 95 suspicious ADE signals were detected,respectively.According to the signal intensity,cytomegalovirus enterocolitis(ROR=416.94)for Pola and interstitial lung disease[reporting odds ratio(ROR)=82.55]for T-Dxd ranked first,both of which were recorded in the drug instructions.According to the frequency of occurrence,the two drugs were most frequently associated with death(n=111)and nausea(n=285),respectively.The risk of Pola was associated with 12 systems/organs,of which 26 risk signals were not documented in the drug instruction,and the risk of T-Dxd was associated with 13 systems/organs,of which 18 risk signals were not documented in the drug instruction.Conclusion By tapping the ADE after real-world administration of Pola and T-Dxd,physicians are prompted to pay attention to the risk of adverse reactions in clinical use and actively take preventive and therapeutic measures to ensure the safety of patients'medication.

BACKGROUND:Although traditional screw fixation has been successful in treating ankle fractures,rigid fixation solutions tend to restrict ankle movement and delay fracture healing,whereas elastic fixation is more compatible with human mechanics and has unique advantages in patients with ankle fractures. OBJECTIVE:To compare the clinical effectiveness of elastic fixation and absolute fixation in repairing ankle fractures in the elderly with lower tibiofibular instability. METHODS:The clinical data of 108 elderly ankle fractures with lower tibiofibular instability in Hengshui People's Hospital from August 2019 to August 2021 were retrospectively collected.They were divided into screw group and elastic fixation group(n=54 per group)according to the surgical protocol,and traditional screw internal fixation and elastic internal fixation were performed respectively.The perioperative indicators,surgical results,economic benefits,and American orthopedic foot and ankle society scores were collected and compared between the two groups.Serum tumor necrosis factor-α,interleukin-8 levels,ankle cavity width,depth,and lower tibiofibular space were compared before and after surgery. RESULTS AND CONCLUSION:(1)The full weight-bearing time was shorter in the elastic fixation group than that in the screw group;the operating angle was greater in the elastic fixation group than that in the screw group,and the complication rate was lower in the elastic fixation group than that in the screw group(P<0.05).(2)Serum tumor necrosis factor-α and interleukin-8 levels in the elastic fixation group were lower than those in the screw group 3 days after surgery(P<0.05).(3)American orthopedic foot and ankle society scores in the two groups were higher than those before surgery at 6 and 12 months after surgery,and the depth and width of the inferior tibiofibular space and ankle cavity were lower than those before surgery(P<0.05);but no significant difference was detected between the two groups(P>0.05).(4)There was no significant difference in the excellent and good rate between the two groups at 12 months after surgery(P>0.05).(5)There was no significant difference in the comparison of direct non-medical costs,direct medical costs,and total costs between the two groups(P>0.05).(6)It is indicated that elastic fixation for the repair of ankle fractures with lower tibiofibular instability in the elderly can obtain effective outcomes,which can shorten the time of complete weight-bearing,diminish complications,and alleviate inflammatory stress.

BACKGROUND:The displacement change parameters of the bone structure of the first metatarsal bone at the two-dimensional level of hallux valgus deformity are of great significance for clinical diagnosis and treatment,while the quantitative analysis of the three-dimensional deformity index may have some influences on the postoperative efficacy. OBJECTIVE:To explore the quantitative change of the three-dimensional deformity index of the first metatarsal bone after routine osteotomy and orthosis for hallux valgus deformity and to provide reference for clinical work. METHODS:100 patients with hallux valgus deformity(foot)in Hengshui People's Hospital from October 2020 to April 2023 were selected and all of them underwent conventional osteotomy and orthosis.Foot function was assessed by the American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale 6 months after surgery.Anterolateral X-rays of the foot in weight-bearing position and CT images in simulated weight-bearing position were taken before surgery and 6 months after surgery.The three-dimensional deformity indexes of the first metatarsal bone before and after surgery were quantitatively analyzed in patients with different ages,genders and therapeutic effects,including first-second intermetatarsal angle,hallux valgus angle,distal metatarsal articular angle,tibial sesamaid position,and first metatarsal rotation α angle.The value of the difference of three-dimensional deformity indexes of the first metatarsal bone before and after operation in evaluating the curative effect was analyzed. RESULTS AND CONCLUSION:(1)Six months after operation,the American Orthopedic Foot and Ankle Society score was 75-98(88.25±4.14)points,among which 56 cases were excellent,28 cases were good,14 cases were average,and 2 cases were poor.The excellent and good rate was 84%(84/100).(2)Compared with the preoperative results,first-second intermetatarsal angle,hallux valgus angle,distal metatarsal articular angle,tibial sesamaid position,and first metatarsal rotation α angle were significantly improved in patients of different ages and genders 6 months after surgery(P<0.05).First-second intermetatarsal angle,hallux valgus angle,distal metatarsal articular angle,tibial sesamaid position,and first metatarsal rotation α angle were all lower in patients with good curative effect 6 months after surgery than those with poor curative effect,and the difference before and after surgery was greater than those with poor curative effect(P<0.05).(3)The area under the curve of the difference evaluation of the first metatarsal three-dimensional deformity index before and after surgery was above 0.7,and the area under the curve of the combined evaluation of all indexes was the largest(0.902),which was significantly greater than the first metatarsal rotation α angle and distal metatarsal articular angle(P<0.05).(4)The quantitative analysis of the three-dimensional deformity index of the first metatarsal in patients with hallux valgus deformity is related to the postoperative effect,which has important guiding significance for improving the accuracy and comprehensiveness of preoperative evaluation and improving the treatment plan.

Ankylosing spondylitis (AS) combined with lower cervical fracture is often categorized into unstable fracture, with a high incidence of neurological injury and a high rate of disability and morbidity. As factors such as shoulder occlusion may affect the accuracy of X-ray imaging diagnosis, it is often easily misdiagnosed at the primary diagnosis. Non-operative treatment has complications such as bone nonunion and the possibility of secondary neurological damage, while the timing, access and choice of surgical treatment are still controversial. Currently, there are no clinical practice guidelines for the treatment of AS combined with lower cervical fracture with or without dislocation. To this end, the Spinal Trauma Group of Orthopedics Branch of Chinese Medical Doctor Association organized experts to formulate Clinical guidelines for the treatment of ankylosing spondylitis combined with lower cervical fracture in adults ( version 2024) in accordance with the principles of evidence-based medicine, scientificity and practicality, in which 11 recommendations were put forward in terms of the diagnosis, imaging evaluation, typing and treatment, etc, to provide guidance for the diagnosis and treatment of AS combined with lower cervical fracture.

Objective To explore the difference in efficacy of metoprolol versus ivabradine in the treatment of postural orthostatic tachycardia syndrome(POTS)in the elderly after COVID-19 infection.Methods A total of 110 patients diagnosed with POTS at our department from Decem-ber 1,2022 to January 31,2023 were included.According to their drug regimen,they were divided into metoprolol group(62 patients)and ivabradine group(48 patients).On the 28th day of out-patient follow-up,the resting heart rate,heart rate of 10 min of standing,symptom disappearance rate,hospitalization rate,and mortality rate were compared between the two groups.Results On the 28th day of treatment,the resting heart rate and postural heart rate for 10 min were decreased in both groups when compared with the levels at initial diagnosis(P＜0.01).And there were no significant differences in the two types of heart rate between the two groups on the 28th day(71.0±7.0 vs 72.1±7.0,P=0.401;76.5±7.2 vs 77.4±7.6,P=0.573).No obvious differences were observed between the two groups in symptom disappearance rate,hospitalization rate,or mortality rate(88.7％vs 89.6％,3.2％vs2.1％,0％vs 0％,P＞0.05).Conclusion Metoprolol and ivabradine can effectively treat POTS in the elderly patients after COVID-19 infection.

Background::Carotid intima-media thickness (IMT) and diameter, stiffness, and wave reflections, are independent and important clinical biomarkers and risk predictors for cardiovascular diseases. The purpose of the present study was to establish nationwide reference values of carotid properties for healthy Chinese adults and to explore potential clinical determinants.Methods::A total of 3053 healthy Han Chinese adults (1922 women) aged 18-79 years were enrolled at 28 collaborating tertiary centers throughout China between April 2021 and July 2022. The real-time tracking of common carotid artery walls was achieved by the radio frequency (RF) ultrasound system. The IMT, diameter, compliance coefficient, β stiffness, local pulse wave velocity (PWV), local systolic blood pressure, augmented pressure (AP), and augmentation index (AIx) were then automatically measured and reported. Data were stratified by age groups and sex. The relationships between age and carotid property parameters were analyzed by Jonckheere-Terpstra test and simple linear regressions. The major clinical determinants of carotid properties were identified by Pearson’s correlation, multiple linear regression, and analyses of covariance.Results::All the parameters of carotid properties demonstrated significantly age-related trajectories. Women showed thinner IMT, smaller carotid diameter, larger AP, and AIx than men. The β stiffness and PWV were significantly higher in men than women before forties, but the differences reversed after that. The increase rate of carotid IMT (5.5 μm/year in women and 5.8 μm/year in men) and diameter (0.03 mm/year in both men and women) were similar between men and women. For the stiffness and wave reflections, women showed significantly larger age-related variations than men as demonstrated by steeper regression slopes (all P for age by sex interaction <0.05). The blood pressures, body mass index (BMI), and triglyceride levels were identified as major clinical determinants of carotid properties with adjustment of age and sex. Conclusions::The age- and sex-specific reference values of carotid properties measured by RF ultrasound for healthy Chinese adults were established. The blood pressures, BMI, and triglyceride levels should be considered for clinical application of corresponding reference values.

Disharmony between nutritive qi(ying)and defensive qi(wei)is the core pathogenesis of insomnia.The normal function of ying-wei in the generation,dispersion,divergence and aggregation is the precondition for the realization of the coordination between ying and wei.The disordered function of ying-wei in the generation,dispersion,divergence and aggregation will cause the disharmony between ying and wei,and then the insomnia occurs.For the treatment of insomnia caused by the disordered function of ying-wei in the generation,Guizhi Decoction associated prescriptions are used for strengthening middle energizer and nourishing ying and wei.For the treatment of insomnia caused by the disordered function of ying-wei in the dispersion,Mahuang Decoction associated prescriptions are used to relieve the exterior and eliminate the pathogen for insomnia patients with the manifestations of the attack of exopathogens,and Xiao Chaihu Decoction associated prescriptions are used to dredge the triple energizer for insomnia patients with the dysfunction of the triple energizer.For the treatment of insomnia caused by the disordered function of ying-wei in the divergence,Rhei Radix et Rhizoma associated bitter-cold prescriptions are used to purge the interior heat for insomnia patients with abundant interior heat syndrome,Gypsum Fibrosum associated pungent-cold prescriptions are used to release muscles and clear heat for insomnia patients with the interior heat complicated by exterior syndrome,Natrii Sulfas Exsiccatus associated salty-cold prescriptions are used to clear heat,moisten dryness and dissipate the masses for insomnia patients with interior heat complicated by dryness syndrome,sour-cold medicines are used to clear heat and remove retained water,supplement deficiency and relieve exterior for insomnia patients with interior heat complicated by water-retention syndrome,deficiency syndrome and exterior syndrome,and Ophiopogonis Radix associated prescriptions and Lillli Bulbus associated prescriptions are used to clear heat and nourish ying for insomnia patients with the consumption of ying and yin.For the treatment of insomnia caused by the disordered function of ying-wei in the aggregation,the compatibility of Poria and Cinnamomi Ramulus is used for warming yang and resolving fluid retention in patients with fluid retention,Taohong Siwu Decoction associated prescriptions are used to activate blood and remove stasis in patients with predominance of blood stasis syndrome,the compatibility of Poria and Paeoniae Radix Alba are used to treat retained water and blood stasis in patients with water-blood co-morbidity.Treating insomnia caused by disharmony between ying and wei from the perspective of the function of ying-wei in the generation,dispersion,divergence and aggregation is aimed at the core pathogenesis of insomnia,which makes the treatment easy to be carried out,and can provide reference for clinical differentiation and treatment of insomnia.

Objective To clarify the understanding of types of laboratories and manufacturers for GB 9706.1-2020 Medical electrical equipment-Part 1:General requirements for basic safety and essential performance by laboratory proficiency testing for creepage distance and electrical clearance test.Methods An operation guide was formed according to the testing program in GB 9706.1-2020,and the homogeneity and stability of the samples were evaluated according to CNAS-GL003:2018 Guidance on Evaluating the Homogenneity and Stability of Samples Used for Proficiency Testing.Robust statistic methods were used to assess the quantitative parameters of the test results of the participating laboratories according to the requirements in GB/T 28043-2019 Statistical methods for use in proficiency testing by interlaboratory comparison;the results reported by the expert laboratories were used as the specified values of the qualitative parameters.SPSS 25.0 statistical software was used for data analysis.Results All the results of the crreepage distance and electrical clearance tests met the requirements for homogeneity and stability.Of the 46 laboratories involved in,37 ones did have comprehensive satisfactory determinations while the remained 9 ones not.Conclusion Some laboratories don't behave well in understanding the standard,which have to be reformed accordingly to enhance their proficiencies.[Chinese Medical Equipment Journal,2024,45(10):54-59]

Objective:To dynamically monitor the changes of fibrinogen-like protein 2 (FGL2), Vaspin and transport protein (TSPO) in the perioperative period of craniocerebral trauma, and analyze their correlation with disease progression and significance.Methods:One hundred and eight patients with craniocerebral trauma admitted to Hubei Jianghan Oilfield General Hospital Guanghuayuan District from June 2019 to June 2022 were selected and according the scores of Glasgow outcome scale (GOS) at 3 months postoperatively they were divided into good group (GOS 4 - 5 scores, 68 cases) and poor group (GOS 1 - 3 scores, 40 cases). The changes of FGL2, Vaspin and TSPO were monitored and compared between the two groups at preoperatively, 1 d postoperatively and 3 d postoperatively. Pearson analysis was applied to analyze the relationship between FGL2, Vaspin and TSPO at 1, 3 d postoperatively. The value of FGL2, Vaspin, TSPO and combined prediction of disease regression at 3 d postoperatively was analyzed by receiver operating characteristic (ROC) curve.Results:The rate of multiple injuries and brain herniation formation in the poor group were higher than those in the good group: 30.00% (12/40) vs. 7.35% (5/68), 20.00% (8/40) vs. 2.94% (2/68), and the scores of Glasgow coma scale (GCS) was lower than that in the good group: (8.04 ± 1.25) scores vs. (9.18 ± 1.33) scores, there were statistical differences ( P<0.05). The levels of FGL2, Vaspin and TSPO were all higher at 1 d postoperatively than before surgery in patients with different disease regressions, with each index decreasing at 3 d postoperatively compared with 1 d postoperatively in the good group, but continuing to increase at 3 d postoperatively in the bad group ( P<0.05). The levels of FGL2, Vaspin and TSPO in the poor group were higher than those in the good group at 1 d and 3 d postoperatively: at 1 d postoperatively: (314.01 ± 88.67) μg/L vs. (275.33 ± 79.24) μg/L, (0.27 ± 0.08) μg/L vs. (0.22 ± 0.07) μg/L, (3.28 ± 1.03) μg/L vs. (2.01 ± 0.64) μg/L; at 3 d postoperatively: (374.85 ± 92.33) μg/L vs. (259.94 ± 81.78) μg/L, (0.30 ± 0.09) μg/L vs. (0.20 ± 0.06) μg/L, (3.77 ± 1.15) μg/L vs. (1.68 ± 0.52) μg/L, there were statistical differences ( P<0.05). The results of Pearson analysis showed that FGL2, Vaspin and TSPO were negatively correlated with GOS scores at 1 d and 3 d postoperatively (at 1 d postoperatively: r = - 0.729, - 0.796, - 0.814, P<0.05; at 3 d postoperatively: r = - 0.862, - 0.855, - 0.905, P<0.05), FGL2, Vaspin and TSPO were more strongly correlated with GOS scores at 3 d postoperatively (larger r values). The results of ROC curve analysis showed that FGL2, Vaspin and TSPO all had a predictive value for disease regression, and the area under the curve of FGL2 combined with Vaspin and TSPO was the largest (0.923 , 95% CI 0.855 to 0.965). Conclusions:There are many influencing factors in the prognosis of craniocerebral trauma. The changes of FGL2, Vaspin and TSPO during the perioperative period can predict the progress and regression of patients, and the combined dynamic monitoring is more conductive to evaluate the prognosis.

Activation of nuclear factor erythroid 2-related factor 2(Nrf2)by Kelch-like ECH-associated protein 1(Keap1)alkylation plays a central role in anti-inflammatory therapy.However,activators of Nrf2 through alkylation of Keap1-Kelch domain have not been identified.Deoxynyboquinone(DNQ)is a natural small molecule discovered from marine actinomycetes.The current study was designed to investigate the anti-inflammatory effects and molecular mechanisms of DNQ via alkylation of Keap1.DNQ exhibited signif-icant anti-inflammatory properties both in vitro and in vivo.The pharmacophore responsible for the anti-inflammatory properties of DNQ was determined to be the α,β-unsaturated amides moieties by a chemical reaction between DNQ and N-acetylcysteine.DNQ exerted anti-inflammatory effects through activation of Nrf2/ARE pathway.Keap1 was demonstrated to be the direct target of DNQ and bound with DNQ through conjugate addition reaction involving alkylation.The specific alkylation site of DNQ on Keap1 for Nrf2 activation was elucidated with a synthesized probe in conjunction with liquid chromatography-tandem mass spectrometry.DNQ triggered the ubiquitination and subsequent degra-dation of Keap1 by alkylation of the cysteine residue 489(Cys489)on Keap1-Kelch domain,ultimately enabling the activation of Nrf2.Our findings revealed that DNQ exhibited potent anti-inflammatory capacity through α,β-unsaturated amides moieties active group which specifically activated Nrf2 signal pathway via alkylation/ubiquitination of Keap1-Kelch domain,suggesting the potential values of targeting Cys489 on Keap1-Kelch domain by DNQ-like small molecules in inflammatory therapies.