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.

Objective:To estimate the costs of dementia from a societal perspective in Tongliao City and ex-plore the influencing factors of these costs.Methods:Dementia was diagnosed using the 10/66 Dementia Research Group assessment instruments.Data on healthcare utilization,caregiver's care time or costs,and the distress due to caregiving were collected.The cost-proportion conversion method was used to estimate the per capita cost of health services based on data from the National Statistical Yearbook.The human capital approach was used to estimate the unit value of informal care time,and the willingness-to-pay method was used to measure the intangible costs of car-egivers.The total societal costs of dementia were calculated based on the reference year 2023,and a two-part model was employed to analyze the factors influencing the societal costs.Results:A total of 390 dementia patients were di-agnosed,with an average societal cost per capita of 117 877 Yuan.The largest cost component was informal care provided by unpaid family members,accounting for 73.1％of the total societal cost.The societal costs for female patients were 61 395 Yuan higher than those for male patients.Patients with comorbid stroke had a higher societal cost of 63 008 Yuan compared to patients without stroke,and each additional chronic disease added 5 868 Yuan to societal costs.Additionally,each non-memory dimension impairment in the Clinical Dementia Rating Scale in-creased the societal costs by 53 997 Yuan.Conclusion:Dementia poses a significant socio-economic burden,with informal care being the major component of this burden.

Objective:To compare clinical characteristics,treatment patterns and physiological indicators in bipolar disorder(BD)patients with different age of onset.Methods:Totally 380 patients with DSM-5 BD were se-lected in this study.Psychiatrists diagnosed the patients using the Mini International Neuropsychiatric Interview.The clinical information questionnaire and the Global Assessment of Functioning scale were utilized to collected clinical characteristics,treatment status,and physiological indicators.The onset age of BD was divided into 21 and 35 years as cut-off points.Multivariate logistic regression and linear regression were used to analyze related factors.Results:Among the 380 patients with BD,199 cases were early-onset group(52.4％),121 cases were middle-onset group(31.8％),and 60 cases were late-onset group(15.8％).There were 26.6％of patients in the early-onset group in-itially diagnosed as depression,23.1％in the middle-onset group,and 11.7％in the late-onset group.Multivariate analysis revealed that compared to the early-onset group of BD,the middle-onset(OR=2.22)and late-onset(OR=4.99)groups had more risk to experience depressive episodes,and the late-onset group(OR=6.74)had 6.74 times of risk to suffer from bipolar Ⅱ disorder.Additionally,patients in the middle-onset(β=-1.52)and late-on-set(β=-4.29)groups had shorter durations of delayed treatment,and those in the middle-onset(β=-1.62)and late-onset(β=-3.14)groups had fewer hospitalizations.Uric acid levels were lower in both the middle-onset(β=-28.39)and late-onset(β=-31.47)groups,and total cholesterol level was lower in the middle-onset group(β=-0.23).Conclusion:Patients with BD in different age of onset show significant differences in clinical charac-teristics,treatment conditions and physiological indicators.

Objective:To explore the expression of fructose bisphosphate aldolase A (ALDOA) in the bone marrow of patients with acute myeloid leukemia (AML) and the correlation with clinical features and prognosis.Methods:The bone marrow samples of 90 newly diagnosed AML (non-acute promyelocytic leukemia) patients and 18 allogeneic hematopoietic stem cell transplantation donors who were treated from January 2013 to December 2015 in the First Affiliated Hospital of Zhengzhou University and the Children's Hospital Affiliated to Zhengzhou University were collected. The relative expression level of ALDOA mRNA in bone marrow samples was detected by using real-time quantitative polymerase chain reaction (qRT-PCR). Clinical data of these patients were retrospectively analyzed, and the patients were divided into continuous complete remission (CR) group and refractory recurrent (RR) group according to the clinical response and follow-up results. The differences of the relative expression level of ALDOA mRNA between AML group and the normal control group, CR group and RR group were analyzed. Univariate and multivariate Cox regression risk model were used for analysis of factors influencing prognosis of AML patients.Results:The relative expression level of ALDOA mRNA in AML group was higher than that in normal control group [(5.71±0.44) vs. (1.10±0.08), t = 4.74, P<0.001]. The relative expression level of ALDOA mRNA in the RR group was higher than that in the CR group [(6.69±0.67) vs. (4.30±0.36) , t = 2.79, P < 0.001]. In addition, there were statistically significant differences in the proportion of patients with ALDOA mRNA high expression and those with ALDOA mRNA low expression stratified by the number of white blood cell, the proportion of bone marrow blasts and whether complete remission could be achieved or not after 1 course of induction therapy (all P < 0.05). Overall survival in patients with ALDOA high expression was worse than that in patients with ALDOA low expression ( χ2 = 5.59, P = 0.018). Multivariate analysis showed that white blood cell count, prognosis stratification, whether complete remission could be achieved or not after 1 course of induction therapy and ALDOA expression were the independent prognostic factors for the death of AML patients (all P < 0.05). Conclusions:ALDOA may play an important role in the development and progression of AML, and the expression level of ALDOA in the bone marrow can be used as an index for the prognosis assessment of AML patients and may be a potential therapeutic target for AML.

OBJECTIVE： To establish the fingerprint of Maizao yishen granules， and to provide scientific basis for its further development. METHODS： HPLC method was adopted to establish the fingerprint by using 10 batches of Maizao yishen granules sa samples. The determination was performed on Venusil XBP C18（L） column with mobile phase consisted of acetonitrile-0.2％ phosphoric acid （gradient elution） at the flow rate of 1→0.7 mL/min at 7-10 min， 0.7→1 mL/min at 10-15 min and 1 mL/min at the rest of time. The detection wavelengths were set at 284 nm （0-7 min）， 330 nm （7-32 min） and 360 nm （32-45 min）. The column temperature was 25 ℃， and sample size was 10 μL. The fingerprint of Maizao yishen granules was established， and the similarity evaluation was performed by using “Similarity Evaluation System of TCM Chromatographic Fingerprints” （2004 A edition） software. Then， the common peaks were assigned and identified by comparing reference substance and control medicinal materials. RESULTS： The precision， stability （24 h） and repeatability of the methodological investigation were all good [RSD values of relative retention time and relative peak area of each chromatographic peak were less than 3％ （n＝6）]. The similarity of 10 batches of samples were all above 0.900. Seventeen common peaks were identified， of which common peak 1 and 6 came from Semen Raphani； common peak 7， 9， 14， 15 and 16 from Citrus reticulata； common peak 5， 10， 11， 12 and 13 came from Glycyrrhiza uralensis； common peak 2 came from C. reticulata， G. uralensis and Ziziphus jujuba； peak 3 came from G. uralensis and Semen Raphani； peak 8 came from Hordeum vulgare and Semen Raphani； peak 4 and 17 came from C. reticulata and G. uralensis. Peak 1 was identified as hesperidin and the peak 9 was identified as sinapine. CONCLUSIONS： Established fingerprint of Maizao yishen granules is accurate and reliable， and can be used for quality control of Maizao yishen granules.

OBJECTIVE:To optimize the technology of supercritical CO2 extraction from Zingiberis rhizoma. METHODS:With the comprehensive score of the contents of 6-ginger phenol,8-ginger phenol and 10-ginger phenol and the extraction rate of the oil from Z. rhizoma as the index,uniform design method was adopted to investigate the effects of extraction pressure,extrac-tion temperature and extraction duration on the extraction result;verification tests were conducted. RESULTS:The optimal condi-tions were as follows as the extraction pressure of 25 MPa,extraction temperature of 30 ℃ and extraction duration of 2 h. In the verification tests,the average extraction rate of the oil from Z. rhizoma was 3.2%(n=3),and the comprehensive score was 1.874 2 (RSD=0.65%,n=3),with the relative deviation of 0.6% between the measured value and the predicted value. CONCLUSIONS:The optimal extraction technology is stable and feasible,with the advantages of low temperature,short duration.

By systematically combing the records of Bladder Meridian of Foot-Taiyang from medical literatures of Zu Bi Shi Yi Mai Jiu Jing (Maxibustion Canon of Foot and Arm), Yin Yang Shi Yi Mai Jiu Jing (Maxibustion Canon of Ying and Yang), Ling Shu Jing Mai (Meridians, a chapter of Miraculous Pivot), Zhen Jiu Jia Yi Jing (A-B Classic of Acupuncture and Moxibustion), Jiu Jing Tu (Illustration of Moxibustion) from Dunhuang, it can be found that the formation and development of theory of main and collateral channels is a long-term dynamic process containing constantly summing up the experiences. The record about only the 2.3 inch one-line loop route carved out beside the posterior midline of dorsal lumbosacral portion by Bladder Meridian Foot-Taiyang may be a positioning mode of acupoint exclusively used by moxibustion and summed up by people good at moxibustion therapy using their clinical experience. In addition, thoughts that the heavy-moxibustion is a good method for difficult miscellaneous diseases (especially for the serious illnesses after attacked by wind and cold pathogens) may be included.

Objective To explore the scanning technology of head-neck-coronaryone-stop-shopCT angiography using 256-slice iCT and complete image quality analysis.Methods 106 consecutive patients underwent 256-slice iCT head-neck-coronaryone-stop-shop CT angiography.According to the average heart rate,patients were divided into three groups,the 1ow heart rate group with the average heart rate ranged from 40 to 60,medium heart rate group with heart rate from 60 to 80 beats per minute and high heart rate group with heart rate more than 80 beats per minute.The volume rendering (VR),maximum intensity projection (MIP), multi-planar reformation (MPR)and curved planar reconstruction (CPR)were employed for three-dimensional reconstruction after the original image reached to the iCT post-processing workstation.The image quality of head-neck artery and coronary artery were assessed by two senior radiologists individually .Results The image quality scores in the three groups show statistic significance (F=14.886 , P =0.000).The difference between low heart rate group and medium heart rate group show statistic significance (P =0.031).The difference between low heart rate group and high heart rate group was statistical significant (P = 0.026 ).There was no statistic difference between medium heart rate group and high heart group.The excellent rates of coronary artery image quality reached to 100%,96.6%,92.6% in low,medium and high heart rate group respectively.The rates of excellent about head-neck vascular im-age quality in the three groups reached to 100%.Conclusion 256-slice iCT head-neck-coronaryone-stop-shopCT angiography can obtain satisfactory image.The image quality does not decrease in patients with high heat rate.

Vascular dementia (VaD) is the second common subtype of dementia after Alzheimer's disease. However, there is still a lack of medication that demonstrates clinically relevant symptomatic improvement. Static blood obstructing the brain is the main Chinese medicine syndrome of VaD.

As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.
Clinical Trials, Phase IV as Topic ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing ; Research Design