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OBJECTIVE：To systematically evaluate therape utic efficacy of Yixinshu preparation combined with conventional treatment plan for angina pectoris of coronary heart disease （CHD）vs. conventional treatment plan ，and to provide evidence-based reference for clinical drug use. METHODS ：Retrieved from Cochrane library ，PubMed，Embase，CBM，CNKI，Wanfang database and VIP ，randomized controlled trials （RCTs）about Yixinshu preparation combined with conventional treatment plan （trial group ） versus conventional treatment plan （control group ）for angina pectoris of coronary heart disease were collected during Jan. 1st in 2012 to Oct. 1st in 2020. After extracting the data ，the quality of included studies were evaluated with Cochrane System Evaluator Handbook 5.3；Meta-analysis was performed by using Stata 15.0 software. RESULTS ：A total of 23 RCTs involving 2 853 subjects were included. The results of Meta-analysis showed that the efficacy of angina pectoris [RR ＝0.92，95％CI（0.87，0.97），P＜0.05]， the times of angina pectoris attack [SMD ＝－0.98，95％CI（－1.09，－0.87），P＜0.05]，the duration of angina pectoris [SMD ＝ －0.77，95％CI（－0.88，－0.67），P＜0.05]，ECG curative effect [RR ＝0.91，95％CI（0.84，0.98），P＜0.05] and the improve rate of TCM syndromes [RR ＝0.89，95％CI（0.85，0.94），P＜0.05] in trial group were all better than control group ，with statistical significance. CONCLUSIONS ：Yixinshu preparation combined with conventional treatment plan is better than conventional treatment plan in terms of improving therapeutic efficacy of angina pectoris and ECG ，TCM syndrome improvement rate ，as well as reducing the frequency of angina pectoris attack ，angina pectoris attack duration.
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Objective:To discuss the clinical efficacy of Yixinshu capsule for viral myocarditis (VMC) with deficiency of Qi and Yin, and to investigate its antioxidant and anti-inflammatory effect. Method:One hundred and thirty-two patients were randomly divided into control group (66 cases) and observation group (66 cases) by random number table. Patients in two group got comprehensive treatment of Western medicine, i.e. intravenous drip of creatine phosphate injection for 14 days, 1 g/time, 1 time/day. Coenzyme Q10 capsule, 1 grain/time, 3 times/day after meals. Trimetazidine dihydrochloride tablets, 1 tablet/time, 3 times/day during meals. And critically ill patients got intravenous drip of dexamethasone sodium phosphate injection for 14 days, 10-20 mg/time, 1 time/day. The control group took Wenxin granules orally,One bag at a time,3 times/day. Patients in observation group additionally got Yixinshu capsule, 3 grains/time, 3 times/days. The courses of treatment were 8 weeks in both groups. The serum troponin I (cTnI) and creatine phosphokinase (CK-MB) were monitored, and after treatment, the recovery rates of cTnI, CK-MB were recorded. Before and after treatment, the electrocardiogram was observed and the recovery rate after treatment was recorded. Before and after treatment, the scores of deficiency of Qi and Yin were graded, and levels of creatine phosphokinase (CPK), hydroxybutyrate dehydrogenase (HBDH), lactate dehydrogenase (LDH), aspartate aminotransferase (AST), superoxide dismutase (SOD), malondialdehyde (MDA), glutathione peroxidase (GSH-Px), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-17 and IL-35 were detected. Echocardiography, left ventricular ejection fraction (LVEF), cardiac index (CI), and maximum velocity values between early and late diastolic (E/A) were detected. Result:In the analysis of rank sum test, clinical efficacy in observation group was better than that in control group (Z=2.151, P<0.05). Recovery rates of cTnI, CK-MB and electrocardiogram in observation group were 82.26% (51/62), 90.32% (56/62) and 80.65% (50/62), higher than 65.00% (39/60), 73.33% (44/60) and 63.33% (38/60) in control group (P<0.05). Levels of serum cTnI, CK-MB, CPK, HBDH, LDH, AST, MDA, IFN-γ and IL-17 were lower than those in control group (P<0.01), while levels of LVEF, CI, E/A, SOD, GSH-Px, IL-10 and IL-35 were higher than those in control group (P<0.01). Conclusion:On the basis of comprehensive anti-infection treatment, Yixinshu capsule can additional protect myocardium by anti-inflammatory and antioxidant effect, reduce myocardial enzyme, promote the recovery of ECG and cardiac enzyme, improve cardiac function and improve the effect of clinical treatment.
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Objective: To establish a reversed phase high- performance liquid chromatography(RP- HPLC) method for determination of salvianolic acid B in rat plasma, and study the pharmacokinetic properties of salvianolic acid B in rats by the intragastric administration of Salvia miltiorrhiza extract and Yixingshu tablets. Methods: The SD rats were orally administered the S. miltiorrhiza extract and Yinxinshu tablets, respectively. The blood was sampled from the orbital venous plexus of rats and centrifuged to obtain plasma. Then, the content of salvianolic acid B in the rat plasma was determined after precipitation of proteins in plasma by adding methanol. The DAS2.0 software was used to analyze the pharmacokinetics parameters. Results: The established method for the determination of salvianolic acid B in rat plasma showed a good linearity in the concentration range of 0.253-10.120 μg/ml, and the limit of determination was 0.063 μg/ml. Meanwhile, the mean recovery of salvianolic acid B for the high, middle and low concentration test was 92.29%, 93.36%, and 96.50%, respectively, and the plasma concentration-time curves of salvianolic acid B for the S. miltiorrhiza extract and Yinxinshu tablets were consistent with the curves of two-compartment model. Compared with the S. miltiorrhiza extract, the Cmax and AUC0→∞ present were 2.50-fold and 2.71-fold, respectively. Conclusion: The present HPLC method was selective, accurate and sensitive for the determination of salvianolic acid B in rat plasma. The present result also indicated that the other medicinal herbs except S. miltiorrhiza in the Yixinshu tables could significantly accelerate the absorption of salvianolic acid B, so as to significantly improve the bioavailability of salvianolic acid B in the Yixinshu tables.
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The clinical value is the core factor for determining the products of Chinese patent medicines on the market. It is clear that defining the clinical positioning of Chinese patent medicines and maximizing their clinical efficacy and value are of great practical significance for each Chinese patent medicine. Precise clinical positioning not only requires systematic analysis and summarization of existing literature and clinical practice data, but also requires verification and proof from detailed experimental data, thus to provide scientific support for basic research. In this research, a three-dimensional integration strategy of " traditional Chinese medicine (TCM) theory-clinical practice-basic research" was proposed to play a vital role in clinical positioning and evaluation of Chinese patent medicines. Yixinshu capsule was taken as an example to discuss clinical positioning of Chinese patent medicines under the guidance of TCM theory. Based on the interpretation of the evolution of the pathogenesis of coronary heart disease (thoracic obstruction), combined with the core efficacy of the drug composition, the effect of Yixinshu capsule in benefiting Zongqi, calming midnd, improving blood circulation and eliminating blood stasis was identified, which was suitable for treatment for the recurrent episodes of angina pectoris, and emergency of symptoms of chronic heart failure. At the level of TCM theory, the clinical positioning of Yixinshu capsule was further defined, and the key points of in-depth research were proposed to provide reference for the mechanism research and clinical application of Yixinshu capsule. Based on the prescription and its score functions, precise analysis of clinical positioning of large varieties of TCM under the guidance of TCM theory, on the one hand will give full play to the value of TCM original knowledge and guide the basic research of Chinese patent medicines, on the other hand the research results will enrich, benefit and sublimate the TCM theory, and finally provide a critical paradigmatic for the clinical positioning of large varieties of TCM under the guidance of TCM theory.
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Objective To investigate the effects of moisture-proof materials and contents on hygroscopicity of Yixinshu Capsules; To improve moisture-proof function of Yixinshu Capsules. Methods The hygroscopicity performance of Yixinshu Capsules was analyzed with the indexes of moisture absorption rate and critical relative humidity (CRH), and effects of soluble starch, maize starch, dextrin, lactose, mannitol, calcium hydrogen phosphate, ethylcellulose, microcrystalline cellulose, hypromellose and low-substituted hydroxypropyl cellulose on hygroscopicity of Yixinshu Capsules were compared. The effects of optimized excipients and capsule contents after granulation on hygroscopicity of Yixinshu Capsules were tested. Results Lactose, microcrystalline cellulose and mannitol were the most appropriate moisture-proof excipients for Yixinshu Capsules with balanced moisture absorption rate of 18.04%, for which the best proportion of Yixinshu Capsules to excipients was 1 to 0.1 (wt%). The balanced moisture absorption rate of the powders were 14.87%, 14.39%, and 15.38%, respectively, whereas the granules were 10.75%, 10.29%, and 11.13%, respectively. Conclusion The selected excipients can effectively reduce the hygroscopic rate of the Yixinshu Capsules, and its granules can promote the moisture resistance of Yixinshu Capsules.
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OBJECTIVE:Tosystematically evaluate the efficacy of Yixinshu capsule in the adjuvant treatmentof angina pecto-ris,and provide evidence-based reference for clinical treatment. METHODS:Retrieved from CJFD,VIP Database,Wanfang Data-base,Medline and EMBase,randomized controlled trials(RCT)about the efficacyof Yixinshu capsule(test group)versus other drugs (control group) in the adjuvant treatment of angina pectoris were collected. Meta-analysis was performed bu using Rev Man 5.2 software after data extraction and quality evaluation by modified Jadad. RESULTS:Totally 11 RCTs were enrolled,involving 1 827 pa-tients. Results of Meta-analysis showed the total effective rate of angina pectoris improvement [OR=0.30,95%CI(0.23,0.40),P<0.001] and electrocardiogram improvement [OR=0.52,95%CI(0.41,0.66),P<0.001] in test group were significantly higher than control group,there was significant difference between 2 groups. CONCLUSIONS:Yixinshu is effective for the adjuvant treatment of angina pectoris.
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This paper was aimed to study effects of different preparation methods on the content of ginsenosides Rg1,Re and Rb1 in Yi-Xin-Shu (YXS) tablets by HPLC-ELSD.HPLC-ELSD was used as the detection method.The separation and content of ginsenosides Rg1,Re and Rb1 were used as indexes.The influences of three different preparation methods (i.e.,defatted alcohol extraction and butanol extraction,alcohol extraction and butanol extraction,alcohol extraction and butanol extraction ammonia solution washing) on the effect of YXS tablets were studied.Then,the same content determination method was used to compare the influence of alkali washing treatment to ginsenosides Rg1,Re and Rb1 among different batches of Panax ginseng.The results showed that a good separation of ginsenosides Rg1,Re and Rb1 component peak of YXS tablets was achieved by three kinds of separation methods.The separation degree was greater than 1.5.Ammonia solution washing had some effect on ginsenosides Rg1,Re and Rb1 content,which made the content of ginsenosides Rg1,Re and Rb1 be 1.5-1.8 times to those without alkali washing.No effect was shown on the content of ginsenosides Rg1,Re and Rb1 during ammonia solution washing.It was concluded that some other ginsenosides can be transferred into ginsenosides Rg1,Re and Rb1 in YXS tablets solution after ammonia solution washing.
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OBJECTIVE:To establish a method for the contents determination of tanshinol,protocatechuic aldehyde,ferulic ac-id and salvianolic acid B in Yixinshu capsule. METHODS:Dual-wavelength HPLC was performed on the column of Eclipse XDB-C18 with mobile phase of 0.5%phosphoric acid-methanol-acetonitrile(gradient elution)at the flow rate of 1.0 ml/min,the de-tection wavelength was 280 nm(tanshinol,protocatechuic aldehyde,salvianolic acid B)and 320 nm(ferulic acid),column tempera-ture was 30℃and volume was 10 μl. RESULTS:The linear range of tanshinol,protocatechuic aldehyde,ferulic acid and salvianolic acid B were respectively 9-144μg/ml(r=0.999 9),0.5-8μg/ml(r=0.999 9),0.65-10.4μg/ml(r=0.999 9)and 221.25-3 540μg/ml (r=0.999 9);RSDs of precision,stability and reproducibility tests were no more than 1.90%;the average recovery was respective-ly 100.8%(RSD=1.65%,n=9),100.1%(RSD=2.87%,n=9),100.1%(RSD=3.01%,n=9) and 99.4%(RSD=2.05%,n=9). CONCLUSIONS:The method is simple and reproducible,and can be used for the quality control of Yixinshu capsule.
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Objective To analyze and explore the clinical efifcacy of Yixinshu capsule combined with isosorbide dinitrate tablets in the treatment of stenocardia. Method 72 patients with stenocardia in cardiovasology of Zizhong county people’s hospital of Sichuan province were randomly divided two groups,36 cases in each group. Control group was treated with isosorbide dinitrate tablets, experimental group was given both Yixinshu capsule and isosorbide dinitrate tablets. Clinical efifcacy, adverse reactions and patients’satisfaction in two groups were analyzed comparitively. Results After treatment, the total effective rate and satisfaction degree in experimental group were signiifcantly higher than control group.Incidence of adverse reactions of experimental groupwas signiifcantly lower than control group(P<0.05). Conclusion Clinical efifcacy of Yixinshu capsule combined with isosorbide dinitrate tablets in the treatment of stenocardia is signiifcantly higher than single isosorbide dinitrate tablets, with higher satisfaction degree and lower incidence of adverse reactions, which can be widely applied in clinic.
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OBJECTIVE:To evaluate the curative efficacy of Yixinshu capsule(YXSC)for patients with chronic heart failure(CHF)and its effects on plasma levels of angiotrnsionⅡ(Ang Ⅱ)and tumor necrosis factor-alpha(TNF-?).MET-HODS:60 patients with CHF were randomly assigned to either treatment group(n=30)or control group(n=30):the control group received conventional symptomatic treatment with western medicines including anti-infection therapy,relieving airway obstruction,continuous low-flow oxygen inhalation,cardiac and diuretic therapy,vasodilator,correcting acid-base imbalance and electrolyte disturbances etc;the treatment group received YXSC in combination with the above conventional symptomatic treatment.Plasma levels of AngⅡ and TNF-? in two groups before and after treatment were detected;and the cardiac function and the indexes of echocardiography(LVEF,A/E)of all cases were recorded in detail before and after treatment.Meanwhile,10 healthy subjects served as normal control.RESULTS:After treatment,plasma levels of AngⅡ and TNF-? in both group decreased remarkably(P
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Objective:To observe and assess the hemorheological efficacy of yixinshu capsules in the treatment of"deficiency of both vital energy and yin or blood stasis"chest-spleen-syndrome patients.Method:According to the stand- ard of the diagnosis of coronary heart diseases and deficiency of both vital energy and yin or blood stasis chest-bi-syndrome, 60 cases were collected from Jan.2006 to Feb.2007 in ward and clinic.Each case was treated with yixinshu capsule for four weeks and its hemorheological efficacy and routine blood change were observed and compared before and after the treat- ment.Result:The yixinshu capsules improved various hemorheological indexes more significantly after the treatment than before it (P0.05).Conclusion:Yixinshu capsules are an effective medicine for the chest-spleen-syndrome case,and recommendable for clinical treatment.
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AIM:To find a new way of treating premature beats(PB) to evaluate the efficacy and safety of Yi-(xinshu) Capsule(Radix et Rhizoma Ginseng,Radix et Rhizoma Salviae miltiorrhizae,Radix Ophiopogonis,Radix Astragali,etc.) METHODS:Randomized,controlled clinical study were conducted in 60 patients with atrial premature beats(APB),and 60 patients with premature ventricular beats(PVB).APB patients were randomly divided into two groups:Yixinshu Capsule plus Isoptin(study group,n=30) and Isoptin group(control group,n=30).PVB patients:Yixinshu Capsule plus Mexiletine(study group,n=30) and Mexiletine group(control group,n=30).Those patients were treated for four weeks.We used 24 h Holter to monitor the times of PB and myocardial ischemia in before and after treatment.RESULTS:In the study group and control group,the times of APB and PVB were decreased obviously after 4 weeks treatment(P