ObjectiveTo explore the mechanism by which Qiangjing tablets （QJT） alleviate the spermatogenic function damage caused by varicocele （VC） based on the Kelch-like ECH-associated protein 1 （Keap1）/nuclear factor erythroid 2-related factor 2 （Nrf2） signaling pathway-mediated oxidative stress. MethodsTen Sprague-Dawley （SD） rats were randomly assigned into a control group and a model group. Pathological examination confirmed the stability of the model. Thirty-six SD rats were randomized into control， model， low-dose （0.23 g·kg^-1） QJT， medium-dose （0.46 g·kg^-1） QJT， high-dose （0.92 g·kg^-1） QJT， and mazhilin （61.7 mg·kg^-1） groups， with 6 rats in each group. A rat model of experimental left varicocele （ELV） was established by partially ligating the left renal vein to simulate the human nutcracker syndrome. The rats were administrated with corresponding agents once a day for 28 consecutive days. The in vitro testicular culture model of rats was established through the Transwell chamber method and intervened with QJT-containing sera （2.3， 4.6， and 9.2 g·kg^-1）. Microscopic observation was carried out for the morphology of the left kidney. A micrometer was used to measure the diameter of the left spermatic vein （LSV）. The body weights of rats were recorded weekly， and the epididymis and testis weights were measured. The pathological changes of the testicular tissue was observed via hematoxylin-eosin （HE） staining. The levels of testosterone （T） in the cell culture supernatant and reactive oxygen species （ROS） in the rat testicular tissue were measured by enzyme-linked immunosorbent assay （ELISA）. Flow cytometry was employed to determine the ROS content. Immunohistochemical staining was conducted to analyze Keap1， Nrf2， 3β-hydroxysteroid dehydrogenase （3β-Hsd）， GATA-binding protein-4 （Gata-4）， and proto-oncogene receptor tyrosine kinase （C-kit）. The ultrastructure of the tissue was observed by transmission electron microscopy （TEM）. Cell apoptosis was detected by terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling （TUNEL） staining. The expression of Keap1， Nrf2， glutathione S-transferase α2 （Gsta2）， glutathione S-transferase μ1 （Gstm1）， heme oxygenase-1 （HO-1）， quinone oxidoreductase 1 （Nqo1）， and thioredoxin reductase 1 （Txnrd1） was quantified by Real-time quantitative polymerase chain reaction（Real-time PCR） and Western blot. ResultsCompared with the control group， the ROS content and the percentage of apoptotic cells in the model group were significantly increased （P<0.01）， the T concentration was significantly decreased （P<0.01）， the mRNA and protein expressions of Keap1 were significantly increased （P<0.01）， and the mRNA and protein expressions of Nrf2， Gsta2， Gstm1， HO-1， Nqo1 and Txnrd1 were significantly decreased （P<0.05）. Compared with the model group， the ROS content and the percentage of apoptotic cells in each dose group of the Qiangjing Tablets were significantly reduced （P<0.05）， and the mRNA and protein expressions of Keap1 were significantly decreased （P<0.05）， while the mRNA and protein expressions of Nrf2， Gsta2， Gstm1， HO-1， Nqo1 and Txnrd1 were significantly increased （P<0.05）. ConclusionQJT improves sperm motility in the rat model of VC by modulating the Keap1/Nrf2 signaling pathway and reducing oxidative stress injury.

Objective:To evaluate the therapeutic efficacy,safety,and factors influencing overall survival(OS)in patients with newly dia-gnosed acute myeloid leukemia(unfit AML)treated with venetoclax(VEN)plus low-dose cytarabine(LDAC)treatment regimen.Methods:In this study,we retrospectively analyzed clinical data from 33 patients with unfit AML treated with VEN plus LDAC at the Affiliated Hospital of Jiangsu University between December 2019 and January 2024.The efficacy and survival outcomes of this regimen were assessed.Results:Thirty-three patients(median age:72 years)were enrolled,including 29 with de novo AML and four with secondary AML.The median follow-up duration was 781 days,with a median OS and progression-free survival(PFS)of 467 days(range:104-812 days)and 395 days(range:104-637 days),respectively.After induction chemotherapy,the overall response rate(ORR)was 69.7%,with a composite rate of complete response(CR)and CR with incomplete blood count recovery(CRi)reaching 36.4%.Morphologic leukemia-free state(MLFS)and partial re-mission(PR)were observed in 3%and 30.3%of patients,respectively.The median number of treatment cycles was three(range:1-6.5).Treatment-related adverse events were primarily hematological,with high rates of grade 3-4 hematologic toxicities.Kaplan-Meier analysis revealed significant associations between survival and ECOG performance status,TP53 mutation status,treatment cycles,and response(P<0.05).Univariate and multivariate Cox regression analyses identified treatment cycles as an independent risk factor for OS(P<0.05).Con-clusions:The VEN plus LDAC regimen demonstrated feasibility and efficacy in patients with newly diagnosed AML;initial response and con-tinuous treatment were associated with favorable survival.

Objective:To investigate the management options for loop plate cutting of the tibial cortex during reconstruction of the anterior cruciate ligament (ACL) by the all-inside technique.Methods:From January 2022 to December 2024, a total of 13 patients with ACL injury who underwent all-inside reconstruction with tibial lateral loop plate cutting of the cortex and immediate revision for ACL injuries at Department of Sports Medicine, the First Affiliated Hospital of University of Science and Technology of China were retrospectively analyzed (cut group). There were 5 males and 8 females with an average age of 28.7±9.1 years (range, 17-39 years). During the revision, a transverse tunnel was drilled at the distal end of the tibial tunnel, and the loop plate was fixed to the lateral tibial cortex through the transverse tunnel. Matched by gender, age, and side, the patients who underwent ACL reconstruction with all-inside loop steel without cutting the tibial cortex during the same period (the uncut group) were selected as the control group at a ratio of 1∶2, including 10 males and 16 females, aged 29.1±9.3 years (range, 17-39 years). The visual analogue scale (VAS), Tegner score, International Knee Documentation Committee (IKDC) and Lysholm score for knee pain before and after surgery were compared between the two groups, and bone tunnel enlargement was assessed using the Peyrache grading scale.Results:All patients were successfully operated and followed up for 13.1±2.5 months and 13.3±2.6 months, respectively. The Lysholm scores of the cutting group before surgery, 6 months after surgery, and 1 year after surgery were 35.44±15.69, 75.21±16.77, and 93.47±18.56 respectively, while those of the uncut group were 37.81±17.33, 71.45±15.82, and 91.05±19.54. The Lysholm scores of both groups 6 months and 1 year after surgery were higher than those before surgery, and the Lysholm scores 1 year after surgery were higher than those 6 months after surgery, with statistically significant differences ( P<0.05). There were no statistically significant differences in the Lysholm scores between the two groups before and after surgery ( P>0.05). The IKDC scores of the cutting group before surgery, 6 months after surgery, and 1 year after surgery were 39.12±14.28, 69.52±15.36, and 84.24±17.91 respectively, while those of the uncut group were 37.46±11.55, 72.81±17.73, and 87.62±18.52. The IKDC scores of both groups 6 months and 1 year after surgery were higher than those before surgery, and the IKDC scores 1 year after surgery were higher than those 6 months after surgery, with statistically significant differences ( P<0.05). There were no statistically significant differences in the IKDC scores between the two groups before and after surgery ( P>0.05). The Tegner scores of the cutting group before surgery, 6 months after surgery, and 1 year after surgery were 1.61±1.11, 3.59±1.66, and 5.59±1.79 respectively, while those of the non-cutting group were 1.57±1.05, 3.47±1.51, and 5.41±1.63. The Tegner scores of both groups 6 months and 1 year after surgery were higher than those before surgery, and the Tegner scores 1 year after surgery were higher than those 6 months after surgery, with statistically significant differences ( P<0.05). There were no statistically significant differences in the Tegner scores between the two groups before and after surgery ( P>0.05). According to Peyrache's grading criteria, 7 cases in the cutting group had femoral side bone tunnel enlargement and 8 cases had tibial side bone tunnel enlargement; 12 cases in the non-cutting group had femoral side bone tunnel enlargement and 15 cases had tibial side bone tunnel enlargement, with no statistically significant differences (χ 2=0.205, P=0.650; χ 2=0.053, P=0.818). At the last follow-up, there were 2 cases of Lachman grade I in the cutting group and 3 cases in the non-cutting group, 1 case of joint stiffness in the cutting group and 2 cases in the non-cutting group. None of the patients in the two groups had vascular nerve injury, deep vein thrombosis, or intra-articular infection. Conclusion:The method of drilling a transverse tunnel at the distal end of the outer opening of the tibial tunnel and fixing the loop plate to the lateral tibial cortex through the transverse tunnel, along with cutting the tibial cortex, can improve the knee joint function.

Objective:To investigate the short-term efficacy and safety of rituximab (RTX) in children with calcineurin inhibitor (CNI) resistant steroid resistant nephrotic syndrome (SRNS).Methods:A retrospective case analysis was conducted. Thirteen children with CNI resistant SRNS who were regularly treated with RTX (375 mg/m 2 per dose (maximum dose 500 mg), 1 dose per week, a total of 4 doses) in Department of Nephrology, Children′s Hospital of Fudan University from January 2016 to December 2023 were enrolled. The general data, disease related information, urinary protein/creatinine, serum albumin, blood creatinine before RTX treatment, immunosuppressants, adverse events, and monthly urinary protein/creatinine, serum albumin, and blood creatinine indexes within 6 months after RTX treatment were collected. The changes of urinary protein/creatinine, serum albumin and estimated glomerular filtration rate (eGFR) before and after RTX at 3 and 6 months were analyzed by using paired sample t test and Wilcoxon signed-rank test. Results:Among the 13 patients, 8 were male and 5 were female. The age of disease onset was 4.0 (2.9, 6.8) years and the age of RTX treatment was 9.8 (5.9, 13.6) years. There were 8 cases of focal segmental glomerulosclerosis, 3 cases of minimal change disease and 2 cases of mesangial proliferative glomerulonephritis. No clinically significant gene variation was detected in 12 cases and the other one did not receive gene test. Before RTX treatment, 11 cases were in chronic kidney disease stage G1, and 1 case each was in stage G2 and stage G3. Ten children completed 4 doses of RTX treatment, 1 patient completed 3 doses, and 2 patients completed 2 doses. Urinary protein/creatinine in 13 children at 3 and 6 months after RTX treatment was significantly lower than baseline (0.60 (0.13, 2.04), 0.49 (0.28, 1.10) vs. 1.44 (0.76, 4.11) mg/mg, Z=-2.34, -2.34, both P<0.05), and serum albumin was significantly higher than baseline ((35±8), (34±7) vs. (30±6) g/L, t=2.30, 2.60, both P<0.05). The eGFR at 6 months after RTX treatment was not significantly different from the baseline ((110±32) vs. (113±35) ml/(min·1.73 m 2), t=-0.76, P>0.05)). No serious adverse reactions occurred in this study. Conclusion:RTX could reduce urinary protein and increase serum albumin in short-term treatment in children with CNI resistant SRNS without significant side effects.

PURPOSE: To investigate the incidence and influencing factors of bone loss in patients with spinal cord injury (SCI). METHODS: A retrospective case-control study was conducted. Patients with SCI in our hospital from January 2019 to March 2023 were collected. According to the correlation between bone mineral density (BMD) at different sites, the patients were divided into the lumbar spine group and the hip joint group. According to the BMD value, the patients were divided into the normal bone mass group (t > -1.0 standard deviation) and the osteopenia group (t ≤ -1.0 standard deviation). The influencing factors accumulated as follows: gender, age, height, weight, cause of injury, injury segment, injury degree, time after injury, start time of rehabilitation, motor score, sensory score, spasticity, serum value of alkaline phosphatase, calcium, and phosphorus. The trend chart was drawn and the influencing factors were analyzed. SPSS 26.0 was used for statistical analysis. Correlation analysis was used to test the correlation between the BMD values of the lumbar spine and bilateral hips. Binary logistic regression analysis was used to explore the influencing factors of osteoporosis after SCI. p < 0.05 was considered statistically significant. RESULTS: The incidence of bone loss in patients with SCI was 66.3%. There was a low concordance between bone loss in the lumbar spine and the hip, and the hip was particularly susceptible to bone loss after SCI, with an upward trend in incidence (36% - 82%). In this study, patients with SCI were divided into the lumbar spine group (n = 100) and the hip group (n = 185) according to the BMD values of different sites. Then, the lumbar spine group was divided into the normal bone mass group (n = 53) and the osteopenia group (n = 47); the hip joint group was divided into the normal bone mass group (n = 83) and the osteopenia group (n = 102). Of these, lumbar bone loss after SCI is correlated with gender and weight (p = 0.032 and < 0.001, respectively), and hip bone loss is correlated with gender, height, weight, and time since injury (p < 0.001, p = 0.015, 0.009, and 0.012, respectively). CONCLUSIONS The incidence of bone loss after SCI was high, especially in the hip. The incidence and influencing factors of bone loss in the lumbar spine and hip were different. Patients with SCI who are male, low height, lightweight, and long time after injury were more likely to have bone loss.
Humans ; Spinal Cord Injuries/complications* ; Male ; Female ; Retrospective Studies ; Incidence ; Adult ; Bone Density ; Middle Aged ; Case-Control Studies ; Osteoporosis/etiology* ; Lumbar Vertebrae ; Bone Diseases, Metabolic/etiology* ; Aged ; Risk Factors

PURPOSE: Bone cement-reinforced fenestrated pedicle screws (FPSs) have been widely used in the internal fixation and repair of the spine with osteoporosis in recent years and show significant improvement in fixation strength and stability. However, compared with conventional reinforcement methods, the advantages of bone cement-reinforced FPSs remain undetermined. This article compares the effects of fenestrated and conventional pedicle screws (CPSs) combined with bone cement in the treatment of osteoporosis. METHODS: A clinical control study of FPSs and CPSs combined with bone cement reinforcement in osteoporotic vertebral internal fixation was performed using the database PubMed, Embase, Cochrane Library, CNKI, the Wanfang, and the China Biomedical Literature Service System. Two evaluators screened the relevant literature in strict accordance with the inclusion criteria (diagnosis of participants, type of clinical study, treatment with FPS and CPS, and outcome indicators) and exclusion criteria (duplicate literature and missing or incorrect data) and independently conducted data extraction and quality evaluation. Clinical control studies of direct comparison between FPS and CPS combined with bone cement reinforcement in patients who were definitively diagnosed with thoracolumbar fractures or spinal degenerative diseases were included. Quality evaluation was conducted using the Cochrane risk bias evaluation tool for randomized controlled studies and using the Newcastle-Ottawa scale for retrospective case-control studies. RevMan software (version 5.3) was used for the meta-analysis to compare the clinical efficacy, radiological results, and related complications of the 2 methods. RESULTS: A total of 13 articles were included, including 7 randomized controlled studies and 6 retrospective case-control studies. There were 909 patients in these studies, 451 in the FPS and polymethyl methacrylate (FPS & PMMA) group and 458 in the CPS and polymethyl methacrylate (CPS & PMMA) group. The results of the meta-analysis showed that there was no significant difference between the 2 groups in operation time, hospital stay, visual analogue score, Japanese orthopaedic association score, Oswestry disability index score, Cobb angle, vertebral body deformation index and fusion rate (p > 0.05). The mean difference of intraoperative bleeding volume was -10.45, (95% confidence intervals (CI) (-16.92, -3.98), p = 0.002), the mean difference of loss height of the anterior edge of the vertebral body after surgery was -0.69 (95% CI (-0.93, -0.44), p < 0.001), and the relative risk (RR) of overall complication rate was 0.43 (95% CI (0.27, 0.68), p < 0.001), including the RR of bone cement leakage rate was 0.57 (95% CI (0.39, 0.85), p = 0.005). The screw loosening rate (RR = 0.26, 95% CI (0.13, 0.54), p < 0.001) of the FPS group was significantly lower than that of the CPS group. CONCLUSION The existing clinical evidence shows that compared with the CPS combined with bone cement, the use of FPS repair in the internal fixation of an osteoporotic vertebral body can reduce the amount of intraoperative bleeding, be more conducive to maintaining the height of the vertebral body, and significantly reduce the incidence of postoperative complications such as bone cement leakage and screw loosening.
Humans ; Pedicle Screws ; Bone Cements ; Spinal Fractures/surgery* ; Osteoporotic Fractures/surgery* ; Fracture Fixation, Internal/instrumentation*

OBJECTIVE: To lay a foundation for formulating clinical evaluation and regulatory policies regarding radiotherapy equipment in China. METHODS: Comprehensive retrieval and comparison of the regulatory requirements for radiotherapy equipment from regulatory agencies in the United States, the European Union, and China are conducted, and their similarities and differences are analyzed. RESULTS: For mature radiotherapy systems in the European and American regions, the comparison of performance parameters serves as an important basis for determining whether a product can be marketed. Both the European Union and China regard the clinical evaluation report as a crucial part of the medical device review and submission process. CONCLUSION Identifying clear state of the art standards, performance parameters, and clinical indicator parameters, and establishing relevant technical guidelines are important directions for promoting the standardized development of radiotherapy equipment supervision.
Radiotherapy/standards* ; United States ; China ; European Union