RESUMEN
Objective: To evaluate the effectiveness and safety of Linggui Zhugan decoction (LZD) as an adjunct treatment of premature contraction in patients with coronary heart disease. Methods: PubMed, Embase, Web of Science, ClinicalTrials.gov Cochrane Library, Chinese Knowledge Infrastructure, Wanfang database, Sino Med, and VIP database were searched from inception until July 2022. Two reviewers independently selected randomized controlled trials assessing the effectiveness of LZD combined with conventional antiarrhythmic drugs in treating premature contraction in patients with coronary heart disease compared to conventional antiarrhythmic drugs only. The clinical effectiveness was considered as the primary outcome, and the times of premature junctional beats in 24 h after treatment along with adverse reactions were considered secondary outcomes. The Cochrane risk of bias 2 tool was used for the risk of bias assessment. Meta-analysis was conducted using RevMan 5.4.1. and RStudio software. Results: A total of 14 studies including 1,236 participants were included. The primary outcome indicated that, compared with antiarrhythmic drugs alone (especially ß receptor blockers), the combination of LZD and conventional antiarrhythmic drugs resulted in higher clinical effectiveness (RR = 1.29, 95% CI: [1.22,1.36]) and lower number of premature junctional beats in 24 h (MD = -71.14, 95% CI: [-76.23, -66.06]) at end-of-intervention. The differences in adverse reactions (RR = 0.42, 95%CI: [0.15, 1.14], p = 0.09) were not significant. The risk of bias was marginally high among the studies. Funnel plot and Harbord's test (t = 1.63, p = 0.1346) indicated no existence of publication bias. Conclusion: The current evidence shows that LZD can increase the effectiveness of conventional antiarrhythmic drugs for treating premature contraction in patients with coronary heart disease. However, the results should be interpreted with caution because of the high overall risk of bias. Future studies with appropriate randomization and double-blind methods are warranted to confirm these findings. Systematic review registration: [https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=296628], identifier [CRD42022296628].
RESUMEN
BACKGROUND & AIMS: Chronic hepatitis B (CHB) and liver fibrosis are associated with a high risk of hepatocellular carcinoma (HCC) development. We assessed whether entecavir (ETV) plus Biejia-Ruangan compound (BRC), an anti-fibrotic traditional Chinese medicine, can further reduce the risk of HCC in treatment-naïve Chinese patients with CHB and an Ishak fibrosis score of ≥3 points derived from our parent double-blind randomized placebo-controlled trial. METHODS: After a 72-week comparison between ETV+BRC and ETV+placebo treatment, participants were eligible to enter an open-label treatment phase and were followed up every 6 months. The primary [secondary] endpoints were the incidence of HCC [liver-related deaths, non-HCC events, and non-liver-related deaths]. Modified intention-to-treat (mITT), intention-to-treat (ITT), and per-protocol (PP) populations were defined for the time-to-event analysis. RESULTS: A total of 1,000 patients were recruited; the median age was 42.0 years; 69.9% were male and 58.3% were HBeAg positive. In the mITT population, the 7-year cumulative incidence of HCC [liver-related deaths] was 4.7% [0.2%] for ETV+BRC, which was significantly lower than 9.3% [2.2%] for ETV monotherapy (p = 0.008 [p = 0.030]). Notably, ETV+BRC treatment yielded a lower incidence of HCC in those who did not achieve regression of fibrosis at week 72 than ETV monotherapy (p = 0.018). There were no differences in the other 2 secondary endpoints or safety profiles between the groups. Multivariable Cox proportional regression analysis, including the treatment allocation as a parameter, also demonstrated that ETV+BRC treatment was associated with a reduced incidence of HCC. The ITT and PP analyses showed consistent results. CONCLUSIONS: ETV plus BRC combination treatment could further reduce the risk of HCC and liver-related deaths in patients with CHB and advanced fibrosis or cirrhosis, which may have important clinical implications for HCC prevention. LAY SUMMARY: Patients with chronic hepatitis B virus infection are at an increased risk of developing liver cancer (specifically hepatocellular carcinoma [HCC]). While there are effective antiviral treatments that can suppress the virus in chronically infected patients, the risk of HCC remains. Herein, we show that adding a traditional Chinese medicine called Biejia-Ruangan compound to an antiviral reduced the risk of HCC in patients with chronic hepatitis B.
Asunto(s)
Carcinoma Hepatocelular , Hepatitis B Crónica , Neoplasias Hepáticas , Humanos , Masculino , Adulto , Femenino , Carcinoma Hepatocelular/epidemiología , Carcinoma Hepatocelular/etiología , Carcinoma Hepatocelular/prevención & control , Hepatitis B Crónica/complicaciones , Hepatitis B Crónica/tratamiento farmacológico , Neoplasias Hepáticas/epidemiología , Neoplasias Hepáticas/etiología , Neoplasias Hepáticas/prevención & control , Cirrosis Hepática/complicaciones , Cirrosis Hepática/tratamiento farmacológico , Antivirales/uso terapéutico , China/epidemiologíaRESUMEN
BACKGROUND: Long-term nucleos(t)ide analogue (NA) treatment can reverse liver fibrosis in chronic hepatitis B (CHB), but its effect on fibrosis regression remains limited. Biejia-Ruangan (BR) has been approved in China as an antifibrotic traditional Chinese medicine drug in patients with chronic liver diseases. A multicenter randomized controlled trial aims to evaluate the effect of BR on fibrosis regression in CHB patients treated with NAs. METHODS: CHB patients with histologically confirmed advanced fibrosis or cirrhosis were randomly assigned to receive entecavir (ETV) (0.5 mg per day) plus BR (2 g 3 times a day) or placebo for 72 weeks. Liver fibrosis regression was defined as a reduction ofâ ≥â 1 point by the Ishak fibrosis stage (IFS). RESULTS: Overall, 500 patients were enrolled in each group as the intention-to-treat population. The rate of fibrosis regression after 72 weeks of treatment was significantly higher in the ETVâ +â BR group (40% vs 31.8%; Pâ =â .0069). Among 388 patients with cirrhosis (ie, IFSâ ≥â 5) at baseline, the rate of cirrhosis reversal (ie, IFSâ ≤â 4) was significantly higher in the ETVâ +â BR group (41.5% vs 30.7%; Pâ =â .0103). CONCLUSIONS: Addition of BR to the current standard treatment with NAs in CHB patients with advanced fibrosis or cirrhosis can improve liver fibrosis regression. CLINICAL TRIALS REGISTRATION: NCT01965418.
Asunto(s)
Hepatitis B Crónica , Antivirales , Guanina/análogos & derivados , Guanina/uso terapéutico , Hepatitis B Crónica/complicaciones , Hepatitis B Crónica/tratamiento farmacológico , Humanos , Cirrosis Hepática/inducido químicamente , Cirrosis Hepática/tratamiento farmacológico , Resultado del TratamientoRESUMEN
BACKGROUND AND AIM: Despite optimal secondary preventive treatment, patients with stable coronary artery disease (SCAD) remain at high risk of cardiovascular events. This multicenter, double-blinded, randomized trial sought to determine whether the addition of Qing-Xin-Jie-Yu Granule (QXJYG), a traditional Chinese medicine prescription, to standard therapy would further reduce risk of cardiovascular events in patients with SCAD. METHODS: A total of 1500 patients with documented SCAD were randomly assigned in a 1:1 ratio to QXJYG or placebo for 6 months, and followed up for another 6 months. The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction (MI) and coronary revascularization. Near the end of the trial, but before unblinding, a commonly used composite 'hard' endpoint composed of cardiovascular death, nonfatal myocardial infarction and ischemic stroke was additionally analyzed. RESULTS: During a median follow-up of 12 months, no significant difference of the primary outcome between the two groups was observed (1.59% vs. 1.62%; hazard ratio, 0.41; 95% CI, 0.13-1.28). However, absolute risk of the composite 'hard' endpoint was reduced by 0.99% (0.31% vs. 1.30%; hazard ratio, 0.06; 95%CI, 0.01 to 0.53). No difference of adverse events between the two groups was observed. CONCLUSION: In patients with SCAD, the addition of QXJYG to standard therapy was associated with reduced risk of nonfatal MI and the composite 'hard' endpoint of cardiovascular death, nonfatal MI and stroke. (http://www.chictr.org.cn/showproj.aspx?proj=5200, ChiCTR-TRC-13004370).
Asunto(s)
Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Infarto del Miocardio/prevención & control , Adolescente , Adulto , Anciano , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
OBJECTIVE: To examine the prognostic value of serum levels of asymmetric dimethylarginine (ADMA) in patients with stable coronary heart disease (CHD) thus explore a potential biomarker of "toxin syndrome" in CHD. METHODS: In this prospective nested case-control study, 36 of 1,503 Chinese patients with stable CHD experienced at least 1 recurrent cardiovascular event (RCE) during 1-year follow-up. Serum levels of ADMA at the start of follow-up were compared between these 36 cases and 36 controls which matched to cases in terms of gender, age, history of hypertension, and myocardial infarction. RESULTS: Based on the crude model, subjects in the 2 highest ADMA quartiles showed significantly higher risk of developing RCE than those in the lowest ADMA quartile [odds ratio (OR) 4.09, 95% confidence interval (CI) 1.01 to 16.58; OR 6.76, 95% CI 1.57 to 29.07]. This association was also observed in the case-mix model (OR 5.51, 95% CI 1.23 to 24.61; OR 7.83, 95% CI 1.68 to 36.41) and multivariable model (OR 6.64, 95% CI 1.40 to 31.49: OR 13.14, 95% CI 2.28 to 75.71) after adjusting for confounders. The multivariable model which combined ADMA and high-sensitivity C-reactive protein (hsCRP) showed better predictive power with areas under the receiver operator characteristic curves (0.779) than the model of either ADMA (0.694) or hsCRP (0.636). CONCLUSION: Serum ADMA level may be a potential biomarker of "toxin syndrome" in CHD which shows favorable prognostic value in predicting 1-year RCE in patients with stable CHD. [The registration number is ChiCTR-PRNRC-07000012].
Asunto(s)
Arginina/análogos & derivados , Enfermedad Coronaria/sangre , Arginina/sangre , Biomarcadores/sangre , Humanos , Oportunidad Relativa , Curva ROC , Recurrencia , Factores de Riesgo , SíndromeRESUMEN
OBJECTIVES: This systemic review evaluated the efficacy and safety of Chinese herbal medicines (CHMs) in patients with coronary heart disease (CHD) complicated with depression. METHODS: All databases were retrieved till September 30, 2014. Randomized controlled trials (RCTs) comparing CHMs with placebo or conventional Western medicine were retrieved. Data extraction, analyses and quality assessment were performed according to the Cochrane standards. RevMan 5.3 was used to synthesize the results. RESULTS: Thirteen RCTs enrolling 1,095 patients were included. Subgroup analysis was used to assess data. In reducing the degree of depression, CHMs showed no statistic difference in the 4th week [mean difference (MD)=-1.06; 95% confidence interval (CI)-2.38 to 0.26; n=501; I(2)=73%], but it was associated with a statistically significant difference in the 8th week (MD=-1.00; 95% CI-1.64 to-0.36; n=436; I(2)=48%). Meanwhile, the combination therapy (CHMs together with antidepressants) showed significant statistic differences both in the 4th week (MD=-1.99; 95% CI-3.80 to-0.18; n=90) and in the 8th week (MD=-5.61; 95% CI-6.26 to-4.97; n=242; I(2)=87%). In CHD-related clinical evaluation, 3 trials reported the intervention group was superior to the control group. Four trials showed adverse events in the intervention group was less than that in the control group. CONCLUSIONS: CHMs showed potentially benefits on patients with CHD complicated with depression. Moreover, the effect of CHMs may be similar to or better than antidepressant in certain fields but with less side effects. However, because of small sample size and potential bias of most trials, this result should be interpreted with caution. More rigorous trials with larger sample size and higher quality are warranted to give high quality of evidence to support the use of CHMs for CHD complicated with depression.
Asunto(s)
Enfermedad Coronaria/complicaciones , Enfermedad Coronaria/tratamiento farmacológico , Depresión/complicaciones , Depresión/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Adulto , Anciano , Anciano de 80 o más Años , Antidepresivos/uso terapéutico , Estudios de Casos y Controles , Medicamentos Herbarios Chinos/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sesgo de Publicación , RiesgoRESUMEN
This is a multicenter prospective cohort study to analyze the correlation of traditional Chinese medicine (TCM) syndrome evolvement and cardiovascular events in patients with stable coronary heart disease (CHD). The impact of syndrome evolvement on cardiovascular events during the 6-month and 12-month follow-up was analyzed using complex networks approach. Results of verification using Chi-square test showed that the occurrence of cardiovascular events was positively correlated with syndrome evolvement when it evolved from toxic syndrome to Qi deficiency, blood stasis, or sustained toxic syndrome, when it evolved from Qi deficiency to blood stasis, toxic syndrome, or sustained Qi deficiency, and when it evolved from blood stasis to Qi deficiency. Blood stasis, Qi deficiency, and toxic syndrome are important syndrome factors for stable CHD. There are positive correlations between cardiovascular events and syndrome evolution from toxic syndrome to Qi deficiency or blood stasis, from Qi deficiency to blood stasis, or toxic syndrome and from blood stasis to Qi deficiency. These results indicate that stable CHD patients with pathogenesis of toxin consuming Qi, toxin leading to blood stasis, and mutual transformation of Qi deficiency and blood stasis are prone to recurrent cardiovascular events.
RESUMEN
BACKGROUND: Chronic hepatitis B (CHB) can progress to cirrhosis, hepatocellular carcinoma (HCC) and ultimately liver-related death. Although oral antiviral therapy for patients with CHB reduces the risk of such complications, once cirrhosis is established, the benefits of antiviral therapy are not robustly demonstrated. According to traditional Chinese medicine (TCM), some Chinese herbal medicines promote blood circulation and soften hard masses, and therefore they may block and reverse hepatic fibrosis. The aim of this study is to evaluate the effects of TCM tablets of the compound biejia ruangan (RGT) administered for fibrosis, and entecavir (ETV), on the development of HCC in patients with CHB or hepatitis B virus (HBV)-related compensated cirrhosis. METHODS/DESIGN: This multicenter, centrally randomized, double-blind, placebo-controlled, parallel-group study is planned to complete within 5 years. For the study, 1,000 with CHB or HBV-related compensated cirrhosis are randomly assigned in a 1:1 ratio to a treatment group (0.5 mg ETV once daily; 2 g RGT three times daily) or a control group (0.5 mg ETV once daily; 2 g RGT dummy agent three times daily). The primary end points are the development of HCC and liver-related death. Secondary end points include disease progression and overall survival. DISCUSSION: Although antiviral therapy can achieve sustained suppression of HBV replication, thereby preventing cirrhosis, patients with CHB treated with nucleos(t)ide analogs (NUCs) retain a higher risk for HCC compared with patients with inactive disease. Although previous clinical trials with RGT have confirmed the efficacy of blocking and reversing hepatic fibrosis in patients with CHB or compensated cirrhosis, the long-term risk for HCC or disease progression in these patients treated with combination of RGT and NUCs compared with NUCs alone is unclear. Therefore, it is necessary to investigate the effects of the RGT blockade and reversal of hepatic fibrosis on the development of HCC in patients with CHB or HBV-related compensated cirrhosis in large, prospective, multicenter, double-blind, randomized, controlled trials in China. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01965418. Date registered: 17 October 2013.
Asunto(s)
Antivirales/uso terapéutico , Medicamentos Herbarios Chinos/administración & dosificación , Guanina/análogos & derivados , Hepatitis B Crónica/tratamiento farmacológico , Cirrosis Hepática/prevención & control , Medicina Tradicional China/métodos , Proyectos de Investigación , Administración Oral , Adolescente , Adulto , Anciano , Antivirales/efectos adversos , China , Protocolos Clínicos , Progresión de la Enfermedad , Método Doble Ciego , Quimioterapia Combinada , Medicamentos Herbarios Chinos/efectos adversos , Femenino , Guanina/efectos adversos , Guanina/uso terapéutico , Hepatitis B Crónica/complicaciones , Hepatitis B Crónica/diagnóstico , Humanos , Cirrosis Hepática/diagnóstico , Cirrosis Hepática/virología , Masculino , Medicina Tradicional China/efectos adversos , Persona de Mediana Edad , Estudios Prospectivos , Comprimidos , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
OBJECTIVE: To analyze the correlation of Chinese medicine syndrome evolvement and cardiovascular: events in patients with stable coronary heart disease (CHD). METHODS: This prospective cohort study investigated and: collected the clinical information of patients with stable CHD and observed the syndrome type at the baseline and 6-month at follow-up, as well as the cardiovascular events during the 6-month and 12-month follow-up. The patients were divided into the event group and the non-event group. The interaction and the impact of syndrome evolvement on cardiovascular events were examined through multifactor dimensionality reduction (MDR) analysis and the results were verified by Chi-square test. RESULTS: Totally 1,333 of 1,503 stable CHD patients enrolled met the inclusion criteria: of MDR analysis. Among them, 959 (71.9%) cases were males and 374 (28.1%) cases were females. Thirty seven cases had cardiovascular events during 6 to 12 months after the study began. The results of the MDR analysis and verification using Chi-square test showed that the development of cardiovascular events was positively correlated with interaction between blood stasis and toxic syndrome at the baseline, blood stasis at the baseline and qi deficiency at the 6-month follow-up, toxic syndrome at the baseline and qi deficiency at the 6-month follow-up, toxic syndrome at the base line and blood stasis at the 6-month follow-up, qi deficiency and blood stasis at the 6-month follow-up (P<0.05 for all). CONCLUSIONS: Blood stasis, toxic syndrome and qi deficiency are important factors of stable CHD. There: are positive correlation between cardiovascular events and syndrome evolution from blood stasis to qi deficiency, from toxic syndrome to qi deficiency and from toxic syndrome to blood stasis, indicating the pathogenesis of toxin consuming qi, toxin leading to blood-stasis in stable CHD patients prone to recurrent cardiovascular events.
Asunto(s)
Enfermedad Coronaria/fisiopatología , Medicina Tradicional China , Reducción de Dimensionalidad Multifactorial , Anciano , Enfermedades Cardiovasculares/etiología , Angiografía Coronaria , Enfermedad Coronaria/complicaciones , Femenino , Humanos , Masculino , Persona de Mediana Edad , SíndromeRESUMEN
Traditional Chinese medicine (TCM) injection is widely used to treat angina pectoris in China. This overview aims to systematically summarize the general characteristics of systematic reviews (SRs) on TCM injection in treating angina, and assess the methodological and reporting quality of these reviews. We searched PubMed, Embase, the Cochrane Library and four Chinese databases from inception until March 2013. Data were extracted according to a preset form. The AMSTAR and PRISMA checklists were used to explore the methodological quality and reporting characteristics of included reviews, respectively. All data analyses were descriptive. 46 SRs involving over 57,463 participants with angina reviewing 23 kinds of TCM injections were included. The main outcomes evaluated in the reviews were symptoms (43/46, 93.5%), surrogate outcomes (42/46, 91.3%) and adverse events (41/46, 87.0%). Few reviews evaluated endpoints (7/46, 15.2%) and quality of life (1/46, 2.2%). One third of the reviews (16/46, 34.8%) drew definitely positive conclusions while the others (30/46, 65.2%) suggested potential benefits mainly in symptoms, electrocardiogram and adverse events. With many serious flaws such as lack of a protocol and inappropriate data synthesis, the overall methodological and reporting quality of the reviews was limited. While many SRs of TCM injection on the treatment of angina suggested potential benefits or definitely positive effects, stakeholders should not accept the findings of these reviews uncritically due to the limited methodological and reporting quality. Future SRs should be appropriately conducted and reported according to international standards such as AMSTAR and PRISMA, rather than published in large numbers.
Asunto(s)
Angina de Pecho/tratamiento farmacológico , Medicamentos Herbarios Chinos/administración & dosificación , Fitoterapia , China , Medicamentos Herbarios Chinos/efectos adversos , Humanos , Inyecciones , PubMed , Calidad de Vida , Resultado del TratamientoRESUMEN
Objective. This trial aims to look for the protein biomarker of "toxin syndrome" of CHD patients. Methods. We have performed two trials in this paper. The first trial was a randomized controlled trial (RCT) of the plasma proteome in unstable angina (UA) patients by Maldi-Tof Mass. The second trial was a nested case-control study in 1503 stable CHD patients with one-year followup for acute cardiovascular events (ACEs). Results. In the RCT study, 12 protein spots were found to be the differential protein for the significant differences between the difference of before and after treatment in group A and group B; 2 of them (3207.37 Da and 4279.95 Da) was considered to be unique to "toxin syndrome" for being differential proteins of group B but not group A. These 2 spots were identified as Isoform 1 of Fibrinogen alpha chain precursor (FGA, 3207.37 Da) and Isoform 2 of inter-alpha-trypsin inhibitor heavy chain H4 (ITIH4, 4279.95 Da), respectively. In the nested case-control study, the result of Western blot demonstrated that protein expression of ITIH4 in the group with followup ACEs was significantly lower than the matched group without followup ACEs (P = 0.027). Conclusion. ITIH4 might be a new potential biomarker of CHD "toxin syndrome" in TCM, indicating the potential role in early identifying high-risk CHD patients in stable period.
RESUMEN
This systematic review aims to evaluate current evidence for the benefit and side effect of oral Panax notoginseng preparation for coronary heart disease (CHD). We included 17 randomized clinical trials (17 papers and 1747 participants). Comparing with no intervention on the basis of conventional therapy, oral Panax notoginseng did not show significant effect on reducing cardiovascular events, but it could alleviate angina pectoris (including improving the symptoms of angina pectoris [RR 1.20; 95% CI 1.12 to 1.28; 7 trials, n = 791], improving electrocardiogram [RR 1.35; 95% CI 1.19 to 1.53; 8 trials, n = 727], decreasing the recurrence of angina pectoris [RR 0.38; 95% CI 0.16 to 0.94; 1 trials, n = 60], duration of angina pectoris [RR -1.88; 95% CI -2.08 to -1.69; 2 trials, n = 292], and dosage of nitroglycerin [MD -1.13; 95% CI -1.70 to -0.56; 2 trials, n = 212]); oral Panax notoginseng had no significant difference compared with isosorbide dinitrate on immediate effect for angina pectoris [RR 0.96; 95% CI 0.81 to 1.15; 1 trial, n = 80]. In conclusion, oral Panax notoginseng preparation could relieve angina pectoris related symptoms. However, the small sample size and potential bias of most trials influence the convincingness of this conclusion. More rigorous trials with high quality are needed to give high level of evidence, especially for the potential benefit of cardiovascular events.
RESUMEN
Aims. To investigate the treatment of hospitalized patients with coronary artery disease (CAD) and the prognostic factors in Beijing, China. Materials and Methods. A multicenter prospective study was conducted through an integrative platform of clinical and research at 12 hospitals in Beijing, China. The clinical information of 3537 hospitalized patients with CAD was collected from September 2009 to May 2011, and the efficacy of secondary prevention during one-year followup was evaluated. In addition, a logistic regression analysis was performed to identify some factors which will have independent impact on the prognosis. Results. The average age of all patients was 64.88 ± 11.97. Of them, 65.42% are males. The medicines for patients were as follows: antiplatelet drugs accounting for 91.97%, statins accounting for 83.66%, ß -receptor blockers accounting for 72.55%, ACEI/ARB accounting for 58.92%, and revascularization (including PCI and CABG) accounting for 40.29%. The overall incidence of cardiovascular events was 13.26% (469/3537). The logistic stepwise regression analysis showed that heart failure (OR, 3.707, 95% CI = 2.756-4.986), age ≥ 65 years old (OR, 2.007, 95% CI = 1.587-2.53), and myocardial infarction (OR, 1.649, 95% CI = 1.322-2.057) were the independent risk factors of others factors for cardiovascular events that occurred during followup of one-year period. Integrative medicine (IM) therapy showed the beneficial tendency for decreasing incidence of cardiovascular events, although no statistical significance was found (OR, 0.797, 95% CI = 0.613~1.036). Conclusions. Heart failure, age ≥ 65 years old, and myocardial infarction were associated with an increase in incidence of cardiovascular events, and treatment with IM showed a tendency for decreasing incidence of cardiovascular events.
RESUMEN
UNLABELLED: Background. Coronary heart disease (CHD) due to atherosclerotic inflammation remains a significant threat to global health despite the success of the lipid-lowering, anti-inflammatory statins. Tanshinone IIA, a potent anti-inflammatory compound derived from Traditional Chinese Medicine (TCM), may be able to supplement statins by further reducing levels of circulating inflammatory markers correlated to cardiovascular risk. Here, we present the protocol of a randomized controlled trial (RCT) that will investigate the synergistic effect of sodium tanshinone IIA sulfate and simvastatin on reducing elevated inflammatory markers in patients with CHD. PARTICIPANTS: Seventy-two inpatients with confirmed CHD, elevated serum high-sensitivity C-reactive protein (Hs-CRP) level, and a TCM diagnosis of blood stasis syndrome will be enrolled and randomized 1 : 1 into the control or experimental group. Intervention. All subjects will receive a standard Western therapy including 20 mg simvastatin orally once per evening. Patients in the experimental group will additionally receive a daily 80 mg dose of sodium tanshinone IIA sulfate intravenously, diluted into 250 mL 0.9% NaCl solution. The treatment period will be 14 days. Outcomes. Primary outcome parameter: serum Hs-CRP level. Secondary outcome parameters: other circulating inflammatory markers (including IL-6, TNF α , VCAM-1, CD40, sCD40L, MCP-1, and MMP-9), improvement in symptoms of angina and blood stasis syndrome, and safety. This trial is registered with ChiCTR-TRC-12002361.
RESUMEN
Background and Purpose. Traditional medicine (TM) has been widely used in China (including the Taiwan region), Korea, and Japan. The purposes of this paper are to summarize the basic data on TM systems in these three countries and to compare them in terms of overall policy, education, and insurance. Methods. Government websites, national statistics, and authoritative papers from each country were fully searched. Further data were gathered by TM experts from each country. Results. China and Korea showed similar patterns in TM systems, whereas Japan showed different patterns. In China and Korea, TM was practiced in a dual system with conventional medicine (CM), and TM education was 6-year training programs on average for TM doctors, and acupuncture, moxibustion, and cupping were completely insured. Whereas, CM was dominant in Japan, and TM was practiced by each health care worker who has received different TM education respectively, and main TM therapies were partially insured. Conclusions. TM was developed similarly or somewhat differently based on differences in cultural background and national policies in East Asia. We cautiously propose that this study could contribute to the development of TM and also be used for reference in complementary and alternative medicine systems.
RESUMEN
Objective. This systematic review aims to evaluate the benefit and side effect of Xuezhikang for coronary heart disease (CHD) complicated by dyslipidemia. Methods. All randomized clinical trials (RCTs) with Xuezhikang as a treatment for CHD combined with dyslipidemia were considered for inclusion. Data extraction and analyses and quality assessment were conducted according to the Cochrane standards. Results. We included 22 randomized trials. Xuezhikang showed significant benefit on the incidence of all-cause deaths, CHD deaths, myocardial infarction, and revascularization as compared with placebo based on conventional treatment for CHD. It remarkably lowered total cholesterol (TC), triglyceride (TG), and low-density lipoprotein-cholesterol (LDL-C) as compared with the placebo or inositol nicotinate group, which was similar to statins group. Xuezhikang also raised high-density lipoprotein cholesterol (HDL-C) compared to placebo or no intervention, which was similar to Inositol nicotinate and slightly inferior to statins. The incidence of adverse events did not differ between the Xuezhikang and control group. Conclusions. Xuezhikang showed a comprehensive lipid-regulating effect and was safe and effective in reducing cardiovascular events in CHD patients complicated by dyslipidemia. However, more rigorous trials with high quality are needed to give high level of evidence.
RESUMEN
Tanshinone IIA (Tan IIA) is a member of the major lipophilic components extracted from the root of Salvia miltiorrhiza Bunge, which is currently used in China and other neighboring countries to treat patients suffering from myocardial infarction (MI), angina pectoris, stroke, diabetes, sepsis, and other conditions. However, Tan IIA is not easy to be absorbed through intestinal pathway. To raise the bioavailability of the herb, sodium tanshinone IIA sulfonate (STS) was developed. This paper discussed the pharmacology of Tan IIA, STS, and their potential cardioprotective effects.
RESUMEN
OBJECTIVE: To evaluate the safety and efficacy of Xiongshao Capsule (XS), consisting of Chuangxiongol and paeoniflorin, in preventing restenosis after percutaneous coronary intervention (PCI) in senile coronary heart disease (CHD) patients. METHODS: A multi-center, randomized, double-blind, placebo-controlled trial was conducted. A total of 335 CHD patients were randomly assigned to treatment with oral administration of XS, or a placebo for 6 months after successful PCI. A clinical follow-up was performed at 1, 3 and 6 months after PCI and an angiographic follow-up was scheduled at 6 months. The primary endpoint was angiographic restenosis defined as a luminal stenosis ≥ 50% in follow-up. The secondary endpoints were combined incidence of death, target lesion nonfatal myocardial infarction, repeat target-vessel angioplasty, and coronary artery bypass graft surgery (CABG). The follow-up for the above clinical endpoint events was continued to 1 year after PCI. RESULTS: The subgroup analysis of 152 senile patients (68 cases angiographic follow-up) showed that the restenosis rates tended to reduce in the XS group as compared with that in the placebo group (24.32% vs. 38.71%, P > 0.05), and the minimum lumen diameter (MLD) significantly increased in the follow-up (2.15 ± 0.84 for XS vs. 1.73 ± 0.91 for placebo, P < 0.05). The incidence of recurrent angina at 3 and 6 months after PCI was also significantly reduced in the XS group (4.11% and 12.33%) as compared with those in the placebo group (17.72% and 43.04%), but there was no significant difference in the combined incidence of clinical outcomes (6.85% in the XS group vs. 11.39% in the placebo group, P > 0.05). No significant adverse reactions occurred within the 6-month follow-up period in the XS group. CONCLUSION: Administration of XS in addition to standardized Western medication for 6 months is demonstrated to be safe and effective in reducing post-PCI recurrent angina and inhibiting luminal restenosis after PCI in senile CHD patients.