Phase Ⅰ clinical trials play a crucial role in the research and development of new drugs, serving as the initial studies to assess their safety, tolerability, effectiveness, and pharmacokinetic properties in humans. These trials involve uncertainties regarding safety and efficacy. Comprehensive management of all aspects of phase Ⅰ clinical trials for anti-tumor drugs is crucial to protect the rights and safety of participants. This article provides an in-depth analysis of the key points and precautions necessary for effective quality control throughout the process. The analysis is informed by guidelines such as the “Good Clinical Practice for Drugs” “Key Points and Judgment Principles for Drug Registration Verification” “Key Points and Judgment Principles for Supervision and Inspection of Drug Clinical Trial Institutions” and the standard operating procedures for quality control of the center. Topics discussed include informed consent, inclusion criteria, experimental drugs, biological samples, adverse events, and serious adverse events. The goal is to standardize quality control in phase Ⅰ clinical trials of anti-tumor drugs, ensure the authenticity and reliability of clinical trial data, and protect the rights and safety of participants.

Objective To investigate the impact of donor kidney histopathological lesions on the risk of BK virus (BKV) infection and progression after kidney transplantation. Methods A retrospective analysis was conducted on the clinical data of 326 kidney transplant recipients from deceased donors at the Department of Kidney Transplantation, the First Affiliated Hospital of Zhengzhou University, from January 2019 to June 2020. The recipients were divided into two groups based on whether BKV infection occurred after kidney transplantation: the BKV infection group (145 cases) and the non-BKV infection group (181 cases). The correlation between donor kidney histopathological findings from zero-hour biopsy and BKV infection, as well as the impact on the risk and progression of BKV infection, was analyzed. Results The incidence of BKV infection among the 326 kidney transplant recipients was 44.5% (145/326). The clearance rate of BKV after infection was 82.1% (119/145), while 17.9% (26/145) progressed to BKV viremia. Among the 326 qualified kidney biopsy specimens, 32 cases showed mild tubular atrophy, 324 cases had mild acute tubular injury, 27 cases exhibited mild hyaline arteriosclerosis, 10 cases had moderate to severe hyaline arteriosclerosis, 7 cases showed mild interstitial inflammation, 23 cases had mild interstitial fibrosis, 6 cases exhibited mild arterial intimal fibrosis, and 1 case had moderate to severe arterial intimal fibrosis. Multivariate logistic regression analysis revealed that male recipients, donor age and tubular atrophy were independent risk factors for BKV infection (all P<0.05). Tubular atrophy was also an independent risk factor for the progression from BKV uria to BKV viremia (P<0.05). Conclusions Donor kidney histopathological lesions have a certain impact on BKV infection and progression after kidney transplantation. Patients with more severe tubular atrophy in donor kidneys have a higher risk of BKV infection after kidney transplantation and are more likely to progress to BKV viremia.

Objective: To analyze the adverse treatment outcome status and spatio temporal characteristics of pulmonary tuberculosis cases among students in Qinghai Province, providing a reference basis for pulmonary tuberculosis prevention and control in schools. Methods: The data of student pulmonary tuberculosis cases during 2013-2023 in Qinghai Province were obtained through the "National Tuberculosis Management Information System", and the treatment outcome was retrospectively analyzed. The Joinpoint model was applied to analyze the adverse outcome rate trend. Global and local spatial autocorrelation analysis, and spatiotemporal scan cluster analysis were conducted on the adverse outcome rate of pulmonary tuberculosis among students in Qinghai Province. Results: During 2013-2023, 488 cases of adverse outcomes were reported among 6 155 students with pulmonary tuberculosis in Qinghai Province, with an adverse outcome rate of 7.93%. The reporting adverse outcome rate of pulmonary tuberculosis among students showed a downward trend from 2013 to 2023 (APC=-16.20, t =-3.89, P <0.05). The results of spatial autocorrelation showed that the adverse outcome rate of pulmonary tuberculosis was Moran s I >0 among students in Qinghai Province. Among them, there was a spatially positive correlation in the adverse outcome rate of pulmonary tuberculosis among students in 2020, 2021 and 2022(all Z >1.96, all P <0.05). The results of clustering and outlier analysis in local spatial autocorrelation showed that the areas with high high aggregation were mainly concentrated in Yushu Prefecture(Zhiduo County, Zaduo County, Nangqian County, Yushu City), Huangnan Prefecture (Zeku County, Henan County) and Hainan Prefecture (Tongde County). The low low concentration areas were distributed in Haidong City, Xining City, Haibei Prefecture (Gangcha County, Qilian County), Haixi Prefecture (Tianjun County, Ulan County), Hainan Prefecture (Gonghe County, Guide County) and Huangnan Prefecture (Tongren City, Jianzha County). The spatio temporal scanning showed that a total of two possible aggregation areas had been detected. Among them, the first level aggregation area composed of 10 counties and districts in Yushu Prefecture and Guoluo Prefecture of Qinghai Province, and the cluster radius was 658.09 km, the RR was 10.58 , and the LLR was 305.91; the second level aggregation area was composed of 16 counties and districts in Hainan Prefecture, Haixi Prefecture, Huangnan Prefecture and Guoluo Prefecture, and the cluster radius was 407.02 km, the RR was 9.83, and the LLR was 152.48 (both P <0.05). Conclusions The reporting rates of adverse treatment outcome of pulmonary tuberculosis cases among students in Qinghai Province remain relatively high and unevenly distribute throughout the province. Supervision should be strengthened to improve cases compliance,and to reduce student pulmonary tuberculosis adverse treatment outcomes incidence.

OBJECTIVE: To review the clinical characteristics of patients with traumatic spinopelvic dissociation (SPD) and explore the diagnostic and therapeutic methods. METHODS: A clinical data of 22 patients with SPD who underwent surgical treatment between March 2019 and August 2024 was retrospectively analyzed. There were 13 males and 9 females, with an average age of 35.5 years (range, 14-61 years). The causes of injury included falling from height in 16 cases, traffic accidents in 5 cases, and compression injury in 1 case. Sacral fractures were classified based on morphology into "U" type (9 cases), "H" type (7 cases), "T" type (4 cases), and "λ" type (2 cases). According to the Roy-Camille classification, there were 4 cases of type Ⅰ, 12 cases of type Ⅱ, 2 cases of type Ⅲ, and 4 cases of type Ⅳ. The Cobb angle was (35.7± 22.0)°. Sixteen patients were accompanied by lumbosacral trunk and cauda equina nerve injury, which was classified as grade Ⅱ in 5 cases, grade Ⅲ in 5 cases, and grade Ⅳ in 6 cases according to the Gibbons grading. The time from injury to operation was 2-17 days (mean, 5.7 days). Based on the type of sacral fracture and sacral nerve injury, 6 cases were treated with closed reduction and minimally invasive percutaneous sacroiliac screw fixation, 16 cases were treated with open reduction and lumbar iliac fixation (8 cases)/triangular fixation (8 cases). Among them, 11 patients with severe fracture displacement and kyphotic deformity leading to sacral canal stenosis or bony impingement within the sacral foramen underwent laminectomy and sacral nerve decompression. X-ray films and CT were reviewed during followed-up. The Matta score was used to evaluate the quality of fracture reduction. At last follow-up, the Majeed score was used to assess the functional recovery, and the Gibbons grading was used to evaluate the nerve function. RESULTS: All operations were successfully completed. All patients were followed up 8-64 months (mean, 20.4 months). Two patients developed deep vein thrombosis of the lower limbs, 2 had incision infections, and 1 developed a sacral pressure ulcer; no other complications occurred. Radiological examination showed that the Cobb angle was (12.0±6.8)°, which was significantly different from the preoperative one ( t=6.000, P<0.001). The Cobb angle in 16 patients who underwent open reduction was (14.9±5.5)°, which was significantly different from the preoperative one [(46.8±13.9)° ] ( t=8.684, P<0.001). According to the Matta scoring criteria, the quality of fracture reduction was rated as excellent in 8 cases, good in 7 cases, fair in 5 cases, and poor in 2 cases, with an excellent and good rate of 68.2%. Bone callus formation was observed at the fracture site in all patients at 12 weeks after operation, and bony union achieved in all cases at last follow-up, with a healing time ranging from 12 to 36 weeks (mean, 17.6 weeks). At last follow-up, the Majeed score was rated as excellent in 7 cases, good in 10 cases, fair in 4 cases, and poor in 1 case, with an excellent and good rate of 77.3%. One patient experienced a unilateral iliac screw breakage at 12 months after operation, but the fracture had already healed, and there was no loss of reduction. Among the 16 patients with preoperative sacral nerve injury, 11 cases showed improvement in nerve function (6 cases) or recovery (5 cases). CONCLUSION SPD with low incidence, multiple associated injuries, and high incidence of sacral nerve injury, requires timely decompression of the sacral canal for symptomatic sacral nerve compression, fractures reduction, deformities correction, and stable fixation.
Humans ; Adult ; Female ; Male ; Retrospective Studies ; Middle Aged ; Spinal Fractures/diagnostic imaging* ; Adolescent ; Sacrum/diagnostic imaging* ; Fracture Fixation, Internal/methods* ; Young Adult ; Pelvic Bones/surgery* ; Treatment Outcome ; Bone Screws

Digital technologies have become an integral part of complete denture restoration. With advancement in computer-aided design and computer-aided manufacturing (CAD/CAM), tools such as intraoral scanning, facial scanning, 3D printing, and numerical control machining are reshaping the workflow of complete denture restoration. Unlike conventional methods that rely heavily on clinical experience and manual techniques, digital technologies offer greater precision, predictability, and efficacy. They also streamline the process by reducing the number of patient visits and improving overall comfort. Despite these improvements, the clinical application of digital complete denture restoration still faces challenges that require further standardization. The major issues include appropriate case selection, establishing consistent digital workflows, and evaluating long-term outcomes. To address these challenges and provide clinical guidance for practitioners, this expert consensus outlines the principles, advantages, and limitations of digital complete denture technology. The aim of this review was to offer practical recommendations on indications, clinical procedures and precautions, evaluation metrics, and outcome assessment to support digital restoration of complete denture in clinical practice.
Humans ; Denture, Complete ; Computer-Aided Design ; Denture Design/methods* ; Consensus ; Printing, Three-Dimensional

Objective: To explore the facilitating and hindering factors of mental health promotion activities in junior and senior high schools from teachers perspectives, as well as coping strategies, so as to provide evidence for implementing teacher led mental health promotion programs. Methods: From September 2023 to September 2024, by using purposive sampling method, 5 junior high schools, 5 regular high schools, 2 vocational high schools in four provinces and municipalities (Tianjin, Shanxi, Shandong, and Jiangxi) were selected. A total of 92 teachers (78 homeroom teachers and 14 full time or part time psychological counselors) were interviewed using semi structured focus group discussions (one session per school, totaling 12 sessions). Thematic analysis was applied to code and analyze the interview transcripts. Results: The implementation of mental health promotion activities in middle schools was influenced by three levels: teachers, schools and society. Specifically, teachers exhibited a high support low capability phenomenon (81 participants supported conducting such activities, but 71 felt lacking in professional capacity); activity effectiveness and support systems were imbalanced (42 mentioned significant effects, while 78 reported insufficient support); there was a mismatch between student demand and activity content (9 mentioned students had psychological needs, but 11 indicated existing activities failed to meet these needs); administrative support and sustainability showed disparities (14 believed sufficient administrative support existed, while 37 noted sustainability issues); parental awareness and participation remained inadequate (11 highlighted parents need for mental health knowledge, and 37 perceived insufficient understanding of psychological issues among parents). Effective strategies included enhancing teachers effectiveness, providing essential skill training, focusing on the needs of teenagers,enhancing program sustainability, and eliminating misconceptions about mental health among parents. Conclusion Mental health promotion activities in junior and senior high schools should focus on enhancing teachers skills, improving activity sustainability, reducing stigma among parents, and establishing a collaborative network for school based mental health promotion.

Objectives:Quantitative flow ratio(QFR)is a coronary angiography-derived functional test without the need of guidewire use.Fractional flow reserve(FFR)is used as the reference standard to verify the diagnostic value of QFR in patients with non-ST-segment elevation acute coronary syndrome(NSTE-ACS)with coronary critical lesion(40%-70%stenosis)and functional stenosis. Methods:This retrospective analysis included patients with NSTE-ACS who were admitted to Fuwai Central China Cardiovascular Hospital from June 1,2018 to February 1,2023 and underwent coronary FFR examination.QFR values of target vessels were analyzed offline by AngioPlus(Shanghai Pulsation Medical Imaging Technology Co.,LTD.),the second-generation QFR detector,and anatomical parameters of the diseased vessels were recorded as follows:minimal luminal diameter(MLD),percent diameter stenosis(DS%),minimal luminal area(MLA),percent area stenosis(AS%).Functional coronary artery stenosis is defined as FFR≤0.80. Results:Using FFR as the gold standard,the AUC values of contrast-flow QFR(cQFR)and fixed-flow QFR(fQFR)for identifying functional coronary artery stenosis in NSTE-ACS patients were 0.829(95%CI:0.773-0.885,P<0.001)and 0.821(95%CI:0.766-0.875,P<0.001),respectively.The diagnostic accuracy,sensitivity and specificity of cQFR and fQFR were 81.30%,56.00%,98.63%and 76.83%,59.00%,99.04%,respectively.DeLong test showed that diagnostic performance of cQFR was significantly better than fQFR in diagnosing functional stenosis of coronary critical lesions in patients with NSTE-ACS. Conclusions:With FFR as the gold standard,QFR(especially cQFR)has certain diagnostic value in patients with NSTE-ACS with functional stenosis of coronary critical lesions.

Objective:To analyze the clinic effects of arthroscopic partial trapeziectomy and suture button suspensionplasty in the treatment of first carpometacarpal joint (CMCJ) Eaton stage II/III arthrosis.Methods:A retrospective study was conducted on a total of 15 cases (16 hands) of patients including 5 males (1 bilateral) and 10 females with CMCJ stage II/III arthrosis who underwent surgical treatment at the first affiliated hospital of Shenzhen university from January 2020 to June 2022, with mean age of 56.7±6.4 years (range, 46-75 years). The duration from pain to treatment was 7.8±3.2 months (range, 4-14 months). X-ray showed narrowing of CMCJ with osteophytes and distal radial subluxation. All the patients were treated with arthroscopic partial trapeziectomy and suture button suspensionplasty. The preoperative and last postoperative follow-up radiographs, visual analogue scale (VAS), thumb's Kapandji scores, disabilies of the arm, shoulder, and hand (DASH) scores, grip and pinch strength and time to return to work were compared.Results:All cases were followed up for 19.6±6.3 months (range, 11-36 months). The postoperative X-ray showed all the CMCJs were reduced with a normal height of first metacarpal. The mean time for patients to return to their daily activities was 18.69±3.70 d and the mean time to return to work was 24.63±4.91 d. The average VAS score decreased from 6.56±1.15 preoperatively to 1.00 (0.75, 1.25). The preoperative Kapandji's score was 8.00±0.82 and the postoperative Kapandji's score was 8.00 (7.25, 9.00). The average DASH values improved from 24.06±3.19 to 4.00 (3.00, 5.00). The were significant differences except for Kapandji score ( Z=-4.905, P<0.001; Z=-0.121, P=0.905; Z=-4.846, P<0.001). The mean grip and pinch strength showed improvement from an average of 16.4 (14.13, 18.68) kg and 1.70±0.35 kg to 26.14±3.27 kg and 3.58±0.91 kg with significant difference ( Z=-4.617, P<0.001; t=-7.669, P<0.001). Conclusion:Arthroscopic partial trapeziectomy and suture button suspensionplasty is a minimally invasive surgery for the treatment of first CMCJ Eaton stage II/III arthrosis. By this technique, the patients' existing instability and pain problems can be solved.

Objective : Mendelian randomization analysis was used to explore the causal relationship of T．gondii in- fection and the cyst distribution and inflammation in brain tissue by immunohistochemistry． Methods : Genome- wide association analysis data of T．gondii infection and encephalitis were obtained ，single nucleotide polymor- phisms (SNPs) were selected，Mendelian randomization analysis was conducted by inverse variance weighting，and the causal relationship between T．gondii infection and encephalitis was evaluated by OR value and 95% CI．Quality control was carried out by using heterogeneity test，horizontal multi-efficiency test and leave-one-out sensitivity test. Immunohistochemical staining was performed using brain sections of mice infected with tissue cysts of Wh6 strain for image analysis using Image J software. Results : A total of 29 SNPs were associated with toxoplasmic encephalitis. The results of IVW method suggested that T．gondii infection made encephalitis risk 0. 98 times higher ( OR = 0. 98， 95% CI = 0. 76 to 1. 27) ，indicating no causal relationship between the two．The quality control results suggested that the selected SNPs were stable and reliable．Toxoplasma cysts were distributed in various parts of the brain tis- sue． Conclusion T．gondii infection and encephalitis are related，but there is no sufficient evidence to prove the causal relationship between the two.