Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards* ; Humans ; Consensus ; Drugs, Chinese Herbal/therapeutic use* ; Surveys and Questionnaires

OBJECTIVE: To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension. METHODS: This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups. RESULTS: A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P<0.05). After 30 days of treatment, the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (P<0.05). After 180 days of treatment, brachial-ankle pulse wave velocity, ankle brachial index and albumin-to-creatinine ratio were improved in both groups, with no statistically significant differences (P>0.05). No serious treatment-related adverse events occurred during the study period. CONCLUSIONS Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470).
Humans ; Amlodipine/adverse effects* ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Hypertension/complications* ; Middle Aged ; Treatment Outcome ; Drug Therapy, Combination ; Adult ; Blood Pressure/drug effects* ; Double-Blind Method ; Aged ; Antihypertensive Agents/adverse effects*

Objective:To explore the therapeutic strategy for laryngeal cysts in infants. Methods:A retrospective analysis of the clinical data of 19 children with laryngeal cysts treated in Kunming Children's Hospital from January 2020 to January 2023. All patients were diagnosed through electronic laryngoscopy examination. Twelve neonates were admitted to the neonatal intensive care unit. Five of them received mechanical ventilation with tracheal intubation before surgery due to severe respiratory distress, and seven received oxygen therapy with a head mask. The remaining seven children were admitted to Department of Otolaryngology Head and Neck Surgery, of which three cases were treated with oxygen therapy through a mask during sleep due to frequent shortness of breath during sleep. All patients underwent low-temperature plasma radiofrequency ablation under general anesthesia to remove the cysts. Results:Three newborns were unable to have their tracheal tubes removed due to complications with pneumonia after surgery, while the rest of the children were able to have their tubes successfully removed after complete anesthesia, and no gastric tubes were placed. All postoperative respiratory difficulties in the children disappeared, and there were no complications such as bleeding, hoarseness, or laryngeal stenosis. Five pediatric patients had incomplete relief of laryngeal ringing symptoms one month after surgery, and electronic laryngoscopy diagnosed laryngeal softening. Regular follow-up is recommended. One child relapsed 4 months after surgery and underwent a follow-up surgery six months later without recurrence. Conclusion:Endoscopic low-temperature plasma radiofrequency ablation is an effective surgical method for treating laryngeal cysts, with a low postoperative recurrence rate. Laryngeal cysts may be accompanied by laryngeal softening, which may be a possible reason for the postoperative symptoms not improving.
Humans ; Retrospective Studies ; Cysts/surgery* ; Laryngeal Diseases/surgery* ; Infant ; Laryngoscopy ; Infant, Newborn ; Male ; Female ; Radiofrequency Ablation

This study analyzed the epidemiological characteristics of imported malaria in Yunnan Province from 2020 to 2023,to provide scientific evidence for formulating measures to decrease imported malaria and prevent re-establishment of malaria transmission.Malaria data reported by the China Disease Prevention and Control Information System were analyzed to determine parasite species;sources of infection;temporal,spatial,and population distributions;and importation routes.A total of 828 malaria cases were reported in the province.Plasmodium vivax and Plasmodium falciparum accounted for 89.98％and 8.33％of cases,respectively.A total of 47.58％of cases were imported from Myanmar,and all P.falciparum malaria ca-ses were from Africa.Thirteen(81.25％)prefectures or municipalities reported malaria,among which Dehong,Baoshan,Kunming,and Lincang reported 94.32％of cases.A total of 52.54％of cases were in young men.The proportion of cross-bor-der personnel flow,land input,and aircraft input were 88.89％and 11.11％respectively.A total of 98.19％of patients sought medical care within 7 days after fever onset,and 82.85％initiated diagnosis for malaria,and 84.90％of diagnoses were con-firmed by health facilities at or below the county level.Imported malaria is a major challenge in preventing re-establishment of transmission in Yunnan.Most imported cases involved cross-border malaria transmission of mainly Plasmodium vivax between China and Myanmar.To achieve malaria elimination,vigilance of health staff in malaria diagnosis and treatment should be pro-moted,and intensive malaria health education should be provided to people traveling to malaria endemic territories,to enable individual protection,and timely diagnosis and treatment after return from endemic countries.

Objective To analyze the basic conditions and pathological characteristics of the samples in the Human Brain Bank of Hebei Medical University,which were pathologically diagnosed as cerebral amyloid angiopathy,and to provide reference for the research of related diseases.Methods The basic data of gender,age,apolipoprotein E genotype,pathological classification of cerebral amyloid angiopathy,Alzheimer's disease-related pathological change score,comorbidities and other pathological information were analyzed.Results Up to October 2024,twenty samples were confirmed by pathological diagnosis,with a male to female ratio of 3:1 and an average age of(80.90±8.08)years.Involve three kinds of apolipoprotein E subtype,5 kinds of genotypes(ε2/ε3 xε2/ε4、ε3/ε3 xε3/ε4、ε4/ε4);There were 2 pathologic types,including 6 cases of type 1 and 14 cases of type 2.The pathological grade included 3 grades.The severity grade and subtype classification of cerebral amyloid vascular disease were correlated with the degree of pathological changes of Alzheimer's disease.Cerebral amyloid angiopathy samples could coexist with other degenerative diseases with high comorbidity.Conclusion The incidence of cerebral amyloid angiopathy is higher in the aged samples collected based on Brain Bank,which coexists with conditions such as Alzheimer's disease and microbleeds,etc.It provides more detailed pathological diagnosis basis for further scientific research sharing of samples.

OBJECTIVE: Lipid oxidation is involved in the pathogenesis of atherosclerosis and may be contribute to the development of Ischemic stroke (IS). However, the lipid profiles associated with IS have been poorly studied. We conducted a pilot study to identify potential IS-related lipid molecules and pathways using lipidomic profiling. METHODS: Serum lipidomic profiling was performed using LC-MS in 20 patients with IS and 20 age- and sex-matched healthy controls. Univariate and multivariate analyses were simultaneously performed to identify the differential lipids. Multiple testing was controlled for using a false discovery rate (FDR) approach. Enrichment analysis was performed using MetaboAnalyst software. RESULTS: Based on the 294 lipids assayed, principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA) models were used to distinguish patients with IS from healthy controls. Fifty-six differential lipids were identified with an FDR-adjusted P less than 0.05 and variable influences in projection (VIP) greater than 1.0. These lipids were significantly enriched in glycerophospholipid metabolism (FDR-adjusted P = 0.009, impact score = 0.216). CONCLUSIONS Serum lipid profiles differed significantly between patients with IS and healthy controls. Thus, glycerophospholipid metabolism may be involved in the development of IS. These results provide initial evidence that lipid molecules and their related metabolites may serve as new biomarkers and potential therapeutic targets for IS.
Humans ; Pilot Projects ; Lipidomics ; Male ; Female ; Biomarkers/blood* ; Middle Aged ; Ischemic Stroke/blood* ; Aged ; China ; Lipids/blood* ; Adult ; Case-Control Studies ; East Asian People

Objective:To investigate the endoscopic and pathological characteristics of metachronous early gastric cancer (EGC) after endoscopic submucosal dissection (ESD) for EGC.Methods:Data of 451 consecutive EGC patients treated with ESD at the Department of Gastroenterology, Peking University Third Hospital between 1 January, 2005 and 31 December, 2022 were retrospectively collected, of which 252 patients who met the criteria and had endoscopic follow-up ≥ 1 year were enrolled in the retrospective dynamic cohort. Multivariate Cox regression analysis was used to identify independent risk factors for metachronous EGC after ESD. Pearson's contingency coefficient was applied to analyze endoscopic correlation between the index and metachronous lesions. T-test, χ2 test, and Fisher exact test were used to compare endoscopic pathological features between index and metachronous lesions, the proportion of lesions meeting absolute ESD indication and their maximum diameters between patients undergoing annual vs bi-annual follow-up. Kaplan-Meier analysis assessed the cumulative incidence of metachronous EGC. Results:During a median follow-up of 40 months, 26 patients [10.3% (26/252)] developed metachronous EGC, with a mean interval of 43.9 months. Multivariate Cox regression identified the independent risk factors of index lesions including location in the middle third of the stomach ( HR=3.783, 95% CI: 1.300-11.011, P=0.015), in the anterior wall ( HR=3.934, 95% CI: 1.113-13.904, P=0.033), and the maximum diameter <15 mm ( HR=3.034, 95% CI: 1.074-8.571, P=0.036). Pearson's contingency coefficient showed no significant concordance between index and metachronous lesions for vertical location (C=0.375, P=0.372), horizontal location (C=0.508, P=0.434), gross morphology (C=0.287, P=0.675), or ulcer presence (C=0.194, P=0.313). Compared to index lesions, metachronous lesions were more frequently located on the posterior wall (lesser curvature/greater curvature/anterior wall/posterior wall: 11/2/1/12 VS 96/49/46/61, P=0.031), more often differentiated (differentiated/undifferentiated: 26/0 VS 214/38, P=0.032), and smaller in maximum diameter (8.08±5.99 mm VS 13.95±10.26 mm, t=4.383, P<0.001). No significant differences were observed between patients undergoing annual vs bi-annual follow-up in the proportion of metachronous lesions meeting absolute ESD indication (14/16 VS 9/9, P=0.520) or in maximum diameter (8.11±6.94 mm VS 6.67±4.35 mm, t=-0.275, P=0.535). The cumulative incidence curve of metachronous EGC plateaued after 10 years. Conclusion:Patients with EGC located in the middle third of the stomach, in the anterior wall, or of smaller diameter need intensive endoscopic surveillance after ESD. Posterior wall deserves particular attention during follow-up, with annual endoscopy recommended for at least 10 years post-ESD.

This study analyzed the epidemiological characteristics of imported malaria in Yunnan Province from 2020 to 2023,to provide scientific evidence for formulating measures to decrease imported malaria and prevent re-establishment of malaria transmission.Malaria data reported by the China Disease Prevention and Control Information System were analyzed to determine parasite species;sources of infection;temporal,spatial,and population distributions;and importation routes.A total of 828 malaria cases were reported in the province.Plasmodium vivax and Plasmodium falciparum accounted for 89.98％and 8.33％of cases,respectively.A total of 47.58％of cases were imported from Myanmar,and all P.falciparum malaria ca-ses were from Africa.Thirteen(81.25％)prefectures or municipalities reported malaria,among which Dehong,Baoshan,Kunming,and Lincang reported 94.32％of cases.A total of 52.54％of cases were in young men.The proportion of cross-bor-der personnel flow,land input,and aircraft input were 88.89％and 11.11％respectively.A total of 98.19％of patients sought medical care within 7 days after fever onset,and 82.85％initiated diagnosis for malaria,and 84.90％of diagnoses were con-firmed by health facilities at or below the county level.Imported malaria is a major challenge in preventing re-establishment of transmission in Yunnan.Most imported cases involved cross-border malaria transmission of mainly Plasmodium vivax between China and Myanmar.To achieve malaria elimination,vigilance of health staff in malaria diagnosis and treatment should be pro-moted,and intensive malaria health education should be provided to people traveling to malaria endemic territories,to enable individual protection,and timely diagnosis and treatment after return from endemic countries.

Objective:To investigate the endoscopic and pathological characteristics of metachronous early gastric cancer (EGC) after endoscopic submucosal dissection (ESD) for EGC.Methods:Data of 451 consecutive EGC patients treated with ESD at the Department of Gastroenterology, Peking University Third Hospital between 1 January, 2005 and 31 December, 2022 were retrospectively collected, of which 252 patients who met the criteria and had endoscopic follow-up ≥ 1 year were enrolled in the retrospective dynamic cohort. Multivariate Cox regression analysis was used to identify independent risk factors for metachronous EGC after ESD. Pearson's contingency coefficient was applied to analyze endoscopic correlation between the index and metachronous lesions. T-test, χ2 test, and Fisher exact test were used to compare endoscopic pathological features between index and metachronous lesions, the proportion of lesions meeting absolute ESD indication and their maximum diameters between patients undergoing annual vs bi-annual follow-up. Kaplan-Meier analysis assessed the cumulative incidence of metachronous EGC. Results:During a median follow-up of 40 months, 26 patients [10.3% (26/252)] developed metachronous EGC, with a mean interval of 43.9 months. Multivariate Cox regression identified the independent risk factors of index lesions including location in the middle third of the stomach ( HR=3.783, 95% CI: 1.300-11.011, P=0.015), in the anterior wall ( HR=3.934, 95% CI: 1.113-13.904, P=0.033), and the maximum diameter <15 mm ( HR=3.034, 95% CI: 1.074-8.571, P=0.036). Pearson's contingency coefficient showed no significant concordance between index and metachronous lesions for vertical location (C=0.375, P=0.372), horizontal location (C=0.508, P=0.434), gross morphology (C=0.287, P=0.675), or ulcer presence (C=0.194, P=0.313). Compared to index lesions, metachronous lesions were more frequently located on the posterior wall (lesser curvature/greater curvature/anterior wall/posterior wall: 11/2/1/12 VS 96/49/46/61, P=0.031), more often differentiated (differentiated/undifferentiated: 26/0 VS 214/38, P=0.032), and smaller in maximum diameter (8.08±5.99 mm VS 13.95±10.26 mm, t=4.383, P<0.001). No significant differences were observed between patients undergoing annual vs bi-annual follow-up in the proportion of metachronous lesions meeting absolute ESD indication (14/16 VS 9/9, P=0.520) or in maximum diameter (8.11±6.94 mm VS 6.67±4.35 mm, t=-0.275, P=0.535). The cumulative incidence curve of metachronous EGC plateaued after 10 years. Conclusion:Patients with EGC located in the middle third of the stomach, in the anterior wall, or of smaller diameter need intensive endoscopic surveillance after ESD. Posterior wall deserves particular attention during follow-up, with annual endoscopy recommended for at least 10 years post-ESD.

Objective To establish the pharmacokinetic model of linezolid in neonates,and to optimize the administration regimen. Methods A prospective study was conducted among 64 neonates with sepsis who received linezolid as anti-infective therapy,and liquid chromatography-tandem mass spectrometry was used to measure the plasma concentration of the drug. Clinical data were collected,and nonlinear mixed effects modeling was used to establish a population pharmacokinetic (PPK) model. Monte Carlo simulation and evaluation was performed for the optimal administration regimen of children with different features. Results The pharmacokinetic properties of linezolid in neonates could be described by a single-compartment model with primary elimination,and the population typical values for apparent volume of distribution and clearance rate were 0.79 L and 0.34 L/h,respectively. The results of goodness of fit,visualization verification,and the Bootstrap method showed that the model was robust with reliable results of parameter estimation and prediction. Monte Carlo simulation results showed that the optimal administration regimen for linezolid in neonates was as follows:6 mg/kg,q8h,at 28 weeks of gestational age (GA);8 mg/kg,q8h,at 32 weeks of GA;9 mg/kg,q8h,at 34-37 weeks of GA;11 mg/kg,q8h,at 40 weeks of GA. Conclusions The PPK model established in this study can provide a reference for individual administration of linezolid in neonates. GA and body weight at the time of administration are significant influencing factors for the clearance rate of linezolid in neonates.