2.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.
3.Exploring the clinical effectiveness of fluid management strategy under lung ultrasound guidance during laparoscopic radical resection for colon cancer
Kun WANG ; Heng ZHANG ; Lei LYU ; Baiwu YANG
Chinese Journal of Postgraduates of Medicine 2025;48(12):1078-1081
Objective:To explore the clinical effect of fluid management strategy guided by lung ultrasound (LUS) during laparoscopic radical resection of colon cancer.Methods:A total of 96 patients with colon cancer diagnosed and treated in Suzhou Hospital Affiliated to Anhui Medical University (Suzhou Municipal Hospital) from November 2020 to April 2023 were retrospectively selected as the study objects, and they were divided into the control group and the study group by different treatment methods, with 48 cases in each group. Both groups underwent laparoscopic radical resection of colon cancer, the control group was given conventional fluid therapy during the operation, and the study group was given LUS-guided fluid therapy strategy. The fluid intake and outflow, postoperative rehabilitation, hemodynamic indexes and tissue perfusion indexes at different time points were compared between the two groups.Results:The intake of crystal and colloid in the study group were less than those in the control group: (1 039.84 ± 227.45) ml vs. (1 245.36 ± 241.87) ml, (598.63 ± 110.92) ml vs. (697.84 ± 135.21) ml, there were statistical differences ( P<0.05). The spontaneous breathing time and time to open eyes upon command in the study group were shorter than those in the control group: (14.26 ± 1.71) min vs. (16.30 ± 1.95) min, (19.32 ± 2.25) min vs. (22.86 ± 2.69) min, there were statistical differences ( P<0.05). At the end of surgery, the heart rate and mean arterial pressure in the study group were lower than those in the control group, while the cerebral oxygen saturation and central venous oxygen saturation were higher than those in the control group: (84.20 ± 7.19) beats/min vs. (87.41 ± 7.60) beats/min, (88.74 ± 7.21) mmHg (1 mmHg = 0.133 kPa) vs. (92.33 ± 7.65) mmHg, (76.33 ± 4.91)% vs.(73.15 ± 5.16)%,(81.16 ± 4.77)% vs.(79.16 ± 4.50)%, there were statistical differences ( P<0.05). Conclusions:The fluid therapy strategy guided by LUS can ensure adequate tissue perfusion, stabilize hemodynamics, and promote postoperative recovery.
4.Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults (version 2025)
Bobin MI ; Faqi CAO ; Weixian HU ; Wu ZHOU ; Chenchen YAN ; Hui LI ; Yun SUN ; Yuan XIONG ; Jinmi ZHAO ; Qikai HUA ; Xinbao WU ; Xieyuan JIANG ; Dianying ZHANG ; Zhongguo FU ; Dankai WU ; Guangyao LIU ; Guodong LIU ; Tengbo YU ; Jinhai TAN ; Xi CHEN ; Fengfei LIN ; Zhangyuan LIN ; Dongfa LIAO ; Aiguo WANG ; Shiwu DONG ; Gaoxing LUO ; Zhao XIE ; Dong SUN ; Dehao FU ; Yunfeng CHEN ; Changqing ZHANG ; Kun LIU ; Deye SONG ; Yongjun RUI ; Fei WU ; Ximing LIU ; Junwen WANG ; Meng ZHAO ; Biao CHE ; Bing HU ; Chengjian HE ; Guanglin WANG ; Xiao CHEN ; Guandong DAI ; Shiyuan FANG ; Wenchao SONG ; Ming CHEN ; Guanghua GUO ; Yongqing XU ; Lei YANG ; Wenqian ZHANG ; Kun ZHANG ; Xin TANG ; Hua CHEN ; Weiguo XU ; Shuquan GUO ; Yong LIU ; Xiaodong GUO ; Zhewei YE ; Liming XIONG ; Tian XIA ; Hongbin WU ; Qisheng ZHOU ; Mengfei LIU ; Yiqiang HU ; Yanjiu HAN ; Hang XUE ; Kangkang ZHA ; Wei CHEN ; Zhiyong HOU ; Bin YU ; Jiacan SU ; Peifu TANG ; Baoguo JIANG ; Guohui LIU
Chinese Journal of Trauma 2025;41(5):421-432
Postoperative infection of internal fixation of closed fractures the lower limbs in adults represents a devastating complication, characterized by diagnostic challenges, prolonged treatment duration and high disability rates. Current management of these infections faces multiple challenges, such as difficulties in early accurate diagnosis, and various controversies about the treatment plan, leading to poor overall diagnosis and treatment results. To address these issues, based on evidence-based medicine and principles with emphasis on scientific rigor, clinical applicability and innovation, the Trauma Branch of the Chinese Medical Association, Orthopedic Branch of the Chinese Medical Doctor Association, Orthopedics Branch of the Chinese Medical Association, and Trauma Orthopedics and Polytrauma Group of the Resuscitation and Emergency Committee of the Chinese Medical Doctor Association have collaboratively organized a panel of relevant experts to develop the Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults ( version 2025). The guideline proposed 10 recommendations, aiming to provide a foundation for standardized diagnosis and treatment of postoperative infection in adults with closed lower limb fractures.
5.Identify Key Mitochondrial Autophagy Genes in Schizophrenia through Integrated Bioinformatics Approaches
Kun LIAN ; Yongmei LI ; Chenglong SHI ; Yilan CHEN ; Lei ZHANG ; Wei YANG ; Xiufeng XU
Journal of Kunming Medical University 2025;46(1):23-35
Objective To utilize single-cell and peripheral blood transcriptomic data from 3D brain organoids,combined with machine learning,to analyze the role of mitochondrial autophagy genes in schizophrenia(SCZ).Methods By integrating two machine learning algorithms,we identified differentially expressed mitochondrial autophagy-related genes between schizophrenia patients and healthy controls using peripheral blood RNA sequencing data.The relationship between mitophagy gene,immune cells and inflammatory factors was further explored.Comprehensive single-cell analysis was used to explore the signaling pathways and specific transcription factors based on mitophagy genes.Results Using machine learning,seven key mitophagy genes expressed in schizophrenia patients were identified.Based on Mitoscore analysis,at the single-cell level,neurons with high mitochondrial autophagy activity(Mitohigh_Neuron)formed new interactions with endothelial cells via the SPP1 signaling pathway.Conclusion This study identified two subtypes of mitophagy and seven key mitophagy genes in schizophrenia,providing new insights into the pathogenesis of the disease.
6.Determination of Seven Kinds of Haloacetic Acids in Drinking Water by In Situ Derivatization-Headspace Gas Chromatography
Deng-Kun LI ; Han-Qing WANG ; Shu-Lin ZHUANG ; Lei LI ; Yu-Lan YANG ; Dong-Xin JIANG ; Jia-You LU ; Jun LIU
Chinese Journal of Analytical Chemistry 2025;53(8):1342-1351
Haloacetic acids(HAAs),as a class of disinfection byproducts in drinking water,pose potential threats to human health,so the rapid,accurate and simultaneous detection of HAAs is of great significance for ensuring drinking water safety.Aiming at the challenges in HAAs detection and risk analysis,a novel method for synchronous rapid detection of seven kinds of HAAs in drinking water based on in situ derivatization technology and headspace gas chromatography was developed in this study.Through single-factor optimization experiments,the optimal reaction parameters for in situ derivatization were determined,including the type and dosage of salting-out agent,the acidity of reaction system,the amount of phase transfer catalyst,the dosage of derivatization agent,and the extraction solvent volume.Methodologic validation showed that the seven kinds of HAAs exhibited excellent linear relationships within their respective detection concentration ranges(R2>0.998).The method detection limits(MDLs)ranged from 0.04 to 0.33 μg/L,and the limits of quantification(LOQs)were between 0.14 and 1.34 μg/L.For real water samples,the average spiked recoveries of the seven HAAs ranged from 90.9%to 107.7%,with relative standard deviation(RSDs)between 1.55%and 6.49%,and the HAAs contents in all tested samples were below the limits specified in the Standards for Drinking Water Quality(GB 5749-2022)of China.This method was featured with simple operation,fast analysis speed,high sensitivity,and good accuracy,providing an efficient and reliable technical support for routine monitoring of HAAs contaminants in drinking water and showing promising application value for widespread promotion.
7.Thoughts of Syndrome Differentiation and Treatment and Effect Mechanism of Haoqin Qingdantang in Treating Viral Pneumonia Based on Theory of Treating Different Diseases with Same Therapy
Xin PENG ; Haotian XU ; Lei LIANG ; Zheyu LUAN ; Hanxiao WANG ; Yihao ZHANG ; Kun YANG ; Jihong FENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):209-217
The principle of treating different diseases with the same therapy is the essence of syndrome differentiation and treatment in traditional Chinese medicine (TCM). It means that when the same pathogenic changes or the same symptoms appear in the development of different diseases, the same principles or methods can be used for treatment. Due to the complexity and high variability of viral pathogenicity, the precise and effective treatment of different types of viral pneumonia (VP) has always been a research focus and difficulty in modern medicine. VP belongs to the category of external-contraction febrile disease, warm disease, and epidemic in TCM. Haoqin Qingdantang (HQQDD) is a representative formula for clearing heat and dispelling dampness in warm diseases, and its intervention in VP caused by various viral infections has significant effects. This study, guided by the theory of treating different diseases with the same therapy, links the related studies on using HQQDD to treat different types of VP and finds that influenza virus pneumonia (IVP), severe acute respiratory syndrome (SARS), and COVID-19 all have a common pathogenic mechanism of dampness-heat at different stages of respective diseases. When these diseases are dominated by damp-heat factors, the use of HQQDD yields remarkable therapeutic effects. Modern pharmacological studies have confirmed that HQQDD can inhibit virus replication, reduce fever reactions, inhibit the expression of inflammatory mediators, and regulate immune balance. Moreover, the sovereign medicine in this formula has excellent antiviral activity, and the formula reflects rich scientific connotations of treating VP. According to the theory of treating different diseases with the same therapy and based on the effective treatment practice and modern pharmacological research of HQQDD for different types of VP, this paper mines the underlying TCM theory of treatment with the same therapy, explores the syndrome differentiation and treatment strategy and effect mechanism of this formula for different types of VP, and analyzes the treatment mechanism and characteristics, with the aim of providing evidence and reference for the clinical application and modern research of HQQDD.
8.Role of Traditional Chinese Medicine in Regulating Immune Inflammation and Microvascular Damage in Preventing Recurrence of Pneumonia During Recovery Based on Combination of Pathogenic Factors
Xin PENG ; Haotian XU ; Lei LIANG ; Zheyu LUAN ; Hanxiao WANG ; Kun YANG ; Jihong FENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):249-258
Pneumonia is an infectious disease with high morbidity and mortality worldwide, and its damage to the body is not limited to the acute phase. The theory of combination of pathogenic factors emphasizes that the combination of new pathogens and residual pathogens in the body leads to the occurrence of diseases, which generalizes the causes of recurrence during pneumonia recovery. During the recovery stage of pneumonia, pathological changes such as disturbance of immune homeostasis, persistent low-grade inflammation, and microvascular damage continue to affect the body function, impair the health and quality of life of patients, and increase the risk of secondary infection. According to the theory of traditional Chinese medicine (TCM), pneumonia is caused by deficiency, and Qi deficiency and blood stasis is the core pathogenesis in the recovery stage. At this time, the body is not full of healthy qi and still has residual pathogens, and thus it is susceptible to external pathogenic factors that lead to disease recurrence. As an important part of the TCM philosophy of treating disease before its onset, prevention of recurrence after recovery emphasizes the need for aftercare in the recovery stage to prevent disease recurrence. Based on the pathogenesis theory of combination of pathogenic factors and the pathogenesis of Qi deficiency and blood stasis, this paper discusses the effect and connotation of TCM in regulating immune inflammation and microvascular damage in preventing recurrence of pneumonia during the recovery stage, aiming to develop new ideas for effective prevention and treatment of pneumonia at this stage.
9.The observational chart for traumatic limb swelling enhances diagnostic accuracy for osteofascial compartment syndrome.
Zhi-Wei YANG ; Zhao-Di WANG ; Jun-Sheng YANG ; Liang-Cheng TONG ; Lei ZHAO ; Wei DAI ; Kun PANG ; Ying LI
Chinese Journal of Traumatology 2025;28(6):454-461
PURPOSE:
To evaluate the diagnostic accuracy of the observational chart for traumatic limb swelling (OCTLS) for osteofascial compartment syndrome (OCS).
METHODS:
This was a descriptive-longitudinal study. Data of 316 patients who underwent surgical treatment for tibial fractures in our department from January 2015 to December 2023 were collected. Patients with Gustilo type II or higher open fractures, vascular injury, or bilateral fractures were excluded from the study. Two groups of double-blinded investigators independently assessed patients for the presence of OCS using 2 distinct diagnostic methods. Three senior orthopedic trauma surgeons evaluated patients with post-fracture calf swelling for OCS and the need for fasciotomy based on clinical signs and their extensive clinical experience. Subsequently, fasciotomy was performed according to their judgment, followed by postoperative examination of muscle and soft tissue conditions. Additionally, a follow-up evaluation was conducted to assess for complications such as ischemic muscle contracture. Another 3 trained researchers used OCTLS to grade swelling severity and determine the need for fasciotomy. The final diagnostic gold standard of OCS was determined by referring to whether there was escape of muscles at fasciotomy and/or color change in the muscles or muscle necrosis intraoperatively, and neurological abnormality or contracture at the last follow-up. The results of the 2 diagnostic methods were compared with the final diagnostic result. Kappa consistency test, paired χ2 test (McNemar test), and receiver operating characteristic curve were used to evaluate the diagnostic efficacy of the 2 diagnostic methods.
RESULTS:
Of the 316 patients, 211 were finally included in the study, including 160 males and 51 females, with an average follow-up time of (14.5 ± 2.7) months. Among the 211 patients with tibial fracture-associated swelling, 42 were definitively diagnosed with OCS. Based on clinical symptoms and signs judgment, among the 65 fasciotomy patients, 38 were confirmed as correct, while among the 146 non-fasciotomy patients, 4 developed ischemic muscle contractures. Based on the OCTLS for assessment, fasciotomy was correctly recommended in 36 out of 43 cases, while 6 out of 168 non-fasciotomy patients developed OCS. Compared to the use of the gold standard, clinical signs judgment showed moderate consistency (McNemar's test p < 0.001, Kappa = 0.618, p < 0.001), whereas OCTLS demonstrated strong agreement (McNemar's test p = 1.000, Kappa = 0.808, p < 0.001). Receiver operating characteristic analysis revealed higher diagnostic accuracy for OCTLS (area under curve = 0.908, 95% CI: 0.843 - 0.972) compared to clinical signs judgment (area under curve = 0.872, 95% CI: 0.812 - 0.933). OCTLS achieved superior accuracy (93.8% vs. 85.3%, χ2 = 8.221, p < 0.001) and a lower fasciotomy rate (20.4% vs. 30.8%, χ2 = 6.023, p = 0.014).
CONCLUSION
Compared to clinical signs judgment, OCTLS significantly reduces unnecessary fasciotomy, improves diagnostic accuracy for OCS, and enables non-invasive, dynamic, and quantitative assessment, making it a valuable tool for clinical practice.
Humans
;
Compartment Syndromes/etiology*
;
Male
;
Female
;
Adult
;
Tibial Fractures/surgery*
;
Middle Aged
;
Fasciotomy
;
Edema/etiology*
;
Longitudinal Studies
;
Aged
;
Young Adult
10.Analysis of payment policies for special cases under the DRG payment mode of different regions in China
Qiang MAO ; Kun YANG ; Peng LEI
Chinese Journal of Hospital Administration 2025;41(3):203-209
Objective:To analyze the payment policies for local special cases in China under the DRG payment mode, for references for improving the construction of China′s DRG payment system.Methods:Policy texts related to DRG settlement management measures and implementation rules were searched on the official websites of the people′s governments, medical security bureaus, and health commissions of prefecture level cities, county-level cities, and DRG payment pilot cities in China. The policy release time range was from May 2019 to March 2024. Content analysis method was used to summarize the judgment criteria and payment methods for determining unstable groups, high-rate and low-rate cases in various regions.Results:This study included a total of 74 policy texts covering 76 cities. 59 cities had established judgment criteria for unstable groups, using the number of enrolled cases and the threshold for the coefficient of variation of hospitalization expenses within the group as the basis for determination; 46 cities had established relevant payment methods, 40 cities of which adopted fee-for-service, or individual payment for special diseases (whole group). 72 cities had established judgment criteria and payment methods for high-rate cases. Among them, 68 cities used " hospitalization expenses for cases are higher than the prescribed multiple of the average cost or payment standard for this disease group" as the judgment criterion, and the majority of cities (40) adopt additional benchmark points for compensation payment. 70 cities had clarified the judgment criteria and payment methods for low-rate cases. Among them, 67 cities used " hospitalization expenses for cases that are less than the prescribed multiple of the payment standard or average cost per case" as the criteria, and pay based on point conversion or fee-for-service.Conclusions:There were certain differences in the judgment criteria and payment methods for special cases among different cities, which provided valuable references for the in-depth exploration of DRG payment reform in China. We should further strengthen the innovation of special case screening methods, attach importance to disease cost accounting, and improve the construction of special case payment systems.

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