Effectiveness of Integrative Medicine Therapy on Coronary Artery Disease Prognosis: A Real-World Study / 中国结合医学杂志

OBJECTIVE@#To evaluate the effectiveness of integrative medicine (IM) on patients with coronary artery disease (CAD) and investigate the prognostic factors of CAD in a real-world setting.@*METHODS@#A total of 1,087 hospitalized patients with CAD from four hospitals in Beijing, China were consecutively selected between August 2011 and February 2012. The patients were assigned to two groups based on the treatment: Chinese medicine (CM) plus conventional treatment, i.e., IM therapy (IM group); or conventional treatment alone (CT group). The endpoint was major adverse cardiac events [MACE; including cardiac death, myocardial infarction (MI), and revascularization].@*RESULTS@#A total of 1,040 patients finished the 2-year follow-up. Of them, 49.4% (514/1,040) received IM therapy. During the 2-year follow-up, the total incidence of MACE was 11.3%. Most of the events involved revascularization (9.3%). Cardiac death/MI occurred in 3.0% of cases. For revascularization, logistic stepwise regression analysis revealed that age ⩾ 65 years [odds ratio (OR), 2.224], MI (OR, 2.561), diabetes mellitus (OR, 1.650), multi-vessel lesions (OR, 2.554), baseline high sensitivity C-reactive protein level ⩾ 3 mg/L (OR, 1.678), and moderate or severe anxiety/depression (OR, 1.849) were negative predictors (P<0.05); while anti-platelet agents (OR, 0.422), β-blockers (OR, 0.626), statins (OR, 0.318), and IM therapy (OR, 0.583) were protective predictors (P<0.05). For cardiac death/MI, age ⩾ 65 years (OR, 6.389) and heart failure (OR, 7.969) were negative predictors (P<0.05), while statin use (OR, 0.323) was a protective predictor (P<0.05) and IM therapy showed a beneficial tendency (OR, 0.587), although the difference was not statistically significant (P=0.218).@*CONCLUSION@#In a real-world setting, for patients with CAD, IM therapy was associated with a decreased incidence of revascularization and showed a potential benefit in reducing the incidence of cardiac death or MI.

Effect of Kuanxiong Aerosol () on Patients with Angina Pectoris: A Non-inferiority Multi-center Randomized Controlled Trial / 中国结合医学杂志

<p><b>OBJECTIVE</b>To evaluate the effect and safety of Kuanxiong Aerosol (, KA) on patients with angina pectoris.</p><p><b>METHODS</b>Block randomization was performed to randomly allocate 750 patients into KA (376 cases) and control groups (374 cases). During an angina attack, the KA group received 3 consecutive sublingual sprays of KA (0.6 mL per spray). The control group received 1 sublingual nitroglycerin tablet (NT, 0.5 mg/tablet). Log-rank tests and Kaplan-Meier estimations were used to estimate the angina remission rates at 6 time-points after treatment (1, 2, 3, 4, 5, and >5 min). Logistic regression analysis was performed to observe the factors inflfluencing the rate of effective angina remission, and the remission rates and incidences of adverse reactions were compared for different Canadian Cardiovascular Society (CCS) classes of angina.</p><p><b>RESULTS</b>The 5-min remission rates in the KA and control groups were not signifificantly different (94.41% vs. 90.64%, P>0.05). The angina CCS class signifificantly inflfluenced the rate of remission (95% confidence interval = 0.483-0.740, P<0.01). In the CCS subgroup analysis, the 3-and 5-min remission rates for KA and NT were similar in the CCSII and III subgroups (P>0.05), while they were signifificantly better for KA in the CCSI and II subgroups (P<0.05 or P<0.01). Furthermore, the incidence of adverse reactions was signifificantly lower in the KA group than in the control group for the CCSII and III subgroups (9.29% vs. 26.22%, 10.13% vs. 20.88%, P<0.05 or P<0.01).</p><p><b>CONCLUSIONS</b>KA is not inferior to NT in the remission of angina. Furthermore, in CCSII and III patients, KA is superior to NT, with a lower incidence of adverse reactions. (Registration No. ChiCTRIPR-15007204).</p>

Long-term follow-up of Chinese herbal medicines combined with conventional treatment in patients with acute coronary syndrome after percutaneous coronary intervention: A multicenter randomized controlled trial / 中国结合医学杂志

<p><b>OBJECTIVE</b>To evaluate the prognosis effect of Chinese herbal medicines (CHMs) for benefiting qi and activating blood circulation adjunctive to conventional treatment in patients with acute coronary syndrome (ACS) after percutaneous coronary intervention (PCI).</p><p><b>METHODS</b>A total of 702 patients with ACS who underwent PCI were enrolled and randomly assigned to receive conventional treatment plus CHMs for benefiting qi and activating blood circulation (treatment group, 351 cases) or conventional treatment alone (control group, 351 cases) for 6 months. Six months later, all patients received conventional treatment alone. Follow-ups were scheduled at 6th, 12th, 18th, 24th month after enrollment in April 2008, and the final follow-up visit was during September 2011 and November 2011. The primary endpoint was the composite of cardiac death, nonfatal myocardial infarction or revascularization (PCI or coronary artery bypass grafting); and the secondary endpoint was the composite of re-admission for ACS, congestive heart failure, nonfatal stroke or other thrombus events.</p><p><b>RESULTS</b>A total of 621 (88.59%) patients completed 35.4±3.8 months follow-up, while 80 (11.41%) patients withdrew from the trial (41 in the treatment group and 39 in the control group). The incidence of primary endpoint was 5.7% (20 patients) in the treatment group versus 10.86% (38 patients) in the control group [relative risk (RR): 0.53; 95% confidence interval (CI): 0.30, 0.88; P=0.013; absolute risk reduction (ARR):-0.052, 95% CI: -0.06, 0.01]. The incidence of secondary endpoint was 5.98% (21 patients) in the treatment group versus 10.28% (36 patients) in control group (RR: 0.58, 95% CI: 0.33, 0.97, P=0.037; ARR: -0.043, 95% CI: 0.06, 0.01). Most of the primary and secondary endpoints were occurred in 18 months (84.50% in the treatment group versus 78.10% in the control group).</p><p><b>CONCLUSION</b>CHMs for benefiting qi and activating blood circulation adjunctive to conventional treatment improved clinical outcomes for patients with ACS after PCI in long-term follow-up.</p>

Effect of Kuanxiong aerosol on coronary heart disease angina patients: a multicenter randomized controlled clinical study / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To evaluate the anginal attack-relieving efficacy and safety of Kuanxiong Aerosol (KA) in patients with coronary heart disease (CHD).</p><p><b>METHODS</b>A total of 780 patients confirmatively diagnosed as CHD angina from November 2011 to December 2012 in 13 medical centers in the mainland area were assigned to 2 groups by blocked randomization, the treatment group (376 cases) and the control group (374 cases). When the angina attacked, patients in the treatment group received sublingual spray three times, 0.6 mL each time, while those in the control group sublingually dissolved Nitroglycerin Tablet (NT), 0.5 mg each tablet. The effective rate of angina relief, efficacy of electrocardiogram (ECG), and the incidence of adverse reactions were observed.</p><p><b>RESULTS</b>The 3 min and 5 min remission rates of angina attack were 53.72% (202/376) and 94.41% (355/376) in the treatment group, and 47.86% (179/374) and 90.64% (339/374) in the control group. The 95% confidence interval (CI) of the difference between the 2 groups of 3 min and 5 min remission rates of angina attacks were [(-1.84%, 12.32%) and (-1.33%, 6.85%) respectively, P > 0.05]. The total improvement rates of ST-T changes in the treatment group and the control group after treatment were 74.07% and 73.13% respectively (P > 0.05). The adverse reaction rate was 9.31 (35/376 cases) in the treatment group and 22.46% (84/374 cases) in the control group (P < 0.01).</p><p><b>CONCLUSION</b>KA was not inferior to NT in relieving anginal attacks and improving ischemic ECG changes, and had obviously less adverse reaction.</p>

Diagnostic standard evaluation of Chinese medicine syndrome for coronary heart disease patients after percutaneous coronary intervention / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To evaluate the validity, reliability, and clinical applicability of Chinese medicine syndrome diagnostic standards for coronary heart disease (CHD) patients after percutaneous coronary intervention (PCI), which was established by expert consultation.</p><p><b>METHODS</b>A total of 1 050 CHD patients after PCI were recruited from 23 hospitals. The sensitivity, specificity, accuracy, positive likelihood ratio, and area under ROC curve were used to evaluate the validity of diagnostic standards for Chinese medical syndrome types. The observable agreement rate and Kappa value were used to evaluate the reliability. Positive predictive value and negative predictive value were used to evaluate the clinical applicability.</p><p><b>RESULTS</b>The sensitivity, specificity, accuracy, positive likelihood ratio, area under ROC curve, observable agreement rate, Kappa value, positive predictive value, and negative predictive value of each Chinese medicine syndrome in CHD patients after PCI were as follows: 95.26%, 93.70%, 94.86%, 15.13, 0.924, 98.76%, 0.969, 97.76%, and 87.24% for blood stasis syndrome; 96.42%, 95.34%, 96.00%, 20.70, 0.957, 99.52%, 0.990, 97.02%, and 94.42% for qi deficiency syndrome; 88.19%, 96.46%, 94.19%, 24.89, 0.923, 96.67%, 0.915, 90.39%, and 95.58% for phlegm turbidity syndrome; 91.06%, 98.77%, 97.05%, 74.22, 0.950, 98.67%, 0.960, 95.54%, and 97.46% for cardiac blood stasis syndrome; 98.41%, 96.73%, 97.33%, 30.10, 0.976, 98.86%, 0.976, 94.40%, and 99.09% for qi deficiency blood stasis syndrome; 94.81%, 94.75%, 94.76%, 18.07, 0.948, 97.71%, 0.918, 72.73%, and 99.20% for phlegm-stasis stagnation syndrome.</p><p><b>CONCLUSION</b>The validity, reliability, and clinical applicability of Chinese medicine syndrome diagnostic standards for CHD patients after PCI were rational and considerable in clinical practice.</p>

Clinical efficacy of traditional chinese medicine on acute myocardial infarction: a prospective cohort study / 中国结合医学杂志

<p><b>OBJECTIVE</b>To evaluate the clinical effects of Chinese medicine (CM) on acute myocardial infarction (AMI) with a prospective cohort study.</p><p><b>METHODS</b>A total of 334 AMI patients from January 2007 to March 2009 were consecutively enrolled, and were assigned to a treatment group (169 cases) treated with combined therapy (CM for at least one month and Western medicine) and a control group (165 cases) with Western medicine alone. Clinical data including age, gender, smoking, medical history, infarction area, heart functional classification, CM syndrome scores, blood-stasis syndrome score, primary end-point (death, nonfatal myocardial infarction, and revascularization) and secondary end-point (ischemic stroke, rehospitalization due to angina, heart failure and shock), were collected. CM syndrome scores, blood-stasis syndrome score, primary end-point and secondary end-point were collected during the 6-month follow-up. Kaplan-Meier method was used for the survival analysis. The multifactor analysis was analyzed by Cox proportional hazards regression.</p><p><b>RESULTS</b>At the end of 6-month the CM syndrome score and bloodstasis syndrome score in the treatment group were lower than those in the control group (P<0.01), especially the symptoms of chest pain, spontaneous perspiration and insomnia. Rehospitalization rate due to angina during the 6-month follow-up in the treatment group (2.96%) was lower than that in the control group (7.88%, P<0.05). Kaplan- Meier survival curve showed that event-free cumulated survival of rehospitalization due to angina during the 6-month follow-up in the treatment group was higher than that in the control group (Log rank 4.700, P=0.03). Cox regression analysis showed that heart dysfunction [hazard ratio (HR)=1.601, 95% CI=1.084-2.364, P=0.018] and diabetes mellitus (HR=1.755, 95% CI=1.031-2.989, P=0.038) were hazard factors to end-point, whereas CM (HR 0.405, 95% CI=0.231-0.712, P=0.002), percutaneous coronary intervention (PCI, HR=0.352, 95% CI=0.204-0.607, P<0.001) and angiotensin converting enzyme (ACE) inhibitors (HR=0.541, 95% CI=0.313-0.936, P=0.028) were protective factors.</p><p><b>CONCLUSIONS</b>CM therapy could decrease CM syndrome scores and blood-stasis syndrome score, reduce the rehospitalization rate during 6-month follow-up due to angina. Heart dysfunction and diabetes mellitus were hazard factors to end-point, whereas CM, PCI and ACE inhibitors were protective factors.</p>

Application of patient-reported outcome in Chinese medical therapeutic efficacy assessment of cardiovascular diseases and some considerations on it / 中国中西医结合杂志

Patient-reported outcome (PRO) is one of the important measures for clinical therapeutic efficacy assessment. The current application and development of PRO in China and abroad were introduced in this paper, put stress on the application of PRO in Chinese medical therapeutic efficacy assessment of cardiovascular diseases. Moreover, some suggestions on its further application were offered.

Treatment of non-ST-elevation acute coronary syndrome with propyl gallate / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To investigate the therapeutic effects of propyl gallate (PrG) in combination with standard medication on patients with non-ST-elevation acute coronary syndrome (NST-ACS), including unstable angina and acute non-ST-elevation myocardial infarction, and its influences on serum inflammatory marker and platelet activation.</p><p><b>METHODS</b>Fifty-five patients with NST-ACS were randomly assigned to two groups. Accessory to the standard Western medicine, the 27 patients in the tested group treated with PrG and the 28 in the control group with salvia composite (SC), all being medicated for 14 days. Effects on angina pectoris and electrocardiogram were observed. The positive rate and mean fluorescence density (MFI) of GP IIb-IIIa and CD62p expression on platelet surface were detected using flow cytometer; the serum concentration of high sensitive C-reactive protein (Hs-CRP) was determined using ELISA before and after treatment respectively.</p><p><b>RESULTS</b>The therapeutic effects on angina and electrocardiogram between the two groups showed no significant difference. Serum level of Hs-CRP, GP IIb-IIIa MFI and CD62p positive rate were significantly lowered after treatment in both groups (P < 0.05), no significant difference was found between groups, though the lowering of Hs-CRP and GP IIb-IIIa MFI in the tested group displayed a further decreasing trend.</p><p><b>CONCLUSION</b>In combination with standard medication of Western medicine, PrG and SC showed no obvious difference in the therapeutic effect and influences on angina pectoris and electrocardiogram in patients with non-ST-elevation acute coronary syndrome.</p>

Effect of xiongshao capsule on lipid metabolism and platelet aggregation in experimental atherosclerosis rabbits / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To study the effect and possible mechanism of xiongshao capsule (XSC) on lipid metabolism and platelet aggregation in experimental atherosclerotic (AS) rabbits.</p><p><b>METHODS</b>Fractional AS rabbits model was established by denuding endothelium of abdominal aorta with 4F x Fogarty catheter, followed by high cholesterol feeding. Seventy model rabbits were equally randomized into 7 groups, namely, the 3 model groups (Group A, B and C) of different observation time (3 days, 2 weeks and 6 weeks respectively after operation); the single endothelium injury group (Group D, adopted denuding but fed with common diet); the 3 treatment groups treated respectively with probucol (Group E), low-dose and high-dose XSC (Group F and G) for 6 weeks. Besides, a control group (Group N) consisting of 10 rabbits underwent sham operation with normal feeding was set up. Animals were killed at different corresponding time points, heart blood was collected before killing for measurements of blood lipid indexes, including total cholesterol (TC), total triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C). The 5 min maximum platelet aggregation rate (mPAGR) was measured with heart blood on the 3rd day after operation and at the terminal of experiment.</p><p><b>RESULTS</b>(1) Indexes of blood lipids were unchanged in Group D and N (P > 0.05); TC and LDL-C in model rabbits began to rise significantly after being fed with high fat forage for 3 days; lipid indexes in Group A, B and C were significantly different to those in Group N, respectively (P < 0.05, P < 0.01); at the end of experiment TC and LDL-C were lower in Group G and E when compared with Group C; the ratio of LDL-C/HDT-C decreased in Group G, E and F, especially in Group G (P < 0.01); a bettering trend of HDL-C presented in Group G, but not in Group E; and reduction of atherosclerosis index (AI, calculated by TC/HDL-C) was found in Group G (P < 0.01), significant difference was shown as compared with that in Group C and E (P < 0.05). (2) The 3rd day mPAGR raised in Group A, B, C and D, showing significant difference as compared with that in Group N (P < 0.01), whereas the index in Group E, F and especially in G was lower significantly than that in Group C (P < 0.05). mPAGR in the 3 treatment groups at the terminal of experiment was lower than that in Group C (P < 0.05, P < 0.01), and the most effective lowering was shown in Group G.</p><p><b>CONCLUSION</b>XSC could reduce the levels of TC, LDL-C and AI in AS model rabbits, also inhibit platelet aggregation at early stage and 6 weeks after endothelium injury, which might be one of the possible acting mechanisms of XSC in preventing AS.</p>