1.Analysis of the Causes of Subject Screening Failures in Clinical Trials of Antineoplastic Drugs and Protocol Nerfing Indicators
Shuopeng JIA ; Hailan MA ; Huiyao HUANG ; Jingxiao ZHU ; Anqi YU ; Yiru HOU ; Yu TANG ; Hong FANG ; Ning LI
Herald of Medicine 2025;44(3):497-502
Objective To analyze the reasons for the failure of subject screening in clinical trials of antineoplastic drugs and the impact of natriuretic criteria on the entry of subjects into clinical trials,to explore the strategies to improve the suc-cessful enrolment of screened subjects,and to provide reference bases for research institutes and sponsors in the formulation of na-triuretic criteria.Methods This study selected data from 40 drug clinical trials conducted at the Drug Clinical Trial Research Center of the Cancer Hospital of the Chinese Academy of Medical Sciences from January 1,2016,to June 30,2022.It statistically described the collected data on the frequency and percentage composition of screening failures among participants and the inclu-sion and exclusion criteria in the protocols.Results A total of 425 subjects were screened out of 40 clinical trial programmers covering 8 tumor types,with the majority being<65 years of age(333,78.4%),of which the most important reasons included vol-untary withdrawal(71,16.7%),tumor metastasis(52,12.2%),failure to recover from treatment of pre-existing disease(38,8.9%),failure of bone marrow function(19,4.5%),and non-compliant liver function(15,3.5%).Among the nadir indicators,the age of the subjects(100%),ECOG score(97.5%),bone marrow function(ANC:95.0%,PLT:97.5%,HB:97.5%),liver function(T-BiL:95.0%,ALT:87.5%,AST:95.0%),renal function(CR:80.0%),and viral screening(HIV:80.0%,HBV:70.0%,HCV:62.5%)were relatively stringent.Conclusion The main reasons for subject screening failure in clinical trials in oncology in our hospital are voluntary withdrawal,brain metastasis,and failure of their biochemical test standards,which are close-ly related to the setting of clinical trial nadir criteria.Therefore,an in-depth understanding of subjects'characteristics,accurate set-ting of appropriate nadir criteria,continuous improvement of trial design,and strengthening of communication with subjects to pro-vide more relevant information will help to improve the screening success rate of clinical trials.
2.Analysis of the Causes of Subject Screening Failures in Clinical Trials of Antineoplastic Drugs and Protocol Nerfing Indicators
Shuopeng JIA ; Hailan MA ; Huiyao HUANG ; Jingxiao ZHU ; Anqi YU ; Yiru HOU ; Yu TANG ; Hong FANG ; Ning LI
Herald of Medicine 2025;44(3):497-502
Objective To analyze the reasons for the failure of subject screening in clinical trials of antineoplastic drugs and the impact of natriuretic criteria on the entry of subjects into clinical trials,to explore the strategies to improve the suc-cessful enrolment of screened subjects,and to provide reference bases for research institutes and sponsors in the formulation of na-triuretic criteria.Methods This study selected data from 40 drug clinical trials conducted at the Drug Clinical Trial Research Center of the Cancer Hospital of the Chinese Academy of Medical Sciences from January 1,2016,to June 30,2022.It statistically described the collected data on the frequency and percentage composition of screening failures among participants and the inclu-sion and exclusion criteria in the protocols.Results A total of 425 subjects were screened out of 40 clinical trial programmers covering 8 tumor types,with the majority being<65 years of age(333,78.4%),of which the most important reasons included vol-untary withdrawal(71,16.7%),tumor metastasis(52,12.2%),failure to recover from treatment of pre-existing disease(38,8.9%),failure of bone marrow function(19,4.5%),and non-compliant liver function(15,3.5%).Among the nadir indicators,the age of the subjects(100%),ECOG score(97.5%),bone marrow function(ANC:95.0%,PLT:97.5%,HB:97.5%),liver function(T-BiL:95.0%,ALT:87.5%,AST:95.0%),renal function(CR:80.0%),and viral screening(HIV:80.0%,HBV:70.0%,HCV:62.5%)were relatively stringent.Conclusion The main reasons for subject screening failure in clinical trials in oncology in our hospital are voluntary withdrawal,brain metastasis,and failure of their biochemical test standards,which are close-ly related to the setting of clinical trial nadir criteria.Therefore,an in-depth understanding of subjects'characteristics,accurate set-ting of appropriate nadir criteria,continuous improvement of trial design,and strengthening of communication with subjects to pro-vide more relevant information will help to improve the screening success rate of clinical trials.
3.Ginsenosides in Treatment of Lung Cancer: A Review
Anqi LYU ; Yufeng SHI ; Jia KE
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(18):270-280
Lung cancer is the leading cause of cancer-related death, characterized by high invasiveness, early metastasis and poor prognosis. It has the highest incidence and mortality rates among cancers in China. Currently, the treatment of lung cancer is still dominated by the classic therapies such as surgery, radiotherapy, chemotherapy and targeted therapy. However, the classic therapies are not suitable for all patients with lung cancer, so new treatment strategies and methods are needed to prevent and treat lung cancer. In recent years, Ginseng Radix et Rhizoma has attracted wide attention in the field of anti-lung cancer research, and traditional Chinese medicine has a substantial theoretical and practical foundation in treating lung cancer. Ginseng Radix et Rhizoma , as a commonly used Chinese herbal medicine, has the functions of replenishing vital Qi, replenishing veins, strengthening the spleen and lung, and nourishing body and blood. The main active components of Ginseng Radix et Rhizoma , known as ginsenosides, exhibit anti-cancer and anti-inflammatory activities. Therefore, the mechanism and pharmacological activity of ginsenosides in the intervention of lung cancer have been extensively studied by researchers worldwide. The results show that ginsenosides can effectively inhibit the proliferation, invasion, migration, epithelial-mesenchymal transition and angiogenesis of lung cancer cells. Additionally, they inhibit drug resistance, enhance chemotherapy sensitivity and efficacy, and promote apoptosis and autophagy of lung cancer cells. Ginsenosides also modulate the tumor microenvironment and regulate immunity, thereby delaying the occurrence and development of lung cancer. The rapid advancements in related research have outpaced previous literature review, creating challenges for scholars seeking the latest information. Based on this, this article summarizes recent findings on the mechanism and pharmacological activities of ginsenosides in lung cancer intervention, aiming to provide new insights for the development of molecular biology, drug treatment research and clinical new drug research in lung cancer. It also provides the reference for further mechanism research.
4.Mechanism of cGAS/STING Signaling Pathway in Regulating Lung Cancer and Traditional Chinese Medicine Treatment: A Review
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(9):236-244
According to the latest global cancer statistics, the incidence and mortality of lung cancer rank first in China. Classical therapies remain the most common cancer treatment options, such as surgical resection, radiotherapy, and chemotherapy, but not all cancer patients respond to classical therapies, which require new lung cancer treatment strategies. After decades of research and development, cancer immunotherapy has achieved certain curative effect, which provides new possibilities for cancer treatment. Cyclic guanosine monophosphate-adenosine monophosphate synthase (cGAS) is a cytosolic DNA sensor. It can induce protective immune defense responses against various DNA-containing pathogens and provide anti-tumor immunity by activating the interferon (IFN) gene stimulator (STING) protein. At present, relevant researchers in China and abroad have done a lot of research on the occurrence and development of lung cancer and the pathophysiological mechanism of drug intervention in the treatment of lung cancer. The results show that cGAS/STING signaling pathway plays an important role in the development of the disease, and traditional Chinese medicine monomers or compounds can intervene in lung cancer cells by regulating the cGAS/STING signaling pathway, induce their autophagy and death, regulate their cycle operation, promote senescence, inhibit their proliferation and tumor angiogenesis, promote their invasion and metastasis, and promote the immune activation of anti-lung cancer cells, so as to inhibit or delay the occurrence and development of lung cancer. In recent years, the related research results have been updated rapidly, and the previous literature has not included the latest research results in time, which causes a lot of inconvenience for many scholars to search the literature. Based on this, this paper mainly summarized the mechanism of cGAS/STING signaling pathway intervention in lung cancer in China and abroad in recent years, as well as the research progress of related traditional Chinese medicine intervention, so as to provide new ideas for the development of lung cancer in molecular biology, drug treatment research, and clinical new drug research and provide a reference for further mechanism research.
5.Oxidative Stress-related Signaling Pathways in Lung Cancer and Chinese Medicine Intervention: A Review
Anqi LYU ; Yufeng SHI ; Cheng JIANG ; Jia KE
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(11):228-237
Lung cancer has the highest incidence and mortality rate among all cancers in China, with its complex and variable nature, long treatment duration, and often poor prognosis. Currently, the treatment of lung cancer mainly employs classical therapies such as surgery, radiotherapy, and chemotherapy, but some patients may experience a series of adverse reactions, which affect their quality of life, survival period, and treatment outcomes. As reported, oxidative stress is one of the important pathogenic factors of lung cancer, affecting its occurrence and development. Oxidative stress is a state of imbalance between oxidative products and antioxidant defense mechanisms in the body. The intervention of oxidative stress in the occurrence and development of lung cancer is related to multiple signaling pathways, including the Kelch-like ECH-associated protein 1 (Keap1)-nuclear factor erythroid 2-related factor 2 (Nrf2) signaling pathway, phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt)/mammalian target of rapamycin (mTOR) signaling pathway, mitogen-activated protein kinase (MAPK) signaling pathway, and nuclear factor-κB (NF-κB) signaling pathway. Currently, researchers in China and abroad have conducted extensive studies on the occurrence and development of lung cancer and the pathophysiological mechanisms of drug intervention. The results have shown that oxidative stress plays an important role in the occurrence and development of lung cancer. Chinese medicine monomers and compounds can regulate oxidative stress levels and intervene in related signaling pathways, thereby inhibiting or delaying the occurrence and development of lung cancer. Based on this, this article mainly summarized the relevant signaling pathways regulating oxidative stress intervention in lung cancer in recent years, and also reviewed the latest research on Chinese medicine monomers and compounds in regulating oxidative stress to treat lung cancer, aiming to provide new ideas for research on drug treatment of lung cancer and clinical drug development, as well as to provide references and guidance for further in-depth mechanistic studies in the future.
6.Study on Zhou Meisheng's moxibustion treatment for epidemic hemorrhagic fever based on data mining and knowledge map
Bingyuan ZHOU ; Caifeng ZHU ; Haiyang ZHAO ; Xiaofeng QIN ; Fei DAI ; Na ZHANG ; Yumei JIA ; Anqi WU
International Journal of Traditional Chinese Medicine 2024;46(3):369-376
Objective:To explore the therapeutic law of moxibustion in Professor Zhou Meisheng's medical manuscripts for epidemic hemorrhagic fever (EHF) based on data mining and knowledge map technology.Methods:The manuscript data of Professor Zhou Meisheng's moxibustion treatment of EHFwere collected from Infectious Diseases Department of Dangshan County People's Hospital from December 16, 1985 to December 25, 1987. Graphpad Grism 8.0 software was used for descriptive analysis. PHP 5.4 program code was used for association rule analysis. SPSS Statistics 26.0 was used for clustering analysis. Neo4j Community 3.5.25 database was used to analyze the syndrome-weight graph.Results:205 prescriptions were included. There were 21 symptoms with frequency>40, in which the frequency of aversion to cold, fever, rash and irritability was 100%. The main types of moxibustion methods used in the treatment included moxibustion frame fumigation moxibustion, Wanying acupoint moxibustion pen moxibustion, and fire needle instead of moxibustion. There were 29 acupoints with a frequency of >25, including Zhongwan (CV12), Shenshu (BL23) and Mingmen (DU4), etc. Association rules showed that Sanyinjiao (SP6)-Zhongwan (CV12)-Feishu (BL13)-Shenshu (BL23)-Zhiyang (DU9) had the highest correlation. Six effective clustering combinations of moxibustion for EHF were summarized by clustering analysis. The weight graph can obtained the first 30 relationships with high correlation of target syndromes.Conclusions:Professor Zhou applied the idea of "moxibustion for heat syndrome" to the treatment of EHF, and took the method of "acupoint selection according to symptoms" as the main acupoint selection idea for moxibustion treatment of EHF. In clinical practice, moxibustion combined with auxiliary operation of TCM is often used to treat EHF, which can achieve good results.
7.TU Jinwen's Experience in the Treatment of Severe Influenza Based on the “Heat Toxin Theory”
Anqi LYU ; Yufeng SHI ; Yi YANG ; Jia KE ; Jinwen TU
Journal of Traditional Chinese Medicine 2024;65(7):674-677
To summarize Professor TU Jinwen's clinical experience in the treatment of severe influenza based on the “heat toxin theory”. He believed that “heat toxin” is the main disease mechanism of severe influenza, emphasized the pathogenesis process that toxin enters with the pathogenic qi, heat generates by the toxin, and changes initiate from the toxin, and proposed simultaneous treatment of warmth and toxin and combination of multiple methods as the treatment principles. Syndrome differentiation in clinic should combine with wei-qi-ying-blood. The disease in the early stage located in wei (defensive) and qi level, treated by clearing heat and resolving toxins, releasing the exterior and expelling pathogen, harmonizing the exterior and interior, dredging the bowels with diarrhea, and combining other methods to get rid of the heat and toxin, and modified Self-Prescribed Tuire No. 1 Formula (自拟退热1号方) is recommended; the disease in progression stage located in ying-blood, treated by relieving heat and resolving toxins, and clearing the ying level and cool the blood, with prescriptions as modified Self-Prescribed Tuire No. 1 Formula plus Qingying Decoction (清营汤), or Xijiao Dihuang Decoction (犀角地黄汤); the disease in the late stage with of yin fluid consumption, and heat toxin in the blood level, treated by eliminating heat and resolving toxins, and enriching yin and cooling the blood, with prescriptions as modified Shashen Maidong Decoction (沙参麦冬汤) and Zhuye Shigao Decoction (竹叶石膏汤). At the same time, it is emphasised that heat-clearing and fire-draining method and harmonising methods are important, and that dispelling pathogen should not injure healthy qi, and that the selection of prescriptions and medicines need consider syndrome differentiation and treatment.
8.Research progress on the relationship between dietary factors and pouchitis
Jinyan JIA ; Baosong LI ; Wanyi XIAO ; Anqi HE ; Qianpeng HUANG ; Gang LIU
Chinese Journal of Inflammatory Bowel Diseases 2023;07(4):360-364
Pouchitis is a common complication of ileal pouch anal anastomosis (IPAA) in patients with ulcerative colitis or familial adenomatous polyposis and the mechanism is unknown. The dietary factors including dietary ingredients and mode are related to the occurrence and progression of pouchitis. Dietary factors may play a potential role in changing gut microbiome and regulating immune response. Therefore, adjusting the diet can prevent and treat pouchitis. This article reviews the research progress of the influence of dietary factors on pouchitis.
9.Research progress on the relationship between dietary factors and pouchitis
Jinyan JIA ; Baosong LI ; Wanyi XIAO ; Anqi HE ; Qianpeng HUANG ; Gang LIU
Chinese Journal of Inflammatory Bowel Diseases 2023;07(4):360-364
Pouchitis is a common complication of ileal pouch anal anastomosis (IPAA) in patients with ulcerative colitis or familial adenomatous polyposis and the mechanism is unknown. The dietary factors including dietary ingredients and mode are related to the occurrence and progression of pouchitis. Dietary factors may play a potential role in changing gut microbiome and regulating immune response. Therefore, adjusting the diet can prevent and treat pouchitis. This article reviews the research progress of the influence of dietary factors on pouchitis.
10.Research progress on the Hippo-YAP signaling pathway mediated osteoimmunology in modulating implant osseointegration
ZHOU Anqi ; LIU Jiayi ; JIA Yinan ; XIANG Lin
Journal of Prevention and Treatment for Stomatological Diseases 2021;29(5):334-339
Ideal osseointegration is intimately related to favorable osteoimmune properties around dental implants. An increasing number of in vitro and in vivo studies have indicated that the Hippo-YAP signaling pathway is involved in this biological process. In this article, the implicated roles of Hippo-YAP the signaling axis in peri-implant osteoimmunology were summarized by reviewing relevant evolving literature. The discrepancy concerning the Hippo-YAP signaling regulatory effect on osteogenesis and polarization direction were analyzed as well as propose the potential mechanism, which may be caused by the maturation of osteogenesis-related cells and heterogeneity of macrophages. More attention should be given to the requirements of promoting osteogenesis and patterns of regulating the immune microenvironment by Hippo-YAP in future studies.


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