Effects of Compound Danshen Dripping Pills on Ventricular Remodeling and Cardiac Function after Acute Anterior Wall ST-Segment Elevation Myocardial Infarction (CODE-AAMI): Protocol for a Randomized Placebo-Controlled Trial / 中国结合医学杂志

BACKGROUND@#Ventricular remodeling after acute anterior wall ST-segment elevation myocardial infarction (AAMI) is an important factor in occurrence of heart failure which additionally results in poor prognosis. Therefore, the treatment of ventricular remodeling needs to be further optimized. Compound Danshen Dripping Pills (CDDP), a traditional Chinese medicine, exerts a protective effect on microcirculatory disturbance caused by ischemia-reperfusion injury and attenuates ventricular remodeling after myocardial infarction.@*OBJECTIVE@#This study is designed to evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after AAMI on a larger scale.@*METHODS@#This study is a multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The total of 268 patients with AAMI after primary percutaneous coronary intervention (pPCI) will be randomly assigned 1:1 to the CDDP group (n=134) and control group (n=134) with a follow-up of 48 weeks. Both groups will be treated with standard therapy of ST-segment elevation myocardial infarction (STEMI), with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets 3 times daily after pPCI, and the control group treated with a placebo simultaneously. The primary endpoint is 48-week echocardiographic outcomes including left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume index (LVEDVI), and left ventricular end-systolic volume index (LVESVI). The secondary endpoint includes the change in N terminal pro-B-type natriuretic peptide (NT-proBNP) level, arrhythmias, and cardiovascular events (death, cardiac arrest, or cardiopulmonary resuscitation, rehospitalization due to heart failure or angina pectoris, deterioration of cardiac function, and stroke). Investigators and patients are both blinded to the allocated treatment.@*DISCUSSION@#This prospective study will investigate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function in patients undergoing pPCI for a first AAMI. Patients in the CDDP group will be compared with those in the control group. If certified to be effective, CDDP treatment in AAMI will probably be advised on a larger scale. (Trial registration No. NCT05000411).

Network meta-analysis of five Chinese patent medicines in the treatment of coronary microvascular disease / 国际中医中药杂志

Objective:To evaluate the clinical efficacy rate, vascular endothelial relaxation factor NO and safety of five different Chinese patent medicines combined with western medicine in the treatment of coronary microvascular disease (CMVD).Methods:Randomized controlled trials (RCTs) of Shexiang Baoxin Pills, Tongxinluo Capsules, Compound Danshen Dripping Pills, Yindan Xinnaotong Soft Capsules, and Xinkeshu Tablets combined with conventional western medicine therapy in the treatment of CMVD were retrieved from China National Knowledge Infrastructure (CNKI), China Academic Journal Database (Wanfang Data), Chinese Science and Technology Journal Database (Chongqing VIP), China Biomedical Literature Service System (SinoMed), PubMed, Cochrance Library and Embase databases from the establishment of the database to June 2022. The literature was imported and screened by EndNote software, and the risk quality of literature bias was evaluated by Revman 5.4 software. StataSE16 (64-bit) software was used for reticular meta analysis to compare the differences in clinical efficacy and drug safety of five proprietary Chinese medicines combined with western medicine.Results:A total of 24 RCT studies were included, 24 of which were double-arm studies, and five kinds of proprietary Chinese medicine combined with western medicine were compared. The results of reticular meta analysis: in terms of improving the clinical effective rate, the order of the five proprietary Chinese medicine combination groups was as follows: Yindan Xinnaotong Soft Capsules group > Shexiang Baoxin Pills group > Tongxinluo Capsules group > Xinkeshu Tablets group > Compound Danshen Dripping Pills group. In terms of regulating vasodilation factor NO, the order of the four proprietary Chinese medicine combination groups is as follows: Yindan Xinnaotong Soft Capsules group > Compound Danshen Dripping Pills group > Tongxinluo Capsules group > Shexiang Baoxin Pills group. In terms of safety, there were 3 reports of adverse reactions in the research literature of the five proprietary Chinese medicines.Conclusions:The clinical efficacy rate of five kinds of proprietary Chinese medicine combined with western medicine routine regimen is better than that of western medicine routine regimen alone, and the combination group of four kinds of proprietary Chinese medicine is superior to western medicine in regulating vasodilation factor NO, and Yindan Xinnaotong Soft Capsules group is superior in clinical efficacy rate and regulation of vasodilation factor NO. However, the quality and samples of this study are different, and the comparison of the curative effect of the combined group of proprietary Chinese medicine still needs a large sample and high-quality RCT study to demonstrate.

Compound Danshen Dripping Pills pretreatment protects the heart from ischemia/reperfusion injury by enhancing autophagic flux

Abstract Compound Danshen Dripping Pills (CDDPs) have been used in clinical treatment to protect the heart from ischemia/reperfusion (IR) injury for many years. However, the underlying mechanism implicated in the protective effects remains to be explored. Here, we determined the effects of CDDPs in Sprague-Dawley rats with the IR model. Cardiac function in vivo was assessed by echocardiography. Transmission electron microscopy, histological and immunohistochemical techniques, Western blotting and recombinant adeno-associated virus 9 transfection were used to illustrate the effects of CDDPs on IR and autophagy. Our results showed that pretreatment with CDDPs decreased the level of serum myocardial enzymes and infarct size in rats after IR. Apoptosis evaluation showed that CDDPs significantly ameliorated the cardiac apoptosis level after IR. Meanwhile, CDDPs pretreatment increased myocardial autophagic flux, with upregulation of LC3B, downregulation of p62, and increased autophagosomes and autolysosomes. Moreover, the autophagic flux inhibitor chloroquine could increase IR injury, while CDDPs could partially reverse the effects. Furthermore, our results showed that the activation of AMPK/mTOR was involved in the cardioprotective effect exerted by CDDPs. Herein, we suggest that CDDPs partially protect the heart from IR injury by enhancing autophagic flux through the activation of AMPK/mTOR.

Meta-analysis of clinical efficacy and safety of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in treatment of hypertensive left ventricular hypertrophy / 中国中药杂志

To systematically evaluate the clinical efficacy and safety of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in the treatment of hypertensive left ventricular hypertrophy. China National Knowledge Infrastructure(CNKI), Wanfang, VIP, PubMed, EMbase, Cochrane Library, Ovid and Web of Science databases were searched by computer to retrieve the randomized controlled trials(RCTs) of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in the treatment of hypertensive left ventricular hypertrophy from the establishment of databases to July 2020. After two researchers performed data retrieval, data extraction, and risk assessment of bias, they used RevMan 5.3 software for Meta-analysis. A total of 10 RCTs were included, with a total of 979 patients. Meta-analysis results showed that in terms of interventricular septal thickness(MD=-0.70, 95%CI[-1.15,-0.24], P=0.003), left ventricular posterior wall thickness(MD=-0.81, 95%CI[-1.41,-0.21], P=0.008), left ventricular mass index(MD=-8.75, 95%CI[-17.40,-0.10], P=0.05), systolic blood pressure(MD=-8.97, 95%CI[-13.46,-4.48], P<0.000 1), diastolic blood pressure(MD=-5.87, 95%CI[-8.39,-3.34], P<0.000 01) and left ventricular end-diastolic diameter(MD=-1.73, 95%CI[-2.38,-1.08], P<0.000 01), Compound Danshen Dripping Pills combined with conventional antihypertensive drugs was superior to conventional antihypertensive drugs. In terms of left ventricular ejection fraction(MD=0.41, 95%CI[-0.74, 1.55], P=0.49), there was no statistical difference in treatment between the two groups. Because of the small amount of literatures included in the safety aspect, it is impossible to give an accurate conclusion. The GRADE score showed that the level of evidence was low and extremely low. The results show that the Compound Danshen Dripping Pills combined with conventional antihypertensive drugs may effectively improve the clinical efficacy for hypertensive ventricular hypertrophy, and the safety needs to be further explored. Due to the low quality of the included literatures, more high-quality RCTs are needed for verification.

Effects of Compound Danshen Dripping Pills on Contrast-induced Nephropathy after Percutaneous Coronary Intervention and Patients ’Prognosis / 中国药房

OBJECTIVE：To observe the effects of Compound danshen drip ping pills on the prevention of contrast-induced nephropathy（CIN）after percutaneous coronary intervention （PCI）and its influence on clinical prognosis. METHODS ：From Jan. to Jun. 2020，240 patients with coronary heart disease receiving PCI in Tianjin Chest Hospital were randomly divided into control group（120 cases）and Danshen dripping pills group （120 cases）according to random number table. The patients in both groups were injected with Lippaclitanol injection 1-5 mL slowly through radial or femoral artery sheath ，and intravenous hydration was performed before and after PCI ；Danshen dripping pills group was additionally given Compound danshen dripping pills 270 mg orally for a long term ，three times a day ，three days before and after PCI ，on the basis of the control group. The levels of renal function indexes [serum creatinine （Scr），blood urea nitrogen （BUN），cystatin C （Cys-C），creatinine clearance rate （Ccr）]， inflammatory reaction indexes [high sensitivity C-reactive protein （hs-CRP）， interleukin-6 （IL-6）] and oxidative stress index [malondialdehyde （MDA）] were observed in 2 groups before and 72 hours after PCI. The occurrence of CIN in 2 groups was recorded 3 days after PCI therapy ；the occurrence of major cardiovascular adverse events was also observed during 1-year follow-up period. RESULTS ：Before treatment ，there was no significant difference in serum renal function indexes ，inflammatory reaction indexes and oxidative stress index between 2 groups（P＞0.05）. Seventy-two hours after PCI ，serum levels of Scr ，BUN， Cys-C，hs-CRP，IL-6 and MDA were increased significantly in 2 groups than before treatment ，while the Ccr were decreased significantly；those indexes of Danshen dripping pills group were significantly better than those of control group （P＜ 0.05）. The incidence of CIN in Danshen dripping pills group was 4.2％ after treatment ， and total incidence of major cardiovascular adverse events was 13.3％ during follow-up period，which were sign ificantly lower than 13.3％ and 27.5％ of control group （P＜0.05）. CONCLUSIONS ：Compound danshen dripping pills may have a certain effect on the prevention of CIN in coronary heart disease patients after PCI ，and can reduce the incidence of major cardiovascular adverse events.

Meta-analysis of the Effectiveness and Safety of Compound Danshen Dripping Pills in Improving Aspirin Resistance / 中国药房

OBJECTIVE：To systematically evaluate the effectiveness and safety of Compound danshen dripping pills in improving aspirin resistance ，and to provide evidence-based evidence for clinical drug use. METHODS ：Retrieved from CNKI ， VIP，Wanfang database ，CBM，PubMed，Embase，the Cochrane L ibrary，randomized controlled trials （RCTs）about Compound danshen dripping pills （trial group ）versus aspirin （control group ）were collected during the inception to Jun. 2020. After literature screening and data extraction ，bias risk assessment tool recommended by the Cochrane evaluation manual handbook 5.1.0 was used to evaluate the quality of the included literatures ，and Rev Man 5.3 software was used for Meta-analysis and publication bias analysis. RESULTS ：A total of 10 RCTs were included ，with a total of 800 patients. Meta-analysis showed that the platelet aggregation rate （PAR）induced by adenosine diphosphate （ADP）in trial group was significantly lower than that of control group [SMD ＝－2.63，95％CI（－3.56，－1.70），P＜0.000 01]. Results of sub-group analysis by treatment cycle showed that PAR induced by ADP in trial group after 2 weeks of treatment [SMD ＝－2.11，95％CI（－2.75，－1.46），P＜0.000 01]，4 weeks of treatment [SMD ＝－2.84，95％CI（－4.26，－1.41），P＜0.000 1] Δ 基金项目 ：国家重点研发计划中医药现代化研究重点专项 and 8 weeks of treatment [SMD ＝－2.63，95％CI（－3.21， （No.2019YFC1710000，No.2019YFC1710003）；国家中医药管理局中 － 2.04），P＜0.000 01] was significantly lower than control 医药循证能力建设项目（No.2019XZZX-XXG003）；河南省创新型科技 团队项目 group. PAR induced by arachidonic acid （AA）of trial group ＊硕士研究生 。研究方向：中西医结合心血管疾病的预防和治 was significantly lower than that of control group [SMD ＝ 疗。E-mail：guohongxin1214@163.com －2.44，95％CI（－3.64，－1.24），P＜0.000 1]. Results of # 通信作者：主任医师，教授，硕士生导师，博士。研究方向：中医 sub-group analysis by treatment cycle showed that PAR 药防治心血管疾病的临床和基础 。电话：0371-66233478。E-mail： induced by AA in trial group after 2 weeks of tre atment [SMD ＝ zhumingjun317@163.com －2.56，95％CI（－3.26，－1.85），P＜0.000 01]，4 weeks of 中国药房 2021年第32卷第6期 China Pharmacy 2021Vol. 32 No. 6 ·743· treatment of [SMD ＝－2.45，95％CI（－4.79，－0.10），P＝0.04]，8 weeks of treatment [SMD ＝－2.38，95％CI（－2.94，－1.82），P＜ 0.000 01] was significantly lower than control group. The decrease of ADP-induced PAR [SMD ＝2.24，95％CI（1.36，3.13），P＜ 0.000 01]，AA-induced PAR [SMD ＝2.42，95％CI（1.94，2.89），P＜0.000 01] and response rate [RR ＝8.56，95％CI（4.38，16.74）， P＜0.000 01] in trial group were significantly higher than control group ，while the incidence of ADR [RR ＝0.30，95％CI（0.15， 0.60），P＝0.000 6]，the incidence of ischemic events [RR ＝0.13，95％CI（0.07，0.27），P＜0.000 01]，CR and RF after treatment （P＜0.05）were significantly lower than control group. There was no statistical significant difference in the incidence of bleeding events between 2 groups [RR ＝0.78，95％ CI（0.34，1.78），P＝0.55]. The results of publication bias showed that there was less possibility of publication bias in this study. CONCLUSIONS ：Compound danshen dripping pills can effectively improve aspirin resistance and has good safety.

Effect of compound Danshen dripping pills on expression of miR-1 in serum after percutaneous coronary intervention in patients with acute myocardial infarction / 中国中西医结合急救杂志

Objective To explore the effects of compound Danshen dripping pills on the expression levels of micro RNA-1 (miR-1) and inflammatory factors in serum of patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI). Methods A total of 180 AMI patients admitted to Mindong Hospital of Ningde City from March 2017 to October 2018 were divided into a compound Danshen dripping pills group and a conventional western medicine treatment group, 90 cases in each group. According to the disease situations of all the patients, they needed to undergo PCI treatment, after the intervention, in the conventional western medicine treatment group, aspirin enteric-coated tablet (metformin hydrochlorid) was given as the basic anti-coagulation medicine and in the compound Danshen dripping pill group, on the basic treatment, 10 Danshenn pills each time, 3 times a day, were orally applied. Both groups were evaluated for efficacy after 2 months of continuous treatment. Echocardiography was used to detect the patients' cardiac functions; the changes of the expression levels of serum miR-1, interleukins (IL-1, IL-6), tumor necrosis factor-α (TNF-α), and myocardial troponin I (cTnI) and creatine kinase isoenzyme (CK-MB) in the two groups before and after treatment were observed. Results After treatment in both groups, the left ventricular ejection fraction (LVEF) and cardiac output index (CI) were significantly higher than those before treatment, while the expression of miR-1 and serum IL-1, IL-6, TNF-α, cTnI and CK-MB were lower than those before treatment, the LVEF and CI in the compound Danshen dripping pill treatment group were obviously higher than those in the conventional western medicine treatment group [LVEF: 0.60±0.08 vs. 0.56±0.08, CI (L·min-1·m-2): 6.02±0.34 vs. 4.91±1.50, both P < 0.05], the expression level of miR-1 and serum IL-1, IL-6, TNF-α, cTnI and CK-MB in the compound Danshen dripping pill group were lower than those in the conventional western medicine treatment group [miR-1 (2-ΔΔCt): 0.69±0.17 vs. 0.85±0.22, IL-1 (μg/L): 59.20±18.67 vs. 68.31±23.69, IL-6 (μg/L): 20.36±1.87 vs. 25.38±2.39, TNF-α (μg/L): 28.65±1.63 vs. 31.86±2.92, cTnI (μg/L):3.12±0.88 vs. 4.03±0.97, CK-MB (U/L): 29.18±10.52 vs. 34.28±10.21, all P < 0.05]. Conclusion Compound Danshen dripping pills can reduce serum the expression levels of miR-1 and inflammatory cytokines in patients with AMI after PCI.

Quality marker research of monarch herb Salvia miltiorrhiza in Compound Danshen Dripping Pills / 中草药

To explore the chemical ingredients of Salvia miltiorrhiza in Compound Danshen Dripping Pills (CDDP) based on the concept of quality marker (Q-marker). Methods The main salvianolic acids of S. miltiorrhiza and CDDP were determined by UPLC method. According to the extraction process of CDDP chemical transformation of salvianolic acids, including lithospermic acid, salvianolic acids B, E, U, and T were studied. Results Salvianolic acid B and rosmarinic acid, more than 90.0% and 5.0% of total salvianolic acid, were the main salvianolic acids in S. miltiorrhiza. But in CDDP, eight salvianolic acids (danshensu, protocatechuic aldehyde, salvianolic acids A, B, D, T, and U) were the main salvianolic acids. And the contents of danshensu and protocatechuic aldehyde were higher than the other six salvianolic acids. Through the study on chemical transformation of salvianolic acids, it was proved that lithospermic acid, salvianolic acids B, E, U, and T could transform into other salvianolic acids with smaller molecular weight, and danshensu and protocatechuic aldehyde were the main end products. Conclusion It is scientific to choose salvianolic acid B as the Q-marker of salvianolic acids of S. miltiorrhiza, and danshensu as the primary Q-marker. During the preparation of CDDP, salvianolic acids from S. miltiorrhiza have chemical chages, eight main salvianolic acids of which have been produced. The contens of danshensu and protocatechuic aldehyde are the highest in the eight salvianolic acids. From the chemical composition level, it is scientific and reasonable to choose danshensu as the Q-marker of monarch herb S. miltiorrhiza in CDDP.

Correlation between CYP2C19 gene polymorphism and clinical efficacy of compound danshen dropping pills in treatment of senile coronary atherosclerotic heart disease / 中国中西医结合急救杂志

Objective To study the correlation between the polymorphism of CYP2C19 gene and the clinical efficacy of compound Danshen dripping pills in treatment of senile coronary atherosclerotic heart disease (CHD) and to provide theoretical basis for rational drug use. Methods Two hundred and six elderly patients with CHD treated in the Third Hospital of Hebei Medical University from June 2015 to December 2017 were screened for genotype detection and classification. All patients were given oral compound Danshen dripping pills, 10 pills each time, 3 times a day, for consecutive 2 months. Serological indexes, electrocardiograph (ECG) monitoring, liver and kidney function testing were performed before and after treatment to evaluate drug efficacy and adverse reactions. Results In senile patients with CHD, after taking compound danshen dripping pills for 2 months, the efficacy in patients with intermediate metabolizer (IM) was more significantly effective than the efficacies of the patients with extensive metabolizer (EM) and poor metabolizer (PM) [clinical efficacy: 95.6% (87/91) vs. 80.5% (33/41), 93.2% (69/74), ECG efficacy: 95.6% (87/91) vs. 78.0% (32/41), 94.6% (70/74)], at the same time, the serum levels of triglyceride (TG) and high-density lipoprotein (HDL) in patients with IM were also higher than those in patients with PM and EM [TG (mmol/L): 1.33±0.52 vs. 1.33±0.41, 1.33±0.27, HDL (mmol/L): 1.58±1.17 vs. 1.44±0.65, 1.38±0.18], and the levels of total cholesterol (TC), low-density lipoprotein (LDL) and hypersensitive C-reactive protein (hs-CRP) were lower than those of PM and EM [TC (mmol/L): 3.48±0.25 vs. 3.56±0.96, 3.51±0.51, LDL (mmol/L): 2.19±0.35 vs. 2.23±0.49, 2.21±0.87, hs-CRP (mg/L): 3.50±1.07 vs. 3.53±1.51, 3.54±2.01]. The incidences of adverse reactions in patients with EM and IM were significantly lower than the incidence of PM [6.8% (5/74), 9.9% (9/91) vs. 31.7% (13/41)], the differences being statistically significant (both P < 0.05). Conclusions CYP2C19 gene polymorphism is closely related to C HD in elderly, in such patients with IM, after taking compound Danshen dripping pills, the efficacy is significant and has low incidence of adverse reactions. Therefore, in the course of clinical treatment of elderly patients with CHD, genetic testing should be carried out to fully consider the influence of CYP2C19 gene polymorphism on the efficacy of the pill, and adopting personalized therapy can increase efficacy and reduce toxicity.

Metabolomics Research on Compound Danshen DrippingPills in Acute Myocardial Infarction Rat / 分析化学

An acute myocardial infarction rat model was established by ligation of the left ventricular coronary artery.Plasma samples of rats were collected and analyzed by ultra performance liquid chromatography coupled with quadrupole time-of-flight mass spectrometry (UPLC-QTOF/MS) to study the myocardial protection mechanism of compound Danshen dropping pill (CDDP).After principal component analysis (PCA) and partial least squares discriminant analysis (PLS-DA), 22 metabolites were identified as potential biomarker of AMI.Furthermore, CDDP had remarkable effect on AMI rats.p-Tolyl sulfate, hippuric acid, equol 7-O-glucuronide, lysoPC(16∶0), cholic acid, oleamide, palmitic amide and SM(d18∶1/16∶0) were significantly changed in treatment group.The results showed that CDDP had a very good myocardial protection effect on AMI rats, and might influence the pathways of phenylalanine metabolism, glycerophospholipid metabolism, fatty acid metabolism, primary bile acid biosynthesis and Sphingolipid metabolism.

Research progress in fingerprint of Compound Danshen Dripping Pills and its raw materials / 药物评价研究

Compound Danshen Dripping Pills has curative effect of angina pectoris,coronary heart disease,and other cardiovascular and cerebrovascular diseases,which is widely used in clinic.With the development of basic research and clinical pharmacology,it is particularly important to carry out more comprehensive and systematic quality control.At present,fingerprint technology is developing rapidly and has been recognized by many countries.In this article,we summarized the research situation of Compound Danshen Dropping Pills and its raw materials from two aspects of chromatography and spectroscopy (such as LC,CE,IR,NMR and so on).It will provide reference or the further establishment of a reasonable quality control method.

Effect of Compound Danshen Dripping Pills on distribution of carbamazepine in brain of normal and refractory epilepsy rats / 中草药

Objective To investigate the effect of Compound Danshen (Salvia miltiorrhiza) Dripping Pills (CDDP) on the distribution of carbamazepine (CBZ) in the brain of normal and refractory epilepsy rats. Methods Wistar male rats were divided into normal and model rats. Normal rats were divided into control group and CDDP group. Model rats were divided into control group, CDDP group and verapamil group. The animal model of refractory epilepsy was induced by intrahippocampal injection of kainic acid. After the success of modeling, CDDP group was given CDDP (85 mg/kg), verapamil group was given verapamil (20 mg/kg) for 10 d, then each group was given CBZ (100 mg/kg) respectively. Brain tissue samples were collected at different time points. After the samples were pretreated, the concentration of CBZ in the brain tissue was detected by HPLC-MS/MS. Results When using carbamazepine alone, the concentration of CBZ in normal rats was obviously higher than epileptic rats. Compared with using carbamazepine alone, CDDP could significantly increase the concentration of CBZ in normal and epileptic rats. For the epileptic rats, the enhancing effect of CDDP to the cerebral distribution of CBZ was similar to that of P-glycoprotein inhibitor verapamil. Conclusion CDDP could enhance the permeability of blood-brain barrier to CBZ and increase the cerebral distribution of CBZ in normal and epileptic rats.

Development method of fingerprint of Compound Danshen Dripping Pills based on analytical quality by design (AQbD) / 中草药

Objective To study the development of analytical quality by design (AQbD) method for the identification of Compound Danshen Dripping Pills (CDDP) by UPLC-UV. Methods The number of peaks and the target peak content (notoginsenoside R1, ginsenoside Rg1, ginsenoside Re and ginsenoside Rb1) were taken as the analytical target profile (ATP), Plackett-Burman design (PBD) method was used to select critical method parameters (CMPs) and critical method attributes (CMAs) on the basis of risk assessment, and then the response model between CMAs and CMPs was established by Box-Behnken design (BBD). The optimal conditions were obtained via multivariable regression analysis and verified. Results From the seven factors of risk assessment, the flow rate (A), sample weight (B), and C18 column weight (C) were selected as CMPs. And CMAs were the number of peaks (N), notoginsenoside R1 (CR1) and ginsenoside Re (CRe). The variation trends of each factor and model were analyzed by response surface analysis. The optimal conditions were as follows: flow rate of 0.28 mL/min, sample weight of 0.30 g, and C18 column weight of 1.10 g. Under the conditions, N was 12, CR1 was 1.676 5 mg/g, and CRe was 0.669 6 mg/g, with differences of 1.34%, 1.33%, and 2.94% respectively from the predictive values. The final method was as follows: chromatographic column was Acquity UPLC BEH C18 chromatographic column (50 mm × 2.1 mm, 1.7 μm), mobile phase was acetonitrile-water gradient elution, detection wavelength was 203 nm, column temperature was 30 ℃, flow rate was 0.28 mL/min, and injection volume was 2 μL. Conclusion The results prove that the method is reliable.

Effects of Compound Danshen Dripping Pills or Tablets on Chronic Hepatitis B Complicated with Hepatic Fibrosis: A Systematic Review / 中国药房

OBJECTIVE:To systematically review the efficacy of Compound danshen dripping pill or Compound danshen tablets for chronic hepatitis B complicated with hepatic fibrosis,and to provide evidence-based reference for clinical treatment.METHODS:Retrieved from PubMed,Cochrane Library,EMBase,Medline,Wanfang database,VIP,CJFD and CBM database,randomized controlled trials (RCTs) about Compound danshen dripping pills or tablets combined with entecavir(trial group) vs.entecavir alone (control group) for chronic hepatitis B complicated with hepatic fibrosis were collected.Meta-analysis was performed by using Rev Man 5.3 statistical software after data extraction and quality evaluation according to Cochrane systematic evaluation manual 5.1.0.RESULTS:A total of 9 RCTs were enrolled,including 714 patients.The results of Meta-analysis showed that ALT [SMD=-0.44,95％CI(-0.86,-0.01),P=0.04],HA [SMD=-1.53,95％CI(-2.28,-0.79),P＜0.001],LN [SMD=-0.93,95％CI(-1.41,-0.46),P＜0.001],CⅣ [SMD=-1.38,95％CI(-2.13,-0.63),P＜0.001] and PCⅢ [SMD=-1.42,95％ CI (-1.60,-1.23),P＜0.001] of trial group were significantly lower than those of control group;HBV-DNA negative rate [OR=3.73,95 ％ CI (2.14,6.49),P ＜ 0.001] was significantly higher than control group,with statistical significance.CONCLUSIONS:Compound danshen dripping pills or tablets can not only improve liver function and liver fibrosis in chronic hepatitis B patients with hepatic fibrosis,but also improve the antiviral effect.

Effects of Compound Danshen Dripping Pills or Tablets on Chronic Hepatitis B Complicated with Hepatic Fibrosis: A Systematic Review / 中国药房

OBJECTIVE:To systematically review the efficacy of Compound danshen dripping pill or Compound danshen tablets for chronic hepatitis B complicated with hepatic fibrosis,and to provide evidence-based reference for clinical treatment.METHODS:Retrieved from PubMed,Cochrane Library,EMBase,Medline,Wanfang database,VIP,CJFD and CBM database,randomized controlled trials (RCTs) about Compound danshen dripping pills or tablets combined with entecavir(trial group) vs.entecavir alone (control group) for chronic hepatitis B complicated with hepatic fibrosis were collected.Meta-analysis was performed by using Rev Man 5.3 statistical software after data extraction and quality evaluation according to Cochrane systematic evaluation manual 5.1.0.RESULTS:A total of 9 RCTs were enrolled,including 714 patients.The results of Meta-analysis showed that ALT [SMD=-0.44,95％CI(-0.86,-0.01),P=0.04],HA [SMD=-1.53,95％CI(-2.28,-0.79),P＜0.001],LN [SMD=-0.93,95％CI(-1.41,-0.46),P＜0.001],CⅣ [SMD=-1.38,95％CI(-2.13,-0.63),P＜0.001] and PCⅢ [SMD=-1.42,95％ CI (-1.60,-1.23),P＜0.001] of trial group were significantly lower than those of control group;HBV-DNA negative rate [OR=3.73,95 ％ CI (2.14,6.49),P ＜ 0.001] was significantly higher than control group,with statistical significance.CONCLUSIONS:Compound danshen dripping pills or tablets can not only improve liver function and liver fibrosis in chronic hepatitis B patients with hepatic fibrosis,but also improve the antiviral effect.

Clinical analysis of effect of quick acting Kyushin Pills and compound Danshen Dropping Pills on angina pectoris of coronary heart disease / 中国生化药物杂志

Objective To compare the clinical effect of quick acting Kyushin pills and compound Danshen dripping pills in the treatment of coronary heart disease angina pectoris. Methods 98 patients with angina pectoris from December 2015 to April 2017 were randomly divided into group A (n=49) and group B (n=49) by random number table. A group on the basis of conventional therapy plus compound Danshen Pill, B group in the conventional treatment based on the use of available Kyushin Pills, recorded the treatment of two groups of patients with angina pectoris of coronary heart disease before and after 2 weeks of treatment, angina frequency (weekly), duration (weekly) changes. Results Two groups of patients with angina pectoris were successfully completed treatment, there was no significant difference in the frequency and duration of angina pectoris before treatment. After the two groups after 2 weeks of treatment duration, seizure frequency were significantly reduced than before (P<0.05), the above indexes in group B decreased than group A (P<0.05). Conclusion The use of conventional therapy based on the use of Kyushin Pills can significantly relieve angina pectoris in patients with coronary heart disease, and has positive significance for the protection of its efficacy and prognosis.

Clinical analysis of effect of quick acting Kyushin Pills and compound Danshen Dropping Pills on angina pectoris of coronary heart disease / 中国生化药物杂志

Objective To compare the clinical effect of quick acting Kyushin pills and compound Danshen dripping pills in the treatment of coronary heart disease angina pectoris. Methods 98 patients with angina pectoris from December 2015 to April 2017 were randomly divided into group A (n=49) and group B (n=49) by random number table. A group on the basis of conventional therapy plus compound Danshen Pill, B group in the conventional treatment based on the use of available Kyushin Pills, recorded the treatment of two groups of patients with angina pectoris of coronary heart disease before and after 2 weeks of treatment, angina frequency (weekly), duration (weekly) changes. Results Two groups of patients with angina pectoris were successfully completed treatment, there was no significant difference in the frequency and duration of angina pectoris before treatment. After the two groups after 2 weeks of treatment duration, seizure frequency were significantly reduced than before (P<0.05), the above indexes in group B decreased than group A (P<0.05). Conclusion The use of conventional therapy based on the use of Kyushin Pills can significantly relieve angina pectoris in patients with coronary heart disease, and has positive significance for the protection of its efficacy and prognosis.

Effects of Compound Danshen Dripping Pills on Hemorheology and Nerve Conduction Velocity of Diabetic Peripheral Neuropathy Patients / 广州中医药大学学报

Objective To compare the effects of oral use of Compound Danshen Dripping Pills and Mecobalamin Tablets on hemorheology and nerve conduction velocity of diabetic peripheral neuropathy patients. Methods A total of 70 diabetic peripheral neuropathy patients were randomized into treatment group and control group, 35 cases in each group. Both groups were given fundamental treatment for controlling blood glucose, blood lipids and blood pressure, and additionally the treatment group was treated with Compound Danshen Dripping Pills orally and the control group was treated with Mecobalamin Tablets orally. The treatment for the two groups lasted 3 continuous months. The changes of hemorheology and nerve conduction velocity of the two groups were observed before and after treatment. Results After treatment, indexes of hemorheology and nerve conduction velocity of the two groups were much improved(P<0.05 compared with those before treatment). The improvement of hemorheology indexes in the treatment group was superior to that in the control group (P < 0.05), but the difference of improvement of nerve conduction velocity was insignificant between the two groups (P > 0.05). Conclusion The effects of oral use of Compound Danshen Dripping Pills on the nerve conduction velocity of diabetic peripheral neuropathy patients are similar to those of Mecobalamin Tablets, but the pills have better effects on improving hemorheology than the tablets. The results indicated that Compound Danshen Dripping Pills are effective on improving blood flow and nerve conduction velocity of the limbs of the patients.

The effects of compound danshen dripping pills combined with triamcinolone acetonide in the treatment of oral submucous fibrosis / 实用口腔医学杂志

Objective:To observe the efficacy and safety of compound danshen dripping pills(DDP)combined with intralesional tri-amcinolone acetonide(TA)injection in the treatment of oral submucous fibrosis(OSF).Methods:34 patients with clinically con-firmed OSF were randomly divided into 2 groups(n =17)and treated with DDP +TA and TA respectively,meanwhile the VAS of pain and mouth opening were recorded and compared.Results:Before treatment there was no statistical difference of the VAS scores and mouth opening between 2 groups(P >0.05),12 weeks after treatment,the difference was significant(P ＜0.05).The clinical condi-tion of treatment group were improved(χ2 =6.051,P ＜0.05),but there were no improvement in control group(χ2 =3.429,P >0.05).Conclusion:Compound danshen dripping pills combined with intralesional triamcinolone acetonide injection can significantly enhance the effects safely in the treatment of OSF.

Effects of intravenous transplantation of human umbilical cord blood mononuclear cells combined compound Danshen dripping pills on the microenvironment and apoptosis in the myocardium of the rabbits with acute myocardial infarction / 中南大学学报(医学版)

Objective:To explore the effects of compound Danshen dripping pills (CDDP) and CDDP combined with transplantation of human umbilical cord blood cells (HUMNCs) on the inlfammatory response, oxidative stress, myocardial cell apoptosis and cardiac function, and also to investigate the possible mechanisms of the combined therapy in the acute myocardial infarction (AMI). Methods:Rabbit model of AMI successfully established by ligation of the letf anterior coronary artery (LAD). Forty rabbits were randomly divided into 4 groups (n=10 per group):a control group, injected with 0.5 mL of saline in 24 h atfer AMI and then gavaged with 5 mL of saline daily;a CDDP group, injected with saline 0.5 mL atfer AMI and then gavaged with CDDP (270 mg/d) daily;a transplantation group, injected with 0.5 mL of saline contained 3 × 107 HUCBMCs [labeled with green fluorescent protein (GFP)] and then gavaged with 5 mL of saline daily;a combined group, injected with 0.5 mL of saline contained 3 × 107 HUCBMCs (labeled with GFP) and then gavaged with CDDP (270 mg/d) daily. Cardiac function index such as left ventricular fractional shorting (LVFS) and ejection fraction(LVEF) were measured by echocardiography;the pathological changes were observed by HE staining and the white blood cells in the myocardium were determined by light microscopy. hTe superoxide dismutase (SOD) activity and malondialdehyde (MDA) content in myocardium were detected by nitrotetrazolium blue chloride (NBT) and thiobarbituric acid colorimetric measurement respectively. hTe number of transplanted cells in the myocardium was examined by GFP positive cells counted with lfuorescence microscopy. Results:1) Compared with the control group (at 1 or 4 week), LVEF and LVFS were signiifcant improved in the CDDP group, the transplantation group and the combined groups (all P Conclusion:The intravenous transplantation of HUMNCs combined with the CDDP in the treatment of rabbits with AMI could increase the survival rate of transplanted cells and inhibit the myocardial cell apoptosis, therefore improve the heart function. hTe possible mechanism of the combined treatment may be involved in the inhibition of the inlfammatory response and oxidative stress in the myocardium following AMI.