Animals ; SARS-CoV-2 ; Antibodies, Neutralizing ; Macaca mulatta ; COVID-19/prevention & control* ; Antibodies, Viral ; Vaccines

Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.

Objective:To investigate the region-specific characteristics of the gut microbiota and evaluate the association of speci?c gut microbes with type 2 diabetes mellitus (T2DM) from the Dongxiang Group in Gansu province, Northwest China.Methods:Fifty-three participants who was born in Dongxiang Autonomous County (Gansu Province) from April 2020 to January 2021 were enrolled, including 25 patients with T2DM recruited from the outpatient departments of internal medicine at The People′s Hospital of Dongxiang County(T2DM group) and 28 healthy controls recruited from the health screening center (HC group). Gut microbiome composition was analyzed using a 16S ribosomal RNA gene-based sequencing protocol.Results:A total of 936 operational taxonomic units (OTU) were obtained in the two groups. Of note, the HC and T2DM groups had 633 OTU in common. The alpha and beta diversity were different between the two groups ( P<0.05). Shannon index was significantly higher than that in the HC group, and Simpson index was significantly lower than that in the HC group, displacement multivariate analysis of variance was used to compare β diversity between the two groups, and the difference was statistically significant ( P<0.05). At the Phylum level, firmicutes and actinomycetes in T2DM group were significantly higher than those in the HC group (37.97% vs. 22.89%, 5.09% vs. 2.08%), and the differences were statistically significant ( P<0.05). The abundance of Bacteroidetes was significantly decreased (68.00% in T2DM group and 49.75% in HC group), and the difference was statistically significant ( P<0.05). At the genus level, there were 20 genera statistically significant differences between the two groups. The abundance of Bifidobacterium, Escherichia, Shigella, and Tyzzerella_4 levels were significantly increased in the T2DM group, but Prevotella_9, Erysipelotrichaceae_UCG-003, and Roseburia levels were significantly decreased in the T2DM group compared to those in the HC group. Conclusions:There is a significant difference in the gut microbiota between patients with T2DM and healthy individuals of the Dongxiang group in Northwest China. So as to preliminary exploration the intestinal flora characteristics of T2DM in the Dongxiang group.The findings of this study provide a theoretical basis for the prevention and control of T2DM in Dongxiang group in the future.

Objective:To investigate whether knee osteoarthritis has an impact on the patient′s depression and whether it′s progression will affect the patient′s depression, and to provide a reference for clinical work.Methods:Patients diagnosed with osteoarthritis in Dalian Central Hospital from 2016 to 2019 were divided into 4 groups according to Kellgren-Lawrence staging, and the patients were scored on WOMAC scale, AKSS clinical scale, and AKSS. The score of the scale and the score of the HAMD scale were collected and statistically analyzed using SPSS 17.0.Results:χ2 test was used to show that there was no difference in the gender composition of patients in different stages ( P<0.05). The AKSS clinical scale score, AKSS functional scale score, WOMAC scale score and HAMD scale score were statistically analyzed for each stage. The results showed that the average AKSS clinical scores of patients in each stage were as follows: stage Ⅰ: (90.01 ± 8.41) points; stage Ⅱ: (79.98 ± 10.93) points; stage Ⅲ: (71.78 ± 13.64) points; stage Ⅳ: (54.18 ± 12.58) points. The AKSS functional scores were as follows, stage Ⅰ: 100 points; stage Ⅱ: 80 points; stage Ⅲ: 70 points; stage Ⅳ: 45 points; the average WOMAC scale scores of patients in each stage were as follows, stage Ⅰ: (28.69 ± 19.22) points ; stage Ⅱ: (49.43 ± 22.69) points; stage Ⅲ (70.13 ± 24.84) points; stage Ⅳ: (107.79 ± 24.39) points. The average HAMD scale scores of patients in each stage were as follows, stage Ⅰ: (4.89 ± 3.42) points; stage Ⅱ: (7.65 ± 4.20) points; Stage Ⅲ: (9.05 ± 5.03) points; stage Ⅳ: (12.35 ± 5.41) points. The analysis showed that there were significant statistical differences in the scale scores between each period ( P<0.05). There was a correlation between the patient′s depression status and the patient′s age, pain, and joint function, and there were statistical differences ( P<0.05). Conclusions:There is a significant correlation between depression and pain and function in patients with knee osteoarthritis. The progress of the osteoarthritis course will aggravate the patient′s depression state. Conversely, the patient′s depression state can also aggravate the symptoms of osteoarthritis patients and affect the clinical efficacy of the patients.

Objective:To evaluate the efficacy of somatosensory evoked potential (SEP) monitoring for prevention of deep venous thrombosis (DVT) in lower extremity of patients undergoing spinal surgery.Methods:A total of 120 patients of both sexes, aged 40-70 yr, of American Society of Anesthesiologists physical status ⅠorⅡ, without impairment of coagulation function, undergoing posterior lumbar interbody fusion, were selected and divided into 3 groups ( n=40 each) using the random number table method and envelope method: basic preventive measure group (group A), compression stocking group (group B) and SEP monitoring group (group C). In group B, elastic stockings were worn at 1 h before surgery.SEP monitoring was performed during surgery, and the intensity of current stimulation was 25 mA in group C. The flow velocity of popliteal vein in both lower extremities was measured using color Doppler ultrasound apparatus during surgery.Venous blood samples were taken to measure plasma D-dimer concentrations at 1 day before surgery, at the end of surgery and at 24 h after surgery.The DVT developed in lower extremities was diagnosed by ultrasound method during surgery and within 24 h after surgery. Results:Compared with A and B groups, the blood flow velocity of popliteal vein was significantly increased, and the plasma D-dimer concentration and incidence of DVT developed in lower extremity during surgery were decreased in group C ( P<0.05). Conclusion:SEP monitoring can effectively prevent the occurrence of DVT in lower extremity while it is used as an electrophysiological monitoring of the spinal cord in patients undergoing spinal surgery.

Objective:To observe the incidence, risk factors of malignant brain edema (MBE) and the influence of MBE on outcomes after early successful recanalization of acute large vascular occlusion stroke (ALVOS).Methods:A total of 149 patients (age (68±11) years, male 85 (57.0%)) with ALVOS who underwent early endovascular treatment and achieved successful recanalization at the First Affiliated Hospital of Wannan Medical College from July 2014 to February 2019 were retrospectively analyzed. Baseline data, perioperative data, and 90-day prognostic information were collected from patients enrolled in the study. Univariate and multivariate analyses were used to explore the relationship between MBE and outcomes, and the risk factors of MBE.Results:Among the 149 patients, baseline National Institutes of Health Stroke Scale score was 16 (13, 20), baseline Alberta Stroke Project early CT score was 9 (8, 10), the time of onset-to-puncture was (248.3±61.3) minutes, and the onset-to-recanalization time was (312.4±69.7) minutes. MBE occurred in 23 patients (15.4%, 23/149). The 90-day favorable outcome (90-day modified Rankin Scale score≤ 2) in patients with MBE was significantly lower than those without MBE (17.4% (4/23) vs 61.1% (77/126), χ 2=14.985, P<0.001), and the 90-day mortality in patients with MBE was significantly higher than those without MBE (43.5% (10/23) vs14.3% (18/126), χ 2=10.861, P=0.003). MBE was shown to be an independent predictor of 90-day poor outcome (adjusted OR=12.078, 95 %CI 1.934-75.443, P=0.008) and death (adjusted OR=4.146, 95 %CI 1.060-16.216, P=0.041). Multivariate Logistic regression analysis showed that the collateral circulation status was related to the incidence of MBE in patients with ALVOS after successful recanalization (level 2 vs level 0, adjusted OR=0.109, 95 %CI 0.021-0.563, P=0.008). Conclusions:MBE is an independent risk factor of ALVOS patients with poor outcome or death in 90 days. For patients with ALVOS, even if the occlusive vessels have been successfully recanalized after early endovascular treatment, MBE is still not uncommon. The collateral circulation state is an independent predictive factor of the development of MBE after recanalization by early endovascular treatment in patients with ALVOS.

Objective To evaluate the value of stroke prognostication using age and National Institute of Health Stroke Scale index (SPAN) for outcome after early endovascular treatment for anterior circulation large vessel occlusion.Methods The patients who underwent early endovascular treatment were prospectively,sequentially collected in Yijishan Hospital of Wannan Medical College from December 2014 to September 2017 and Jinling Hospital from March 2014 to March 2017.Individuals whose age in years plus NIHSS score was greater than or equal to 100 were designated as SPAN-100-positive patients,while those with a score less than 100 were designated as SPAN-100-negative patients.We compared the baseline data and perioperative data between the two groups.The 90 days modified Rankin Scale score≤2 was regarded as favorable outcome.Single factor and multivariable Logistic regression analyses were used to determine the association between SPAN-100 and outcomes.Results One hundred and ninety patients were enrolled,20 (10.5％) of which were SPAN-100 positive,and 170(89.5％) were SPAN-100 negative.There were no significant differences between the two groups on postoperative intracerebral hemorrhage and 90 days mortality.Ninety days independence rates were higher in SPAN-100-negative patients (77/170,45.3％) than in SPAN-100 positive patients (4/20,20.0％;x2 =4.681,P =0.030).Multi-factor Logistic regression analysis showed that the higher preoperation systolic pressure (OR =1.030,95％ CI 1.008-1.052,P =0.007),the lower Alberta Stroke Program Early CT Score (OR =1.609,95％ CI 1.056-2.453,P =0.027) and poor collateral circulation(OR =5.714,95％ CI 1.668-19.570,P =0.006) were the independent risk factors of outcomes.Conclusion SPAN-100 is not an independent predictor of favorable outcome after adjusting for factors of outcomes in patients with anterior circulation large vessel occlusion.

Objective To investigated the effect of the risk factors for stroke on the development of leptomeningeal colateral circulation in patients with middle cerebral artery occlusion. Methods Patients with acute ischemic stroke confirmed as middle cerebral artery occlusion by imaging were extracted from the Nanjing Stroke Registry Program between June 2006 and December 2011. The baseline clinical data were colected. Leptomeningeal colateral circulation was assessed by angiography. Results A total of 137 patients were enroled, including 100 males and 37 females; mean age 55. 26 ± 11. 71 years. The colateral circulation of 65 patients (47. 4% ) was good. Univariate analysis showed that the ages (52. 3 ± 13. 2 years vs. 57. 9 ± 9. 5 years; t = 2. 866, P = 0. 005) and the proportion of hypertension (52. 3% vs. 70. 8% ; χ2 = 4. 978, P =0. 026) in the good colateral circulation group were significantly lower than those in the poor colateral circulation group. Multivariate logistic regression analysis showed that age was an independent risk factor for affecting the leptomeningeal colateral circulation in patients with acute middle cerebral artery occlusion (odds ratio, 0. 965, 95% confidence interval 0. 934-0. 997, P = 0. 034). Conclusions Age is an independent risk factor for affecting the leptomeningeal colateral circulation in patients with middle cerebral artery occlusion.

Objective Excimer laser coronary atherecomy ( ELCA) has been recently used for the treatment of complex coronary lesions including calcified stenosis , chronic total occlusions and in-stent restenosis. Such complex lesions are difficult to adequately treat with balloon angioplasty and /or intracoronary stenting.The aim of this study was to introduce our early experiences in using ELCA in China . Methods Fifteen patients were enrolled through our center from March 2015 to April 2016 , and excimer laser coronary angioplasty was performed on 15 lesions.Eleven patients were previously failed cases either from uncrossable balloon ( 9 lesions ) or expandable balloon ( 6 lesions ) . The procedure and clinical endpoints were recorded .Results Laser catheter with 0.9 mm diameters were used in all 15 coronary lesions.All the lesions were successfully crossed with laser catheter and finally dilated with balloon .The procedural success rate was 100%.Drug eluting stents ( DES ) were implanted in 86.7% lesions and 2 cases were treated with drug eluting balloon .Clinical success was obtained in all patients (100%).There was no dissection , major side branch occlusion , spasm, no-reflow phenomenon nor acute vessel closure . Conclusions This study shows that laser-facilitated coronary angioplasty is a simple , safe and effective device for the management of complex coronary lesions .

Background: Nasal?type extranodal natural killer/T?cell lymphoma (ENKTCL) originates primarily in the nasal cavity or extra?nasal sites within the upper aerodigestive tract. However, it is unclear whether the primary site can serve as an independent prognostic factor or whether the varying clinical outcomes observed with different primary sites can be attributed merely to their propensities of regional lymph node involvement. The aim of this study was to investigate the prognostic implications of the primary site and regional lymph node involvement in patients with early?stage nasal?type ENKTCL. Methods: To develop a nomogram, we reviewed the clinical data of 215 consecutively diagnosed patients with early?stage nasal?type ENKTCL who were treated in Sun Yat?sen University Cancer Center with chemotherapy and radiotherapy between 2000 and 2011. The predictive accuracy and discriminative ability of the nomogram were determined using a concordance index (C?index) and calibration curve. Results: The 5?year overall survival (OS) and progression?free survival (PFS) rates of patients with nasal ENKTCL were higher than those of patients with extra?nasal ENKTCL (OS: 68.2% vs. 46.0%, P = 0.030; PFS: 53.4% vs. 26.6%, P = 0.010).The 5?year OS and PFS rates of patients with Ann Arbor stage IE ENKTCL were higher than those of patients with Ann Arbor stage IIE ENKTCL (OS: 66.3% vs. 59.2%, P = 0.003; PFS: 51.4% vs. 40.3%, P = 0.009). Multivariate analysisshowed that age >60 years, ECOG performance status score nasal primary site, and regional lymph node involvement were significantly associated with lower 5?year OS rate;&ge;2, elevated lactate dehydrogenase (LDH) level, extra?age >60 years, elevated LDH level, extra?nasal primary site, and regional lymph node involvement were significantly associated with lower 5?year PFS rate. The nomogram included the primary site and regional lymph node involve?ment based on multivariate analysis. The calibration curve showed good agreement between the predicted and actual 5?year OS and PFS rates, and the C?indexes of the nomogram for the OS and PFS rates were 0.697 and 0.634, respectively. Conclusions: The primary site and regional lymph node involvement are independent prognostic factors for early?stage ENKTCL treated with chemotherapy followed by definitive radiotherapy.