1.Integrated evidence chain (Eff-iEC) based effectiveness evaluation of a multifunctional traditional Chinese medicine formula: Taking Xiaoyao San as an example
Caiping HE ; Ye LUO ; Zhiqi LI ; Haocheng YANG ; Lu LIU ; Yingjie XU ; Xiaoyan CHEN ; Siqi HUANG ; Jincai WEN ; Xiaoyan ZHAN ; Zhaofang BAI ; Xu ZHAO ; Xiaohe XIAO
Science of Traditional Chinese Medicine 2026;4(1):96-103
The study focuses on the concept of multifunctional traditional Chinese medicine (TCM) formulas and aims to evaluate the efficacy of the classical formula Xiaoyao San (逍遥散). Study employs the integrated evidence chain (Eff-iEC) method to organize, integrate, and evaluate its therapeutic efficacy in treating different diseases with the same therapy, and to investigate the feasibility of using Eff-iEC to evaluate the multifunctionality of TCM formulas. The evaluation covered Xiaoyao San's therapeutic effects on depression, premenstrual syndrome, chronic hepatitis, irritable bowel syndrome, dyspepsia, and menopausal syndrome. Concurrently, the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system was used for evaluation, and authoritative medical documents were incorporated to corroborate the recognition of Xiaoyao San within the medical community. Depression and menopausal syndrome received higher ratings than other conditions in the Eff-iEC, GRADE, and Medical Community Recognition assessments. The Eff-iEC evidence grade for Xiaoyao San was rated as "High" or above for chronic hepatitis, irritable bowel syndrome, dyspepsia, and menopausal syndrome. Premenstrual syndrome received a "Moderate +" rating. The GRADE evidence level was "Low-〇〇⨁⨁" for depression, premenstrual syndrome, and chronic hepatitis; "Moderate-〇⨁⨁⨁" for dyspepsia and menopausal syndrome; and "Very Low-〇〇〇⨁" for irritable bowel syndrome. Depression and menopausal syndrome had the highest inclusion frequency, appearing in all 4 categories. Premenstrual syndrome, chronic hepatitis, and dyspepsia are not recommended in Western medical guidelines, but they are included in TCM guidelines, the China National Basic Medical Insurance Drug List, and the China National Essential Drug List. Irritable bowel syndrome appears only in the China National Basic Medical Insurance Drug List and China National Essential Drug List. The evaluation results obtained using the Eff-iEC method align with Medical Community Recognition, providing an objective and comprehensive assessment of Xiaoyao San's efficacy. The findings suggest that Xiaoyao San has strong evidence for treating depression and menopausal syndrome. However, further experimental and clinical trials are needed to assess its efficacy in treating premenstrual syndrome, chronic hepatitis, irritable bowel syndrome, and dyspepsia. These results support the clinical efficacy and rational use of Xiaoyao San, expand the application scope of the Eff-iEC method, and offer valuable insights and methodological references for the comparative evaluation of multifunctional TCM formulas.
3.Association of baseline cerebral blood flow and cerebral metabolic rate of oxygen with sleep structure disorder after thrombolytic therapy in stroke patients and their value in clinical assessment
Journal of Apoplexy and Nervous Diseases 2026;43(4):332-337
Objective To investigate the association of baseline cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRO2) with sleep structure disorder after thrombolytic therapy in stroke patients, as well as their value in clinical assessment. Methods A total of 145 patients with stroke were enrolled as subjects, and all of them received thrombolytic therapy in our hospital from January 2023 to June 2025. Before thrombolytic therapy, 3.0 T magnetic resonance imaging was used to obtain relative CBF (rCBF) and relative CMRO2 (rCMRO2), and rCBF/rCMRO2 ratio was calculated. At week 1 after thrombolysis, overnight polysomnography (PSG) was conducted to obtain parameters such as total sleep time, sleep efficiency, the proportion of each NREM stage, and REM sleep duration. According to the presence or absence of sleep structure disorder, the subjects were divided into disorder group and non-disorder group. The Pearson correlation method was used for correlation analysis. A multivariate logistic regression analysis was used to identify the influencing factors for sleep structure disorder in subjects after thrombolytic therapy. The receiver operating characteristic (ROC) curve was plotted to analyze the performance of rCBF/rCMRO2 ratio in predicting sleep structure disorder in subjects after thrombolytic therapy. Results Compared with the non-disorder group, the disorder group had significantly higher age, infarct volume, NIHSS score on admission, and proportion of patients with infarction in the thalamus (P<0.05). Compared with the non-disorder group, the disorder group had significantly lower rCBF, rCMRO2, rCBF/rCMRO2 ratio, total sleep time, proportion of NREM 3 sleep, proportion of REM sleep, and sleep efficiency (P<0.05) and significantly higher proportion of NREM 1 sleep and sleep arousal index (P<0.05). The Pearson correlation analysis showed that rCBF, rCMRO2, and rCBF/rCMRO2 ratio were positively correlated with total sleep time, proportion of NREM 3 sleep, proportion of REM sleep, and sleep efficiency (P<0.001) and were negatively correlated with the proportion of NREM 1 sleep and sleep arousal index (P<0.001). The Logistic regression analysis showed that age, infarct volume, infarction location (thalamus), and NIHSS score on admission were risk factors for sleep structure disorder in stroke patients after thrombolytic therapy (P<0.05), while rCBF, rCMRO2, and rCBF/rCMRO2 ratio were protective factors against sleep structure disorder (P<0.05). The ROC curve analysis showed that rCBF/rCMRO2 ratio had an area under the ROC curve of 0.901 (95% CI 0.869-0.938) in predicting sleep structure disorder in stroke patients after thrombolytic therapy, with a sensitivity of 95.50% and a specificity of 82.40%. Conclusion Baseline rCBF, rCMRO2, and rCBF/rCMRO2 ratio are closely associated with sleep structure disorder in stroke patients after thrombolytic therapy, among which rCBF/rCMRO2 ratio has excellent performance in predicting sleep structure disorder and can be used as a sensitive indicator for clinical assessment of high-risk patients.
Stroke
4.Preparation of Trop2-ECD_HPF fusion nanoparticles and their immunotherapeutic effects against triple-negative breast cancer
HU Meilin1 ; PENG Haojie2 ; QIU Guochang2 ; MA Xiancai2 ; CHEN Xinxin1
Chinese Journal of Cancer Biotherapy 2026;33(5):494-499
[摘 要] 目的:旨在构建Trop2-ECD与幽门螺杆菌铁蛋白(HPF)融合纳米颗粒疫苗,并评价其免疫原性与抗三阴性乳腺癌(TNBC)活性。方法:构建Trop2-ECD_HPF纳米颗粒疫苗,并在293F细胞中表达和纯化。通过尺寸排阻色谱和透射电子显微镜验证疫苗的纯度和均一性。使用铝佐剂配制疫苗对雌性BALB/c小鼠进行免疫,通过酶联免疫吸附法(ELISA)检测血清中Trop2特异性抗体滴度,并评估其对4T1-Trop2肿瘤模型的抑制效果。结果:Trop2-ECD_HPF纳米颗粒粒径约20 nm,颗粒形成率较高,纯度较高,能够显著诱导小鼠产生高滴度的Trop2特异性抗体,疫苗组第6周抗体滴度达106,显著高于佐剂组(P < 0.000 1)。在动物实验中,疫苗组小鼠的肿瘤体积显著减小(抑瘤率为38.6%),肿瘤增长速度显著减缓(P < 0.001),显示出较强的抗肿瘤效果。结论:Trop2-ECD_HPF融合纳米颗粒疫苗可有效诱导特异性体液免疫应答,显著抑制TNBC生长,为靶向Trop2的纳米疫苗开发提供了实验依据。
5.Current Status and Reflections on Key Technologies and Methods for Clinical Research Design and Evaluation of Traditional Chinese Medicine in Spleen and Stomach Diseases
Fang LU ; Ping WANG ; Liqun BIAN ; Lin LYU ; Mengli XIAO ; Tai ZHANG ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(5):498-503
Clinical trials represent a pivotal stage in the development of pharmaceutical drugs. Nevertheless, given the unique characteristics of traditional Chinese medicine (TCM) and the diagnostic and treatment principle of syndrome differentiation and treatment in TCM, the clinical evaluation techniques and methods that can comprehensively reflect the characteristics of TCM and are tailored to its specificities are still in need of refinement and innovation. This paper systematically summarizes the key techniques and methods for designing and evaluating the clinical research on the treatment of the spleen and stomach diseases with TCM from three aspects including clinical research design, evaluation, and platform construction, compares domestic and international research landscapes, and proposes for future directions. It is suggested that a multidimensional evaluation system integrating modern medicine and TCM theory should be established, and further innovation is needed in TCM research design and methodologies, leveraging intelligent devices and technologies powered by next-generation information technology to transform clinical data into high-quality TCM evidence. Moreover, standardized and shared platforms for TCM clinical data should be accelerated, so as to provide references for the design, implementation, and evaluation of future clinical research on the treatment of the spleen and stomach diseases with TCM.
6.Application Value of Scales for Symptom & Syndrome Evaluation in Spleen-Stomach Diseases Related New Drug Research and Development
Fengbin LIU ; Simeng YAO ; Ping WANG ; Liqun BIAN ; Zhengkun HOU ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(5):504-509
Symptom and syndrome efficacy evaluation scales are indispensable tools for clinical efficacy assessment in traditional Chinese medicine (TCM), and hold significant value at all stages of new drug research development for spleen and stomach diseases. These scales can provide scientific basis for clinical positioning, efficacy evaluation, and expansion of indications of new drugs. By analyzing the current hotspots and difficulties in research, this study aims to explore the important significance of these scales in the development of new drugs for spleen and stomach diseases, summarize the domestic research progress, and conduct comparative analyses with international studies. Future development trends are also discussed in order to promote the application of symptom and syndrome efficacy evaluation scales in the development of new drugs for spleen and stomach diseases and to advance the moder-nization process of TCM.
7.Clinical Efficacy of Janus Kinase Inhibitors in Combination with Chinese Herbal Medicine for Rheumatoid Arthritis:A Retrospective Study and A Meta-analysis
Chenguang ZHAN ; Shengqin YANG ; Xin LI ; Yu WEN ; Peng ZHANG ; Xingrui YAN ; Haifang DU ; Maojie WANG ; Xiaodong WU ; Liyan MEI ; Xiumin CHEN ; Yanlin LI ; Runyue HUANG
Journal of Traditional Chinese Medicine 2026;67(5):534-543
ObjectiveTo evaluate the efficacy and safety of Janus kinase (JAK) inhibitors combined with Chinese herbal medicine (CHM) in treating rheumatoid arthritis (RA). MethodsClinical data from 169 RA patients were retrospectively collected. Among them, 71 cases received JAK inhibitors as the control group, while 98 cases received JAK inhibitors plus CHM as the observation group, both treated for 24 weeks. The rheumatoid factor (RF), cyclic citic peptide antibody (anti-CCP), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and white blood cell count (WBC) were recorded before and after treatment. Databases including CNKI, Wanfang, VIP, PubMed and Web of Science were searched from inception till August 31st, 2025 for randomized controlled trials (RCTs) on the combined use of JAK inhibitors and CHM for RA. The methodological quality of the included studies was evaluated using the risk of bias assessment tool. Meta-analyses were performed for RF, anti-CCP, ESR, CRP, 28-joint disease activity score (DAS28), overall clinical effective rate, and incidence of adverse events. Sensitivity analysis were also performed. ResultsThe retrospective study demonstrated that after treatment, ESR, CRP, and anti-CCP levels decreased in the observation group, while ESR and CRP levels decreased in the control group (P<0.05). Moreover, ESR and RF levels in the observation group were lower than those in the control group (P<0.05). A total of 9 RCTs involving 770 patients were included in the meta-analysis. The results indicated that the JAK inhibitors plus CHM group was superior to the JAK inhibitors group in reducing RF (MD=-8.97, 95%CI -15.01 to -2.94, P=0.004), CRP (MD=-3.34, 95%CI -3.82 to -2.86, P<0.001), ESR (MD=-5.33, 95%CI -7.98 to -2.69, P<0.001), and DAS28 score (MD=-0.54, 95%CI -0.74 to -0.34, P<0.001), as well as in improving the overall clinical effective rate (OR=4.53, 95%CI 2.55 to 8.03, P<0.001). No statistically significant differences were observed between groups in anti-CCP levels (SMD=-2.08, 95%CI -4.41 to 0.24, P=0.080) or incidence of adverse events (OR=0.93, 95%CI 0.55 to 1.57, P=0.790). ConclusionThe combination of JAK inhibitors and CHM demonstrates remarkable efficacy in treating RA, contributing to improved disease activity and reduced inflammatory markers with a favorable safety profile.
8.Relationship between short video addiction and learning burnout in adolescent patients with depression: the pathways of impulsivity and coping disposition
Yanyun QIN ; Jianghui DONG ; Lichang WU ; Shanshan QI ; Minmin CHEN ; Yanling ZHOU
Sichuan Mental Health 2026;39(2):126-132
BackgroundCurrently, the incidence of depression among teenagers is on the rise, and the related academic problems are becoming increasingly serious. Short video addiction has a negative impact on teenagers' emotional issues and academic achievements. However, few studies have explored the relationship between this addiction and the learning burnout of teenagers with depression, and even fewer have focused on the role paths of impulsivity and coping disposition in this process. ObjectiveTo explore the relationship between short video addiction and learning burnout in adolescent patients with depression, as well as the pathway of impulsivity and coping disposition, so as to provide references for the intervention of learning burnout in adolescent patients with depression. MethodsA total of 191 adolescent patients who were hospitalized at The Affiliated Brain Hospital of Guangzhou Medical University from December 2024 to April 2025 and met the diagnostic criteria for depression according to the International Classification of Diseases, tenth edition (ICD-10) were selected consecutively. The Short Video Addiction Measurement Scale (SVAMS), the Brief Barratt Impulsiveness Scale (BBIS), the Simplified Coping Style Questionnaire (SCSQ), and the Adolescent Student Burnout Inventory (ASBI) were used for assessment. Pearson correlation analysis was employed to examine the correlations of the scores of each scale. Model 6 of the SPSS macro Process 4.2 was employed to analyze the chained mediation pathway of impulsivity and coping disposition between short video addiction and learning burnout. ResultsA total of 173 cases (90.58%) of adolescent patients with depression completed the valid questionnaire survey. Correlation analysis showed that SCSQ coping disposition score was negatively correlated with the SVAMS score, the BBIS score, and the ASBI score (r=-0.282, -0.341, -0.431, P<0.01), the SVAMS score was positively correlated with the BBIS score and the ASBI score (r=0.339, 0.262, P<0.01), and the BBIS score was positively correlated with the ASBI score (r=0.486, P<0.01). The pathway analysis showed that the direct effect of short video addiction on learning burnout was not statistically significant, but the total effect and the indirect effect were statistically significant. The effect values were 0.275 (95% CI: 0.207–0.343) and 0.193 (95% CI: 0.143–0.246), respectively, with the indirect effect accounting for 70.18%. Impulsivity and coping disposition both played independent mediating roles between short video addiction and learning burnout, with effect values of 0.122 (95% CI: 0.090–0.156) and 0.054 (95% CI: 0.032–0.079), accounting for 44.36% and 19.64% of the total effect, respectively. The chained mediation effect of impulsivity and coping disposition was significant, with an effect value of 0.017 (95% CI: 0.011–0.026), accounting for 6.18% of the total effect. ConclusionAlthough short video addiction does not directly affect learning burnout in adolescent patients with depression, it may indirectly influence learning burnout through independent and chain paths of impulsivity and coping disposition. [Funded by Guangzhou Key Clinical Specialty (Clinical Medical Research Institute)]
9.A method for the simultaneous determination of 12 antipsychotic drugs and their main metabolites in human serum
Xi CHEN ; Yanfang XIAO ; Yang DING ; Weitao HONG ; Lijun MAI ; Xuan ZENG
Sichuan Mental Health 2026;39(2):140-148
BackgroundMonitoring the blood concentrations of antipsychotic drugs and their metabolites can guide the adjustment of clinical treatment plans, improving therapeutic efficacy while reducing adverse effects. However, there is currently a lack of a method that can accurately and efficiently quantitatively detect multiple antipsychotic drugs and their metabolites. ObjectiveTo establish a ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for the simultaneous identification and quantitation of 12 antipsychotic drugs and their main metabolites in human serum. MethodsUsing UPLC-MS/MS technology, protein precipitation method was employed for sample pretreatment. An Agela Technologies Durashell C8 chromatographic column (50 mm×3.0 mm, 5 μm) was selected for chromatographic separation with gradient elution. The flow rate was 0.4 mL/min, and the total analysis time was 5 minutes. The column temperature was 40℃. The mass spectrometry detection was carried out in the multiple reaction monitoring (MRM) mode, and the isotope internal standard method was used for quantification. ResultsThe relative standard deviation (RSD) of the internal standard normalization matrix effect factor for 12 antipsychotic drugs and their main metabolites at low and high quality concentrations was all less than 15%. The extraction recovery rate was 85% to 115%. They showed good linear relationships within their respective standard curve ranges (r>0.995). At low, medium, and high quality concentrations, the accuracy was 85.24% to 114.71%, and the RSD of intra-batch and inter-batch precision was all ≤14.15%, with good stability. ConclusionAll the analytical performance indicators of this method meet the verification requirements, providing an analytical means for the quantitative detection of antipsychotic drugs and their main metabolites in human serum. [Funded by The Third Batch of Science and Technology Projects in Chaozhou City in 2023 (number, 202303GY02)]
10.Advances in genomics of SGLT2 and clinical application of SGLT2 inhibitors
Xiaoxia DENG ; Jing TIAN ; Jianfen SU
Journal of Pharmaceutical Practice and Service 2026;44(5):228-232
Sodium-glucose cotransporter 2 (SGLT2) is involved in most glucose reabsorption in the kidney. Inhibition of SGLT2 leads to the excretion of glucose through urine and represents an important concept in the treatment of type 2 diabetes. With the development of pharmacogenomics, it was found that SGLT2 gene polymorphism had certain effects on fasting blood glucose, glycosylated hemoglobin and insulin levels, and may affect the risk of type 2 diabetes and response to treatment with SGLT2 inhibitors, which is of great significance in the treatment of T2DM. Domestic and international studies on SGLT2 gene polymorphism were reviewed and effects of SGLT2 inhibitor (SGLT2i) in the treatment of T2DM were discussed in this paper.


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