Objective:To characterize the drug-drug interaction (DDI) profile of the novel, long-acting GLP-1 receptor agonist ecnoglutide (XW003) with two widely co-prescribed drugs: metformin and narrow therapeutic index agent, warfarin. Methods:In this open-label, fixed-sequence, crossover study, 28 healthy participants received a single dose of warfarin and multiple doses of metformin, both with and without steady-state XW003 coadministration. The primary endpoint was the comparison of systemic exposure, assessed by whether the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) of key pharmacokinetic (PK) parameters fell within the 80.00%-125.00% no-effect bounds. The pharmacodynamic (PD) impact on warfarin was evaluated via International Normalized Ratio (INR). Results:Coadministration of XW003 did not clinically alter the total systemic exposure (AUC) of metformin or of either S- or R-warfarin enantiomer, as all corresponding GMRs and 90% CIs for AUC met the pre-specified no-effect criteria. While modest reductions in Cmax and delays in Tmax were observed for both object drugs, warfarin's anticoagulant activity remained unaffected, with INR profiles showing no clinically relevant changes. The safety profile of XW003 was consistent with the GLP-1 receptor agonist class. Conclusion:The findings demonstrate the absence of a clinically significant interaction between XW003 and either metformin or warfarin. This supports the concomitant use of XW003 with these medications without dose adjustment, providing crucial evidence for its safe application in real-world clinical practice where polypharmacy is common.

AIM:Evaluate ecnoglutide (XW003) effects on rosuvastatin and digoxin pharmacokinetics (PKs) in healthy adults. METHODS:This was an open-label, single-sequence crossover Phase 1 study. Eligible participants received rosuvastatin (10 mg, single dose) and digoxin (0.25 mg, single dose) in two periods: Once before subcutaneous treatment with ecnoglutide and once during steady-state subcutaneous ecnoglutide (1.2 mg). Coadministration effect was assessed via PK parameters of both drugs. RESULTS:A total of 28 volunteers received at least one dose of study drug. Co-administration of ecnoglutide did not affect rosuvastatin and digoxin to a clinically relevant degree. For the area under the concentration-time curve from time zero to infinity, the geometric mean (GM) ratio (with ecnoglutide vs. alone) [90% confidence interval (CI)] was 106% (94%, 120%) for rosuvastatin and 84% (76%, 94%) for digoxin. Additionally, the maximum plasma concentration (C max) of digoxin decreased from 1.39 to 1.31 ng/mL but remained within the therapeutic window. The most common adverse events (AEs) were weight loss and gastrointestinal AEs, which are pharmacologically associated with glucagon-like peptide-1 (GLP-1). No serious AEs were reported. Notably, ecnoglutide treatment led to substantial body weight reduction, with a mean decrease of 11.2% across the 14-week intervention. CONCLUSION:Based on the PK and safety evaluations, ecnoglutide does not cause clinically significant PK interactions with rosuvastatin or digoxin. Consequently, no dose adjustments for rosuvastatin or digoxin are required when ecnoglutide is co-administered. However, close clinical and plasma monitoring is advised during the coadministration of digoxin, especially in patients with renal impairment.

Polyphenolic flavonoids have shown promising therapeutic effects in spinal cord injury (SCI) due to their outstanding antioxidative and anti-inflammatory functions. However, some of their inherent physicochemical properties such as poor water solubility, low stability and bioavailability, and strong biological metabolism, severely limit the clinical applications. Moreover, the current polyphenolic flavonoid delivery systems have some problems such as sophisticated preparation processes, low yields, high cost, and lack of targeted traceless release. To address those critical issues, we have proposed a general, facile and robust delivery strategy to prepare functional nanoparticles (NPs) through one-pot assembly of polyphenolic flavonoids and their molecular adaptors. Polyethylene glycol (PEG), one of the most widely used biocompatible polymers, and o-aldehyde phenylboric acid, a kind of small molecule adapters, were selected to form NPs with flavonoids. In addition to excellent anti-inflammatory and antioxidant properties, resulting NPs have also demonstrated possess the targeted enrichment of high reactive oxygen species levels in damaged areas and long-term blood circulation stability, which worked well for SCI therapy. This strategy takes the most commonly used PEG as an example, which can be further applied to many other types of hydrophilic polymers with amino groups, such as polysaccharides, peptides and proteins etc.

Acute kidney injury (AKI) has been confirmed to be related to the prognosis of aSAH patients. Evaluating the risk of AKI in the early stage is important to avoid the unfavorable outcome of aSAH patients. However, no study has explored the predictive value of machine learning algorithms for AKI after aSAH. This study was designed to develop a machine learning algorithm-based predictive model for AKI among aSAH patients. The outcome of this study was the AKI confirmed using the KDIGO criteria. The predictive value of seven machine learning algorithms for the AKI among aSAH patients was explored and verified using the 5-fold cross-validation. The predictive efficiency of machine learning algorithms-based predictive models was evaluated by the area under the receiver operating characteristics curve (AUC). The Shapley Additive explanation method was performed to visualize the importance of features incorporated in machine learning algorithms-based predictive models. 711 aSAH patients were enrolled with an AKI incidence of 7.7

To provide a theoretical basis for the rational use of cefditoren pivoxil in lactating women by conducting a pharmacokinetic study of cefditoren in the blood and milk of these women. Twelve participants meeting the inclusion criteria took cefditoren pivoxil tablets 200 mg after a meal, and the breast milk was collected over certain time periods with their volumes recorded. Blood samples were also collected at certain time points for pharmacokinetic analysis. Conduct a statistical analysis on the drug concentrations in breast milk and plasma and their correlation. Assessing the risk of taking cefditoren pivoxil during lactation using the milk-to-plasma ratio (M/P) and the relative infant dose (RID). Adverse events were monitored throughout the study period. Twelve lactating women participated in the study, providing a total of 84 breast milk samples. The correlation coefficient between cefditoren in breast milk and cefditoren in maternal plasma is 0.748 and is significant at the 0.01 level, with an M/P ratio of 0.008, and a RID of 0.0073%. Cefditoren is minimally distributed in human breast milk. There is a significant positive correlation between maternal blood drug levels and milk drug levels. Based on the M/P ratio and RID, it is inferred that the infant's exposure is low, that is, the absolute dose of cefditoren transmitted to the infant through breastfeeding is low and is unlikely to cause any significant adverse effects. The results of this study will provide information for the use of cefditoren pivoxil in lactating women.

Background:This paper summarizes the cell therapy clinical trials in China over the past decade to put forward suggestions for future clinical development in this field. Methods:Mainly based on the Centre for Drug Evaluation of China National Medical Products Administration (NMPA) website, a list and detailed information of cell therapy drugs in China were acquired. The annual number and basic characteristics including cell type, clinical trial phase, clinical trial status, geographical distribution, disease types, and drug target of registered drugs were summarized. Results:There have been 206 cell therapy trials between 2014 and 2024 in China. The top three cell types are T cells (51.4%, 106/206), stem cells (34.0%, 70/206), and progenitor cells (4.9%, 10/206), respectively. In terms of the phase distribution, 64.1% (132/206) were Phase I, 32.5% (67/206) were Phase II, and 3.4% (7/206) were Phase III. Currently, 86.4% (178/206) of cell therapy trials are open, 9.7% (20/206) have been completed, and the remainder are either suspended or terminated. Geographical analysis showed that 31.6% (65/206) of trials were conducted in Shanghai, 20.4% (42/206) in Beijing, and 9.2% (19/206) in Jiangsu. Twenty-eight disease types were identified, of which lymphoma (15.5%, 32/206) was the top disease type, followed by leukemia (12.6%, 26/206) and inflammation (9.2%, 19/206). The three most common targets were CD19 (54.9%, 39/71), BCMA (9.9%, 7/71), and EGFR (5.6%, 4/71). Conclusions:Cell therapy clinical trials in China have developed rapidly in the past decade. Perhaps in the future, the direction worthy of attention could include increasing funding for Phase III clinical trials, supporting a more balanced geographical distribution of trials, and more investment in target development. With the continuous progress of technology, cell therapy is expected to become an important means to treat various diseases.

ObjectiveThis study aimed to evaluate the pharmacokinetic (PK) bioequivalence, safety, and immunogenicity of recombinant human follicle-stimulating hormone (rhFSH) for injection (code name: JZB30), developed by Chengdu Jingze Biopharmaceutical Co., Ltd., in comparison with Gonal-f® developed by Merck Serono in healthy adult Chinese female participants.Methodssingle-center, randomized, open-label, two-period crossover study for bioequivalence assessment enrolled 48 healthy adult female participants, who were equally and randomly assigned to two treatment sequences. Each participant received a single subcutaneous injection of either JZB30 or Gonal-f® at a dose of 225 IU on Day 1 and again on Day 11 as part of the crossover design. Blood concentrations of FSH were measured using a validated electrochemiluminescence immunoassay, followed by non-compartmental PK analysis. Safety and immunogenicity were systematically monitored throughout the study period, including adverse events and anti-FSH antibody testing.ResultsThe geometric mean ratios (GMRs) of the primary PK parameters—Cmax, AUC0-t, and AUC0−∞–after baseline correction were 106.12%, 108.04%, and 115.32%, respectively. The 90% confidence intervals for these parameters (Cmax:101.92%–110.49%; AUC0-t:104.13%–112.09%; AUC0−∞,: 106.47%–124.90%) all fell within the predefined bioequivalence range of 80%–125%. All adverse events (AEs) were mild (Grade 1) and resolved spontaneously without requiring medical intervention. One participant tested positive for anti-FSH antibodies following administration of the reference formulation; however, the antibody response reverted to negative without any intervention, indicating a low risk of immunogenicity.ConclusionJZB30 was demonstrated to be pharmacokinetically bioequivalent to Gonal-f® in healthy adult Chinese female participants, with comparable safety profiles and a low risk of immunogenicity. These findings provide evidence to support the clinical application of JZB30 as a biosimilar to Gonal-f®.Clinical Trial RegistrationThe trial was registered on ClinicalTrials.gov under identifier NCT06778304.

Oncolytic viruses represent a promising frontier in glioma immunotherapy; however, they often encounter challenges, such as inadequate glioma infiltration and limited viral persistence in clinical settings. Macrophages are known to effectively infiltrate glioma tissue and have emerged as potential cell vectors. Nevertheless, they naturally resist viral infection. In this study, we engineered a chimeric adenovirus, OAd5/F35 [E2F1], by incorporating the E2F1 promoter and adenovirus E1A gene into the adenovirus backbone. The virus was then transported by macrophages to the tumor site in xenograft glioma-bearing mice. The genetically engineered adenovirus selectively eradicates tumor cells while sparing normal human cells. Moreover, the virus efficiently infected macrophages and was effectively delivered to the tumor site. This therapeutic system exhibited robust infiltration of tumor tissues and prolonged survival in mice. Exploiting macrophage carriers is a promising approach to enhance the penetration and therapeutic efficacy of oncolytic adenoviruses, with considerable potential for clinical translation.

This randomized, open-label, 2-period crossover study evaluated food effects on SPH3348 pharmacokinetics (PK) and safety in 16 healthy participants receiving a single 480-mg dose under fasting and high-fat fed conditions. PK profiling involved serial blood sampling at 15 predefined time points per period, while safety assessments included continuous monitoring of adverse events throughout the study. PK analysis revealed pronounced food-dependent alterations. Under fed conditions, the median time to peak concentration was delayed by 1 hour compared to fasting (4.00 vs. 3.00 hours), reflecting a slowdown in absorption rate (median time to peak concentration delay was statistically significant [P < .05 by Wilcoxon signed-rank test]). PK analysis demonstrated marked food-induced increases in systemic exposure. The fed-to-fasted geometric mean ratios and 90% confidence intervals were 1.9023 (1.5975-2.2653) for maximum concentration and 2.3667 (2.1140-2.6490) for AUC from time zero extrapolated to infinity, both exceeding the 1.25 threshold for bioequivalence. These exposure increases (greater than 2-fold) confirm that meal-induced enhancement of absorption is clinically significant. Safety profiles remained comparable between dosing conditions, with adverse event incidence rates of 13.3% (fasting) versus 18.8% (fed) and predominantly mild severity, primarily involving transient gastrointestinal events. These findings indicate that while food intake significantly increases SPH3348 bioavailability and slightly delays absorption kinetics, both fasting and fed administrations are well tolerated following single-dose exposure. The observed PK modifications highlight the necessity of standardizing dietary conditions in clinical use to ensure consistent drug exposure. The systematic characterization of these food effects provides critical evidence for optimizing dosing regimens and informing subsequent-phase clinical development, particularly regarding administration guidelines to manage variability between patients.

Clevidipine emulsion is an intravenous antihypertensive agent indicated for acute blood pressure control when oral therapies are contraindicated or ineffective. To address this gap in availability, a randomized, 2-period, 2-sequence crossover trial was conducted to evaluate the bioequivalence and safety of a generic clevidipine emulsion versus the reference product in 32 healthy Chinese adults. Participants received a 30-minute intravenous infusion of 3 mg of clevidipine (test or reference formulation) in each study period, with serial blood samples collected from the contralateral arm relative to the infusion site for pharmacokinetic analysis. Treatment-emergent adverse events (TEAEs) were monitored throughout the study. All participants completed both treatment phases. The generic formulation satisfied bioequivalence criteria for all primary pharmacokinetic parameters, with geometric mean ratios (90% confidence intervals) of Cmax, AUC0-t, and AUC0-∞ fully contained within the 80%-125% equivalence range. Three participants (9.4%) experienced mild TEAEs assessed as treatment-related, including transient sinus tachycardia (n = 2) and asymptomatic alanine aminotransferase elevation (n = 1). The generic formulation met bioequivalence criteria and exhibited comparable safety profiles to the reference product.

Despite decades of laboratory and clinical trials, breast cancer remains the main cause of cancer-related disease burden in women. Considering the metabolism destruction effect of metformin (Met) and cancer cell starvation induced by glucose oxidase (GOx), after their efficient delivery to tumor sites, GOx and Met may consume a large amount of glucose and produce sufficient hydrogen peroxide in situ. Herein, a pH-responsive epigallocatechin gallate (EGCG)-conjugated low-molecular-weight chitosan (LC-EGCG, LE) nanoplatform (Met-GOx/Fe@LE NPs) was constructed. The coordination between iron ions (Fe3+) and EGCG in this nanoplatform can enhance the efficacy of chemodynamic therapy via the Fenton reaction. Met-GOx/Fe@LE NPs allow GOx to retain its enzymatic activity while simultaneously improving its stability. Moreover, this pH-responsive nanoplatform presents controllable drug release behavior. An in vivo biodistribution study showed that the intracranial accumulation of GOx delivered by this nanoplatform was 3.6-fold higher than that of the free drug. The in vivo anticancer results indicated that this metabolism destruction/starvation/chemodynamic triple-combination therapy could induce increased apoptosis/death of tumor cells and reduce their proliferation. This triple-combination therapy approach is promising for efficient and targeted cancer treatment.

Oral gonadotropin-releasing hormone (GnRH) antagonists are promising agents in the treatment of endometriosis-related pain. Here we assessed the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of SHR7280, an oral non-peptide GnRH antagonist in premenopausal women with endometriosis. In the Phase 1 part of the randomized, double-blinded, placebo-controlled, dose-ascending, Phase 1/2 trial, premenopausal women with endometriosis were randomized (4:1) to receive SHR7280 or placebo treatment for 21 consecutive days. The treatment dose started from 200 mg QD, and then increased to 300 mg QD and 200 mg BID. Safety, PK, and PD parameters were assessed. In total, 30 patients received assigned treatment, 24 with SHR7280 and 6 with placebo. SHR7280 was well tolerated. Adverse events (AEs) were reported in 19 (79.2

目的:评价比卡鲁胺片(50 mg)在中国健康成年男性志愿者体内药动学特征及国产受试制剂与参比制剂(康士得?)的生物等效性.方法:空腹与餐后试验各入组40例健康志愿者,采用随机开放两周期两序列交叉试验设计,志愿者两周期分别服用50 mg比卡鲁胺片受试制剂或参比制剂,清洗期为56 d,采集给药后576 h内的血样,采用液相色谱-串联质谱法(LC-MS/MS)测定EDTA-K2人血浆中比卡鲁胺浓度,采用非房室模型计算药动学参数,根据Cmax,AUC0-t,AUC0-∞几何均值比值(GMR)90％置信区间(CI)是否在80.00％ ～125.00％范围内判断两制剂生物等效性.结果:空腹状态下比卡鲁胺片受试制剂与参比制剂药动学参数Cmax分别为(1030±196)和(898±167)ng·mL-1,AUC0-t分别为(224000±42900)和(196000±48400)h·ng·mL-1,AUC0-∞分别为(243000±56900)和(212000±60100)h·ng·mL-1,餐后状态下比卡鲁胺片受试制剂与参比制剂药动学参数Cmax分别为(1260±164)和(1210±153)ng·mL-1,AUC0-t分别为(245000±40700)和(241000±44700)h·ng·mL-1,AUC0-∞分别为(266000±55700)和(259000±57000)h·ng·mL-1.空腹及餐后条件下Cmax,AUC0-t,AUC0-∞的几何均值比值90％CI均在80.00％ ～125.00％等效范围内.试验过程无严重不良事件发生.结论:在空腹及餐后状态下,比卡鲁胺片受试制剂与参比制剂生物等效,安全性良好.

AimsThis study aims to evaluate the drug–drug interaction (DDI) between hetrombopag and cyclosporine in healthy Chinese subjects.MethodsTwenty‐six eligible subjects enrolled in this single‐centre, single‐sequence, open‐label, DDI study with 3 treatment periods, receiving 5 mg hetrombopag once on Day 1, 100 mg cyclosporine twice daily from Day 11 to Day 15 and 5 mg hetrombopag + 100 mg cyclosporine on Day 16. Serial blood samples were collected for pharmacokinetic evaluation. Adverse events were monitored throughout the study.ResultsThe plasma hetrombopag geometric mean ratios (90% confidence interval) of maximum plasma concentration, area under the plasma concentration–time curve (AUC) from predose to time of last quantifiable sample and AUC to infinity of coadministration of hetrombopag with cyclosporine vs. hetrombopag alone were 95.97% (70.08–131.43%), 105.75% (75.04–149.04%) and 104.19% (74.71–145.32%), respectively, indicating multiple doses of cyclosporine had minimal effects on hetrombopag exposure. The geometric mean ratios (90% confidence interval) of maximum blood concentration and AUC at steady state during a dosing interval for blood cyclosporine of coadministration vs. cyclosporine alone were 100.49% (91.89–109.89%) and 100.81% (107.88–103.82%), respectively, suggesting a single dose of hetrombopag had no impact on the exposure of cyclosporine. Coadministration of hetrombopag with cyclosporine was generally well tolerated.ConclusionNo clinically significant DDI was observed when coadministration of hetrombopag with cyclosporine. The results of this study will inform the appropriate use of this combination therapy both in clinical trials and clinical settings.

Background: Acute respiratory distress syndrome (ARDS) commonly develops in traumatic brain injury (TBI) patients and is a risk factor for poor prognosis. We designed this study to evaluate the performance of several machine learning algorithms for predicting ARDS in TBI patients. Methods: TBI patients from the Medical Information Mart for Intensive Care-III (MIMIC-III) database were eligible for this study. ARDS was identified according to the Berlin definition. Included TBI patients were divided into the training cohort and the validation cohort with a ratio of 7:3. Several machine learning algorithms were utilized to develop predictive models with five-fold cross validation for ARDS including extreme gradient boosting, light gradient boosting machine, Random Forest, adaptive boosting, complement naïve Bayes, and support vector machine. The performance of machine learning algorithms were evaluated by the area under the receiver operating characteristic curve (AUC), sensitivity, specificity, accuracy and F score. Results: 649 TBI patients from the MIMIC-III database were included with an ARDS incidence of 49.5%. The random forest performed the best in predicting ARDS in the training cohort with an AUC of 1.000. The XGBoost and AdaBoost ranked the second and the third with an AUC of 0.989 and 0.815 in the training cohort. The random forest still performed the best in predicting ARDS in the validation cohort with an AUC of 0.652. AdaBoost and XGBoost ranked the second and the third with an AUC of 0.631 and 0.620 in the validation cohort. Several mutual top features in the random forest and AdaBoost were discovered including age, initial systolic blood pressure and heart rate, Abbreviated Injury Score chest, white blood cells, platelets, and international normalized ratio. Conclusions: The random forest and AdaBoost based models have stable and good performance for predicting ARDS in TBI patients. These models could help clinicians to evaluate the risk of ARDS in early stages after TBI and consequently adjust treatment decisions.

Abstract Objective The objective of the present research was to examine the correlation between the neutrophil‐to‐lymphocyte ratio (NLR) and stroke progression (SP) as well as the functional outcome following an ischemic stroke (IS). Methods The current study was conducted as prospective observational research. A cohort of 341 participants diagnosed with IS was included in the study from March 2019 to August 2021. This study's primary measure of interest was the occurrence of SP within the initial week following hospital admission. The secondary outcome was functional status 3 months after IS as measured by a modified Rankin scale score. The association between NLR with SP, and poor functional outcomes was examined using multivariate logistic regression. The predictive value of NLR for SP and poor functional outcomes was evaluated using the receiver operating characteristic (ROC) curve. Results Among the 341 enrolled patients, 56 (16.4%) had SP, and 285 (83.6%) had no SP. The results of the multivariate logistic regression analysis demonstrated that the existence of diabetes mellitus and the NLR were independently associated with SP and poor functional outcomes. The area under the ROC curve of NLR in predicting poor functional outcome was 0.6117 (95% confidence interval, .5341–.6893, p = .0032), and the optimal cut‐off point was 4.2139. The sensitivity and specificity of NLR in predicting poor functional outcomes were 52.7% and 72.0%, respectively. Conclusion Patients with acute IS exhibited a very high incidence of SP. NLR may be a valuable prognostic indicator in clinical practice because it was independently associated with SP and a poor functional outcome.

Liraglutide, a glucagon-like peptide 1 receptor agonist, is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. The original liraglutide products are costly, which limits patient access to this therapeutic treatment. Herein, a biosimilar was developed that is highly similar to the reference drug in molecular structure and bioactivity, and is expected to have similar pharmacokinetic (PK) and safety profiles in clinical studies. This study aimed to primarily evaluate the bioequivalence of 2 liraglutide formulations and secondarily assess their safety in healthy Chinese subjects following a single-dose subcutaneous injection. Thirty-two healthy volunteers were recruited in this randomized, open-label, single-dose, 2-period crossover bioequivalence study (ChiCTR2100043348). The geometric mean ratios (GMRs) of the test drug to the reference drug (T/R) and corresponding 90% confidence intervals (CIs) for maximum concentration (Cmax ) and the area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t ) were estimated using a mixed-effects model, and bioequivalence was determined to have been achieved if the 2-sided 90%CI fell within the predefined range of 80%-125%. PK parameters were comparable between T and R, with GMRs of T/R for Cmax and AUC0-t being 105.7% and 107.7%, respectively, the 90%CI of which met the acceptance criteria for bioequivalence. We also observed a similar and favorable safety profile in the T and R arms, with adverse events being predominantly mild in severity and of gastrointestinal origin. Our findings indicate that the test drug is safe and well tolerated, bioequivalent to the reference drug, and warrants further testing in a phase III clinical trial.

Photodynamic therapy (PDT) as emerging phototherapy has attracted extensive attention in cancer therapy. However, the overexpressed glutathione (GSH) and hypoxic conditions of the tumor microenvironment (TME) sevely limit the therapeutic efficiency of PDT. Herein, we design a multifunctional nanoplatform (CBDM) for cancer therapy consisting of photosensitizer (Ce6), bovine serum albumin (BSA), and polydopamine-manganese dioxide (MnO2) nanocomplex, which is simultaneously modified by nucleolin-targeting AS1411 aptamer. This MnO2-based nanoplatform ameliorates tumor hypoxia and promotes oxygen production via the reaction between MnO2 and endogenous H2O2 and acid H+ in the TME. Besides, this biocompatibility nanoplatform exhibits an augmented PDT effect and high photothermal conversion efficiency under 808 nm laser irradiation. Importantly, the MnO2-based nanoplatform achieves a significant in vivo synergistic therapeutic effect and fights against liver metastasis of breast cancer. As a result, the excellent biocompatibility, especially the superior anticancer efficacy, and suppression of tumor metastasis make the MnO2-based nanoplatform a promising candidate for cancer therapy.

目的:探讨清单式管理在Ⅰ期临床试验风险防范中的作用.方法:按照Ⅰ期临床试验流程,梳理人员、设备、物资和操作等环节,制定风险防控清单.结果 与结论:清单管理模式可系统呈现各环节风险因素,最大限度避免遗漏,实现质量管理前置,同时提高工作效率.新技术应用所带来的风险因素变化需进一步研究.