1.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
2.Progress in the application of deep learning in prognostic models for non-small cell lung cancer
Ruikang ZHONG ; Jinghua LI ; Ximing LIN ; Xueni FANG ; Kaiwen HU ; Tian ZHOU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(09):1345-1350
Non-small cell lung cancer is one of the cancers with the highest incidence and mortality rate in the world, and precise prognostic models can guide clinical treatment plans. With the continuous upgrading of computer technology, deep learning as a breakthrough technology of artificial intelligence has shown good performance and great potential in the application of non-small cell lung cancer prognosis model. The research on the application of deep learning in survival and recurrence prediction, efficacy prediction, distant metastasis prediction, and complication prediction of non-small cell lung cancer has made some progress, and it shows a trend of multi-omics and multi-modal joint, but there are still shortcomings, which should be further explored in the future to strengthen model verification and solve practical problems in clinical practice.
3.Traditional Chinese Medicine Injections in The Treatment of Cancer-Related Fatigue:A Network Meta-Analysis
Keyi XU ; Kaiwen HU ; Jianhao SUN ; Jiao WU ; Ning CUI ; Liusheng LI ; Yu WU
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(12):4017-4031
Objective Network Meta-analysis was conducted to evaluate the differences in the efficacy of different traditional Chinese medicine injections(TCMI)in patients with cancer-related fatigue.Methods The database was systematically searched and included in Cochrane Library,PubMed,Web of Science,CNKI,Wan Fang,China Biomedical Literature Database and Database of Chinese sci-tech periodicals until September,2022.These relevant randomized controlled trial literatures were evaluated the methodological quality by using of Cochrane risk of bias assessment tool.Results 18 articles involving 1404 patients and 6 traditional Chinese medicine injections(TCMI)were included.The results showed that Kangai injection[MD=-2.30,95%CI(-3.09,-1.52)]and Aidi injection[MD=-1.31,95%CI(-1.99,-0.62)]combined with chemotherapy were better than chemotherapy alone in improving CRF in cancer patients during chemotherapy,among which Kangai injection is more effective[MD=-1.05,95%CI(-1.89,-0.21)];Shenmai injection[MD=-1.24,95%CI(-1.91,-0.57)],Kangai injection[MD=-1.02,95%CI(-1.65,-0.39)],and Shenqifuzheng injection[MD=-0.54,95%CI(-0.90,-0.19)]were superior to palliative care alone in improving CRF in palliative care of cancer patients,among which Shenmai injection[MD=-1.26,95%CI(-2.15,-0.37)]is more effective.Conclusions The results demonstrated that TCMI can improve the degree of cancer-related fatigue in tumor patients at different stages.When combined with chemotherapy,Kangai injection was superior to other TCMI,while when combined with palliative treatment,Shenmai injection was superior to other TCMI.
4.Mechanism of Therapeutic Methods of Activating Blood, Resolving Phlegm, and Removing Toxins in Liver Cancer Based on Immune Microenvironment
Lihui YANG ; Kaiwen HU ; Jingxiao WANG
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(14):172-178
Primary liver cancer is one of the common tumors in China, which seriously endangers human health. With the advancement in medical science and technology, some achievements have been made in the clinical treatment of liver cancer, but there is an urgent need to find a safe and effective solution for patients with advanced liver cancer. As a unique therapy in China, traditional Chinese medicine (TCM) has the characteristics of multiple targets and multiple pathways and plays a certain role in the treatment of malignancies. The present study aimed to clarify the mechanism of action of "dispelling pathogens" in the treatment of liver cancer through literature research. In TCM etiology and pathogenesis, deficient healthy Qi and exuberance of pathogenic Qi, such as phlegm, blood stasis, and toxins, lead to the development of liver cancer. The treatment should follow the principles of reinforcing healthy Qi and eliminating pathogens. It has been generally believed that tumor cell is the "pathogenic factor" and the immune function serves as the "healthy Qi". In the treatment of malignancies and the regulation of the immune function of patients, it is often advocated to reinforce healthy Qi to eliminate the accumulation. With the continuous updating of knowledge on tumors and tumor microenvironment, it is also recognized that there are "healthy Qi" and "pathogenic Qi" in the immune microenvironment of tumors. For example, the immune cells and immune factors that inhibit tumor growth can be classified as "healthy Qi" with TCM attributes, while those promoting tumor growth can be classified as "pathogenic Qi". Additionally, as proved by clinical data and experimental research, the elimination methods represented by "activating blood, resolving phlegm, and removing toxins" in the treatment of liver cancer can combat tumor cells and also regulate the "healthy Qi" and "pathogenic Qi" in the immune microenvironment of liver cancer to achieve the balance of Yin and Yang. Based on this, the present study reviewed from the TCM theory and the mechanisms of western medicine to provide theoretical support for the TCM treatment of malignancies by elimination methods and some ideas for TCM in tumor resistance.
5.Effect of cryotherapy on apoptosis of lung adenocarcinoma cells
Shicheng Lin ; Dianna Liu ; Yaoxue Zhuang ; Tianyu Liang ; Xiaofan Wang ; Kaiwen Hu ; Quanwang Li
Acta Universitatis Medicinalis Anhui 2022;57(6):963-967
Objective:
To explore the effect of cryoablation on apoptosis of lung adenocarcinoma cells.
Methods:
According to the district in the tumor following cryoablation, human lung adenocarcinoma H1299 cells were divided into four groups to construct the freezing model of lung cancer in cell level: group A, untreated cells, as the control group. In group B, the necrotic solution was added to the untreated cell culture medium(the cell suspension was frozen in a liquid nitrogen tank for 5 min, and centrifuged to obtain the supernatant after rewarming at 37 ℃).Group C, sublethal cells(cells were frozen at-80 ℃ for 7 min to mimic sublethal state). In group D, necrotic solution was added into sublethal cell culture medium. Cell apoptosis was observed by flow cytometry analysis 24 h later. The expression of apoptosis related molecules Bax and Bcl-2 was detected by qRT-PCR and Western blot. Lewis lung adenocarcinoma cell line was used to establish subcutaneous transplanted tumor model of C57 BL/6 mice. The successful model mice were randomly divided into two groups: sham operation group and argon-helium cryoablation group, with 4 mice in each group. After argon-helium cryoablation for 14 days, the tumor tissues were taken. The expression of apoptosis-related molecules Bax and Bcl-2 was detected by qRT-PCR and Western blot.
Results:
In the cell freezing model, compared with group A in the control group B,C and D groups could promote cell apoptosis(P<0.05), and group D had the highest apoptosis rate, which was significantly higher than other groups(P<0.05). Bothin vitroandin vivoexperiments showed that cryoablation could increase the expression of Bax mRNA and protein(P<0.05). Bcl-2 mRNA and protein expression decreasedin vivo(P<0.05). There was no significant change in the in cell freezing model.
Conclusion
Cryoablation can achieve effective ablation through cell apoptosis mechanism, which may be related to the reduction of Bcl-2/Bax.
6.Discrimination of TCM constitutions by biochemical and routine urine indexes
Liu XIAOLING ; Zhao PENGFEI ; Zhen JIANHUA ; Zhang SHEN ; Wang HESONG ; Sun YUXIU ; Wang WEI ; Wang TINGJIAN ; Hu KAIWEN ; Huang GUANGRUI
Journal of Traditional Chinese Medical Sciences 2022;9(2):153-159
Objective:To investigate whether the specific traditional Chinese medicine(TCM)constitution of in-dividuals can be defined by certain biological indexes instead of answering the questionnaire,and to explore the possibility of discriminating nine TCM constitutions from each other simultaneously using biological indexes.Methods:Blood and urine samples from 152 individuals with nine TCM constitutions were collected,and the related biological indexes were analyzed combining ANOVA,multiple comparison,discriminant analysis,and support vector machine.Results:We found that 4 out of 24 blood routine indexes,7 out of 10 urine routine indexes,and 12 out of 32 biochemical indexes showed differences among the constitutions.High-sensitivity C-reactive protein,apolipoprotein A1,and alkaline phosphatase were potential candidates for screening out individuals with unbalanced constitutions.Combining uric acid,high-density lipoprotein,apolipoprotein A1,creatine kinase,total protein,aspartate aminotransferase,total bile acid,dehydrogenase,sodium,and calcium levels had the potential to directly distinguish the nine TCM constitutions from each other.Among these indexes,the highest ratio of discriminant analysis between two constitutions was 95.5%,while the lowest was 66.1%.Conclusion:Our results suggest that some biochemical and urine indexes are related to various TCM constitutions,and thus they have the potential to be used for TCM constitution classification.
7.Expert Consensus for Thermal Ablation of Pulmonary Subsolid Nodules (2021 Edition).
Xin YE ; Weijun FAN ; Zhongmin WANG ; Junjie WANG ; Hui WANG ; Jun WANG ; Chuntang WANG ; Lizhi NIU ; Yong FANG ; Shanzhi GU ; Hui TIAN ; Baodong LIU ; Lou ZHONG ; Yiping ZHUANG ; Jiachang CHI ; Xichao SUN ; Nuo YANG ; Zhigang WEI ; Xiao LI ; Xiaoguang LI ; Yuliang LI ; Chunhai LI ; Yan LI ; Xia YANG ; Wuwei YANG ; Po YANG ; Zhengqiang YANG ; Yueyong XIAO ; Xiaoming SONG ; Kaixian ZHANG ; Shilin CHEN ; Weisheng CHEN ; Zhengyu LIN ; Dianjie LIN ; Zhiqiang MENG ; Xiaojing ZHAO ; Kaiwen HU ; Chen LIU ; Cheng LIU ; Chundong GU ; Dong XU ; Yong HUANG ; Guanghui HUANG ; Zhongmin PENG ; Liang DONG ; Lei JIANG ; Yue HAN ; Qingshi ZENG ; Yong JIN ; Guangyan LEI ; Bo ZHAI ; Hailiang LI ; Jie PAN
Chinese Journal of Lung Cancer 2021;24(5):305-322
"The Expert Group on Tumor Ablation Therapy of Chinese Medical Doctor Association, The Tumor Ablation Committee of Chinese College of Interventionalists, The Society of Tumor Ablation Therapy of Chinese Anti-Cancer Association and The Ablation Expert Committee of the Chinese Society of Clinical Oncology" have organized multidisciplinary experts to formulate the consensus for thermal ablation of pulmonary subsolid nodules or ground-glass nodule (GGN). The expert consensus reviews current literatures and provides clinical practices for thermal ablation of GGN. The main contents include: (1) clinical evaluation of GGN, (2) procedures, indications, contraindications, outcomes evaluation and related complications of thermal ablation for GGN and (3) future development directions.
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8.The efficacy of intravesical instillation of domestic BCG versus epirubicin in the prevention of recurrence of intermediate-risk or high-risk non-muscular invasive bladder cancer and predictive factors of BCG instillation: a randomized, controlled, multi-center clinical trial with 2 years’ follow-up
Hao YU ; Kaiwen LI ; Hailong HU ; Xiang LI ; Nan LIU ; Jian ZHANG ; Xudong YAO ; Xiaodong ZHANG ; Wei LI ; Liqun ZHOU ; Xiangbo KONG ; Jinjian YANG ; Youhan CAO ; Junli WEI ; Jiacun CHEN ; Zhaoyang WU ; Dongwen WANG ; Xuhui ZHANG ; Jinkai SHAO ; Qingwen LI ; Huiqing ZHANG ; Xiaolin WANG ; Shaozhong WEI ; Ye TIAN ; Tie ZHONG ; Hongshun MA ; Kun LI ; Benkang SHI ; Jin YANG ; Yuhua QIAO ; Hongxing HUANG ; Liming LI ; Zhimin WANG ; Jianhua TIAN ; Tianxin LIN ; Jian HUANG
Chinese Journal of Urology 2020;41(10):724-730
Objective:To investigate the 2 years’ efficacy of intravesical instillation of domestic BCG versus epirubicin in the prevention of recurrence of intermediate-risk or high-risk non-muscular invasive bladder cancer and predictive factors of BCG instillation.Methods:From July 2015 to June 2020, 18-75 years old patients with moderate to high-risk non muscle invasive bladder cancer (NMIBC) confirmed by pathological examination were involved. The ECOG score was 0-2. Exclusion criteria included ①immune deficiency or impairment (such as AIDS), using immunosuppressive drugs or radiotherapy, suspected allergic to BCG or epirubicin or excipients of the two drugs, fever or acute infectious diseases including active tuberculosis or receiving anti tuberculosis treatment, with severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease; ②combined with other urogenital system tumors or other organ tumors; ③combined with muscle invasive bladder urothelial carcinoma (≥T 2); ④undergoing chemotherapy, radiotherapy or immunotherapy within 4 weeks (immediate instillation after surgery not included); ⑤ pregnant or lactating women; ⑥ comfirmed or suspected bladder perforation; ⑦gross hematuria; ⑧cystitis with severe bladder irritation that may affect the evaluation; ⑨participat in other clinical trials within 3 months; ⑩alcohol or drug addiction; ?any risk factors that may increasing the risk of patients. Epirubicin 50 mg was irrigated immediately after the operation(TURBT or laser resection). The patients were randomly divided into BCG15 group, BCG19 group and epirubicin group by the ratio of 2∶2∶1, and the patients were maintained intravescical instillation for 1 year. The recurrence and adverse events of the three groups were compared. Univariate and multivariate analysis was performed to predict the risk factors of BCG irrigated therapy failure. Result:By June 15, 2020, the median follow-up duration was 22.1 months(12.1, 32.3), and there was no statistical difference between the groups ( P=0.9024). There were 274 patients enrolled in BCG19 group, 277 patients enrolled in BCG15 group and 130 patients enrolled in the epirubicin group. The drop-off rate was 16.6%(113 cases)and made no difference between groups( P=0.6222). There were no significant difference in age, gender, BMI, or ECOG score( P>0.05). During the follow-up, 116 cases was detected recurrence or progression. The recurrence rate of the three groups was 14.2% and 14.8% in BCG19 group and BCG15 group, and 27.7% in the epirubicin group. There was no difference in recurrence rate between BCG19 and BCG15 group( P=0.9464). The recurrence rate of BCG19 group was lower than that of the epirubicin group ( P=0.0017). The recurrence rate of BCG15 group was lower than that of the epirubicin group ( P=0.0020). There was no difference in the cumulative recurrence free survival rate between BCG19 and BCG15 group (95% CI0.57-1.46, P=0.7173). The cumulative recurrence free survival rate of BCG 19 group was better than that of the epirubicin group( HR=0.439, 95% CI0.26-0.74, P=0.0006), and the cumulative recurrence free survival rate of BCG15 group was better than that of the epirubicin group ( HR=0.448, 95% CI0.29-0.80, P=0.0021). The total incidence of adverse events in 19 BCG19, BCG15 and epirubicin group were 74.5%, 72.6% and 69.8% respectively. There was no difference in the incidence of adverse events between BCG19 and BCG15 group( P=0.6153). The incidence of adverse events in epirubicin group was lower than that of BCG19( P=0.0051) and BCG15( P=0.0167) groups.There was no significant difference in the incidence of serious adverse events (SAE) among the three groups ( P=0.5064). Log rank test univariate analysis and Cox risk regression model multivariate analysis showed that the history of bladder cancer recurrence( HR=6.397, 95% CI1.95-20.94, P=0.0001)was independent risk factor for BCG irrigation failure. Conclusions:The 2 years’ efficacy of intravesical instillation of domestic BCG is better than than of epirubicin with good tolerance and safety. There is no difference between BCG19 and BCG15 group. BCG doesn’t increase SAE compared with epirubicin. Recurrence status was an independent prognostic factor regarding recurrence-free survival.
9.Research on Reversal Effects in Cisplatin-resistant Human Lung Adenocarcinoma Cell Line A549/DDP by Standard Substances from Traditional Chinese Medicine
Xinjie YANG ; Jingxiao WANG ; Lin WANG ; Xiaoyi CHI ; Jiaqi CHI ; Tian ZHOU ; Tonghua LIU ; Kaiwen HU
World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(4):521-526
Objective: To investigate the reversal effects in A549/DDP by standard substances (SS) from Traditional Chinese Medicine. Methods: Cell proliferation assays were performed to investigate the Resistant Index of A549/DDP and its tolerance to selected SS. The working concentrations of SS, IC5 calculated by nonlinear regressions, were applied as reversal doses to investigate the effects. Results: The resistant index of A549/DDP was 31.79. Tetramethylpyrazine and Matrine were well tolerated. Berberine hydrochloride, Dauricine, Oridomin exhibited dose-depend inhibitory effects on A549/DDP cell line. The working concentrations of them could effectively reverse the resistance of A549/DDP cell line to DDP. (P<0.01) . Conclusion: The selected standard substances from Traditional Chinese Medicine were capable to reverse the resistance of A549/DDP cell line to DDP.
10.Discussion on Treatment of Anti-cancer Medicine Based on Principles of Cold and Heat Syndrome Differentiation
Man WANG ; Tian ZHOU ; Chuanbo LIU ; Kaiwen HU
Herald of Medicine 2018;37(11):1363-1365
Due to the differences of background, ways of thinking, visual angle and research tools between Chinese medicine and Western medicine,most Chinese medicine research based on western medicine are of low clinical value,although the combination of the Western and Traditional Chinese Medicine has gaining popularity.It is possible to change our perspective and use Chinese medicine theory to think and guide all modern treatment methods.This theory which is explained in the Tumor Green Therapeutics,has achieved remarkable clinical results and gained rapid development.Syndrome differentiation and treatment is the essence of TCM.Eight principles of syndrome differentiation of TCM are the general principles. The principles of cold and heat syndrome differentiation are the basis for the complex syndrome types.Therefore, this article will be a preliminary study for anti-cancer medicine from point of view of the principles of cold and heat syndrome differentiation, and will provide more clinical reference.


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