Aim To evaluate the bioequivalence of two oral preparations of rivaroxaban tablets(test preparation T and refe-rence preparation R)in fasting/postprandibular state in healthy Chinese subjects.Methods A randomized,open,single-dose,four-cycle,completely repeated crossover experiment was used in this study.A total of 70 healthy male and female subjects were enrolled,including 38 subjects in the fasting group and 32 sub-jects in the postprandial group.Rivaroxaban tablets(2.5 mg/tablet)were taken orally once per cycle and their reference preparations were tested.The plasma rivaroxaban concentration was determined by LC-MS/MS method.The pharmacokinetic parameters of rivaroxaban tablets were calculated by WinNonlin software,and the parameters were analyzed and processed.Re-sults The PK parameters of rivaroxaban tablets and reference preparations in fasting group were as follows:Cmax was(72.48±17.08)and(66.36±15.64)μg·L-1,respectively.AUC0-t were(383.49±101.06)and(370.43±102.16)h·ng·mL-1,and AUC0-inr were(389.58±102.28)and(375.84±103.01)h·μg·L-,respectively.Main PK parameters of subjects taking rivaroxaban tablets orally after meals:Cmax were(66.48±15.64 and 60.87±13.44)μg·L-1,AUC0-t were(404.44±72.58)and(381.80±79.93)h·μg·L-1,re-spectively.AUC0_inf was(410.88±73.55)and(393.64±69.71)h·μg·L-1,respectively.Under fasting and postmeal conditions,subjects took rivaroxaban test and reference prepara-tion orally,one tablet(2.5 mg/tablet)each time.The geometric mean of the main pharmacokinetic parameters of rivaroxaban in plasma(Cmax,AUC0-t,AUC0-inf)and their corresponding values had a 90％confidence interval ranging from 80.00％to 125.00％.No serious adverse events or unexpected adverse e-vents occurred in both groups.Conclusion Rivaroxaban tablets are bioequivalent and safe in vivo under fasting and postprandial conditions.

Objective:To study the epidemiological characteristics of human brucellosis in Ordos City and provide reference and theoretical guidance for prevention and control of the disease.Methods:The surveillance data of human brucellosis cases and the serological surveillance data of key occupational populations reported by the Ordos City Center for Disease Control and Prevention from 2013 to 2022 were collected and analyzed descriptively. ArcGIS 10.8 software was used to draw a spatial distribution map of human brucellosis in Ordos City, and SPSS 26.0 software was used to conduct Spearman correlation analysis to further explore the impact of economic factors on human brucellosis.Results:From 2013 to 2022, a total of 8 676 cases of human brucellosis were reported in Ordos City, with an average annual incidence rate of 40.93/100 000. In 2022, 2 570 cases were reported, with an incidence rate of 116.78/100 000, reaching the peak in the past 10 years. The cases were mainly distributed in Dalad Banner, Hangjin Banner, and Otog Front Banner, with a total of 6 415 cases, accounting for 73.94% of the total number of cases. The spatial distribution spread from north to south and from north to east. The majority of cases were in the age group of 40 to 65 years old (6 061 cases, accounting for 69.86%), male (6 089 cases, accounting for 70.18%), and farmers and herdsmen (7 367 cases, accounting for 84.91%). The median time interval between onset and diagnosis was 16 days. The positive rate of serological surveillance in key occupational groups was 5.38% (7 058/131 229). The results of Spearman correlation analysis showed that the number of agricultural legal entities, the number of animal husbandry legal entities, regional gross domestic product, per capita disposable income of rural and pastoral residents, total agricultural output value, the number of cattle and sheep at the end of the year, milk production, and mutton production were important factors affecting the incidence of brucellosis ( P < 0.05). Conclusions:The incidence of brucellosis in Ordos City is on the rise, and the epidemic situation is severe. It is necessary to strengthen the surveillance and joint prevention and control of human brucellosis to prevent the spread and expansion of the epidemic.

Objective:To evaluate the efficacy of eradication therapy based on potassium-competitive acid blocker (P-CAB) for Helicobacter pylori( HP) infection in re-eradication therapy (the second-line therapy treatment after initial eradication failure of HP infection) and determine whether it can achieve the ideal eradication rate (90%). Methods:From January 2022 to December 2023, the clinical data of patients who received vonoprazan-based HP re-eradication therapy were collected in Department of Gastroenterology, the First Affiliated Hospital of Soochow University. The patients were divided into 4 groups according to their different HP treatment regimens, including VAMB group (vonoprazan 20 mg, quaque die( qd)+ amoxicillin 1 g, bis in die( bid)+ minocycline 100 mg, bid+ potassium bismuth citrate 220 mg, bid; 156 cases), VA group (vonoprazan 20 mg, bid+ amoxicillin 1 g, ter in die( tid); 44 cases), VMFB group (vonoprazan 20 mg qd+ minocycline 100 mg, bid+ furazolidone 100 mg, bid+ potassium bismuth citrate 220 mg, bid; 42 cases), and VAFB group (vonoprazan 20 mg, qd+ amoxicillin 1 g, bid+ furazolidone 100 mg, bid + potassium bismuth citrate 220 mg, bid; 13 cases). All the 4 groups of patients took the medication for 14 days. The 13C or 14C urea breath test would be conducted 4 weeks after the treatment. The overall eradication rate to evaluate the treatment efficacy. The eradication rate and adverse reaction rate were calculated for each group, and the eradication rates and adverse reaction rates between groups were compared using the chi-square test or Fisher′s exact test. Results:The total eradication rate of HP infection based on P-CAB therapy was 91.8% (234/255), and the total adverse reaction rate was 5.1% (13/255). The eradication rate and adverse reaction rate were 92.9% (145/156) and 3.2% (5/156) in the VAMB group, 84.1% (37/44) and 0 in the VA group 95.2% (40/42) and 11.9% (5/42) in the VMFB group, 12/13 and 3/13 in the VAFB group, respectively. Additionally, there was no statistical difference in the eradication rate among the 4 groups (Fisher′s exact test, P=0.227), but there was a statistical difference in the adverse reaction rates (Fisher′s exact test, P=0.002), and the adverse reaction rate of the VAFB group was higher than that of VAMB and VA groups and the differences were statistically significant (both Fisher′s excact test, P=0.016 and 0.010). Conclusions:The total HP re-eradication rate based on P-CAB therapies can reach 91.8%, achieving the ideal eradication rate of HP infection. The VA therapeutic regimen has the lowest incidence of adverse reactions, representing a novel therapeutic option for HP re-eradication.

OBJECTIVE: The relationship between fish consumption and stroke is inconsistent, and it is uncertain whether this association varies across predicted stroke risks. METHODS: A cohort study comprising 95,800 participants from the Prediction for Atherosclerotic Cardiovascular Disease Risk in China project was conducted. A standardized questionnaire was used to collect data on fish consumption. Participants were stratified into low- and moderate-to-high-risk categories based on their 10-year stroke risk prediction scores. Hazard ratios ( HRs) and 95% confidence intervals ( CIs) were estimated using Cox proportional hazard models and additive interaction by relative excess risk due to interaction (RERI), attributable proportion (AP), and synergy index (SI). RESULTS: During 703,869 person-years of follow-up, 2,773 incident stroke events were identified. Higher fish consumption was associated with a lower risk of stroke, particularly among moderate-to-high-risk individuals ( HR = 0.53, 95% CI: 0.47-0.60) than among low-risk individuals ( HR = 0.64, 95% CI: 0.49-0.85). A significant additive interaction between fish consumption and predicted stroke risk was observed (RERI = 4.08, 95% CI: 2.80-5.36; SI = 1.64, 95% CI: 1.42-1.89; AP = 0.36, 95% CI: 0.28-0.43). CONCLUSION Higher fish consumption was associated with a lower risk of stroke, and this beneficial association was more pronounced in individuals with moderate-to-high stroke risk.
Humans ; China/epidemiology* ; Male ; Female ; Stroke/etiology* ; Middle Aged ; Prospective Studies ; Incidence ; Aged ; Animals ; Fishes ; Risk Factors ; Diet ; Seafood ; Adult ; Cohort Studies

Aim To evaluate the bioequivalence of two oral preparations of rivaroxaban tablets(test preparation T and refe-rence preparation R)in fasting/postprandibular state in healthy Chinese subjects.Methods A randomized,open,single-dose,four-cycle,completely repeated crossover experiment was used in this study.A total of 70 healthy male and female subjects were enrolled,including 38 subjects in the fasting group and 32 sub-jects in the postprandial group.Rivaroxaban tablets(2.5 mg/tablet)were taken orally once per cycle and their reference preparations were tested.The plasma rivaroxaban concentration was determined by LC-MS/MS method.The pharmacokinetic parameters of rivaroxaban tablets were calculated by WinNonlin software,and the parameters were analyzed and processed.Re-sults The PK parameters of rivaroxaban tablets and reference preparations in fasting group were as follows:Cmax was(72.48±17.08)and(66.36±15.64)μg·L-1,respectively.AUC0-t were(383.49±101.06)and(370.43±102.16)h·ng·mL-1,and AUC0-inr were(389.58±102.28)and(375.84±103.01)h·μg·L-,respectively.Main PK parameters of subjects taking rivaroxaban tablets orally after meals:Cmax were(66.48±15.64 and 60.87±13.44)μg·L-1,AUC0-t were(404.44±72.58)and(381.80±79.93)h·μg·L-1,re-spectively.AUC0_inf was(410.88±73.55)and(393.64±69.71)h·μg·L-1,respectively.Under fasting and postmeal conditions,subjects took rivaroxaban test and reference prepara-tion orally,one tablet(2.5 mg/tablet)each time.The geometric mean of the main pharmacokinetic parameters of rivaroxaban in plasma(Cmax,AUC0-t,AUC0-inf)and their corresponding values had a 90％confidence interval ranging from 80.00％to 125.00％.No serious adverse events or unexpected adverse e-vents occurred in both groups.Conclusion Rivaroxaban tablets are bioequivalent and safe in vivo under fasting and postprandial conditions.

Objective:To study the epidemiological characteristics of human brucellosis in Ordos City and provide reference and theoretical guidance for prevention and control of the disease.Methods:The surveillance data of human brucellosis cases and the serological surveillance data of key occupational populations reported by the Ordos City Center for Disease Control and Prevention from 2013 to 2022 were collected and analyzed descriptively. ArcGIS 10.8 software was used to draw a spatial distribution map of human brucellosis in Ordos City, and SPSS 26.0 software was used to conduct Spearman correlation analysis to further explore the impact of economic factors on human brucellosis.Results:From 2013 to 2022, a total of 8 676 cases of human brucellosis were reported in Ordos City, with an average annual incidence rate of 40.93/100 000. In 2022, 2 570 cases were reported, with an incidence rate of 116.78/100 000, reaching the peak in the past 10 years. The cases were mainly distributed in Dalad Banner, Hangjin Banner, and Otog Front Banner, with a total of 6 415 cases, accounting for 73.94% of the total number of cases. The spatial distribution spread from north to south and from north to east. The majority of cases were in the age group of 40 to 65 years old (6 061 cases, accounting for 69.86%), male (6 089 cases, accounting for 70.18%), and farmers and herdsmen (7 367 cases, accounting for 84.91%). The median time interval between onset and diagnosis was 16 days. The positive rate of serological surveillance in key occupational groups was 5.38% (7 058/131 229). The results of Spearman correlation analysis showed that the number of agricultural legal entities, the number of animal husbandry legal entities, regional gross domestic product, per capita disposable income of rural and pastoral residents, total agricultural output value, the number of cattle and sheep at the end of the year, milk production, and mutton production were important factors affecting the incidence of brucellosis ( P < 0.05). Conclusions:The incidence of brucellosis in Ordos City is on the rise, and the epidemic situation is severe. It is necessary to strengthen the surveillance and joint prevention and control of human brucellosis to prevent the spread and expansion of the epidemic.

Objective:To compare the efficacy of body posture combined with pharmacotherapy and pharmacotherapy alone in the treatment of chronic subdural hematoma(CSDH).Methods:Firstly, retrospective case series study was conducted. Thirty cases of CSDH that had received body posture combined with pharmacotherapy at Department of Neurosurgery, Huashan Hospital Affiliated to Fudan University from December 2016 to October 2020 were studied retrospectively. Twenty-seven patients were male, and 3 patients were female. The age of patients ( M(IQR)) was 66(16) years (range:28 to 84). Nineteen patients had unilateral hematoma, and 11 patients had bilateral hematoma. All patients received pharmacotherapy and body posture therapy that was to raise their lower limbs 20 to 30 cm with leg lift pad and get abdominal compressed with customized abdominal belt in supine position. Patients were required to maintain the body posture as much as possible, with the maximum to 16 to 18 hours per day. Patients with unilateral hematoma should tilt the head to the affected side and avoid tilting it to the opposite side. For patients with bilateral hematoma, there was no need for head lateralization. Patient were treated with oral dexamethasone and atorvastatin simultaneously. The preliminary efficacy of body posture combined with pharmacotherapy was determined by hematoma improvement rate which was analyzed by Clopper-Pearson method. Then, the multi-center, prospective, randomized controlled trial had carried out in 9 medical centers from August 2020 to November 2021. The stratified block randomization method was adopted. Patients were randomized in a ratio of 1∶1 to either receive pharmacotherapy alone(the control group) or body posture combined with pharmacotherapy(the experiment group) for 3 months and followed up for 6 months. Effective treatment was defined as complete absorption of hematoma, or the hematoma volume decreased by more than 10 ml and Markwalder grading scale score had improved by more than 1 point compared to the baseline. The efficacy rate and surgery conversion rate at 3 months and recurrence at 6 months were observed. Comparison between groups was performed with paired sample t test, Mann-Whitney U test, χ2 test, corrected χ2 test, or Fisher exact probability method. Logistic regression was used to compare the effective rate and operation rate between the two groups. Results:In the respective study, 30 patients completed follow-up 13 to 353 days after treatment. At the last follow-up, the incidence of almost complete absorption or significantly absorption of hematoma (hematoma volume was significantly reduced accompanied by symptom improvement) was 93.3%. The 95% CI for the incidence that analyzed by the Clopper-Pearson method was 77.9% to 99.2%. One hundred and six patients were enrolled in the multicenter study. Fifty-five patients underwent body posture combined with pharmacotherapy. The age was 74(17) years (range:26 to 92). Thirty-nine patients were males and 16 were females. Fifty-one patients underwent pharmacotherapy alone. The age was 69(12) years (range:48 to 84). Thirty-seven patients were males and 14 were females. The length of body posture recorded in diary card was (15.7±2.3) hours(range:7.6 to 19.3 hours). The efficacy rate in the body posture combined with pharmacotherapy group and pharmacotherapy alone group were 83.6% (46/55) and 56.9% (29/51), respectively at 3 months. The result of the logistic regression analysis showed that the efficacy of body posture combined with pharmacotherapy group was better than that of pharmacotherapy alone group ( OR=3.88,95% CI:1.57 to 9.58, P=0.003). Surgery rate in the body posture combined with pharmacotherapy group and pharmacotherapy alone group were 5.5% (3/55) and 21.6% (11/51) respectively. The result of Logistic regression showed that the pharmacotherapy alone group was more likely to be converted to surgery ( OR=0.21,95% CI:0.05 to 0.80, P=0.023). At the 6 months, no recurrence of cases was found in the body posture combined with pharmacotherapy group. However, the recurrence rate of pharmacotherapy alone group was 6.3% (3/48), there was no significant difference between the two groups ( P>0.05). Conclusion:The effect of body posture combined with pharmacotherapy for chronic subdural hematoma is better than that of pharmacotherapy alone.

Objective:To evaluate the efficacy of eradication therapy based on potassium-competitive acid blocker (P-CAB) for Helicobacter pylori( HP) infection in re-eradication therapy (the second-line therapy treatment after initial eradication failure of HP infection) and determine whether it can achieve the ideal eradication rate (90%). Methods:From January 2022 to December 2023, the clinical data of patients who received vonoprazan-based HP re-eradication therapy were collected in Department of Gastroenterology, the First Affiliated Hospital of Soochow University. The patients were divided into 4 groups according to their different HP treatment regimens, including VAMB group (vonoprazan 20 mg, quaque die( qd)+ amoxicillin 1 g, bis in die( bid)+ minocycline 100 mg, bid+ potassium bismuth citrate 220 mg, bid; 156 cases), VA group (vonoprazan 20 mg, bid+ amoxicillin 1 g, ter in die( tid); 44 cases), VMFB group (vonoprazan 20 mg qd+ minocycline 100 mg, bid+ furazolidone 100 mg, bid+ potassium bismuth citrate 220 mg, bid; 42 cases), and VAFB group (vonoprazan 20 mg, qd+ amoxicillin 1 g, bid+ furazolidone 100 mg, bid + potassium bismuth citrate 220 mg, bid; 13 cases). All the 4 groups of patients took the medication for 14 days. The 13C or 14C urea breath test would be conducted 4 weeks after the treatment. The overall eradication rate to evaluate the treatment efficacy. The eradication rate and adverse reaction rate were calculated for each group, and the eradication rates and adverse reaction rates between groups were compared using the chi-square test or Fisher′s exact test. Results:The total eradication rate of HP infection based on P-CAB therapy was 91.8% (234/255), and the total adverse reaction rate was 5.1% (13/255). The eradication rate and adverse reaction rate were 92.9% (145/156) and 3.2% (5/156) in the VAMB group, 84.1% (37/44) and 0 in the VA group 95.2% (40/42) and 11.9% (5/42) in the VMFB group, 12/13 and 3/13 in the VAFB group, respectively. Additionally, there was no statistical difference in the eradication rate among the 4 groups (Fisher′s exact test, P=0.227), but there was a statistical difference in the adverse reaction rates (Fisher′s exact test, P=0.002), and the adverse reaction rate of the VAFB group was higher than that of VAMB and VA groups and the differences were statistically significant (both Fisher′s excact test, P=0.016 and 0.010). Conclusions:The total HP re-eradication rate based on P-CAB therapies can reach 91.8%, achieving the ideal eradication rate of HP infection. The VA therapeutic regimen has the lowest incidence of adverse reactions, representing a novel therapeutic option for HP re-eradication.

Nonunion of osteoporotic vertebral fractures (OVF), predominantly affecting the elderly, can lead to intractable pain, vertebral collapse, progressive kyphotic deformity, and neurological impairment, significantly compromising patients′ quality of life. There exists considerable debate on diagnosis and management of OVF, encompassing key issues such as clinical diagnosis and staging criteria for nonunion, surgical indications and procedure selection, and postoperative rehabilitation planning. Currently, there lacks standardized clinical guideline and expert consensus on the diagnosis and management of OVF nonunion in China. To address this gap, Minimally Invasive Surgery Group of Chinese Orthopedic Association, Osteoporosis Committee of Chinese Association of Orthopedic Surgeons, Prevention and Rehabilitation Committee for Osteoporosis of Chinese Association of Rehabilitation Medicine and Minimally Invasive Orthopedic Surgery Branch of China Association for Geriatric Care jointly organized domestic experts in spinal surgery, endocrinology, and rehabilitation to formulate the Clinical guideline for the diagnosis and treatment for nonunion of osteoporotic vertebral fractures ( version 2025), based on existing literature and clinical experience and adhering to principles of scientific rigor and practicality. The guideline provided 13 evidence-based recommendations encompassing diagnosis and treatment of OVF nonunion, aiming to standardize its clinical management.

Objective:To evaluate the clinical value and safety of an intraperitoneal chemotherapy port technique in patients with gastric cancer and peritoneal metastases undergoing intraperitoneal chemotherapy.Methods:This was a retrospective, descriptive case analysis. From November 2022 to October 2024, patients diagnosed with gastric cancer and peritoneal metastases at Wuxi Branch of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine with an expected survival >3 months, underwent laparoscopic exploration combined with implantation of an intraperitoneal chemotherapy port [PORT-A-CATH II system (Model 21-4055-24)] implantation. The procedure was as follows: (1) after laparoscopic exploration, a 4-cm skin incision was made at a predetermined site and a subcutaneous pocket created by dissecting to the muscle fascia and removing subcutaneous fat as needed to position the port septum 0.5-1.0 cm from the skin surface; (2) under direct laparoscopic visualization, the abdominal cavity was punctured and a guidewire inserted, followed by an 8.5 Fr sheath, through which a catheter with three trimmed side holes was placed after removal of the sheath; (3) the catheter length in the abdominal cavity was adjusted to 25–30 cm and the catheter trimmed, and connected to the port base, ensuring it extended beyond the connector's visible hole; (4) the whole port was placed within the subcutaneous pocket, and non-absorbable sutures used to create a double purse-string suture at the catheter's abdominal entry, forming an anti-reflux ring; (5) non-absorbable sutures were used to securely fix the port to the fascia through its four base holes and the exposed catheter segments on the fascia sutured and buried; (6) patency was confirmed by injecting saline and followed by intermittent skin closure provided there was no bleeding; and (7) the catheter tip was positioned in the pelvic cavity under laparoscopic guidance. Postoperatively, the patients underwent normothermic intraperitoneal and systemic treatment. The port infusion protocol involved disinfecting the skin (>10 cm diameter) around the port, confirming the puncture site, inserting a Huber needle vertically at 90° to the port base, infusing 100 mL saline to ensure patency, followed by continuous infusion of 1000 mL paclitaxel solution, and sealing with 20 mL saline before removing the needle. No saline flushing was required between chemotherapy infusions. The primary outcomes were the incidence and management of complications post-port implantation.Results:The study cohort comprised 225 patients with gastric cancer and peritoneal metastases. Using standardized port implantation and postoperative puncture procedures, the complication rate during follow-up was 14.2% (32/225), including effusion in 14 patients (6.2%), port infection in 10 (4.4%), incision dehiscence in four (1.8%), port inversion in two (0.9%), hematoma in one (0.4%), and catheter rupture in one (0.4%). Seventy-five percent (24/32) of patients with complications recovered and continued using the port after conservative treatments (e. g., aspiration of effusions, antibiotic therapy, incision management), whereas the remaining 25.0% (8/32) with complications required surgical removal of the port because the treatment was ineffective. The presence of preoperative ascites ( P=0.019) and peritoneal cancer index score>15 ( P=0.038) were significantly associated with development of complications. Conclusions:Our standardized procedure for intraperitoneal chemotherapy port implantation is safe and feasible for patients with gastric cancer and peritoneal metastases, having a low overall complication rate. Most complications can be successfully managed with conservative treatment, the device thus providing reliable support for intraperitoneal chemotherapy.