1.Pathogenic Mechanisms of Spleen Deficiency-Phlegm Dampness in Obesity and Traditional Chinese Medicine Prevention and Treatment Strategies:from the Perspective of Immune Inflammation
Yumei LI ; Peng XU ; Xiaowan WANG ; Shudong CHEN ; Le YANG ; Lihua HUANG ; Chuang LI ; Qinchi HE ; Xiangxi ZENG ; Juanjuan WANG ; Wei MAO ; Ruimin TIAN
Journal of Traditional Chinese Medicine 2026;67(1):31-37
Based on spleen deficiency-phlegm dampness as the core pathogenesis of obesity, and integrating recent advances in modern medicine regarding the key role of immune inflammation in obesity, this paper proposes a multidimensional pathogenic network of "obesity-spleen deficiency-phlegm dampness-immune imbalance". Various traditional Chinese medicine (TCM) herbs that strengthen the spleen, regulate qi, and resolve phlegm and dampness can treat obesity by improving spleen-stomach transport and transformation, promoting water-damp metabolism, and regulating immune homeostasis. This highlights immune inflammation as an important entry point to elucidate the TCM concepts of "spleen deficiency-phlegm dampness" and the therapeutic principle of "strengthening the spleen and eliminating dampness to treat obesity". By systematically analyzing the intrinsic connection between "spleen deficiency generating dampness, internal accumulation of phlegm dampness" and immune dysregulation in obesity, this paper aims to provide theoretical support for TCM treatment of obesity based on dampness.
2.Epidemiological characteristics analysis of tuberculosis among college students in Yangzhou during 2020-2024
Chinese Journal of School Health 2026;47(1):109-112
Objective:
To analyze the epidemiological characteristics of pulmonary tuberculosis (PTB) among college students in Yangzhou from 2020 to 2024, so as to provide a scientific basis for developing prevention and control strategies.
Methods:
An epidemiological investigation was conducted among 162 college students with PTB, and 7 134 of their contacts were screened. Data were obtained from the tuberculosis information management system and on campus screening records. Using descriptive epidemiological methods, trends in incidence, seasonal distribution, and bacteriological characteristics were analyzed.
Results:
From 2020 to 2024, the annual average incidence of pulmonary tuberculosis among college students in Yangzhou was 29.42 per 100 000, showing an overall fluctuating downward trend ( χ 2=12.36, P <0.01). Cases were mainly concentrated in summer and autumn, with the highest proportion in autumn (41.36%, 67/162), followed by summer (23.46%, 38/162). The proportion of etiologically positive cases increased from 37.21% in 2020 to 71.43% in 2024; among positive cases, the proportion of latent tuberculosis infection (LTBI) decreased from 66.67% (10/15) to 26.67% (4/15). The etiological positive rate was higher in females than in males ( χ 2= 11.76 , P <0.01). Comparison of screening methods showed that among index cases, the LTBI detection rate of the recombinant Mycobacterium tuberculosis fusion protein skin test (C-TST) was higher than that of the tuberculin skin test (TST), but the difference was not statistically significant ( χ 2=0.65, P =0.42); among close contacts, the detection rate of TST was higher than that of C-TST (15.1%,10.1%; χ 2=5.23, P <0.05).
Conclusion
From 2020 to 2024, the annual average incidence of pulmonary tuberculosis among college students in Yangzhou showed an overall fluctuating downward trend, with differences in TB infection screening methods and gender.
3.Quality evaluation of methodological and reporting quality of clinical practice guidelines and expert consensuses on blood transfusion and blood utilization in china
Yumei YANG ; Yuting WU ; Yu TIAN ; Weifeng DING ; Jiaying WANG ; Lei YANG ; Aiyuan DU ; Xiaofeng PAN ; Xiaoshan LI ; Rong GAO ; Tingting WANG
Chinese Journal of Blood Transfusion 2026;39(7):952-962
Objective: To evaluate the methodological quality and reporting quality of clinical practice guidelines or expert consensus on blood transfusion and blood use (BTBU) in China (hereinafter referred to as "guidelines/consensus"), providing reference for the development and updating of future BTBU guidelines/consensus. Methods: A systematic search was conducted in Chinese databases such as China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP Data-base, relevant guideline release platforms, and professional association websites. BTBU-related guidelines/consensus published between January 2006 and December 2025 were included. According to the inclusion and exclusion criteria, after completing literature screening and data extraction, three evaluators independently assessed the quality of the included literature using the Scientificity, Transparency, and Applicability of Guidelines Rating Tool (STAR), the Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREE Ⅱ), and the International Practice Guideline Reporting Standards (RIGHT). Results: A total of 29 documents were included, including 5 guidelines, 22 consensus statements, and 2 protocols. The results of the STAR assessment showed that the total score was (21.7±8.8)%. The domain score ratios for registration, research protocol, funding, working group, conflict of interest, clinical question, evidence, consensus method, recommendation, accessibility and other domains were (2.2±12.1)%, 0, (36.7±25.1)%, (18.3±7.6)%, (19.2±15.3)%, (16.6±23.1)%, (15.1±6.3)%, (9.6±21.2)%, (54.3±18.4)%, (31.7±10.4)% and (10.3±31.0)%, respectively. For the AGREE Ⅱ assessment, the methodological quality of 26 articles was rated Grade B and 3 articles Grade C. The results of the RIGHT assessment indicated that the overall reporting rate of all guidelines/consensuses was (65.3±4.0)%. Conclusion: The methodological and reporting quality of current expert guidelines/consensus on BTBU in China still need improvement, and guidelines and consensus should be strictly formulated and standardized according to the standards of STAR, AGREE II and RIGHT.
4.Research progress on doctor-patient shared decision-making in chronic disease management
Mengge ZHANG ; Xiuwen HE ; Haohui SHEN ; Yilong YANG ; Yumei WANG
Chinese Medical Ethics 2026;39(7):941-950
Utilizing CiteSpace and VOSviewer, a bibliometric analysis was conducted on 1,496 articles from the China National Knowledge Infrastructure, Chinese Science and Technology periodical database, Wanfang data, and the Web of Science database spanning 2006 to 2025, systematically revealing the evolutionary patterns of knowledge regarding doctor‐patient shared decision‐making (SDM) in the field of chronic disease management. The research indicated that the number of publications at home and abroad displayed an overall upward trend, yet their development paths differed significantly. International research has formed a “core-periphery” cooperation network, with research hotspots focusing on the improvement of decision-making quality, optimization of decision-making aids, application in primary care settings, and ethical issues in decision-making. Domestic research, driven by policies, developed rapidly and paid more attention to coverage improvement and cultural adaptation, but notable gaps remained in cross-institutional cooperation and tool localization. Currently, China’s practice still encountered multiple challenges, including restricted patients’ participation willingness due to “family-oriented” cultural values, inadequate localization of decision-making aids, and imperfect decision-making support systems in primary healthcare institutions. On this basis, this paper put forward localized suggestions from three dimensions, including cultural adaptation, technological innovation, and institutional coordination. Through multi-dimensional strategies such as advocating for constructing a family-empowered decision-making model, developing decision-making aids integrated with the dialectical logic of traditional Chinese medicine, and promoting the linkage between SDM implementation and the reform of medical insurance payment methods, it was expected to connect international experience with China’s practice. This aimed to provide references for building a chronic disease decision-making model with Chinese characteristics and contribute to the “patient-centered” medical transformation.
5.Hei Xiaoyaosan Ameliorates Cognitive Impairment in Rat Model of Alzheimer's Disease by Clearing Peripheral Aβ via AMPK/SREBP2/PCSK9/LRP-1 Signaling Pathway
Zifan NIE ; Yingchuan MA ; Wenli PEI ; Yumei HAN ; Jiao YANG ; Ruixue JIN ; Qian WANG ; Huping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(22):61-73
ObjectiveTo investigate the mechanism of Hei Xiaoyaosan (HXS) in ameliorating cognitive impairment in the rat model of Alzheimer's disease (AD) by regulating the adenosine 5'-monophosphate-activated protein kinase (AMPK)/sterol regulatory element-binding protein 2 (SREBP2)/proprotein convertase subtilisin/kexin type 9 (PCSK9)/low-density lipoprotein receptor-related protein 1 (LRP-1) signaling pathway to clear amyloid-β (Aβ) from the peripheral circulation. MethodsNinety 8-week-old specific pathogen-free (SPF)-grade male Sprague-Dawley (SD) rats were acclimatized for 1 week. After acclimatization, 10 rats were randomly selected as the blank control group, and the remaining 80 rats were prepared for surgical modeling. Among the 80 rats for modeling, 70 were anesthetized and injected with 1 μL of amyloid-β1-42 (Aβ1-42) solution into the bilateral hippocampal CA1 region for the modeling of AD, and the remaining 10 were assigned to the sham operation group, which received an injection of 1 μL normal saline at the same anatomical site. The successfully modeled rats were randomly assigned into 6 groups (n=10 per group): a model group, a donepezil hydrochloride group, an acadesine (AICAR, an AMPK agonist) group, and high-, medium-, and low-dose HXS groups. After 42 consecutive days of administration intervention, the Morris water maze test and T-maze test were performed to evaluate the learning and memory abilities of rats. Fluoro-Jade B (FJB) staining was conducted to observe pathological changes of neurons in the rat hippocampus, and thioflavin S staining to quantify the area of Aβ deposition in the hippocampal region. Immunofluorescence double staining (IF-DS) was performed to detect the expression of LRP-1 and Aβ signals in the liver tissue. Enzyme-linked immunosorbent assay (ELISA) was employed to measure the levels of Aβ1-42 and soluble LRP-1 (sLRP-1) in the serum. Western blot was performed to determine the protein levels of AMPK, phosphorylated AMPK (p-AMPK), SREBP2, PCSK9, and LRP-1 in the liver tissue. Real time polymerase chain reaction(Real-time PCR) was adopted to assess the mRNA levels of AMPK, SREBP2, PCSK9, and LRP-1 in the liver tissue. ResultsCompared with the blank control group, the model group showed increased total swimming distance on day 6 and path length in the target quadrant on day 7 (P<0.01), a decreased correct alternation rate in the T-maze test (P<0.01), disarrangement of hippocampal neurons, increased FJB-positive cells (P<0.01), enlarged area of Aβ deposition (P<0.01). reduced LRP-1 fluorescence signals and enhanced Aβ fluorescence signals in the liver tissue (P<0.01), elevated serum level of Aβ1-42, declined serum level of sLRP-1 (P<0.01), downregulated protein levels of p-AMPK and LRP-1 as well as mRNA levels of AMPK and LRP-1, and upregulated protein and mRNA levels of SREBP2 and PCSK9 in the liver tissue (P<0.01). Compared with the model group, the high-dose HXS group, donepezil hydrochloride group, and AICAR group exhibited reduced total swimming distance and target quadrant path length (P<0.05, P<0.01), an increased correct alternation rate in the T-maze test (P<0.05), decreased FJB-positive cells (P<0.01), reduced Aβ deposition (P<0.01) in the hippocampal tissue, enhanced LRP-1 signals and weakened Aβ signals in the liver tissue (P<0.01), a declined serum level of Aβ1-42 and an elevated serum level of sLRP-1 (P<0.01), upregulated protein levels of p-AMPK and LRP-1 as well as mRNA levels of AMPK and LRP-1, and downregulated protein and mRNA levels of SREBP2 and PCSK9 in the liver tissue (P<0.01). ConclusionHei Xiaoyaosan can regulate the AMPK/SREBP2/PCSK9/LRP-1 signaling pathway to enhance the clearance of peripheral Aβ by the liver tissue and reduce Aβ deposition in the brain, thereby improving the learning and memory abilities of AD rats.
6.Hei Xiaoyaosan Inhibits AEP to Prevent and Treat Alzheimer's Disease
Yumei HAN ; Wenli PEI ; Zifan NIE ; Yingchuan MA ; Jiao YANG ; Huping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(22):74-82
ObjectiveTo investigate the role and mechanism of Hei Xiaoyaosan in regulating asparaginyl endopeptidase (AEP) to inhibit tau protein (tau) phosphorylation, amyloid-beta protein (Aβ) deposition, and neuroinflammation in the prevention and treatment of Alzheimer's disease (AD). MethodsNinety SPF-grade SD male rats of 8 weeks old were selected and randomly grouped as follows: 10 rats in the blank group, 10 rats in the sham group (bilateral hippocampus injected with 1 μL normal saline), and 70 rats in the modeling group (bilateral hippocampus injected with 1 μL Aβ1-42 solution for the modeling of AD). Fifty successfully modeled rats were selected and randomly assigned into the model, donepezil hydrochloride (positive control, 0.45 mg·kg-1), and high-, medium-, and low-dose (15.30, 7.65, and 3.82 g·kg-1, respectively) Hei Xiaoyaosan groups. Rats were administrated with corresponding agents by gavage once a day for 42 days. Morris water maze and Y maze tests were carried out to assess the cognitive abilities of rats. Hematoxylin-eosin (HE) staining was employed to observe morphological changes in hippocampal neurons, and immunohistochemistry (IHC) was employed to assess phosphorylation (p)-tau and Aβ expression in the hippocampal tissue of rats. Enzyme-linked immunosorbent assay (ELISA) was employed to measure the levels of interleukin-1 beta (IL-1β), interleukin-18 (IL-18), and Aβ1-42 in the hippocampal tissue. Western blot was employed to determine the protein levels of AEP, tau, phosphorylated tau (p-tau), α-Syn (α-Syn), phosphorylated α-Syn (p-α-Syn), Toll-like receptor 2 (TLR2), and NOD-like receptor thermal protein domain associated protein 3 (NLRP3). Real time polymerase chain reaction (Real-time PCR) was employed to determine the mRNA levels of AEP, tau, α-Syn, TLR2, and NLRP3. ResultsCompared with the blank group, the model group showed prolonged escape latency, a decreased percentage of time spent in the platform quadrant, and a decreased alternation rate (P<0.01), a reduced number, shrinkage, and increased vacuoles of hippocampal neurons, increased expression of p-tau and Aβ in the hippocampus (P<0.01), elevated levels of IL-1β, IL-18, and Aβ1-42, up-regulated protein and mRNA levels of AEP, tau, α-Syn, TLR2, and NLRP3, and up-regulated protein levels of p-tau and p-α-Syn (P<0.01). Compared with the model group, the positive control group and the high-dose Hei Xiaoyaosan group exhibited shortened escape latency (P<0.01), an increased percentage of retention time in the target quadrant, an increased alternation response rate (P<0.05, P<0.01), alleviated neuronal shrinkage, regular morphology and arrangement of neurons in the hippocampal tissue, lowered levels of p-tau and Aβ in the hippocampal tissue (P<0.05, P<0.01), declined levels of IL-1β, IL-18, and Aβ1-42, downregulated mRNA and protein levels of AEP, tau, α-Syn, TLR2, and NLRP3, and downregulated protein levels of p-tau and p-α-Syn (P<0.05, P<0.01). ConclusionHei Xiaoyaosan can protect hippocampal neurons and ameliorate cognitive impairment in the rat model of AD. Specifically, it may inhibit AEP to regulate tau phosphorylation, Aβ deposition, and neuroinflammation.
7.Hei Xiaoyaosan Reduces Neuroinflammation in APP/PS1 Mice via CX3CL1-CX3CR1 Signaling Axis
Yujie LYU ; Jiao YANG ; Yunyun HU ; Zhipeng MENG ; Yiqin CHEN ; Wenli PEI ; Yumei HAN ; Huping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(22):83-90
ObjectiveTo investigate the effects of Hei Xiaoyaosan on neuroinflammation in APP/PS1 mice and decipher the mechanism based on the C-X3-C chemokine ligand 1 (CX3CL1)-CX3CL1 receptor 1 (CX3CR1) signaling axis. MethodsSixty 16-week-old male APP/PS1 mice were selected and acclimatized for one week, and they were then randomly allocated into a model group, a CX3CL1 group (bilateral hippocampal injection of CX3CL1 at 0.5 g·L-1), and high-, medium-, and low-dose (22.10, 11.05, and 5.53 g·kg-1, respectively) Hei Xiaoyaosan groups, with 12 mice in each group. Twelve age-matched male C57BL/6J mice served as the blank group (bilateral hippocampal injection of an equal volume of PBS). The high-, medium-, and low-dose Hei Xiaoyaosan groups received corresponding drugs via gavage, while the blank group received an equal volume of normal saline, with an intervention period of 90 days. Morris water maze was used to assess learning and memory abilities. Nissl staining was performed to observe the pathological changes in neurons of the hippocampal CA1 region. Immunohistochemistry was adopted to detect amyloid-β1-42 (Aβ1-42) deposition in the hippocampal CA1 region. The immunofluorescence assay was employed to detect the expression of M1 and M2 microglial markers, including cluster of differentiation 86 (CD86)/ionized calcium-binding adapter molecule 1 (Iba-1) and arginase-1 (Arg1)/Iba1. Enzyme-linked immunosorbent assay (ELISA) was employed to measure the levels of interleukin-8 (IL-8) and interleukin-13 (IL-13) in the hippocampal tissue. Western blot was employed to determine the protein levels of CX3CL1, CX3CR1, CREB-binding protein (CBP), cyclic AMP response element-binding protein (CREB), phosphorylated (p)-CREB, and brain-derived neurotrophic factor (BDNF) in the hippocampal tissue. ResultsCompared with the blank group, the model group exhibited prolonged escape latency on day 5 and a reduced swimming distance in the target quadrant (P<0.01), disarrangement of hippocampal neurons, with a reduced number of cells and uneven Nissl body staining, increased CD86/Iba1 expression, decreased Arg1/Iba1 expression (P<0.01), enhanced Aβ expression (P<0.01), an elevated IL-8 level and a declined IL-13 level (P<0.01), and downregulated protein levels of CX3CL1, CX3CR1, CBP, p-CREB, and BDNF (P<0.01). Compared with the model group, all treatment groups showed shortened escape latency on day 5 and an increased swimming distance in the target quadrant (P<0.05, P<0.01), regular arrangement of neurons with an increased number and increased Nissl bodies, reduced CD86/Iba1 expression, increased Arg1/Iba1 and decreased Aβ expression (P<0.01), and a declined IL-8 level and an elevated IL-13 level (P<0.05, P<0.01). In the CX3CL1 group and the high- and medium-dose Hei Xiaoyaosan groups, the relative expression levels of CX3CL1, CX3CR1, CBP, and p-CREB were upregulated (P<0.01). In the low-dose Hei Xiaoyaosan group, the relative expression levels of CX3CL1, CX3CR1, CBP, p-CREB/CREB, and BDNF were upregulated (P<0.05, P<0.01). ConclusionHei Xiaoyaosan can improve learning and cognitive abilities in APP/PS1 mice. Specifically, it may regulate the CX3CL1/CX3CR1 signaling axis to activate the CREB/BDNF signaling pathway for the subsequent release of BDNF, modulation of microglial polarization, reduction of inflammatory cytokine levels, and attenuation of Aβ deposition.
8.Hei Xiaoyaosan Ameliorates Cognitive Impairment in Rat Model of Alzheimer's Disease by Activating Autophagy Through Regulating AMPK/ULK1 Signaling Pathway
Wenli PEI ; Yumei HAN ; Zifan NIE ; Yingchuan MA ; Ruixue JIN ; Qian WANG ; Jiao YANG ; Huping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(22):91-101
ObjectiveTo investigate the effect and mechanism of Hei Xiaoyaosan in preventing and treating Alzheimer's disease (AD) by activating autophagy through regulating the adenosine monophosphate-activated protein kinase (AMPK)/UNC-51 like autophagy activating kinase 1 (ULK1) signaling pathway. MethodsNinety 8-week-old male SPF-grade SD rats were selected and randomized into two groups: a blank control group (n=10) and a modeling group (n=80). From the modeling group, 10 rats were randomly assigned as a sham group (bilateral hippocampal injection of 1 μL normal saline), while the remaining 70 rats were injected with 1 μL Aβ1-42 solution bilaterally into the hippocampus to replicate the AD model. The Morris water maze test was conducted to screen the successfully modeled rats, which were then randomly allocated to the model, donepezil hydrochloride, 5-aminoimidazole-4-carboxamide 1-β-D-ribofuranoside (AICAR, an AMPK agonist), and high-, medium-, and low-dose Hei Xiaoyaosan groups, with 10 rats per group. After 42 days of drug intervention, the Morris water maze and open field tests were conducted to assess learning and memory abilities and motor function. Pathological changes in the hippocampal tissue were observed by Nissl staining, and autophagy-related pathological damage was examined via transmission electron microscopy (TEM). The expression of LC3 in the hippocampus was observed by immunofluorescence staining. The protein levels of AMPK, phosphorylate (p)-AMPK, ULK1, p-ULK1, p62, and autophagy related 7 (Atg7) were determined by Western blot, while the mRNA levels of AMPK and ULK1 were measured by Real-time polymerase chain reaction (Real-time PCR). ResultsCompared with the blank control group, the model group showed increased escape latency (P<0.01) and decreased platform crossings (P<0.01) on day 6 in the water maze test, reduced total distance traveled and average speed in the open field test (P<0.01), disarranged neurons with Nissl body loss and evident autophagic damage, weakened LC3 fluorescence signal (P<0.01), downregulated protein levels of p-AMPK, p-ULK1, and Atg7 and mRNA levels of AMPK and ULK1 in the hippocampus (P<0.01), and upregulated protein level of p62 (P<0.01). Compared with the model group, the positive drug group, high-dose Hei Xiaoyaosan group, and AICAR group showed decreased escape latency (P<0.05, P<0.01) and increased platform crossings (P<0.01) on day 6, and increased total distance traveled and average speed in the open field test (P<0.05). The positive drug group, high- and medium-dose Hei Xiaoyaosan groups, and the AICAR group showed alleviated cellular structural damage, regular neuronal arrangement, increased Nissl bodies, and orderly distribution of autophagosomes. Furthermore, the LC3 fluorescence intensity was enhanced in the positive drug group, high- and medium-dose Hei Xiaoyaosan groups, and the AICAR group (P<0.01). The positive drug group, high-dose Hei Xiaoyaosan group, and the AICAR group exhibited upregulated protein and mRNA levels of p-AMPK and p-ULK1 (P<0.05, P<0.01), upregulated protein level of Atg7 (P<0.05, P<0.01), and downregulated protein level of p62 (P<0.01). ConclusionHei Xiaoyaosan can improve learning and memory abilities and alleviate pathological status in the rat model of AD by regulating the AMPK/ULK1 signaling pathway, enhancing cellular autophagy, and repairing damaged nerve cells.
9.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.
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.


Result Analysis
Print
Save
E-mail