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新型立体式网状宫内节育器初步临床观察

邱毅,王磊光,于玲

《中国工程科学》 2014年第16卷第5期页码 39-46

摘要：

为了观察新型立体式网状宫内节育器（3-DR-IUD）的避孕效果及副反应，将152 例志愿受试者随机分为两组，即接受3-DR-IUD组和放置元宫药铜宫内节育器(2-D-IUD)组，每组各76 例，常规放置3-DR-IUD和2-D-IUD。分别于术后1 个月、3 个月、6 个月和12 个月进行随访，了解放置宫内节育器（IUD）后副反应（如腹痛、腰痛、阴道出血持续时间及出血量、白带等）的发生率、带器妊娠率、IUD脱落率、因症取出率、续用率及避孕效果，并利用B超、X光腹部平片检查3-DR-IUD位置等。两组各76 例均成功放置了IUD，术中均无明显疼痛。3-DR-IUD组术后出现白带增多、月经期延长、不规则出血、月经量增多及腰腹部疼痛等副反应6例(7.9%)，而2-D-IUD组出现31例（40.8%），两组比较差异有统计学意义(P<0.000 1)。3-DR-IUD 组无脱落，无带器妊娠者，3 个月时因对硅橡胶过敏取出1 例，12 个月时终止率为1.3 %，续用率为98.7 %（75/76）；2-DIUD组终止率为13.2 %，续用率为86.8 %（66/76），两组比较差异有统计学意义(P=0.009)。实验结果表明，3-DR-IUD具有很好的避孕效果，术后副反应轻微，可为育龄妇女提供新的、安全、高效的IUD。

关键词： 3-DR-IUD 临床实验副反应避孕效果

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Rare tumors: a blue ocean of investigation

《医学前沿（英文）》 2023年第17卷第2期页码 220-230 doi: 10.1007/s11684-023-0984-z

摘要： Advances in novel drugs, therapies, and genetic techniques have revolutionized the diagnosis and treatment of cancers, substantially improving cancer patients’ prognosis. Although rare tumors account for a non-negligible number, the practice of precision medicine and development of novel therapies are largely hampered by many obstacles. Their low incidence and drastic regional disparities result in the difficulty of informative evidence-based diagnosis and subtyping. Sample exhaustion due to difficulty in diagnosis also leads to a lack of recommended therapeutic strategies in clinical guidelines, insufficient biomarkers for prognosis/efficacy, and inability to identify potential novel therapies in clinical trials. Herein, by reviewing the epidemiological data of Chinese solid tumors and publications defining rare tumors in other areas, we proposed a definition of rare tumor in China, including 515 tumor types with incidences of less than 2.5/100 000 per year. We also summarized the current diagnosis process, treatment recommendations, and global developmental progress of targeted drugs and immunotherapy agents on the status quo. Lastly, we pinpointed the current recommendation chance for patients with rare tumors to be involved in a clinical trial by NCCN. With this informative report, we aimed to raise awareness on the importance of rare tumor investigations and guarantee a bright future for rare tumor patients.

关键词： rare tumors diagnosis flowchart treatment strategy clinical trials recommendation

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Overcoming the challenges of conducting translational research in cell therapy

Sowmya Viswanathan, Armand Keating

《医学前沿（英文）》 2011年第5卷第4期页码 333-335 doi: 10.1007/s11684-011-0166-2

摘要： Cell therapy holds promise in addressing a number of unmet medical needs but despite its considerable impetus, faces numerous challenges including support for translational research in this area. Here, we examine the challenges confronting cell therapy research including the limited funding available for translational research partly due to the uncompetitive nature of required validation studies in cell therapy that of necessity are not hypothesis-driven. Other issues include lack of standardization of definitions of cell products, uncertainty regarding optimum preclinical animal models, duplication of efforts to secure regulatory approval and a lack of uniformity of nomenclature for some cell products. Nonetheless, several initiatives to address all of these issues are underway.

关键词： stem cells clinical trials funding animal models standardization common definitions

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Clinical efficacy of comprehensive therapy based on traditional Chinese medicine patterns on patients

《医学前沿（英文）》 2022年第16卷第5期页码 736-744 doi: 10.1007/s11684-021-0870-5

摘要： Effective therapy options for pneumoconiosis are lacking. Traditional Chinese medicine (TCM) presents a favorable prospect in the treatment of pneumoconiosis. A pilot study on TCM syndrome differentiation can evaluate the clinical efficacy and safety of TCM and lay a foundation for further clinical research. A double-blind, randomized, and placebo-controlled trial was conducted for 24 weeks, in which 96 patients with pneumoconiosis were randomly divided into the control and treatment groups. Symptomatic treatment was conducted for the two groups. The treatment group was treated with TCM syndrome differentiation, and the control group was treated with placebo. The primary outcomes were the six-minute walking distance (6MWD) and the St. George Respiratory Questionnaire (SGRQ) score. The secondary outcomes were the modified British Medical Research Council Dyspnea Scale (mMRC), Chronic Obstructive Pulmonary Disease Assessment Test (CAT), Hospital Anxiety and Depression Scale (HADS), and pulmonary function. Only 83 patients from the 96 patients with pneumoconiosis finished the study. For the primary outcome, compared with the control groups, the treatment group showed a significantly increased 6MWD (407.90 m vs. 499.51 m; 95% confidence interval (CI) 47.25 to 135.97; P <0.001) and improved SGRQ total score (44.48 vs. 25.67; 95% CI −27.87 to −9.74; P <0.001). The treatment group also significantly improved compared with the control group on mMRC score (1.4 vs. 0.74; 95% CI −1.08 to −0.23; P =0.003), CAT score (18.40 vs. 14.65; 95% CI −7.07 to −0.43; P =0.027), and the total symptom score (7.90 vs. 5.14; 95% CI −4.40 to −1.12; P <0.001). No serious adverse events occurred. This study showed that TCM syndrome differentiation and treatment had a favorable impact on the exercise endurance and quality of life of patients with pneumoconiosis.

关键词： pneumoconiosis randomized controlled trials traditional Chinese medicine

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新冠病毒疫苗的下一步效力评价

江湖大川, 张力, 李靖欣,朱凤才

《工程（英文）》 2021年第7卷第7期页码 903-907 doi: 10.1016/j.eng.2021.04.013

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Overcoming resistance to endocrine therapy in hormone receptor-positive human epidermal growth factor receptor 2-negative (HR

Wenjie Zhu, Binghe Xu

《医学前沿（英文）》 2021年第15卷第2期页码 208-220 doi: 10.1007/s11684-020-0795-4

摘要： New targeted therapies have been developed to overcome resistance to endocrine therapy (ET) and improve the outcome of HR /HER2 advanced breast cancer (ABC). We conducted a meta-analysis and systemic review on randomized controlled trials evaluating various targeted therapies in combination with ET in HR /HER2 ABC. PUBMED and EMBASE databases were searched for eligible trials. Hazard ratios (HRs) for progression-free survival (PFS), odds ratios (ORs) for objective response rate (ORR), clinical benefit rate (CBR), and toxicity were meta-analyzed. Twenty-six studies with data on 10 347 patients were included and pooled. The addition of cyclin-dependent kinase 4/6 inhibitors to ET significantly improved median PFS (pooled HR= 0.547, <0.001), overall survival (pooled HR= 0.755, <0.001), and tumor response rates (ORR, pooled OR= 1.478, <0.001; CBR, pooled OR= 1.201, <0.001) with manageable toxicities (pooled OR= 3.280, <0.001). The mammalian targets of rapamycin inhibitors and exemestane were not clinically beneficial for this pooled population including ET-naïve and ET-resistant patients. Moderate improvement in PFS (pooled HR= 0.686, <0.001) yet pronounced toxicities (pooled OR= 2.154, <0.001) were noted in the combination of phosphatidylinositol-4,5-bisphosphate 3-kinase inhibitors with fulvestrant. Future studies are warranted to optimize the population and the dosing sequence of these available options.

关键词： endocrine-resistant HR⁺/HER2^- advanced breast cancer randomized clinical trials meta-analysis targeted therapy

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Consolidated standards of reporting trials (CONSORT) for traditional Chinese medicine: current situation

Zhaoxiang Bian, Baoyan Liu, David Moher, Taixiang Wu, Youping Li, Hongcai Shang, Chungwah Cheng

《医学前沿（英文）》 2011年第5卷第2期页码 171-177 doi: 10.1007/s11684-011-0132-z

摘要： The reporting standards for randomized controlled trials were first published in 1996 by a group of scientists under the name “CONSORT,” which means consolidated standards of reporting trials. Revisions followed in 2001 and 2010. A draft of the CONSORT for traditional Chinese medicine (TCM) was published in both Chinese and English in 2007. After publication of the draft, comments were solicited from the medical community. Some papers did raise concerns about which items should be included in the CONSORT for TCM such as the rationale of the trial design, intervention, outcome assessment, and adverse events. We have now reached the next step which is the finalization of the CONSORT for TCM. Three tasks remain. First, the major changes in CONSORT statement 2010 should be integrated into the CONSORT for TCM. Second, Chinese drugs from minerals and animals should be included in the guidelines. Finally, agreement must be reached among the working groups. Once the draft is finalized, wide dissemination and co-publication will be considered.

关键词： CONSORT for TCM reporting standards future development

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原发性肝癌三维适形和调强放疗的基础和临床研究

蒋国梁

《中国工程科学》 2009年第11卷第10期页码 129-136

摘要：

报告三维适形（3-dimensional conformal radiation therapy, 3DCRT）和调强放疗（intensity-modulated radiation therapy, IMRT）治疗原发性肝癌（HCC）的基础和临床研究,建立了3DCRT和IMRT放疗HCC的技术，进行3个临床试验，获得了令人鼓舞的3年总生存率：28 ％～33 ％。治疗并发症主要是放射性肝病（RILD），此并发症的死亡率为76 ％，预防RILD最有效的方法是把对正常肝脏的放射剂量限制在安全的范围内。我国的HCC病人大都伴有肝硬化，伴发的肝硬化损害了肝脏对放射损伤的修复和肝脏再生的能力，他们的放射耐受剂量是（全肝平均剂量）：Child-Pugh A病人23 Gy，Child-Pugh B病人6 Gy，这个耐受量显著低于目前国际上通用的30 Gy。研究建立了用于预测我国HCC病人放疗中发生RILD发生概率的Lyman数学模式，其参数明显不同于国外的模式，并将一整套适合我国国情的HCC放疗技术成功地进行了临床实践，证实了放疗可以作为不能手术肝癌的一种治疗选择。

关键词：三维适形放疗束流调强放疗肝细胞性肝癌肝脏放射耐受性

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单克隆抗体治疗过敏性疾病的研究现状 Review

陈彦, 王炜, 袁慧慧, 李艳, 吕喆, 崔烨, 刘杰, 孙英

《工程（英文）》 2021年第7卷第11期页码 1552-1556 doi: 10.1016/j.eng.2020.06.029

摘要：

过敏性疾病是常见的慢性疾病之一，由变应原在不同器官上引发变态反应，在临床上以不同器官的疾病为主要表现形式，如哮喘、特应性皮炎、鼻-鼻窦炎等，常累及儿童和成人。由于其在世界范围内的广泛流行和对患者生活质量的影响，采用新型生物疗法治疗过敏性疾病的研究业已成为该领域的热点。已知多种因素可促进或触发Th2 型免疫应答，导致2 型细胞因子和免疫球蛋白E（IgE）的产生并参与过敏性疾病的发生发展，因此，开发针对2 型细胞因子和IgE 的单克隆抗体为治疗过敏性疾病提供了新的策略。此外，一些潜在的靶点，如上皮源性预警素-胸腺基质淋巴细胞生成素（TSLP）和白介素33（IL-33）业已进入临床研究阶段。这些新的和潜在的靶点极大地提高了变应性疾病的治疗机会。本文阐述了目前已开发的针对细胞因子、细胞因子受体和IgE 的单克隆抗体在过敏性疾病治疗中的作用，并对这些抗体的临床效果进行了讨论和分析。

关键词：过敏性疾病单克隆抗体抗免疫球蛋白E 细胞因子临床试验

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CAR-T细胞产品的质量控制和非临床研究——一般原则和关键问题 Review

李永红, 霍艳, 于雷, 王军志

《工程（英文）》 2019年第5卷第1期页码 122-131 doi: 10.1016/j.eng.2018.12.003

摘要：

采用嵌合抗原受体T 细胞（chimeric antigen receptor T cells, CAR-T cells）的过继性细胞治疗是一种很有前途的肿瘤免疫治疗策略，近年来发展迅速。CAR-T 细胞是通过基因修饰能够特异性识别肿瘤细胞表面特定抗原的T 细胞，对肿瘤细胞具有强大的杀灭作用。目前CAR-T 细胞在恶性血液病患者中的临床应用已经取得振奋人心的结果，国内外对于CAR-T 细胞针对多种靶点以及用于治疗实体瘤的研究开发形成了很大的热点，越来越多的产品将会进入临床试验和上市使用。这些产品的质量控制和非临床研究对于保障产品安全、有效具有重要意义，同时也具有较大的挑战和困难。本文在相关细胞治疗和基因治疗产品指导原则的基础上，结合CAR-T 细胞产品的具体特点，探讨其质量控制和非临床前研究的一般原则，以及其中的一些关键问题。

关键词：嵌合抗原受体T细胞质量控制非临床研究安全性有效性临床试验癌症免疫治疗

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A meta-analysis of randomized trials of maintenance bacillus Calmette-Guerin instillation efficacy against

PAN Jiangang, ZHOU Xing, CHEN Zhiguang, HAN Ruifa

《医学前沿（英文）》 2008年第2卷第3期页码 259-263 doi: 10.1007/s11684-008-0049-3

摘要： Meta-analysis was used to determine whether maintenance intravesical bacillus Calmette-Guerin (BCG) could reduce recurrence after transurethral resection of tumor 1 grade 3 (T1G3) superficial bladder cancer. All available published data of randomized clinical trials comparing transurethral resection plus intravesical BCG to either resection alone or resection plus another treatment on the treatment results in patients with superficial bladder cancer of T1G3 were selected for analysis. Both the fixed effects model and random effects model were applied, and the odds ratio () with its 95% confidence interval (CI) was used as the effect size estimate. Sensitivity analysis and publication bias determination were performed by funnel plots and comparing s of different models. Within the follow-up period, 375 of 915 (41.0%) BCG-treated patients and 332 of 733 (45.3%) non-BCG-treated patients developed tumor recurrence. In the combined results, a statistically significant difference in the s for tumor recurrence between the two treatment groups was found (randomized model combined effect 0.58, 95% CI 0.41 to 0.83, = 0.003). The stratified meta-analysis did not show any statistically significant confounding effects on the results when stratified by BCG strains. The randomized model combined effect of Pasteur F and other strains were 0.50 (95% CI 0.26 to 0.95, = 0.04) and 0.63 (95% CI 0.40 to 0.99, = 0.04), respectively. Therefore, we came to the conclusion that adjuvant maintenance instillation BCG combined with transurethral resection of bladder tumor (TURBT) is an effective conservative treatment for preventing recurrence of T1G3 bladder cancer.

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新冠病毒肺炎临床试验核心指标集（COS-COVID） Article

金鑫瑶, 庞博, 张俊华, 刘清泉, 杨忠奇, 封继宏, 刘学政, 张磊, 王保和, 黄宇虹, Alice Josephine Fauci, 马玉玲, Myeong Soo Lee, 元唯安, 谢雁鸣, 唐健元, 高蕊, 杜亮, 张硕, 祁寒梅, 孙宇, 郑文科, 杨丰文, 蔡慧姿, 王可仪, 欧益, 黄明, 朱彦, 喻佳洁, 田金徽, 赵敏, 胡镜清, 姚晨, 李幼平, 张伯礼

《工程（英文）》 2020年第6卷第10期页码 1147-1152 doi: 10.1016/j.eng.2020.03.002

摘要：

自2019年12月新型冠状病毒肺炎（Coronavirus Disease 2019, COVID-19）暴发以来，已有大量相关临床研究完成注册或已启动。然而，不同研究间临床结局指标存在显著的异质性，同时一些不关键的指标会造成研究资源的浪费。本研究旨在构建COVID-19临床试验核心结局指标集（core outcome set, COS），为相关临床研究方案设计、开展和证据转化提供参考。本研究的实施参照《有效性试验核心结局指标（COMET）手册》（1.0版），研究组成员包括呼吸系统和危重医学、中医学、循证医学、临床药理学、统计学专家以及医学杂志编辑等。通过检索临床试验注册网站（chictr.org.cn和clinicaltrials.gov）中COVID-19相关临床研究方案，提取方案中的结局指标，形成指标池。78个COVID-19临床试验方案纳入研究，收集结局指标259个，合并规范后确定132个结局指标，涉及7个指标域。经遴选，形成了包括58个结局指标在内的初始指标清单。经过两轮德尔菲调查和一轮共识会议，最终确立针对COVID-19不同临床分型的核心指标集（COS-COVID）。COS-COVID包括1个轻型指标（病毒核酸检测转阴时间）、4个普通型指标（住院时间、复合事件发生率、临床症状积分和病毒核酸检测转阴时间）、5个重型指标（复合事件发生率、住院时间、PaO₂/FiO₂、机械通气时间和病毒核酸检测转阴时间）、1个危重型指标（全因死亡率）及1个康复期指标（肺功能）。COS-COVID作为目前临床评价COVID-19干预效果最具临床价值及操作性的指标集合，对证据评估和决策具有重要意义。随着对疾病认知的不断深入和COS-COVID应用的反馈，课题组将对本核心指标集进行进一步完善并更新。

关键词：核心指标集 COVID-19 2019-nCoV 冠状病毒疾病临床试验

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伙伴合作模式工程合同的进化——新工程合同

刘正光

《中国工程科学》 2012年第14卷第12期页码 81-84

摘要：

随着社会的发展,工程行业变得十分复杂,因而传统的施工合同已经不能满足工程界日益多元化的发展。因此,英国土木工程师学会和业界经过广泛研究和讨论,一致同意要改善业界互相监视和不信任的现状,因而在1993年,推出新工程合同(NEC), 鼓励成立“团体精神”,即建立良好伙伴关系。经过近20年的应用,NEC成效卓越。香港特区政府也在2009年跟进,试验性地引用NEC。文章介绍了第一个引用NEC项目的经验,该项目成果证明NEC可节省工期和工程费用,减少合同争端,增加成本效益，因而大大增强了业界引用NEC的信心。

关键词：传统工程合同新工程合同新工程合同经验

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Ontological reconstruction of the clinical terminology of traditional Chinese medicine

null

《医学前沿（英文）》 2014年第8卷第3期页码 358-361 doi: 10.1007/s11684-014-0348-9

摘要：

This study proposes the ontological reconstruction of the current clinical terminology of traditional Chinese medicine (TCM). It also provides an overview of preliminary work related to the said reconstruction, including the ontology-based analysis of TCM clinical terminology. We conclude that the ontological reconstruction of TCM clinical terminology provides a proper translation from the idealized organizational model to real-world implementation and to a formalized, shared, and knowledge-based framework.

关键词： ontology traditional Chinese medicine clinical terminology

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The clinical impact of tricuspid regurgitation in patients with a biatrial orthotopic heart transplant

《医学前沿（英文）》 2023年第17卷第3期页码 527-533 doi: 10.1007/s11684-022-0967-5

摘要： In this study, we aim to elucidate the clinical impact and long-term course of tricuspid regurgitation (TR), taking into account its dynamic nature, after biatrial orthotopic heart transplant (OHT). All consecutive adult patients undergoing biatrial OHT (1984−2017) with an available follow-up echocardiogram were included. Mixed-models were used to model the evolution of TR. The mixed-model was inserted into a Cox model in order to address the association of the dynamic TR with mortality. In total, 572 patients were included (median age: 50 years, males: 74.9%). Approximately 32% of patients had moderate-to-severe TR immediately after surgery. However, this declined to 11% on 5 years and 9% on 10 years after surgery, adjusted for survival bias. Pre-implant mechanical support was associated with less TR during follow-up, whereas concurrent LV dysfunction was significantly associated with more TR during follow-up. Survival at 1, 5, 10, 20 years was 97% ± 1%, 88% ± 1%, 66% ± 2% and 23% ± 2%, respectively. The presence of moderate-to-severe TR during follow-up was associated with higher mortality (HR: 1.07, 95% CI (1.02–1.12), p = 0.006). The course of TR was positively correlated with the course of creatinine (R = 0.45). TR during follow-up is significantly associated with higher mortality and worse renal function. Nevertheless, probability of TR is the highest immediately after OHT and decreases thereafter. Therefore, it may be reasonable to refrain from surgical intervention for TR during earlier phase after OHT.

关键词： orthotopic heart transplant tricuspid regurgitation clinical impact biatrial heart transplantation