Background::A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has previously shown its preliminary efficacy in ST elevation myocardial infarction (STEMI) patients. This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase (rt-PA) in Chinese patients with STEMI.Methods::In this multicenter, randomized, open-label, non-inferiority trial, patients with acute STEMI were randomly assigned (1:1) to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min. The primary endpoint was recanalization defined by thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3. The secondary endpoint was clinically justified recanalization. Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events (MACCEs) and safety endpoints.Results::From July 2016 to September 2019, 767 eligible patients were randomly assigned to receive rhTNK-tPA ( n = 384) or rt-PA ( n = 383). Among them, 369 patients had coronary angiography data on TIMI flow, and 711 patients had data on clinically justified recanalization. Both used a –15% difference as the non-inferiority efficacy margin. In comparison to rt-PA, both the proportion of patients with TIMI grade 2 or 3 flow (78.3% [148/189] vs. 81.7% [147/180]; differences: –3.4%; 95% confidence interval [CI]: –11.5%, 4.8%) and clinically justified recanalization (85.4% [305/357] vs. 85.9% [304/354]; difference: –0.5%; 95% CI: –5.6%, 4.7%) in the rhTNK-tPA group were non-inferior. The occurrence of 30-day MACCEs (10.2% [39/384] vs. 11.0% [42/383]; hazard ratio: 0.96; 95% CI: 0.61, 1.50) did not differ significantly between groups. No safety outcomes significantly differed between groups. Conclusion::rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery, a validated surrogate of clinical outcomes, among Chinese patients with acute STEMI.Trial registration::www.ClinicalTrials.gov (No. NCT02835534).

Objective To compare the effects of different approaches of laparoscopic adrenal tumor resection in treating functional adrenal tumors.Methods Sixty patients with functional adrenal tumors admitted to the Anyang District Hospital from September 2012 to September 2022 were selected as the research subjects.According to different laparoscopic approaches,the patients were divided into a retroperitoneal laparoscopic adrenalectomy group(n=31)and an intraperitoneal laparoscopic adrenalectomy group(n=29).The operation related indexes,stress indexes,immunological indexes,and postoperative complications were compared between the two groups.Results The amount of bleeding and treatment cost in the retroperitoneal laparoscopic adrenalectomy group were lower than those in the intraperitoneal laparoscopic adrenalectomy group,and the operation time,the first meal time after operation,and the hospital stay were shorter than those in the intraperitoneal laparoscopic adrenalectomy group(P＜0.05).There was no statistically significant difference in serum cortisol(Cor),noradrenaline(NE)and adrenaline(E)levels between the two groups before and after operation(P＞0.05).After operation,the levels of serum Cor,NE and E in the two groups were significantly higher than those before operation(P＜0.05).Before operation,there was no statistically significant difference in CD4+level,CD8+level,and CD4+/CD8+ratio between the two groups(P＞0.05).After operation,the CD4+level and CD4+/CD8+ratio in both groups were significantly lower than those before operation,while the CD8+level was significantly higher than that before operation(P＜0.05).After operation,the CD4+level and CD4+/CD8+ratio in the intraperitoneal laparoscopic adrenalectomy group were significantly lower than those in the retroperitoneal laparoscopic adrenalectomy group(P＜0.05);there was no statistically significant difference in the CD8+level between the two groups(P＞0.05).The incidence of postoperative complications in the retroperitoneal laparoscopic adrenalectomy group and the intraperitoneal laparoscopic adrenalectomy group was 6.45％(2/31)and 31.03％(9/29),respectively;it was significantly lower in the retroperitoneal laparoscopic adrenalectomy group(x2=6.048,P＜0.05).Conclusion Laparoscopic adrenalectomy via intraperitoneal approach and retroperitoneal approach is effective in the treatment of functional adrenal tumors.The degree of stress response generated by the two approaches is similar,but the retroperitoneal approach has shorter operation time,less intraoperative bleeding,faster postoperative recovery,less damage to immune function,lower incidence of postoperative complications,and fewer costs.

Objective To study the risk factors and prognostic characteristics of pediatric silent lupus nephritis(SLN)with class Ⅲ to V.Methods A retrospective study was conducted to collect clinical data from 30 children diagnosed with SLN at the Department of Pediatrics,Second Xiangya Hospital,Central South University,from May 2007 to April 2023.Based on renal pathological classification,the patients were divided into a class Ⅱ group(12 cases)and a class Ⅲ to Ⅴ group(18 cases).The risk factors for the occurrence of class Ⅲ to Ⅴ SLN were analyzed,and the prognostic characteristics were summarized.Results Among the 30 SLN patients,the median follow-up time was 61.50 months.There were no statistically significant differences in the proportions of patients who discontinued glucocorticoids or achieved low disease activity status,nor in the annual decline rate of estimated glomerular filtration rate(eGFR)between the class Ⅱ and class Ⅲ to V groups(P>0.05).However,three patients in the class Ⅱ group progressed to stage 1 chronic kidney disease(CKD),while eight patients in the class Ⅲ to Ⅴ group reached stage 1 CKD,and four patients reached stage 2 CKD.Among the 26 female SLN patients,serum complement C3 levels in the class Ⅲ to Ⅴ group were lower than those in the class Ⅱ group(P<0.05).Serum C3 levels in SLN patients,as well as in female SLN patients,were negatively correlated with the fluorescence intensity of IgA,IgG,and C3 immune complexes in the kidneys(P<0.05).Additionally,serum C3 levels in female SLN patients were negatively correlated with the renal pathological activity index(P<0.05).Binary logistic regression analysis indicated that being female and having low serum complement C3 levels were risk factors for the occurrence of class Ⅲ to Ⅴ SLN in children(P<0.05).Conclusions Class Ⅲ to Ⅴ SLN is not uncommon among SLN children,and there remains a risk of long-term renal function progression.Being female and having low serum complement C3 levels are identified as risk factors for class Ⅲ to Ⅴ SLN in children.

Objective: To investigate the association between muscle mass and quality of life in adults in Shaanxi adults. Methods: The data in this analysis were part of the baseline survey of the Regional Ethnic Cohort Study in Northwest China from June 2018 to May 2019 in Shaanxi Province. The participants' quality of life, including physical component summary (PCS) and mental component summary (MCS), was assessed by the 12-Item Short Form Survey, and the Body Fat Determination System measured muscle mass. A logistic regression model with adjustment for confounding factors was established to analyze the association between muscle mass and quality of life in different genders. Further, sensitivity and subgroup analyses were conducted to explore its stability. Finally, a restricted cubic spline was employed to investigate the dose-response relationship between muscle mass and quality of life in different genders. Results: A total of 20 595 participants were included, with an average age of 55.0, and 33.4% were male. After controlling for potential confounders, compared with the Q₁ group, the risk of low PCS was reduced by 20.6% (OR=0.794, 95%CI: 0.681-0.925) and the risk of low MCS was lower reduced by 20.1% (OR=0.799, 95%CI: 0.689-0.926) in female Q₅ groups. Compared with the Q₁ group, the risk of low PCS was reduced by 24.4% (OR=0.756, 95%CI: 0.644-0.888) in the male Q₂ group. However, no significant association between muscle mass and MCS in males has been found. In females, restricted cubic spline analysis showed a significant linear dose-response relationship between muscle mass and PCS and MCS. Conclusions: There is a positive association between muscle mass and quality of life in Shaanxi adults, especially females. With the increase in muscle mass, the physical and mental functions of the population continue to improve.
Humans ; Female ; Adult ; Male ; Quality of Life ; Cohort Studies ; Adipose Tissue ; China ; Muscles

Objective:To investigate the relationship between triglyceride glucose index (TyG) and body inflammation.Methods:The data were obtained from a baseline survey in population in Xi'an in natural population cohort study in northwest China established in 2018-2019. Based on TG and FPG, TyG/TyG-BMI was constructed to reflect insulin resistance (IR) in the body, and systemic immune-inflammation index (SII) reflecting inflammation in the body was constructed using neutrophil, lymphocyte, and platelet counts. A logistic regression model was used to explore the relationship between the TyG and the SII.Results:A total of 11 491 subjects were included in the analysis. After adjusting for covariates, each unit increase in the TyG increased the risk of high SII by 21% ( OR=1.21, 95% CI:1.12-1.30). The risk of high SII in the group with the TyG in Q4 was 1.34 times higher than that in the group Q1 ( OR=1.34, 95% CI:1.18-1.52). Both sensitivity analysis and subgroup analysis further confirmed the stability of the association between the TyG and the SII. In the population with a BMI ranging from 18.5 to 23.9 kg/m 2, for every unit increase in the TyG as a continuous variable, the risk for high SII increased by 31% ( OR=1.31, 95% CI:1.18-1.45). As a categorical variable, the risk for high SII in the Q4 group was 1.52 times higher than that in the Q1 group ( OR=1.52, 95% CI:1.27-1.83). In a population with BMIs ranging from 24.0 to 27.9 kg/m 2, for every unit increase in the TyG as a continuous variable, the risk for high SII increased by 20% ( OR=1.20, 95% CI:1.07-1.35), and there was no significant difference when it was a categorical variable. Conclusions:The increase in IR is closely related to the development of inflammation in the body, and BMI may regulate their relationship. Early prevention of elevated IR levels before overweight or obesity may have a positive effect on the control of inflammation in the body.

Objective:To investigate the effects of types of ulnar styloid process fracture on the treatment of distal radius fracture.Methods:The 80 patients were analyzed retrospectively who had been treated at The First Department of Hand Surgery, Honghui Hospital from January 2019 to January 2020 for fracture of distal radius complicated with fracture of ulnar styloid process. They were 25 males and 55 females, aged from 30 to 85 years (average, 58.6 years). According to the types of ulnar styloid process fracture, 40 patients were assigned into a Hauck type Ⅰ group and the other 40 into a Hauck type Ⅱ group. The 2 groups were compared in terms of operation, postoperative complications, hospital stay, bone union, visual analogue scale (VAS) on postoperative 1 to 3 days, and modified Mayo wrist function score, wrist range of motion and quality of life by WHOQOL-BREF at the last follow-up.Results:The 2 groups were comparable because there was no significant difference in age, gender, American Society of Anesthesiologists (ASA) rating, or time from injury to operation between them ( P>0.05). All the patients were followed up for 12 to 24 months (average, 17 months). There was no significant difference between Hauck type Ⅰ group and Hauck type Ⅱ group in operation time, intraoperative blood loss, hospital stay, rate of postoperative complications, fracture union, modified Mayo wrist function score or VAS on postoperative 1 to 3 days ( P>0.05). At the last follow-up, the palm tilt and ulnar inclination angles were 13.8°±1.9° and 21.6°±2.8° in Hauck type Ⅰ group, significantly larger than those in Hauck type Ⅱ group (11.9°±1.6° and 18.8°±2.3°) ( P<0.05). At the last follow-up, Hauck Ⅰ group scored 85.3±6.4,85.6±6.5, 84.7±6.3 and 85.0±6.7 respectively in the domains of physical health, psychology, environment and social relationships, significantly higher than those Hauck type Ⅱ group did (78.5±6.5, 78.9±6.5, 77.8±6.1 and 77.9±6.3) ( P<0.05). Conclusions:In open reduction and internal fixation for distal radius fracture, Hauck Type Ⅰ fracture of ulnar styloid process has no significant effect on the functional recovery of the wrist but Hauck Type Ⅱ fracture of ulnar styloid process may. Therefore, surgical fixation needs to be strengthened if Hauck Type Ⅱ fracture of ulnar styloid process is complicated.

Animals ; Coronary Vessels ; Diabetes Mellitus ; Muscle, Smooth, Vascular ; Myocytes, Smooth Muscle ; Rats

Altitude ; Exercise/physiology* ; Heart Rate/physiology* ; Humans ; Lung ; Respiration

Objective:To investigate the epidemiological characteristics, diagnosis, treat-ment and prognosis of gallbladder cancer in China from 2010 to 2017.Methods:The single disease retrospective registration cohort study was conducted. Based on the concept of the real world study, the clinicopathological data, from multicenter retrospective clinical data database of gallbladder cancer of Chinese Research Group of Gallbladder Cancer (CRGGC), of 6 159 patients with gallbladder cancer who were admitted to 42 hospitals from January 2010 to December 2017 were collected. Observation indicators: (1) case resources; (2) age and sex distribution; (3) diagnosis; (4) surgical treatment and prognosis; (5) multimodality therapy and prognosis. The follow-up data of the 42 hospitals were collected and analyzed by the CRGGC. The main outcome indicator was the overall survival time from date of operation for surgical patients or date of diagnosis for non-surgical patients to the end of outcome event or the last follow-up. Measurement data with normal distribu-tion were represented as Mean±SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented as M( Q1, Q3) or M(range), and com-parison between groups was conducted using the U test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test. Univariate analysis was performed using the Logistic forced regression model, and variables with P<0.1 in the univariate analysis were included for multivariate analysis. Multivariate analysis was performed using the Logistic stepwise regression model. The life table method was used to calculate survival rates and the Kaplan-Meier method was used to draw survival curves. Log-rank test was used for survival analysis. Results:(1) Case resources: of the 42 hospitals, there were 35 class A of tertiary hospitals and 7 class B of tertiary hospitals, 16 hospitals with high admission of gallbladder cancer and 26 hospitals with low admission of gallbladder cancer, respectively. Geographical distribution of the 42 hospitals: there were 9 hospitals in central China, 5 hospitals in northeast China, 22 hospitals in eastern China and 6 hospitals in western China. Geographical distribution of the 6 159 patients: there were 2 154 cases(34.973%) from central China, 705 cases(11.447%) from northeast China, 1 969 cases(31.969%) from eastern China and 1 331 cases(21.611%) from western China. The total average number of cases undergoing diagnosis and treatment in hospitals of the 6 159 patients was 18.3±4.5 per year, in which the average number of cases undergoing diagnosis and treatment in hospitals of 4 974 patients(80.760%) from hospitals with high admission of gallbladder cancer was 38.8±8.9 per year and the average number of cases undergoing diagnosis and treatment in hospitals of 1 185 patients(19.240%) from hospitals with low admission of gallbladder cancer was 5.7±1.9 per year. (2) Age and sex distribution: the age of 6 159 patients diagnosed as gallbladder cancer was 64(56,71) years, in which the age of 2 247 male patients(36.483%) diagnosed as gallbladder cancer was 64(58,71)years and the age of 3 912 female patients(63.517%) diagnosed as gallbladder cancer was 63(55,71)years. The sex ratio of female to male was 1.74:1. Of 6 159 patients, 3 886 cases(63.095%) were diagnosed as gallbladder cancer at 56 to 75 years old. There was a significant difference on age at diagnosis between male and female patients ( Z=-3.99, P<0.001). (3) Diagnosis: of 6 159 patients, 2 503 cases(40.640%) were initially diagnosed as gallbladder cancer and 3 656 cases(59.360%) were initially diagnosed as non-gallbladder cancer. There were 2 110 patients(34.259%) not undergoing surgical treatment, of which 200 cases(9.479%) were initially diagnosed as gallbladder cancer and 1 910 cases(90.521%) were initially diagnosed as non-gallbladder cancer. There were 4 049 patients(65.741%) undergoing surgical treatment, of which 2 303 cases(56.878%) were initially diagnosed as gallbladder cancer and 1 746 cases(43.122%) were initial diagnosed as non-gallbladder cancer. Of the 1 746 patients who were initially diagnosed as non-gallbladder cancer, there were 774 cases(19.116%) diagnosed as gallbladder cancer during operation and 972 cases(24.006%) diagnosed as gallbladder cancer after operation. Of 6 159 patients, there were 2 521 cases(40.932%), 2 335 cases(37.912%) and 1 114 cases(18.087%) undergoing ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) examination before initial diagnosis, respec-tively, and there were 3 259 cases(52.914%), 3 172 cases(51.502%) and 4 016 cases(65.205%) undergoing serum carcinoembryonic antigen, CA19-9 or CA125 examination before initially diagnosis, respectively. One patient may underwent multiple examinations. Results of univariate analysis showed that geographical distribution of hospitals (eastern China or western China), age ≥72 years, gallbladder cancer annual admission of hospitals, whether undergoing ultrasound, CT, MRI, serum carcinoembryonic antigen, CA19-9 or CA125 examination before initially diagnosis were related factors influencing initial diagnosis of gallbladder cancer patients ( odds ratio=1.45, 1.98, 0.69, 0.68, 2.43, 0.41, 1.63, 0.41, 0.39, 0.42, 95% confidence interval as 1.21-1.74, 1.64-2.40, 0.59-0.80, 0.60-0.78, 2.19-2.70, 0.37-0.45, 1.43-1.86, 0.37-0.45, 0.35-0.43, 0.38-0.47, P<0.05). Results of multivariate analysis showed that geographical distribution of hospitals (eastern China or western China), sex, age ≥72 years, gallbladder cancer annual admission of hospitals and cases undergoing ultrasound, CT, serum CA19-9 examination before initially diagnosis were indepen-dent influencing factors influencing initial diagnosis of gallbladder cancer patients ( odds ratio=1.36, 1.42, 0.89, 0.67, 1.85, 1.56, 1.57, 0.39, 95% confidence interval as 1.13-1.64, 1.16-1.73, 0.79-0.99, 0.57-0.78, 1.60-2.14, 1.38-1.77, 1.38-1.79, 0.35-0.43, P<0.05). (4) Surgical treatment and prognosis. Of the 4 049 patients undergoing surgical treatment, there were 2 447 cases(60.435%) with complete pathological staging data and follow-up data. Cases with pathological staging as stage 0, stage Ⅰ, stage Ⅱ, stage Ⅲa, stage Ⅲb, stage Ⅳa and stage Ⅳb were 85(3.474%), 201(8.214%), 71(2.902%), 890(36.371%), 382(15.611%), 33(1.348%) and 785(32.080%), respectively. The median follow-up time and median postoperative overall survival time of the 2 447 cases were 55.75 months (95% confidence interval as 52.78-58.35) and 23.46 months (95% confidence interval as 21.23-25.71), respectively. There was a significant difference in the overall survival between cases with pathological staging as stage 0, stage Ⅰ, stage Ⅱ, stage Ⅲa, stage Ⅲb, stage Ⅳa and stage Ⅳb ( χ2=512.47, P<0.001). Of the 4 049 patients undergoing surgical treatment, there were 2 988 cases(73.796%) with resectable tumor, 177 cases(4.371%) with unresectable tumor and 884 cases(21.833%) with tumor unassessable for resectabi-lity. Of the 2 988 cases with resectable tumor, there were 2 036 cases(68.139%) undergoing radical resection, 504 cases(16.867%) undergoing non-radical resection and 448 cases(14.994%) with operation unassessable for curative effect. Of the 2 447 cases with complete pathological staging data and follow-up data who underwent surgical treatment, there were 53 cases(2.166%) with unresectable tumor, 300 cases(12.260%) with resectable tumor and receiving non-radical resection, 1 441 cases(58.888%) with resectable tumor and receiving radical resection, 653 cases(26.686%) with resectable tumor and receiving operation unassessable for curative effect. There were 733 cases not undergoing surgical treatment with complete pathological staging data and follow-up data. There was a significant difference in the overall survival between cases not undergoing surgical treatment, cases undergoing surgical treatment for unresectable tumor, cases undergoing non-radical resection for resectable tumor and cases undergoing radical resection for resectable tumor ( χ2=121.04, P<0.001). (5) Multimodality therapy and prognosis: of 6 159 patients, there were 541 cases(8.784%) under-going postoperative adjuvant chemotherapy and advanced chemotherapy, 76 cases(1.234%) under-going radiotherapy. There were 1 170 advanced gallbladder cancer (pathological staging ≥stage Ⅲa) patients undergoing radical resection, including 126 cases(10.769%) with post-operative adjuvant chemotherapy and 1 044 cases(89.231%) without postoperative adjuvant chemo-therapy. There was no significant difference in the overall survival between cases with post-operative adjuvant chemotherapy and cases without postoperative adjuvant chemotherapy ( χ2=0.23, P=0.629). There were 658 patients with pathological staging as stage Ⅲa who underwent radical resection, including 66 cases(10.030%) with postoperative adjuvant chemotherapy and 592 cases(89.970%) without postoperative adjuvant chemotherapy. There was no significant difference in the overall survival between cases with postoperative adjuvant chemotherapy and cases without postoperative adjuvant chemotherapy ( χ2=0.05, P=0.817). There were 512 patients with pathological staging ≥stage Ⅲb who underwent radical resection, including 60 cases(11.719%) with postoperative adjuvant chemotherapy and 452 cases(88.281%) without postoperative adjuvant chemotherapy. There was no significant difference in the overall survival between cases with postoperative adjuvant chemo-therapy and cases without post-operative adjuvant chemo-therapy ( χ2=1.50, P=0.220). Conclusions:There are more women than men with gallbladder cancer in China and more than half of patients are diagnosed at the age of 56 to 75 years. Cases undergoing ultrasound, CT, serum CA19-9 examination before initial diagnosis are independent influencing factors influencing initial diagnosis of gallbladder cancer patients. Preoperative resectability evaluation can improve the therapy strategy and patient prognosis. Adjuvant chemotherapy for gallbladder cancer is not standardized and in low proportion in China.

OBJECTIVES: To analyze the characteristics of diphenidol poisoning cases and to provide clues and technical means for the identification of such cases. METHODS: Biological samples of 9 deaths caused by diphenidol poisoning were detected by ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS), and the characteristics of these cases were analyzed retrospectively. RESULTS: Most of the deaths caused by diphenidol poisoning were young females. The dosage was between 60 and 300 tablets, and the mass concentration of diphenidol in the postmortem blood ranged from 0.87 to 99.00 μg/mL. There was no correlation between the dosage and the concentration of diphenidol in the blood. CONCLUSIONS Diphenidol poisoning has the characteristics of high concealment and lethality. More attention should be paid to suicide cases, and diphenidol should be recommended as a routine detection item to avoid missing detection.
Female ; Humans ; Chromatography, Liquid/methods* ; Tandem Mass Spectrometry/methods* ; Retrospective Studies ; Administration, Oral