Virtual clinical trials are clinical trials conducted through computer simulation technology, which breaks through the limitations of traditional clinical trials and has the advantages of saving time, reducing costs, and reducing the risk of human trials. With the application of new computer technologies such as population pharmacokinetics, physiologically-based pharmacokinetics, quantitative systems pharmacology, and artificial intelligence, the field of virtual clinical trials in healthcare has become an important development direction. This article will give a preliminary review of the connotation, methods and future development trends of virtual clinical trials, aiming to provide reference for the application of new technologies and methods in clinical trials.
Population pharmacokinetics is a research technique based on computer simulation and data analysis, and it has been employed to investigate the dynamic behavior of drug metabolism in different populations. This approach could address practical challenges such as prolonged clinical trial durations, high costs, and increased difficulty in traditional clinical trials. By comprehensively analyzing differences in the internal drug metabolism processes across populations with varying physiological and pathological conditions, population pharmacokinetics has emerged as an effective method to optimize drug development and clinical applications. This article provides a preliminary overview of the essence of population pharmacokinetics, its application in clinical trials, and potential future trends. We hope to serve as a reference and guidance for the application of new technologies and methods in clinical trials.
Objective To systematically evaluate and comparatively analyze the mental health status of adolescents with different genders in middle schools of China, and to provide scientific evidence for the improvement of adolescents’ mental health level. Methods Such databases as CNKI, VIP, WanFang Data, and CBM (1989 to Dec, 2009) were searched. Data were extracted from the included literature and RevMan 4.2 software was used for meta-analyses. Results Twenty-seven original literatures were included. The results of meta-analyses showed: the total anxious trend of girls was higher than that of boys (OR= –?2.14, 95%CI –?2.93 to –?1.35, Plt;0.000 01); the result of each scale displayed that girls scored higher than boys in terms of study-anxiety (OR= –?0.53, 95%CI –?0.67 to –?0. 39, Plt;0.00001), social-anxiety (OR= –?0.30, 95%CI –?0.45 to –?0.15, Plt;0.000 1), self-accusation trend (OR= –?0.30, 95%CI –?0.46 to –?0.13, Plt;0.000 6), allergy trend (OR= –?0.18, 95%CI 0.31 to –?0.05, P=0.008), body symptom (OR= –0.21, 95%CI –0.34 to –0.08, P=0.001), and phobia trend (OR= –?0.80, 95%CI –?0.91 to –?0.68, Plt;0.000 01); No significant differences were identified between boys and girls in terms of solitude trend (OR=0.09, 95%CI –?0.04 to 0.22, P=0.2) and actuation trend (OR=0.06, 95%CI –?0.15 to 0.28, P=0.56). Conclusion Targeted measures should be taken for adolescent mental health education, especially for girls.
Objective To investigate the molecular mechanisms by which the long non-coding RNA (lncRNA) MIR223HG affects the proliferation, migration and apoptosis of lung adenocarcinoma cells. MethodsDNA damaging agent Zeocin was used to treat human embryo lung cell (MRC-5) and lung cancer cell (A549 and H1299), and the expression of MIR223HG was tested by quantitative real-time polymerase chain reaction (qRT-PCR) analysis. Moreover, the ataxia-telangiectasia mutated (ATM) protein and ATM pathway downstream factor Cell cycle checkpoint kinase 2 (Chk2), p53 tumor suppressor protein (p53) in the lung cancer cell (A549 and H1299) with Zeocin were also tested by qRT-PCR. Cell transfection and Transwell migration assay, colony formation assays, apoptosis assays were performed to verify the role of ATM in the expression of MIR223HG in lung adenocarcinoma. ResultsThe expression of MIR223HG was reduced markedly in the lung cancer cells (A549 and H1299) compared with human embryo lung cell (MRC-5) after treated with Zeocin. ATM protein and its downstream factors Chk2, p53 involved in the process, and ATM regulated the expression of MIR223HG in the lung cancer cells with Zeocin. Futhermore, ATM joined in the processes that MIR223HG regulated the lung cancer cells proliferation, migration and apoptosis. Conclusions The expression of MIR223HG is related to the DNA damage response in the lung cancer, and MIR223HG regulates lung cancer cells proliferation, migration and apoptosis by ATM/Chk2/p53 pathway. MIR223HG may be a potential therapeutic target for lung adenocarcinoma treatment.
Objective To evaluate the safety and tolerance of pegfilgrastin (PEG-G-CSF) in Chinese healthy volunteers. Methods Thirty healthy volunteers were randomly divided into five single-dose groups to receive PEG-G-CSF 15, 30, 50, 60 or 75μg/kg by hypodermic injection. The safety profile and tolerability were evaluated by observing symptoms, vital signs, laboratory tests and electro cardiogram. Results No serious adverse event was reported for any volunteer. Transient dizziness occurred in one person in the 50 μg/kg dose group, and mild dizziness and ostalgia was found in all six people in the 75μg/kg dose group, of whom one experienced transient fever and two experienced mild diarrhea. No clinically significant changes in laboratory tests and electrocardiogram were found during the follow-up period. Conclusions The maximum tolerated dose of PEG-G-CSF injection in Chinese healthy volunteers is 60 μg/kg. Doses below 60μg/kg can be well tolerated. The recommended dose for phase II clinical trials is 60 μg/kgone, one dose for each cycle of chemotherapy.
目的 評價LB-SDS2.0型酸性氧化電位水生成機生成的酸性氧化電位水對皮膚（手）消毒的有效性和安全性。 方法 2006年2月－8月將90例健康志愿受試者隨機分為3組，各組30例。A組用LB-SDS2.0型酸性氧化電位水生成機生成的酸性氧化電位水（試驗產品）消毒2 min，B組用試驗產品消毒4 min，C組（對照組）用聚維酮碘溶液擦拭3 min。檢測消毒后菌落總數和致病菌，以及受試者不良反應情況。 結果 按照Ⅲ類區域工作人員洗手消毒標準，A、C組合格率均為100%，B組為96.7%；按照Ⅰ、Ⅱ類區域工作人員洗手消毒標準，A組合格率為86.7%；B組合格率為93.3%，C組合格率為100%。各組受試者試驗后生命體征均無臨床意義的改變，未出現任何不良反應。 結論 試驗產品消毒手是安全有效的，可推薦用在Ⅲ類區域工作人員中使用，并進一步觀察其安全性和有效性。建議擴大樣本含量進一步評價其試驗產品是否適用于Ⅰ、Ⅱ類區域工作人員洗手消毒。
Objective To evaluate the clinical efficacy and safety of sparfioxacin in treatment of the acute respiratory tract infections. Methods A randomized-controlled clinical trial was carried out. Sparfloxaein 200 mg once daily and ofioxacin, as a control drug, 200 mg twice a day, both drugs were given by infusion for 7-14 days. There were 30 cases in each group. Results The clinical cure rates and the clinical efficacy rates of the two groups were 33.33%, 26.67%, and 80.00%, 76.67 % respectively. The bacterial clearance rates were 89.66% and 89.29% respectively. The adverse drug reaction rates were 13.33% and 16.67% respectively. There were no statistical differences between the two groups (Pgt;0.05). Photosensitive reaction was not observed in this study. Conclusion Sparfloxacin was effective in the treatment of the respiratory infections.
Objective To evaluate the clinical efficacy and safety of pazufloxacin for the treatment of moderate and severe acute bacterial respiratory infections.Methods A multicenter randomized controlled trial was conducted to compare the efficacy and safety of pazufloxacin versus levofloxacin. Patients in the pazufloxacin group were treated with pazufloxacin (500 mg twice daily for 7 to 10 days), and patients in the levofloxacin group were treated with levofloxacin (300 mg twice daily for 7 to 10 days). Results A total of 134 patients were enrolled in the study, 68 cases in pazufloxacin group and 66 cases in levofloxacin group were assessable for clinical efficacy by full analysis set(FAS). At the end of the treatment, in FAS analysis the total cure rates and effective rates were 52.9% and 86.7% in pazufloxacin group, 57.6% and 87.9% in levofloxacin group, in PPS analysis the total cure rats and effective rates were 57.1% and 93.7% in pazufloxacin group respectively, 61.3% and 93.6% in levofloxacin group. The bacterial clearance rates were 92.5% and 94.3% respectively. There were no statistically significant differences between the two groups. Adverse reactions were observed in 16.2% of patients in the pazufloxacin group and in 16.7% of patients in the levofloxacin group. These reactions were mainly local stimulation, nausea and diarrhea. No serious adverse event was reported in either group. Conclusion Pazufloxacin is as effective and safe as levofloxacin for the treatment of moderate to severe acute respiratory infections.
The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.
目的 采用高效液相色譜法測定受試者口服埃索美拉唑腸溶膠囊與埃索美拉唑鎂腸溶片后血藥濃度，評價埃索美拉唑腸溶膠囊的生物等效性。 方法 2009年9月－10月，36例健康男性受試者單次交叉口服埃索美拉唑腸溶膠囊（試驗制劑）和埃索美拉唑鎂腸溶片（參比制劑），測定給藥后不同時間點血漿中埃索美拉唑經時血藥濃度，采用DAS 2.0軟件進行藥物代謝動力學參數計算和生物等效性評價。 結果 受試者單次口服試驗制劑與參比制劑后，達峰時間分別為（2.19 ± 0.96）、（2.43 ± 0.92） h，峰濃度分別為（1 748.86 ± 615.81）、（1 442.92 ± 476.41） μg/L，藥時曲線下面積（AUC）0-t分別為（3 927.14 ± 1 839.10）、（3 878.79 ± 1 734.84） μg/L·h，AUC0-∞分別為（3 998.36 ± 1 866.22）、（3 918.31 ± 1 773.44） μg/L·h。試驗制劑與參比制劑的生物等效性為94.0%，其90%CI為（82.3%，107.2%）。 結論 埃索美拉唑腸溶膠囊與埃索美拉唑鎂腸溶片生物等效。