1.Preliminary evaluation of the effect of comprehensive health management on the prevention and treatment of ischemic stroke
Shuai ZHU ; Genming ZHAO ; Yiying ZHANG ; Dongni LIANG ; Hongjie YU ; Qian PENG ; Fang XIANG ; Na WANG
Journal of Public Health and Preventive Medicine 2026;37(2):89-93
Objective To evaluate the short-term effects of comprehensive health management interventions for stroke high-risk population screening on the prevention and treatment of ischemic stroke, and to provide reference and basis for improving and exploring health management and prevention strategies for stroke high-risk population. Methods From 2018 to 2022, 13 community health service centers in Jiading District, Shanghai were selected in the present study. Based on information push platform, stroke risk assessment and health intervention follow-up were conducted for community residents through convenience sampling. The residents were divided into a full course intervention group (intervention group) and a routine intervention group (control group) according to different health intervention measures and forms. The incidence of ischemic stroke in the two groups of survey subjects was tracked within 36 months. Results A total of 52144 subjects were included in the study. The total number of patients in the full course intervention group was 14227, with an incidence density of 577.32/100 000 (556.49/100 000-598.12/100 000), which was lower than that of the conventional intervention group (37 917), with an incidence density of 1 485.47/100 000 (1 464.99/100 000-1 505.94/100 000) (χ2=2490.212, P<0.001). The relative risk of the full course intervention group was 0.39, and the relative risk of stroke risk factors in the full course intervention group from low to high was 0.33, 0.43, 0.45, and 0.49, respectively. The incidence density of males in the full course intervention group was 660.76 (627.46/100 000 - 694.05/100 000), with a relative risk of 0.43, and the incidence density of female patients was 509.71/100 000 (483.37/100 000 - 536.05/100 000), with a relative risk of 0.35. The overall incidence density of the population under 62 years old gourp, 62-75 years old group and over 75 years old group was 197.45/100 000 (173.09/100 000 -221.80/100 000), 608.36/100 000 (580.19/100 000-636.54/100 000), and 1 025.06/100 000 (958.51/100 000-1 091.61/100 000), with relative risks of 0.51, 0.44, and 0.38, respectively. Conclusion Comprehensive health management measures can effectively reduce the short-term risk of ischemic stroke, and should be further promoted and improved to enhance the effectiveness of stroke prevention and control.
2.Preoperative probing and dilation in nasolacrimal silicone intubation for incomplete primary acquired nasolacrimal duct obstruction
Cheng HU ; Yin LIU ; Jing CHEN ; Jinran FANG ; Nian XIANG ; Fan DU ; Bo ZENG
International Eye Science 2026;26(8):1316-1322
AIM:To assess the influence of preoperative lacrimal passage probing and dilation on the therapeutic effectiveness of nasolacrimal silicone intubation in cases of incomplete primary acquired nasolacrimal duct obstruction(PANDO).METHODS: A retrospective case-control clinical study was conducted. The study included patients with incomplete PANDO who underwent nasolacrimal silicone intubation at the hospital between October 2022 and October 2024. Participants were categorized into two groups based on their receipt of nasolacrimal duct probing and dilation prior to intubation. Group A consisted of patients who had undergone one or more sessions of nasolacrimal duct probing and dilation before nasolacrimal silicone intubation, while Group B included patients who did not receive nasolacrimal duct probing and dilation before intubation. All patients had their nasolacrimal silicone tubes removed 3 mo postoperatively and were monitored for 6 mo following tube removal to evaluate surgical success rates.RESULTS: A total of 136 patients(152 eyes)completed the six-month follow-up period. The overall surgical success rate for both groups was 72.4%(110/152 eyes).Group A included 22 males and 36 females, mean age 58.09±11.07 y, and achieved a success rate of 82.8%(53/64 eyes), while Group B included 27 males and 51 females, mean age 59.35±8.84 y and attained a success rate of 64.8%(57/88 eyes). The difference in surgical success rates between the two groups was statistically significant(P=0.014). Furthermore, Group A achieved a complete success rate of 67.2%(43/64 eyes), compared to 47.7%(42/88 eyes)in Group B, with this difference also reaching statistical significance(P=0.017). No serious postoperative complications were observed in either group.CONCLUSION: Nasolacrimal silicone intubation is a safe and effective intervention for incomplete PANDO, with preoperative nasolacrimal duct probing and dilation potentially enhancing therapeutic outcomes.
3.Asociation between intolerance of uncertainty and severity of obsessive-compulsive symptom: the mediating role of cerebellar ALFF value
Shaoxia WANG ; Xiang ZHANG ; Shihao LU ; Yuhan LI ; Fangqing SONG ; Jianqun FANG
Sichuan Mental Health 2026;39(3):227-233
BackgroundObsessive-compulsive disorder (OCD) carries a considerable disability burden. Intolerance of uncertainty (IU) is associated with the severity of obsessive-compulsive symptoms, yet its neural underpinnings remain unclear. The cerebellum has been implicated in uncertainty processing and demonstrates structural and functional abnormalities in OCD, but direct evidence linking its spontaneous activity to the relationship between IU and obsessive-compulsive symptoms is still lacking. ObjectiveTo explore the pathway through which spontaneous cerebellar neural activity mediates the relationship between IU and obsessive-compulsive symptoms in OCD patients, with the aim of providing a new perspective for understanding the neural mechanisms of OCD. MethodsA total of 51 patients with OCD who visited the Mental Health Center outpatient clinic of the General Hospital of Ningxia Medical University from November 2022 to November 2024 and met the diagnostic criteria for OCD according to the International Classification of Diseases, tenth edition (ICD-10). During the same period, 43 community-based volunteers matched for gender and age were enrolled as the control group. Resting-state functional magnetic resonance imaging data were collected from two groups. Amplitude of low-frequency fluctuation (ALFF) analysis was used to compare whole-brain spontaneous neural activity between two groups. Clinical assessments were conducted using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Intolerance of Uncertainty Scale-12 (IUS-12). Pearson correlation analysis was used to examine correlations between cerebellar ALFF values and scale scores in OCD patients. Using IU as the independent variable, obsessive-compulsive symptoms as the dependent variable, and ALFF values from between-group difference brain regions as the mediator, Process 4.0 for SPSS 24.0 (model 4) was used to examine the mediating role of these ALFF values between IU and obsessive-compulsive symptoms. The Bootstrap method was used to test the mediation effect. ResultsA total of 47 OCD patients and 40 controls completed this study. Compared with the control group, the OCD group showed decreased ALFF values in the right cerebellar Crus Ⅱ (t=-5.254, FWE-corrected P<0.01). Correlation analysis revealed that ALFF value in the right cerebellar Crus Ⅱ was negatively correlated with Y-BOCS total score (r=-0.851), compulsive behavior subscale score (r=-0.647), IUS-12 total scores (r=-0.617), and prospective IU subscale scores (r=-0.717) in OCD group (P<0.01). Prospective IU subscale scores were positively correlated with Y-BOCS total scores (r=0.811) and compulsive behavior subscale score (r=0.535) (P<0.01). Mediation analysis showed that ALFF value in the right cerebellar Crus Ⅱ region partially mediated the effect of prospective IU on obsessive-compulsive behavior, with a mediation effect of 0.064 (95% CI: 0.004–0.136), accounting for 24.57% of the total effect. ConclusionPatients with OCD showed reduced spontaneous neural activity in the right cerebellar Crus Ⅱ region, which was significantly associated with IU and obsessive-compulsive symptoms. This region partially mediated the effect of IU on compulsive behaviors. [Funded by Basic Conditions and Innovation Platform Construction Project of Ningxia Hui Autonomous Region in 2023 (number, 2022YXGCJS001)]
4.Nomogram prediction model for the risk of ICU-acquired weakness in patients with sepsis
Zhen TAN ; Ling YANG ; Lin LI ; Tingting XIANG ; Guirong FANG ; Ying ZHOU ; Qunrong SONG
Journal of Public Health and Preventive Medicine 2026;37(5):150-154
Objective To investigate the risk factors for ICU-acquired weakness (ICU-AW) in patients with sepsis, and to construct a nomogram prediction model. Methods A total of 360 patients with sepsis admitted from January 2020 to December 2025 were enrolled as study subjects. The risk factors for ICU-AW were identified by logistic regression analysis. A nomogram prediction model was constructed, and the model was validated. Results Multivariate logistic regression analysis indicated that age, APACHE II score, duration of mechanical ventilation, duration of immobilization, duration of sedation, and NLR were risk factors for the occurrence of ICU-AW (P<0.05), while ALB was a protective factor (P<0.05). A nomogram model was constructed based on these seven variables. After validation via Bootstrap resampling, ROC curve showed an AUC of 0.949 (0.929–0.969) and a corrected AUC of 0.942 (0.940–0.948), indicating good discrimination degree of the model. Hosmer-Lemeshow test for calibration curve revealed a chi-square value of 10.188 (P=0.252), suggesting that the predicted value of fitting was generally consistent with the actual value. Decision curve analysis demonstrated that when the threshold was in the range of 0.05–0.9, the model had a good net benefit. Conclusion The nomogram prediction model for sepsis ICU-AW based on seven indicators including age, APACHE II score, NLR, ALB, and the durations of mechanical ventilation, immobilization, and sedation exhibits good predictive efficiency and stability. This nomogram prediction model is helpful for the clinical rapid screening of ICU-AW high-risk groups in patients with sepsis, and meets clinical needs for early warning and precise prevention and control.
5.Construction and evaluation of a perioperative pharmaceutical care model for orthopedic joint replacement
Ting XIANG ; Yao LIU ; Xue YANG ; Fang LIU ; Xia YANG
China Pharmacy 2026;37(18):2424-2429
OBJECTIVE To construct and evaluate a perioperative pharmaceutical care model for orthopedic joint replacement based on clinical pharmacy specialty collaboration and medication therapy management (MTM), so as to provide a reference for improving the level of clinical rational drug use and reducing medical costs.METHODS Patients undergoing orthopedic joint replacement were taken as the research subjects. A specialized collaboration group was established, consisting of the head of the clinical pharmacy group, ward-based clinical pharmacists, and multi-specialty clinical pharmacists. The practice path, service contents,and workflow of MTM for the perioperative period of orthopedic joint replacement were clarified,and a perioperative pharmaceutical care model for orthopedic joint replacement was developed. Data of patients in the orthopedic diagnosis-related groups (DRG)-IC29 group of the department of orthopedics in Daping Hospital,Army Medical University were collected from July 2022 to June 2023 (pre-intervention, 581 cases) and from July 2023 to June 2024 (post-intervention, 843 cases). The work-implementation indicators in the post-intervention period were counted, and the efficiency indicators and pharmaceutical management indicators were compared between the pre- and post-intervention periods. Meanwhile,200 patients were randomly selected from the pre-intervention and post-intervention groups, respectively, to evaluate the rate of rational medical orders.RESULTS From July 2023 to June 2024, the collaboration group implemented MTM for 843 patients undergoing orthopedic joint replacement via the established perioperative pharmaceutical care model. A total of 1 163 drug‑related problems (DRPs) were identified, and 79 patients with high medication‑related risks were screened out. The most common types of DRPs included (possible) adverse drug events/reactions (48.93%), unnecessary drug therapy (21.58%), and ineffective drug therapy (16.25%). Among the 1 163 DRPs, 895 (76.96%) were completely resolved. Compared with the pre‑intervention period, the post‑intervention period showed reductions in average hospitalization cost per case, average drug cost per case, average length of hospital stay, proportion of drug cost, utilization rate and use intensity of antibacterial agents, and per‑capita drug cost of six main drug categories. The rate of rational medical orders increased from 78.25% to 98.11%.CONCLUSIONS The perioperative pharmaceutical care model for orthopedic joint replacement based on clinical pharmacy specialty collaboration and MTM can help pharmacists identify and resolve DRPs during the perioperative period of orthopedic joint replacement,improve the level of clinical rational drug use,and reduce treatment costs.
6.Efficacy of Ureteral Dilation Versus Ureteral Reimplantation for Primary Obstructed Megaureter in Children
Jiabin JIANG ; Yin ZHANG ; Ye ZHANG ; Xiang FANG ; Daolong LI ; Peng TANG ; Tengyun LONG ; Min CHAO
Journal of Sun Yat-sen University(Medical Sciences) 2025;46(4):686-692
[Objective]To evaluate the efficacy of ureteral dilation versus ureteral reimplantation in treating pediatric primary obstructive megaureter(POM).[Methods]A retrospective analysis was conducted on clinical data of 53 pediatric patients with POM treated in the Department of Urology,Anhui Provincial Children's Hospital from April 2019 to September 2023.The cohort included 37 boys and 16 girls with 5 bilateral and 48 unilateral cases.The age ranged from 1 to 157 months,with a median age of 17.00(5.50-48.00)months.Patients were assigned to 3 groups based on the management of the ureteral stricture segment:dilation group(18 cases,19 sides),Cohen group(20 cases,24 sides),and Lich-Gregoir group(15 cases,15 sides).The duration of the operations,postoperative hospital stays,postoperative indwelling catheters,postoperative D-J stents;changes in renal pelvis anteroposterior diameter and ureteral diameter;and postoperative complications were compared to evaluate the therapeutic effects.[Results]All 53 patients successfully underwent surgery.The dilation group showed significantly shorter operative time,postoperative hospital stay,and postoperative catheterization duration compared to the Cohen and Lich-Gregoir groups(P<0.05).However,the postoperative D-J stent time was longer in the dilation group than in the other 2 groups(P<0.05).Upon follow-ups for 6-12 months after stent removal,all groups demonstrated statistically significant reductions in renal pelvis anteroposterior diameter and ureteral diameter compared to preoperative values(P<0.05).No significant differences were observed among the 3 groups in hydronephrosis resolution rates(P>0.05).Additionally,the incidence of postoperative complications(urinary tract infection,vesicoureteral reflux,and reoperation for restenosis)did not differ significantly among the groups(P>0.05).[Conclusions]Ureteral dilation demonstrated non-inferior short-term clinical efficacy compared to ureteral reimplantation in managing POM in pediatric patients.With reduced operative time,minimal invasiveness,and technical simplicity,ureteral dilation may be considered a preferential treatment option for children with POM.
7.Efficacy of dual-approach bicondylar fixation under adjustable positioning for Schatzker type IV trans-midline tibial plateau fractures
Guqi HONG ; Tianrun LYU ; Yu ZHANG ; Jiahu FANG ; Lijun SONG ; Xiang LI
Chinese Journal of Trauma 2025;41(6):580-586
Objective:To assess the clinical outcomes of dual-approach bicondylar fixation under adjustable positioning for Schatzker type IV trans-midline tibial plateau fractures.Methods:A retrospective cohort study was conducted to analyze the clinical data of 52 patients with Schatzker type IV trans-midline tibial plateau fractures admitted to First Affiliated Hospital to Nanjing Medical University from January 2014 to August 2023, including 37 males and 15 females, aged 19-68 years [(42.3±14.0)years]. All the patients were treated with the surgical scheme of anterior and medial dual-approach bicondylar internal fixation under adjustable positioning. The operation duration, intraoperative blood loss, and fracture healing time were counted. X-ray films were reviewed at 2 days after surgery for residual knee subluxation. At 2 days, 3 and 6 months after surgery, and at the last follow-up, the tibial plateau angle (TPA) and posterior slope angle (PA) were measured with follow-up X-ray films to evaluate whether there was loss of reduction. The knee function was evaluated with the American Hospital for Special Surgery (HSS) knee function score at 3 and 6 months after surgery and at the last follow-up. The anterior posterior displacement and rotation stability of the knee were evaluated with Lachman test and pivot-shift test at the last follow-up. The postoperative complications were recorded.Results:All the patients were followed up for 12-118 months [70(46, 85)months]. The operation duration was 100-180 minutes [145(120, 160)minutes], with intraoperative blood loss of 100-550 ml [(323.8±135.1)ml]. Fractures were healed well in all the patients, with the healing time of 2-4 months [3.0(2.4, 3.5)months]. None of the patients had residual subluxation by X-ray films at 2 days after surgery. There were no significant differences in TPA or PA at each time point after surgery ( P>0.05). The HSS knee function score was (69.4±4.9)points, (80.9±7.0)points, and (90.1±7.9)points at 3 and 6 months after surgery and at the last follow-up, respectively and the score gradually increased with the passage of time ( P<0.05). At the last follow-up, all the patients were negative in Lachman test and pivot-shift test. Three patients developed fat liquefaction around medial wounds after surgery, which were healed after dressing change. While the wounds were healed by first intention in the other patients. Postoperative complications such as knee instability, implant loosening, fracture or refracture not occurred. Conclusion:Dual-approach bicondylar fixation under adjustable positioning for Schatzker type IV trans-midline tibial plateau fractures has the advantages including high fracture healing rate, precise fracture reduction and fixation, satisfactory postoperative functional recovery and fewer complications, without increasing operation duration or intraoperative blood loss.
8.Acute impact of persistent high ambient fine particulate matter exposures on hospital visits for respiratory diseases from 2013 to 2018 in the Beijing-Tianjin-Hebei region and surrounding areas
Yiqi QIU ; Chen CHEN ; Jianan LI ; Yue LIANG ; Changzhen XIANG ; Huiting LING ; Jinxia YANG ; Yu WANG ; Jianlong FANG ; Jiaonan WANG ; Chen MAO ; Xiaoming SHI
Chinese Journal of Epidemiology 2025;46(6):979-985
Objective:To investigate the acute effects of persistent high exposure to atmospheric fine particulate matter (PM 2.5) on residents' outpatient visits for respiratory diseases. Methods:We collected daily outpatient records from 92 hospitals in 13 cities across the Beijing-Tianjin-Hebei region, along with daily PM 2.5, nitrogen dioxide (NO 2), and meteorological data from 2013 to 2018. Five persistent high PM 2.5 exposure scenarios were defined in terms of daily mean PM 2.5 concentrations (>75 μg/m 3 and >150 μg/m 3), duration (≥2 days and ≥3 days), and whether or not there was concurrent exposure to high levels of NO 2 (daily mean NO 2 concentration >50 μg/m 3). A two-stage statistical analysis strategy based on a generalized linear model was applied to conduct a time-series analysis to assess the exposure-response relationship between persistent high PM 2.5 exposure scenarios and residents' outpatient visits for a variety of respiratory diseases, and to estimate excess outpatient visits. Results:During the period, M ( Q1, Q3) PM 2.5 and NO 2 concentrations were 61.2 (42.3, 95.1) μg/m 3 and 40.2 (31.4, 54.4) μg/m 3, respectively, and the daily respiratory disease outpatient visits were 57 (52, 66) cases. When compared with non-permanent high PM 2.5 exposure periods, exposure scenarios with PM 2.5 >75 μg/m 3 and lasting for ≥2 days caused an increased risk of outpatient visits for respiratory diseases by 2.10% (95% CI: 1.44%-2.77%), and resulted in 43 787 (95% CI: 30 025-57 757) excess visits; in this scenario, the concurrent exposure to high levels of NO 2 had a greater acute effect on respiratory disease visits than the absence of exposure to high levels of NO 2 ( P<0.001). The risk of respiratory disease visits increased substantially by 4.41% (95% CI: 3.15%-5.68%) when the daily mean PM 2.5 concentration exceeded 150 μg/m 3 for ≥2 days. Subgroup disease analyses showed that scenarios with daily mean PM 2.5 concentrations exceeding 75 μg/m 3 for ≥3 days caused a significant increase in the risk of lower respiratory tract infections, chronic lower respiratory disease, and asthma visits. Conclusions:Sustained persistent high PM 2.5 exposure increases the risk of outpatient visits for various respiratory diseases; concurrent exposure to high concentrations of NO 2 leads to a greater risk of visiting the clinic, suggesting that the prevention and control of PM 2.5 pollution should be synchronized with the control of mobile source emissions, to synergistically manage the compound pollution of PM 2.5 and NO 2 in the atmosphere.
9.Clinical analysis of 44 patients with infantile myofibroma/myofibromatosis
Xin MENG ; Nan ZHANG ; Jiaosheng XU ; Fang WANG ; Jingyi FAN ; Xin XIANG ; Xiaofeng HAN ; Zigang XU
Chinese Journal of Dermatology 2025;58(10):957-963
Objective:To delineate clinical characteristics of infantile myofibroma/myofibromatosis (IM) .Methods:A retrospective analysis was conducted on histologically confirmed IM cases from Beijing Children's Hospital, Henan Children's Hospital, and Maternity and Child Health Care of Guangxi Zhuang Autonomous Region between August 2014 and July 2021. The clinical, pathological, imaging features, and outcomes were analyzed and summarized.Results:A total of 44 IM patients were included, comprising 28 males (63.6%) and 16 females (36.4%). Their ages at onset ( M[ Q1, Q3]) were 14.8 (4.7, 42.4) months, and 26 patients (59.1%) developed IM before the age of 1 year. Seven patients (15.9%) were initially diagnosed with IM. Skin involvement occurred in 42 patients (95.5%), of whom 30 (71.4%) presented with a solitary lesion and 12 (28.6%) with multiple lesions. Skin lesions mainly manifested as painless, firm nodules or masses. The most commonly involved extracutaneous site was the skeletal system (21/44, 47.7%). Histopathological examination of all 44 IM cases revealed a biphasic architecture pattern, characterized by the coexistence of two distinct morphologies or cell types within the tumor tissues (including spindle cell areas composed of fascicularly and densely arranged myofibroblasts, and primitive mesenchymal cell areas composed of small, round undifferentiated cells. Immunohistochemical study was performed in 42 cases; 40 (95.2%) were positive for smooth muscle actin, and 20 (47.6%) were positive for CD34. Genetic testing was conducted in 3 cases, and NOTCH mutations were identified in 2. Among the 44 patients, 30 patients (68.2%) underwent surgical excision, 5 patients (11.4%) received intralesional injections of triamcinolone acetonide, 1 patient (2.3%) received chemotherapy for intestinal involvement, and 8 patients were managed expectantly. During the follow-up of 49 (36, 60) months, lesions completely resolved in 42 cases (95.5%), while 2 cases died of pulmonary infection following chemotherapy or postoperative airway compression. Conclusions:IM predominantly affected infants and young children, with the skin and skeletal system being the most commonly involved sites. Skin lesions often manifested as firm nodules or masses, and histopathological examination was crucial for definitive diagnoses. Most IM cases exhibited favorable outcomes.
10.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.


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