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Volume 45 期 2,2026 2026年第45卷第2期

    HUANG Qiuchen, WANG Lei, LAN Haibing, LI Naifang, QIAN Qing, SU Jie, ZHOU Yu, YU Hongda, YANG Haoyu, BAI Yanping

    Vol. 45, Issue 2, Pages: 149-154(2026) DOI: 10.16025/j.1674-1307.2026.02.001
    摘要:ObjectiveTo observe the efficacy and safety of Huashi Xiaoyin Decoction combined with secukinumab in the treatment of moderate-to-severe plaque psoriasis with spleen deficiency and dampness syndrome.MethodsThis study was a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 128 patients with psoriasis of the spleen deficiency and dampness syndrome treated in the dermatology departments of China-Japan Friendship Hospital, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, Beijing Hepingli Hospital, Beijing Gulou Hospital of Traditional Chinese Medicine, Changping District Hospital of Traditional Chinese Medicine, and Beijing Hospital of Integrated Traditional Chinese and Western Medicine between August 2022 and December 2023 were enrolled. Participants were randomly assigned in a 1∶1 ratio to the observation group or the control group using block randomization. Both groups received standardized subcutaneous secukinumab treatment for 24 weeks. During the first 8 weeks, the observation group received Huashi Xiaoyin Decoction, while the control group received a traditional Chinese medicine (TCM) placebo. Psoriasis Area and Severity Index (PASI) score, PASI response rates, Investigator's Global Assessment (IGA) score, Dermatology Life Quality Index (DLQI) score, and Body Surface Area (BSA) were assessed before and after treatment.ResultsAfter treatment, the BSA score in the observation group was lower than that in the control group (P<0.05). At weeks 4, 12, and 24, PASI scores in both groups were significantly reduced compared with baseline (P<0.05). At weeks 4 and 12, there were no statistically significant differences between the two groups in PASI50, PASI75, or PASI90 response rates (P>0.05). At week 24, the PASI90 response rate in the observation group was higher than that in the control group (P=0.015), while no significant differences were observed in PASI50 or PASI75 response rates (P>0.05). After treatment, DLQI scores in both groups were significantly reduced compared with baseline (P<0.05). At week 24, the IGA 0/1 response rate in the observation group was higher than that in the control group (P<0.01). The recurrence rate in the observation group was lower than that in the control group, and the median time to relapse was shorter than that in the control group (P<0.05). There was no statistically significant difference in the incidence of adverse events between the two groups (P>0.05).ConclusionHuashi Xiaoyin Decoction combined with secukinumab can significantly improve clinical symptoms, enhance quality of life, and reduce recurrence in patients with moderate-to-severe psoriasis of the spleen deficiency and dampness syndrome. Its efficacy is superior to that of secukinumab combined with a TCM placebo, with a favorable safety profile.  
    关键词:Huashi Xiaoyin Decoction;secukinumab;plaque psoriasis;traditional Chinese medicine;randomized controlled trial   
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    更新时间:2026-04-08

    XING Liang, KONG Hua, ZHANG Hua, LI Gaobiao, AN Qi, SHA Fei, CHEN Tianxin, WU Xin

    Vol. 45, Issue 2, Pages: 155-159(2026) DOI: 10.16025/j.1674-1307.2026.02.002
    摘要:ObjectiveTo observe the clinical efficacy of herbal compress therapy with modified Taohong Siwu Decoction combined with compression therapy in the treatment of venous leg ulcers (VLU) with qi deficiency-blood stasis syndrome.MethodsA total of 72 patients with VLU who visited Wangjing Hospital of the China Academy of Chinese Medical Sciences between July 2024 and February 2025 were enrolled and randomly divided into an observation group and a control group (n=36 each) using a random number table method. The control group received compression therapy, routine wound dressing changes, and health education. Based on the treatment of the control group, the observation group additionally received herbal compress therapy with modified Taohong Siwu Decoction. The treatment duration was 4 weeks or until ulcer healing (complete epithelialization). The Chronic Venous Insufficiency Questionnaire (CIVIQ) score and Venous Clinical Severity Score (VCSS) were assessed before treatment and at weeks 2 and 4. Serum levels of growth factors [platelet-derived growth factor (PDGF), epidermal growth factor (EGF), and transforming growth factor-β (TGF-β)] and extracellular matrix factors [tissue inhibitor of metalloproteinases-1 (TIMP-1) and matrix metalloproteinase-2 (MMP-2)] were measured before treatment and at week 4. Adverse events during treatment and the total effective rate after treatment were also recorded.ResultsThe total effective rate in the observation group was 91.7%, which was higher than 80.6% in the control group (P=0.021). At weeks 2 and 4, CIVIQ scores in both groups were significantly increased compared with those before treatment (P<0.05), while VCSS scores were significantly decreased (P<0.05); both CIVIQ and VCSS scores in the observation group were superior to those in the control group (P<0.05). After 4 weeks, serum levels of PDGF, EGF, and TGF-β in both groups were significantly increased compared with baseline (P<0.05), and were higher in the observation group than in the control group (P<0.05). Meanwhile, serum levels of TIMP-1 and MMP-2 in both groups were significantly decreased compared with baseline (P<0.05), and were lower in the observation group than in the control group (P<0.05). No serious adverse events occurred in either group.ConclusionHerbal compress therapy with modified Taohong Siwu Decoction demonstrates significant efficacy in the treatment of VLU, improving quality of life, regulating serum growth factors and extracellular matrix components, and exhibiting a high safety profile.  
    关键词:venous leg ulcer;modified Taohong Siwu Decoction;herbal compress therapy;qi deficiency and blood stasis;quality of life;growth factors;extracellular matrix   
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    更新时间:2026-04-08

    LEI Xulu, SUN Mingzi, LIU Sihan, LIU Yujing, GAO Jiayin, FANG Jin, ZHANG Fengchuan

    Vol. 45, Issue 2, Pages: 160-164(2026) DOI: 10.16025/j.1674-1307.2026.02.003
    摘要:ObjectiveTo observe the clinical efficacy of Meibai Yurong Decoction in the treatment of patients with chloasma characterized by kidney deficiency and blood stasis syndrome.MethodsPatients with chloasma diagnosed as kidney deficiency with blood stasis syndrome who first visited the Dermatology Department of Dongfang Hospital, Beijing University of Chinese Medicine, and the Center for Preventive Medicine and Dermatology outpatient clinic of Beijing Fengtai Integrated Traditional Chinese and Western Medicine Hospital between May 2020 and May 2025 were enrolled. A total of 357 patients were included and divided into an observation group (n=189) and a control group (n=168). The control group received oral vitamin E and vitamin C for 12 consecutive weeks. The observation group received oral Meibai Yurong Decoction for 12 consecutive weeks. The Melasma Area and Severity Index (MASI) scores, VISIA image analysis scores, distribution of Physician Global Assessment (PGA) scores after treatment, and overall clinical efficacy were compared between the two groups.ResultsAfter treatment, MASI scores in both groups were significantly reduced compared with those before treatment(P<0.05), and the MASI score in the observation group was lower than that in the control group (P<0.05). The absolute scores of spots, brown spots, and red areas in both groups were significantly decreased compared with those before treatment (P<0.01), and the absolute spot score in the observation group was lower than that in the control group (P<0.05). After treatment, in the observation group, 41.80% of patients had a PGA score of≤3 and 84.66% had a PGA score of≤4; in the control group, 16.67% had a PGA score of≤3 and 70.94% had a PGA score of≤4. The distribution of PGA scores in the observation group was superior to that in the control group (P<0.05). The total effective rate in the observation group was 82.01%, which was higher than 65.47% in the control group (P<0.05).ConclusionMeibai Yurong Decoction can effectively improve the lesion area and severity in patients with chloasma.  
    关键词:Meibai Yurong Decoction;chloasma;kidney deficiency and blood stasis syndrome   
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    更新时间:2026-04-08

    CAO Renshuang, WANG Bin, LAI Xue, LIU Huimei, LI Shan, LUO Xiaojun, HUANG Tianjiao, WANG Yuan, GAO Feng

    Vol. 45, Issue 2, Pages: 165-171(2026) DOI: 10.16025/j.1674-1307.2026.02.004
    摘要:ObjectiveTo investigate the effects of Qingjin Sanjie Formula on the methylation levels of short stature homeobox 2 (SHOX2), Ras association domain family 1 isoform A (RASSF1A), and prostaglandin E receptor 4 (PTGER4) genes in circulating tumor DNA (ctDNA) from peripheral blood of patients with intermediate- to high-risk pulmonary small nodules (PSNs), and to evaluate its potential role in early epigenetic regulation of lung cancer.MethodsBioinformatics analysis was performed based on methylation and gene expression data of lung adenocarcinoma from The Cancer Genome Atlas (TCGA) database to identify differentially methylated regions (DMRs) associated with lung cancer. Meanwhile, a prospective, single-arm clinical observational study was conducted, enrolling 23 patients with intermediate- to high-risk PSNs who met the inclusion criteria. Patients received Qingjin Sanjie Formula decoction orally, twice daily, for 12 weeks. Peripheral blood samples were collected before and after treatment to assess site-specific methylation levels of SHOX2, RASSF1A, and PTGER4 genes in ctDNA. Nodule imaging characteristics and traditional Chinese medicine (TCM) constitution scores were also recorded.ResultsBioinformatics analysis showed that the promoter region of SHOX2 was hypermethylated in lung cancer tissues and positively correlated with its gene expression, whereas hypermethylation of the promoter regions of RASSF1A and PTGER4 was associated with gene silencing. Clinical results demonstrated that after 12 weeks of intervention with Qingjin Sanjie Formula, methylation levels of SHOX2, RASSF1A, and PTGER4 in ctDNA were significantly reduced compared with baseline (P<0.05), and the methylation levels were positively correlated with the maximum diameter of pulmonary nodules. However, no significant changes were observed in TCM constitution scores or maximum nodule diameter before and after treatment (P>0.05). Subgroup analysis suggested that improvements in methylation levels were more pronounced in female patients and non-smokers.ConclusionThe methylation status of SHOX2, RASSF1A, and PTGER4 genes is closely associated with lung cancer risk. Qingjin Sanjie Formula can significantly reduce ctDNA methylation levels of these genes in patients with intermediate- to high-risk PSNs, suggesting that it may exert therapeutic effects by modulating epigenetic mechanisms.  
    关键词:Qingjin Sanjie Formula;intermediate- and high-risk pulmonary nodules;short stature homeobox 2 (SHOX2);methylation;Ras association domain family 1 isoform A (RASSF1A);prostaglandin E receptor 4 (PTGER4);circulating tumor DNA (ctDNA)   
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    更新时间:2026-04-08

    CAI Yun, SUN Chunquan, LU Zhenkai, SU Xinxin, XIE Yanming

    Vol. 45, Issue 2, Pages: 172-180(2026) DOI: 10.16025/j.1674-1307.2026.02.005
    摘要:ObjectiveTo evaluate the clinical evidence and comprehensive value of compound salvia spray in the treatment of angina pectoris in coronary heart disease, and to provide academic support for clinical and basic research.MethodUsing research methods including evidence-based medicine, questionnaire surveys, real-world studies, health technology assessment, and pharmacoeconomic evaluation, the clinical value of compound salvia spray was comprehensively assessed from nine aspects: safety, effectiveness, economy, innovation, appropriateness, accessibility, and characteristics of traditional Chinese medicine (TCM) within a “6+1” framework, as well as drug information service evaluation and overall clinical value evaluation.Result① Safety: Based on the evaluation of known risks and the adequacy of safety evidence, compound salvia spray was considered to have controllable risks and good safety, with no serious adverse reactions reported. ② Effectiveness: In terms of angina symptom markedly effective rate and electrocardiogram (ECG) markedly effective rate, compound salvia spray/aerosol monotherapy was superior to compound salvia tablets and equivalent to isosorbide dinitrate and compound salvia dripping pills. When combined with nitrate drugs, its efficacy in treating angina pectoris of coronary heart disease was comparable to that of nitrate drugs alone. In addition, compound salvia spray/aerosol monotherapy showed a faster onset in relieving angina compared with compound salvia tablets. Overall, compound salvia spray demonstrated good effectiveness with significant clinical value. ③ Economy: Compound salvia spray has been included in the National Medical Insurance Class B Catalog. Based on evaluations of evidence quality and economic value, it was considered to have high economic value, with relatively sufficient evidence and clear results. ④ Innovation: Compound salvia spray shows innovation in dosage form, route of administration, and formulation compatibility, and has been granted one national invention patent, indicating good innovation. ⑤ Appropriateness: Questionnaire survey results indicated that clinicians, nurses, pharmacists, and patients considered the drug to have good appropriateness in terms of ease of administration, technical management, and safety. ⑥ Accessibility: The daily treatment cost of compound salvia spray accounts for 0.76% of the per capita daily disposable income of urban residents and 3.11% of that of rural residents, indicating good overall accessibility. However, its availability across hospitals at different levels nationwide remains limited and requires further promotion and wider adoption. ⑦ TCM characteristics: Based on evaluation principles of TCM, the formulation demonstrates appropriate compatibility of medicinal components and strong targeted efficacy, reflecting distinctive characteristics of TCM.ConclusionCompound salvia spray demonstrates high clinical value in the treatment of angina pectoris in coronary heart disease and possesses distinctive characteristics of TCM.  
    关键词:Multi-Criteria Decision Analysis (MCDA);compound salvia spray;angina pectoris in coronary heart disease;clinical comprehensive evaluation;characteristics of traditional Chinese medicine   
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    更新时间:2026-04-08

    LI Wenjing, WANG Gesheng, YUAN Jian, LI Ruiping, LIU Yixing, WANG Qinghua, ZHENG Can, ZHAO Cong, JIANG Li

    Vol. 45, Issue 2, Pages: 181-189(2026) DOI: 10.16025/j.1674-1307.2026.02.006
    摘要:ObjectiveTo investigate the mechanisms by which Yiqi Tongluo Formula inhibits vascular intimal hyperplasia based on the angiotensin II type 1 receptor-associated protein (ATRAP)/NADPH oxidase 4 (NOX4)/reactive oxygen species (ROS) signaling pathway.MethodsRats were randomly divided into a sham operation group, a blank group, a model group, a positive drug group, and low-, medium-, and high-dose Yiqi Tongluo Formula groups (n=15 each). Except for the sham operation and blank groups, all other groups underwent balloon injury of the common carotid artery to establish a vascular intimal hyperplasia model, and the sham operation group received ligation of the external carotid artery only. No drug intervention was given to the sham operation, blank, or model groups. The positive drug group received atorvastatin calcium tablets (1.02 mg/kg). The low-, medium-, and high-dose groups were administered Yiqi Tongluo Formula at doses of 6.0, 12.0, and 24.0 g/kg (crude drug), respectively, once daily for 14 days. Hematoxylin-eosin staining was used to observe pathological changes in the common carotid artery. Luminal area (LA), area within the internal elastic lamina (IELA), and area within the external elastic lamina (EELA) were measured to calculate intimal area (IA), medial area (MA), IA/MA ratio, intimal thickness (IT), medial thickness (MT), intimal area hyperplasia rate (HRIA), and intimal thickness hyperplasia rate (HRIT). Oxidative stress-related indicators, including ROS, malondialdehyde (MDA), lactate dehydrogenase (LDH), and superoxide dismutase (SOD), were measured by ELISA. Immunofluorescence staining was used to detect protein expression of ATRAP, NOX4, smooth muscle 22α (SM22α), and osteopontin (OPN). Western blot was performed to assess the expression of ATRAP, NOX4, SM22α, OPN, matrix metalloproteinase-9 (MMP-9), and tissue inhibitor of metalloproteinases-1 (TIMP-1) in carotid artery tissues.ResultsCompared with the model group, all Yiqi Tongluo Formula groups showed reduced vascular intimal hyperplasia, with lower IA, IT, HRIA, HRIT, ROS, LDH, and MDA levels (P<0.01), and higher SOD levels (P<0.01). Protein expression of ATRAP, SM22α, and TIMP-1 was significantly increased (P<0.01), whereas expression of NOX4, OPN, and MMP-9 was significantly decreased (P<0.01).ConclusionYiqi Tongluo Formula may inhibit vascular intimal hyperplasia by regulating the ATRAP/NOX4/ROS signaling pathway, suppressing vascular smooth muscle cell (VSMC) proliferation and migration, alleviating oxidative stress, and maintaining the balance between TIMP-1 and MMP-9.  
    关键词:Yiqi Tongluo Formula;vascular intimal hyperplasia;vascular smooth muscle cells;phenotypic transformation;angiotensin Ⅱ type 1 receptor-associated protein/NADPH oxidase 4/reactive oxygen species signaling pathway   
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