1.Progress in artificial intelligence for predicting therapeutic efficacy of intravitreal injection
Xiaofeng WU ; Jiayi ZHANG ; Chunyan XIAO ; Yanshuang GENG ; Yonggang LIU ; Boxuan SONG ; Jiawei WANG
International Eye Science 2026;26(4):687-693
Intravitreal anti-vascular endothelial growth factor(anti-VEGF)therapy has been widely used, but the variability in its therapeutic efficacy limits individualized treatment. In recent years, the application of artificial intelligence(AI)has opened up new avenues for personalized treatment response prediction, and its core branches include machine learning(ML)and deep learning(DL). This review systematically retrieved and analyzed 41 relevant studies published up to April 2025. Comprehensive analysis reveals that AI predictive models are evolving from forecasting single endpoints(such as visual acuity or central retinal thickness)to integrating multi-dimensional endpoints(encompassing anatomical, functional, and treatment demand parameters)and generating predictive imaging outputs. In terms of technical approaches, DL models(28 studies, accounting for 68.3%)dominate this field due to their robust image interpretation capabilities, while ML models(10 studies, 24.4%)retain significant value in the analysis of structured clinical data. Cross-disease comparisons indicate that research efforts are most concentrated on age-related macular degeneration(ARMD)and diabetic macular edema(DME), with shared conceptual frameworks for model construction, yet distinct anatomical and functional indicators are prioritized for each disease. Currently, the field confronts several key challenges, including insufficient prospective clinical validation, limited model interpretability(the “black box problem”), and a scarcity of high-quality multi-center datasets. Moving forward, it is imperative to advance real-world validation and develop explainable AI techniques to expedite the clinical translation of these predictive models.
2.The prediction of clinical severity grading of catecholaminergic polymorphic ventricular tachycardia by RyR2 gene mutation: A systematic review
Ruyuan HE ; Jingxuan ZHANG ; Song DING ; Qing GENG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(01):141-149
Objective To explore the genetic mutation characteristics, clinical manifestations, and treatment outcomes of catecholaminergic polymorphic ventricular tachycardia (CPVT), and to construct a quantitative scoring system for the severity of CPVT. The correlation between the mutations in different structural domains of the RyR2 gene and clinical manifestations and prognosis was analyzed. Methods By searching the PubMed and Web of Science databases for CPVT-related case reports published up to December 2024, data such as patient age, clinical manifestations, gene mutation sites, and treatment responses were collected. The quality of the literature was assessed using the CARE guidelines. The χ2 test was used to compare the severity and treatment response differences among different RyR2 structural domain mutation groups, and an innovative quantitative scoring system based on symptoms and efficacy was established. Results A total of 80 articles were included, with 102 patients in total. The quality of the literature was reliable. The age of the patients ranged from 1 to 84 years, with a higher proportion of children under 10 years old (25.5%). Female patients (54.9%) outnumbered males (45.1%). For CPVT patients, a quantitative scoring system was developed, with a total score of 2 to 10 points. Among them, 2 to 4 points were classified as mild, 5 to 7 points as moderate, and 8 to 10 points as severe. The results showed that severe patients often had a history of cardiac arrest and were resistant to treatment. Out of the 102 CPVT patients, RyR2 gene mutations accounted for 53.9% (55/102) of patients. Among them, the proportion of severe patients with N-terminal structural domain mutations was significantly higher than other regions, indicating that the RyR2 gene mutation structural domain has a significant impact on the severity of CPVT (χ2=17.530, P=0.008). The proportion of patients with mutations in the central hinge region who were ineffective with β-blockers reached 42.9% (3/7), which was significantly higher than other regions. Left cardiac sympathectomy was performed in 24 cases, and postoperative symptoms were almost completely controlled, significantly better than the drug treatment group.Conclusion Mutations in the N-terminal structural domain of the RyR2 gene are significantly correlated with the severity of CPVT. Left cardiac sympathectomy has gradually become an effective intervention for refractory cases. The scoring system proposed in this study can provide a basis for clinical stratified treatment. In the future, there is a need to expand the sample size to verify mutation-specific treatment strategies.
3.Influence of emergency endovascular treatment on the prognosis of minor stroke caused by posterior circulation large vessel occlusion
Xi CHEN ; Chen CHEN ; Yufei GENG ; Suhang SHANG ; Wenfeng SONG ; Suixia CAO ; Ying TAN ; Jia YU ; Jianfeng HAN
Chinese Journal of Cerebrovascular Diseases 2025;22(10):677-689
Objective To investigate the effects of emergency endovascular treatment on the short-term and long-term prognosis of patients with minor stroke(National Institutes of Health stroke scale[NIHSS]score≤5)caused by posterior circulation large vessel occlusion(LVO).Methods A retrospective analysis was performed on consecutive patients with minor stroke caused by posterior circulation LVO admitted to the Department of Neurology,the First Affiliated Hospital of Xi'an Jiaotong University from July 2019 to March 2024.The patients were divided into the emergency endovascular treatment group and the standard medical treatment group according to the treatment method.Baseline and clinical data were collected from all patients enrolled,including age,sex,smoking history,history of alcohol consumption,medical history(hypertension,diabetes,hyperlipidemia,atrial fibrillation,transient ischemic attack[TIA],blood pressure on admission,stroke history,coronary heart disease),intravenous thrombolysis,tandem lesions,posterior circulation Alberta stroke program early CT score(pc-ASPECTS)on admission,NIHSS score on admission and discharge,time from onset to admission,responsible occluded vessel(basilar artery,left vertebral artery,right vertebral artery),vertebral artery development(left vertebral artery dominant,right vertebral artery dominant,bilateral vertebral artery dominant),non-lesion side vertebral artery development(poor,good,not applicable),basilar artery on CT angiography(BATMAN)score,leptomeningeal branch compensation(open,not open),surgery-related indicators(number of thrombectomy passes[≤2 times,>2 times],rescue interventions[stent placement,balloon dilation,arterial thrombolysis,intra-arterial tirofiban infusion],immediate postoperative modified thrombolysis in cerebral infarction[mTICI]grade≥2b[successful recanalization],anesthesia method[general,local],endotracheal intubation status[yes,no],duration of mechanical ventilation[not using a ventilator or successfully intubation for≤24 hours and>24 hours]),in-hospital systematic complications(deep-vein thrombosis,urinary tract infection,lung infection).The primary outcome for short-term prognosis was an excellent outcome(modified Rankin scale[mRS]score of 0-1)within 90 days after onset.Secondary outcomes included a good outcome(mRS score of 0-2)within 90days after onset,recurrent ischemic stroke within 90 days after onset,all-cause mortality within 90 days after onset.Safety outcomes were symptomatic intracerebral hemorrhage(sICH)within 24 hours of treatment(NIHSS score increased by≥4 points or increased level of consciousness score by≥1 point compared with admission,with visible hemorrhagic lesions on follow-up CT scan)and early neurological deterioration(END,NIHSS score increased by≥2 points or motor score increased by≥1 point compared with admission,within 24 hours after treatment).Long-term outcome was defined as recurrent ischemic stroke within 1 year after onset.Short-term and safety outcomes were compared between the emergency endovascular treatment group and the standard medical treatment group.Kaplan-Meier survival curves was used to evaluate the effect of emergency endovascular treatment on the long-term prognosis.Based on the mRS score at 90 days from onset,all patients were divided into an excellent outcome(mRS score 0-1)group and a non-excellent outcome(mRS score 2-6)group.Baseline and clinical data were compared across the two groups.Variables with statistically significant differences were included in the multivariate Logistic regression analysis to investigate the influencing factor of 90-day excellent outcomes in patients with minor stroke caused by posterior circulation LVO.Results A total of 56 patients with minor stroke caused by posterior circulation LVO were enrolled,including 18 patients in the emergency endovascular treatment group and 38 patients in the standard medical treatment group.45 patients achieved excellent outcomes and 11 patients achieved non-excellent outcomes.(1)The emergency endovascular treatment group had lower pc-ASPECTS on admission(8.0[7.0,9.0]points vs.9.0[8.0,10.0]points,P=0.043)and There were no statistically significant differences in the excellent outcome rate,good outcome rate,and ischemic stroke recurrence rate within 90 days after onset between the two groups(all P>0.05).No all-cause mortality occurred within 90 days after onset in either group.In the emergency endovascular treatment group,one patient developed sICH and one developed END within 24 hours after treatment.(3)No recurrent ischemic stroke in the emergency endovascular treatment group within 1 year after onset,while 3cases(7.89%)of recurrence were observed within 1year after onset in the standard medical treatment group.The Kaplan-Meier survival curve analysis showed that there was no statistically significant difference in the incidence of ischemic stroke within one year after onset between the two groups(P=0.341).(4)There were statistically significant differences between patients with excellent outcome and patients with non excellent outcome in drinking history,diabetes history,NIHSS score after discharge,distribution of responsible occlusive vessels,and distribution of vertebral artery development(all P<0.05).The results of multivariate Logistic regression analysis showed that the NIHSS score at discharge was an independent influencing factor for excellent outcome at 90 days after onset in patients with minor stroke caused by posterior circulation LVO(OR,0.448,95%CI 0.275-0.728,P=0.001).Conclusions This study shows potential safety and effectiveness of emergency endovascular treatment on patients with minor stroke caused by posterior circulation LVO,but it is not superior to standard medical treatment in terms of short-term and long-term outcomes.Further large-sample randomized controlled trials are warranted to validate the findings of this study.
4.A prospective single-arm study on surgical treatment of pulmonary nodules located beneath the interlobar pleura and adjacent to the pulmonary hilum
Wenli WU ; Qingping SONG ; Dongxiao GENG ; Yanfeng ZHAO ; Haiquan CHEN ; Qiufeng YU ; Feng JIANG
China Oncology 2025;35(4):412-417
Background and purpose:Accurately locating pulmonary nodules is the key to the success of thoracoscopic surgery.This study aimed to investigate the strategy and evaluate the feasibility,safety,and clinical value of thoracoscopic surgical treatment for pulmonary nodules located beneath the interlobar pleura and close to the pulmonary hilum.Methods:The patients who underwent pulmonary nodule surgery at Liaocheng Tumor Hospital from May 2023 to November 2024 were enrolled,and the patients who did not meet the inclusion criteria were excluded.This study was approved by the Ethics Committee of Liaocheng Tumor Hospital(EC-20240112-1020)and informed consent was obtained from the patients.The research was designed as a prospective single-arm study.The patients were treated with wedge resection,which was performed following CT-guided localization,where the location needle was inserted through the interlobar pleura.The feasibility of the procedure was evaluated by analyzing the success rate of preoperative localization and perioperative complications.Results:A total of 28 patients who met the inclusion criteria were included in this study.There were 5 male and 23 female patients with an average age of(56.0±8.5)years(range 38-69 years).In all,28 patients with 28 nodules underwent thoracoscopic wedge resection,and the preoperative CT-guided localization was successfully performed in all patients,without urgent complications.The mean operation time of thoracoscopic surgery was(15.6±4.0)min,intraoperative bleeding was(20.9±14.3)mL,and postoperative drainage was(214.3±62.2)mL.No cases of postoperative air leaks or conversion to thoracotomy were observed.The average length of hospital stay was(5.4±0.9)days.The postoperative histological diagnosis revealed 3 benign lesions(pulmonary fibrosis in 2 cases,atypical adenomatous hyperplasia in 1 case)and 25 malignant lesions(adenocarcinoma in situ in 5 cases,minimally invasive adenocarcinoma in 16 cases,and invasive adenocarcinoma in 4 cases).Conclusion:Thoracoscopic wedge resection following CT-guided nodule localization through the interlobar pleura is a feasible approach for nodules located beneath the interlobar pleura and close to the pulmonary hilum.The method ensures precise tumor localization,adequate margin,and minimal loss of normal lung tissue,with a low incidence of postoperative complication,which has important guiding significance for the surgical treatment of pulmonary nodules in such special locations.
5.Clinical trial of budesonide and formoterol fumarate powder for inhalation in the treatment of elderly patients with cough variant asthma
Ying SUN ; Xin SONG ; Jia WANG ; Yan-fang HOU ; Qun FU ; Qi ZHANG ; Jie LAI ; Tao GENG ; Chang-xin LI ; Jia-hui HUO ; Ying ZHANG ; Yan WENG
The Chinese Journal of Clinical Pharmacology 2025;41(1):1-5
Objective To compare the effects of different doses of budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet in the treatment of cough variant asthma(CVA)and the improvement of airway function and inflammatory factors.Methods Elderly patients with cough variant asthma were randomly divided into group A and group B.Both groups of patients received budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet.Group A was given budesonide and formoterol fumarate powder for inhalation(Ⅱ),2 inhalation per time,twice a day;Group B was given budesonide and formoterol fumarate powder for inhalation,4 inhalation per time,twice a day;budesonide fumatrol inhalation powder mist for continuous treatment for 6 months,and montelukast sodium tablet 10 mg once a day for at least 3 months.The nighttime cough scores of the two groups were compared before treatment and after treatment.The percentage of forced expiratory volume in one second(FEV1)in the predicted value,the maximum mid expiratory flow(MMEF),the fractional exhaled nitric oxide(FeNO),interleukin-5(IL-5)and eosinophils were compared between the two groups.The incidence of adverse drug reactions and the recurrence rate within 1 year were compared between the two groups.Results A total of 45 cases were enrolled in both the group A and the group B.At 9 months after treatment,the nocturnal cough scores of the group A and the group B were(0.93±0.42)and(0.65±0.29)points,respectively;the percentage of FEV1 in the predicted value were(97.75±9.67)%and(100.93±11.06)%,respectively;the MMEF values were(2.81±1.04)and(3.08±1.09)L·s-1,respectively;the FeNO values were(18.94±9.75)and(15.94±7.96)ppb,respectively;the IL-5 levels were(10.88±7.06)and(8.11±5.56)pg·mL-1,respectively.The above indicators in group B showed statistically significant differences compared to group A(all P<0.05).The total incidence of adverse drug reactions in group A and group B were 8.89%(5 cases/45 cases)and 13.33%(6 cases/45 cases),respectively.The recurrence rates was 15.56%(7 cases/45 cases)and 13.33%(6 cases/45 cases),respectively.There was no statistically significant difference in the above indicators between group B and group A(all P>0.05).Conclusion For elderly patients with CVA,higher dose of budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet can better improve cough symptoms,reduce the level of airway hyperresponsiveness and inflammatory factors,reduce the recurrence rate,and the patients are well tolerated.
6.Analysis of subclinical atherosclerosis and its associated factors in patients with psoriatic arthritis
Jingli DOU ; Guangtao LI ; Yan GENG ; Zhibo SONG ; Xiaohui ZHANG ; Zhuoli ZHANG
Chinese Journal of Rheumatology 2025;29(4):286-292
Objective:To analyze the condition of subclinical atherosclerosis (SCA) in patients with psoriatic arthritis (PsA) and to provide a reference for better management of the associated cardiovascular risk in patients with PsA.Methods:Based on the cohort of PsA patients (PKUPsA) in the Department of Rheumatism and Immunology, Peking University First Hospital, 240 PsA patients without previous clinical atherosclerotic disease between July 2018 and June 2024 were included. The demographic data traditional cardiovascular disease risk factors, PsA related indicators and medications were collected when all patients were entered into the cohort. Increased intima-media thickness and/or arterial plaque formation in bilateral carotid arteries examined by ultrasonography are defined as the presence of SCA. Based on this, patients were divided into SCA and no SCA groups, and the two groups were compared and analyzed. Statistics were performed using the Mann-Whitney U test, independent sample t test, χ2 test and Logistic regression analysis. Results:Eighty-five of 240 patients (35.4%) had SCA, including 55 (22.9%) with cIMT thickening and 51 (21.2%) with carotid plaque. Compared with the PsA patients without SCA, patients with SCA were older [55.0 (42.0, 62.5) vs. 42.0(35.0, 53.0) year of age, Z=-4.90, P<0.001], had longer disease course of arthritis [4.6 (1.0, 10.1) vs. 3.0(1.0, 6.1) years, Z=-1.98, P=0.048], more patients with combined hypertension [34.1%(29/85) vs. 15.5%(24/155), χ2=11.08, P<0.001], hyperlipidemia [47.1%(40/85) vs. 27.1%(42/155), χ2=1.22, P=0.002] and the taking of statins [14.1%(12/85) vs. 5.8%(9/155), χ2=4.75 , P=0.029], hypoglycemic agents [10.6%(9/85) vs. 3.9%(6/155), χ2=4.23, P=0.040] and antihypertensive drugs [17.6%(15/85) vs 6.5%(10/155), χ2=7.37, P=0.007]. They also had a higher blood glucose level[5.37 (5.17, 6.09)mmol/L vs. 5.26(4.97, 5.67)mmol/L, Z=-2.82 , P=0.005], low-density lipoprotein [(3.05± 0.76)mmol/L vs. (2.78±0.75)mmol/L, t=2.60, P=0.010] and blood uric acid level[351 (312, 412)μmol/L vs. 333(279, 408)μmol/L, Z=-2.10, P=0.036]. Multivariate analysis showed that older [ OR (95% CI) =1.059 (1.033, 1.086), P<0.001], increased low density lipoprotein [ OR (95% CI) =1.519 (1.018, 2.267), P=0.041] and increased blood uric acid levels [ OR (95% CI)=1.004 (1.001, 1.007), P=0.017] were an independent risk of SCA in PsA patients. Conclusion:More than 1/3 of PsA patients with SCA without past history of clinical atherosclerosis with SCA, advanced age, increased blood low density lipoprotein level, and elevated uric acid level are independent risk factors for PsA with SCA, so attention should be paid to the assessment and management of cardiovascular-related risk. Early intervention can help to improve patient prognosis.
7.Analysis of target and treatment goals achievement in patients with psoriatic arthritis based on a large cohort
Xinyi HU ; Zhibo SONG ; Xiaohui ZHANG ; Yan GENG ; Zhuoli ZHANG
Chinese Journal of Rheumatology 2025;29(5):365-371
Objective:Treat-to-target strategies for psoriatic arthritis (PsA) have been proposed for several years, however, the status of target and goal achievement in China is unknown. Therefore, we aimed to investigate the target achievement of PsA patients, and differences of treatment goals were further analyzed.Methods:A total of 360 PsA patients from Peking University First Hospital PsA patient cohort (PKUPsA) between January 2016 and March 2024 were included. We retrospectively analyzed the disease activity of patients at their enrollment. Minimal disease activity (MDA), disease activity index for PsA (DAPSA), clinical DAPSA (cDAPSA) and disease activity score based on 28 joint counts (DAS28) were evaluated. Interclass correlation coefficient (ICC) was used to test the consistency of all these assessments.Results:Three hundred and sixty patients were included in this study, with 149 females (41.4%), median age 47 (36, 57) years and duration of PsA for 2.0(1.0, 6.8) years. 129 (35.8%) patients reported family history of PsO. The most common comorbidities were hyperlipidemia (101, 28.1%) and hypertension (78, 21.7%). There were 217 (60.3%), 75 (20.8%) and 18 (5.0%) patients treated with conventional synthetic DMARDs, biologics and JAK inhibitors respectively. Forty-nine (13.6%) patients ever received intra-articular injection of glucocorticoid. Based on the different definitions, the rates of target achievement were 33.9% (MDA), 56.1% (DAPSA), 60.8% (DAS28-ESR), 63.9% (DAS28-CRP) and 64.2% (cDAPSA). The main limiting factors for MDA attainment among those who had achieved DAPSA or DAS-defined targets were pain VAS, Psoriasis Area and Severity Index (PASI), tender/swollen joint count, patient global assessment, HAQ, and number of enthesitis, based on leeds Enthesitis Index(LEI). The ICCs of these evaluation methods were 0.489~0.819 ( P<0.001). The consistency was the best between DAPSA and cDAPSA, medium between DAS28-CRP and DAS28-ESR, and worst between MDA and DAS28-CRP. Moreover, DAPSA was more consistent with DAS28 than cDASPA. MDA showed moderate consistency with all other assessments. Conclusion:33.9%~64.2% of PsA patients achieved targets based on different definitions. MDA was the most stringent target, while cDAPSA was the most loose one. In general, MDA was not well consistent with other assessments.
8.Prediction of risk for cardiovascular disease developmentand lipid management in patients with psoriatic arthritis
Shuyan CHEN ; Yong FAN ; Zhibo SONG ; Xiaohui ZHANG ; Zhuoli ZHANG ; Yan GENG
Chinese Journal of Rheumatology 2025;29(6):481-487
Objective:To explore the differences in the CVD risk and lipid profiles in psoriatic arthritis (PsA) patients with different disease activity and investigate lipid management status in Chinese patients with PsA.Methods:Patients were enrolled from PKUPsA-PC cohort in Peking University First Hospital from January 2016 to January 2024. Data were collected at their first visit, including disease activity score, lipid profiles and treatment. Two modified CVD risk prediction models (modified China-PAR and modified FRS-CVD) were applied to predict the CVD risk over 10 years. All enrolled patients were subsequently stratified into low, intermediate and high-risk groups. The status of lipid target achievement was assessed based on lipid management recommendations proposed by prediction models. In addition, DAPSA was used to stratify PsA patients into remission, low, moderate and high-disease activity groups, and the differences in CVD risk and lipid profiles among PsA patients with different disease activity status were explored. The t test was used for comparison between 2 groups for measures that conformed to normal distribution; the Mann-Whitney U test was used for comparison between 2 groups for measures that were skewed; and the chi-square test was used for comparison between 2 groups for categorical data.Results:Three hundred and seven PsA patients were included in this study. They were aged 47 (36, 57) years with 121 (39.4%) female, disease duration of skin lesions of 14 (7, 23) years and disease duration of PsA for 3 (1, 8) years. There were 148 (48.2%) patients with dyslipidemia, and 38 (25.7%) of them were receiving lipid lowering drugs. By the modified China-PAR model, there were 174 (56.7%), 76 (24.8%) and 57 (18.5%) in the low-, moderate- and high-risk groups. By the modified FRS-CVD model, there were 173 (56.4%), 58 (18.9%) and 76 (24.7%) patients in the corresponding groups. According to the recommendations for lipid management based on FRS-CVD model, 80 (26.1%) patients did not achieve the target of lipid profile, including 9/174 (5.2%) in the modified model low-risk group, 20/76 (26.3%) in the intermediate-risk group, and 51/57 (89.5%) in the high-risk group, but there were only 12 (15.0%) patients receiving statin therapy. Compared with the remission and low disease activity groups, patients in the moderate-to-high disease activity group were older [50 (37, 60) years vs. 43 (35, 55) years, Z=-2.42, P=0.016]; had a higher proportion of hypertension (30.3% vs. 15.0%, χ2=9.60, P=0.002); and had lower HDL-C levels [1.1 (0.9, 1.3) mmol/L vs. 1.2 (1.0, 1.4) mmol/L, Z=-3.18, P=0.001]. Under the modified China-PAR and modified FRS-CVD risk prediction models, a higher proportion of patients with high disease activity in PsA were stratified at high 10-year CVD risk compared with the remission and low disease activity groups (29.5% vs. 19.6%, χ2=3.81, P=0.005) and (23.5% vs. 12.4%, χ2=6.00, P=0.014). Conclusion:Nearly half of the PsA patients are at medium-high risk to CVD. CVD risk is significantly higher in patients with moderate to high disease activity than in patients with remission and low disease activity. HDL-c levels are lower in patients with high disease activity. Nevertheless a quarter of patients did not achieve the target of lipid profile, and few patients are receiving statin. More attention should be paid to CVD risk evaluation and lipid management as a part of treat-to-target strategy to improve the prognosis.
9.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.
10.Case 06 (2025): A case of pregnancy complicated by type 1 diabetes with severe diabetic nephropathy and retinopathy
Hongli HUANG ; Huixia YANG ; Geng SONG ; Shuxian WANG ; Ye FENG ; Yumei WEI ; Yu SUN ; Sufang SHI ; Xiaoyong YUAN ; Jing ZHANG
Chinese Journal of Perinatal Medicine 2025;28(1):51-56
This paper reported a type 1 diabetes patient who had severe diabetic nephropathy, retinopathy, hypertension, and hypothyroidism before pregnancy. The patient's blood glucose control was poor before pregnancy, and the complications were not properly treated. This was an unintended pregnancy, with a pre-pregnancy glycated hemoglobin A1c of 7.8% and early pregnancy urine protein of 3.81-4.53 g/24 h. Considering the patient's poor blood glucose control before pregnancy and the lack of proper treatment for multiple complications including nephropathy, a multidisciplinary consultation at an external hospital recommended termination of the pregnancy. However, the patient was determined to continue the pregnancy and was referred to Peking University First Hospital. Through strict blood glucose control, monitoring and evaluation of complications, and comprehensive management, the patient's blood glucose and blood pressure were well controlled during pregnancy. Regular monitoring of urine protein, renal function, and ocular fundus was conducted. At 31 weeks and 4 days of gestation, the patient's 24-hour urine protein significantly increased. After promoting fetal lung maturity, a cesarean section was performed at 34 weeks and 1 day of gestation, resulting in a successful delivery with good maternal and neonatal outcomes. At the 42-day postpartum follow-up, the patient's blood glucose and blood pressure were stable, urine protein returned to pre-pregnancy levels, and the infant was in good general condition.

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