OBJECTIVE: To explore the efficacy and safety of Juan Bi Pill (JBP) in treatment of active rheumatoid arthritis (RA). METHODS: From February 2017 to May 2018, 115 participants from 4 centers were randomly divided into JBP group (57 cases) and placebo group (58 cases) in a 1:1 ratio using a random number table method. Participants received a dose of JBP (4 g, twice a day, orally) combined with methotrexate (MTX, 10 mg per week) or placebo (4 g, twice a day, orally) combined with MTX for 12 weeks. Participants were required with follow-up visits at 24 and 48 weeks, attending 7 assessment visits. Participants were undergo disease activity assessment 7 times (at baseline and 2, 4, 8, 12, 24, 48 weeks) and safety assessments 6 times (at baseline and 4, 8, 12, 24, 48 weeks). The primary endpoint was 28-joint Disease Activity Score (DAS28-ESR and DAS28-CRP). The secondary endpoints included American College of Rheumatology (ACR) criteria for 20% and 50% improvement (ACR20/50), Health Assessment Questionnaire Disability Index (HAQ-DI), clinical disease activity index (CDAI), visual analog scale (VAS), Short Form-36 (SF-36) score, Medial Outcomes Study (MOS) sleep scale score, serum erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), tender joint count, swollen joint count, and morning stiffness. The adverse reactions were observed during the treatment. RESULTS: After 12 weeks of treatment, DAS28-ESR and DAS28-CRP scores in both groups were lower than before treatment (both P<0.01), while the remission rate of DAS28-ESR and DAS28-CRP and low disease activity of JBP group were higher than those in the placebo group (both P<0.01). JBP demonstrated better efficacy on ACR20 and ACR50 compliance rate at 12 and 48 weeks comparing to placebo (all P<0.05). The CDAI and HAQ-DI score, pain VAS and global VAS change of RA patients and physicians, the serum ESR and CRP levels, and the number of tenderness and swelling joints were lower than before treatment at 4, 8, 12, 24, 48 weeks in both groups (P<0.05 or P<0.01), while the reduction of above indices in the JBP group was more obvious than those in the placebo group at 12 weeks (ESR and CRP, both P<0.05) or at 12 and 48 weeks (all P<0.01). There was no difference in adverse reactions between the 2 groups during treatment (P=0.75). CONCLUSION JBP combined with MTX could effectively reduce disease activity in patients with RA in active stage, reduce the symptoms of arthritis, and improve the quality of life, while ensuring safety, reliability, and fewer adverse effects. (Trial Registration: ClinicalTrials.gov, No. NCT02885597).
Humans ; Arthritis, Rheumatoid/drug therapy* ; Methotrexate/adverse effects* ; Female ; Double-Blind Method ; Male ; Middle Aged ; Treatment Outcome ; Drugs, Chinese Herbal/adverse effects* ; Drug Therapy, Combination ; Adult ; Antirheumatic Agents/adverse effects* ; Aged

Superior vena cava syndrome(SVCS)is a group of clinical syndromes caused by obstruction of the superior vena cava and its major branches from various causes.Pulmonary artery stenosis(PS)is a complication of lung cancer or mediastinal tumours.SVCS combined with PS due to pulmonary metastases from bladder cancer is extremely rare and has not been reported in the literature.Here we reported an old male patient with pulmonary metastases from bladder cancer presenting with swelling of the head,neck and both upper limbs.SVCS combined with PS was clarified by pulmonary artery computed tomography angiography(CTA)and digital subtraction angiography(DSA).Endovascular stenting was used to treat SVCS.Angiography also showed that PS had not caused pulmonary hypertension and did not need to be treated.The swelling of the patient's head,neck and upper limbs was gradually reduced after the procedure.

The composition and characteristics of TiRobot orthopaedic surgery robot were introduced,and its application in treating traumas was reviewed such as pelvic fracture,acetabular fracture,femoral neck fracture,intertrochanteric fracture,Achilles fracture and navicular fracture.The advantages and disadvantages of TiRobot orthopaedic surgery robot were analyzed when used in the field of traumatic orthopaedics.It's pointed out TiRobot orthopaedic surgery robot be optimized in terms of the existing technical shortcomings and application cost to promote its wide application in the field of traumatic orthopaedics.[Chinese Medical Equipment Journal,2024,45(5):104-110]

Objective To evaluate the clinical value of left bundle branch pacing(LBBP)in HF pa-tients requiring cardiac resynchronization therapy(CRT).Methods A total of 128 HF patients who met the indicatons for CRT Class Ⅰ and Ⅱ and admitted in Department of Cardiology of Northern Jiangsu People's Hospital from January 2018 to January 2023 were consecutively recrui-ted,and 32 patients of them having left bundle branch electrode implantation due to failure of cor-onary sinus electrode implantation were assigned into the LBBP group,and the rest 96 patients getting conventional biventricular pacing(BVP)into the BVP group.The pacing parameters and other indicators were observed in the two groups at the time of implantation.Follow-up visits were made to the Special Clinic of"Arrhythmia and Cardiac Pacemaker"in Northern Jiangsu People's Hospital at 1,3,6,and 12 months after surgery,and then,the visits were conducted every 3 to 4 months thereafter.Clinical evaluation,12-lead electrocardiography,echocardiography,detections for programmable controller and pacemaker function and other tests were completed at each follow-up.Readmission or death events due to HF were recorded.Results Compared with the preoperative results,both groups obtained shorter QRS duration,better NYHA class,smaller LVEDD and increased LVEF at the last follow-up(P＜0.05).At the time point,shorter QRS du-ration,better NYHA class and higher LVEF were observed in the LBBP group than the BVP group(P＜0.05).There were no significant differences in pacing parameters between the two groups at the time of implantation and the last follow-up(P＞0.05).No statistical difference was found in readmission rate between the LBBP group and the BVP group(18.75％vs 16.67％,P＞0.05).Conclusion LBBP is safe and effective,and can improve the cardiac function of HF pa-tients.LBBP may provide a new option for patients who have failed traditional CRT.

Objective:To analyze regional differences in MMACHC gene variations among patients with cblC-type methylmalonic acidemia (MMA) in China and to explore the relationship between these variations and neonatal screening, biochemical markers and prognosis.Methods:Retrospective case summary. Clinical and laboratory data, including general condition, biochemical markers and genetic analysis, were collected from 1 859 cblC MMA patients from 2005 to 2023. Patients were divided into 7 groups according to their regions: north China, northeast China, east China, central China, south China, southwest China and northwest China. They were also classified into neonatal screening and non-neonatal screening groups. Mann-Whitney U and Kruskal-Wallis tests were used to compare biochemical marker levels. In contrast, the Chi-square test was applied to compare MMACHC gene variant frequencies, neonatal screening proportion, onset age and prognosis between groups. Results:Among 1 859 cases of cblC MMA, 1 019 were male and 840 were female, with a consultation age of 1.0 (0.1, 5.0) month. A total of 1 787 cases carried compound heterozygous or homozygous variants and only 1 variant site was identified in 72 cases. The 10 most frequent variants were c.609G>A (1 238 cases), c.658_660delAAG (343 cases), c.80A>G (284 cases), c.482G>A (239 cases), c.567dupT (191 cases), c.656_658delAGA (131 cases), c.217C>T (109 cases), c.394C>T (105 cases), c.445_446delTG (51 cases) and c.1A>G (50 cases). The frequency of the c.609G>A was the lowest in northwest China (28.8% (44/154), χ2=-18.42, P<0.05). The frequency of the c.567dupT was the most common in southwest China (25.0% (20/80), χ2=71.70, P<0.001) and c.656_658delAGA had the highest frequency in northeast China (9.3% (19/205), χ2=32.08, P<0.001). Non-missense variants (91.2% (62/68), 88.5% (46/52)) and early-onset patients (90.0% (36/40), 94.4% (34/36)) were both more prevalent in southwest and south China ( χ2=14.95, 31.69, both P<0.05). The proportion of neonatal screening was the lowest in south China (22.2% (8/36), χ2=98.48, P<0.05), where the mortality rate was the highest (19.1% (4/21), χ2=38.98, P<0.001). East China exhibited the highest frequency of missense variants (21.5% (339/1 579)), the highest proportion of patients identified through neonatal screening (54.5% (465/853)), and a more significant proportion of patients with good prognosis (36.6% (227/621), χ2=14.57, 93.49, 38.98, all P<0.05). In addition, the c.482G>A variant was more frequent in patients diagnosed by neonatal screening compared to those diagnosed by other methods (8.3% (132/1 586) vs. 5.9% (122/2 060), χ2=7.97, P<0.05). Conclusions:The frequency of MMACHC gene variation varies across different regions. The c.609G>A was least frequent in northwest China, c.567dupT was most common in southwest China, and c.656_658delAGA was most prevalent in northeast China. South China had the lowest neonatal screening rate and the highest mortality. At the same time, east China exhibited the highest frequency of missense variants, the highest proportion of patients identified through neonatal screening and the best prognosis. The c.482G>A variant was more frequent in patients diagnosed by neonatal screening compared to those diagnosed by other methods.

Objective To investigate the clinical application value of contrast-enhanced chest CT in the detection of responsible vessels for hemoptysis before selective arterial embolization(SAE).Methods The clinical data of 74 patients with hemoptysis trea-ted with interventional therapy and preoperative contrast-enhanced chest CT and digital subtraction angiography(DSA)were ana-lyzed retrospectively.The responsible vessels were identified and then embolized via angiography.The detection of the responsible vessels via preoperative contrast-enhanced chest CT was analyzed.The patients were followed up to observe the efficacy and compli-cations,and the influencing factors of interventional efficacy and recurrence were analyzed.Results A total of 245 responsible ves-sels were detected by preoperative contrast-enhanced chest CT,including bronchial arteries(n=178),ectopic bronchial arteries(n=10)and non-bronchial systemic artery(NBSA)(n=57),which could accurately show the anatomical information of responsible vessels.A total of 4 posterior intercostal arteries were missed.The diagnostic accuracy was 98.4％(245/249).All patients were followed up for 12 to 25.6 months.The immediate hemostasis rate was 93.2％(69/74)and the effective rate was 79.7％(59/74),respectively.The factors affecting the efficacy were bronchial artery to pulmonary circulation fistula,pleural thickening at the bleeding site,and underly-ing lung disease.Among the 59 patients with effective treatment,underlying lung disease was the influencing factor for postoperative recurrence.Conclusion Contrast-enhanced chest CT can provide anatomical information about the responsible vessels for interven-tional therapy of hemoptysis,improving surgical efficiency and reducing the recurrence rate of hemoptysis.

Objective To analyze the prognosis and influencing factors of patients with acute myocardial infarction(AMI)complicated with cardiogenic shock(CS)under extracorporeal membrane oxygenation(ECMO)support.Methods Retrospective analysis of the clinical data of ECMO supported coronary angiography and percutaneous coronary intervention(PCI)treatment for AMI complicated with CS patients who visited the department of emergency medicine of the Second Hospital of Hebei Medical University from December 2018 to December 2021,including gender,age,body mass index(BMI),past history(smoking history,coronary heart disease,diabetes,hypertension,hyperlipidemia,cerebrovascular disease),acute physiological and chronic health evaluationⅡ(APACHEⅡ),vasoactive-inotropic score(VIS),the worst auxiliary examination indicators within 24 hours before ECMO[arterial lactate acid,white blood cell count(WBC),cardiac troponin I(cTnI),alanine transferase(ALT),total bilirubin(TBil),creatinine(Cr),serum potassium(K+),left ventricular ejection fraction(LVEF)],time from onset to PCI,coronary angiography results(involved anterior descending branch,circumflex branch,right coronary artery,three-vessel lesions,left main artery lesions),whether to use intra aortic-balloon counterpulsation(IABP)and continuous renal replacement therapy(CRRT).Patients were divided into survival and death groups based on the prognosis after 30 days of onset.Univariate analysis was used to compare the differences in the above indicators between the two groups with different prognoses,Logistic regression analysis was used to analyze the independent risk factors affecting the prognosis of AMI patients with CS under ECMO support coronary angiography and PCI treatment,and the receiver operator characteristic curve(ROC curve)was drawn to evaluate the predictive value of risk factors on patient prognosis.Results Out of 39 patients,21 cases(53.8%)survived and 18 cases(46.2%)died.Compared with the survival group,the VIS score,lactate acid,time from onset to PCI,involvement of the circumflex artery,three-vessel disease,and left main artery lesions significantly increased in the death group(all P＜0.05).Logistic regression analysis showed that lactate acid and three-vessel lesions were independent risk factors affecting the 30-day prognosis of AMI patients with CS[odds ratio(OR)and 95%confidence interval(95%CI)were 1.845(1.018-3.342)and 107.171(1.307-8 785.901),all P＜0.05].ROC curve analysis showed that lactate acid and three-vessel lesions has predictive value for the prognosis of AMI combined with CS patients undergoing ECMO supported coronary angiography and PCI treatment,the area under the ROC curve(AUC)were 0.756 and 0.752,95%CI were 0.601-0.911 and 0.588-0.916,P value were 0.007 and 0.008.When the cut-off value of lactic acid was 5 mmol/L,the sensitivity and specificity of predicting the prognosis of AMI combined with CS patients undergoing coronary angiography and PCI treatment were 94.1%and 57.1%,respectively.Conclusions The indications for using ECMO in critically ill patients with AMI combined with CS need to be further refined.VIS score,lactate acid,time from onset to PCI,three-vessel lesions,and left main artery lesions are risk factors for patient death.When using ECMO support for high lactate,high VIS score,and three-vessel lesions,caution should be exercised.Early ECMO support can improve the prognosis of appropriate patients by reducing lactate,reducing the use of vasoactive drugs,and shortening the time from onset to PCI.

ObjectiveTo introduce the Hr gene of spontaneously mutated SHJH^hr mice into BALB/cAShjh inbred mice with clear genetic background,and provide a basis for study on the molecular mechanism of Hr gene mutation-induced abnormal phenotype and the application of this model.Methods Using a backcross-intercross breeding method guided by phenotypic monitoring, mutant genes from SHJH^hr mice bred by spontaneous mutation were introduced into inbred BALB/cAShjh mice by homozygous mutation introgression, and the mice were bred into BALB/cA.Cg.SHJH^hr (abbreviated as C.Cg.SHJH^hr) mice after 10 generations. The genotypes of 90 single nucleotide polymorphism (SNP) detection sites were analyzed in C.Cg.SHJH^hr mice by multiplex PCR library construction followed by next generation sequencing. Then 14 biochemical locus marker genes were detected in C.Cg.SHJH^hr mice according to the method of GB/T 14927.1-2008. Finally, whole genome exon sequencing was utilized to detect the mutated genes in this mouse. ResultsFrom May 2018 to March 2022, a total of 10 generations of backcross-intercross were conducted to complete the construction of the C.Cg.SHJH^hr mouse line. Among the 90 SNPs loci detected, except for rs13484115 and rs13484116, all the other loci had the same genotype as the recipient mice BALB/cAShjh. The results of biochemical marker gene detection showed that all the 14 loci of the mouse were the same as those of the recipient mouse. Whole genome exon sequencing found that the mouse had 109 site mutations compared with the recipient mouse strain, including 71 synonymous mutations, 1 stopgain, 37 missense mutations, and 20 genes involved in protein sequence alterations (including the reported Hr gene). ConclusionC.Cg.SHJH^hr mice were created. Through exon sequencing and genetic analysis, three Hr mutated genes and associated mutated genes that mainly cause phenotypic variations were identified, which provides a basis for expanding the application of C.Cg.SHJH^hr mice in biomedical research.

Objective: To explore the prognostic factors of extracellular NK/T cell lymphoma (ENKTL) treated with pegaspargase/L-asparaginase. Methods: The clinical data of 656 ENKTL patients diagnosed at 11 medical centers in the Huaihai Lymphoma Working Group from March 2014 to April 2021 were retrospectively analyzed. The patients were randomly divided into two groups: a training set (460 cases) and a validation set (196 cases) at 7∶3, and the prognostic factors of the patients were analyzed. A prognostic scoring system was established, and the predictive performance of different models was compared. Results: Patients' median age was 46 (34, 57) years, with 456 males (69.5% ) and 561 nasal involvement (85.5% ). 203 patients (30.9% ) received a chemotherapy regimen based on L-asparaginase combined with anthracyclines, and the 5-year overall survival rate of patients treated with P-GEMOX regimen (pegaspargase+gemcitabine+oxaliplatin) was better than those treated with SMILE regimen (methotrexate+dexamethasone+cyclophosphamide+L-asparaginase+etoposide) (85.9% vs 63.8% ; P=0.004). The results of multivariate analysis showed that gender, CA stage, the Eastern Cooperative Oncology Group performance status (ECOG PS) score, HGB, and EB virus DNA were independent influencing factors for the prognosis of ENKTL patients (P<0.05). In this study, the predictive performance of the prognostic factors is superior to the international prognostic index, Korean prognostic index, and prognostic index of natural killer lymphoma. Conclusion: Gender, CA stage, ECOG PS score, HGB, and EB virus DNA are prognostic factors for ENKTL patients treated with pegaspargase/L-asparaginase.
Male ; Humans ; Middle Aged ; Asparaginase/therapeutic use* ; Prognosis ; Retrospective Studies ; Lymphoma, Extranodal NK-T-Cell/drug therapy* ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Etoposide ; Cyclophosphamide ; Methotrexate/therapeutic use* ; DNA/therapeutic use* ; Treatment Outcome

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone