1.Effect of Icariin on Myocardial Remodeling in Rats Based on Vitamin D Regulation of Dendritic Cell Phenotype
Qian LI ; Yujia CHEN ; Yan ZHOU ; Wen LI ; Liancheng GUAN ; Huanzhen WANG ; Yunzhi CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):76-85
ObjectiveTo investigate the effect of icariin (ICA) on the phenotype of dendritic cells (DCs) in heart tissue of the Dahl salt-sensitive myocardial remodeling model of rats and its regulation on the vitamin D system. MethodsMale Dahl salt-resistant rats were divided into a normal group, and male Dahl salt-sensitive rats were divided into a model group, low-, medium-, and high-dose ICA groups (30, 60, 120 mg·kg-1·d-1), and Vitamin D group (3×10-5 mg·kg-1·d-1). In addition to the normal group, the other groups were given an 8% high salt diet to establish a myocardial remodeling model and received intragastric administration after successful modelling once a day for six weeks. The dynamic changes in tail artery blood pressure were monitored, and detection of cardiac ultrasound function in rats was performed. Hematoxylin-eosin (HE) staining and Masson staining were used to observe the morphological changes in rat heart tissue. The phenotype of DCs and T helper cell 17 (Th17)/regulatory T cell (Treg) ratio were detected by flow cytometry. The mRNA and protein expression of vitamin D receptor (VDR), 1α-hydroxylase (CYP27B1), 24-hydroxylase (CYP24A1), forkhead frame protein 3 (FoxP3), solitaire receptor γt (RORγt), myocardial type Ⅰ collagen (ColⅠ), and type collagen (ColⅢ) in heart tissue was detected by real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) and Western blot. ResultsCompared with the normal group, the model group showed disordered arrangement and rupture of myocardial cells, nuclear condensation, significant edema of myocardial tissue, significant proliferation of collagen fibers in a network distribution, and a significant increase in tail artery blood pressure, left ventricular end diastolic diameter (LVEDD), and left ventricular end systolic diameter (LVESD) (P<0.05). The phenotype of cardiac DCs was CD40, CD80, and CD86, and the levels of major histocompatibility complex Ⅱ (MHC-Ⅱ), Th17 cells, and Th17/Treg were significantly increased (P<0.05). The mRNA and protein expression of CYP24A1 and RORγt in the heart, as well as the mRNA expression of ColⅠ and ColⅢ, were significantly increased (P<0.05). The left ventricular ejection fraction (LVEF), interventricular septal thickness (IVSD), and left ventricular posterior wall thickness (LVPWD) were significantly decreased (P<0.05). The phenotype of cardiac DCs such as CD11, CD11b, and Treg cells, were significantly reduced (P<0.05), while the mRNA and protein expression of cardiac VDR, CYP27B1, and FoxP3 were significantly decreased (P<0.05). Compared with the model group, the low-, medium-, and high-dose ICA groups and vitamin D group significantly reduced myocardial cell rupture and nuclear consolidation in rats. The high-dose ICA group and vitamin D group showed a small amount of myocardial cell rupture and nuclear consolidation, improving myocardial fiber arrangement to varying degrees and significantly reducing myocardial fiber rupture and proliferation. The tail artery blood pressure, LVEDD, and LVESD were significantly decreased in the low-, medium-, and high-dose ICA groups and vitamin D group (P<0.05), and the phenotype of cardiac DCs including CD40, CD80, CD86, MHC-Ⅱ, Th17 cells, and Th17/Treg were significantly decreased (P<0.05). The mRNA and protein expression of CYP24A1 and RORγt, and the mRNA expression of ColⅠ and ColⅢ in the heart were significantly decreased in the medium- and high-dose ICA groups and vitamin D group (P<0.05). The LVEF, IVSD, and LVPWD of myocardial remodeling model rats in the low-, medium-, and high-dose ICA groups and vitamin D group were significantly increased (P<0.05). The phenotypes of cardiac DCs including CD11, CD11b, and Treg cells were significantly increased in the medium- and high-dose ICA groups and the Vitamin D group (P<0.05). The mRNA and protein expressions of VDR, CYP27B1, and FoxP3 in the heart were significantly increased in the medium- and high-dose ICA groups and vitamin D group (P<0.05). ConclusionICA can regulate tail artery blood pressure, cardiac structural and functional damage, and myocardial tissue fibrosis and inhibit phenotype and functional maturation of DCs in heart tissue in the myocardial remodeling model of Dahl salt-sensitive rats. It can also affect the gene and protein expression of VDR, CYP24A1, and CYP27B1, achieving its intervention in Th17/Treg balance in the immune process of myocardial remodeling possibly by regulating vitamin D/VDR in heart tissue.
2.Meta-analysis and Grade Evidence Evaluation of Qi-reinforcing and Blood-activating/ Stasis-expelling Chinese Patent Medicines in Treatment of Coronary Microvascular Disease
Jiaping CHEN ; Juju SHANG ; Hongxu LIU ; Xiang LI ; Xiaolei LAI ; Huiwen ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):157-166
ObjectiveTo systematically evaluate the efficacy and safety of Qi-reinforcing and blood-activating/stasis-expelling Chinese patent medicines in the treatment of coronary microvascular disease (CMD). MethodsPubMed, Cochrane Library, CNKI, Wanfang Data, and VIP were searched for the randomized controlled trials (RCTs) on the treatment of CMD with Chinese patent medicines for reinforcing Qi and activating blood/expelling stasis with the time interval from inception to December 31, 2023. The primary outcome indicators included the index of microcirculatory resistance (IMR), coronary flow reserve (CFR), and corrected TIMI flow frame count (cTFC). The secondary outcome indicators included symptomatic efficacy, left ventricular ejection fraction (LVEF), hypersensitive C-reactive protein (hs-CRP), nitric oxide (NO), and adverse events. Cochrane risk-of-bias assessment tool 2.0 (RoB 2.0) and Stata 17.0 were used for literature quality evaluation and meta-analysis of the included RCTs. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used to evaluate the quality of evidence. ResultsA total of 36 RCTs were included in this study, involving 3 029 patients. Compared with conventional Western medicine alone, the combined use of Chinese patent medicines for reinforcing Qi and activating blood/expelling stasis and Western medicine reduced the IMR [mean difference (MD)=-5.93, 95% confidence interval (95%CI) [-8.73,-3.14], n=382, P<0.01], cTFC (MD=-9.35, 95%CI [-13.94,-4.76], n=618, P<0.01), and hs-CRP [standard mean difference (SMD)=-1.50, 95%CI [-1.90,-1.11], n=1 483, P<0.01], improved the CFR (SMD=1.14, 95%CI [0.08,2.19], n=304, P=0.03), symptomatic efficacy [relative risk (RR)=1.36, 95%CI [1.21,1.53], n=756, P<0.01], LVEF (MD=4.39, 95%CI [2.31,6.47], n=533, P<0.01), and NO (SMD=3.16, 95%CI [2.07,4.25], n=946, P<0.01) of CMD patients. In terms of safety, the combined therapy reduced the occurrence of adverse events in CMD patients (RR=0.49, 95%CI [0.29,0.82], n=591, P=0.01). GRADE showed moderate quality evidence for adverse events, low quality evidence for cTFC, symptomatic efficacy, LVEF, and NO, and very low quality evidence for IMR, CFR, and hs-CRP. ConclusionBased on microcirculatory function indicators, the combined use of Qi-reinforcing and blood-activating/stasis-expelling Chinese patent medicines and Western medicine may further improve the coronary microvascular function in CMD patients with good safety. The above conclusions remain to be verified with high-quality clinical trials.
3.Clinical Diseases Responding Specially to TCM Treatment: Psoriasis
Liu LIU ; Xiaoying SUN ; Mei MO ; Yaqiong ZHOU ; Bin LI ; Xiaoxiao ZHANG ; Xin LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):260-268
Psoriasis is a common chronic inflammatory systemic disease in dermatology. Its high prevalence, recurrence rate, and numerous comorbidities impose a significant physical and mental burden on patients. With the continuous advancement of modern medicine, the emergence of biological agents has improved clinical efficacy, making it possible to overcome psoriasis, in addition to classical treatments. However, in clinical practice, adverse reactions, drug resistance, recurrence rates, and immune drift cannot be ignored. Traditional Chinese medicine (TCM) has a history of thousands of years in treating psoriasis, demonstrating good efficacy, high safety, and a low recurrence rate, but a standardized management system is lacking. Therefore, the 25th Clinical Diseases Responding Specially to TCM Treatment Series (Psoriasis) Youth Salon, hosted by the Chinese Association of Chinese Medicine and organized by the Youth Committee of the Chinese Association of Chinese Medicine, invited 29 experts and scholars from TCM, Western medicine, and interdisciplinary fields to actively discuss the "Advantages, Challenges, and Clinical Transformation of TCM and Western Medicine in the Diagnosis and Treatment of Psoriasis". The experts at the meeting concluded that the advantages of TCM in the treatment of psoriasis are as follows. Firstly, in the TCM-led treatment plan, TCM's understanding of psoriasis follows the principle of combining the differentiation of disease and syndrome. This approach distinguishes the basic contradiction from the current main contradiction and enables a clear grasp of the dynamic process of psoriasis development. Based on the system of syndrome differentiation and treatment, TCM intervention is applied to address the current main contradiction, and the optimal TCM treatment plan is formulated by combining internal and external treatments. Adhering to the principle of "what is visible outside must be addressed inside", TCM can prevent and treat psoriasis comorbidities early by differentiating syndrome types. Secondly, in the integrated TCM and Western medicine treatment plan, the combination of both methods not only enhances efficacy but also reduces the adverse reactions of immunosuppressants and biological agents, lowering the recurrence rate. This conference provides a reference for the diagnosis and treatment of psoriasis using TCM and integrated TCM and Western medicine, opening up new ideas for clinical and basic research and guiding future research directions.
4.Optimization of osmotic pressure swelling method in the process of hemoglobin extraction from red blood cells
Honghui ZHANG ; Wentao ZHOU ; Shasha HAO ; Hong WANG ; Jiaxin LIU ; Chengmin YANG ; Shen LI ; Fengjuan LI
Chinese Journal of Blood Transfusion 2025;38(1):91-96
[Objective] To extract hemoglobin (Hb) from red blood cells using osmotic pressure swelling method, expected to achieve a hemoglobin dissolution rate of ≥80% and a cell membrane integrity rate of ≥70%. [Methods] Human umbilical cord blood red blood cells were used as raw materials and phosphate buffer solution was used as the swelling solution for red blood cells. A three factor three-level orthogonal experiment (n=3) was conducted to determine the optimal matching conditions for selecting the osmolality molar concentration of phosphate buffer solution, pH value of hypotonic phosphate buffer solution and volume ratio of hypotonic phosphate buffer solution to washed red blood cells. Red blood cell swelling solution samples (n=6) were prepared by the optimal matching conditions and the original process conditions. The hemoglobin dissolution rate and cell membrane integrity rate were checked. In the expanded comparative experiment, red blood cell swelling solution samples (n=6) were prepared by the optimal matching conditions and the original process conditions, which was filtered by ultrafiltration membranes. The filtration time and hemoglobin yield were checked. [Results] The optimal matching conditions for preparing red blood cell swelling solution were obtained through orthogonal experiment as follows: osmotic pressure molar concentration was 30 mOsmol/Kg, pH was 7.8, and phosphate buffer to red blood cell volume ratio was 6∶1. On the basis of the above conditions, the red blood cell swelling solution sample was compared with the original process sample: the hemoglobin dissolution rate was (82.4±1.8)% vs (78.6±3.0)% (P<0.05), and the cell membrane integrity rate was (65.8±4.0)% vs (28.7±2.3)% (P<0.05). In the expanded comparative experiment, the optimal matching conditions were compared with the original process conditions: filtration time(s) (327±9) vs (434±13) (P<0.05), and hemoglobin yield was (72.3±1.2)% vs (66.0±1.4)% (P<0.05). [Conclusion] Compared with the original preparation process, the hemoglobin extraction process which optimized through orthogonal experiments greatly reduces the cell membrane fragmentation rate and minimizes the entry of cell membrane matrix into the target solution, ensuring a slightly higher hemoglobin dissolution rate, and reducing the preparation difficulty for the subsequent cell membrane separation and further purification.
5.Research advances on traditional Chinese medicine monomers and compounds intervening in ankylosing spondy-litis-related signaling pathways
Haidong ZHOU ; Yaohong LU ; Liangshen HU ; Li GONG ; Maohua LIN ; Shipeng HAO ; Jianbin YAN ; Weihui CHEN ; Shaoyong FAN
China Pharmacy 2025;36(3):373-378
Ankylosing spondylitis is a chronic immunoinflammatory disease that mainly affects the spine and the sacroiliac joint, the mechanism of which is closely related to signaling pathways, such as osteoprotegerin (OPG)/receptor activator of nuclear factor-κB (RANK)/RANK ligand, mitogen-activated protein kinase (MAPK), Wnt/β-catenin (β-catenin), phosphoinositide 3- kinase/protein kinase B/mammalian target of rapamycin (PI3K/Akt/mTOR). Traditional Chinese medicine has the characteristics of multiple components and targets, and is widely used for the treatment of autoimmune diseases due to its low toxicity, strong specificity, and high efficacy. This review found that monomers and compounds of traditional Chinese medicine can exert anti ankylosing spondylitis effects by intervening in the aforementioned signaling pathways, regulating immune inflammatory responses, and inhibiting biological processes such as bone destruction, ectopic osteogenic differentiation, cell apoptosis, and autophagy.
6.Optimization Strategy and Practice of Traditional Chinese Medicine Compound and Its Component Compatibility
Zhihao WANG ; Wenjing ZHOU ; Chenghao FEI ; Yunlu LIU ; Yijing ZHANG ; Yue ZHAO ; Lan WANG ; Liang FENG ; Zhiyong LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):299-310
Prescription optimization is a crucial aspect in the study of traditional Chinese medicine (TCM) compounds. In recent years, the introduction of mathematical methods, data mining techniques, and artificial neural networks has provided new tools for elucidating the compatibility rules of TCM compounds. The study of TCM compounds involves numerous variables, including the proportions of different herbs, the specific extraction parts of each ingredient, and the interactions among multiple components. These factors together create a complex nonlinear dose-effect relationship. In this context, it is essential to identify methods that suit the characteristics of TCM compounds and can leverage their advantages for effective application in new drug development. This paper provided a comprehensive review of the cutting-edge optimization experimental design methods applied in recent studies of TCM compound compatibilities. The key technical issues, such as the optimization of source material selection, dosage optimization of compatible herbs, and multi-objective optimization indicators, were discussed. Furthermore, the evaluation methods for component effects were summarized during the optimization process, so as to provide scientific and practical foundations for innovative research in TCM and the development of new drugs based on TCM compounds.
7.Rehmanniae Radix Iridoid Glycosides Protect Kidneys of Diabetic Mice by Regulating TGF-β1/Smads Signaling Pathway
Hongwei ZHANG ; Ming LIU ; Huisen WANG ; Wenjing GE ; Xuexia ZHANG ; Qian ZHOU ; Huani LI ; Suqin TANG ; Gengsheng LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):56-66
ObjectiveTo investigate the protective effect of Rehmanniae Radix iridoid glycosides (RIG) on the kidney tissue of streptozotocin (STZ)-induced diabetic mice and explore the underlying mechanism. MethodsTwelve of 72 male C57BL/6J mice were randomly selected as the normal group, and the remaining 60 mice were fed with a high-fat diet for six weeks combined with injection of 60 mg·kg-1 STZ for 4 days to model type 2 diabetes mellitus. The successfully modeled mice were randomized into model, metformin (250 mg·kg-1), catalpol (100 mg·kg-1), low-dose RIG (RIG-L, 200 mg·kg-1) and high-dose RIG (RIG-H, 400 mg·kg-1) groups (n=11). Mice in each group were administrated with corresponding drugs, while those in the normal group and model group were administrated with the same dose of distilled water by gavage once a day. After 8 weeks of intervention, an oral glucose tolerance test (OGTT) was performed, and the area under the curve (AUC) was calculated. After mice were sacrificed, both kidneys were collected. The body weight, kidney weight, and fasting blood glucose (FBG) were measured. Biochemical assays were performed to measure the serum levels of triglycerides (TG), total cholesterol (TC), serum creatinine (SCr), and blood urea nitrogen (BUN). Enzyme-linked immunosorbent assay (ELISA) was employed to determine the serum level of fasting insulin (FINS), and the insulin sensitivity index (ISI) and homeostatic model assessment for insulin resistance (HOMA-IR) were calculated. The pathological changes in kidneys of mice were observed by hematoxylin-eosin staining and Masson staining. The immunohistochemical method (IHC) was employed to assess the expression of interleukin-1 (IL-1), interleukin-6 (IL-6), tumor necrosis factor-α(TNF-α), transforming growth factor-β1 (TGF-β1), and collagen-3 (ColⅢ) in the kidney tissue. The protein levels of TGF-β1, cell signal transduction molecule 3 (Smad3), matrix metalloproteinase-9 (MMP-9), and ColⅢ in kidneys of mice were determined by Western blot. ResultsCompared with the normal group, the model group showcased decreased body weight and ISI (P<0.01), increased kidney weight, FBG, AUC, FINS, HOMA-IR, TC, TG, SCr, and BUN (P<0.01), glomerular hypertrophy, capsular space narrowing, and collagen deposition in the kidney, up-regulated protein levels of IL-1, IL-6, TNF-α, TGF-β1, ColⅢ, and Smad3 (P<0.01), and down-regulated protein level of MMP-9 (P<0.01) in the kidney tissue. Compared with the model group, the treatment groups had no significant difference in the body weight and decreased kidney weight (P<0.05, P<0.01). The FBG level declined in the RIG-H group after treatment for 4-8 weeks and in the metformin, catalpol, and RIG-L groups after treatment for 6-8 weeks (P<0.01). The AUC in the RIG-L, RIG-H, and metformin groups decreased (P<0.05, P<0.01). The levels of TC, SCr, and BUN in the serum of mice in each treatment group became lowered (P<0.05, P<0.01). The level of TG declined in the RIG-L, RIG-H, and metformin groups (P<0.05, P<0.01). The serum level of FINS declined in the catalpol, RIG-L, and metformin groups (P<0.01). Compared with the model group, the treatment groups showed decreased HOMA-IR (P<0.01), increased ISI (P<0.01), alleviated pathological changes in the kidney tissue, and down-regulated expression of IL-1 and TGF-β1. In addition, the protein levels of IL-6, TNF-α, and ColⅢ in the RIG-H and metformin groups and IL-6 and TNF-α in the RIG-L group were down-regulated (P<0.05, P<0.01), and the protein levels of IL-6, TNF-α, and ColⅢ in the catalpol group and ColⅢ in the RIG-L group showed a decreasing trend without statistical difference. The protein levels of TGF-β1, Smad3, and ColⅢ in the RIG-H and metformin groups were down-regulated (P<0.01). Compared with that in the model group, the protein level of MMP-9 was up-regulated in each treatment group (P<0.01). ConclusionRIG can improve the renal structure and function of diabetic mice by regulating the TGF-β1/Smads signaling pathway.
8.Application Analysis of Animal Models of Diarrhea-predominant Irritable Bowel Syndrome Based on Data Mining
Fangli LUO ; Luqiang SUN ; Yujun HOU ; Siqi WANG ; Ying LI ; Siyuan ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):219-226
ObjectiveBased on literature data mining, this study explores the modeling elements of diarrhea-predominant irritable bowel syndrome (IBS-D) animal models in China and abroad, providing references and suggestions for improving modeling methods and evaluation indicators. MethodsRelevant literature on IBS-D animal experiments from 2014 to 2024 was retrieved through computer searches in databases such as China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, Chinese Medical Journals Full-text Database, and PubMed. Information on experimental animal species, gender, body weight, modeling methods, modeling periods, intervention controls, modeling standards, and detection indicators was organized. Microsoft Excel 2021 software was used to establish a database and perform statistical analysis to examine the characteristics of IBS-D animal models. ResultsA total of 398 articles that met the inclusion criteria were reviewed. The IBS-D animal models were predominantly established using SD rats, Wistar rats, and C57BL/6 mice. Male animals were more commonly used, with rats typically aged 6-8 weeks and mice aged 4-6 weeks. In terms of interventions, piverium bromide was the main Western medicine, Tongxieyaofang was the primary Chinese medicine, and electroacupuncture was the primary acupuncture method. Among the modeling methods, the multi-factor combined composite modeling approach was the most common. Modeling periods were mainly concentrated between 1-14 days and 15-30 days. The success criteria for modeling were mainly evaluated based on the animal's general condition, fecal appearance, visceral sensitivity, gastrointestinal motility, behavior, and pathology. Detection indicators included apparent indexes, pathological markers, biochemical indicators, oxidative stress, brain-gut peptides, neurotransmitters, inflammatory factors, immune function, intestinal permeability, autophagy, apoptosis, proteins related to relevant signaling pathways, intestinal microbiota and its metabolites, etc. ConclusionThere are various methods for establishing IBS-D animal models, but no unified and universally accepted method has been established. The operation of the same modeling methods and the evaluation standards of the models vary across studies. Based on the results of data mining, the authors suggest that the multi-factor combined composite modeling approach most closely reflects the pathophysiological processes of IBS-D, better simulating the complex clinical symptoms of IBS-D patients, such as abdominal pain and diarrhea, and has a high degree of clinical relevance. This method is relatively recommended. While animal models in general align with Western medicine standards, models incorporating traditional Chinese medicine (TCM) syndromes are relatively few. Therefore, one of the future directions for research is to establish IBS-D animal models that meet the combined clinical disease and syndrome requirements of both Western and Chinese medicine.
9.Textual Research and Application of Famous Classical Formula Huopo Xialingtang
Miao YU ; Huikang ZHANG ; Xiaofan QI ; Fuping LI ; Jichun ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):192-200
Huopo Xialingtang is a famous classical formula for treating dampness and warmth, which is included in the Catalogue of Ancient Famous Classical Formulas(The First Batch). In this paper, bibliometric methods was used to collect the literature related to Huopo Xialingtang, and 16 items of related literature were retrieved, involving five medical books, which were used to textual research on the origin, name, composition, drug dosage, preparation method, processing and main treatment symptoms of this formula. The results indicated that Huopo Xialingtang was originated from Yiyuan written by Shi Funan in the Qing dynasty, and and was later named and extended by He Lianchen. The composition of the proposed formula was consistent with the record of Yiyuan, and the origin of each Chinese materia medica was basically clear. Houpo was the dried bark and root bark of Magnolia officinalis, Zexie was the dried tubers of Alisma orientale, Kuxingren was the dried mature seeds of Prunus armeniaca, Doukou was the dried mature fruits of Amomum kravanh, the origin of Tuhuoxiang was consistent with the 2018 edition of Shanghai Standards of Processing Chinese Crud Drugs, and the origins of the remaining Chinese medicines were consistent with the 2020 edition of Chinese Pharmacopoeia. The converted dose of each Chinese medicine was 7.46 g for Agastache rugosa, 3.73 g for Magnoliae Officinalis Cortex, 8.39 g for Pinelliae Rhizoma Praeparatum cum Zingibere et Alumine, 11.19 g for Poria, 11.19 g for Armeniacae Semen Amarum, 14.92 g for Coicis Semen, 2.61 g for Amomi Fructus Rotundus, 5.60 g for Polyporus, 5.60 g for Alismatis Rhizoma, 14.92 g for Tetrapanacis Medulla. Huopo Xialingtang was initially used for the treatment of dampness and warmth at the beginning of the disease, and was later expanded to treat dampness obstruction, dampness-warming dysentery and so on, but always with the dampness-heat in the lungs and spleen as the pathogenesis. In modern times, the clinical application is more extensive, used in digestive, respiratory, endocrine, nervous system and other types of diseases, especially for chronic gastritis, stomach pain and fever. By combing the ancient literature of Huopo Xialingtang, we verified the origin of the formula and determined the key information of the prescription, which can provide literature reference for the clinical application and drug development of this formula.
10.Development of Patient Self-Reported Core Outcome Set in Community Studies on Heat-Sensitive Moxibustion for Primary Hypertension
Jianyu YOU ; Shuqing LI ; Guihua DENG ; Xu ZHOU
Journal of Traditional Chinese Medicine 2025;66(1):34-41
ObjectiveTo establish the self-reported core outcome set (COS) for patients with an example of a community study on heat-sensitive moxibustion for primary hypertension (PH), to provide a reference for the selection of effectiveness evaluation indicators in community study on heat-sensitive moxibustion. MethodsA systematic literature search was conducted to collect outcomes used in randomized controlled trials and systematic review of heat-sensitive moxibustion for PH (Jan 2021), and additional outcomes were added through patient and expert questionnaires (Feb 2021) to create a pool of outcome entries. A multidisciplinary expert Delphi survey was conducted to screen outcomes applicable to patient self-reporting (Apr 2021), and the importance of outcome indicators was rated on a 5-Point Likert Scale. Finally, patient self-reported COS was determined through a consensus conference (June 2021). ResultsA pool of patient self-reported indicators in the community study of heat-sensitive moxibustion treatment for PH was generated by standardizing and combining the outcome indicators based on the results of the literature search and the questionnaire survey, which consisted of totally 100 measurement tools or contents, excluding 51 indicators or measurement tools required measurement by specialized physicians or hospital equipment, and 49 items were retained to enter the initial list of indicator entries. For the first round of Delphi survey, the mean score for expert familiarity was 0.819, the mean score for basis of judgment was 0.710, and the expert authority coefficient was 0.765, with a total of 21 indicator measurement tools or contents deleted (significance score ≤ 75 or coefficient of variation > 0.25), 28 retained, and 3 new expert-added indicator entries added. In the second round of Delphi survey, the average score for expert familiarity was 0.859, the average score for basis for judgment was 0.763, and the expert authority coefficient was 0.811, with a total of 11 indicator measurement tools or contents deleted and 20 retained involving 5 domains. Following an expert consensus meeting, 8 outcome indicators were finalized for inclusion in the patient self-reported COS, including 6 indicators of effectiveness evaluation such as quality-of-life scores, blood pressure, traditional Chinese medicine symptom scores, cost-benefit, cardiovascular and cerebrovascular events, and adverse reactions/events, and 2 indicators of factors influencing effectiveness such as sensation of heat-sensitive moxibustion, and adherence. ConclusionIn this study, we initially established a criteria for evaluating the effectiveness in the community study on heat-sensitive moxibustion by constructing patient self-reported COS in the community study on heat-sensitive moxibustion for PH, which can provide a scientific research paradigm for the subsequent development of the community study on heat-sensitive moxibustion.

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