1.Post-marketing effectiveness evaluation of traditional Chinese medicine in paradigm based on "proving efficacy, conforming standard, and exploring mechanism":a case study of Danhong Injection.
Ya-Nan YU ; Jun LIU ; Zhong WANG
China Journal of Chinese Materia Medica 2023;48(1):279-284
At present, new concepts, new technologies, and new methods are emerging in the field of medical research, breaking through the inherent thinking patterns and research models, and promoting the transformation of the research paradigm of traditional Chinese medicine(TCM). This paper gave a case study of clinical research in Danhong Injection in the treatment of chronic stable angina, and based on the background of the study, index evaluation model, experimental design method, blind implementation of placebo, data management system, and exploration of clinical efficacy mechanism of traditional Chinese medicine compounds under the framework of modular pharmacology, the scientific idea of "proving efficacy, conforming standard, and exploring mechanism" was used as the guideline to discuss the research model of reevaluation of the effectiveness of post-marketing TCM varieties. This paper drew a target network map of Danhong Injection in the treatment of chronic stable angina for the first time, which was composed of targeted functional modules. By combining evidence-based clinical research with modular pharmacology framework, changes in the pharmacolo-gical mechanism were finally associated with changes in clinical efficacy, and the advantages of phenotypic correlation of efficacy were explored. This study is expected to provide references for the post-marketing effectiveness evaluation and new ideas for the phenotypic pharmacological mechanism study of multi-target TCM compounds and precise treatment, thereby promoting the innovative development of TCM.
Humans
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Medicine, Chinese Traditional
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Angina, Stable/drug therapy*
;
Drugs, Chinese Herbal/therapeutic use*
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Treatment Outcome
2.Network Meta-analysis of Chinese medicine injection combined with conventional western medicine in treatment of stable angina pectoris.
Wei WANG ; Lu CAO ; Peng REN ; Bei-Bei ZHU ; Kai LIU
China Journal of Chinese Materia Medica 2023;48(6):1652-1663
This study aimed to systematically evaluate the efficacy and safety of different Chinese medicine injections combined with conventional western medicine for stable angina pectoris. PubMed, Cochrane Library, EMbase, Web of Science, CNKI, Wanfang, VIP, and SinoMed were searched to collect randomized controlled trial(RCT) of Chinese medicine injection combined with conventio-nal western medicine in the treatment of stable angina pectoris from the inception of the databases to July 8, 2022. Two researchers independently screened the literature, extracted the data, and evaluated the risk of bias of the included studies. Stata 15.1 was used for network Meta-analysis. A total of 52 RCTs were included, involving 4 828 patients treated by 9 Chinese medicine injections(Danhong Injection, Salvia Miltiorrhiza Polyphenol Hydrochloride Injection, Tanshinone Sodium Ⅱ_A Sulfonate Injection, Salvia Miltiorrhiza Ligustrazine Injection, Dazhu Hongjingtian Injection, Puerarin Injection, Safflower Yellow Pigment Injection, Shenmai Injection and Xuesaitong Injection). The network Meta-analysis showed that:(1)in terms of improving the efficacy of angina pectoris, the surface under the cumulative ranking curve(SUCRA) followed the order of conventional western medicine combined with Salvia Miltiorrhiza Ligustrazine Injection>Tanshinone Sodium Ⅱ_A Sulfonate Injection>Danhong Injection>Salvia Miltiorrhiza Polyphenol Hydrochloride Injection>Xuesaitong Injection>Shenmai Injection>Puerarin Injection>Safflower Yellow Pigment Injection>Dazhu Hongjingtian Injection;(2)in terms of improving the efficacy of electrocardiogram(ECG), SUCRA followed the order of conventional western medicine combined with Salvia Miltiorrhiza Ligustrazine Injection>Puerarin Injection>Danhong Injection>Salvia Miltiorrhiza Polyphenol Hydrochloride Injection>Shenmai Injection>Xuesaitong Injection>Safflower Yellow Pigment Injection>Tanshinone Sodium Ⅱ_A Sulfonate Injection>Dazhu Hongjingtian Injection;(3)in terms of increasing high-density lipoprotein cholesterol(HDL-C), SUCRA followed the order of conventional western medicine combined with Danhong Injection>Shenmai Injection>Safflower Yellow Pigment Injection>Xuesaitong Injection>Tanshinone Sodium Ⅱ_A Sulfonate Injection>Dazhu Hongjingtian Injection;(4)in terms of lowering low-density lipoprotein cholesterol(LDL-C), SUCRA followed the order of conventional western medicine combined with Safflower Yellow Pigment Injection>Danhong Injection>Shenmai Injection>Tanshinone Sodium Ⅱ_A Sulfonate Injection>Dazhu Hongjingtian Injection>Xuesaitong Injection;(5)in terms of safety, the overall adverse reactions of Chinese medicine injection combined with conventional western medicine were less than those of the control group. Current evidence indicated that Chinese medicine injection combined with conventional western medicine could improve the curative effect of stable angina pectoris with higher safety. Limited by the number and quality of included studies, the above conclusion needed to be verified by more high-quality studies.
Humans
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Angina, Stable/drug therapy*
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Medicine, Chinese Traditional
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Network Meta-Analysis
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Drugs, Chinese Herbal
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Salvia miltiorrhiza
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Cholesterol
3.Risk factors in blood for attacks of angina in patients with coronavirus disease 2019 and stable angina.
Song GENG ; Donghui ZHOU ; Qi WANG ; Guofeng WANG ; Wei WEI ; Tao YU ; Zhiying DUAN ; Jing LIU ; Fei YU ; Yuanzhe JIN
Chinese Medical Journal 2023;136(11):1373-1375
Humans
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Angina, Stable
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COVID-19
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Risk Factors
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Patients
5.Discussion on
Chang-Zhen GONG ; Fan-Rong LIANG ; Can-Hui LI ; Wei-Xing PAN ; Yong-Ming LI ; San-Hua LENG ; Arthur Yin FAN ; Song-Ping HAN ; Jing LIU ; Shan WANG ; Zeng-Fu PENG ; Ye-Meng CHEN ; Guan-Hu YANG ; Xu-Ming GU ; Hong SU ; Shao-Bai WANG
Chinese Acupuncture & Moxibustion 2021;41(4):359-364
Professor
Acupuncture
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Acupuncture Therapy
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Angina, Stable
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Combined Modality Therapy
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Humans
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Moxibustion
6.Effectiveness and Safety of Acupoint Application of Guan Xin Su He Pill () for Patients with Chronic Stable Angina Pectoris: A Multi-Center, Randomized Controlled Trial.
De-Hua LI ; Jin XIE ; Yu-Lan REN ; Hui ZHENG ; Jun-Ling LYU ; Jun-Yan LENG ; Ling-Lin ZHANG ; Jie ZHANG ; Hai-Long FAN ; Fan-Rong LIANG
Chinese journal of integrative medicine 2021;27(11):838-845
OBJECTIVE:
To assess the clinical effectiveness of acupoint application (AP) of Guan Xin Su He Pill (, GXSHP) for patients with chronic stable angina pectoris (CSAP).
METHODS:
This study was carried out in 3 local hospitals in Chengdu, China. After baseline evaluation, eligible patients were randomly assigned to the placebo application for acupoints (PAA) group or the herbal application for acupoints (HAA) group. Patients in the HAA group underwent AP with herbal powder, which was mainly GXSHP, and patients in the PAA group underwent AP with sham drugs. For each treatment session, unilateral acupoints including Neiguan (PC 6), Danzhong (RN 17), Xinshu (BL 15) and Jueyinshu (BL 14), were stimulated for both groups. AP was performed 3 times a week with a 2-day interval for 4 weeks. The primary outcome was the frequency of angina pectoris attacks per week, while the secondary outcomes included angina pain intensity measured by the Visual Analogue Scale (VAS), dose of rescue oral drugs (nitroglycerin), scores on the Seattle Angina Questionnaire (SAQ), Self-Rating Anxiety Scale scores (SAS) and Self-Rating Depression Scale scores (SDS). Clinical outcomes were measured at week 0, 4 and 8. The safety of AP of GXSHP treatment for CSAP were assessed.
RESULTS:
A total of 121 patients were enrolled. Baseline characteristics were comparable across the 2 groups. After treatment, the angina attack numbers in the HAA group were significantly reduced from 11.00 to 4.81 (P<0.05). While, for PAA group, the angina frequency was not significantly improved (baseline 10.55; post-treatment 11.05). The HAA group had significantly fewer angina attacks than the PAA group (P<0.05). Pain intensity measured by VAS in HAA group was significantly reduced from 4.06 to 3.02 (P<0.05). While, for PAA group, the VAS was significantly increased (baseline 3.62; post-treatment 3.96; P<0.05). Clinical outcomes showed better improvement after treatment in the HAA group than in the PAA group in terms of oral administration of rescue drugs, SAS, SDS and SAQ scores (P<0.05). The adverse events were also reported.
CONCLUSION
AP of GXSHP is a safe and effective treatment for CSAP patients (Registration No. NCT02029118).
Acupuncture Points
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Angina, Stable/drug therapy*
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China
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Drugs, Chinese Herbal/adverse effects*
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Female
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Humans
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Male
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Treatment Outcome
7.Comparison of Exercise Performance and Clinical Outcome Between Functional Complete and Incomplete Revascularization
Jihoon KIM ; Joo Myung LEE ; Seung Hyuk CHOI ; Ki Hong CHOI ; Taek Kyu PARK ; Sung Ji PARK ; Jeong Hoon YANG ; Young Bin SONG ; Joo Yong HAHN ; Mi Ja JANG ; Bon Kwon KOO ; Hyeon Cheol GWON
Korean Circulation Journal 2020;50(5):406-417
BACKGROUND AND OBJECTIVES: Although percutaneous coronary intervention (PCI) is recommended to improve symptoms in patients with stable ischemic heart disease (SIHD), improvement of exercise performance is controversial. This study aimed to investigate changes in exercise duration after PCI according to functional completeness of revascularization by comparing pre- and post-PCI exercise stress test (EST).METHODS: Patients with SIHD were enrolled from a prospective PCI registry, and divided into 2 groups: 1) functional complete revascularization (CR) group had a positive EST before PCI and negative EST after PCI, 2) functional incomplete revascularization (IR) group had positive EST before and after PCI. Primary outcome was change in exercise duration after PCI and secondary outcome was major adverse cardiac events (MACE, a composite of any death, any myocardial infarction, and any ischemia-driven revascularization) at 3 years after PCI.RESULTS: A total of 256 patients (149 for CR group, and 107 for IR group) were eligible for analysis. Before PCI, exercise duration was not significantly different between the functional CR and IR groups (median 540 [interquartile range; IQR, 414, 602] vs. 480 [402, 589] seconds, p=0.091). After PCI, however, the CR group had a significantly higher increment of exercise duration than the IR group (median 62.0 [IQR, 12.0, 141.0] vs. 30.0 [−11.0, 103.5] seconds, p=0.011). The functional CR group also had a significantly lower risk of 3-year MACE (6.2% vs. 26.1%; adjusted hazard ratio, 0.19; 95% confidence interval, 0.09–0.41; p<0.001).CONCLUSIONS: Functional CR showed a higher increment of exercise duration than functional IR.
Angina, Stable
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Exercise Test
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Humans
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Myocardial Infarction
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Myocardial Ischemia
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Percutaneous Coronary Intervention
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Prognosis
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Prospective Studies
8.SYNTAX Score and SYNTAX Score II Can Predict the Clinical Outcomes of Patients with Left Main and/or 3-Vessel Disease Undergoing Percutaneous Coronary Intervention in the Contemporary Cobalt-Chromium Everolimus-Eluting Stent Era
Jeehoon KANG ; Jung Kyu HAN ; Do Yoon KANG ; Chengbin ZHENG ; Han Mo YANG ; Kyung Woo PARK ; Hyun Jae KANG ; Bon Kwon KOO ; Hyo Soo KIM
Korean Circulation Journal 2020;50(1):22-34
BACKGROUND AND OBJECTIVES: The impact of SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery score (SS) and SS II in patients who receive percutaneous coronary intervention with second-generation everolimus-eluting stents (EES) has not been fully validated.METHODS: The SS, SS II were calculated in 1,248 patients with left main and/or 3-vessel disease treated with EES. Patient-oriented composite endpoint (POCE; all-cause death, any myocardial infarction (MI), any revascularization) and target lesion failure (TLF: cardiac death, target-vessel MI, target lesion revascularization) were analyzed.RESULTS: The mean SS was 21.1±9.6. Three-year POCE increased according to the SS group (15.2% vs. 19.9% vs. 27.4% for low (≤22), intermediate (≥23, ≤32), high (≥33) SS groups, p<0.001). By multivariate Cox proportional hazard analysis, SS group was an independent predictor of 3-year POCE (hazard ratio, 1.324; 95% confidence interval, 1.095–1.601; p=0.004). The receiver operating characteristic curves revealed that the SS II was superior to the SS for 3-year POCE prediction (area under the curve [AUC]: 0.611 vs. 0.669 for SS vs. SS II, p=0.019), but not for 3-year TLF (AUC: 0.631 vs. 0.660 for SS vs. SS II, p=0.996). In subgroup analysis, SS II was superior to SS in patients with cardiovascular clinical risk factors, and in those presenting as stable angina.CONCLUSIONS: The usefulness of SS and SS II was still valid in patients with left main and/or 3-vessel disease. SS II was superior to SS for the prediction of patient-oriented outcomes, but not for lesion-oriented outcomes.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00698607ClinicalTrials.gov Identifier: NCT01605721
Angina, Stable
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Death
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Drug-Eluting Stents
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Humans
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Myocardial Infarction
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Percutaneous Coronary Intervention
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Risk Factors
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ROC Curve
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Stents
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Taxus
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Thoracic Surgery
9.Long-Term Outcomes in Patients Undergoing Percutaneous Coronary Intervention with or without Preprocedural Exercise Stress Test
Jihoon KIM ; Joo Myung LEE ; Taek Kyu PARK ; Jeong Hoon YANG ; Young Bin SONG ; Jin Ho CHOI ; Seung Hyuk CHOI ; Hyeon Cheol GWON ; Sang Hoon LEE ; Joo Yong HAHN
Journal of Korean Medical Science 2020;35(1):3-
stable ischemic heart disease (SIHD). This study aimed to investigate long-term outcomes in patients undergoing elective PCI with or without EST.METHODS: We studied 2,674 patients undergoing elective PCI using drug-eluting stents for SIHD. Patients were divided into the 2 groups: the test group underwent EST with a positive result within 180 days prior to PCI (n = 668), whereas the non-test group did not undergo any noninvasive stress tests (n = 2,006). The primary outcome was all-cause death or myocardial infarction (MI).RESULTS: Over 5 years after the index PCI, the risk of all-cause death or MI was significantly lower in the test group than in the non-test group in overall population (3.3% vs. 10.9%; adjusted hazard ratio [HR], 0.34; 95% confidence interval [CI], 0.22–0.55; P < 0.001), and in propensity score-matched population (668 pairs) (3.3% vs. 6.3%; adjusted HR, 0.52; 95% CI, 0.30–0.89; P = 0.018). However, the incidence of any revascularization was similar between the 2 groups in overall (16.7% vs. 16.8%; adjusted HR, 0.99; 95% CI, 0.79–1.25; P = 0.962) and matched population (16.7% vs. 18.3%; adjusted HR, 0.91; 95% CI, 0.70–1.19; P = 0.509).CONCLUSION: Patients who underwent elective PCI with EST had a reduced risk of all-cause death or MI than those undergoing PCI without stress tests.]]>
Angina, Stable
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Drug-Eluting Stents
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Exercise Test
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Humans
;
Incidence
;
Myocardial Infarction
;
Myocardial Ischemia
;
Percutaneous Coronary Intervention
10.Shensong Yangxin Capsules in the adjuvant treatment of stable angina pectoris:a Meta-analysis and trial sequential analysis.
Yuan-Tang XI ; Li-Yi YUAN ; Yuan-Yuan ZENG ; Man-Li YAN ; Xiao-Ru LIANG ; Ai-Ting FENG ; Wei WU
China Journal of Chinese Materia Medica 2019;44(17):3816-3824
To systemically evaluate the benefits and side effects of Shensong Yangxin Capsules( SYC) in the adjuvant treatment of stable angina pectoris( SAP). Chinese and English databases( PubMed,EMbase,the Cochrane Library,CBM,CNKI,VIP,Wan Fang database) were retrieved to collect the randomized controlled trials( RCTs) about therapeutic efficacy of SYC combined with routine drug( trial group) vs routine drug( control group) in the treatment of SAP. The methodological quality of the RCTs was evaluated based on the cochrane risk of bias assessment tool. The data were extracted and Meta-analyzed by Reviewer Manager 5. 3. TSA 0. 9 software was used for trial sequential analysis( TSA) of the total effective rate of symptoms improvement. A total of 15 RCTs with 1 316 participants were included. RESULTS:: of Meta-analysis showed that the total effective rate of angina symptoms improvement( RR = 1. 15,95% CI[1. 09,1. 21],P<0. 001) of trial group were significantly higher than those of control group,with statistical significance,the total effective rate of electrocardiograms( ECG) improvement( RR = 1. 10,95% CI[0. 94,1. 29],P = 0. 25) of trial group were significantly higher than those of control group,but the difference was not statistically significant. After treatment,the improvement of the total time of 24 h general ischemia( SMD =-1. 21,95%CI[-1. 97,-0. 45],P = 0. 002),the ST-segment depression amplitude( SMD =-1. 30,95%CI [-1. 52,-1. 09],P<0. 001),the duration of angina pectoris attack( SMD =-1. 16,95% CI[-1. 36,-0. 95],P< 0. 001),the angina pectoris attack every week( SMD =-0. 80,95%CI[-1. 10,-0. 50],P<0. 001),the onsumption of nitroglycerin every week( SMD=-0. 72,95%CI[-1. 05,-0. 39],P<0. 001) in the trial group were better than that of the control group,and the difference was statistically significant. Besides,the improvement of the blood lipid and high sensitivity C reactive protein( hs-CRP) in the trial group were better than those of the control group after treatment,and the difference was statistically significant( P< 0. 001). Funnel plots and Egger's linear regression showed that there was no publication bias. By sensitivity analysis,it showed that the results of this study were stable and reliable. No obvious adverse drug reactions were observed in all studies. TSA analysis showed that the evidence of Meta-analysis was reliable. SYC combined with routine Western medicine treatment for SAP can improve the total effective rate of angina pectoris,reduce 24 h total ischemia time,ST segment depression amplitude,duration of angina pectoris attack,frequency of angina pectoris attack and nitroglycerin dosage,and also can improve blood lipid and hs-CRP levels.
Adjuvants, Pharmaceutic
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Angina, Stable
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drug therapy
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C-Reactive Protein
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analysis
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Capsules
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Drugs, Chinese Herbal
;
therapeutic use
;
Electrocardiography
;
Humans
;
Lipids
;
blood
;
Randomized Controlled Trials as Topic

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