1.Regulatory Pathways of Cell Apoptosis in Diabetic Kidney Disease and Intervention by Traditional Chinese Medicine: A Review
Yunjie YANG ; Mingqian JIANG ; Chen QIU ; Yaqing RUAN ; Senlin CHEN ; Wenxin HUANG ; Hangbin ZHENG ; Yi WEI ; Pengfei LI ; Xueqin LIN ; Jing WU ; Shiwei RUAN ; Jianting WANG ; Yuliang QIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):294-306
Diabetic kidney disease(DKD) is a chronic kidney structural and functional disorder caused by diabetes. With the global prevalence of diabetes continuing to rise, DKD has gradually become a major cause of chronic kidney disease and end-stage renal disease(ESRD), posing a serious threat to patients' quality of life and long-term health outcomes. Studies have shown that apoptosis plays a pivotal role in the development and progression of DKD, with its mechanisms involving abnormal activation of multiple signaling pathways such as Toll-like receptor 4(TLR4)/nuclear transcription factor-κB(NF-κB)/B-cell lymphoma-2(Bcl-2)/cysteinyl aspartate-specific proteinase(Caspase)-3, protein kinase R-like endoplasmic reticulum kinase(PERK)/eukaryotic initiation factor 2α(eIF2α)/activating transcript factor 4(ATF4)/CCAAT enhancer-binding protein homologous protein(CHOP), phosphatidylinositol 3-kinase(PI3K)/protein kinase B(Akt)/glycogen synthase kinase-3β(GSK-3β), Janus kinase 2(JAK2)/signal transducer and activator of transcription 3(STAT3), adenosine monophosphate-activated protein kinase(AMPK)/mammalian target of rapamycin(mTOR) and silent information regulator 1(SIRT1)/tumor suppressor protein 53(p53), thereby accelerating renal pathological damage in DKD. Extensive evidence-based medical studies have confirmed that traditional Chinese medicine(TCM), leveraging its unique therapeutic advantages of multi-target, multi-component and multi-pathway approaches, has demonstrated remarkable efficacy and favorable safety profiles in treating DKD. Recent studies have demonstrated that active components of TCM can specifically target and modulate key effectors in apoptotic signaling pathways. Meanwhile, traditional compound formulations exert synergistic effects through multiple approaches such as replenishing deficiency and activating blood circulation, detoxifying and dredging collaterals, tonifying kidney essence, and removing stasis and purging turbidity, thereby comprehensively regulating critical pathological processes including endoplasmic reticulum stress and mitochondrial apoptosis pathways. This combined therapeutic approach of molecular targeting and holistic regulation provides novel strategies for delaying the progression of DKD. Based on this, this paper provides an in-depth analysis of key apoptotic signaling pathways and their regulatory mechanisms, while systematically summarizing recent research advances regarding the therapeutic effects of TCM active components, compound formulations, and proprietary Chinese medicines on DKD through modulation of these pathways, with particular emphasis on their underlying molecular mechanisms. These findings not only elucidate the modern scientific connotation and theoretical basis of TCM in treating DKD but also establish a solid theoretical and practical foundation for promoting the wider clinical application and further research of TCM in the field of DKD treatment.
2.Association between sunshine duration and hospitalization risk for mental and behavioral disorders in Zigong City, Sichuan Province
Xianyan JIANG ; Fengyuan TIAN ; Yang LI ; Shijuan RUAN ; Yue WEN ; Chunli SHI
Journal of Environmental and Occupational Medicine 2026;43(4):485-492
Background Sunshine duration is closely associated with population mental health and emotional states, although its relationship with mental and behavioral disorders (MBD) remains insufficiently studied. Objective To analyze the effect of sunshine duration on hospital admissions for MBD in Zigong City, Sichuan Province. Methods Hospital admission records for MBD from 10 medical institutions, meteorological data, and ambient air pollutant concentrations were collected in Zigong City from January 1, 2019 to December 31, 2024. A distributed lag non-linear model (DLNM) was employed to calculate single-day and cumulative lag effects of different sunshine duration exposures—0 h (P0, P5, P25), 6 h (P75), and 10.4 h (P95)—on hospitalization risks for MBD, stratified by diagnostic category, sex, and age groups. Results This study analyzed
3.Mechanisms of Salvianolic Acid B in Inhibiting Epithelial-mesenchymal Transition in Non-small Cell Lung Cancer by Downregulating PAICS Expression
Bo XU ; Jixian ZHANG ; Linling HU ; Bo JIANG ; Shasha YUAN ; Yiling FAN ; Zhishen RUAN ; Yihan YU ; Qing MIAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):23-33
ObjectiveTo investigate the molecular mechanisms by which salvianolic acid B (SalB) inhibits epithelial-mesenchymal transition (EMT) in non-small cell lung cancer (NSCLC) by downregulating phosphoribosylaminoimidazole carboxylase and phosphoribosylaminoimidazole succinocarboxamide synthetase (PAICS) expression. MethodsNSCLC A549 cells and normal bronchial epithelial cells (bronchial epithelium transformed with Ad12-SV40 2B, BEAS-2B) were used as models. Cell viability was assessed using the cell counting kit-8 (CCK-8) assay after treatment with SalB (0, 50, 100, 200, 300, 400, 500 μmol·L-1 for 24 or 48 h to determine effective and safe intervention concentrations. Cell proliferation, cell cycle distribution, and apoptosis were evaluated by 5-ethynyl-2′-deoxyuridine (EdU) staining and flow cytometry, respectively. Wound healing and Transwell invasion assays were performed to assess cell migration and invasion. RNA sequencing combined with bioinformatic analysis was conducted to identify differentially expressed genes and functional enrichment. Molecular docking was used to predict the binding ability between SalB and PAICS, and the cellular thermal shift assay (CETSA) was performed to evaluate the effect of SalB on the thermal stability of the PAICS protein. Western blot (WB) was used to detect the effects of SalB on PAICS and EMT-related proteins (E-cadherin, N-cadherin, Vimentin, Snail, and Slug). A functional rescue assay was conducted by PAICS overexpression via plasmid transfection. ResultsCompared with the control group, SalB inhibited A549 cell viability in a dose-dependent manner (P<0.05), and the effective concentrations (≤300 μmol·L-1) showed no significant cytotoxicity in BEAS-2B cells. Within this concentration range, SalB significantly inhibited A549 cell proliferation, migration, and invasion, and induced G0/G1 phase arrest and apoptosis (P<0.05). Transcriptomic analysis showed that SalB significantly downregulated PAICS expression, and its functions were enriched in cell proliferation and EMT. Bioinformatic analysis indicated that PAICS is highly expressed in lung adenocarcinoma and is associated with poor prognosis (P<0.01). Molecular docking showed that SalB has strong binding ability to PAICS (binding energy -9.1 kcal·mol-1. CETSA results showed that SalB significantly increased the thermal stability of the PAICS protein (P<0.05). WB results showed that, compared with the control group, SalB dose-dependently downregulated PAICS expression, upregulated E-cadherin, and downregulated N-cadherin, Vimentin, Snail, and Slug (P<0.05). Functional rescue experiments showed that, compared with the empty vector group, PAICS overexpression significantly enhanced A549 cell proliferation, migration, and invasion, promoted cell cycle progression, and inhibited apoptosis (P<0.05). Meanwhile, compared with the empty vector + SalB-H group, PAICS overexpression partially reversed the inhibitory effects of SalB on malignant phenotypes and EMT-related proteins (N-cadherin, Vimentin, Snail, and Slug), and downregulated E-cadherin expression (P<0.05,P<0.01), indicating that PAICS is a key functional target mediating the antitumor effects of SalB. ConclusionSalB effectively inhibits EMT progression and cell cycle progression in A549 cells by downregulating PAICS expression, thereby exerting anti-NSCLC effects. This study not only reveals that PAICS is a key functional target through which SalB regulates EMT, but also provides experimental evidence supporting SalB as a potential candidate drug for inhibiting NSCLC metastasis.
4.Mechanisms of Salvianolic Acid B in Inhibiting Epithelial-mesenchymal Transition in Non-small Cell Lung Cancer by Downregulating PAICS Expression
Bo XU ; Jixian ZHANG ; Linling HU ; Bo JIANG ; Shasha YUAN ; Yiling FAN ; Zhishen RUAN ; Yihan YU ; Qing MIAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(10):23-33
ObjectiveTo investigate the molecular mechanisms by which salvianolic acid B (SalB) inhibits epithelial-mesenchymal transition (EMT) in non-small cell lung cancer (NSCLC) by downregulating phosphoribosylaminoimidazole carboxylase and phosphoribosylaminoimidazole succinocarboxamide synthetase (PAICS) expression. MethodsNSCLC A549 cells and normal bronchial epithelial cells (bronchial epithelium transformed with Ad12-SV40 2B, BEAS-2B) were used as models. Cell viability was assessed using the cell counting kit-8 (CCK-8) assay after treatment with SalB (0, 50, 100, 200, 300, 400, 500 μmol·L-1 for 24 or 48 h to determine effective and safe intervention concentrations. Cell proliferation, cell cycle distribution, and apoptosis were evaluated by 5-ethynyl-2′-deoxyuridine (EdU) staining and flow cytometry, respectively. Wound healing and Transwell invasion assays were performed to assess cell migration and invasion. RNA sequencing combined with bioinformatic analysis was conducted to identify differentially expressed genes and functional enrichment. Molecular docking was used to predict the binding ability between SalB and PAICS, and the cellular thermal shift assay (CETSA) was performed to evaluate the effect of SalB on the thermal stability of the PAICS protein. Western blot (WB) was used to detect the effects of SalB on PAICS and EMT-related proteins (E-cadherin, N-cadherin, Vimentin, Snail, and Slug). A functional rescue assay was conducted by PAICS overexpression via plasmid transfection. ResultsCompared with the control group, SalB inhibited A549 cell viability in a dose-dependent manner (P<0.05), and the effective concentrations (≤300 μmol·L-1) showed no significant cytotoxicity in BEAS-2B cells. Within this concentration range, SalB significantly inhibited A549 cell proliferation, migration, and invasion, and induced G0/G1 phase arrest and apoptosis (P<0.05). Transcriptomic analysis showed that SalB significantly downregulated PAICS expression, and its functions were enriched in cell proliferation and EMT. Bioinformatic analysis indicated that PAICS is highly expressed in lung adenocarcinoma and is associated with poor prognosis (P<0.01). Molecular docking showed that SalB has strong binding ability to PAICS (binding energy -9.1 kcal·mol-1. CETSA results showed that SalB significantly increased the thermal stability of the PAICS protein (P<0.05). WB results showed that, compared with the control group, SalB dose-dependently downregulated PAICS expression, upregulated E-cadherin, and downregulated N-cadherin, Vimentin, Snail, and Slug (P<0.05). Functional rescue experiments showed that, compared with the empty vector group, PAICS overexpression significantly enhanced A549 cell proliferation, migration, and invasion, promoted cell cycle progression, and inhibited apoptosis (P<0.05). Meanwhile, compared with the empty vector + SalB-H group, PAICS overexpression partially reversed the inhibitory effects of SalB on malignant phenotypes and EMT-related proteins (N-cadherin, Vimentin, Snail, and Slug), and downregulated E-cadherin expression (P<0.05,P<0.01), indicating that PAICS is a key functional target mediating the antitumor effects of SalB. ConclusionSalB effectively inhibits EMT progression and cell cycle progression in A549 cells by downregulating PAICS expression, thereby exerting anti-NSCLC effects. This study not only reveals that PAICS is a key functional target through which SalB regulates EMT, but also provides experimental evidence supporting SalB as a potential candidate drug for inhibiting NSCLC metastasis.
5.Research priorities on physical and mental comorbidity among children and adolescents in Zhejiang Province
Chinese Journal of School Health 2026;47(4):498-501
Objective:
To identify research priorities on physical and mental comorbidity among children and adolescents in Zhejiang Province, so as to provide a theoretical base for improving their physical and mental health.
Methods:
In May 2025, 77 experts in the fields of health and education from 11 cities in Zhejiang Province were selected by convenient sampling method to participate in the first round of expert consultation. In June, 2025, snowball sampling was used to expand to 194 experts for the second round of consultation, and it was convenient to select 21 students from primary schools to high schools in Zhejiang Province and 29 parents to empower the evaluation criteria. It applied the Child Health and Nutrition Research Initiative (CHNRI) method in a structured process, which encompassed the definition of the research field, generation of research ideas, scoring, and quantitative ranking of priorities. Research ideas were evaluated against 6 predefined criteria: effectiveness, safety, answerability, feasibility, sustainability, and scientific significance.
Results:
After 2 rounds of structured consultations, 81 research ideas on physical and mental comorbidity among children and adolescents were established and classified into 7 subthemes: epidemiological characteristics and influencing factors, optimization of primary service systems and policies, comprehensive intervention strategies for physical and mental comorbidity, biological mechanisms and clinical research, the impact of education and environment on physical and mental health, special populations and social support, and digital and technology driven disease prevention and intervention. The top 10 research priorities primarily centered on the subdomain of "epidemiological characteristics and influencing factors" (5 items). The top 3 research priorities were "the association between outdoor activity duration and the incidence of common diseases (including mental disorders) among children and adolescents" "the impact of outdoor activity duration on the physical and mental health of adolescents" "comprehensive intervention strategies for myopia, obesity, and their comorbidities among children and adolescents".
Conclusion
The framework of priority issues in the field of psychosomatic comorbidity of children and adolescents in Zhejiang Province based on CHNRI method provides a reference for optimizing the allocation of provincial research resources.
6.Mechanism of Yishen Jiangtang Decoction in regulating endoplasmic reticulum stress-mediated NLRP3 inflammasome to improve renal damage in diabetic nephropathy db/db mice.
Yun-Jie YANG ; Bin-Hua YE ; Chen QIU ; Han-Qing WU ; Bo-Wei HUANG ; Tong WANG ; Shi-Wei RUAN ; Fang GUO ; Jian-Ting WANG ; Ming-Qian JIANG
China Journal of Chinese Materia Medica 2025;50(10):2740-2749
This study aims to explore the mechanism through which Yishen Jiangtang Decoction(YSJTD) regulates endoplasmic reticulum stress(ERS)-mediated NOD-like receptor thermal protein domain associated protein 3(NLRP3) inflammasome to improve diabetic nephropathy(DN) in db/db mice. Thirty db/db mice were randomly divided into the model group, YSJTD group, ERS inhibitor 4-phenylbutyric acid(4-PBA) group, with 10 mice in each group. Additionally, 10 db/m mice were selected as the control group. The YSJTD group was orally administered YSJTD at a dose of 0.01 mL·g~(-1), the 4-PBA group was orally administered 4-PBA at a dose of 0.5 mg·g~(-1), and the control and model groups were given an equal volume of carboxylmethyl cellulose sodium. The treatments were administered once daily for 8 weeks. Food intake, water consumption, and body weight were recorded every 2 weeks. After the intervention, fasting blood glucose(FBG), glycosylated hemoglobin(HbA1c), urine microalbumin(U-mALB), 24-hour urine volume, serum creatinine(Scr), and blood urea nitrogen(BUN) were measured. Inflammatory markers interleukin-1β(IL-1β) and interleukin-18(IL-18) were detected using the enzyme-linked immunosorbent assay(ELISA). Renal pathology was assessed through hematoxylin-eosin(HE), periodic acid-Schiff(PAS), and Masson staining, and transmission electron microscopy(TEM). Western blot was used to detect the expression levels of glucose-regulated protein 78(GRP78), C/EBP homologous protein(CHOP), NLRP3, apoptosis-associated speck-like protein containing CARD(ASC), cysteinyl aspartate-specific proteinase(caspase-1), and gasdermin D(GSDMD) in kidney tissues. The results showed that compared to the control group, the model group exhibited poor general condition, increased weight and food and water intake, and significantly higher levels of FBG, HbA1c, U-mALB, kidney index, 24-hour urine volume, IL-1β, and IL-18. Compared to the model group, the YSJTD and 4-PBA groups showed improved general condition, increased body weight, decreased food intake, and lower levels of FBG, U-mALB, kidney index, 24-hour urine volume, and IL-1β. Specifically, the YSJTD group showed a significant reduction in IL-18 levels compared to the model group, while the 4-PBA group exhibited decreased water intake and HbA1c levels compared to the model group. Although there was a decreasing trend in water intake and HbA1c in the YSJTD group, the differences were not statistically significant. No significant differences were observed in BUN, Scr, and kidney weight among the groups. Renal pathology revealed that the model group exhibited more severe renal damage compared to the control group. Kidney sections from the model group showed diffuse mesangial proliferation in the glomeruli, tubular edema, tubular dilation, significant inflammatory cell infiltration in the interstitium, and increased glycogen staining and blue collagen deposition in the basement membrane. In contrast, the YSJTD and 4-PBA groups showed varying degrees of improvement in renal damage, glycogen staining, and collagen deposition, with the YSJTD group showing more significant improvements. TEM analysis indicated that the model group had extensive cytoplasmic edema, homogeneous thickening of the basement membrane, fewer foot processes, and widening of fused foot processes. In the YSJTD and 4-PBA groups, cytoplasmic swelling of renal tissues was reduced, the basement membrane remained intact and uniform, and foot process fusion improved.Western blot results indicated that compared to the control group, the model group showed upregulation of GRP78, CHOP, GSDMD, NLRP3, ASC, and caspase-1 expression. In contrast, both the YSJTD and 4-PBA groups showed downregulation of these markers compared to the model group. These findings suggest that YSJTD exerts a protective effect against DN by alleviating NLRP3 inflammasome activation through the inhibition of ERS, thereby improving the inflammatory response in db/db DN mice.
Animals
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Endoplasmic Reticulum Stress/drug effects*
;
Diabetic Nephropathies/metabolism*
;
NLR Family, Pyrin Domain-Containing 3 Protein/genetics*
;
Drugs, Chinese Herbal/administration & dosage*
;
Mice
;
Inflammasomes/drug effects*
;
Male
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Kidney/pathology*
;
Endoplasmic Reticulum Chaperone BiP
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Humans
;
Interleukin-18/genetics*
;
Mice, Inbred C57BL
7.Application progress on functional insoles in the prevention and treatment of diabetic foot.
Heng-Yu LIU ; Zhen-de JIANG ; Yao-Kuan RUAN ; Qiu-Ju LI ; Si-Yuan CHEN ; Shun-Yu WEI ; Nan MEI ; Chou WU ; Fei CHANG
China Journal of Orthopaedics and Traumatology 2025;38(9):969-975
Diabetic foot (DF) is one of the most serious chronic complications of diabetes. The incidence rate among global diabetes patients is as high as 15% to 25%, and about 50% of patients will develop contralateral foot ulcers within 5 years after the first unilateral ulcer. As a non-invasive prevention and control solution, the application progress of functional insoles is mainly reflected in the following aspects:(1) Material innovation. The application of new composite materials and smart materials has significantly enhanced the pressure reduction effect and comfort. (2) Structural optimization. The development of multi-layer design and local pressure reduction structure has achieved more precise pressure distribution regulation. (3) Manufacturing process. 3D printing and parametric design have enabled the personalized customization of functional insoles. (4) Intelligent monitoring. It integrates functions such as pressure sensing and temperature monitoring, achieving real-time monitoring and early warning of foot conditions. Clinical research has confirmed that personalized functional insoles could reduce the incidence of foot ulcers and shorten the healing time of ulcers. At present, the research hotspots mainly focus on the development of smart materials, the construction of multi-functional integration and remote monitoring systems. However, in-depth research is still needed in the aspects of biomechanical mechanisms, standardized evaluation systems and long-term efficacy assessment. The development of future functional insoles should focus on the coordinated advancement of "personalization-intelligence-standardization", with the aim of providing more effective solutions for the prevention and treatment of DF.
Humans
;
Diabetic Foot/therapy*
;
Foot Orthoses
8.Preliminary efficacy and safety of a dose-intensified C5VD regimen in 24 children with locally advanced hepatoblastoma.
Jia-Xin PENG ; Can HUANG ; An-An ZHANG ; Ya-Li HAN ; Hai-Shan RUAN ; Xiao-Xia WANG ; Min XU ; Yuan XIN ; Li-Ting YU ; Zhi-Bao LYU ; Sha-Yi JIANG ; Yi-Jin GAO
Chinese Journal of Contemporary Pediatrics 2025;27(10):1247-1252
OBJECTIVES:
To assess the preliminary efficacy and safety of a dose-intensified C5VD regimen (cisplatin, 5-fluorouracil, vincristine, and doxorubicin) in children with locally advanced hepatoblastoma.
METHODS:
This prospective study enrolled 24 children with newly diagnosed, locally advanced hepatoblastoma who received the dose-intensified C5VD regimen at Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, and Shanghai Children's Hospital between January 2020 and December 2023. Clinical characteristics, treatment outcomes, and chemotherapy-related toxicities were analyzed.
RESULTS:
Of the 24 patients, 13 were male and 11 were female, with a median age at diagnosis of 18.7 months (range: 3.5-79.4 months). All patients achieved complete macroscopic resection of hepatic lesions without liver transplantation. Serum alpha-fetoprotein levels decreased significantly after two chemotherapy cycles. During a median follow-up of 38.4 months (range: 15.8-50.7 months), all patients maintained continuous complete remission, with 3-year event-free survival and overall survival rates of 100%. Across 144 chemotherapy cycles, the incidence rates of grade 3-4 neutropenia, thrombocytopenia, and infections were 97%, 77%, and 71%, respectively; no treatment-related deaths occurred. Notably, 5 patients (21%) developed Brock grade ≥3 hearing loss, of whom 1 required a hearing aid.
CONCLUSIONS
The dose-intensified C5VD regimen demonstrates significant efficacy with an overall favorable safety profile in the treatment of newly diagnosed, locally advanced pediatric hepatoblastoma. Grade 3-4 myelosuppression and infection are the predominant toxicities. However, high‑dose cisplatin-induced ototoxicity remains a concern, highlighting the need for improved otoprotective strategies.
Humans
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Hepatoblastoma/pathology*
;
Male
;
Female
;
Infant
;
Liver Neoplasms/pathology*
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Child, Preschool
;
Prospective Studies
;
Doxorubicin/adverse effects*
;
Child
;
Cisplatin/adverse effects*
;
Vincristine/adverse effects*
;
Fluorouracil/adverse effects*
9.Diagnostic performance evaluation of artificial intelligence-assisted diagnostic systems in cervical cytopathological examination
Zichen YE ; Yihui YANG ; Lian XU ; Ronggan WEI ; Xiling RUAN ; Peng XUE ; Yu JIANG ; Youlin QIAO
Chinese Journal of Epidemiology 2025;46(3):499-505
Objective:To evaluate the diagnostic performance of artificial intelligence-assisted diagnostic systems in cervical cytopathological examination.Methods:Cervical cytology slide data were retrospectively collected from four hospitals for the external validation of the developed artificial intelligence-assisted diagnostic system. Subsequently, prospective data collection was conducted for human-machine assisted studies.Results:In the retrospective study, a total of 3 162 valid samples were collected as external validation data. The system showed an area under the curve (AUC) of 0.890 (95% CI: 0.878-0.902), accuracy of 0.885 (95% CI: 0.873-0.896), sensitivity of 0.928 (95% CI: 0.914-0.941), and specificity of 0.852 (95% CI: 0.834-0.867). In the prospective study, 212 valid samples were collected, and five junior cytologists participated in the human-machine assisted study. Without artificial intelligence assistance, the average AUC for the five cytologists was 0.686 (95% CI: 0.650-0.722), the accuracy was 0.699 (95% CI: 0.671-0.727), the sensitivity was 0.653 (95% CI: 0.599-0.703), the specificity was 0.719 (95% CI: 0.685-0.750), the Fleiss κ value was 0.510, and the reading time was 223 seconds. With artificial intelligence assistance, the AUC, accuracy, sensitivity, and specificity increased by 0.166, 0.143, 0.225, and 0.107, respectively. Additionally, Fleiss κ was 0.730 and the reading time decreased by 188 seconds. All differences were statistically significant (all P<0.001). Conclusions:Artificial intelligence-assisted diagnosis system shows excellent performance and good generalizability, significantly improving the diagnostic accuracy, consistency, and efficiency of junior cytologists. It can be an effective auxiliary tool for junior cytologists in clinical practice.
10.Comparison of ethinyl-estradiol/drospirenone tablets alone or in combination with orlistat on ovulation recovery rate and metabolic indices in overweight/obese patients with polycystic ovary syndrome
Lingling JIANG ; Xiangyan RUAN ; Yanqiu LI ; Mingzhen ZHANG ; Zecheng WANG ; Jing JIN ; Xuanxuan TIAN ; Anming LIU ; O.Mueck ALFRED
Journal of Capital Medical University 2025;46(4):607-613
Objective To compare ovulation recovery rate and metabolic indicators between ethinyl-estradiol/drospirenone(EE/DRSP)combined with orlistat and EE/DRSP alone in overweight/obese patients with polycystic ovary syndrome(PCOS).Methods This study was a randomized controlled clinical trial conducted based on the 2004 Rotterdam criteria.From October 2020 to December 2023,180 overweight/obese PCOS patients aged 20-40 were recruited from the Department of Department of Gynecological Endocrinology,Beijing Obstetrics and Gynecology Hospital,Capital Medical University.The patients were randomly divided into two groups in a 1∶2 ratio.Among them,60 patients received treatment with EE/DRSP(EE20 μg,DRSP 3 mg),while 120 patients received a combination treatment of EE/DRSP and orlistat(360 mg/d).The height,weight,waist circumference,hip circumference,and blood pressure of the patients were measured before treatment and after 12 weeks of treatment.Laboratory tests included measurements of follicle-stimulating hormone(FSH),luteinizing hormone(LH),fasting insulin(FINS),homeostasis model assessment of insulin resistance(HOMA-IR),free androgen index(FAI),alanine transaminase(ALT),aspartate transaminase(AST),gamma-glutamyl transferase(GGT),fasting plasma glucose(FPG),total cholesterol(TC),triglycerides(TG),high density lipoprotein-cholesterol(HDL-C),low density lipoprotein-cholesterol(LDL-C),lipoprotein(a)[Lp(a)],sex hormone-binding globulin(SHBG),total testosterone(T),and free testosterone(FT).After 12 weeks of treatment,the medication was discontinued,and natural ovulation was observed.Results After 12 weeks of treatment,the ovulation rate of the EE/DRSP combined with orlistat group reached 70.8%,while the natural ovulation rate of the EE/DRSP group alone was only 35%,indicating that the ovulation rate was significantly increased after EE/DRSP combined with orlistat treatment.After 12 weeks of treatment,both groups showed a significant decrease in total testosterone,free testosterone,and low-density lipoprotein levels(all P<0.05),and the decrease in BMI,waist circumference,fasting insulin,and HOMA-IR in the EE/DRSP combined with orlistat group was greater than that in the EE/DRSP group alone(P<0.05).After treatment,both groups showed a significant increase in high-density lipoprotein and triglyceride levels(all P<0.05),with no significant changes in total cholesterol and fasting blood glucose(all P>0.05).Conclusion After 12 weeks of treatment,EE/DRSP combined with orlistat can significantly improve the ovulation rate of PCOS patients.It is superior to EE/DRSP alone in reducing androgen levels,body weight,insulin resistance,and low-density lipoprotein levels.


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