1.Evaluation of NaTto Red Yeast Rice on Regulating Blood Lipid (ENTRY) Study: A Multicenter, Double-Placebo, Double-Blinded, Randomized Controlled Trial in Chinese Adults
Shufeng CHEN ; Fangchao LIU ; Jinyue LI ; Fengchao LIANG ; Jianxin LI ; Jie CAO ; Donghua LIU ; Keyong HUANG ; Hongfan LI ; Xiangfeng LU ; Jianfeng HUANG ; Dongfeng GU
Chronic Diseases and Translational Medicine 2025;11(2):122-129
Background::Statins are the first line of treatment for dyslipidemia, but their side effects often reduce medication compliance. Natto and red yeast rice are natural ingredients with lipid-lowering effects. However, the efficacy of Natto Red Yeast Rice (NRYR) supplement in combination with statins in regulating blood lipid levels has not been fully evaluated.Methods::A multicenter, double-blinded, randomized-controlled trial was conducted among individuals with low-density lipoprotein cholesterol (LDL-C) of 3.4 to 5.0 mmol/L at six sites in China, of those at moderate risk of cardiovascular disease (CVD) are prioritized. Participants are enrolled and randomly assigned into four groups by a combination of NRYR (or its placebo) and Simvastatin (or its placebo) in a ratio of 1:1:1:1. After examination at baseline, all participants underwent intervention for 3 months and two follow-up visits at 1 month and 3 months after the intervention. The primary outcome is the change in LDL-C level at 3 months, and secondary outcomes include changes in levels of other lipid profiles and biomarkers, as well as calculated 10-year CVD risk. A total of 1136 participants were randomly assigned, of whom 1110 received the intervention.Discussion::This study may provide new evidence for the efficacy of NRYR supplement in combination with statins to regulate lipid levels and optimize lipid management.Trial Registration::Chinese Clinical Trial Registry database: registration nos. ChiCTR2200064214, ChiCTR2200064215.
2.Effect of manual lymphatic drainage on prevention and treatment of lymphedema after breast cancer surgery: a meta-analysis of randomized controlled trials
Chengfei LI ; Shiyi LI ; Hongfan DING ; Minliang CHEN
Chinese Journal of Plastic Surgery 2025;41(3):277-286
Objective:To systematically evaluate the effectiveness of manual lymphatic drainage (MLD) in the prevention and treatment of breast cancer-related lymphedema (BCRL).Methods:Randomized controlled trials (RCTs) on the application of MLD for lymphedema after breast cancer surgery were retrieved from PubMed, Embase, Web of Science, CNKI, and Wanfang databases. The search covered studies published in English and Chinese from January 1, 2000 to February 1, 2024. Literature management and screening were conducted using EndNote X9 software based on inclusion and exclusion criteria. Relevant data from the final included studies for the meta-analysis were extracted. The outcome measures included the incidence of BCRL, reduced values in upper limb volume or circumference in BCRL patients, and the incidence of axillary web syndrome (AWS). Meta-analysis was performed using RevMan 5.4 software. The incidence of BCRL and AWS was expressed as relative risk ( RR) with 95% confidence intervals ( CI), and the Mantel-Haenszel method was used to calculate pooled effect sizes. For the reduction in limb volume or circumference in BCRL patients, standard mean difference ( SMD) with 95% CI was used, and the inverse variance method was applied to calculate pooled effect sizes. A P-value of <0.05 was considered statistically significant. The I2statistic was used to assess heterogeneity among studies; a fixed-effect model was applied when I2<50%, and a random-effects model was used when I2≥50%. Results:A total of 760 studies were retrieved, and 12 RCTs involving 2 279 post-breast cancer surgery patients were ultimately included. Among them, 1 132 patients in the control group received conventional treatment or combined compression bandaging, while 1 147 patients in the experimental group received MLD in addition to the control group interventions. Moderate to high heterogeneity was observed among the studies ( I2>50%, P<0.05), and a random-effects model was used for the analysis of all outcome measures between the two groups. The result showed that compared to the control group, the experimental group had a lower incidence of BCRL ( RR=0.35, 95% CI: 0.20-0.64, Z=3.42, P<0.001), the reduction in limb volume or circumference measurements increased( SWD=-1.28, 95% CI: -2.45~-0.10, Z=2.13, P=0.030), and a lower incidence of AWS ( RR=0.20, 95% CI: 0.07-0.55, Z=3.11, P=0.002). Conclusion:MLD can significantly prevent the occurrence of lymphedema and AWS in patients after breast cancer surgery, and for patients who have already developed lymphedema, MLD can also effectively reduces the degree of swelling. However, more high quality clinical studies are still needed for further verification.
3.Investigation of physician countermeasures for mild progression after treatment with EGFR-TKI in lung adenocarcinoma
Wang QIMING ; Wang LU ; Yu HONGFAN ; Shen BO ; Chen CHENG ; Yan ZHAO ; Huang CHENG ; Wang YUMENG ; Li KAI ; Wang JING ; Shi QIULING
Chinese Journal of Clinical Oncology 2025;52(3):109-114
Objective:To investigate the views of doctors on the incidence and treatment tactics of mild progression after epithelial growth factor receptor tyrosine kinase inhibitor(EGFR-TKI)treatment in lung adenocarcinoma and provide suggestions to optimize the counter-measure strategies.Methods:Convenience sampling was used to conduct an online questionnaire survey for doctors specializing in onco-logy and respiratory diseases.Results:584 valid questionnaires were collected,and all the doctors expressed concerns regarding mild tumor progression after EGFR-TKI treatment.The coping strategies included maintaining the original TKI treatment,adding other treatments to the original TKI,changing the regimen,and performing secondary tissue biopsy,among which,most doctors chose to add other treatments to the original TKI.Conclusions:Doctors have noticed the enlargement of target lesions in still stable disease(SD)and most frequently chose to add other treatments to the original TKI as a coping strategy.This finding can provide a reference for framing future guidelines for large sample prospective clinical studies that are needed to find the most effective synergistic treatment options.
4.Differentiation and Treatment of Vascular Dementia Applying the Method of Promoting Yang
Hongfan QIU ; Weilu CUI ; Haixia LI
Journal of Traditional Chinese Medicine 2025;66(5):537-540
It is believed that the root cause of vascular dementia lies in insufficient primal yang and weakness in the circulation of blood. The key pathological factors are the mutual stagnation of phlegm and blood stasis, and the obstruction of blood vessels. The general treatment principle is to tonify qi and promote yang, expel pathogenic factors, and unblock yang. This involves supplementing the innate and acquired yang qi of the spleen and kidneys, removing pathogenic factors like phlegm, turbidity, and blood stasis, in order to restore the function of yang qi and promote the circulation of blood and qi. The basic prescription for tonifying qi and promoting yang includes Heishunpian (Lycium Ruthenicum), Zhichuanwu (Aconitum Carmichaelii), Guizhi (Cinnamomum Cassia), Renshen (Panax Ginseng), and Huangqi (Astragalus Membranaceus). Depending on the type of pathogenic excess, the treatment can be modified with Tongqiao Huoxue Decoction (通窍活血汤), adding Yujin (Curcuma Longa) and Xiangfu (Cyperus Rotundus) to invigorate blood and promote yang, or with Fabanxia (Pinellia Ternata), Chenpi (Citrus Reticulata), Zhishi (Citrus Aurantium) plus Sijunzi Decoction (四君子汤) to resolve phlegm and promote yang. Both the root and branch are treated simultaneously. When yang qi is activated, blood and qi are nourished, and when pathogenic excess is expelled, the blood vessels are unblocked. This approach aims to provide a treatment strategy for vascular dementia.
5.Psychological outcomes of patients with cutaneous vascular compromise caused by hyaluronic acid injection after sequential therapy
Guiwen ZHOU ; Hongfan DING ; Qiang FU ; Qian WU ; Pianpian LIN ; Guangdi LI ; Xiao XU ; Minliang CHEN
Chinese Journal of Medical Aesthetics and Cosmetology 2025;31(4):388-393
Objective:To investigate changes in psychological status before and after sequential therapy in patients with skin circulatory disorders following hyaluronic acid injection.Methods:A retrospective study was conducted on 17 female patients, with a mean age of 28-54 (39.5±1.2) years, admitted to the Fourth Medical Center of PLA General Hospital from December 2021 to July 2022. Patients received ultrasound-guided percutaneous arterial puncture or digital subtraction angiography (DSA) guided catheter intervention for hyaluronidase injection, alongside corticosteroid pulse therapy, diuretic administration, neurotrophic support, wound protection, and laser therapy. Psychological assessments, including the Minnesota multiphasic personality inventory (MMPI) and symptom check list-90 (SCL-90), were performed at admission and 30-45 days post-discharge. Changes in assessment scores and patient satisfaction were analyzed.Results:Two patients failed to complete all assessments, leaving 15 cases for final analysis. Affected anatomical regions included the nose/perinasal area (13 cases), temporal region (3 cases), lips (3 cases), and forehead (7 cases). MMPI scores for hypochondriasis, depression, hysteria, psychopathic deviation, paranoia, psychasthenia, and hypomania showed statistically significant reductions compared to baseline (all P<0.05). SCL-90 scores for somatization, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and sleep/appetite disturbances also demonstrated significant decreases (all P<0.05). Among the 15 patients, 7 patients reported being very satisfied, 6 patients were satisfied, and 2 patients were moderately satisfied, with no dissatisfaction reported. Conclusion:Sequential therapy is associated with improved psychological outcomes in patients with skin circulatory disorders secondary to hyaluronic acid injection.
6.Evaluation of NaTto Red Yeast Rice on Regulating Blood Lipid (ENTRY) Study: A Multicenter, Double-Placebo, Double-Blinded, Randomized Controlled Trial in Chinese Adults
Shufeng CHEN ; Fangchao LIU ; Jinyue LI ; Fengchao LIANG ; Jianxin LI ; Jie CAO ; Donghua LIU ; Keyong HUANG ; Hongfan LI ; Xiangfeng LU ; Jianfeng HUANG ; Dongfeng GU
Chronic Diseases and Translational Medicine 2025;11(2):122-129
Background::Statins are the first line of treatment for dyslipidemia, but their side effects often reduce medication compliance. Natto and red yeast rice are natural ingredients with lipid-lowering effects. However, the efficacy of Natto Red Yeast Rice (NRYR) supplement in combination with statins in regulating blood lipid levels has not been fully evaluated.Methods::A multicenter, double-blinded, randomized-controlled trial was conducted among individuals with low-density lipoprotein cholesterol (LDL-C) of 3.4 to 5.0 mmol/L at six sites in China, of those at moderate risk of cardiovascular disease (CVD) are prioritized. Participants are enrolled and randomly assigned into four groups by a combination of NRYR (or its placebo) and Simvastatin (or its placebo) in a ratio of 1:1:1:1. After examination at baseline, all participants underwent intervention for 3 months and two follow-up visits at 1 month and 3 months after the intervention. The primary outcome is the change in LDL-C level at 3 months, and secondary outcomes include changes in levels of other lipid profiles and biomarkers, as well as calculated 10-year CVD risk. A total of 1136 participants were randomly assigned, of whom 1110 received the intervention.Discussion::This study may provide new evidence for the efficacy of NRYR supplement in combination with statins to regulate lipid levels and optimize lipid management.Trial Registration::Chinese Clinical Trial Registry database: registration nos. ChiCTR2200064214, ChiCTR2200064215.
7.Effect of manual lymphatic drainage on prevention and treatment of lymphedema after breast cancer surgery: a meta-analysis of randomized controlled trials
Chengfei LI ; Shiyi LI ; Hongfan DING ; Minliang CHEN
Chinese Journal of Plastic Surgery 2025;41(3):277-286
Objective:To systematically evaluate the effectiveness of manual lymphatic drainage (MLD) in the prevention and treatment of breast cancer-related lymphedema (BCRL).Methods:Randomized controlled trials (RCTs) on the application of MLD for lymphedema after breast cancer surgery were retrieved from PubMed, Embase, Web of Science, CNKI, and Wanfang databases. The search covered studies published in English and Chinese from January 1, 2000 to February 1, 2024. Literature management and screening were conducted using EndNote X9 software based on inclusion and exclusion criteria. Relevant data from the final included studies for the meta-analysis were extracted. The outcome measures included the incidence of BCRL, reduced values in upper limb volume or circumference in BCRL patients, and the incidence of axillary web syndrome (AWS). Meta-analysis was performed using RevMan 5.4 software. The incidence of BCRL and AWS was expressed as relative risk ( RR) with 95% confidence intervals ( CI), and the Mantel-Haenszel method was used to calculate pooled effect sizes. For the reduction in limb volume or circumference in BCRL patients, standard mean difference ( SMD) with 95% CI was used, and the inverse variance method was applied to calculate pooled effect sizes. A P-value of <0.05 was considered statistically significant. The I2statistic was used to assess heterogeneity among studies; a fixed-effect model was applied when I2<50%, and a random-effects model was used when I2≥50%. Results:A total of 760 studies were retrieved, and 12 RCTs involving 2 279 post-breast cancer surgery patients were ultimately included. Among them, 1 132 patients in the control group received conventional treatment or combined compression bandaging, while 1 147 patients in the experimental group received MLD in addition to the control group interventions. Moderate to high heterogeneity was observed among the studies ( I2>50%, P<0.05), and a random-effects model was used for the analysis of all outcome measures between the two groups. The result showed that compared to the control group, the experimental group had a lower incidence of BCRL ( RR=0.35, 95% CI: 0.20-0.64, Z=3.42, P<0.001), the reduction in limb volume or circumference measurements increased( SWD=-1.28, 95% CI: -2.45~-0.10, Z=2.13, P=0.030), and a lower incidence of AWS ( RR=0.20, 95% CI: 0.07-0.55, Z=3.11, P=0.002). Conclusion:MLD can significantly prevent the occurrence of lymphedema and AWS in patients after breast cancer surgery, and for patients who have already developed lymphedema, MLD can also effectively reduces the degree of swelling. However, more high quality clinical studies are still needed for further verification.
8.Investigation of physician countermeasures for mild progression after treatment with EGFR-TKI in lung adenocarcinoma
Wang QIMING ; Wang LU ; Yu HONGFAN ; Shen BO ; Chen CHENG ; Yan ZHAO ; Huang CHENG ; Wang YUMENG ; Li KAI ; Wang JING ; Shi QIULING
Chinese Journal of Clinical Oncology 2025;52(3):109-114
Objective:To investigate the views of doctors on the incidence and treatment tactics of mild progression after epithelial growth factor receptor tyrosine kinase inhibitor(EGFR-TKI)treatment in lung adenocarcinoma and provide suggestions to optimize the counter-measure strategies.Methods:Convenience sampling was used to conduct an online questionnaire survey for doctors specializing in onco-logy and respiratory diseases.Results:584 valid questionnaires were collected,and all the doctors expressed concerns regarding mild tumor progression after EGFR-TKI treatment.The coping strategies included maintaining the original TKI treatment,adding other treatments to the original TKI,changing the regimen,and performing secondary tissue biopsy,among which,most doctors chose to add other treatments to the original TKI.Conclusions:Doctors have noticed the enlargement of target lesions in still stable disease(SD)and most frequently chose to add other treatments to the original TKI as a coping strategy.This finding can provide a reference for framing future guidelines for large sample prospective clinical studies that are needed to find the most effective synergistic treatment options.
9.Psychological outcomes of patients with cutaneous vascular compromise caused by hyaluronic acid injection after sequential therapy
Guiwen ZHOU ; Hongfan DING ; Qiang FU ; Qian WU ; Pianpian LIN ; Guangdi LI ; Xiao XU ; Minliang CHEN
Chinese Journal of Medical Aesthetics and Cosmetology 2025;31(4):388-393
Objective:To investigate changes in psychological status before and after sequential therapy in patients with skin circulatory disorders following hyaluronic acid injection.Methods:A retrospective study was conducted on 17 female patients, with a mean age of 28-54 (39.5±1.2) years, admitted to the Fourth Medical Center of PLA General Hospital from December 2021 to July 2022. Patients received ultrasound-guided percutaneous arterial puncture or digital subtraction angiography (DSA) guided catheter intervention for hyaluronidase injection, alongside corticosteroid pulse therapy, diuretic administration, neurotrophic support, wound protection, and laser therapy. Psychological assessments, including the Minnesota multiphasic personality inventory (MMPI) and symptom check list-90 (SCL-90), were performed at admission and 30-45 days post-discharge. Changes in assessment scores and patient satisfaction were analyzed.Results:Two patients failed to complete all assessments, leaving 15 cases for final analysis. Affected anatomical regions included the nose/perinasal area (13 cases), temporal region (3 cases), lips (3 cases), and forehead (7 cases). MMPI scores for hypochondriasis, depression, hysteria, psychopathic deviation, paranoia, psychasthenia, and hypomania showed statistically significant reductions compared to baseline (all P<0.05). SCL-90 scores for somatization, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, and sleep/appetite disturbances also demonstrated significant decreases (all P<0.05). Among the 15 patients, 7 patients reported being very satisfied, 6 patients were satisfied, and 2 patients were moderately satisfied, with no dissatisfaction reported. Conclusion:Sequential therapy is associated with improved psychological outcomes in patients with skin circulatory disorders secondary to hyaluronic acid injection.
10.Effects of hydrogel loaded with gene-modified stem cell exosomes on radioactive skin injury
Boyuan REN ; Qiang LI ; Jiayan JIN ; Yichen WANG ; Hongfan DING ; Jide JIN
Military Medical Sciences 2024;48(5):325-333
Objective To evaluate the therapeutic effect of poloxamer hydrogel loaded with exosomes derived from human dental pulp stem cells genetically modified with human hepatocyte growth factor against radiation skin injuries.Methods Human dental pulp stem cells derived exosomes(DPSC-Exo)and hepatocyte growth factor modified DPSC-Exo(HGF-DPSC-Exo)were extracted via ultracentrifugation separation,identified in terms of particle size and morphology,and analyzed separately by means of nanoparticle tracking analysis and scanning electron microscopy(SEM),while exosome marker proteins were determined by Western blot.Then,the effect of exosomes on radiation-damaged skin cells was assessed.The poloxamer hydrogel was prepared and its safety was evaluated with CCK-8.A mouse model of injury combined with radiation injury was established,and the therapeutic effect of hydrogel loaded with exosomes was determined based on wound size,HE and Masson staining.Furthermore,the underlining therapeutic mechanism was explored with Tunnel assay,malondialdehyde content and peroxidase activity.Results The diameter exosomes ranged from 30 to 150 nm and their morphology was a disc-shaped vesicle under SEM.Moreover,CD9,CD63 and TSG101 were expressed.The results of cellular experiments showed that exosomes significantly promoted the proliferation and migration of radiation-damaged skin keratinocytes and fibroblasts,and reduced their apoptosis.HGF modification enhanced the healing effect of exosomes.Poloxamer hydrogel showed good temperature-sensitive properties and biocompatibility.The results of animal experiments showed that exosomes significantly accelerated the healing of radiation-combined injuries in mice,inhibited inflammatory infiltration and mitigated collagen deposition in the wound.Interestingly,the healing effect in the group treated with hydrogel loaded with exosomes was the best.The underlining mechanism was possibly related to promotion of cell proliferation and inhibition of apoptosis and oxidative stress.Conclusion A novel poloxamer hydrogel loaded HGF-DPSC-Exo has been prepared and its therapeutic effect against radiation combined injury has been proved,thus providing a new strategy for the treatment of radiation skin injury in clinic.

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