1.Jingmaiyan Granules Combined with External Application of Jinhuang Ointment in Treatment of Acute Stage Blood Heat Stasis Type Superficial Thrombophlebitis of Lower Extremities: A Randomized, Double-blind, Placebo-controlled Clinical Trial
Qiaoyilan LIANG ; Hong CHEN ; Weijing FAN ; Hongshuo SHI ; Fangfang WU ; Guobin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):196-202
ObjectiveTo evaluate the clinical efficacy and safety of Jingmaiyan granules (composed of Lonicerae Japonicae Flos, Sedi Herba, Paeoniae Radix Rubra, Moutan Cortex, Rhei Radix et Rhizoma Praeparata, and Glycyrrhizae Radix et Rhizoma) combined with external application of Jinhuang Ointment in treating acute-stage blood heat stasis type superficial thrombophlebitis (ST) of lower extremities, and to explore their effects on hemorheology and serum inflammatory factors. MethodsA randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 124 patients with lower extremity ST were randomized into two groups(62 cases in each group). The control group received external application of Jinhuang ointment and oral placebo treatment, while the observation group received external application of Jinhuang ointment and oral Jingmaiyan granules. Both groups were treated for 2 weeks. The clinical symptom scores, therapeutic efficacy of traditional Chinese medicine (TCM) syndrome, pain visual analog scale (VAS) scores, hemorheological indices [including whole blood high-shear, medium-shear, and low-shear viscosity, as well as plasma viscosity (PV)], and inflammatory factors [C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α)] were compared before and after treatment. ResultsAfter 2 weeks of treatment, the total effective rate in the observation group (98.3%, 60/62) was significantly higher than that in the control group (83.8%, 52/62), with a statistically significant difference (Z=3.512 1, P<0.05). Compared with pre-treatment scores, the scores for skin color, skin temperature, swelling, pain, and cord or nodules were significantly reduced in both groups (P<0.05), with more pronounced improvement in the observation group (P<0.05). Additionally, compared with pre-treatment levels, the whole blood viscosity (low-, medium-, and high-shear) significantly improved in both groups after treatment (P<0.05), with more marked improvement in the observation group (P<0.05). Furthermore, the plasma viscosity, CRP, IL-6, and TNF-α levels were significantly reduced in both groups after treatment (P<0.05), with more pronounced improvement observed in the observation group (P<0.05). ConclusionThe combination of external application of Jinhuang ointment and oral Jingmaiyan granules effectively improves clinical symptoms, hemorheological abnormalities, and inflammatory responses in patients with acute stage blood heat stasis type ST of lower extremities. The treatment is safe and holds clinical promotion value.
2.Expert consensus on neoadjuvant PD-1 inhibitors for locally advanced oral squamous cell carcinoma (2026)
LI Jinsong ; LIAO Guiqing ; LI Longjiang ; ZHANG Chenping ; SHANG Chenping ; ZHANG Jie ; ZHONG Laiping ; LIU Bing ; CHEN Gang ; WEI Jianhua ; JI Tong ; LI Chunjie ; LIN Lisong ; REN Guoxin ; LI Yi ; SHANG Wei ; HAN Bing ; JIANG Canhua ; ZHANG Sheng ; SONG Ming ; LIU Xuekui ; WANG Anxun ; LIU Shuguang ; CHEN Zhanhong ; WANG Youyuan ; LIN Zhaoyu ; LI Haigang ; DUAN Xiaohui ; YE Ling ; ZHENG Jun ; WANG Jun ; LV Xiaozhi ; ZHU Lijun ; CAO Haotian
Journal of Prevention and Treatment for Stomatological Diseases 2026;34(2):105-118
Oral squamous cell carcinoma (OSCC) is a common head and neck malignancy. Approximately 50% to 60% of patients with OSCC are diagnosed at a locally advanced stage (clinical staging III-IVa). Even with comprehensive and sequential treatment primarily based on surgery, the 5-year overall survival rate remains below 50%, and patients often suffer from postoperative functional impairments such as difficulties with speaking and swallowing. Programmed death receptor-1 (PD-1) inhibitors are increasingly used in the neoadjuvant treatment of locally advanced OSCC and have shown encouraging efficacy. However, clinical practice still faces key challenges, including the definition of indications, optimization of combination regimens, and standards for efficacy evaluation. Based on the latest research advances worldwide and the clinical experience of the expert group, this expert consensus systematically evaluates the application of PD-1 inhibitors in the neoadjuvant treatment of locally advanced OSCC, covering combination strategies, treatment cycles and surgical timing, efficacy assessment, use of biomarkers, management of special populations and immune related adverse events, principles for immunotherapy rechallenge, and function preservation strategies. After multiple rounds of panel discussion and through anonymous voting using the Delphi method, the following consensus statements have been formulated: 1) Neoadjuvant therapy with PD-1 inhibitors can be used preoperatively in patients with locally advanced OSCC. The preferred regimen is a PD-1 inhibitor combined with platinum based chemotherapy, administered for 2-3 cycles. 2) During the efficacy evaluation of neoadjuvant therapy, radiographic assessment should follow the dual criteria of Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune RECIST (iRECIST). After surgery, systematic pathological evaluation of both the primary lesion and regional lymph nodes is required. For combination chemotherapy regimens, PD-L1 expression and combined positive score need not be used as mandatory inclusion or exclusion criteria. 3) For special populations such as the elderly (≥ 70 years), individuals with stable HIV viral load, and carriers of chronic HBV/HCV, PD-1 inhibitors may be used cautiously under the guidance of a multidisciplinary team (MDT), with close monitoring for adverse events. 4) For patients with a poor response to neoadjuvant therapy, continuation of the original treatment regimen is not recommended; the subsequent treatment plan should be adjusted promptly after MDT assessment. Organ transplant recipients and patients with active autoimmune diseases are not recommended to receive neoadjuvant PD-1 inhibitor therapy due to the high risk of immune related activation. Rechallenge is generally not advised for patients who have experienced high risk immune related adverse events such as immune mediated myocarditis, neurotoxicity, or pneumonitis. 5) For patients with a good pathological response, individualized de escalation surgery and function preservation strategies can be explored. This consensus aims to promote the standardized, safe, and precise application of neoadjuvant PD-1 inhibitor strategies in the management of locally advanced OSCC patients.
3.Effect and mechanism of transplantation of human umbilical cord mesenchymal stem cells with overexpression of the Numb gene in treatment of cholestatic liver fibrosis
Shihao ZHANG ; Changqing ZHAO ; Mingyan YANG ; Feifei XING ; Wei LIU ; Gaofeng CHEN ; Jiamei CHEN ; Ping LIU ; Yongping MU
Journal of Clinical Hepatology 2026;42(1):80-89
ObjectiveTo investigate the effect and mechanism of transplantation of human umbilical cord mesenchymal stem cell (hUC-MSC) with overexpression of the Numb gene in the treatment of cholestatic liver fibrosis (CLF). MethodsThe technique of lentiviral transfection was used to induce the overexpression of the Numb gene in hUC-MSC (hUC-MSCNumb-OE), and hUC-MSC transfected with empty vector (hUC-MSCOE-EV) was used as negative control. Bile duct ligation (BDL) was performed to establish a rat model of CLF, and then the rats were randomly divided into BDL group, hUC-MSC group, hUC-MSCOE-EV group, and hUC-MSCNumb-OE group, while a sham-operation group was also established. The rats in the intervention groups were given a single splenic injection of the corresponding cells after BDL, and samples were collected at the end of week 4. Related indicators were measured, including serum biochemistry, liver histopathology, the content of hydroxyproline (Hyp) in the liver, hepatic stellate cell activation, ductular reaction, liver regeneration, and the expression levels of key molecules in the Numb-p53 signaling axis. A one-way analysis of variance was used for comparison of continuous data between multiple groups, and the least significant difference t-test was used for further comparison between two groups. ResultsCompared with the BDL group, the hUC-MSC group and the hUC-MSCOE-EV group had significant reductions in the levels of serum biochemical parameters (aspartate aminotransferase, gamma-glutamyl transpeptidase, total bile acid, total bilirubin, and direct bilirubin), liver fibrosis markers (the content of Hyp and the expression levels of alpha-smooth muscle actin, tumor necrosis factor-α, and transforming growth factor-beta 1), and ductular reaction markers (the expression levels of CK7 and CK19) (all P <0.05), and compared with the hUC-MSCOE-EV group, the hUC-MSCNumb-OE group had significantly greater improvements in the above indicators (all P <0.05). In addition, compared with the hUC-MSCOE-EV group, the hUC-MSCNumb-OE group had significant improvements in the expression levels of liver regeneration-related markers (albumin and hepatocyte nuclear factor 4α) and the molecules associated with the Numb-p53 signaling axis (Numb, pNumb, Mdm2, and p53) (all P <0.05). ConclusionOverexpression of the Numb gene can enhance the therapeutic effect of hUC-MSC on CLF, possibly by activating the Numb-PTBL-p53-HNF4α axis, promoting the hepatic differentiation of hUC-MSCs and subsequently enhancing liver regeneration.
4.Wumeiwan Promotes M1 Polarization of Tumor-associated Macrophages to Treat Metastatic Colorectal Cancer
Nianzhi CHEN ; Shiyun TANG ; Yuanyuan FENG ; Yan WANG ; Ningning LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):92-100
ObjectiveTo explore the effects of Wumeiwan on liver metastasis and lung metastasis of colorectal cancer and its potential mechanism. MethodsFirstly, mice were randomized into control, low-dose (20 g·kg-1) Wumeiwan, high-dose (40 g·kg-1) Wumeiwan, and paclitaxel (10 mg·kg-1) groups. Secondly, liver metastasis and lung metastasis models of colorectal cancer were established in mice. After 4 weeks of intervention, the body weight of each mouse was recorded, and the lung weight, liver weight, and survival time of mice with metastatic colorectal cancer were determined. Hematoxylin-eosin (HE) staining was employed to detect the effects of Wumeiwan on liver metastasis and lung metastasis. Real-time PCR was employed to determine the mRNA levels of M1 and M2 macrophage markers in the liver tissue. Finally, the content of M1 macrophage markers CD80 and CD86 in the liver tissue was measured by flow cytometry. ResultsCompared with the control group, Wumeiwan and paclitaxel reduced the body weight (P<0.01) and liver weight (P<0.01) and prolonged the survival of the mouse model of liver metastasis of colorectal cancer (P<0.01). In the mouse model of lung metastasis of colorectal cancer, Wumeiwan and paclitaxel also reduced the body weight (P<0.01) and lung weight (P<0.01) and extended the survival time (P<0.01). Histopathological results showed that compared with the control group, Wumeiwan inhibited the liver and lung metastases of colorectal cancer. Real-time PCR results showed that compared with the control group, Wumeiwan upregulated the mRNA levels of M1 macrophage markers IL-1β, IL-6, tumor necrosis factor-α (TNF-α), inducible nitric oxide synthase (iNOS), and prostaglandin-endoperoxide synthase 2 (PTGS2) in the liver and lung tissue of mice with liver metastasis and lung metastasis of colorectal cancer (P<0.01). Meanwhile, Wumeiwan downregulated the mRNA levels of M2 macrophage markers Arg1, CD163, and CD206 (P<0.01). Meanwhile, the flow cytometry results showed that compared with the control group, Wumeiwan increased the content of CD86 and CD80 (P<0.01). In addition, immunohistochemical results showed that Wumeiwan promoted the expression of CD86 and inhibited the expression of CD206 in the liver and lung tissue of mice with liver metastasis and lung metastasis. ConclusionWumeiwan can inhibit the liver metastasis and lung metastasis of colorectal cancer by promoting the M1 polarization of macrophages in the liver and lung of the model mice.
5.Changes in hepatic bile acid profile in a mouse model of metabolic-associated steatohepatitis induced by a high-fat, high-sugar, and high-cholesterol diet combined with carbon tetrachloride
Jingjing WANG ; Jinghua PENG ; Yu LIU ; Feipeng XU ; Wei LIU ; Hailin YANG ; Ping LIU
Journal of Clinical Hepatology 2025;41(4):661-669
ObjectiveTo compare the hepatic bile acid profile between a mouse model of metabolic-associated steatohepatitis (MASH) induced by a high-fat, high-sugar, and high-cholesterol diet combined with intraperitoneal injection of 10% carbon tetrachloride (CCl4) and MASH cases in clinical practice, and to investigate the feasibility of this model in studying drug interventions on bile acid profile in MASH. MethodsA total of 30 male C57BL/6J mice were randomly divided into control group and model group, with 15 mice in each group. The mice in the control group were given normal diet and drinking water and weekly injections of olive oil, and those in the model group were given a high-fat, high-sugar, and high-cholesterol diet, high-sugar drinking water, and weekly injections of CCl4+olive oil. At the end of weeks 8, 12, and 16, 5 mice were selected from each group to collect samples. Behavioral assessments were performed, and body weight and liver wet weight were measured; liver pathology and lipid deposition were evaluated by HE staining, SAF scoring, oil Red O staining, the semi-quantitative analysis of stained area, the serum levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and liver triglyceride (TG) content; Sirius Red staining was performed for liver tissue to assess liver fibrosis; ultra-performance liquid chromatography-tandem mass spectrometry and targeted metabolomics were used to measure the hepatic bile acid profile, including cholic acid (CA), glycocholic acid (GCA), chenodeoxycholic acid (CDCA), glycochenodeoxycholic acid (GCDCA), ursodeoxycholic acid (UDCA), tauroursodeoxycholic acid (TUDCA), hyodeoxycholic acid (HDCA), and glycodeoxycholic acid (GDCA). The independent-samples t test was used for comparison of normally distributed continuous data between two groups, and the Wilcoxon rank-sum test was used for comparison of non-normally distributed continuous data between two groups. ResultsCompared with the control group at the same time point, the model group had disheveled and dull fur, reduced activity, and relatively slow reactions at weeks 8, 12, and 16, as well as significant increases in liver wet weight (P<0.05), the serum level of ALT (P<0.05), the content of TG in the liver (P<0.05), and SAF score (P<0.05). As for the differentially expressed bile acids in liver tissue, compared with the control group at week 8, the model group had significantly higher levels of CA and CDCA and significantly lower levels of UDCA, TUDCA, HDCA, and GDCA (all P<0.05); compared with the control group at week 12, the model group had significantly higher levels of CA, GCA, CDCA, and GCDCA and significantly lower levels of UDCA and HDCA (all P<0.05); compared with the control group at week 16, the model group had significantly higher levels of CA, GCA, CDCA, GCDCA, and TUDCA and significantly lower levels of UDCA, HDCA, and GDCA (all P<0.05). As for the differentially expressed bile acids in the bile acid pool of liver tissue, compared with the control group at week 8, the model group had significantly higher levels of CA and CDCA and significantly lower levels of UDCA, TUDCA, GDCA, and HDCA (all P<0.05); compared with the control group at weeks 12 and 16, the model group had significantly higher levels of GCA and GCDCA and significantly lower levels of UDCA, GDCA, and HDCA (all P<0.05). ConclusionThere are significant changes in the hepatic bile acid profile in a mouse model of MASH induced by a high-fat, high-sugar, and high-cholesterol diet combined with CCl4, which are similar to the changes in bile acids in MASH cases in clinical practice, suggesting that this model can be used to explore the interventional effect of drugs on the bile acid profile in MASH.
6.Mechanism of action of Homebox A6 in regulating the proliferation, invasion, metastasis, and apoptosis of HepG2 hepatoma cells
Yuting LIU ; Jingyin MAI ; Tianlu HOU ; Yang CHENG
Journal of Clinical Hepatology 2025;41(4):690-697
ObjectiveTo investigate the effect of Homebox A6 (HOXA6) on the proliferation, invasion, metastasis, and apoptosis of HepG2 hepatoma cells and its association with the PI3K/AKT signaling pathway. MethodsHepG2 hepatoma cells were cultured, and HOXA6 overexpression plasmid and siRNA were constructed and transfected into cells. The cells were randomly divided into empty plasmid group, HOXA 6 overexpression group, siRNA negative control group, and siRNA HOXA6 interference group. CCK8 assay was used to measure cell proliferation, Transwell assay was used to observe cell invasion, and wound healing assay was used to observe cell migration (related proteins TIMP3, MMP9, and MMP3). Flow cytometry was used to measure cell apoptosis (related proteins BAX and BCL2), the BCA method was used to measure protein concentration, and Western Blot was used to measure the expression of related proteins. A one-way analysis of variance was used for comparison of continuous data between multiple groups, and the SNK-q test was used for further comparison between two groups. ResultsCompared with the empty plasmid group, HOXA6 overexpression significantly promoted the proliferation, invasion, and migration of HepG2 hepatoma cells (all P<0.001), and there was a significant reduction in the protein expression of TIMP3 (P<0.001), while there were significant increases in the expression levels of MMP9 and MMP3 (both P<0.001). Compared with the siRNA negative control group, HOXA6 interference significantly inhibited the proliferation, invasion, and migration of HepG2 hepatoma cells (all P<0.001), and there was a significant increase in the protein expression of TIMP3 (P<0.001), while there were significant reductions in the expression levels of MMP9 and MMP3 (both P<0.001). Flow cytometry showed that compared with the empty plasmid group, HOXA6 overexpression inhibited the apoptosis of HepG2 hepatoma cells (P<0.001), with a significant reduction in the expression of the apoptosis-related protein BAX and a significant increase in the expression of BCL2 (both P<0.001). Compared with siRNA negative control group, HOXA6 interference promoted the apoptosis of HepG2 hepatoma cells (P<0.001), with a significant increase in the expression of BAX and a significant reduction in the expression of BCL2 (both P<0.001). Compared with the empty plasmid group, the HOXA6 overexpression group had significantly higher ratios of p-AKT/AKT and p-PI3K/PI3K (both P<0.001), and compared with the siRNA negative control group, the siRNA HOXA6 interference group had significantly lower ratios of p-AKT/AKT and p-PI3K/PI3K (both P<0.001). ConclusionHOXA6 can promote the proliferation, invasion, and metastasis of HepG2 hepatoma cells and inhibit their apoptosis by activating the PI3K/AKT signaling pathway through phosphorylation.
7.Clinical Efficacy of Fuyuan Tongluo Prescription in Prevention and Treatment of Restenosis with Collateral Obstruction Syndrome After Interventional Operation of Lower Limb Arteriosclerosis Obliterans
Fangfang WU ; Xiaoyu LI ; Guobin LIU ; Hongfei WANG ; Weijing FAN ; Renyan HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):134-140
ObjectiveTo observe the effects of the Fuyuan Tongluo prescription (composed of Astragali Radix, Carthami Flos, Spatholobi Caulis, Liquidambaris Fructus, Lycopodii Herba, Centellae Herba, etc.) in the treatment of restenosis with collateral obstruction syndrome after interventional operation of lower limb arteriosclerosis obliterans, and its impact on the primary patency rate. MethodsA total of 88 patients with collateral obstruction syndrome after interventional surgery for lower limb arteriosclerosis obliterans were randomly divided into two groups. The control group (n1=44) received dual antiplatelet therapy with aspirin and clopidogrel. The observation group (n2=44) was treated with Fuyuan Tongluo prescription non-decocted granules in addition to aspirin and clopidogrel. Both groups received treatment for 24 weeks and were followed up for 36 weeks. The changes in primary patency rate, symptom scores, ankle-brachial index (ABI), coagulation function, and inflammatory markers before and after treatment were compared between the two groups. ResultsFor primary patency rate, after 36 weeks of treatment, the observation group had a significantly better primary patency rate than the control group (χ2=4.14,P<0.05). After 24 weeks of treatment, there was no significant difference in primary patency rate between the two groups. Clinical efficacy comparison: Based on symptom quantification scores, and using the Nimodipine method as a reference, the overall efficacy of the observation group was superior to that of the control group after 24 weeks of treatment (χ2=2.24,P<0.05). ABI levels: The observation group had a higher ABI than the control group after 24 and 36 weeks of treatment (P<0.05). Coagulation function indicators: After 24 and 36 weeks of treatment, D-dimer and fibrinogen levels in both groups were lower than before treatment (P<0.05). Inflammatory markers: After 24 and 36 weeks of treatment, CRP levels in the observation group were lower than those in the control group (P<0.05). There were no significant differences in white blood cell (WBC) and erythrocyte sedimentation rate (ESR) levels before and after treatment between the two groups. ConclusionAdding Fuyuan Tongluo prescription non-decocted granules to dual antiplatelet therapy can improve the primary patency rate of the affected vessels in patients with lower limb arteriosclerosis obliterans after interventional surgery. Longer use of Fuyuan Tongluo prescription can significantly improve clinical symptoms, demonstrating clinical application value.
8.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.
9.Clinical Efficacy of Fuyuan Tongluo Prescription in Prevention and Treatment of Restenosis with Collateral Obstruction Syndrome After Interventional Operation of Lower Limb Arteriosclerosis Obliterans
Fangfang WU ; Xiaoyu LI ; Guobin LIU ; Hongfei WANG ; Weijing FAN ; Renyan HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):134-140
ObjectiveTo observe the effects of the Fuyuan Tongluo prescription (composed of Astragali Radix, Carthami Flos, Spatholobi Caulis, Liquidambaris Fructus, Lycopodii Herba, Centellae Herba, etc.) in the treatment of restenosis with collateral obstruction syndrome after interventional operation of lower limb arteriosclerosis obliterans, and its impact on the primary patency rate. MethodsA total of 88 patients with collateral obstruction syndrome after interventional surgery for lower limb arteriosclerosis obliterans were randomly divided into two groups. The control group (n1=44) received dual antiplatelet therapy with aspirin and clopidogrel. The observation group (n2=44) was treated with Fuyuan Tongluo prescription non-decocted granules in addition to aspirin and clopidogrel. Both groups received treatment for 24 weeks and were followed up for 36 weeks. The changes in primary patency rate, symptom scores, ankle-brachial index (ABI), coagulation function, and inflammatory markers before and after treatment were compared between the two groups. ResultsFor primary patency rate, after 36 weeks of treatment, the observation group had a significantly better primary patency rate than the control group (χ2=4.14,P<0.05). After 24 weeks of treatment, there was no significant difference in primary patency rate between the two groups. Clinical efficacy comparison: Based on symptom quantification scores, and using the Nimodipine method as a reference, the overall efficacy of the observation group was superior to that of the control group after 24 weeks of treatment (χ2=2.24,P<0.05). ABI levels: The observation group had a higher ABI than the control group after 24 and 36 weeks of treatment (P<0.05). Coagulation function indicators: After 24 and 36 weeks of treatment, D-dimer and fibrinogen levels in both groups were lower than before treatment (P<0.05). Inflammatory markers: After 24 and 36 weeks of treatment, CRP levels in the observation group were lower than those in the control group (P<0.05). There were no significant differences in white blood cell (WBC) and erythrocyte sedimentation rate (ESR) levels before and after treatment between the two groups. ConclusionAdding Fuyuan Tongluo prescription non-decocted granules to dual antiplatelet therapy can improve the primary patency rate of the affected vessels in patients with lower limb arteriosclerosis obliterans after interventional surgery. Longer use of Fuyuan Tongluo prescription can significantly improve clinical symptoms, demonstrating clinical application value.
10.Outcome Indicators in Randomized Controlled Trials of Traditional Chinese Medicine Intervention in Ulcerative Colitis
Yasheng DENG ; Lanfang MAO ; Jiang LIN ; Yanping FAN ; Wenyue LI ; Yonghui LIU ; Zhaobing NI ; Jinzhong YU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):245-251
To systematically review randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) intervention in ulcerative colitis (UC), and analyze the characteristics of these studies and their outcome indicators, thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed, and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included, with a sample size of 44 853 participants. The largest sample size was 218 cases, and the smallest was 28 cases, with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types, the top three were large intestine dampness-heat syndrome (31.05%), spleen and kidney yang deficiency syndrome (12.47%), and spleen deficiency with dampness syndrome (9.17%). The interventions, ranked by frequency of use, included internal Chinese medicine compounds/preparations (64.5%), Chinese medicine compounds/preparations with retained enema (18.2%), internal Chinese medicine compounds/preparations + external TCM treatment (5.95%), and external TCM treatment alone (4.86%). The treatment duration was mainly 4-8 weeks (64.86%), with 61 studies (10.99%) reporting follow-up time. A total of 157 outcome indicators were used, with a frequency of 3 460 occurrences, classified into six domains: TCM syndromes and symptoms (346 occurrences, 10%), symptoms/signs (541 occurrences, 15.64%), physical and chemical examinations (2 119 occurrences, 61.24%), quality of life (107 occurrences, 3.09%), long-term prognosis (61 occurrences, 1.76%), and safety events (284 occurrences, 8.21%). The analysis reveals several limitations in the outcome indicators of TCM intervention in UC, including the lack of a basis for sample size calculation, non-standardized TCM syndrome classification, absence of trial design and registration, inadequate blinding and allocation concealment, adherence issues with interventions, imbalanced selection of surrogate and endpoint indicators, inconsistency in the timing of outcome measurements, design issues that require standardization, and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification, clear efficacy evaluation indicators, key endpoint indicators, and reasonable measurement time points. Long-term prognostic impacts, comprehensive assessments of patients' quality of life, and consideration of economic benefits should be emphasized, providing a basis for the clinical practice of TCM in the treatment of UC.


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