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Analysis on the distinguishing features of traditional Chinese therapeutics and related statistical issues

Jingqing Hu, Jie Qiao, Deying Kang, Baoyan Liu

《医学前沿（英文）》 2011年第5卷第2期页码 203-207 doi: 10.1007/s11684-011-0138-6

摘要： Traditional Chinese medicine (TCM) is one of the rarely existing ancient traditional medicines that hold systematic theories as well as preventative and therapeutic methods for diseases in practice. From the 1950s, such research methods as mathematics, statistics, and data mining (DM) have been gradually introduced to TCM studies, making it more scientific. Meanwhile, the distinct features of TCM theories and diagnostic-model have constantly challenged the methodology of statistics. This paper introduces the following scientific features of traditional Chinese therapeutics: 1) its goal is to balance the functions and conditions of human body; 2) it emphasizes on holism and individualization; 3) it stresses the longitudinal regulation and evaluation mode, which is a circle of syndrome diagnosis, treatment and evaluation; 4) the interventions of TCM are abundant, compound and natural; and 5) humanistic thought is everywhere. Some statistical problems are raised based on these features. First, complex statistical methods that can analyze subjective indexes and latent variables, multidimensional and multistage data, non-equilibrium designed studies, and longitudinal data are required. Second, comprehensive evaluation on multiple-target mechanism has been brought in by combination treatment. Third, there is a need to analyze how humanity and related cultural factors may influence the effect of interventions. Thus, promoting implemented studies of statistics as well as carrying out the TCM scientific propositions have become the common expectations of both TCM and modern medicine.

关键词： traditional Chinese therapeutics feature statistic

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Developing macromolecular therapeutics: the future drug-of-choice

Huining HE, Victor C. YANG, Weibing DONG, Junbo GONG, Jingkang WANG,

《化学科学与工程前沿（英文）》 2010年第4卷第1期页码 10-17 doi: 10.1007/s11705-009-0291-5

摘要： Macromolecular drugs including peptides, proteins, antibodies, polysaccharides and nucleic acids have been widely used for therapy of major diseases such as carcinoma and AIDS as well as cardiovascular and neurodegenerative disorders among other medical conditions. Due to their unmatched properties of high selectivity and efficiency, macromolecular drugs have been recognized as the drug-of-choice of the future. Since worldwide progress on macromolecular therapeutics still remains in the infant stage and is therefore wide open for equal-ground competition, R&D related to macromolecular drugs should be considered as the main point of focus in China in setting up its strategic plans in pharmaceutical development. In this article, research strategies and drug delivery approaches that should be adopted to enhance the therapeutic effects of macromolecular drugs are reviewed. In addition, comments concerning how to implement such strategies to excel from competition in this challenging research field, such as the design of innovative and highly effective delivery systems of macromolecular drugs with self-owned intellectual property rights, are provided.

关键词： worldwide challenging effective macromolecular self-owned intellectual

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Human monoclonal antibodies as candidate therapeutics against emerging viruses

null

《医学前沿（英文）》 2017年第11卷第4期页码 462-470 doi: 10.1007/s11684-017-0596-6

摘要：

The emergence of new pathogens, such as severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV), and Ebola virus, poses serious challenges to global public health and highlights the urgent need for novel antiviral approaches. Monoclonal antibodies (mAbs) have been successfully used to treat various diseases, particularly cancer and immunological disorders. Antigen-specific mAbs have been isolated using several different approaches, including hybridoma, transgenic mice, phage display, yeast display, and single B-cell isolation. Consequently, an increasing number of mAbs, which exhibit high potency against emerging viruses in vitro and in animal models of infection, have been developed. In this paper, we summarize historical trends and recent developments in mAb discovery, compare the advantages and disadvantages of various approaches to mAb production, and discuss the potential use of such strategies for the development of antivirals against emerging diseases. We also review the application of recently developed human mAbs against SARS-CoV, MERS-CoV, and Ebola virus and discuss prospects for the development of mAbs as therapeutic agents against emerging viral diseases.

关键词： human monoclonal antibodies emerging infectious diseases SARS-CoV MERS-CoV Ebola virus

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Comparison of the clinical features and therapeutics of COVID-19 in cardio-cerebrovascular disease (CCVD

Yu Wang, Lan Li, Yuanjiang Pan, Yu He, Zuhua Chen, Yunhao Xun, Yuhan Xu, Yilei Guo, Jiehong Yang, Jianchun Guo, Haitong Wan

《医学前沿（英文）》 2021年第15卷第4期页码 629-637 doi: 10.1007/s11684-020-0825-2

摘要： Cardio-cerebrovascular disease (CCVD) is a major comorbidity of coronavirus disease 2019 (COVID-19). However, the clinical characteristics and outcomes remain unclear. In this study, 102 cases of COVID-19 from January 22, 2020 to March 26, 2020 in Xixi Hospital of Hangzhou were included. Twenty cases had pre-existing CCVD. Results showed that compared with non-CCVD patients, those with CCVD are more likely to develop severe disease (15% versus 1%), and the proportion of pneumonia severity index grade IV was significantly higher (25% versus 3.6%). Computed tomography images demonstrated that the proportion of multiple lobe lesion involvement was significantly higher in the CCVD group than in the non-CCVD group (90% versus 63.4%). Compared with non-CCVD group, the levels of C-reactive protein, fibrinogen, D-dimer, and serum amyloid-A were higher, whereas the total protein and arterial partial PaO were lower in the CCVD group. Although no statistical difference was observed in the outcomes between groups, CCVD patients received more intensive comprehensive treatment to improve COVID-19 symptoms compared with non-CCVD patients. Integrated Chinese and Western medicine treatments have certain advantages in controlling the severe conversion rate and mortality of COVID-19. In addition, given that COVID-19 patients are usually related to coagulation disorders and thrombosis risk, the application of Chinese medicine in promoting blood circulation and removing stasis should be strengthened.

关键词： COVID-19 cardio-cerebrovascular disease traditional Chinese medicine clinical features clinical therapeutics

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Precision medicine in acute lymphoblastic leukemia

Ching-Hon Pui

《医学前沿（英文）》 2020年第14卷第6期页码 689-700 doi: 10.1007/s11684-020-0759-8

摘要： The cure rate of childhood acute lymphoblastic leukemia (ALL) has exceeded 90% in some contemporary clinical trials. However, the dose intensity of conventional chemotherapy has been pushed to its limit. Further improvement in outcome will need to rely more heavily on molecular therapeutic as well as immuno- and cellular-therapy approaches together with precise risk stratification. Children with or hyperdiploid>50 ALL who achieve negative minimal residual disease during early remission induction are suitable candidates for reduction in treatment. Patients with Philadelphia chromosome (Ph)-positive or Ph-like ALL with ABL-class fusion should be treated with dasatinib. BH3 profiling and other preclinical methods have identified several high-risk subtypes, such as hypodiplod, early T-cell precursor, immature T-cell, -rearranged, Ph-positive and -positive ALL, that may respond to BCL-2 inhibitor venetoclax. There are other fusions or mutations that may serve as putative targets, but effective targeted therapy has yet to be established. For other high-risk patients or poor early treatment responders who do not have targetable genetic lesions, current approaches that offer hope include blinatumomab, inotuzumab and CAR-T cell therapy for B-ALL, and daratumumab and nelarabine for T-ALL. With the expanding therapeutic armamentarium, we should start focus on rational combinations of targeted therapy with non-overlapping toxicities.

关键词： acute lymphoblastic leukemia molecular therapeutics targeted therapy tyrosine kinase inhibitors immunotherapy CAR T-cell therapy

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ANTIVIRAL EFFECTS OF BACTERIOCIN AGAINST ANIMAL-TO-HUMAN TRANSMITTABLE MUTATED SARS-COV-2: A SYSTEMATIC REVIEW

《农业科学与工程前沿（英文）》 2021年第8卷第4期页码 603-622 doi: 10.15302/J-FASE -2021397

摘要：

The COVID-19 infections caused by SARS-CoV-2 have resulted in millions of people being infected and thousands of deaths globally since November 2019. To date, no unique therapeutic agent has been developed to slow the progression of this pandemic. Despite possessing antiviral traits the potential of bacteriocins to combat SARS-CoV-2 infection has not been fully investigated. This review summarizes the mechanisms by which bacteriocins can be manipulated and implemented as effective virus entry blockers with infection suppression potential properties to highly transmissible viruses through comprehensive immune modulations that are potentially effective against COVID-19. These antimicrobial peptides have been suggested as effective antiviral therapeutics and therapeutic supplements to prevent rapid virus transmission. This review also provides a new insight into the cellular and molecular alterations which have made SARS-CoV-2 self-modified with diversified infection patterns. In addition, the possible applications of antimicrobial peptides through both natural and induced mechanisms in infection prevention perspectives on changeable virulence cases are comprehensively analyzed. Specific attention is given to the antiviral mechanisms of the molecules along with their integrative use with synthetic biology and nanosensor technology for rapid detection. Novel bacteriocin based therapeutics with cutting-edge technologies might be potential substitutes for existing time-consuming and expensive approaches to fight this newly emerged global threat.

关键词： antimicrobial proteins / antiviral profiling of bacteriocins / antiviral therapeutics / immunomodulation / nanosensor technology / mutated SARS-CoV-2

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Molecular engineering of dendrimer nanovectors for siRNA delivery and gene silencing

Yu Cao, Xiaoxuan Liu, Ling Peng

《化学科学与工程前沿（英文）》 2017年第11卷第4期页码 663-675 doi: 10.1007/s11705-017-1623-5

摘要： Small interfering RNA (siRNA) therapeutics hold great promise to treat a variety of diseases, as long as they can be delivered safely and effectively into cells. Dendrimers are appealing vectors for siRNA delivery by virtue of their well-defined molecular architecture and multivalent cooperativity. However, the clinical translation of RNA therapeutics mediated by dendrimer delivery is hampered by the lack of dendrimers that are of high quality to meet good manufacturing practice standard. In this context, we have developed small amphiphilic dendrimers that self-assemble into supramolecular structures, which mimic high-generation dendrimers synthesized with covalent construction, yet are easy to produce in large amount and superior quality. Indeed, the concept of supramolecular dendrimers has proved to be very promising, and has opened up a new avenue for dendrimer-mediated siRNA delivery. A series of self-assembling supramolecular dendrimers have consequently been established, some of them out-performing the currently available nonviral vectors in delivering siRNA to various cell types and , including human primary cells and stem cells. This short review presents a brief introduction to RNAi therapeutics, the obstacles to their delivery and the advantages of dendrimer delivery vectors as well as our bio-inspired structurally flexible dendrimers for siRNA delivery. We then highlight our efforts in creating self-assembling amphiphilic dendrimers to construct supramolecular dendrimer nanosystems for effective siRNA delivery as well as the related structural alterations to enhance delivery efficiency. The advent of self-assembling supramolecular dendrimer nanovectors holds great promise and heralds a new era of dendrimer-mediated delivery of RNA therapeutics in biomedical applications.

关键词： gene therapy RNAi therapeutics dendrimer nanovectors gene silencing

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Enhanced penetration strategies for transdermal delivery

Qiaofei Pan, Yinglin Yu, Dong Chen, Genlong Jiao, Xiaowen Liu

《化学科学与工程前沿（英文）》 2020年第14卷第3期页码 378-388 doi: 10.1007/s11705-019-1913-1

摘要： Transdermal delivery offers several advantages in drug distribution, including convenience, painless administration, avoidance of first-pass metabolism, and ease of termination. However, the natural protective barriers of the skin, such as the stratum corneum, the topmost layer of skin, limit the systemic absorption of external therapeutics via transdermal delivery. Therefore, extensive application of transdermal delivery in medical treatment has been limited. Over the past few years, many formulation strategies and physical technologies, therefore, have been developed to enhance transdermal delivery. This review summarizes various formulation strategies proposed for transdermal delivery and their application in medical treatment.

关键词： transdermal delivery stratum corneum enhanced penetration therapeutics

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Clinical study using mesenchymal stem cells for the treatment of patients with severe COVID-19

Lingling Tang, Yingan Jiang, Mengfei Zhu, Lijun Chen, Xiaoyang Zhou, Chenliang Zhou, Peng Ye, Xiaobei Chen, Baohong Wang, Zhenyu Xu, Qiang Zhang, Xiaowei Xu, Hainv Gao, Xiaojun Wu, Dong Li, Wanli Jiang, Jingjing Qu, Charlie Xiang, Lanjuan Li

《医学前沿（英文）》 2020年第14卷第5期页码 664-673 doi: 10.1007/s11684-020-0810-9

摘要： The coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 was identified in December 2019. The symptoms include fever, cough, dyspnea, early symptom of sputum, and acute respiratory distress syndrome (ARDS). Mesenchymal stem cell (MSC) therapy is the immediate treatment used for patients with severe cases of COVID-19. Herein, we describe two confirmed cases of COVID-19 in Wuhan to explore the role of MSC in the treatment of COVID-19. MSC transplantation increases the immune indicators (including CD4 and lymphocytes) and decreases the inflammation indicators (interleukin-6 and C-reactive protein). High-flow nasal cannula can be used as an initial support strategy for patients with ARDS. With MSC transplantation, the fraction of inspired O (FiO ) of the two patients gradually decreased while the oxygen saturation (SaO ) and partial pressure of oxygen (PO ) improved. Additionally, the patients’ chest computed tomography showed that bilateral lung exudate lesions were adsorbed after MSC infusion. Results indicated that MSC transplantation provides clinical data on the treatment of COVID-19 and may serve as an alternative method for treating COVID-19, particularly in patients with ARDS.

关键词： coronavirus disease 2019 (COVID-19) mesenchymal stem cell acute respiratory distress syndrome stem cell therapeutics

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间充质干细胞治疗人感染H7N9禽流感病毒所致急性呼吸窘迫综合征的临床研究——为新冠病毒肺炎救治提供新策略 Article

陈佳佳, 胡晨霞, 陈利军, 汤灵玲, 朱一新, 徐小微, 陈露, 高海女, 鲁晓庆, 俞亮, 戴霞红, 项春生, 李兰娟

《工程（英文）》 2020年第6卷第10期页码 1153-1161 doi: 10.1016/j.eng.2020.02.006

摘要：

2013年，H7N9病毒在哺乳动物宿主之间迅速传播，并具有人与人之间传播的风险。患者表现为重症肺炎、急性呼吸窘迫综合征（acute respiratory distress syndrome, ARDS）和呼吸衰竭。间充质干细胞（mesenchymal stem cell, MSC）移植在病毒性肺炎的治疗中有广阔的前景，并于2013年作为应急性治疗方法来治疗H7N9感染的ARDS。该研究在单中心开展，为开放式临床研究。根据自愿和知情同意的原则，17例H7N9感染的ARDS患者移植同种异体经血来源的MSC作为治疗组，44例H7N9感染的ARDS患者作为对照组。与对照组相比，MSC移植显著降低了ARDS病死率（MSC治疗组和对照组死亡率分别为17.6％和54.5％）。此外，在对4名MSC移植患者进行为期5年的随访中，未发现MSC移植产生有害影响。总体而言，该研究结果表明MSC移植显著提高了H7N9感染的ARDS的存活率，并为开展临床前和临床应用MSC治疗H7N9感染的ARDS的研究提供了理论基础。由于H7N9和2019新型冠状病毒性肺炎（coronavirus disease 2019, COVID-19）临床表现相似（如ARDS和呼吸衰竭），并继发多器官功能障碍，因此基于MSC的疗法可能为COVID-19所致的ARDS患者获益。

关键词： H7N9 间充质干细胞甲型流感急性呼吸窘迫综合征新型冠状病毒性肺炎干细胞治疗