ObjectiveTo carry out a health technology assessment （HTA） of acupuncture for secondary dysmenorrhea （SD） caused by adenomyosis and endometriosis， in order to provide a reference for relevant medical decision-making. MethodsFrom the perspective of the health system， the assessment covers seven areas， including the technical characteristics， safety， effectiveness， economics， ethical fairness， organizational adaptability， and impact on patients and society. The results are reported accordingly. ResultsThe operational specifications of acupuncture are standardized， and the conditions for its use are clearly defined. Acupuncture has a lower overall incidence of adverse events. The main adverse events are localized pain， subcutaneous bleeding， and dizziness， with most symptoms being mild， all of which have corresponding standard treatments. No reports on occupational or environmental safety were found， and the safety operation specifications are available for reference. Compared with conventional Western medicine， acupuncture demonstrates higher effectiveness. Acupuncture may improve the quality of life scores of patients， though no significant difference was observed. The cost of acupuncture is higher than that of conventional Western medicine， but its overall economic value is greater. The informed consent information is relatively comprehensive. Most patients are aware of the potential benefits and risks of acupuncture and voluntarily opt for it. The treatment process fully respects patient privacy and human rights. The clinical application of acupuncture follows the current acupuncture medical service model， with no special requirements for the level of medical institutions. Patient accessibility and affordability are suitable. Patient satisfaction is high. Most patients indicated they would choose acupuncture again for SD. The main barriers to choosing acupuncture are psychological factors （such as fear of acupuncture）， cost， and transportation issues. Nearly 70% of patients receiving acupuncture treatment benefit from medical insurance reimbursement， with reimbursement rates generally above 50%， indicating strong social security support. ConclusionThe implementation of HTA for acupuncture in the treatment of SD， using the standards for traditional Chinese medicine （TCM）， is feasible. The implementation steps are clear， the data sources for each evaluation domain are adequate， the analysis methods are practical， and the evaluation results are comprehensive. Experts recommend that the findings be used as a reference for relevant medical decision-making.

ObjectiveTo investigate the effects and potential mechanisms of Tongmai Yangxin Pills （通脉养心丸） （TYPs） in preventing ischemia-reperfusion （I/R）-induced arrhythmia. MethodsSixty male SD rats were randomly assigned to sham operation group， model group， amiodarone group， low-dose and high-dose TYPs group， with 12 rats in each group. The sham operation group and the model group received 10 g/（kg·d） normal saline by gavage， the amiodarone group received 60 mg/（kg·d） amiodarone， and the low-dose and high-dose TMP groups received 1 g/（kg·d） and 2 g/（kg·d） TYPs solution respectively， for 21 days， administered twice daily. On the day after the last administration， the I/R model was established in the model and medication groups by ligation of the left anterior descending coronary artery with a cannula， while the sham operation group underwent the same procedure without ligation. Electrocardiogram recordings were continuously monitored throughout the modeling process. Heart rate was recorded at five time points， before ischemia （t-0）， 5-10 min after ischemia （t-1）， 10-15 min after ischemia （t-2）， 15-30 min after ischemia （t-3）， and during the first 2 min of reperfusion （t-4）； the incidence of arrhythmia including ventricular premature beats （VPB）， ventricular tachycardia （VT）， and ventricular fibrillation （VF） was recorded； arrhythmia scores were calculated. After 24 hours of reperfusion， left ventricular myocardial tissue was collected. Hematoxylin-eosin （HE） staining was performed to observe pathological changes. RT-PCR was used to detect the mRNA expression of microRNA-1 （miRNA-1）， microRNA-133a （miRNA-133a）， and potassium （K⁺） and calcium （Ca²⁺） ion channel-related genes including KCND2， KCNH2， KCNE2， KCNQ1， KCNE1， KCNJ2， CACNA1C， and CACNB1. Western blot analysis was used to measure protein levels of transient outward potassium current protein （Kv4.2）， rapidly activating delayed rectifier potassium current protein （HERG）， slowly activating delayed rectifier potassium current protein （KvLQT1）， inward rectifier potassium current protein （Kir2.1）， and L-type calcium channel protein （Cav1.2）. ResultsCompared with sham operation group， the model group showed diffuse myocardial hemorrhage， inflammatory cell infiltration， myocardial necrosis， nuclear pyknosis， vacuolar degeneration， and disrupted myocardial fibers； the model group also exhibited a decreased heart rate （t-1 to t-4）， increased arrhythmia scores， elevated miRNA-1 and miRNA-133a expression， and decreased mRNA expression of KCND2， KCNH2， KCNE2， KCNQ1， KCNE1， KCNJ2， CACNA1C， and CACNB1 in myocardial tissue； additionally， Kv4.2， HERG， KvLQT1， Kir2.1， and Cav1.2 protein levels significantly reduced （P＜0.01）. Compared to the model group， all medication-treated groups showed reduced myocardial damage， including less hemorrhage， reduced inflammatory infiltration， and improved myocardial structure， with the high-dose TYPs group exhibiting the most significant improvement； the amiodarone group and high-dose TYPs group showed a significant increase in heart rate （t-1 to t-4）， lower arrhythmia scores， reduced miRNA-1 and miRNA-133a expression； the high-dose TYPs group exhibited significantly increased mRNA expression levels of KCND2， KCNH2， KCNQ1， KCNJ2， and CACNA1C， as well as elevated protein levels of Kv4.2， HERG， KvLQT1， Kir2.1， and Cav1.2 （P＜0.05 or P＜0.01）. ConclusionTMPs can improve myocardial damage and reduce the incidence of ventricular arrhythmia in I/R rats. The underlying mechanism may be related to the downregulation of miRNA-1 and miRNA-133a gene expression， as well as the upregulation of K⁺ and Ca²⁺ channel-related genes and proteins.

This article introduces Professor LIU Xing's clinical experience in treatment of peripheral facial paralysis at the recovery and sequelae stages with the combination of acupotomy, cupping and herbal medication. Based on the analysis of etiology and pathogenesis of peripheral facial paralysis, Professor LIU believes that "invasion of pathogenic wind to collaterals and obstruction of qi and blood" is crucial. Therefore, the treatment focuses on "dispelling wind and harmonizing blood". The compound therapeutic mode is proposed, with acupotomy, cupping and herbal decoction involved, in which, "three-step sequential method of acupotomy" is predominated. Firstly, in the prone position, five "feng" (wind) points are stimulated in patient, Fengfu (GV16), Fengchi (GB20), Yifeng (TE17), Bingfeng (SI12) and Fengmen (BL12). Secondly, in the lateral position, three-facial points are stimulated (FaceⅠneedle: Yangbai [GB14]-Yuyao [EX-HN4]; Face Ⅱ needle: Sibai [ST2]-Quanliao [SI18]; Face Ⅲ needle: Jiache [ST6]-Dicang [ST4]) to restore the deviated facial muscles. Finally, in the supine, two Dantian points are stimulated on the forehead and chest, respectively (upper Dantian: Yintang [GV24⁺], middle Dantian: Danzhong [CV17]), to regulate qi and blood. As the adjunctive therapies, cupping is used to remove stasis, and herbal decoction is to harmonize the body interior. In view of holistic regulation, the treatment is administered in accordance with the affected meridians, so as to expel wind, remove obstruction in collaterals and regulate qi and blood.
Humans ; Facial Paralysis/drug therapy* ; Drugs, Chinese Herbal/administration & dosage* ; Acupuncture Therapy ; Male ; Female ; Middle Aged ; Adult ; Combined Modality Therapy ; Acupuncture Points ; Cupping Therapy ; Aged ; Young Adult

Purpose: The genomic characteristics of uterine sarcomas have not been fully elucidated. This study aimed to explore the genomic landscape of the uterine sarcomas (USs). Materials and Methods: Comprehensive genomic analysis through RNA-sequencing was conducted. Gene fusion, differentially expressed genes (DEGs), signaling pathway enrichment, immune cell infiltration, and prognosis were analyzed. A deep learning model was constructed to predict the survival of US patients. Results: A total of 71 US samples were examined, including 47 endometrial stromal sarcomas (ESS), 18 uterine leiomyosarcomas (uLMS), three adenosarcomas, two carcinosarcomas, and one uterine tumor resembling an ovarian sex-cord tumor. ESS (including high-grade ESS [HGESS] and low-grade ESS [LGESS]) and uLMS showed distinct gene fusion signatures; a novel gene fusion site, MRPS18A–PDC-AS1 could be a potential diagnostic marker for the pathology differential diagnosis of uLMS and ESS; 797 and 477 uterine sarcoma DEGs (uDEGs) were identified in the ESS vs. uLMS and HGESS vs. LGESS groups, respectively. The uDEGs were enriched in multiple pathways. Fifteen genes including LAMB4 were confirmed with prognostic value in USs; immune infiltration analysis revealed the prognositic value of myeloid dendritic cells, plasmacytoid dendritic cells, natural killer cells, macrophage M1, monocytes and hematopoietic stem cells in USs; the deep learning model named Max-Mean Non-Local multi-instance learning (MMN-MIL) showed satisfactory performance in predicting the survival of US patients, with the area under the receiver operating curve curve reached 0.909 and accuracy achieved 0.804. Conclusion USs harbored distinct gene fusion characteristics and gene expression features between HGESS, LGESS, and uLMS. The MMN-MIL model could effectively predict the survival of US patients.

Purpose: The genomic characteristics of uterine sarcomas have not been fully elucidated. This study aimed to explore the genomic landscape of the uterine sarcomas (USs). Materials and Methods: Comprehensive genomic analysis through RNA-sequencing was conducted. Gene fusion, differentially expressed genes (DEGs), signaling pathway enrichment, immune cell infiltration, and prognosis were analyzed. A deep learning model was constructed to predict the survival of US patients. Results: A total of 71 US samples were examined, including 47 endometrial stromal sarcomas (ESS), 18 uterine leiomyosarcomas (uLMS), three adenosarcomas, two carcinosarcomas, and one uterine tumor resembling an ovarian sex-cord tumor. ESS (including high-grade ESS [HGESS] and low-grade ESS [LGESS]) and uLMS showed distinct gene fusion signatures; a novel gene fusion site, MRPS18A–PDC-AS1 could be a potential diagnostic marker for the pathology differential diagnosis of uLMS and ESS; 797 and 477 uterine sarcoma DEGs (uDEGs) were identified in the ESS vs. uLMS and HGESS vs. LGESS groups, respectively. The uDEGs were enriched in multiple pathways. Fifteen genes including LAMB4 were confirmed with prognostic value in USs; immune infiltration analysis revealed the prognositic value of myeloid dendritic cells, plasmacytoid dendritic cells, natural killer cells, macrophage M1, monocytes and hematopoietic stem cells in USs; the deep learning model named Max-Mean Non-Local multi-instance learning (MMN-MIL) showed satisfactory performance in predicting the survival of US patients, with the area under the receiver operating curve curve reached 0.909 and accuracy achieved 0.804. Conclusion USs harbored distinct gene fusion characteristics and gene expression features between HGESS, LGESS, and uLMS. The MMN-MIL model could effectively predict the survival of US patients.

Purpose: The genomic characteristics of uterine sarcomas have not been fully elucidated. This study aimed to explore the genomic landscape of the uterine sarcomas (USs). Materials and Methods: Comprehensive genomic analysis through RNA-sequencing was conducted. Gene fusion, differentially expressed genes (DEGs), signaling pathway enrichment, immune cell infiltration, and prognosis were analyzed. A deep learning model was constructed to predict the survival of US patients. Results: A total of 71 US samples were examined, including 47 endometrial stromal sarcomas (ESS), 18 uterine leiomyosarcomas (uLMS), three adenosarcomas, two carcinosarcomas, and one uterine tumor resembling an ovarian sex-cord tumor. ESS (including high-grade ESS [HGESS] and low-grade ESS [LGESS]) and uLMS showed distinct gene fusion signatures; a novel gene fusion site, MRPS18A–PDC-AS1 could be a potential diagnostic marker for the pathology differential diagnosis of uLMS and ESS; 797 and 477 uterine sarcoma DEGs (uDEGs) were identified in the ESS vs. uLMS and HGESS vs. LGESS groups, respectively. The uDEGs were enriched in multiple pathways. Fifteen genes including LAMB4 were confirmed with prognostic value in USs; immune infiltration analysis revealed the prognositic value of myeloid dendritic cells, plasmacytoid dendritic cells, natural killer cells, macrophage M1, monocytes and hematopoietic stem cells in USs; the deep learning model named Max-Mean Non-Local multi-instance learning (MMN-MIL) showed satisfactory performance in predicting the survival of US patients, with the area under the receiver operating curve curve reached 0.909 and accuracy achieved 0.804. Conclusion USs harbored distinct gene fusion characteristics and gene expression features between HGESS, LGESS, and uLMS. The MMN-MIL model could effectively predict the survival of US patients.

Based on the theory of toxin in The Inner Canon of Yellow Emperor （《黄帝内经》）， this paper explores the concept and connotation of toxin from several aspects， including medicinal toxicity， pathogenic toxicity， pathoge-nesis and treatment of toxin pathogen. It explores the mechanism and significance of using toxin substances in curing and inducing diseases， sorts out the etiological and pathological evolution of toxic pathogens， clarifies the derivation and differentiation process from external toxins to internal toxins， and elucidates the interactions between toxin and other pathogenic factors such as phlegm， stasis， dampness， and fire. It further distinguishes the logical hierarchy of toxin caused by metabolic disorders such as sugar， fat， and drowning， clarifies that the essence of the etiology of "hidden toxin"， and determines the corresponding treatment principles and methods for toxic pathogens. It establishes a theoretical framework of traditional Chinese medicine toxic pathogen theory， providing theoretical basis for the clinical treatment of many diseases.

BACKGROUND: The role of inflammation in the development of gestational diabetes mellitus (GDM) has recently become a focus of research. The systemic immune-inflammation index (SII) and systemic inflammation response index (SIRI), novel indices, reflect the body's chronic immune-inflammatory state. This study aimed to investigate the associations between the SII or SIRI and GDM. METHODS: A prospective birth cohort study was conducted at Beijing Obstetrics and Gynecology Hospital from February 2018 to December 2020, recruiting participants in their first trimester of pregnancy. Baseline SII and SIRI values were derived from routine clinical blood results, calculated as follows: SII = neutrophil (Neut) count × platelet (PLT) count/lymphocyte (Lymph) count, SIRI = Neut count × monocyte (Mono) count/Lymph count, with participants being grouped by quartiles of their SII or SIRI values. Participants were followed up for GDM with a 75-g, 2-h oral glucose tolerance test (OGTT) at 24-28 weeks of gestation using the glucose thresholds of the International Association of Diabetes and Pregnancy Study Groups (IADPSG). Logistic regression was used to analyze the odds ratios (ORs) (95% confidence intervals [CIs]) for the the associations between SII, SIRI, and the risk of GDM. RESULTS: Among the 28,124 women included in the study, the average age was 31.8 ± 3.8 years, and 15.76% (4432/28,124) developed GDM. Higher SII and SIRI quartiles were correlated with increased GDM rates, with rates ranging from 12.26% (862/7031) in the lowest quartile to 20.10% (1413/7031) in the highest quartile for the SII ( Ptrend <0.001) and 11.92-19.31% for the SIRI ( Ptrend <0.001). The ORs (95% CIs) of the second, third, and fourth SII quartiles were 1.09 (0.98-1.21), 1.21 (1.09-1.34), and 1.39 (1.26-1.54), respectively. The SIRI findings paralleled the SII outcomes. For the second through fourth quartiles, the ORs (95% CIs) were 1.24 (1.12-1.38), 1.41 (1.27-1.57), and 1.64 (1.48-1.82), respectively. These associations were maintained in subgroup and sensitivity analyses. CONCLUSION The SII and SIRI are potential independent risk factors contributing to the onset of GDM.
Humans ; Female ; Pregnancy ; Diabetes, Gestational/immunology* ; Prospective Studies ; Adult ; Inflammation/immunology* ; Glucose Tolerance Test ; Birth Cohort

Randomized controlled trial(RCT) is considered to represent the gold standard for evaluating the efficacy of interventions and has been widely used to evaluate the clinical efficacy of traditional Chinese medicine(TCM). However, there are unique challenges in implementing RCT in TCM. Patients seeking TCM treatment often have preferences for TCM due to the unsatisfactory therapeutic effect of western medicine, their personal intolerance, and their rejection of certain drugs, medical devices, or surgery. Patients are generally reluctant to be randomly assigned to a group, making it challenging to enroll patients in the control group of western medicine during the implementation of RCT in TCM. This has become a prominent problem restricting the implementation of RCT in TCM and needs to be solved urgently. Therefore, this paper introduced commonly used research designs used in solving the problem of enrolling patients in control group during the implementation of RCT in TCM, including Zelen design, partially randomized patient preference trial(PRPP), single-arm objective performance criteria(OPC), cohort studies, single-arm clinical trials using real world data(RWD) alone as the external control group, and the design method based on RWD-augmented control group samples in RCT. The paper outlined the definitions and principles of these methods, evaluated their advantages, disadvantages, and applicable scenarios, and explored their applications in the TCM field, so as to offer insights for solving the difficulty in enrolling patients in the control group during the implementation of RCT in TCM.
Humans ; Medicine, Chinese Traditional/methods* ; Randomized Controlled Trials as Topic/methods* ; Research Design ; Patient Selection ; Drugs, Chinese Herbal/therapeutic use* ; Control Groups

Guided by the concept of quality by design(QbD), this study optimizes the calcination and quenching process of calcined Magnetitum and establishes the XRD characteristic spectra of calcined Magnetitum, providing a scientific basis for the formulation of quality standards. Based on the processing methods and quality requirements of Magnetitum in the Chinese Pharmacopoeia, the critical process parameters(CPPs) identified were calcination temperature, calcination time, particle size, laying thickness, and the number of vinegar quenching cycles. The critical quality attributes(CQAs) included Fe mass fraction, Fe~(2+) dissolution, and surface color. The weight coefficients were determined by combining Analytic Hierarchy Process(AHP) and the criteria importance though intercrieria correlation(CRITIC) method, and the calcination process was optimized using orthogonal experimentation. Surface color was selected as a CQA, and based on the principle of color value, the surface color of calcined Magnetitum was objectively quantified. The vinegar quenching process was then optimized to determine the best processing conditions. X-ray diffraction(XRD) was used to establish the characteristic spectra of calcined Magnetitum, and methods such as similarity evaluation, cluster analysis, and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to evaluate the quality of the spectra. The optimized calcined Magnetitum preparation process was found to be calcination at 750 ℃ for 1 h, with a laying thickness of 4 cm, a particle size of 0.4-0.8 cm, and one vinegar quenching cycle(Magnetitum-vinegar ratio 10∶3), which was stable and feasible. The XRD characteristic spectra analysis method, featuring 9 common peaks as fingerprint information, was established. The average correlation coefficient ranged from 0.839 5-0.988 1, and the average angle cosine ranged from 0.914 4 to 0.995 6, indicating good similarity. Cluster analysis results showed that Magnetitum and calcined Magnetitum could be grouped together, with similar compositions. OPLS-DA discriminant analysis identified three key characteristic peaks, with Fe_2O_3 being the distinguishing component between the two. The final optimized processing method is stable and feasible, and the XRD characteristic spectra of calcined Magnetitum was initially established, providing a reference for subsequent quality control and the formulation of quality standards for calcined Magnetitum.
X-Ray Diffraction/methods* ; Drugs, Chinese Herbal/chemistry* ; Quality Control ; Particle Size