1.A panel study on association of short-term air pollution exposure and peripheral blood microparticles in healthy adults
Bin ZHANG ; Xinghou HE ; Jiahui LIU ; Xuyang SHAN ; Yan FANG ; Huiying XU ; Erlu ZHAO ; Shengcong LIU ; Hongbing XU ; Jianping LI ; Wei HUANG
Journal of Environmental and Occupational Medicine 2026;43(1):1-7
Background Microparticles (MPs) are one of the main medium of inflammatory reaction with an important role in atherosclerotic progression. Studies on association of air pollution exposure and levels of peripheral blood MPs are limited among human. Objective To evaluate the effects of short-term exposure to air pollution on levels of peripheral blood MPs. Method A panel of 73 healthy adults was followed with 4 repeated follow-ups in Beijing, China, from November 2014 to January 2016. During each visit, we collected questionnaire information, fasting venous blood, urine, and exposures to fine particulate matter (PM2.5), black carbon, nitric oxide, nitrogen dioxide, nitrogen oxide, sulfur dioxide, carbon monoxide, and ozone. We used linear mixed-effect models to analyze associations of air pollution exposure with levels of total MPs (TMPs) and MPs derived from various cells. Stratified analysis was conducted by levels of C-reactive protein (CRP) and malondialdehyde (MDA). Results The results showed significant associations between air pollution exposure and peripheral blood TMPs at 2 h-6 d prior to the follow-ups (P<0.05), while no statistical associations were found for MPs derived from different cell types. Significant increases in TMPs of 7.8% (95%CI: 0.7%, 15.3%) and 14.3% (95%CI: 2.8%, 27.2%) were observed with each interquartile range (IQR) increase in PM2.5 (IQR=64.9 μg·m−3) at prior 18 h and NO (IQR=40.5 μg·m−3) at prior 48 h. Among participants with low levels of CRP and MDA, significantly positive associations were observed between air pollution exposure and levels of TMPs (P<0.05). Conclusion Short-term exposure to air pollution is significantly associated with increased levels of circulating MPs in healthy adults, and in people with lower systemic inflammation, peripheral blood MPs levels are more easily affected after exposure to air pollutants.
2.Differences in deltamethrin resistance and kdr gene mutation in Culex tritaeniorhynchus population in and outside the Yellow Sea wetland
Xiao-er ZHANG ; Zhi-ming WU ; Ye TIAN ; Qian CUI ; Yu-qian JI ; Huan WANG ; Shu-juan YANG ; Yi-chao ZHAO ; Yu WANG ; Hua-yu YIN ; Yu DING ; Guo-jin YAN ; Min-sen ZHAO ; Shou-gang ZHANG ; Bing-dong SONG ; Hong-na CHEN ; Jian GAO ; Wei-fang YANG ; Yu-fu ZHANG ; Hui LIU ; Hong-liang CHU
Acta Parasitologica et Medica Entomologica Sinica 2026;33(2):101-107
Objective To gain insights into the biological characteristics of different populations of Culex tritaeniorhynchus within and around the Yellow Sea wetland from the perspective of the occurrence of resistance, we investigated the levels of resistance to deltamethrin and kdr gene mutation in the wetland and its peripheral areas. Methods Specimens were collected from Cx. tritaeniorhynchus populations at two monitoring sites in the Rare Bird National Nature Reserve and Tiaozi Ni Wetland Scenic Area, and also from two populations in Yancheng City and the Liuhe District of Nanjing, and the resistance of these mosquitoes to deltamethrin was determined using the CDC biotest bottle method. For each concentration of deltamethrin assessed, a random subset of exposed specimens was selected for amplification of the kdr gene fragment, followed by Sanger sequencing to identify and analyze resistance-associated mutations. Results The LC50 levels of deltamethrin among mosquitoes from the four populations in Luhe, Yancheng, the Rare Bird National Nature Reserve and the Tiaozi Ni Wetland Scenic Area were 2.048 5, 7.798 2, 3.473 3, and 17.695 5 mg/mL, respectively, with corresponding concentrations of deltamethrin ranging from 0.005 to 5.000,0.050 to 50.000,0.050 to 25.000 and 0.050 to 50.000 mg/mL, respectively. Furthermore, the ranges of the KT50 values were 11.76-107.43, 67.05-216.30,29.77-107.43 and 28.40-329.51 min; the 1-h knockdown rates were 34.58%-99.15%, 9.52%-43.80%, 55.09%-73.01%, and 10.09%-68.07%; and the 24-h mortality rates were 12.15%-67.52%,9.52%-79.56%,13.17%-82.21%, and 11.01%-78.99%, respectively. With respect to kdr gene mutation, we assayed a total of 63,70,59, and 57 mosquitoes for the four populations, for which we detected L1014F mutation frequencies of 14.29%, 35.00%, 20.34%, and 31.58%, respectively, with a majority of these mutations being heterozygous for resistance. In addition, five adult mosquitoes were identified has having synonymous mutations at site 1011[i. e. , AAT(asparagine)mutation to AAC(asparagine)]. Conclusions Our findings revealed the clear resistance of Cx. tritaeniorhynchus to deltamethrin in the Yancheng region of the Yellow Sea wetland, and the resistance phenotype and kdr frequency of Cx. tritaeniorhynchus in the wetland environment were comparable to those of Cx. tritaeniorhynchus in the wetland environment, thereby indicating that the resistance of different populations of Cx. tritaeniorhynchus was homogeneous under the pressure of different insecticide selection within and around the wetland. However, the underlying mechanisms need to be further studied.
3.A panel study on effects of short-term exposure to ambient particulate matter and nitrogen dioxide on serum reproductive hormones in healthy adults
Yan FANG ; Xinghou HE ; Erlu ZHAO ; Bin ZHANG ; Yutong ZHU ; Tong WANG ; Xiaoming SONG ; Hongbing XU ; Wei HUANG
Journal of Environmental and Occupational Medicine 2026;43(6):709-716
Background Air pollution has widespread adverse health effects on human health, but research on its impact on reproductive health and related physiological mechanisms remains insufficient. Objective To investigate the associations between short-term exposure to particulate matter and nitrogen dioxide (NO2) and serum levels of anti-Müllerian hormone (AMH) and testosterone in healthy adults. Methods A total of 152 healthy adults were recruited for a panel study, undergoing four follow-up visits from September 2019 to January 2020. Basic demographic information and serum samples were collected. Reproductive hormone levels were measured by enzyme-linked immunosorbent assay kits. Concurrently, environmental data in the study area were monitored, including fine particulate matter (PM2.5), black carbon (BC), NO2, particle number concentrations in the 5-560 nm size fraction (PNC5_560), and meteorological variables. Linear mixed-effects models were constructed to estimate the effects of short-term exposure to these particulate matter on serum reproductive hormone levels. Results The participants had an average age of (23.9±2.4) years, with 102 women. For each interquartile range (IQR) increment in pollutant moving average concentrations, PM2.5, PNC5_25, PNC100_560, BC, and NO2 were associated with relative decreases in female serum AMH levels by 10.2%-16.9%, 46.2%-58.0%, 16.9%-21.2%, 14.8%-26.5%, and 11.3%-17.6%, respectively. These negative associations were stronger in females with waist-to-hip ratio > 0.76 and physical activity levels ≤ 1217 metabolic equivalents (MET) min per week. Similarly, in males, an IQR increase in the same pollutants was associated with relative decreases in serum free testosterone by 11.1%-17.2%, 35.2%, 10.5%-18.9%, 18.7%-24.2%, and 10.3%-26.0%, respectively. These effects were more pronounce in male with a waist-to-hip ratios > 0.81 and physical activity levels ≤ 1498 MET-min per week. Conclusion Short-term exposure to particulate matter and NO2 may reduce serum levels of AMH and testosterone in healthy adults. Furthermore, these adverse effects appears to be stronger in adults with higher waist-to-hip ratios.
4.Regulatory effect of Shugan Yunpi Decoction on depressive and anxiety symptoms in colorectal cancer patients with depressive disorder based on the PI3K-AKT signaling pathway
Jing MENG ; Jingman ZHAO ; Fang TIAN ; Dong WEI ; Hairu YU ; Chaonan FENG ; Yanan LI ; Ying YANG
Sichuan Mental Health 2026;39(4):324-330
BackgroundPatients with colorectal cancer are frequently comorbid with depression, which severely affects the quality of life and treatment compliance, while compromising the efficacy of anticancer treament and prognosis. Current therapeutic strategies still have notable limitations, particularly the lack of systematic and targeted synergistic regimens that integrate oncological management and anti-depressive intervention. It is of great clinical significance to explore a safe and effective new comprehensive intervention protocol and clarify its underlying mechanism of action. ObjectiveTo explore the effectiveness and safety of Shugan Yunpi Decoction in alleviating depressive and anxiety symptoms in colorectal cancer patients with depressive disorder through the PI3K-AKT signaling pathway, in order to provide references for the comprehensive treatment of colorectal cancer and depressive disorder. MethodsThis study was a randomized controlled trial. A total of 106 patients admitted to the Baoding No.1 Hospital of traditional Chinese medicine from November 2023 to July 2025 were enrolled, who met the diagnostic criteria for the Chinese protocol of diagnosis and treatment of colorectal cancer (2023 edition) and the diagnostic criteria for depressive disorder as specified in the Chinese Classification and Diagnostic Criteria of Mental Disease, third edition (CCMD-3). Patients were divided into the study group and the control group using a random number table, with 53 cases in each group. The control group received conventional chemotherapy combined with traditional Chinese medicine five-element music therapy, while the study group received conventional chemotherapy combined with Shugan Yunpi Decoction therapy. Both groups were treated for 8 weeks. Depressive and anxiety symptoms were assessed using the Hamilton Depression Scale-17 item(HAMD-17) and Hamilton Anxiety Scale (HAMA), respectively. Western blot protein immunoblotting was used to detect the expression levels of PI3K, AKT, and pAKT. Real-time fluorescence quantitative reverse transcription polymerase chain reaction (qRT-PCR) was used to detect the expression levels of PI3K mRNA and AKT mRNA. Adverse reactions were recorded using a self-designed adverse reaction record form. ResultsRepeated measures analysis of variance showed that the time effects (F=139.336, 234.747), group effects (F=43.900, 101.266), and time-group interaction effects (F=13.409, 43.216) for HAMD-17 and HAMA scores in both groups were statistically significant (P<0.01). After 4 and 8 weeks of treatment, the HAMD-17 and HAMA scores in both groups were lower than those before treatment, with statistically significant differences (P<0.05). HAMD-17 and HAMA scores in the study group were lower than those in the control group (P<0.05). The time effects (F=571.356, 309.266, 414.492), group effects (F=6.901, 26.361, 39.362), and time-group interaction effects (F=18.592, 19.266, 33.484) for the protein expression levels of PI3K, AKT, and pAKT in both groups were all statistically significant (P<0.01). After 8 weeks of treatment, the protein expression levels of PI3K and pAKT in the study group were lower than those in the control group, while the AKT protein expression level was higher than that in the control group(P<0.01). The time effects (F=338.555, 225.059), group effects (F=5.429, 9.726), and time-group interaction effects (F=12.953, 21.214) for PI3K mRNA and AKT mRNA expression levels in two groups were all statistically significant (P<0.01). After 8 weeks of treatment, the expression levels of PI3K mRNA and AKT mRNA in the study group were lower than those in the control group (P<0.05). The incidence of adverse reactions in the study group was lower than that in the control group (χ2=4.810, P<0.05). ConclusionShugan Yunpi Decoction may help to ameliorate depressive and anxiety symptoms in colorectal cancer patients with depressive disorder by regulating the PI3K-AKT signaling pathway, decreasing the levels of PI3K, pAKT, PI3K mRNA, and AKT mRNA, with a favorable safety profile. [Funded by Baoding City Science and Technology Planning Project (number, 2341ZF291)]
5.Mechanism of Qiju Dihuang Wan in Treatment of Diabetic Retinopathy Based on NLRP3/Caspase-1/GSDMD Signaling Pathway
Ge ZHANG ; Chunlin ZHAO ; Li PAN ; Ying ZHANG ; Zehai CHEN ; Siya ZHANG ; Yiming FANG ; Wei SHI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):11-21
ObjectiveTo investigate the protective effect of Qiju Dihuang Wan on diabetic retinopathy (DR) and its regulatory mechanism on the NOD-like receptor protein 3/Cysteinyl aspartate-specific proteinase-1/Gasdermin D (NLRP3/Caspase-1/GSDMD) signaling pathway. MethodsHuman retinal microvascular endothelial cells (HRMEC) were divided into the blank group, model group, and Qiju Dihuang Wan low- and high-dose groups. Except for the blank group, all groups were induced with 40 mmol·L-1 high glucose, and the treatment groups were supplemented with 6% and 12% Qiju Dihuang Wan-containing serum, respectively, based on the induction. After 24 h of culture, the levels of interleukin (IL)-1β and IL-18 were measured by enzyme-linked immunosorbent assay (ELISA), pyroptosis-related protein expression was detected by immunofluorescence and Western blot, and the mRNA levels of NLRP3/Caspase-1/GSDMD signaling pathway-related molecules were determined by real-time polymerase chain reaction (Real-time PCR). The mice were randomly divided into the blank group, model group, Qiju Dihuang Wan low-, medium-, and high-dose groups (11, 22, 44 g·kg-1·d-1), and calcium dobesilate group (0.13 g·kg-1·d-1). Except for the blank group, all groups were intraperitoneally injected with streptozotocin to establish the DR model. After successful modeling, the treatment groups received corresponding doses of Qiju Dihuang Wan crude drug or calcium dobesilate suspension by gavage once daily, while the blank group and model group received an equal volume of normal saline, for 8 consecutive weeks. Fundus changes were examined by optical coherence tomography, optical coherence tomography angiography, and fundus fluorescein angiography. Retinal pathological morphology was observed by hematoxylin-eosin staining. Real-time PCR was used to detect the mRNA levels of NLRP3, Caspase‑1, GSDMD, IL‑1β, and IL‑18 in retinal tissue, and Western blot was used to detect the protein expression of NLRP3, ASC, cleaved Caspase‑1, and GSDMD‑N. ResultsCell experiments showed that compared with the blank group, the model group showed significantly decreased HRMEC viability (P<0.01), and significantly increased levels of IL-1β, IL-18, as well as increased protein expression of NLRP3, cleaved Caspase-1, and GSDMD-N (P<0.01). Compared with the model group, the above indicators were significantly reduced in the high-dose Qiju Dihuang Wan groups (P<0.05, P<0.01). Animal experiments showed that compared with the blank group, the model group had elevated blood glucose (P<0.01), decreased retinal thickness and vascular density (P<0.01), up‑regulated mRNA expression of NLRP3, Caspase‑1, GSDMD, IL‑1β and IL‑18 in retinal tissue (P<0.01), and up‑regulated protein expression of NLRP3, ASC, cleaved Caspase‑1 and GSDMD‑N (P<0.01). Compared with the model group, the Qiju Dihuang Wan medium- and high‑dose groups showed decreased blood glucose (P<0.01), increased retinal thickness and vascular density (P<0.01), alleviated retinal pathological damage, and down‑regulated mRNA expression of NLRP3, Caspase‑1, GSDMD, IL‑1β, IL‑18, as well as protein expression of NLRP3, ASC, cleaved Caspase‑1, and GSDMD‑N (P<0.05, P<0.01). ConclusionQiju Dihuang Wan may exert protective effects against diabetic retinopathy by inhibiting the activation of the NLRP3/Caspase-1/GSDMD signaling pathway and alleviating high glucose-induced retinal pyroptosis.
6.Mechanism of Qiju Dihuang Wan in Treatment of Diabetic Retinopathy Based on NLRP3/Caspase-1/GSDMD Signaling Pathway
Ge ZHANG ; Chunlin ZHAO ; Li PAN ; Ying ZHANG ; Zehai CHEN ; Siya ZHANG ; Yiming FANG ; Wei SHI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):11-21
ObjectiveTo investigate the protective effect of Qiju Dihuang Wan on diabetic retinopathy (DR) and its regulatory mechanism on the NOD-like receptor protein 3/Cysteinyl aspartate-specific proteinase-1/Gasdermin D (NLRP3/Caspase-1/GSDMD) signaling pathway. MethodsHuman retinal microvascular endothelial cells (HRMEC) were divided into the blank group, model group, and Qiju Dihuang Wan low- and high-dose groups. Except for the blank group, all groups were induced with 40 mmol·L-1 high glucose, and the treatment groups were supplemented with 6% and 12% Qiju Dihuang Wan-containing serum, respectively, based on the induction. After 24 h of culture, the levels of interleukin (IL)-1β and IL-18 were measured by enzyme-linked immunosorbent assay (ELISA), pyroptosis-related protein expression was detected by immunofluorescence and Western blot, and the mRNA levels of NLRP3/Caspase-1/GSDMD signaling pathway-related molecules were determined by real-time polymerase chain reaction (Real-time PCR). The mice were randomly divided into the blank group, model group, Qiju Dihuang Wan low-, medium-, and high-dose groups (11, 22, 44 g·kg-1·d-1), and calcium dobesilate group (0.13 g·kg-1·d-1). Except for the blank group, all groups were intraperitoneally injected with streptozotocin to establish the DR model. After successful modeling, the treatment groups received corresponding doses of Qiju Dihuang Wan crude drug or calcium dobesilate suspension by gavage once daily, while the blank group and model group received an equal volume of normal saline, for 8 consecutive weeks. Fundus changes were examined by optical coherence tomography, optical coherence tomography angiography, and fundus fluorescein angiography. Retinal pathological morphology was observed by hematoxylin-eosin staining. Real-time PCR was used to detect the mRNA levels of NLRP3, Caspase‑1, GSDMD, IL‑1β, and IL‑18 in retinal tissue, and Western blot was used to detect the protein expression of NLRP3, ASC, cleaved Caspase‑1, and GSDMD‑N. ResultsCell experiments showed that compared with the blank group, the model group showed significantly decreased HRMEC viability (P<0.01), and significantly increased levels of IL-1β, IL-18, as well as increased protein expression of NLRP3, cleaved Caspase-1, and GSDMD-N (P<0.01). Compared with the model group, the above indicators were significantly reduced in the high-dose Qiju Dihuang Wan groups (P<0.05, P<0.01). Animal experiments showed that compared with the blank group, the model group had elevated blood glucose (P<0.01), decreased retinal thickness and vascular density (P<0.01), up‑regulated mRNA expression of NLRP3, Caspase‑1, GSDMD, IL‑1β and IL‑18 in retinal tissue (P<0.01), and up‑regulated protein expression of NLRP3, ASC, cleaved Caspase‑1 and GSDMD‑N (P<0.01). Compared with the model group, the Qiju Dihuang Wan medium- and high‑dose groups showed decreased blood glucose (P<0.01), increased retinal thickness and vascular density (P<0.01), alleviated retinal pathological damage, and down‑regulated mRNA expression of NLRP3, Caspase‑1, GSDMD, IL‑1β, IL‑18, as well as protein expression of NLRP3, ASC, cleaved Caspase‑1, and GSDMD‑N (P<0.05, P<0.01). ConclusionQiju Dihuang Wan may exert protective effects against diabetic retinopathy by inhibiting the activation of the NLRP3/Caspase-1/GSDMD signaling pathway and alleviating high glucose-induced retinal pyroptosis.
7.Chinese expert consensus on the clinical application of recombinant human thyroid-stimulating hormone (2025 edition)
Chentian SHEN ; Yushen GU ; Hui TAN ; Anren KUANG ; Sijin LI ; Yaming LI ; Jing WANG ; Ningyi JIANG ; Jian TAN ; Zhuoying WANG ; Shaoyan LIU ; Xiaoyi LI ; Jugao FANG ; Dingcun LUO ; Youben FAN ; Hui WANG ; Yuetao WANG ; Xuemei WANG ; Feng WANG ; Wei FU ; Feng SHI ; Xuegong LIU ; Zhongwei LÜ ; Yan XING ; Lin LI ; Hui YANG ; Jun XIN ; Yifan ZHANG ; Yue CHEN ; Yansong LIN ; Wei OUYANG ; Shuzhan YAO ; Changjiu ZHAO ; Xinming ZHAO ; Zairong GAO ; Dingde HUANG ; Qiang WEN ; Xingmin HAN ; Cen LOU ; Weibing MIAO ; Wei FAN ; Quanyong LUO ; Hongcheng SHI
Chinese Journal of Clinical Medicine 2026;33(5):932-944
The recombinant human thyroid-stimulating hormone (rhTSH) can be used for differentiated thyroid cancer (DTC) preparation before 131I therapy, and follow-up. Since its approval by the American Food and Drug Administration (FDA) in 1998, rhTSH has been clinically used in European countries, the United States, and other countries for nearly 30 years. In April 2024, China’s first independently developed rhTSH agent was approved. Based on clinical experience and evidence from domestic and international studies, an expert consensus on the application of rhTSH has been developed following thorough consultations among experts. The consensus offers evidence-based recommendations to guide the appropriate use of rhTSH in clinical practice.
8.Proteomic Preparation Techniques for Formalin-Fixed Paraffin-Embedded Tissue Samples
Ao LU ; Bo MENG ; Jia-Wei ZHAO ; Huan-Yue LIAO ; Zi-Hong YE ; Xiang FANG ; Yang ZHAO
Chinese Journal of Analytical Chemistry 2025;53(1):84-93,中插4-中插8
Twelve pre-processing protocols for formalin-fixed paraffin-embedded(FFPE)tissue samples were developed by orthogonal experimental design,incorporating different dewaxing buffers(Triton X-100 and xylene),lysis buffers(TFE and RapiGest),and enzyme digestion methods(iST,SP3,and FASP)to explore the optimal experimental conditions.These protocols were assessed based on protein and peptide identification depth,identification stability,and quantitative levels of protein abundance.The results indicated that Triton X-100 and xylene minimally impacted proteomics identification,whereas the TFE lysis buffer and iST digestion method significantly enhanced the proteomics analysis of FFPE samples.Considering the potential toxicity of xylene,the TTI protocol based on Triton X-100,TFE,and iST was determined to be the optimal choice.This protocol exhibited the best repeatability and stability,and a higher number of proteins associated with significant biological functions were identified.In conclusion,the established TTI protocol offered an efficient and comprehensive approach for proteomic analysis of FFPE samples,significantly enhancing the repeatability and stability of protein identification.
9.Exploration of factors influencing abnormal iodine nutrition and pregnancy outcome in pregnant women during pregnancy based on thyroid function and thyroid autoantibody analysis
Yanping JIANG ; Wei YUAN ; Shuqiong WANG ; Yongli YAO ; Wei LUO ; Kang SONG ; Xiaoxia FAN ; Lijun LIN ; Ya'nan LI ; Yanling XIE ; Lingling ZHAO ; Beibei WANG ; Fang DANG ; Jingyuan WANG ; Wenyan MA ; Peiyun FAN
The Journal of Practical Medicine 2025;41(16):2549-2555
Objective To analyze the factors influencing iodine nutritional status in pregnant women dur-ing pregnancy,based on thyroid function and thyroid autoantibody levels,and to explore the association between iodine nutritional abnormalities and pregnancy outcomes.Methods A total of 838 pregnant women who underwent routine prenatal checkups at Qinghai Provincial People's Hospital between January 2021 and June 2023 were pro-spectively enrolled in this study.All participants were followed until delivery.Seven cases were lost to follow-up,resulting in a final sample size of 831 participants.Among them,276 were in the first trimester,384 in the second trimester,and 171 in the third trimester.Data on urinary iodine concentration(UIC),urinary creatinine(UCr),thyroid function indicators,and thyroid autoantibodies were collected.Based on their iodine nutritional status,the participants were categorized into either the iodine-sufficient group or the iodine-abnormal group(including iodine-deficient,iodine-hyper-sufficient,and iodine-excessive subgroups).This study analyzed the iodine nutritional sta-tus of pregnant women during different gestational periods,compared thyroid function indices,prevalence of thy-roid diseases,and the positivity rates of thyroid peroxidase antibody(TPOAb),thyroglobulin antibody(TGAb),and thyroid-stimulating hormone receptor antibody(TRAb)among different iodine status groups.Additionally,ad-verse pregnancy outcomes were compared across groups.Multivariate logistic regression analysis was conducted to identify risk factors associated with iodine abnormalities during pregnancy,and a predictive model was developed to assess its potential predictive value.Results Among the 831 pregnant women included in the study,373 cases(44.89%)exhibited iodine sufficiency,while 458 cases(55.11%)presented with iodine abnormalities,including 282 cases of iodine deficiency,144 cases of iodine hypersufficiency,and 32 cases of iodine excess.No statistically significant differences were observed in the iodine nutritional status across different trimesters(P>0.05).The se-rum level of thyroid-stimulating hormone(TSH)was significantly higher in the iodine abnormal group compared to the iodine sufficient group(P<0.05).Additionally,the iodine abnormal group demonstrated higher positivity rates of TPOAb alone,TGAb,and TRAb,as well as increased incidence of thyroid dysfunction and total adverse pregnancy outcomes compared to the iodine sufficient group(all P<0.05).These adverse indicators were also sig-nificantly elevated in the iodine-deficient,iodine super-sufficient,and iodine overdose subgroups compared to the iodine sufficient group(P<0.05).Elevated serum TSH levels and the presence of TPOAb,TGAb,and TRAb were identified as risk factors for iodine abnormalities during pregnancy(P<0.05).The predictive model con-structed for identifying iodine abnormalities in pregnant women demonstrated an area under the curve(AUC)of 0.876,with a sensitivity of 72.27%and a specificity of 89.01%.Conclusions The prevalence of iodine nutritional abnormalities among pregnant women during pregnancy was high,with most cases presenting iodine deficiency.These abnormalities were associated with thyroid function,thyroid autoimmunity,and pregnancy outcomes,but showed no significant correlation with gestational age.Furthermore,the prediction model developed based on iden-tified risk factors demonstrated effective performance in predicting iodine nutritional abnormalities during preg-nancy.
10.Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellitus
Yiming WU ; Jian ZHANG ; Nan GU ; Qijuan DONG ; Ruiyun LIU ; Hong ZHANG ; Haixia LIU ; Yongcai ZHAO ; Lin CHENG ; Lianshan PU ; Fang BIAN ; Gang HE ; Quanmin LI ; Wei DU ; Zhaoling WANG ; Wei XU ; Liyong ZHONG ; Xiaohui GUO
Chinese Journal of Diabetes 2025;33(3):210-214
Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384~0.069)and PPS(-0.139,95%CI-0.390~0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.


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