Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent ; Child ; Child, Preschool ; Female ; Humans ; Male ; Double-Blind Method ; Drugs, Chinese Herbal/therapeutic use* ; Tic Disorders/drug therapy* ; Treatment Outcome

Objective:To comprehensively evaluate the skin thickness, blood flow grades, skin stiffness, and post-treatment changes in ultrasound indices in patients with different clinical types of port-wine stains (PWS) by multimodal ultrasound, and to explore the application value of multimodal ultrasound in the quantitative evaluation of and efficacy assessment for PWS.Methods:An observational study was conducted, including 298 patients with PWS. High-frequency ultrasound was used to measure the thickness of and blood flow signals in skin lesions, and shear wave elastography to measure the maximum Young's modulus (Emax) and maximum shear wave propagation velocity (Cmax) of the skin layers. Differences in various ultrasound indices were analyzed between skin lesions and surrounding normal skin. After photodynamic therapy, ultrasound re-evaluation was performed on 124 patients to analyze changes in ultrasound indices before and after treatment. Statistical analysis was conducted using t test, analysis of variance, and rank sum test. Results:In 106 patients with pink PWS, the skin thickness was 1.41 ± 0.28 mm, the blood flow was mainly rated as grade 0 (81%), the Emax was 16.24 ± 1.82 kPa, and the Cmax was 2.28 ± 0.09 m/s. There were no significant differences in the above indices between normal skin and treated skin (all P > 0.05). In the 121 patients with purplish red PWS, the skin thickness was 1.86 ± 0.23 mm; the blood flow was mainly rated as grade 1 (45%), which was higher than that of normal skin; after treatment, both the skin thickness and blood flow grades were decreased ( P < 0.05) ; there were no significant differences in the Emax and Cmax between purplish red PWS lesions (16.41 ± 1.82 kPa, 2.32 ± 0.13 m/s, respectively) and normal skin or treated skin (all P > 0.05). In the 71 patients with thickened PWS, the skin thickness was 2.51 ± 0.32 mm, the blood flow was mainly trated as grade 3 (55%), the Emax was 22.22 ± 2.46 kPa, and the Cmax was 2.75 ± 0.11 m/s, which were all significantly higher than those of normal skin (all P < 0.05) ; all the indices were decreased after treatment. Conclusions:Multimodal ultrasound can be used for the quantitative assessment of different clinical types of PWS and their treatment outcomes. Purplish red PWS and thickened PWS showed thicker skin layers and higher blood flow grades, and thickened PWS showed higher skin stiffness values. All ultrasound indices were decreased after treatment.

As artificial intelligence technology rapidly advances, its deployment within the medical sector presents substantial ethical challenges. Consequently, it becomes crucial to create a standardized, transparent, and secure framework for processing medical data. This includes setting the ethical boundaries for medical artificial intelligence and safeguarding both patient rights and data integrity. This consensus governs every facet of medical data handling through artificial intelligence, encompassing data gathering, processing, storage, transmission, utilization, and sharing. Its purpose is to ensure the management of medical data adheres to ethical standards and legal requirements, while safeguarding patient privacy and data security. Concurrently, the principles of compliance with the law, patient privacy respect, patient interest protection, and safety and reliability are underscored. Key issues such as informed consent, data usage, intellectual property protection, conflict of interest, and benefit sharing are examined in depth. The enactment of this expert consensus is intended to foster the profound integration and sustainable advancement of artificial intelligence within the medical domain, while simultaneously ensuring that artificial intelligence adheres strictly to the relevant ethical norms and legal frameworks during the processing of medical data.
Artificial Intelligence/legislation & jurisprudence* ; Humans ; Consensus ; Computer Security/standards* ; Confidentiality/ethics* ; Informed Consent/ethics*

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

Objective: To establish and optimize a TaqMan-probe quantitative real-time PCR (qPCR) assay for the detection of 7 important Rickettsiales pathogens and simultaneous identification of the infection types. Methods: Based on the ompB gene of Rickettsia prowazekii, Rickettsia mooseri and spotted fever group rickettsiae, the groEL gene of Orientia tsutsugamushi, the 16S rRNA of Ehrlichia chaffeensis, the gltA gene of Anaplasma phagocytophilum and the com1 gene of Coxiella burnetii, we synthesized primers and TaqMan-probes and optimized the reaction system and reaction process to same solution. The sensitivity, specificity and reproducibility of this assay were evaluated and the assay was used for the detection of simulated and actual samples. Results: The Ct value of the standard curves of the 7 pathogens showed a good linear relationship with the number of DNA copies (all R² >0.990 0), the minimum detection limit was 10 copies/μl, showing good specificity. In the 96 tick nucleic acid extracts, Coxiella burnetii was detected in 1 sampleand spotted fever group Rickettsiae was detected in 3 samples. In the 80 blood samples from patients with undefined febrile illness, Orientia tsutsugamushi was detected in 1 sample and spotted fever group rickettsiae was detected in 2 samples. Conclusions: In this study, based on the established TaqMan-probe qPCR assay, the reaction system and reaction condition of the 7 important pathogens of Rickettsiales were optimized to the same solution. This method overcomes the shortcomings of using different reaction systems and reaction conditions for different pathogens, which can precisely identify the species of 7 important pathogens of Rickettsiales in clinical sample detections and is important for the infection type identification and laboratory detection time reduction to facilitate precise treatment of the patients.
Humans ; Rickettsiales ; Real-Time Polymerase Chain Reaction ; RNA, Ribosomal, 16S ; Reproducibility of Results ; Orientia tsutsugamushi ; Spotted Fever Group Rickettsiosis

Humans ; Female ; Fumarate Hydratase/genetics* ; Kidney Neoplasms ; Carcinoma, Renal Cell ; Leiomyomatosis ; Uterine Neoplasms

The high incidence of cardiovascular diseases is a serious threat to human health, and endovascular surgery has become the standard treatment for most interventional cardiovascular diseases. The robotassisted endovascular surgery system further enhances surgeons' ability to perform minimally invasive endovascular procedures in interventional cardiology. This study presents a new robotic technique for coronary intervention from the perspective of clinical application. Aiming at clinical application scenarios, this scheme proposed an intuitive guide wire catheter mechanism design, which accurately and perfectly simulates the doctor's hand movements, realizes the positive and negative direction translation of the guide wire catheter, accurate torque control of the guide wire rotation and locking. The results of animal test showed that the R-One^TM has a high degree of dexterity, accuracy and stability,and meets the clinical needs.
Animals ; Cardiovascular Diseases ; Catheterization ; Equipment Design ; Robotic Surgical Procedures ; Robotics

Carcinoma, Large Cell ; Carcinoma, Neuroendocrine/surgery* ; Female ; Humans ; Uterine Cervical Neoplasms

The UHPLC-LTQ-orbitrap-MS metabolomics technique was used to determine the effect of deapio-platycodin D (DPD) on endogenous metabolites in lung tissues of mice with ammonia-induced cough, and to identify the metabolic regulatory pathways of DPD in its antitussive and expectorant activities. This work was approved by the Animal Ethics Committee of Jiangxi University of Chinese Medicine (Approval No. JZLLSC-20190235). Metabolites were identified by UHPLC-LTQ-orbitrap-MS method and the metabolic pathways related to differentially-expressed metabolites were analyzed by the MetaboAnalyst platform. DPD significantly prolonged (P < 0.05) cough latency, reduced the number of coughs, and significantly increased (P < 0.05) phenol red excretion in ammonia-induced cough mice. Twenty-five metabolites related to cough and 38 metabolites related to sputum excretion were identified by UHPLC-LTQ-orbitrap-MS. Changes in the metabolism of linoleic acid, arachidonic acid, glycerophospholipid, alanine, aspartic acid and glutamic acid, pentose and glucuronate interconversions, and lysine degradation were evident with DPD treatment of ammonia-induced cough mice. Changes in the metabolism of linoleic acid, taurine and hypotaurine, glycerophospholipid, purines and pyrimidines, arachidonic acid and the biosynthesis of unsaturated fatty acids after DPD treatment were related to phenol red excretion. Linoleic acid metabolism, arachidonic acid metabolism and glycerophospholipid metabolism are common regulatory pathways by which DPD appears to exert its antitussive and expectorant activity. These metabolic pathways are closely related to anti-inflammatory pathways, immune function regulation, neurotransmitter release, cell signal transduction, energy metabolism and apoptosis. This study clarifies the antitussive and expectorant activity and mechanism of DPD.

Ferroptosis， a new type of iron-dependent programmed cell death， is related to multiple pathways such as glutathione/glutathione peroxidase 4， iron metabolism， lipid metabolism， and iron autophagy， and plays an important part in the occurrence and development of many diseases， such as tumor， cerebral ischemia， and Parkinson's disease. Ferroptosis is a double-edged sword as it can eliminate pathological cells （such as tumor cells） but long-term ferroptosis may cause or aggravate other disorders related to abnormal lipid metabolism and iron metabolism. Regulating the balance between cell proliferation and ferroptosis may be an important target for drug intervention in diseases. The Yin-yang theory is one of the foundational principles of traditional Chinese medicine （TCM）， which is used to explain the physiological functions and pathological changes of human body and to guide the diagnosis and prevention of disease and health care. The balance of cell proliferation and programmed death is essentially the balance of Yin and Yang at the cellular level， which is governed and regulated by the law of balance. TCM intervenes in ferroptosis by promoting ferroptosis of tumor cells （damaging the excess） and inhibiting ferroptosis of other diseases （compensating the deficiency）， which is similar to the treatment principle of adjusting Yin and Yang. On this basis， this article aims to use the Yin-yang theory to clarify the relationship between TCM promoting ferroptosis and inhibiting ferroptosis， which is expected to lay a basis for the modern application of Yin-yang theory and provide new targets for TCM treatment.