Objective: To refine and evaluate the clinical evidence, and provide proof and reference for Xinxuening's clinical program establishment from the perspective of evidence-based medicine through screening the clinical studies of cardiovascular disease by Xinxuening.s treatment. Method: The included and excluded criteria was established before the setting of search terms, eligible databases (PubMed, Web of Science, Ovid, Embase, Cochrane, CNKI, CBM, Wanfang and Vip) were searched and the quality evaluation and evidence classification was conducted for eligible documents. The software RevMan was used to evaluate the clinical evidence of Xinxuening in the treatment of cardiovascular disease (primary hypertension, coronary heart disease, heart failure and hyperlipidemia) and to explore the specific mechanism.Results: A total of 16 suitable studies were included, of which 15 were RCTs and 1 was observation study. 9 of the 16 studies were the C level evidence and 7 were the D level. The included studies were all low quality. The outcome indicators of clinical treatment for cardiovascular disease were: the efficacy of hypertension therapy, the level of systolic and diastolic blood pressure after therapy, the efficacy of angina pectoris and hyperlipidemia treatment, and the total cholesterol and triglyceride levels after treatment. The results showed that Xinxuening could significantly reduce the level of blood pressure for patients with hypertension, improve the symptoms of angina pectoris in patients with coronary heart disease, and reduce the levels of blood lipids (triglycerides and total cholesterol) . The results have statistical differences (P ＜ 0.05) . However, it the specific mechanism of Xinxuening in the treatment of cardiovascular disease was not found.Conclusion: Xinxuening has higher clinical effect on the treatment of some cardiovascular diseases compared with some western drugs and other proprietary Chinese medicine. However, it still needs further exploration of the specific clinical mechanism and to conduct high-quality clinical research.

Objective: To evaluate the efficacy and safety of Shexiang Tongxin dropping pill (ShXT) in the treatment ofslow blood flow after PCI (Percutaneous Transluminal Coronary Intervention), and to provide evidence for clinicaltreatment of patients with slow blood flow after PCI or to provide evidence for further research and design. Methods: "Shexiang Tongxin", "PCI", "percutaneous coronary intervention", "shexiangtongxin", "shexiang tongxin", "percutaneouscoronary intervention" were used as key words. Randomized controlled clinical trial (RCT), system evaluation, retrospective case analysis and case-control trials of randomized controlled clinical trials were searched in the databasesof Pubmed, Cochrane, web of science, CNKI, WIP, CBM, and other databases. Cochrane risk assessment tool and NOSrating scale were used to evaluate the quality of literature, and the classification of literature evidence was evaluatedaccording to Oxford criteria of evidence classification and recommended opinion strength in 2001. Results: A total of 3 articles of RCT related to the subject were selected, including 1 case control trial, including 335 patients. The resultsshowed that: (1) The frequency of thrombolysis, heart ejection fraction and TIMI blood flow in patients with slow coronaryartery flow after treatment with Shexiang Tongxin dropping pills were significantly higher than those before treatment. (P ＜ 0.05) . (2) After treatment with Shexiang Tongxin dropping pills, the effective rate of clinical symptoms was 97.8％, which was higher than that of the treatment group 11.1％. (3) There were no adverse reactions in the ShXT group duringthe treatment period. Conclusion: The efficacy and safety of Shexiang Tongxin dropping pills for patients with slow bloodflow after PCI were good. However, the dosage, method, period and outcome of the clinical study of slow blood flow afterPCI were not uniform because of the dosage, method, period of taking Shexiang Tongxin dropping pills in patients afterPCI. It is suggested that the clinical study should be aimed at the choice of different dosages before and after theadministration of drugs. The multicenter prospective randomized controlled trial can provide more evidence for itsclinical application.

Objective: To evaluate the effect of Danhong injection on endothelial function after percutaneous coronaryintervention (PCI) in coronary heart disease (CHD) . It provides the basis for further research and design. Methods: Sevendatabases of CNKI, VIP, Wanfang Data, CBM, PubMed, The Cochrane Library, Embase and others were searched bycomputer cents with coronary heart disease treated by Danhong injection combined with conventional drugs. Twoevaluators independently sifted the literature, extracted the data and evaluated the bias risk in the study. The data werestatistically analyzed by RevMan 5.3 software. Results: A total of 12 RCTs, involving 1325 patients were included. Metaanalysis showed that the treatment group (Danhong injection combined with routine therapy) was superior to the controlgroup in improving the endothelium index after operation. The index NO[MD=9.57, 95％CI (8.22, 10.93), P ＜ 0.00001], vWF [MD=-31.60, 95％CI (-41.47, -21.72), P ＜ 0.00001], ET-1 [MD=-2.19, 95％CI (-3.11, -1.27), P ＜ 0.00001], ET[SMD=-0.92, 95％CI (-1.49, -0.35), P ＜ 0.01], FMD[MD = 1.81, 95％CI (1.26, 2.37), P ＜ 0.00001]. There was statisticalsignificance between each index. Conclusion: Danhong injection combined with conventional therapy can improveendothelial function after PCI. However, due to the low quality of included studies and the problem of heterogeneity, these conclusions need to be further verified by high quality multicenter, large sample and double blind randomizedcontrolled trials.

OBJECTIVETo investigate the safety and efficacy of trastuzumab administered concurrently with anthracycline-containing adjuvant regimen for breast cancer.

METHODSIt is a prospective, randomized and controlled trial. Participants were randomized to receive trastuzumab administered concurrently or sequentially with anthracycline-containing adjuvant regimen. The primary endpoint was cardiac safety. The second endpoints were disease-free survival (DFS) and overall survival (OS).

RESULTSOne hundred and nine breast cancer patients were enrolled and randomized in this trial. Fifty-five participants received trastuzumab administered concurrently with anthracycline-containing adjuvant regimen and 54 patients received trastuzumab administered sequentially with anthracycline. The primary cardiac event was asymptomatic decrease in the left ventricular ejection fraction (LVEF). There was no significant difference between concurrent and sequential groups in cardiac event rates (9.1% vs13.0%, P = 0.556), neither of LVEF values at basline or at 3, 6, 9 and 12 months during trastuzumab treatment (P > 0.05). Four patients (7.3%) in the concurrent group suffered local recurrences or distant metastases, and 6 participants (11.1%) in the sequential group had distant metastases. There was no significant difference between the two groups in DFS (P = 0.724). There was no death in both groups.

CONCLUSIONSTrastuzumab administered concurrently with anthracycline is a safe adjuvant regimen for breast cancer and does not increase cardiac events. Further research is needed to determine the efficacy of this treatment regimen.

Adult ; Anthracyclines ; administration & dosage ; Antibodies, Monoclonal, Humanized ; administration & dosage ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Breast Neoplasms ; drug therapy ; pathology ; surgery ; Carcinoma, Ductal, Breast ; drug therapy ; pathology ; surgery ; Chemotherapy, Adjuvant ; Disease-Free Survival ; Female ; Follow-Up Studies ; Humans ; Liver Neoplasms ; secondary ; Lymphatic Metastasis ; Middle Aged ; Neoplasm Recurrence, Local ; Prospective Studies ; Stroke Volume ; Trastuzumab

Objective: To summarize the clinical effects of Shuxuening Injection on diseases and evaluate the quality of evidence to provide reference for the clinical application of Shuxuening Injection. Methods: Journal articles and conference papers were retrieved from the databases CNKI, Wanfang, VIP, CBM, EMbase, Pubmed and Cochrane with thematic word"Shuxuening"in Chinese and English, then all forms of clinical studies were screened and the disease types and frequency were analyzed, the dominant disease types of Shuxuening Injection were identified. Futhermore, RCT was extracted, and the literature quality was graded using the cochrane manual recommendation method, and its effectiveness and safety were evaluated. Results: All clinical research results show that Shuxuening Injection to treat disease with as many as 74 kinds of varieties, mainly circulation system disease and neural system disease, followed by endocrine disease, respiratory disease, scattered remaining research in ten other system diseases. These researches appeared with the highest frequency of the three diseases were cerebral infarction and its aftermath, angina pectoris and coronary heart disease, diabetes mellitus and its complication. A total of 337 RCT articles were included, all of which were of poor quality. In general, the efficiency of Shuxuening Injection treatment group was significantly higher than that of the control group, with a total efficiency of 84.48％. There were 21.96％ references to adverse reactions, but all of them were minor adverse reactions, such as pruritus, which generally got better by itself or after treatment. Conclusion:Shuxuening Injection has a wide range of clinical application and remarkable effect, especially for the ischemic diseases of cardiovascular and cerebrovascular diseases with good efficacy, less adverse reactions and safety. However, the quality of evidence is generally poor, which needs further study.

The insufficient reporting of adverse reactions of Chinese proprietary medicines is common. In addition, there is a lack of safety information in the specifications of Chinese proprietary medicines, which led to less evidence for clinical safety of Chinese proprietary medicines in clinical practice. It is urgent to carry out post-marketing clinical safety re-evaluation of Chinese proprietary medicine. Developing a clinical safety evaluation data set for Chinese proprietary medicine may reduce the insufficient reporting of safety information and the inconsistency of data reporting in similar studies, as well as include more studies in systematic reviews, so that they can provide higher-level evidence for clinical safety of Chinese proprietary medicine. This paper proposes a method for developing core data set of clinical safety evaluation of Chinese proprietary medicine: firstly, the application scope of core data set for clinical safety evaluation was determined according to the characteristics of diseases, population, research objectives, administration methods, evaluation methods, etc. Systematic reviews and semi-structured interviews should be conducted to develop the list of original items for clinical safety evaluation. Based on the list, Delphi surveys can be developed in different stakeholders. Then the final core data set can be developed via consensus meetings.

Objective: To conduct a comprehensive and systematic review of the efficacy and safety of Wenxin Keli (WXKL) in the treatment of atrial fibrillation (AF) . Methods: Seven databases (PubMed, The Cochrane Library, Web ofScience, CNKI, Wanfang Database, VIP and SinoMed) were searched to identify relevant randomized controlled trials (RCTs) from inceptions to 1 October, 2018. Two review authors independently assessed the methodological quality andanalyzed data by Cochrane handbook and the Rev Man 5.3 software. Begg.s test was conducted to assess publication biasvia Stata 14 software. Results: Twenty-four RCTs with 2246 patients were included in this review. Compared with blankcontrol, placebo or western medicine alone, WXKL alone or combined with western medicine could effectively reducerapid ventricular rate (MD=-7.14, 95％CI:-8.42——5.87), the frequency and duration of AF. It could also shorten thesinus rhythm conversion time (MD=-3.04, 95％CI:-3.47——2.61), increase the sinus rhythm conversion rate (RR=1.19, 95％ CI: 1.09～1.29) and decrease recurrence rate of AF (RR=0.28, 95％ CI: 0.13-0.59) . Besides, WXKL alone orcombined with western medicine was beneficial for improving the left ventricular ejection fraction (LVEF) (MD=3.44, 95％ CI: 0.87-6.01), left ventricular end diastolic diameter (LVEDD) (MD=-2.47, 95％ CI:-2.86——2.08), left atrialdiameter (LAd) (MD=-0.91, 95％CI:-1.58——0.25) and P wave dispersion (Pd) (MD=-4.04, 95％CI:-4.15——3.93) .WXKL combined with low-dose amiodarone was superior to conventional-dose amiodarone alone in improving themaximum P wave (Pmax) (MD=-8.25, 95％ CI:-10.33——6.17), and WXKL combined with conventional-doseamiodarone is more effective (MD=-13.10, 95％CI:-13.65——12.55) . Compared with the control group, the treatmentgroup had fewer adverse reactions, and the Begg.s test did not find any publication bias. Conclusion: WXKL alone orcombined with western medicine exhibited better therapeutic effects in the treatment of AF, but these results still needhigh-quality evidence to verify.