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 investigate impacts of lycopene on myocardial damage in preeclampsia(PE)rats by regulating IL-6/signal transducer and activator of transcription 3(STAT3)/endothelin-1(ET-1)signaling pathway.Methods:Pregnant rats were divided into model group,experimental-L group,experimental-M group,experimental-H group,combination group and control group,with 15 rats in each group.PE rat model was established by intraperitoneal injection of 300 mg/kg N-nitro-L-arginine methyl ester(L-NAME)hydrochloride.Experimental-L,experimental-M,experimental-H groups were intraperitoneally injected with 2,4 and 8 mg/kg lycopene,combination group was intraperitoneally injected with 8 mg/kg lycopene and 1 mg/kg STAT3 activator Colivelin,control group and model group were injected with same amount of normal saline intraperitoneally,once a day for 5 consecutive days.Myocardial troponin Ⅰ(cTnⅠ),creatine kinase isozyme(CK-MB)and myoglobin(Mb)levels were detected by ELISA 24 h after the last administration.Western blot was applied to detect IL-6,p-STAT3/STAT3 and ET-1 proteins expressions.Results:Comparison between model group and control group,experimental-L,M,H groups and model group,combined group and high dose experimental group,cTnⅠ,CK-MB,Mb,IL-6 protein,p-STAT3/STAT3 protein,ET-1 protein showed statistically significant differences(all P<0.05).Conclusion:Lycopene alleviates myocardial damage in PE rats by inhibiting IL-6/STAT3/ET-1 signaling pathway.

Objective:To investigate impacts of lycopene on myocardial damage in preeclampsia(PE)rats by regulating IL-6/signal transducer and activator of transcription 3(STAT3)/endothelin-1(ET-1)signaling pathway.Methods:Pregnant rats were divided into model group,experimental-L group,experimental-M group,experimental-H group,combination group and control group,with 15 rats in each group.PE rat model was established by intraperitoneal injection of 300 mg/kg N-nitro-L-arginine methyl ester(L-NAME)hydrochloride.Experimental-L,experimental-M,experimental-H groups were intraperitoneally injected with 2,4 and 8 mg/kg lycopene,combination group was intraperitoneally injected with 8 mg/kg lycopene and 1 mg/kg STAT3 activator Colivelin,control group and model group were injected with same amount of normal saline intraperitoneally,once a day for 5 consecutive days.Myocardial troponin Ⅰ(cTnⅠ),creatine kinase isozyme(CK-MB)and myoglobin(Mb)levels were detected by ELISA 24 h after the last administration.Western blot was applied to detect IL-6,p-STAT3/STAT3 and ET-1 proteins expressions.Results:Comparison between model group and control group,experimental-L,M,H groups and model group,combined group and high dose experimental group,cTnⅠ,CK-MB,Mb,IL-6 protein,p-STAT3/STAT3 protein,ET-1 protein showed statistically significant differences(all P<0.05).Conclusion:Lycopene alleviates myocardial damage in PE rats by inhibiting IL-6/STAT3/ET-1 signaling pathway.

ObjectiveTo determine the drug sensitivity and molecular typing characteristics of Klebsiella pneumoniae isolated from meat and diarrhea samples in a local area. MethodsSeventy-one strains of K.pneumoniae were isolated from 118 meat food （chicken and pork） randomly sampled in the markets in Jinshan District， Shanghai， 2020‒2021， and 1 499 diarrhea samples from outpatient diarrhoea patients in hospitals in the same district. Then drug susceptibility testing was conducted by micro-broth dilution method， and sequence identity was determined by pulsed field gel electrophoresis（PFGE）. ResultsThe overall detection rate of K.pneumoniae in meat was 11.86% （14/118）， with detection rate 20.93% （9/43） in chicken and 6.67% （5/75） in pork. The difference in detection between meats was statistically significant （χ²=5.317，P<0.05）. The detection rate of K.pneumoniae in diarrhea samples was 3.80% （57/1 499）. Furthermore， the isolated strains showed the highest resistance to ampicillin at 76.06%. The multi-drug resistant strains included 5 of human origin （8.77%） and 2 of foodborne origin （14.28%）. Additionally， 1 foodborne imipenem-resistant strain was detected. A total of 71 strains of K.pneumoniae were found to have 70 banding types， with similarity ranging from 39.4% to 100%， suggesting genetic diversity. ConclusionK.pneumoniae isolated from foodborne and diarrhea samples showed multi-drug resistance in Jinshan District， . with scattered PFGE banding patterns. It is recommended to strengthen the monitoring of this pathogen in the population and animal food， and be alert to the emerging multi-drug resistant strains and risk of food chain transmission.

Cough variant asthma （CVA） is a chronic respiratory disease with cough as its main symptom. The occurrence of CVA is closely related to non-specific airway inflammation， and its pathogenesis involves environmental， genetic， immune， and other factors. In recent years， the advantages of traditional Chinese medicine （TCM） in the treatment of CVA have attracted the attention of experts and scholars in China and abroad， especially its prominent role in regulating immune balance， relieving cough symptoms in CVA patients， and reducing recurrence. T Helper cells 1 （Th1）， T helper cells 2 （Th2）， T helper cells 17 （Th17）， and regulatory T cells （Treg） are derived from CD4⁺ T cells. Immune imbalance of Th1/Th2 and Th17/Treg is a new hotspot in the pathogenesis of CVA and a potential key target in the treatment of CVA by TCM. Th cell subsets are in dynamic balance under physiological conditions， maintaining respiratory immune homeostasis in which pro-inflammatory cytokines and anti-inflammatory cytokines are balanced. Immature helper T cells （Th0） can be differentiated into Th1， Th2， Th17， Treg， and other cell subsets due to cytokine types in the microenvironment in the stage of CVA maturation. The proliferation of Th2 cells leads to eosinophilic airway inflammation. Excessive differentiation of Th17 cells induces neutrophil airway inflammation. Th1/Th2 and Th17/Treg cells are mutually restricted in number and function， and the immune imbalance of Th1/Th2 and Th17/Treg is easy to aggravate the generation of inflammatory response. Restoring immune balance is particularly important for the airway anti-inflammatory therapy of CVA. In this paper， the imbalance of Th1/Th2 and Th17/Treg and the pathogenesis of CVA were systematically expounded. Meanwhile， the latest research on the regulation of immune imbalance by TCM compound， single TCM， and its effective ingredients in the treatment of CVA was reviewed. It provides ideas and references for revealing the scientific connotation of TCM regulating immune balance therapy of CVA， as well as the development of clinical treatment and basic research of CVA.

Objective:To investigate the management of granulation tissue during surgery for infected congenital preauricular fistula and to assess the surgical outcomes. Methods:To summarize the surgical methods and the treatment of granulation methods in 140 cases of congenital preauricular fistula during the period of infection treated in our department from January 2018 to September 2022. The study divided patients into an observation group （79 patients） undergoing fistulectomy without granulation treatment, and a control group （61 patients） where fistulectomy and granulation resection were performed concurrently.. After six months of follow-up, the wound healing, recurrence rates, and the aesthetic assessment of granulation healing were evaluated using the Stony Brook Scar Evaluation Scale（SBSES）. Results:The two surgical approaches were applied to a total of 140 patients with infected congenital preauricular fistula. There was no statistical difference in wound healing and recurrence rates between the observation group and the control group. However, the observation group exhibited smaller scars. Conclusion:In cases of infected congenital preauricular fistula, surgical removal without excising granulation tissue is feasible, leading to effective healing and lesser scar formation.
Humans ; Cicatrix ; Wound Healing ; Craniofacial Abnormalities ; Fistula/surgery* ; Treatment Outcome

ObjectiveTo evaluate the clinical efficacy and safety of Tongluo Mingmu capsules in the treatment of diabetic retinopathy with blood stasis， collateral obstruction， and Qi and Yin deficiency syndrome. MethodA randomized， double-blind， positive-control， and multi-center clinical trial design method was used. 416 patients with diabetic retinopathy with blood stasis， collateral obstruction， and Qi and Yin deficiency syndrome in four test centers were included （the ratio of the treatment group to the control group was 3∶1）. On the basis of standardized hypoglycemic treatment， the treatment group was given both four Tongluo Mingmu capsules and two Calcium Dobesilate capsule agents three times a day， while the control group were given both two Calcium Dobesilate capsules and four Tongluo Mingmu capsule agents three times a day. The course of treatment was 12 weeks. The curative effect of Tongluo Mingmu capsules was evaluated by comparing the comprehensive curative effect of diabetic retinopathy， traditional Chinese medicine（TCM） syndrome score， corrected visual acuity， fundus changes， fundus fluorescence angiography， and other curative effect indexes before and after treatment in the two groups. At the same time， general examination， laboratory examination， and adverse events were performed to evaluate the safety of the drug. ResultThe baseline demographic data and disease characteristics of the treatment group and the control group were balanced and comparable， with the difference not statistically significant. After 12 weeks of treatment， the total effective rate of the comprehensive curative effect of diabetic retinopathy in the treatment group （61.0%， 189/310） was better than that in the control group （44.1%， 45/102）， and the difference was statistically significant （χ²=8.880， P<0.01）. The total effective rate of TCM syndromes in the treatment group （88.4%， 259/293） was better than that in the control group （69.9%， 65/93）， and the difference was statistically significant （χ²=17.927， P<0.01）. The disappearance rate of dry eyes （χ²=8.305）， dull complexion （χ²=4.053）， lassitude （χ²=10.267）， shortness of breath （χ²=8.494）， and dry stool （χ²=8.657） in the treatment group was higher than that in the control group， and the difference between the groups was statistically significant （P<0.05， P<0.01）. In terms of improving corrected visual acuity （χ²=8.382）， fundus changes （χ²=6.026） ， the treatment group was significantly better than the control group （P<0.05）. During the trial， the incidence of adverse events in the treatment group and the control group was 1.3% and 2.9%， respectively. There was no significant difference between the two groups. In addition， there were no serious adverse events and adverse events leading to withdrawal in both groups. ConclusionTongluo Mingmu capsules can improve the comprehensive curative effect of diabetic retinopathy and enhance the efficacy of TCM syndromes， visual acuity， fundus changes， and fundus fluorescein angiography， with great safety. Therefore， it can provide a new alternative therapeutic drug for patients with diabetic retinopathy.

Objective To explore the health promotion behaviors among patients with pulmonary tuberculosis(TB),and to analyze its relationship with health locus of control,in order to provide scientific references for improving TB patients'health-promotion behaviors in clinical nursing care.Methods The interpretive sequence mixed method design was utilized.A convenient sampling was used to enroll 300 TB patients from 2 TB specialized tertiary hospitals in Xi'an as research subjects from January to April 2023.General information questionnaire,Health promoting lifestyle profile-Ⅱ,and Multidimensional health locus of control scale were used to collect data,and single-factor analysis and multiple linear regression analysis were conducted.Purposeful sampling was used to select 11 TB patients for a semi-structured interview,and the Colaizzi 7-step method was used to extract themes.Results In the quantitative study,the total score of health promoting behaviors in 294 TB patients was(110.26±15.74).Patients'intemal health locus of control,chance health locus of control,and occupational status significantly influenced their health-promotion behaviors(P＜0.05).In the qualitative study,4 themes were extracted,including awakening self-awareness of health,the desire to establish a normal life,the distress of multiple uncertainties,and the immediate effect of authoritative guidance.The qualitative and quantitative studies complemented each other and further verified the relationship between health promotion behaviors and health locus of control of TB patients.Conclusion The level of health-promotion behaviors in TB patients needs to be further improved.Nurses need to take systematic health education as an opportunity by the catalytic effect of individual health awareness,to improve their internal locus of control,reduce their opportunity control tendency due to multiple uncertainties,with the ultimate purpose of helping TB patients form and maintain health promotion behaviors.

Objective:To investigate the impacts of galangin(Gal)on the immune inflammatory response in preeclampsia(PE)rats by regulating the IL-6/signal transducer and activator of transcription 3(STAT3)signaling pathway.Methods:Pregnant rats were injected subcutaneously with L-arginine methyl ester(L-NAME 125 mg/kg)to establish a PE model.After successful modeling,they were randomly grouped into Model group,low,medium and high doses Gal groups(10,30,and 60 mg/kg)and activator group(60 mg/kg Gal+0.05 mg/kg IL-6/STAT3 pathway activator rIL-6).Twelve pregnant rats of the same period were randomly selected as the control group,and each group was given corresponding drugs by gavage and intraperitoneal injection,once a day for a continuous week.The levels of mean caudal artery pressure(MAP)and 24-hour urinary protein and blood urea nitrogen(BUN)in rats during the third trimester of pregnancy were measured using a blood pressure tester and a fully automated biochemical analyzer;the number and weight of the average offspring of pregnant mice in each group were calculated,and the pregnancy outcome was analyzed;HE staining was applied to observe the pathological damage of rat placenta;ELISA was applied to detect the levels of IL-6,IL-1β and TNF-α in the placenta of rats in each group;the proportion of T lymphocytes in rat peripheral blood was detected by flow cytometry;Western blot was applied to detect the expression of IL-6/STAT3 pathway protein in rat placenta.Results:Compared with control group,the lev-els of MAP,24-hour urinary protein,BUN,IL-6,IL-1β,TNF-α,the CD8+T cells,and the expression levels of IL-6 and p-STAT3/STAT3 proteins in Model group were obviously increased,the placenta tissue was severely damaged,the mean offspring number and mean offspring weight,the proportions of CD3+T,CD4+T,and CD4+/CD8+T cells were decreased(P<0.05);compared with Model group,the levels of MAP,24-hour urinary protein,BUN,IL-6,IL-1β,TNF-α,the CD8+T cells,and the expression levels of IL-6 and p-STAT3/STAT3 proteins in Gal low,medium and high doses groups were obviously decreased,the damage to placental tissue was reduced,the mean offspring number and mean offspring weight,the proportions of CD3+T,CD4+T,and CD4+/CD8+T cells were in-creased(P<0.05);compared with Gal high-dose group,the levels of MAP,24-hour urinary protein,BUN,IL-6,IL-1β,TNF-α,the CD8+T cells,and the expression levels of IL-6 and p-STAT3/STAT3 proteins in activator group were obviously increased,the placenta tissue was aggravated,the mean offspring number and mean offspring weight,the proportions of CD3+T,CD4+T and CD4+/CD8+T cells were decreased(P<0.05).Conclusion:Gal may play a role in alleviating PE symptoms and improving pregnancy outcomes by inhibit-ing the IL-6/STAT3 pathway,inhibiting inflammatory reactions,and regulating cellular immunity.

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
Medicine, Chinese Traditional ; Nonprescription Drugs ; Consensus ; China ; Reference Standards ; Drugs, Chinese Herbal