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  • Exclusive:Real world clinical research of Traditional Chinese Medicine
    GUO Ran, ZENG Dian,HU Yuhan, LIU Yuanli, LIU Baoyan
    Science & Technology Review. 2023, 41(14): 14-21. https://doi.org/10.3981/j.issn.1000-7857.2023.14.002
    The purpose of this study is to fill the gaps in the scientific and systematic evaluation of the advantages of Traditional Chinese Medicine (TCM) by modern evaluation methods. In recent years, "Value-based healthcare" is a theoretical framework widely used in the comprehensive evaluation of healthcare performance. It advocates patients-centered integrated practice units, emphasizes cost-effective medical services, and pays attention to clinical indicators, functional status and rehabilitation of patients in the outcome measurement, which is consistent with the characteristics of TCM "people-oriented, from the function of the human body to grasp and regulate the life activities of the human body". Therefore, the evaluation method based on value-based healthcare has reference significance for the evaluation of TCM. Based on the theory and evaluation framework of value-based healthcare, this study proposes to take "value" as the core index of TCM advantage evaluation, and divides its measurement and evaluation into three aspects, namely efficacy, cost, patient experience and compliance, to reflect the multi-dimension of TCM advantage evaluation. The applicability of the theoretical framework of value medicine to the evaluation of the advantages of TCM was demonstrated through the existing studies on stroke and lung cancer, thus providing an international framework and ideas for the comprehensive evaluation of the advantages of TCM and the systematic integration of literature.
  • Exclusive:Real world clinical research of Traditional Chinese Medicine
    ZHOU Xuezhong, WANG Shihua,ZHANG Di, LUO Lin, HUANG Xingxian,LAN Tian, ZHANG Runshun, GAO Zhuye,LI Xiaodong, HE Liyun, YANG Zhuoxin, ZENG Yide, LIU Baoyan
    Science & Technology Review. 2023, 41(14): 22-31. https://doi.org/10.3981/j.issn.1000-7857.2023.14.003
    Based on the research progress in real-world clinical study and artificial intelligence technology domestically and internationally, aiming at the issues of the concepts, methods, and technologies for conducting high-quality TCM real world clinical research, this article focuses on the challenges and solutions for the transformation of real world research paradigms, the establishment of clinical problem-oriented research models, the quality of real world data, and the methodology of inferring high-quality causal evidences. With a view to fully understanding the importance and difficulty of real world TCM research for the high-quality development of TCM from the ontological perspective of TCM clinical diagnosis and treatment, it is expected to provide reference for establishing a new real-world research system with TCM characteristics and creating a new model of TCM clinical research.
  • Exclusive:Real world clinical research of Traditional Chinese Medicine
    ZHANG Di, LUO Lin, WEN Tiancai, QIN Yuning, LU Enshi, WANG Shihua, HE Liyun, WANG Chao
    Science & Technology Review. 2023, 41(14): 32-41. https://doi.org/10.3981/j.issn.1000-7857.2023.14.004
    The evaluation of the efficacy of syndrome differentiation and treatment is to use scientific and reasonable methods to objectively evaluate the effect of the doctor's syndrome differentiation and treatment of the patient group. Syndrome differentiation and treatment based on TCM can be roughly divided into two forms: Individualized intervention and special disease intervention. The efficacy evaluation research literatures on syndrome differentiation and treatment in 2013(265 articles) and 2022(281 articles) were compared in this article. According to the PICOS principle, the research progress of efficacy evaluation of syndrome differentiation and treatment was analyzed from the aspects of TCM and Western medicine disease diagnosis, TCM syndrome diagnosis, treatment method, treatment content, treatment time, control group selection, and grouping method. The study found that among different literatures on syndrome differentiation and treatment, although there was a certain degree of concentration in the key elements of efficacy evaluation such as evaluation objects, treatment methods, and grouping, there were also certain differences due to different research purposes, which affected the results of syndrome differentiation treatment efficacy evaluation. Evaluating the curative effect of doctors who control intervention methods in the process of syndrome differentiation and treatment will be the development direction of continuous improvement and optimization of syndrome differentiation and treatment.
  • Exclusive:Real world clinical research of Traditional Chinese Medicine
    XIE Yixuan, YAN Shiyan, CHEN Bo, LIU Baoyan
    Science & Technology Review. 2023, 41(14): 42-50. https://doi.org/10.3981/j.issn.1000-7857.2023.14.005
    With the deepening development of China's reform and opening up and the Belt and Road Initiative, Chinese acupuncture and moxibustion has gradually moved towards the world stage. Under the background of the new era, the clinical application of acupuncture and moxibustion in China has become more extensive, the treatment methods have bloomed, the clinical, basic and theoretical research has been deepened, and the standards and regulations of acupuncture and moxibustion have gradually led the world: The disease spectrum of acupuncture and moxibustion has been continuously expanded, the clinical application has been increasingly extensive; the treatment methods have been innovated and developed; the clinical research has continuously produced high-quality evidence; the standards and specifications have been published one after another; the theoretical system has been constantly improved; the basic research has made breakthroughs; the international development has been deepened, and the localization of acupuncture overseas has been developed rapidly. At the same time, the current development of acupuncture and moxibustion also faces a series of challenges: It is urgent to establish a diagnosis and treatment system that conforms to the rules of acupuncture and moxibustion itself; the evaluation system of clinical efficacy of acupuncture and moxibustion still needs to be improved; the systematic research of acupuncture and moxibustion still needs to be strengthened; the high-quality clinical evidence of acupuncture and moxibustion is still insufficient; the promotion and transformation of acupuncture and moxibustion research results need to be strengthened. Under the new situation of rapid development of science and technology, how to make full use of modern information technology, big data, artificial intelligence to realize the digital transformation and promote the comprehensive development of acupuncture and moxibustion is the only way for the modernization of acupuncture and moxibustion in the future.
  • Exclusive:Real world clinical research of Traditional Chinese Medicine
    GUO Yi, WANG Jiang, LIU Baoyan, CHEN Bo, GUO Yang, XU Yuan
    Science & Technology Review. 2023, 41(14): 51-55. https://doi.org/10.3981/j.issn.1000-7857.2023.14.006
    The rapid development of information technology has accumulated massive data for acupuncture research, but the characteristics and laws behind these data have not yet been systematically and deeply excavated and researched, restricting the development of acupuncture to a certain extent. In response to the above problems, we first put forward the concept of "computational acupuncture", which integrates traditional acupuncture and computational science. Taking acupuncture as the research object, data as the driving force, and calculation as the approach, we revealed the law and mechanism of acupuncture, in order to guide clinical practice and improve clinical efficacy. This paper reviewed the significance of the establishment of computational acupuncture, the characteristics of computational acupuncture, the challenges and suggestions currently faced with, and scientifically explained the connotation and future development trend of computational acupuncture, which can serve as a reference for the high-quality innovative development of computational acupuncture.
  • Exclusive:Real world clinical research of Traditional Chinese Medicine
    YUAN Jingyun, DING Nan, LIU Qingguo, ZHAO Nanqi, LIU Baoyan, JING Xianghong, WU Xiaodong
    Science & Technology Review. 2023, 41(14): 56-63. https://doi.org/10.3981/j.issn.1000-7857.2023.14.007
    This article reviews the status of acupuncture-moxibustion clinical practice guidelines (CPGs), and discovers that during the formulation of acupuncture-moxibustion CPGs, the developers not only face the evidence dilemma, but also pay less attention to the disciplinary characteristics of acupuncture-moxibustion, which affects the clinical guidance of acupuncture-moxibustion CPGs. To solve these problems, this article presents the determination methods of clinical questions in acupuncture-moxibustion CPGs, the transformation and application methods in guidelines of clinical experiences of ancient and modern acupuncturists, and the methodological suggestions related to the consensus process of forming the treatment protocols. In the future, the aspects which should be taken into account during the development of acupuncture-moxibustion CPGs and disciplines include the construction of the "evidence system" conformed to the characteristics of acupuncture-moxibustion, the standardization of the consensus process of CPGs and the establishment of a promotion system of research achievements conformed to the characteristics of acupuncture-moxibustion.
  • Exclusive:Real world clinical research of Traditional Chinese Medicine
    QIN Yuning, HE Liyun, YAN Shiyan, LIU Yanjiao, WANG Songling, GUO Rongjuan, WANG Ping, AI Yanke, LV Xiaoying, LUO Lin, ZHANG Yanhong, LI Xinlong, LI Lingxiang, BAI Hetian, LIU Baoyan
    Science & Technology Review. 2023, 41(14): 64-74. https://doi.org/10.3981/j.issn.1000-7857.2023.14.008
    To summarize the research phases of the efficacy evaluation of stepwise progressive evidence-based treatment, and to verify the efficacy and safety of the core prescriptions of evidence-based treatment of insomnia by individual practitioners, the scientific problems and solution strategies in the three stages of "description-exploration-validation" were compared and analyzed in this paper. Based on the observational study of the evidence-based treatment efficacy by famous TCM practitioners, the further validation of the efficacy was carried out through a multicenter blinded randomized controlled trial design. 133 insomnia patients with TCM classification of phlegm-heat-disturbing-the-mind were used as the study population. The patients were randomly divided into three treatment groups, namely Qing Tan Ning Shen Fang, Xiang Fu Wen Dan Tang and Huang Lian Wen Dan Tang; all of them were prepared as Chinese medicine compound granules and taken for 28 days. The differences in total sleep time (TST) and sleep latency (SL) were observed before and after treatment; the Pittsburgh Sleep Quality Index (PSQI) scores, Insomnia Severity Index (ISI) scores before and after treatment were compared between the groups. After 4 weeks of treatment, sleep efficiency (SE) and clinical efficiency were calculated. After 4 weeks of treatment, the decrease of PSQI score was 4.64, 4.91, and 5.43 in the three groups, respectively; the total sleep time was prolonged by 1.22, 1.14, and 1.62 hours, and the sleep latency was shortened by 43.81, 55.44, and 53.37 minutes on average, the decrease of ISI score was 6.79, 7.98, and 7.43 in the three groups, and the SE was improved by 15.18% and 10.26%, respectively. The overall effective rates were 73.81%, 73.33%, and 76.09%, with no statistically significant differences between groups (P>0.05). Compared with the results of the observational study, the efficacy was reduced. The effective core prescriptions of the famous TCM discriminative treatment are effective, safe and reliable for patients with phlegm-heat disturbed insomnia, and the stepwise progressive discriminative treatment efficacy evaluation research method can gradually increase the level of evidence of TCM clinical research and finally obtain objective and scientific research conclusions.
  • Exclusive:Real world clinical research of Traditional Chinese Medicine
    XU Jianqin, YU Haibo, WANG Chao, LIU Jia, HUANG Xingxian, CAO Xuemei, MA Xiaoming, JIANG Jiaona, YAN Bing, YANG Fuxia, ZHOU Yumei, QIU Jiangning, WANG Li, DENG Rong, YUAN Jinyun, ZHU Yanxian, XU Yuqin
    Science & Technology Review. 2023, 41(14): 75-81. https://doi.org/10.3981/j.issn.1000-7857.2023.14.009
    Postpartum depression (PPD) is a common mental disorder in postpartum women, and the therapy for mild to moderate postpartum depression by“Tiao Ren Tong Du”Acupuncture has achieved satisfactory clinical efficacy. In this study, 173 patients with mild to moderate postpartum depression were divided into acupuncture group and control group according to whether they received acupuncture treatment, and the acupuncture group was divided into acupuncture group A (total treatment course≤4 weeks) and acupuncture group B (total treatment course>4 weeks) according to the treatment course. By comparing the Hamilton depression scale (HAMD) score at different time points, and five factor scores of anxiety/somatization, weight loss, cognitive impairment, block, and sleep disorders before and after treatment, and the effective rate of each group, the clinical efficacy of“Tiao Ren Tong Du”Acupuncture in treating mild to moderate postpartum depression was observed. The results show that the HAMD score of acupuncture group B is lower than that of acupuncture group A and control group at 8 weeks after treatment (P<0.05). After treatment, the anxiety/somatization score in acupuncture group B is lower than that in the control group (P<0.05), and there is no significant difference between acupuncture group B and acupuncture group A (P>0.05). The effective rate of acupuncture group B is better than that of acupuncture group A and control group. The study shows that“Tiao Ren Tong Du”Acupuncture can effectively improve the depressive symptoms of PPD patients, and the acupuncture treatment period of more than 4 weeks is more effective.
  • Exclusive:Real world clinical research of Traditional Chinese Medicine
    LIU Qiang, YU Mingwei, WU Wanyin, GUO Yong, CHEN Jun, HE Yutong, XUE Wenhan, ZHANG Hongzhen, GUO Qiuxiang, YANG Guowang, ZHANG Yi, YOU Jiafeng, YANG Yong, GAO Chong, NIAN Jiayun, HE Liyun, WANG Xiaomi
    Science & Technology Review. 2023, 41(14): 82-91. https://doi.org/10.3981/j.issn.1000-7857.2023.14.010
    To conduct an interim analysis on the data of an ongoing prospective real world study of Zilongjin tablet in the treatment of non-small cell lung cancer (NSCLC), and preliminarily evaluate the potential advantages of Zilongjin tablets in improving clinical outcomes of patients, a prospective registry study was designed to enroll patients with NSCLC. The patients were divided into exposure group and non-exposure group according to using Zilongjin tablets for treatment. Analysis was focused on the subjects been followed up for more than 18 months, and propensity score matching was adopted to control confounding factors. Kaplan-Meier method was used to calculate the estimated survival rate, Cox proportional risk regression model was used to estimate the risk ratio between the two groups, and the incidence of end events, estimated survival rate, physical strength and quality of life scores were compared between groups. The mortality and loss of follow-up in exposure group was lower than that in non-exposure group before and after matching (P<0.05). The survival analysis showed that the estimated survival rate of the exposure group before and after matching was higher than that of the non-exposure group. The estimated survival rates of the two groups at the 18th month were 0.872 and 0.823 before the match, and 0.865 and 0.816 after matching, respectively. There was a significant difference in the survival curve between the two groups (P<0.05). The risk ratio (HR) before and after matching was 0.661 and 0.474, respectively. For ECOG-PS score before and after matching, the proportion of zero point in exposure group at the 6th and 18th month was higher (P<0.05). After matching, the EQ-VAS of exposure group was significantly higher than that of non-exposure group at the 6th month (P<0.05). The clinical application of Zilongjin tablets can reduce the incidence of death end points and improve the survival rate of patients with non-small cell lung cancer. Compared with the non-exposure group, it also showed potential advantages in maintaining patients' physical strength and quality of life scores.
  • Exclusive:Real world clinical research of Traditional Chinese Medicine
    WANG Shihua, ZHANG Li, WU Xiaowen, WEN Tiancai, AI Yanke, SUN Yuanyuan, LIU Jia, HE Liyun
    Science & Technology Review. 2023, 41(14): 92-100. https://doi.org/10.3981/j.issn.1000-7857.2023.14.011
    This study used electronic medical record (EMR) data to explore the risk factors for recurrence in patients with the first attack of cerebral infarction (CI). It expected to provide a scientific basis for improving the prognosis and reducing the recurrence rate of patients with CI. In this study, a retrospective search was performed for patients with the first attack of CI from 2017 to 2019 in the inpatient EMR system of a Traditional Chinese Medicine (TCM) hospital in Shandong. Patients were divided into 2 groups according to the recurrence of CI. The Mann-Whitney U Test and the chi-square test were used for statistical analysis. And the binary Logistic regression model and the Cox proportional hazards model were used to explore the risk factors affecting the recurrence of patients with CI and the factors affecting the recurrence days of patients with CI, respectively. Finally, 4597 patients with the first attack of CI were included, including 618 patients (13.44%) in the "recurrent CI group" and 3979 patients (86.56%) in the "non-recurrent CI group". Binary Logistic regression analysis showed that LOS (OR=1.035), type 2 diabetes mellitus (T2D) (OR=2.695), CMD (OR=3.272) and PLT (OR=2.628) were risk factors for recurrence in patients with CI. The results of Cox proportional hazards model analysis showed that the LOS at the first onset (HR=1.009) were the promoting factors affecting the recurrence days of patients with CI, and the CMD (HR=0.509) was the hindering factor affecting the recurrence days of patients with CI. This study proved the treatment of patients with CI with TCM decoction after discharge can delay the recurrence of CI. At the same time, attention should be paid to the treatment of patients with combined diseases, and the patients should be discharged after their condition being stable. When the patient was discharged from the hospital, a complete discharge doctor's order should be formulated to prevent recurrence, including medication for comorbid diseases, anti-platelet therapy, etc. In turn, it can improve the prognosis, reduce the recurrence, readmission rates, and reduce the disease burden of patients with CI.
  • Exclusive:Real world clinical research of Traditional Chinese Medicine
    LAI Keyun, LAI Changsheng, HE Liyun, WANG Guangjun, CHEN Xiao
    Science & Technology Review. 2023, 41(14): 101-108. https://doi.org/10.3981/j.issn.1000-7857.2023.14.012
    Graph neural network (GNN) is another major development after convolutional neural network, and it belongs to an emerging deep learning method in the field of artificial intelligence. It mainly preserves the topological information in graph data through end-to-end learning from graph to prediction, and overcomes the defect that traditional deep learning cannot be applied to non-Euclidean data. This paper demonstrates the advantages of GNN for processing complex non-Euclidean data through the application progress of GNN in brain-related mental and nervous system diseases. GNN shows great potential in the medical field, furthermore, the network structure of the syndrome differentiation system of Traditional Chinese Medicine (TCM) is similar to the structure of the brain active area, and it is highly compatible with the schematic unstructured data processed by GNN, so GNN has great application prospect in the field of TCM. This article summarizes the application of GNN in the field of TCM and brain-related mental and nervous system diseases, and analyzes the advantages of TCM diagnosis and treatment models from the theoretical level, in order to explore and build a GNN-based model for fitting with the thinking mode of "syndrome differentiation and treatment" and realizing the objective diagnosis in TCM. It provides new means for solving the problems of complex relationship representation in TCM and mining the individual characteristics of patients. And it also provides a favorable tool for revealing the potential mechanism of TCM from multiple perspectives, and developing and improving the science of TCM.