1.Cost-effectiveness of angiographic quantitative flow ratio-guided coronary intervention: A multicenter, randomized, sham-controlled trial.
Yanyan ZHAO ; Changdong GUAN ; Yang WANG ; Zening JIN ; Bo YU ; Guosheng FU ; Yundai CHEN ; Lijun GUO ; Xinkai QU ; Yaojun ZHANG ; Kefei DOU ; Yongjian WU ; Weixian YANG ; Shengxian TU ; Javier ESCANED ; William F FEARON ; Shubin QIAO ; David J COHEN ; Harlan M KRUMHOLZ ; Bo XU ; Lei SONG
Chinese Medical Journal 2025;138(10):1186-1193
BACKGROUND:
The FAVOR (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) III China trial demonstrated that percutaneous coronary intervention (PCI) lesion selection using quantitative flow ratio (QFR) measurement, a novel angiography-based approach for estimating fractional flow reserve, improved two-year clinical outcomes compared with standard angiography guidance. This study aimed to assess the cost-effectiveness of QFR-guided PCI from the perspective of the current Chinese healthcare system.
METHODS:
This study is a pre-specified analysis of the FAVOR III China trial, which included 3825 patients randomized between December 25, 2018, and January 19, 2020, from 26 centers in China. Patients with stable or unstable angina pectoris or those ≥72 hours post-myocardial infarction who had at least one lesion with a diameter stenosis between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment were randomized to a QFR-guided strategy or an angiography-guided strategy with 1:1 ratio. During the two-year follow-up, data were collected on clinical outcomes, quality-adjusted life-years (QALYs), estimated costs of index procedure hospitalization, outpatient cardiovascular medication use, and rehospitalization due to major adverse cardiac and cerebrovascular events (MACCE). The primary analysis calculated the incremental cost-effectiveness ratio (ICER) as the cost per MACCE avoided. An ICER of ¥10,000/MACCE event avoided was considered economically attractive in China.
RESULTS:
At two years, the QFR-guided group demonstrated a reduced rate of MACCE compared to the angiography-guided group (10.8% vs . 14.7%, P <0.01). Total two-year costs were similar between the groups (¥50,803 ± 21,121 vs . ¥50,685 ± 23,495, P = 0.87). The ICER for the QFR-guided strategy was ¥3055 per MACCE avoided, and the probability of QFR being economically attractive was 64% at a willingness-to-pay threshold of ¥10,000/MACCE avoided. Sensitivity analysis showed that QFR-guided PCI would become cost-saving if the cost of QFR were below ¥3682 (current cost: ¥3800). Cost-utility analysis yielded an ICER of ¥56,163 per QALY gained, with a 53% probability of being cost-effective at a willingness-to-pay threshold of ¥85,000 per QALY gained.
CONCLUSION:
In patients undergoing PCI, a QFR-guided strategy appears economically attractive compared to angiographic guidance from the perspective of the Chinese healthcare system.
TRIAL REGISTRATION
ClinicalTrials.gov , NCT03656848.
Humans
;
Cost-Benefit Analysis
;
Percutaneous Coronary Intervention/methods*
;
Male
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Female
;
Coronary Angiography/methods*
;
Middle Aged
;
Aged
;
Coronary Artery Disease/surgery*
;
Quality-Adjusted Life Years
;
Fractional Flow Reserve, Myocardial/physiology*
2.Potential efficacy and mechanism of eight mild-natured and bitter-flavored TCMs based on gut microbiota: A review.
Wenquan SU ; Yanan YANG ; Xiaohui ZHAO ; Jiale CHENG ; Yuan LI ; Shengxian WU ; Chongming WU
Chinese Herbal Medicines 2024;16(1):42-55
The mild-natured and bitter-flavored traditional Chinese medicines (MB-TCMs) are an important class of TCMs that have been widely used in clinical practice and recognized as safe long-term treatments for chronic diseases. However, as an important class of TCMs, the panorama of pharmacological effects and the mechanisms of MB-TCMs have not been systemically reviewed. Compelling studies have shown that gut microbiota can mediate the therapeutic activity of TCMs and help to elucidate the core principles of TCM medicinal theory. In this systematic review, we found that MB-TCMs commonly participated in the modulation of metabolic syndrome, intestinal inflammation, nervous system disease and cardiovascular system disease in association with promoting the growth of beneficial bacteria Bacteroides, Akkermansia, Lactobacillus, Bifidobacterium, Roseburia as well as inhibiting the proliferation of harmful bacteria Helicobacter, Enterococcus, Desulfovibrio and Escherichia-Shigella. These alterations, correspondingly, enhance the generation of protective metabolites, mainly including short-chain fatty acids (SCFAs), bile acid (BAs), 5-hydroxytryptamine (5-HT), indole and gamma-aminobutyric acid (GABA), and inhibit the generation of harmful metabolites, such as proinflammatory factors trimethylamine oxide (TAMO) and lipopolysaccharide (LPS), to further exert multiplicative effects for the maintenance of human health through several different signaling pathways. Altogether, this present review has attempted to comprehensively summarize the relationship between MB-TCMs and gut microbiota by establishing the TCMs-gut microbiota-metabolite-signaling pathway-diseases axis, which may provide new insight into the study of TCM medicinal theories and their clinical applications.
3.Exploring the etiology and pathogenesis of atherosclerosis based on the theory"pathogenic cold affecting in the evening"
Jinrui ZHANG ; Shengxian WU ; Yawei DU
Journal of Beijing University of Traditional Chinese Medicine 2024;47(1):92-96
Atherosclerosis is classified as"vessel bi"in traditional Chinese medicine,and cold evil is one of its important causes.Cold,having the properties of coagulation,stagnation,and contraction,tends to narrow the diameter of blood vessels and slow down blood flow,which can promote the pathophysiological process of atherosclerosis.At present,the etiological theory of vessel bi caused by cold evil has not been fully elaborated.Based on the explanations of"evening"in"pathogenic cold affecting in the evening",such as"ying","end of year","end of day",and"time of yang decline and yin exuberance",this paper proposes the viewpoint that the cold evil tends to affect ying-blood and cause vessel bi,and discusses its pathogenesis.From the perspective of the external environment,cold evil affecting the vessel is conditional,often occurring in winter and in the middle of the night.From the perspective of internal environment,the cold evil affects the vessel in a process which can be manifested in three stages:cold injury,cold stagnation,and cold congelation.The strength of yang qi is the factor that determine whether the cold evil can cause disease.Exploring the etiology and pathogenesis of atherosclerosis from the perspective of"pathogenic cold affecting in the evening"provides a new idea for further elucidating the pathogenesis of the disease and expanding its clinical treatment.
4.Comparison of Jinzhen oral liquid and ambroxol hydrochloride and clenbuterol hydrochloride oral solution in the treatment of acute bronchitis in children: A multicenter, non-inferiority, prospective, randomized controlled trial.
Qinhua FAN ; Chongming WU ; Yawei DU ; Boyang WANG ; Yanming XIE ; Zeling ZHANG ; Wenquan SU ; Zizhuo WANG ; Changchang XU ; Xueke LI ; Ying DING ; Xinjiang AN ; Jing CHEN ; Yunying XIAO ; Rong YU ; Nan LI ; Juan WANG ; Yiqun TENG ; Hongfen LV ; Nian YANG ; Yuling WEN ; Xiaoli HUANG ; Wei PAN ; Yufeng LIU ; Xueqin XI ; Qianye ZHAO ; Changshan LIU ; Jian XU ; Haitao ZHANG ; Lie ZHUO ; Qiangquan RONG ; Yu XIA ; Qin SHEN ; Shao LI ; Junhong WANG ; Shengxian WU
Acta Pharmaceutica Sinica B 2024;14(12):5186-5200
The comparison between traditional Chinese medicine Jinzhen oral liquid (JZOL) and Western medicine in treating children with acute bronchitis (AB) showed encouraging outcomes. This trial evaluated the efficacy and safety of the JZOL for improving cough and expectoration in children with AB. 480 children were randomly assigned to take JZOL or ambroxol hydrochloride and clenbuterol hydrochloride oral solution for 7 days. The primary outcome was time-to-cough resolution. The median time-to-cough resolution in both groups was 5.0 days and the antitussive onset median time was only 1 day. This randomized controlled trial showed that JZOL was not inferior to cough suppressant and phlegm resolving western medicine in treating cough and sputum and could comprehensively treat respiratory and systemic discomfort symptoms. Combined with clinical trials, the mechanism of JZOL against AB was uncovered by network target analysis, it was found that the pathways in TRP channels like IL-1β/IL1R/TRPV1/TRPA1, NGF/TrkA/TRPV1/TRPA1, and PGE2/EP/PKA/TRPV1/TRPA1 might play important roles. Animal experiments further confirmed that inflammation and the immune regulatory effect of JZOL in the treatment of AB were of vital importance and TRP channels were the key mechanism of action.
5.Clinical study on the treatment of kidney deficiency and blood stasis syndrome of lumbar intervertebral disc herniation with Bushen Huoxue Shujin Decoction and thunder fire moxibustion
Jiajing LUO ; Ming LI ; Qi LI ; Jianuo ZHANG ; Shengxian WU ; Xiangchun LIU
International Journal of Traditional Chinese Medicine 2023;45(12):1502-1507
Objective:To evaluate the clinical efficacy of Bushen Huoxue Shujin Decoction combined with thunder fire moxibustion in the treatment of lumbar intervertebral disc herniation with kidney deficiency and blood stasis syndrome.Methods:Randomized controlled trial. A total of 200 lumbar intervertebral disc herniation patients from Dongzhimen Hospital of Beijing University of Chinese Medicine from January to December 2021 were selected as observation objects and the computer random method was used to divide 66 patients into combination group, 67 in the control group 1, and 67 in the control group 2. The Control group 1 was given conventional western medicine and thunder fire moxibustion, the control group 2 was given conventional western medicine and Bushen Huoxue Shujin Decoction, and the combined group was given conventional western medicine and Bushen Huoxue Shujin Decoction and thunder fire moxibustion. All the groups were treated with 14 days as a course of treatment, a total of 3 courses. TCM syndrome scores were performed before and after treatment, and lumbar joint activity was measured by using a muscle state testing analyzer; the levels of NF-κB, prostaglandin E2 (PGE2) and hypoxia-inducible factor-2α (HIF-2α) were determined by ELISA; adverse reactions during treatment were recorded and clinical efficacy was evaluated.Results:The total effective rate of the combination group was 92.42%(61/66), the control group 1 was 71.64% (48/67), and the control group 2 was 74.63% (50/67), with a statistically significant difference among the three groups ( χ2=10.28, P=0.006). After treatment, the scores of waist and leg pain, lumbar stiffness, lower limb numbness, and tongue dullness in the combination group were significantly lower than those in the control group 1 and control group 2 ( F values were 15.25, 12.21, 11.77, 14.49, respectively, P<0.01); the range of motion of lumbar joint forward flexion, backward extension, lateral flexion, and lateral rotation in the combination group were significantly greater than those in the control group 1 and control group 2 ( F values were 19.66, 29.50, 33.33, and 24.54, respectively, P<0.01); the levels of serum NF-κB [(41.29±5.91)ng/L vs. (49.97±5.98)ng/L, (50.92±6.02)ng/L, F=47.00], PGE2 [(67.09±8.08)ng/L vs. (80.22±9.92)ng/L, (78.17±9.09)ng/L, F=40.27], HIF-2α[(16.95±3.46) ng/L vs. (20.83±3.98)ng/L, (19.67±3.89)ng/L, F=18.38] in combination group were significantly lower than those in the control group 1 and control group 2 ( P<0.01). During the treatment period, the incidence of adverse reactions in the combination group was 15.15% (10/66), control group 1 was 8.96% (6/67), and control group 2 was 10.45% (7/67), there was no statistically significant difference between the three groups ( χ2=1.36, P=0.506). Conclusion:The combination of Bushen Huoxue Shujin Decoction and thunder fire moxibustion can improve the TCM syndrome and range of motion of patients with kidney deficiency and blood stasis syndrome of lumbar intervertebral disc herniation, inhibit the expression of inflammatory factors, improve clinical efficacy, and have good safety.
6.A multi-center, randomized, double-blind and controlled study of BP180NC16a enzyme-linked immu-nosorbent assay (BP180NC16a-ELISA) in the diagnosis of bullous pemphigoid
Yan LI ; Xixue CHEN ; Junyu ZHAO ; Ke WANG ; Shan ZHONG ; Hongzhong JIN ; Yan YAN ; Jinbo CHEN ; Haoxiang XU ; Yueping ZENG ; Shengxian WU ; Xuejun ZHU
Chinese Journal of Dermatology 2011;44(1):23-25
Objective To evaluate the sensitivity and specificity of BP180NC16a-ELISA in the diagnosis of bullous pemphigoid (BP). Methods A multi-center, randomized, double-blind, parallel-controlled study was conducted. Sera were collected from 106 patients with clinically confirmed active BP and 106 control subjects including patients with non-BP bullous diseases, scleroderma, psoriasis or systemic lupus erythematosus,late pregnant women and healthy blood donors. BP180NC16a-ELISA was performed on these sera. The IgG antibody levels measured by ELISA kit were compared with those measured by indirect immunofluorescence (IIF) test. Results Of the 106 BP sera, 81 were positive for BP180NC16a-ELISA with a sensitivity of 76.4%,83 for ⅡF test with a sensitivity of 78.3%. Among the 106 control serum samples, 95 were negative for BP180NC16A-ELISA with a specificity of 89.6%, and 102 for ⅡF test with a specificity of 96.2%. There was no significant difference between the two tests in dignostic sensitivity and specificity for BP (both P > 0.05).Conclusion BP180NC16A-ELISA may serve as an adjuvant tool for the diagnosis of BP.
7.Expression of pituitary glucocorticoid receptor and 11β-hydroxysteroid dehydrogenase 1 in obese diabetic rats
Shengxian LI ; Wei LIU ; Lihua WANG ; Yihua WU ; Juan WANG ; Xuerong LIU
Chinese Journal of Endocrinology and Metabolism 2010;26(8):654-656
Diabetic rat model was induced by high fat diet combined with streptozotocin (STZ). After the model was established, blood samples were taken from jugular veins to examine plasma adrenocorticotropic hormone (ACTH) and corticosterone, and hypothalamus and pituitary were removed for real-time PCR. There were no significant differences in basal plasma ACTH and corticosterone level among control, obese, and obese diabetic rats (P=0.07). The corticosterone rhythm in obese and obese diabetic rats was impaired. Hypothalamus glucocorticoid receptors (GR) mRNA expressions yielded similar results in the groups, but 11β-HSD1 mRNA expression in obese diabetic rats was up-regulated ( vs control rats, P<0.05 ). The expressions of GR and 11β-HSD1 in pituitary of obese diabetic and obese rats were significantly down-regulated (both P<0.05). In the obese diabetic rats, the impaired glucocorticoid negative feedback was partly due to down-regulation of 11 β-HSD1 and GR expressions in pituitary.
8.Hypothalamic-pituitary-adrenal axis in postmenopausal women with type 2 diabetes mellitus and visceral obesity
Shengxian LI ; Wei LIU ; Lihua WANG ; Rong HUANG ; Qi CHENG ; Yihua WU ; Yawen CHENG
Chinese Journal of Endocrinology and Metabolism 2008;24(6):633-636
Objective To investigate the function of the hypothalamic-pituitary-adrenal (HPA) axis in postmenopausal women with type 2 diabetes and visceral obesity. Methods Subjects were divided into three groups:control group(group C),type 2 diabetes mellitus with non-obesity group (group DM) and type 2 diabetes mellitus with visceral obesity group (group DM + OB). General clinical characteristics, morning blood cortisol concentrations and 24 h urine free cortisol of three groups were compared. Serum cortisol levels were also compared after 0.25 mg dexamethasone suppression test and followed by oral intake of 25 mg cortisone acetate. Results (1) There were no significant differences in basal cortisol levels, but after inhibition with dexamethasone the group DM + OB showed significantly higher cortisol level than that in the control group (P < 0.01). (2) Conversion of oral cortisone to plasma cortisol differed significantly between the group C (lower) and group DM + OB (P < 0.05). (3) Plasma LH and FSH concerntrations were significantly lower in group DM + OB compared with group C (P < 0.01). Conclusion In the postmenopausal women with type 2 diabetes mellitus, the negative feedback mechanism and hepatic 11β-HSD-1 activity were impaired, especially in those with visceral obesity.
9.Investigation of the plasma cortisol and the function of hypothalamic-pituitary-adrenal axis in type 2 diabetic patients
Lihua WANG ; Wei LIU ; Shengxian LI ; Rong HUANG ; Qi CHENG ; Yihua WU
Chinese Journal of Endocrinology and Metabolism 2008;24(5):525-526
The plasma level and the regulation of cortisol in type 2 diabetic patients were invesligated.Plasma and urinary cortisol levels were measured, and dexamethasonc suppression test and oral cortisone test in vivo were performed. Compared with controls, diabetic patients had higher urinary cortisol level. The activity of hepatic 11 β-hydroxy-steroid dehydrogenase-1 (11β-HSD1) in type 2 diabetic patients was decreased, suggesting that the elevated basal cortisol in type 2 diabetic patiens may due to impaired hepatic degradation of cortisol.

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