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 explore the clinical value of methylation at promoter sites of urine protein kinase Y-linked(PRKY)gene in the early diagnosis of prostate cancer(PCa).Methods Urine samples were collected from 50 suspected PCa patients.After extracting DNA,the methylation levels of the PRKY gene promoter sites cg05163709,cg08045599,and cg05618150 were detected using quantitative methylation-specific PCR(qMSP).Simultaneously,the patients were divided into the benign prostatic hyperplasia(BPH)group and the PCa group.The differences in clinical indicators between the two groups were analyzed,as well as the methylation status of the PRKY gene promoter sites in the urine of the two groups of patients.The receiver operating charac-teristic(ROC)curve of PRKY promoter sites methylation was established,and the area under the curve(AUC)was calculated to analyze the diagnostic value of PRKY promoter sites methylation in PCa,and to perform com-bined diagnosis with clinical indicators.Results The methylation rates of cg05163709 and cg05618150 in urine specimens of PCa patients were significantly higher than those of BPH patients.The AUC for cg05163709 methyla-tion in diagnosing PCa was 0.762,with a sensitivity of 86.70%.It showed better performance in early screening for PCa compared to total prostate specific antigen(tPSA),percentage free prostate specific antigen(f/tPSA)and prostate specific antigen density(PSAD)index.We found that the AUC for cg05618150 methylation in conjunc-tion with PSAD in diagnosing PCa was 0.787,with a sensitivity of 86.70%.The AUC of cg05163709 methylation and PSAD in the joint diagnosis of PCa was 0.855,and the specificity could reach 95.00%.Conclusion The methylation of urine PRKY gene promoter sites cg05163709 and cg05618150 shows high sensitivity and specificity in diagnosing PCa,making them promising biomarkers for early detection of PCa.

Objective:To compare and analyze the effects of impulse oscillometry (IOS) and pulmonary function test (PFT) in the assessment of asthma control in children.Methods:A cross-sectional study of 323 children with bronchial asthma who visited the outpatient pediatric clinic of Shandong Provincial Hospital Affiliated to Shandong First Medical University from March to December 2020 was conducted.The patients were divided into the control group (123 cases) and the uncontrolled group (200 cases) according to the Childhood Asthma Control Test (C-ACT) score.In both groups, PFT and IOS were performed.The PFT test included the forced expiratory volume in one second (FEV 1), force expiratory volume in one second/forced vital capacity (FEV 1/FVC), peak expiratory flow (PEF), the instantaneous forced expiratory flow at 50% of forced vital capacity (FEF 50), the instantaneous forced expiratory flow at 75% of forced vital capacity (FEF 75), and maximum mid expiratory flow (MMEF). In the IOS test, the total respiratory impedance at 5 Hz (Z5), respiratory resistance at 5 Hz (R5), respiratory resistance at 20 Hz (R20), reactance at 5 Hz (X5), respiratory resistance at 5 Hz-respiratory resistance at 20 Hz (R5-R20), reactance area (AX), and resonance frequency (Fres) were measured.The data obtained were analyzed statistically using SPSS 25.0 software. ANOVA or Mann- Whitney U rank-sum test was used to compare data between groups.Receiver′s operating characteristic (ROC) curves were drawn to determine the predictive value of PFT and IOS parameters for uncontrolled asthma. Results:(1) According to the comparison results of PFT indexes between the two groups of children with asthma, the levels of FEV 1, FEV 1/FVC, PEF, FEF 50, FEF 75, MMEF in the control group were all higher than those in the uncontrolled group [(104.41±12.38)% vs.(98.89±16.61)%, 100.50 (94.40, 103.50)% vs.96.00 (89.83, 101.88)%, (100.29±15.31)% vs.(93.19±18.43)%, 85.60(70.60, 96.60)% vs.72.35 (57.08, 91.10)%, 67.20 (53.60, 81.70)% vs.56.80 (41.10, 74.73)%, 80.70 (66.80, 95.10)% vs.69.50 (54.03, 90.05)%] (all P<0.01). (2) According to the comparison results of IOS indices between the two groups, the levels of Z5, R5, R20, R5-R20, X5, AX and Fres in the control group were lower than those in the uncontrolled group {68.58 (63.29, 77.43)% vs.81.27(70.93, 91.96)%, 68.91(62.94, 77.60)% vs.80.61 (70.02, 89.29)%, 75.78 (67.50, 87.55)% vs.82.97 (71.50, 95.50)%, 0.51 (0.43, 0.59) [kPa/(L·S)] vs.0.62 (0.53, 0.74) [kPa/(L·S)], 69.31 (59.93, 79.14)% vs.86.48 (70.00, 102.48)%, 1.11 (0.76, 1.60) kPa/L vs.2.14 (1.42, 2.85) kPa/L, 18.21 (16.06, 19.56) Hz vs.20.56 (18.92, 22.81) Hz} (all P<0.01). (3) In the control group, 31 children (25.20%) had pulmonary dysfunction.(4) In the uncontrolled group, 95 children (47.50%) had pulmonary ventilation dysfunction.Only 20 children (10.00%) had a R5 larger than 120% of the predicted value and/or a R20 larger than 120% of the predicted value.(5) According to the ROC analysis results of the IOS indices for predicting asthma exacerbations, all of the areas under the ROC (AUC) of Z5, R5, R5-R20, X5, AX and Fres were greater than 0.7.AX had the highest value in predicting asthma exacerbations (AUC=0.785, 95% CI: 0.735-0.835), with sensitivity of 78.50% and specificity of 64.20%.All of the AUCs of PFT indices were smaller than 0.7.FEF 50 and MMEF had the largest AUC. Conclusions:PFT and IOS have good sensitivity in evaluating the level of asthma control in children, and IOS has good value in predicting asthma exacerbations.AX has the highest predictive value for asthma exacerbations.Asthma control levels of children should be evaluated using not only subjective (such as C-ACT score) but also objective (e.g.PFT, IOS) indices.

Objective : To compare the accuracies of implants with dynamic real-time navigation versus digital guide navigation to provide a reference for clinical precision dental implants. Methods: Forty-six cases (seventy teeth) with missing teeth admitted to the Department of Stomatology, Wuzhou Red Cross Hospital from April 2018 to December 2019 were randomly divided into two groups (thirty-five teeth in each group) for dynamic real-time navigation and digital guide navigation implantation techniques. To compare the entry point, apex point, depth and angle deviation of the preoperative and postoperative position of implants in the two groups. SPSS 21.0 software was used for statistical analysis. Results : Dental implants were successfully placed in both groups. The deviations of apex point, depth and angle in the dynamic real-time navigation group were all smaller than those in the digital guide navigation group, and the differences were statistically significant (P < 0.05). There was no statistically significant deviation in the entry point between the two groups (P > 0.05). Conclusion In this study, both techniques had good clinical effects. The accuracy of dynamic real-time navigation was higher than that of digital guidance.

Objective: To study the clinical outcomes of anatomical hepatectomy combined with intraoperative choledochoscopy in treatment of complicated hepatolithiasis. Methods: The clinical data of 176 patients with complicated hepatolithiasis who underwent operation at the Department of General Surgery of No.960 Hospital of PLA from May 2005 to July 2015 were analyzed retrospectively. The data included general data, clinical manifestations, types of stones, operative methods, postoperative complications and follow-up. Results: There was no perioperative death. The postoperative complications which occurred in 31 patients (17.6%) included lung infection, intra-abdominal infection, bile leakage, and liver failure. Eighteen patients (10.2%) were found to have residual stones. After a follow-up which ranged from 1 to 3 years, 152 patients (94.4%) had good clinical outcomes. Recurrent stones were found in 12 patients (7.5%). Conclusion Anatomical hepatectomy combined with intraoperative choledochoscopy improved operative outcomes in patients with complicated hepatolithiasis and decreased residual stone and recurrence rates.

OBJECTIVETo observe the effects of acupuncture-moxibustion on chronic allograft nephropathy (CAN) and explore the methods of acupoint selection along meridian for transplanted-kidney-related diseases.

METHODSA total of 180 patients of CAN were randomized into a syndrome differentiation group, a spleen-meridian group, a kidney-meridian group and a control group, 45 cases in each one. A total of 33 cases dropped out before the end of the study, including 8 cases in the syndrome differentiation group, 12 cases in the spleen-meridian group, 13 cases in the kidney-meridian group and no case in the control group. Patients in the control group were treated with conventional western medicine; based on this, patients in other three groups were treated with acupuncture-moxibustion. In the syndrome differentiation group, Qihai (CV 6), Hegu (LI 4), Guanyuan (CV 4), Feishu (BL 13), Shenshu (BL 23), etc. were selected for qi deficiency of lung and kidney; Qihai (CV 6), Zusanli (ST 36), Sanyinjiao (SP 6), Taixi (KI 3), Yinlingquan (SP 9), etc. were selected for deficiency of qi and yin; Ganshu (BL 18), Shenshu (BL 23), Sanyinjiao (SP 6), Taixi (KI 3), Yinlingquan (SP 9), Ququan (LR 8), etc. were selected for yin deficiency of liver and kidney; Zhongji (CV 3), Guanyuan (CV 4), Mingmen (GV 4), Guanyuanshu (BL 26), etc. were selected for yang deficiency of spleen and kidney. In addition, Sanyinjiao (SP 6), Diji (SP 8), Yinlingquan (SP 9), Xuehai (SP 10), etc. were added in the spleen-meridian group; Taixi (KI 3), Zhaohai (KI 6), Fuliu (KI 7), Ciliao (BL 32), etc: were added in the kidney-meridian group. Serum creatinine (Scr), creatinine clearance (Ccr) and 24-hour urinary protein before and after the treatment were com- pared among the four groups.

RESULTSAfter treatment, 24-hour urinary protein in the acupuncture-moxibustion groups and control group were all reduced (all P < 0.05); compared before treatment, the Scr in the spleen-meridian group was significantly reduced (P < 0.05); the difference of Ccr before and after treatment was insignificant in all the groups (all P > 0.05). Compared with the control group, 24-hour urinary protein in spleen-meridian group could relieve or recover the damage of transplant kidney induced by CAN. A new interlink may be established between the transplanted kidneys and the spleen meridians, indicating that transplanted kidney-related diseases can be treated by selecting acupoints of spleen meridian.

Acupuncture Points ; Acupuncture Therapy ; Adult ; Aged ; Allografts ; physiopathology ; Female ; Graft Rejection ; Humans ; Kidney Transplantation ; adverse effects ; Male ; Meridians ; Middle Aged ; Moxibustion ; Renal Insufficiency, Chronic ; etiology ; therapy ; Transplantation, Homologous ; adverse effects

OBJECTIVETo study on the differences between chromatopharmacokinetics (pharmacokinetics with fingerprint chromatography) and chromatopharmacodynamics (pharmacodynamics with fingerprint chromatography) of Chinese materia medica formulae to answer the question whether the pharmacokinetic parameters of multiple composites can be utilized to guide the medication of multiple composites.

METHODOn the base of established four chromatopharmacology (pharmacology with chromatographic fingerprint), the pharmacokinetics, and pharmacodynamics were analyzed comparably on their mathematical model and parameter definition.

RESULTOn the basis of quantitative pharmacology, the function expressions and total statistical parameters, such as total zero moment, total first moment, total second moment of the pharmacokinetics, and pharmacodynamics were analyzed to the common expressions and elucidated results for single and multiple components in Chinese materia medica formulae. Total quantitative pharmacokinetic, i.e., chromatopharmacokinetic parameter were decided by each component pharmacokinetic parameters, whereas the total quantitative pharmacodynamic, i.e., chromatopharmacodynamic parameter were decided by both of pharmacokinetic and pharmacodynamic parameters of each components. The pharmacokinetic parameters were corresponded to pharmacodynamic parameters with an existing stable effective coefficient when the constitutive ratio of each composite was a constant.

CONCLUSIONThe effects of Chinese materia medica were all controlled by pharmacokinetic and pharmacodynamic coefficient. It is a special case that the pharmacokinetic parameter could independently guide the clinical medication for single component whereas the chromatopharmacokinetic parameters are not applied to the multiple drug combination system, and not be used to solve problems of chromatopharmacokinetic of Chinese materia medica formulae.

Chromatography ; Drugs, Chinese Herbal ; chemistry ; pharmacokinetics ; Materia Medica ; chemistry

OBJECTIVETo study on the differences of metabolites in the blood of rats after injection or oral administration of volatile oil in Houttuyniae Herba and of 2-undecanone in order to validate hypothesis of network compatability and to establish the theoretical foundation of elucidating metabolic mechanism for multiple constituents in Chinese Material.

METHODA gas chromatography-mass spectrometry method was employed for qualitative determination of the metabolites in blood of rats by injection or oral administration of volatile oil in Houttuyniae Herba and of 2-undecanone, which were compared with the differences between binary two drugs as well as two administration.

RESULTThere were 45 kinds of ingredients in volatile oil for original materials for Houttuyniae Herba, and 53, 69 kinds of metabolites were detected in blood of rats for oral administration of volatile oil in Houttuyniae Herba, and 2-undecanone, respectively, whereas 52, 42 kinds of metabolites were detected for injection administration. Although there were various constitutes, i. e. single versus multiple ingredients, administrated by various ways, i. e. oral versus injection, the metabolites were so similar with each manners, in which alpha-pinene and beta-myrcene occurred in two constitute forms and two administrations, while there were 18, 13 kinds of ingredients for oral or injection administration of volatile oil in Houttuyniae Herba, i. e. 34%, 25% of total ingredients, respectively, and 17, 15 kinds of ingredients, i. e. 24.6%, 35.7% for that of, 2-undecanone, respectively, on average of 29.8% that suggested one of third as co-metabolites.

CONCLUSIONThere are network compatibility existed in metabolism of the houttuynia volatile oil in rats, and similar metabolic pathways in accordance with original plant, among their ingredients no matter alone or multiple constitute forms and oral or injection administration.

Administration, Oral ; Animals ; Gas Chromatography-Mass Spectrometry ; Herb-Drug Interactions ; Houttuynia ; chemistry ; Injections, Intravenous ; Ketones ; administration & dosage ; pharmacokinetics ; Oils, Volatile ; administration & dosage ; pharmacokinetics ; Plants, Medicinal ; chemistry ; Rats