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Phase I study of CBM.CD19 chimeric antigen receptor T cell in the treatment of refractory diffuse large B-cell lymphoma in Chinese patients

《医学前沿（英文）》 2022年 第16卷 第2期   页码 285-294 doi: 10.1007/s11684-021-0843-8

摘要： Anti-CD19 chimeric antigen receptor (CAR) T cell therapy has shown impressive efficacy in treating B-cell malignancies. A single-center phase I dose-escalation study was conducted to evaluate the safety and efficacy of T cells transduced with CBM.CD19 CAR, a second-generation anti-CD19 CAR bearing 4-1BB costimulatory molecule, for the treatment of patients with refractory diffuse large B-cell lymphoma (DLBCL). Ten heavily treated patients with refractory DLBCL were given CBM.CD19 CAR-T cell (C-CAR011) treatment. The overall response rate was 20% and 50% at 4 and 12 weeks after the infusion of C-CAR011, respectively, and the disease control rate was 60% at 12 weeks after infusion. Treatment-emergent adverse events occurred in all patients. The incidence of cytokine release syndrome in all grades and grade≥3 was 90% and 0, respectively, which is consistent with the safety profile of axicabtagene ciloleucel and tisagenlecleucel. Neurotoxicity or other dose-limiting toxicities was not observed in any dose cohort of C-CAR011 therapy. Antitumor efficacy was apparent across dose cohorts. Therefore, C-CAR011 is a safe and effective therapeutic option for Chinese patients with refractory DLBCL, and further large-scale clinical trials are warranted.

关键词： CAR-T cell therapy     refractory diffuse large B-cell lymphoma     cytokine release syndrome     dose-limiting toxicity    

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Low-dose CT for lung cancer screening: opportunities and challenges

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《医学前沿（英文）》 2018年 第12卷 第1期   页码 116-121 doi: 10.1007/s11684-017-0600-1

摘要：

Lung cancer is among the most frequently diagnosed cancers worldwide and the leading cause of cancer death in both males and females. Screening for lung cancer coupled with earlier intervention has long been studied as an approach to mortality reduction. However, minimal progress was achieved until recently, when low-dose spiral computed tomography (LDCT) screening demonstrated a 20% reduction in mortality from lung cancer in a randomized controlled trial (RCT), the National Lung Screening Trial, from the United States. On the basis of this finding, LDCT has been recommended for lung cancer screening in high-risk populations by several clinical guidelines. However, results from the following independent RCTs in Europe failed to show consistent conclusions. In addition, intractable problems gradually emerged with the progress of LDCT screening. This paper summarizes and discusses the main observations and challenges of LDCT screening for lung cancer. Before spreading implementation of LDCT screening, challenges, including high false-positive rates, overdiagnosis, enormous costs, and radiation risk, must be addressed. Complementary biomarkers and technical improvement are expected in the field of lung cancer screening in the near future.

关键词： lung cancer     low-dose computerized tomography     early detection     opportunities     challenges    

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Estimation of the minimum effective dose of tramadol for postoperative analgesia in infants using the

null

《医学前沿（英文）》 2012年 第6卷 第3期   页码 288-295 doi: 10.1007/s11684-012-0208-4

摘要：

Tramadol is a potent analgesic. However, the analgesia efficacy of tramadol, particularly its minimum effective dose (MED), is not clear. The aim of this study is to find MED of tramadol for postoperative analgesia in infants. The continual reassessment method (CRM) was performed to find MED. Infants undergoing surgeries were included in the 3 phases of this series. In each phase, 24 participants were allocated a different tramadol dose. Pain intensity was measured by face, legs, activity, cry, consolability (FLACC) measurement at 3-hour intervals. Tramadol was considered ineffective if the FLACC score was higher than 4 in 10 at anytime. In phase 1, seven dose levels were used within the range 0.1–0.4 mg?kg-1·h-1. Phase 1 was insufficient to identify the MED, and we increased the dose to 0.4–0.8 mg?kg-1·h-1 in phase 2. Phase 2 was insufficient to identify the MED. In phase 3, local anesthetic wound infiltration was introduced, and the tramadol dose levels tested were the same as in phase 1. The successful analgesia probability of tramadol 0.4 mg?kg-1?h-1 was 82.1% (95% CI, 0.742–0.925) in phase 1. In phase 2, it was 84.7% (95% CI, 0.789–0.991) with the dose 0.8 mg?kg-1?h-1. Phase 1 and phase 2 were insufficient to identify the MED. In phase 3, the successful analgesia probability for dose 0.35 mg?kg-1?h-1was 96.7% (95% CI, 0.853–0.997).We have demonstrated that tramadol provides insufficient analgesia for surgeries considered to cause moderate-to-severe postoperative pain in infants if used as the sole analgesic, and that local anesthetic wound infiltration enhances the efficacy of tramadol.

关键词： tramadol     minimum effective dose     postoperative analgesia     infants     continual reassessment method    

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Comparison of exogenous degrader-enhanced bioremediation with low-dose persulfate oxidation for polycyclic

《环境科学与工程前沿（英文）》 2023年 第17卷 第11期 doi: 10.1007/s11783-023-1733-x

摘要： Polycyclic aromatic hydrocarbon (PAH)-contaminated soils are usually complex and characterized by a lack of nutrition and soil salinization, resulting in difficulties in soil remediation. In this study, bioaugmentation with a PAH-degrading Bacillus PheN7 (BA) and low-dose persulfate oxidation (PS), along with natural biodegradation, were utilized to remediate alkaline PAH-contaminated soil. The soil used in the study had a pH of 9.35, and the total PAH content was 568.8 ± 31.0 mg/kg dry soil. After 42 d of remediation, the degradation efficiency of PAHs was 96.72% and 93.88% using persulfate oxidation and bioaugmentation, respectively, whereas 38.66% of PAHs were degraded in natural attenuation (NA). Bacillus was the dominant genera throughout the process of bioremediation with the relative abundance of 79.3% on day 42 in the BA system, whereas, Alcanivorax was enriched and became the dominant genera in PS systems. In the meantime, PAH degradation genes were detected with remarkably higher level in the BA system than in PS system during the remediation. In addition to the degradation of contaminants, persulfate oxidation promotes microbial bioremediation efficiency mainly by lowering the pH to neutral and increasing the active phosphorus content in the soil. Microbial species and ecological niches were less reduced in the PS system than in the BA system. Collectively, persulfate oxidation had a better impact on the soil microbiome and is more suitable for long-term soil health than bioaugmentation through PheN7 addition.

关键词： Bioaugmentation     Low-dose persulfate oxidation     Polycyclic aromatic hydrocarbon     Remediation    

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Collapse fragility assessment of steel roof framings with force limiting devices under transient wind

Linjia BAI, Yunfeng ZHANG

《结构与土木工程前沿（英文）》 2012年 第6卷 第3期   页码 199-209 doi: 10.1007/s11709-012-0168-4

摘要： Steel structural frame is a popular structural form to cover large-span roof space and under high winds. Either part of the roof enclosure or the entire roof structure can be lifted off a building, particularly for low sloped roofs subject to wind-induced suction force. Collapse of roof could cause severe economic loss and poses safety risk to residents in the building. The buckling of members in a steel roof frame structure, which may lead to progressive collapse, may be dynamic in nature. This paper presents a fragility analysis of the collapse of steel roof frame structures under combined static and transient wind loading. Uncertainties associated with wind load change rate and member imperfections are taken into account in this study. A numerical example based on a Steel Joist Institute (SJI) K series joist was used to demonstrate the use of force limiting devices for collapse risk mitigation. For the presented fragility assessment of steel roof collapse, a Monte Carlo method combined with response surface approach was adopted, which greatly reduces the computation time and makes the Monte Carlo simulation feasible for probabilistic collapse analysis of steel roof frame structures.

关键词： collapse     dynamic response     fragility analysis     Monte Carlo simulation     wind load    

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Early assessment of the safety and immunogenicity of a third dose (booster) of COVID-19 immunization

《医学前沿（英文）》 2022年 第16卷 第1期   页码 93-101 doi: 10.1007/s11684-021-0914-x

摘要： Inducing durable and effective immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) via vaccination is essential to combat the current pandemic of coronavirus disease 2019 (COVID-19). It has been noticed that the strength of anti-COVID-19 vaccination-induced immunity fades over time, which calls for an additional vaccination regime, as known as booster immunization, to restore immunity among previously vaccinated populations. Here we report a pilot open-label trial of a third dose of BBIBP-CorV, an inactivated SARS-CoV-2 vaccine (Vero cell), on 136 participants aged between 18 to 63 years. Safety and immunogenicity in terms of neutralizing antibody titers and cytokine/chemokine responses were analyzed as the main endpoint until day 28. While systemic reactogenicity was either absent or mild, SARS-CoV-2-specific neutralizing antibody titers rapidly arose in all participants within 4 weeks, surpassing the peak antibody titers elicited by the initial two-dose immunization regime. Broad increases of cellular immunity-associated cytokines and chemokines were also detected in the majority of participants after the third vaccination. Furthermore, in an exploratory study, a newly developed recombinant protein vaccine, NVSI-06-08 (CHO Cells), was found to be safe and even more effective than BBIBP-CorV in eliciting humoral immune responses in BBIBP-CorV-primed individuals. Together, these results indicate that a third immunization schedule with either homologous or heterologous vaccine showed favorable safety profiles and restored potent SARS-CoV-2-specific immunity, providing support for further trials of booster vaccination in larger populations.

关键词： COVID-19     SARS-CoV-2     vaccine     immunization     booster immunization    

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Reproductive toxicity study with a novel deoxyguanosine analogue (Metacavir) in pregnant SD rats

null

《医学前沿（英文）》 2015年 第9卷 第1期   页码 82-89 doi: 10.1007/s11684-015-0376-0

摘要：

Our preliminary studies demonstrated that Metacavir has potential to become a new anti-HBV agent. The main targets of the toxic effects of Metacavir, in rhesus monkeys, were gastrointestinal tracts, liver, blood, and kidneys, which were not related to mitochondrial effects. In this study, the maternal toxicity, embryo-fetal developmental toxicity and teratogenicity were studied in pregnant Sprague-Dawley rats after intragastric administration of Metacavir (200, 100, 50, 0 mg/kg body weight) during the first 6–15 days of pregnancy. Slower weight gain was observed in 5 out of 21 rats subjected to a 200 mg/kg dose, as well as 2 out of 20 subjected to a 100 mg/kg dose. Compared with the solvent control group, the calibration weight gain in the 200 mg/kg and 100 mg/kg dosage groups respectively, during first 6–20 pregnant days were significantly different (P<0.01, P<0.05). Significant dose related adverse effects to other reproductive parameters were not seen in F0 and F1, but the number of stillbirths in high dose group showed notably difference compared with the control group (P<0.05), while the litter incidence showed no difference. No Metacavir-associated pathological changes were observed. The present research indicated that at a dose of 200 mg/(kg·d) (i.e., 40 times the effective dose in rats), Metacavir shows some maternal toxicity to SD rats. The embryotoxicity in the 200 mg/kg group encompass decreased fetal body weight, and higher fetal mortality rates, compared with the control group. However, the litter incidence showed no statistical difference. All the treated rats displayed normal bone development, no teratogenicity and without adverse effects on fetal development, thus indicating that below a dose of 200 mg/(kg·d) there is no teratogenic side effects.

关键词： deoxyguanosine analogue     Metacavir     pregnancy     maternal toxicity     embryo toxicity     teratogenicity    

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Interaction and combined toxicity of microplastics and per- and polyfluoroalkyl substances in aquatic

《环境科学与工程前沿（英文）》 2022年 第16卷 第10期 doi: 10.1007/s11783-022-1571-2

摘要：

● Adsorption of PFASs on MPs and its mechanisms are critically reviewed.

关键词： Microplastics     Per- and Polyfluoroalkyl substances     Adsorption     Transport     Transformation    

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Product identification and toxicity change during oxidation of methotrexate by ferrate and permanganate

《环境科学与工程前沿（英文）》 2022年 第16卷 第7期 doi: 10.1007/s11783-021-1501-8

摘要：

• Oxidation of methotrexate by high-valent metal-oxo species was first explored.

关键词： Anticancer drugs     High-valent metal-oxo species     Oxidation kinetics     Reaction mechanisms     Multi-endpoint toxicity    

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Evaluation of soil microbial toxicity of waste foundry sand for soil-related reuse

Haifeng ZHANG, Lu SU, Xiangyu LI, Jiane ZUO, Guangli LIU, Yujue WANG

《环境科学与工程前沿（英文）》 2014年 第8卷 第1期   页码 89-98 doi: 10.1007/s11783-013-0591-3

摘要： The relationship between the chemical contaminants and soil microbial toxicity of waste foundry sand (WFS) was investigated. Five different types of WFS from typical ferrous, aluminum, and steel foundries in China were examined for total metals, leachable metals, and organic contaminants. The soil microbial toxicity of each WFS was evaluated by measuring the dehydrogenase activity (DHA) of a blended soil and WFS mixture and then comparing it to that of unblended soil. The results show that the five WFSs had very different compositions of metal and organic contaminants and thus exhibited very different levels of soil microbial inhibition when blended with soil. For a given WFS blended with soil in the range of 10 wt.%–50 wt.% WFS, the DHA decreased almost linearly with increased blending ratio. Furthermore, for a given blending ratio, the WFSs with higher concentrations of metal and organic contaminants exhibited greater microbial toxicity. Correlation analysis shows that the relationship between ecotoxicity and metal and organic contaminants of WFSs can be described by an empirical logarithmic linear model. This model may be used to control WFS blending ratios in soil-related applications based on chemical analysis results to prevent significant inhibition of soil microbial activity.

关键词： waste foundry sand     toxicity     bioassay     soil microbial activity     waste reuse    

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ROUTE DEVELOPMENT, ANTIVIRAL STUDIES, FIELD EVALUATION AND TOXICITY OF AN ANTIVIRAL PLANT PROTECTANT

《农业科学与工程前沿（英文）》 2022年 第9卷 第1期 doi: 10.15302/J-FASE- 2021390

摘要：

It has previously been shown that tryptophan, the biosynthesis precursor of Peganum harmala alkaloids, and its derivatives have anti-TMV activity both in vitro and in vivo. Further exploration of this led to the identification of NK0238 as a highly effective agent for the prevention and control of diseases caused by plant viruses, but the existing routes are unsuitable for its large-scale synthesis. This study optimized a route for two-step synthesis of this virucide candidate via reaction of l-tryptophan with triphosgene to produce l-tryptophan-N-carboxylic anhydride, which then reacts with n-octylamine to give NK0238 at up to 94% yield and nearly 97% HPLC purity. In addition, the route was used for the preparation of NK0238 on a>40 g scale permitting further assessment of its antivirus activity in the greenhouse and field experiments, and toxicity tests. NK0238 exhibited useful antiviral activities against a variety of viruses both in greenhouse and field experiments. The toxicity tests showed that NK0238 was not acutely toxic to birds, fish, honey bees and silkworms. The optimized route provides a solid foundation for its large-scale synthesis and subsequent efficacy and toxicity studies, its excellent activity and safety make NK0238 a promising drug candidate for further development.

 

关键词： antiviral plant protectant / antiviral in the greenhouse / field evaluation / l-trp-NCA / synthesis optimization / toxicity tests    

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An investigation on patient dose in screen-film diagnostic radiology in Lhasa City, Xizang Autonomous

null

《医学前沿（英文）》 2013年 第7卷 第4期   页码 506-509 doi: 10.1007/s11684-013-0294-y

摘要：

This study aimed to investigate patient dose in diagnostic screen-film radiographic examinations in the city of Lhasa, China. Seven out of the twenty-six hospitals registered with the Lhasa Health Bureau were included in the investigation. The entrance surface air Kerma (ESAK) of seven conventional screen-film radiology X-ray equipment in these hospitals was measured with a QA dosimeter in September 2012. The X-ray examinations were divided into three categories: PA (posterior-anterior) chest, upper/lower limb, and AP (anterior-posterior) lumbar spine. For each category, ESAKs were calculated and analyzed. The mean ESAK was 0.6 mGy for PA chest, 0.3 mGy for upper/lower limb, and 1.8 mGy for AP lumbar spine. In addition, the mean ESAK value recorded for PA chest X-ray examinations exceeded the corresponding value recommended by the International Atomic Energy Agency (0.4 mGy).

关键词： radiation dosage     radiology     radiation protection     radiography/statistics & numerical data    

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Understanding the role of nano-TiO on the toxicity of Pb on through modeling–Is it additive or synergistic

《环境科学与工程前沿（英文）》 2022年 第16卷 第5期 doi: 10.1007/s11783-021-1493-4

摘要：

• A two-compartment model is able to quantify the effect of nano-TiO2 on Pb toxicity.

关键词： Algae     C. dubia     Lead     Nano-TiO2     Synergistic toxicity     Two-compartment toxicokinetic-toxicodynamic model    

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Toxicity models of metal mixtures established on the basis of “additivity” and “interactions”

Yang Liu,Martina G. Vijver,Bo Pan,Willie J. G. M. Peijnenburg

《环境科学与工程前沿（英文）》 2017年 第11卷 第2期 doi: 10.1007/s11783-017-0916-8

摘要： · No preference is set between CA and IA models to assess toxicity of metal mixtures. · Increased model complexity does not, by itself, lead to improved performance. · Not all significant deviations have biological meaning due to poor reproducibility. · Interactions are suggested to incorporate when they are significant and repeated. Observed effects of metal mixtures on animals and plants often differ from the estimates, which are commonly calculated by adding up the biological responses of individual metals. This difference from additivity is commonly referred to as being a consequence of specific interactions between metals. The science of how to quantify metal interactions and whether to include them in risk assessment models is in its infancy. This review summarizes the existing predictive tools for evaluating the combined toxicity of metals present in mixtures and indicates the advantages and disadvantages of each method. We intend to provide eco-toxicologists with background information on how to make good use of the tools and how to advance the methods for assessing toxicity of metal mixtures. It is concluded that statistically significant deviations from additivity are not necessarily biologically relevant. Incorporation of interactions between metals in a model does not on forehand mean that the model is more accurate than a model developed based on additivity only. It is recommended to first use a relatively simple method for effect prediction of uninvestigated metal mixtures. To improve the reliability of toxicity modeling for metal mixtures, further efforts should focus on balancing the relationship between the significance of statistics and the biological meaning, and unraveling the toxicity mechanisms of metals and their mixtures.

关键词： Metal     Mixtures     Toxicity     Additivity     Modeling     Interactions    

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Leaching toxicity characteristics of municipal solid waste incineration bottom ash

Khamphe PHOUNGTHONG,Yi XIA,Hua ZHANG,Liming SHAO,Pinjing HE

《环境科学与工程前沿（英文）》 2016年 第10卷 第2期   页码 399-411 doi: 10.1007/s11783-015-0819-5

摘要： The continuously increasing production of municipal solid waste incineration bottom ash (MSWIBA) has promoted its utilization as construction material and raised environmental concern. The physico-chemical properties and leaching behavior of MSWIBA were studied, and ecotoxicological testing using a luminescent bacterium bioassay was performed to assess the ecological pollution risks associated with its leached constituents. The MSWIBA was leached by two types of leachants, H SO /HNO and HAc solution, at different liquid to solid ratios and contact times. The concentrations of heavy metals and anions in the leachates were analyzed. Multivariate statistical analyses, including principle component analysis, Pearson's correlation analysis and hierarchical cluster analysis, were used to evaluate the contributions of the constituents to the toxicity ( ) of the MSWIBA leachate. The statistical analyses of the ecotoxicological results showed that the Ba, Cr, Cu, Pb, F and total organic carbon (TOC) concentrations were closely correlated with the value, and these substances were the main contributors to the ecotoxicity of the MSWIBA leachate. In addition, the cluster of these variables indicated similar leaching behaviors. Overall, the research demonstrated that the ecotoxicological risks resulting from MSWIBA leaching could be assessed before its utilization, which provides crucial information for the adaptation of MSWIBA as alternative materials.

关键词： Municipal solid waste incineration     bottom ash     alternative material     leaching tests     toxicity     Vibrio qinghaiensis (Q67)    

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标题 作者 时间 类型 操作

Phase I study of CBM.CD19 chimeric antigen receptor T cell in the treatment of refractory diffuse large B-cell lymphoma in Chinese patients

期刊论文

Low-dose CT for lung cancer screening: opportunities and challenges

null

期刊论文

Estimation of the minimum effective dose of tramadol for postoperative analgesia in infants using the

null

期刊论文

Comparison of exogenous degrader-enhanced bioremediation with low-dose persulfate oxidation for polycyclic

期刊论文

Collapse fragility assessment of steel roof framings with force limiting devices under transient wind

Linjia BAI, Yunfeng ZHANG

期刊论文

Early assessment of the safety and immunogenicity of a third dose (booster) of COVID-19 immunization

期刊论文

Reproductive toxicity study with a novel deoxyguanosine analogue (Metacavir) in pregnant SD rats

null

期刊论文

Interaction and combined toxicity of microplastics and per- and polyfluoroalkyl substances in aquatic

期刊论文

Product identification and toxicity change during oxidation of methotrexate by ferrate and permanganate

期刊论文

Evaluation of soil microbial toxicity of waste foundry sand for soil-related reuse

Haifeng ZHANG, Lu SU, Xiangyu LI, Jiane ZUO, Guangli LIU, Yujue WANG

期刊论文

ROUTE DEVELOPMENT, ANTIVIRAL STUDIES, FIELD EVALUATION AND TOXICITY OF AN ANTIVIRAL PLANT PROTECTANT

期刊论文

An investigation on patient dose in screen-film diagnostic radiology in Lhasa City, Xizang Autonomous

null

期刊论文

Understanding the role of nano-TiO on the toxicity of Pb on through modeling–Is it additive or synergistic

期刊论文

Toxicity models of metal mixtures established on the basis of “additivity” and “interactions”

Yang Liu,Martina G. Vijver,Bo Pan,Willie J. G. M. Peijnenburg

期刊论文

Leaching toxicity characteristics of municipal solid waste incineration bottom ash

Khamphe PHOUNGTHONG,Yi XIA,Hua ZHANG,Liming SHAO,Pinjing HE

期刊论文