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Patient-derived xenograft platform of OSCC: a renewable human bio-bank for preclinical cancer research and a new co-clinical

null

《医学前沿（英文）》 2016年第10卷第1期页码 104-110 doi: 10.1007/s11684-016-0432-4

摘要：

Advances in next-generation sequencing and bioinformatics have begun to reveal the complex genetic landscape in human cancer genomes, including oral squamous cell carcinoma (OSCC). Sophisticated preclinical models that fully represent intra- and inter-tumoral heterogeneity are required to understand the molecular diversity of cancer and achieve the goal of personalized therapies. Patient-derived xenograft (PDX) models generated from human tumor samples that can retain the histological and genetic features of their donor tumors have been shown to be the preferred preclinical tool in translational cancer research compared with other conventional preclinical models. Specifically, genetically well-defined PDX models can be applied to accelerate targeted antitumor drug development and biomarker discovery. Recently, we have successfully established and characterized an OSCC PDX panel as part of our tumor bio-bank for translational cancer research. In this paper, we discuss the establishment, characterization, and preclinical applications of the PDX models. In particular, we focus on the classification and applications of the PDX models based on validated annotations, including clinicopathological features, genomic profiles, and pharmacological testing information. We also explore the translational value of this well-annotated PDX panel in the development of co-clinical trials for patient stratification and treatment optimization in the near future. Although various limitations still exist, this preclinical approach should be further tested and improved.

关键词： patient-derived xenograft models personalized medicine co-clinical trial patient stratification oral squamous cell carcinoma

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Development and clinical trial of a novel bioactive bone cement

LEONG John, LI Zhaoyang, LU William

《医学前沿（英文）》 2008年第2卷第2期页码 117-126 doi: 10.1007/s11684-008-0022-1

摘要： Strontium (Sr) and related compounds have become more attractive in the prevention and treatment of osteoporosis. Previously, we developed a novel bioactive bone cement which is mainly composed of strontium-containing hydroxyapatite (Sr-HA) filler and bisphenol A diglycidylether dimethacrylate (Bis-GMA) resin. This bone cement is superior to conventional polymethylmethacrylate (PMMA) bone cement in bioactivity, biocompatibility, and osseointegration. It also has shown sufficient mechanical strength properties for its use in percutaneous vertebroplasty (PVP) and total hip replacement (THR). In this paper, we review the and clinical evidence for the effectiveness of this bioactive bone cement.

关键词： bioactivity effectiveness strontium-containing hydroxyapatite osseointegration sufficient mechanical

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Low-carbohydrate diets lead to greater weight loss and better glucose homeostasis than exercise: a randomized clinicaltrial

《医学前沿（英文）》 2021年第15卷第3期页码 460-471 doi: 10.1007/s11684-021-0861-6

摘要： Lifestyle interventions, including dietary adjustments and exercise, are important for obesity management. This study enrolled adults with overweight or obesity to explore whether either low-carbohydrate diet (LCD) or exercise is more effective in metabolism improvement. Forty-five eligible subjects were randomly divided into an LCD group (n=22) and an exercise group (EX, n=23). The subjects either adopted LCD (carbohydrate intake<50 g/day) or performed moderate-to-vigorous exercise (≥30 min/day) for 3 weeks. After the interventions, LCD led to a larger weight loss than EX (−3.56±0.37 kg vs. −1.24±0.39 kg, P<0.001), as well as a larger reduction in fat mass (−2.10±0.18 kg vs. −1.25±0.24 kg, P=0.007) and waist circumference (−5.25±0.52 cm vs. −3.45±0.38 cm, P=0.008). Both interventions reduced visceral and subcutaneous fat and improved liver steatosis and insulin resistance. Triglycerides decreased in both two groups, whereas low-density lipoprotein cholesterol increased in the LCD group but decreased in the EX group. Various glycemic parameters, including serum glycated albumin, mean sensor glucose, coefficient of variability (CV), and largest amplitude of glycemic excursions, substantially declined in the LCD group. Only CV slightly decreased after exercise. This pilot study suggested that the effects of LCD and exercise are similar in alleviating liver steatosis and insulin resistance. Compared with exercise, LCD might be more efficient for weight loss and glucose homeostasis in people with obesity.

关键词： low-carbohydrate diet obesity nonalcoholic fatty liver disease continuous glucose monitoring mean sensor glucose

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multi-course methotrexate for low-risk gestational trophoblastic neoplasia: a multi-centric randomized clinicaltrial

《医学前沿（英文）》 2022年第16卷第2期页码 276-284 doi: 10.1007/s11684-021-0855-4

摘要： We aimed to evaluate the effectiveness and safety of single-course initial regimens in patients with low-risk gestational trophoblastic neoplasia (GTN). In this trial (NCT01823315), 276 patients were analyzed. Patients were allocated to three initiated regimens: single-course methotrexate (MTX), single-course MTX+ dactinomycin (ACTD), and multi-course MTX (control arm). The primary endpoint was the complete remission (CR) rate by initial drug(s). The primary CR rate was 64.4% with multi-course MTX in the control arm. For the single-course MTX arm, the CR rate was 35.8% by one course; it increased to 59.3% after subsequent multi-course MTX, with non-inferiority to the control (difference –5.1%, 95% confidence interval (CI) –19.4% to 9.2%, P=0.014). After further treatment with multi-course ACTD, the CR rate (93.3%) was similar to that of the control (95.2%, P=0.577). For the single-course MTX+ACTD arm, the CR rate was 46.7% by one course, which increased to 89.1% after subsequent multi-course, with non-inferiority (difference 24.7%, 95% CI 12.8%–36.6%, P<0.001) to the control. It was similar to the CR rate by MTX and further ACTD in the control arm (89.1% vs. 95.2%, P=0.135). Four patients experienced recurrence, with no death, during the 2-year follow-up. We demonstrated that chemotherapy initiation with single-course MTX may be an alternative regimen for patients with low-risk GTN.

关键词： gestational trophoblastic neoplasia (GTN) methotrexate (MTX) dactinomycin (ACTD)

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免疫抑制和肝移植 Review

Jan Lerut, Samuele Iesari

《工程（英文）》 2023年第21卷第2期页码 175-187 doi: 10.1016/j.eng.2022.07.007

摘要：

完美的手术技术和充分的免疫抑制是确保最佳移植物和患者存活的关键。不同药物的可用性导致了一些通常由行业驱动的不同类型的临床试验，以寻找理想的免疫抑制方案。然而，大量概念不同的研究设计未能明确定义最佳免疫抑制方案。基于钙调神经磷酸酶抑制剂他克莫司、抗代谢药物霉酚酸酯或硫唑嘌呤和短期类固醇（除了可能的诱导外）的三联免疫抑制方案仍然是目前公认的肝移植标准免疫抑制方案。然而，鉴于排斥定义的变化、免疫抑制负荷的定制以及由于慢性免疫抑制引起的长期副作用，未来的试验最好包括一个以上的终点，而不是急性T细胞介导的急性排斥（a-TCMR）或肾衰竭。相反，需要一个涵盖患者和移植物存活率以及急性和慢性排斥反应发生率的综合终点。这些免疫现象应根据一系列长期的生物学和组织学随访进行检查。临床相关α-TCMR的诊断和治疗应基于综合生物学、免疫学和组织病理学的发现。这两个要素对于朝着更谨慎的免疫抑制处理和有利于临床操作耐受性的方向发展至关重要。

关键词：肝移植免疫抑制排斥耐受性临床试验

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cancer: safety and efficacy outcomes from an open-label, dose-escalation, single-center, phase I/II clinicaltrial

《医学前沿（英文）》 2023年第17卷第2期页码 231-239 doi: 10.1007/s11684-022-0939-9

摘要： To evaluate the safety and efficacy of neoadjuvant radiohormonal therapy for oligometastatic prostate cancer (OMPC), we conducted a 3 + 3 dose escalation, prospective, phase I/II, single-arm clinical trial (CHiCTR1900025743), in which long-term neoadjuvant androgen deprivation was adopted 1 month before radiotherapy, comprising intensity modulated radiotherapy to the pelvis, and stereotactic body radiation therapy to all extra-pelvic bone metastases for 4‒7 weeks, at 39.6, 45, 50.4, and 54 Gy. Robotic-assisted radical prostatectomy was performed after 5‒14 weeks. The primary outcome was treatment-related toxicities and adverse events; secondary outcomes were radiological treatment response, positive surgical margin (pSM), postoperative prostate-specific antigen (PSA), pathological down-grading and tumor regression grade, and survival parameters. Twelve patients were recruited from March 2019 to February 2020, aging 66.2 years in average (range, 52‒80). Median baseline PSA was 62.0 ng/mL. All underwent RARP successfully without open conversions. Ten patients recorded pathological tumor down-staging (83.3%), and 5 (41.7%) with cN1 recorded negative regional lymph nodes on final pathology. 66.7% (8/12) recorded tumor regression grading (TRG) –I and 25% (3/12) recorded TRG-II. Median follow-up was 16.5 months. Mean radiological progression-free survival (RPFS) was 21.3 months, with 2-year RPFS of 83.3%. In all, neoadjuvant radiohormonal therapy is well tolerated for oligometastatic prostate cancer.

关键词： neoadjuvant radiotherapy oligometastatic prostate cancer radical prostatectomy

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基于自然杀伤细胞的癌症免疫疗法的进展和前景 Review

胡渊, 田志刚, 张彩

《工程（英文）》 2019年第5卷第1期页码 106-114 doi: 10.1016/j.eng.2018.11.015

摘要：

自然杀伤（natural killer，NK）细胞是重要的先天免疫细胞，位于机体抵御病毒感染和癌症的第一道防线。尽管自然杀伤细胞可以区分“自身”和“非自身”，识别异常细胞，并实时清除恶性转化的细胞和肿瘤，但肿瘤也形成了一些逃逸自然杀伤细胞攻击的策略。这些策略包括：上调自然杀伤细胞抑制性受体的配体，产生可溶性分子或免疫抑制因子。目前，临床试验正在应用各种类型的自然杀伤细胞治疗不同类型的肿瘤，包括自体或同种异体自然杀伤细胞、脐带血（umbilical cord blood，UCB）或诱导性多能干细胞（induced pluripotent stem cell，iPSC）来源的自然杀伤细胞、记忆样自然杀伤细胞和自然杀伤细胞系NK-92 细胞。近来，嵌合抗原受体（chimeric antigen receptor，CAR）修饰的自然杀伤细胞因其再导向特异性和有效的抗肿瘤活性而展现出巨大潜力。文中总结了肿瘤逃逸自然杀伤细胞识别的机制、自然杀伤细胞免疫疗法的现状和进展、提升自然杀伤细胞体内抗肿瘤能力的途径以及该领域在临床实践中所面临的重大挑战。

关键词：自然杀伤细胞免疫疗法癌症临床试验嵌合抗原受体

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植物乳杆菌CCFM8610缓解肠易激综合征并改善肠道菌群失调——一项随机、双盲、安慰剂对照的先导性临床试验 Article

刘洋, 郁辛杰, 于雷雷, 田丰伟, 赵建新, 张灏, 钱龙, 王群, 薛正青, 翟齐啸, 陈卫

《工程（英文）》 2021年第7卷第3期页码 376-385 doi: 10.1016/j.eng.2020.06.026

摘要：

腹泻型肠易激综合征（irritable bowel syndrome with diarrhea, IBS-D）是一种伴有腹泻等复杂临床症状的慢性肠功能障碍，对患者的日常生活和精神状态具有极大影响。一些研究报道称，摄入益生菌可显著缓解多种肠道疾病。本研究的目的是探究一株具有多种保健作用的益生植物乳杆菌（Lactobacillus plantarum）CCFM8610对IBS-D的缓解作用。这项研究是一项为期12周的随机、双盲、安慰剂对照的先导性临床试验。75名患者被随机分配接受安慰剂、低聚糖或植物乳杆菌CCFM8610 [每天1 × 10¹⁰ CFU（菌落形成单位）]，进行为期两周的观察、8周的干预及两周的后续随访。采用IBS症状严重程度量表（IBS-SSS）及IBS生活质量量表（IBS-QOL）评定患者的临床症状和生活质量。在干预期结束时，测定肠道菌群组成和多样性的变化。结果表明，口服植物乳杆菌CCFM8610显著降低了IBS-SSS和IBS-QOL评分，减轻了IBS-D症状的严重程度，恢复了肠道菌群的多样性，降低了与腹胀相关的甲烷短杆菌属（Methanobrevibacter）的相对丰度，增加了厌氧棒状菌属（Anaerostipes）、双歧杆菌属（Bifidobacterium）、丁酸弧菌属（Butyricimonas）及臭杆菌属（Odoribacter）等丁酸生产种属的相对丰度。这些结果表明，摄入植物乳杆菌CCFM8610可以显著缓解IBS-D患者的临床症状及肠道菌群失调。植物乳杆菌CCFM8610对IBS-D的缓解作用可能与肠道中丁酸生产种属的相对丰度上升有关。

关键词：植物乳杆菌肠易激综合征肠道菌群丁酸临床试验

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迈入新世纪的硼中子俘获疗法（BNCT）

周永茂

《中国工程科学》 2012年第14卷第8期页码 4-13

摘要：

扼要叙述进入21世纪之际，硼中子俘获疗法（boron neutorn capture therapy，BNCT）在国际范围内的一些显著进展，包括BNCT的临床定位、肿瘤复发的探索、硼浓度的定量探测、靶向掺硼药物的开发以及我国医院中子照射器的问世。这些BNCT长期开发中的瓶颈趋于缓解，预示了BNCT个性化与例行化的前景更为清晰。

关键词：中子俘获疗法临床试治肿瘤复发硼浓度探测靶向药物医院中子照射器

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Trial design of arch bridge of composite box section with steel web-concrete flange

Jiangang WEI, Qingwei HUANG, Baochun CHEN,

《结构与土木工程前沿（英文）》 2010年第4卷第3期页码 370-375 doi: 10.1007/s11709-010-0073-7

摘要： The concrete arch bridge is a natural and appropriate structural solution, aesthetically pleasing and easily integrated into the environment, especially in mountainous and island areas. However, construction difficulty and cost will increase with heavy self-weight when the span enlarges. A potential solution is to use a composite box arch ring with steel web-concrete flange. Taking Wanzhou Yangtze River Bridge (the longest concrete arch bridge in the world with a main span of 420 m) as a prototype, trial designs of a composite box arch with steel webs (including corrugated steel webs and plain steel webs) and concrete flanges were carried out. Comparison of quantities and structural behaviors of the prototype concrete arch with the two trial designed composite arch was presented. It is shown that the self-weight of the composite arch can reduce about 28% and the structures can meet the design requirements, therefore it is possible to use the two composite arches in long span arch bridges.

关键词： steel webs concrete box arch trial design structural behaviors finite element method

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Balancing method without trial weights for rotor systems based on similitude scale model

Ruiduo YE, Liping WANG, Xiaojie HOU, Zhong LUO, Qingkai HAN

《机械工程前沿（英文）》 2018年第13卷第4期页码 571-580 doi: 10.1007/s11465-018-0478-x

摘要：

A balancing method without trial weights based on the dynamic similitude scale model was proposed as a solution to the balancing problem of a large-scale rotor system. This method could be used to directly obtain the required coefficients for the balancing problem of the prototype system through a similarity model test without a prototype test. Thus, the weight test process of the prototype system was effectively eliminated in the proposed balancing method. First, with the rotor system as the research object, the analytical expression of the influence coefficient was derived on the basis of rotor dynamics theory. Then, through calculation and dimensional analysis methods, the similitude relationships of the rotor system and the influence coefficient were deduced on the basis of dynamic similitude theory. The correctness of the proposed similitude relationships was verified through numerical simulation and experiment. The balancing method without trial weights was proposed based on the similitude relationship of the influence coefficient. The effect of the balancing method without trial weights was compared with that of the traditional influence coefficient method through numerical simulation, and the results verified the correctness and effectiveness of the proposed balancing method. The results of this study provide theoretical supplements for the balancing method and the similitude design of the rotor system.

关键词： rotor system dynamic similitude balancing without trial weights influence coefficient

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Effects of comprehensive therapy based on traditional Chinese medicine patterns on older patients with chronic obstructive pulmonary disease: a subgroup analysis from a four-center, randomized, controlled study

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《医学前沿（英文）》 2014年第8卷第3期页码 368-375 doi: 10.1007/s11684-014-0360-0

摘要：

This study aimed to evaluate the efficacy of comprehensive therapy based on traditional Chinese medicine (TCM) patterns on older patients with chronic obstructive pulmonary disease (COPD) through a four-center, open-label, randomized controlled trial. Patients were divided into the trial group treated using conventional western medicine and Bu-Fei Jian-Pi granules, Bu-Fei Yi-Shen granules, and Yi-Qi Zi-Shen granules based on TCM patterns respectively; and the control group treated using conventional western medicine. A total of 136 patients≥65 years completed the study, with 63 patients comprising the trial group and 73 comprising the control group. After the six-month treatment and the 12-month follow-up period, significant differences were observed between the trial and control groups in the following aspects: frequency of acute exacerbation (P≤0.040), duration of acute exacerbation (P = 0.034), symptoms (P≤0.034), 6-min walking distance (6MWD) (P≤0.039), dyspnea scale (P≤0.036); physical domain (P≤0.019), psychological domain (P≤0.033), social domain (P≤0.020), and environmental domain (P≤0.044) of the WHOQOL-BREF questionnaire; and daily living ability domain (P≤0.007), social activity domain (P≤0.018), depression symptoms domain (P≤0.025), and anxiety symptoms domain (P≤0.037) of the COPD-QOL. No differences were observed between the trial and control groups with regard to FVC, FEV1, and FEV1%.

关键词： chronic obstructive pulmonary disease older adult clinical trial Bu-Fei Jian-Pi granules Bu-Fei Yi-Shen granules Yi-Qi Zi-Shen granules

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oral liquids on patients with COVID-19: a randomized, open-label, parallel-controlled, multicenter clinicaltrial

Li Ni, Zheng Wen, Xiaowen Hu, Wei Tang, Haisheng Wang, Ling Zhou, Lujin Wu, Hong Wang, Chang Xu, Xizhen Xu, Zhichao Xiao, Zongzhe Li, Chenze Li, Yujian Liu, Jialin Duan, Chen Chen, Dan Li, Runhua Zhang, Jinliang Li, Yongxiang Yi, Wei Huang, Yanyan Chen, Jianping Zhao, Jianping Zuo, Jianping Weng, Hualiang Jiang, Dao Wen Wang

《医学前沿（英文）》 2021年第15卷第5期页码 704-717 doi: 10.1007/s11684-021-0853-6

摘要： We conducted a randomized, open-label, parallel-controlled, multicenter trial on the use of Shuanghuanglian (SHL), a traditional Chinese patent medicine, in treating cases of COVID-19. A total of 176 patients received SHL by three doses (56 in low dose, 61 in middle dose, and 59 in high dose) in addition to standard care. The control group was composed of 59 patients who received standard therapy alone. Treatment with SHL was not associated with a difference from standard care in the time to disease recovery. Patients with 14-day SHL treatment had significantly higher rate in negative conversion of SARS-CoV-2 in nucleic acid swab tests than the patients from the control group (93.4% vs. 73.9%, =0.006). Analysis of chest computed tomography images showed that treatment with high-dose SHL significantly promoted absorption of inflammatory focus of pneumonia, which was evaluated by density reduction of inflammatory focus from baseline, at day 7 (mean difference (95% CI), −46.39 (−86.83 to −5.94) HU; =0.025) and day 14 (mean difference (95% CI), −74.21 (−133.35 to −15.08) HU; =0.014). No serious adverse events occurred in the SHL groups. This study illustrated that SHL in combination with standard care was safe and partially effective for the treatment of COVID-19.

关键词： COVID-19 SARS-CoV-2 Shuanghuanglian oral liquid clinical trial

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肖永红：临床高耐药与高毒性病原体共进化（2023年2月22日）

2023年03月10日

关键词：代谢与免疫

A randomized, controlled, open label non-inferiority trial of intravenous ferric carboxymaltose versus

《医学前沿（英文）》 doi: 10.1007/s11684-023-1001-2

摘要： Iron deficiency (ID) and ID anemia (IDA) pose significant public health concerns in China. Although iron sucrose (IS) treatment is well-established in the country, ferric carboxymaltose (FCM) offers the advantage of higher doses and fewer infusions. This open label, randomized, controlled, non-inferiority trial was conducted at multiple sites in China to compare the outcomes of FCM (maximum of 2 doses, 500 or 1000 mg iron) and IS (up to 11 infusions, 200 mg iron) treatments in subjects with IDA. The primary endpoint was the achievement of hemoglobin (Hb) response (an increase of ≥2 g/dL from baseline) within 8 weeks, whereas secondary endpoints included changes in Hb, transferrin saturation, and serum ferritin levels. Among the 371 randomized subjects, a similar percentage of subjects treated with FCM and IS achieved Hb-response (FCM 99.4%, IS 98.3%), thereby confirming the non-inferiority of FCM compared with IS (difference 1.12 (−2.15, 4.71; 95% confidence interval (CI))). Furthermore, a significantly higher proportion of FCM-treated subjects achieved early Hb-response at Week 2 (FCM 85.2%, IS 73.2%; difference 12.1 (3.31, 20.65; 95% CI)). Additionally, the increase in TSAT and serum ferritin levels from baseline was significantly greater at all time points for FCM-treated subjects. The safety profiles of FCM and IS were comparable, with the exception of transient hypophosphatemia and pyrexia, which are consistent with FCM’s known safety profile. In conclusion, FCM proves to be an efficacious treatment for IDA, providing faster Hb-response and correction of ID with fewer administrations than IS.

关键词： iron deficiency anemia intravenous iron ferric carboxymaltose iron sucrose Hb response early response