Promoting Innovative Development of Traditional Chinese Medicine Case Report Based on China Clinical Cases Library of Traditional Chinese Medicine / 中国实验方剂学杂志

China Clinical Cases Library of Traditional Chinese Medicine is built to promote the establishment of a scientific and technological talent evaluation system oriented on innovative value， ability and contribution in the backgroud of breaking the four only and setting new standards required by the document jointly issued by several national administrations and commissions. In the process of the construction， in order to further consolidate the foundation and ensure the quality and authority of case reports， we need to fully understand the origin and development of Chinese medical cases. Therefore， we clarified the development situation of Chinese medical cases by combing the characteristics of ancient and modern case reports， comparing the differences between Chinese and western medical case reports in terms of content and writing requirements， finally formed the main points of systematic case report norms and quality evaluation system， aiming to fully explore the unique advantages of Chinese medical cases in the fields of discipline development， scientific research innovation， clinical practice and guidance， talent evaluation and training， so as to promote its innovative development in a broader direction.

Online pharmaceutical process analysis of Chinese medicine using a miniature mass spectrometer:Extraction of active ingredients as an example / 药物分析学报

The automation of traditional Chinese medicine(TCM)pharmaceuticals has driven the development of process analysis from offline to online.Most of common online process analytical technologies are based on spectroscopy,making the identification and quantification of specific ingredients still a challenge.Herein,we developed a quality control(QC)system for monitoring TCM pharmaceuticals based on paper spray ionization miniature mass spectrometry(mini-MS).It enabled real-time online qualitative and quantitative detection of target ingredients in herbal extracts using mini-MS without chromatographic separation for the first time.Dynamic changes of alkaloids in Aconiti Lateralis Radix Praeparata(Fuzi)during decoction were used as examples,and the scientific principle of Fuzi compatibility was also investigated.Finally,the system was verified to work stably at the hourly level for pilot-scale extraction.This mini-MS based online analytical system is expected to be further developed for QC applications in a wider range of pharmaceutical processes.

The traditional Chinese medicines treat chronic heart failure and their main bioactive constituents and mechanisms

Chronic heart failure (CHF) is a severe public health problem with increasing morbidity and mortality, any treatment targeting a single session is insufficient to tackle this. CHF is characterized by reduced cardiac output resulting from neurohumoral dysregulation and cardiac remodeling, which might be related to oxidative stress, inflammation, endoplasmic reticulum stress, apoptosis, autophagy, mitochondrial function, and angiogenesis. These molecular mechanisms interact with each other through crosstalk. Historically, Chinese medicinal herbs have been widely applied in the treatment of CHF, and therapeutic effects of Chinese medicinal herbs and their ingredients have been scientifically confirmed over the past decades. Traditional Chinese medicine (TCM) with multiple components can confront the different pathogenesis of CHF through multiple targets. This review analyzes commonly used TCM patent drugs and TCM decoctions that are applicable to different stages of CHF based on clinical trials. Diverse bioactive ingredients in Chinese medicinal herbs have been found to treat CHF via multiple molecular mechanisms. This review comprehensively covers the key works on the effects and underlying mechanisms of TCM, herbal ingredients and synergistic effects of constituent compatibility in treating CHF, providing additional ideas to address this threat.

Cardioprotective mechanism of SGLT2 inhibitor against myocardial infarction is through reduction of autosis

Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce cardiovascular mortality in patients with diabetes mellitus but the protective mechanism remains elusive. Here we demonstrated that the SGLT2 inhibitor, Empagliflozin (EMPA), suppresses cardiomyocytes autosis (autophagic cell death) to confer cardioprotective effects. Using myocardial infarction (MI) mouse models with and without diabetes mellitus, EMPA treatment significantly reduced infarct size, and myocardial fibrosis, thereby leading to improved cardiac function and survival. In the context of ischemia and nutritional glucose deprivation where autosis is already highly stimulated, EMPA directly inhibits the activity of the Na+/H+ exchanger 1 (NHE1) in the cardiomyocytes to regulate excessive autophagy. Knockdown of NHE1 significantly rescued glucose deprivation-induced autosis. In contrast, overexpression of NHE1 aggravated the cardiomyocytes death in response to starvation, which was effectively rescued by EMPA treatment. Furthermore, in vitro and in vivo analysis of NHE1 and Beclin 1 knockout mice validated that EMPA's cardioprotective effects are at least in part through downregulation of autophagic flux. These findings provide new insights for drug development, specifically targeting NHE1 and autosis for ventricular remodeling and heart failure after MI in both diabetic and non-diabetic patients.

Study on the policies for the development of traditional Chinese medicine injection in China based on the per- spective of policy tools / 中国药房

OBJE CTIVE To provide reference for the adjustment and optimization of the policies related to traditional Chinese medicine（TCM）injection in China. METHODS The policies related to TCM injections issued at the national level were collected from Jan. 1，1990 to May 31，2021. Based on the perspective of policy tool ，the content analysis and quantitative analysis were used to classify ，code and analyze the policy terms according to “policy serial number-chapter number-specific terms ”. RESULTS & CONCLUSIONS Totally 30 policy documents related to TCM injection were included ， with a total of 389 codes. Environment-based policy tools were the most widely used （79.95％），followed by supply-oriented policy tools ，accounting for 15.42％. Demand-based policy tools accounted for the least proportion （4.63％）. Among environment-based policy tools ，the regulatory and control policy tools （38.05％） received more attention，and the policy publicity （2.06％） received fewer applications. Among supply-oriented policy tools ，there were more applications of science and technology support （10.80％）， and fewer applications of capital investment （0.26％）. Among demand- based policy tools ，organizational coordination was the most widely used （3.34％），followed by experience demonstration （1.29％），which had not yet involved the relevant policies of international exchange. In order to promote the development of TCM injection ，it is necessary to appropriately reduce the application of environment-based policy tools ，increase the application of policies such as policy publicity ，and improve the external environment for TCM injection ；optimize the internal combination of supply-oriented policy tools ，increase the use of capital investment tools ，and effectively play the role of policy boosting；emphasize the application of demand-based policy XJY21013） tools to form an effective policy pulling force for the healthy development of TCM injection.

A multicenter prospective cohort study of Xuebijing injection in the treatment of severe coronavirus disease 2019 / 中华危重病急救医学

Objective:To evaluate the effect of Xuebijing injection on the improvement of pneumonia severity index (PSI) and prognosis in patients with severe coronavirus disease 2019 (COVID-19).Methods:A multicenter prospective cohort study was designed. Adult patients with COVID-19 admitted to the intensive care unit (ICU) of 28 designated COVID-19 hospitals in 15 provinces and cities of China from January to March 2020 were enrolled. All patients were treated according to the standard treatment plan of COVID-19 issued by the National Health Commission of the People's Republic of China. They were divided into Xuebijing group and standard treatment group according to whether they received Xuebijing injection or not. In the standard treatment group, routine medical care measures such as antiviral, respiratory support, circulatory support and symptomatic treatment were taken. In the Xuebijing group, on the basis of standard treatment, Xuebijing was used within 12 hours of admission to the ICU, 100 mL each time, twice daily. The minimum duration of Xuebijing administration was 1 day. The improvement rate of PSI risk rating on the 8th day and clinical outcome on the 28th day were recorded.Results:A total of 276 COVID-19 patients were screened continuously, and the data of 144 severe patients who met PSI risk rating Ⅲ-Ⅴ were analyzed. Seventy-two cases were involved each in standard treatment group and Xuebijing group. The average age of the standard treatment group and Xuebijing group were (65.7±7.9) years old and (63.5±10.9) years old, and male accounted for 75.0% (54/72) and 70.8% (51/72), respectively. There were no significant differences in general conditions, comorbidities, PSI risk rating and score, sequential organ failure assessment (SOFA) score, oxygenation index (PaO 2/FiO 2), respiratory support mode and other baseline indicators between the two groups. Compared with the standard treatment group, the improvement rate of PSI risk rating in Xuebijing group on the 8th day after admission was significantly improved [56.9% (41/72) vs. 20.8% (15/72), between-group difference and 95% confidence interval (95% CI) was 36.1% (21.3% to 50.9%), P < 0.01], PSI score, SOFA score and PaO 2/FiO 2 were significantly improved [PSI score: 83.7±34.8 vs. 108.2±25.6, between-group difference (95% CI) was -24.5 (-34.9 to -14.1); SOFA score: 2.0 (1.0, 4.0) vs. 7.0 (4.0, 10.0), between-group difference (95% CI) was -3.5 (-5.0 to -2.0); PaO 2/FiO 2 (mmHg, 1 mmHg = 0.133 kPa): 289.4±111.6 vs. 188.5±98.1, between-group difference (95% CI) was 100.9 (65.3 to 136.5); all P < 0.01]. The 28-day discharge rate of Xuebijing group was 44.5% higher than that of standard treatment group [66.7% (48/72) vs. 22.2% (16/72), P < 0.01], and the 28-day survival rate was 9.8% [91.7% (66/72) vs. 81.9% (59/72), P < 0.01]. There was no significant difference in the combination of antiviral drugs, antibiotics, anticoagulants and vasopressor drugs between the two groups. There was no significant difference in the incidence of adverse events between the Xuebijing group and standard treatment group [41.7% (30/72) vs. 43.1% (31/72), P > 0.05], and no serious adverse events and adverse reactions of Xuebijing were reported. Conclusion:Standard treatment combined with Xuebijing injection can significantly improve the PSI risk score and clinical prognosis of patients with severe COVID-19 without increasing drug safety risk.

Core Outcome Set for Traditional Chinese and Western Medicine Clinical Trials of COVID-19

BackgroundDevelopment of a core outcome set (COS) for clinical trials for COVID-19 is urgent because of the pandemic wreaking havoc worldwide and the heterogeneity of outcomes in clinical trials. MethodsA preliminary list of outcomes were developed after a systematic review of protocols of clinical trials for COVID-19. Then, two rounds of the Delphi survey were conducted. Stakeholders were traditional Chinese medicine (TCM) experts, Western medicine (WM) experts, nurses and the public. Patients with confirmed COVID-19 were also invited to participate in a questionnaire written in understandable language. Frontline clinicians, as well as nurse, methodologist, evidence based-medicine researcher, and staff from the Chinese Clinical Trials Registry participated by video conference to vote. ResultsNinety-seven eligible study protocols were identified from 160 clinical trials. Seventy-six outcomes were identified from TCM clinical trials and 126 outcomes were identified from WM clinical trials. Finally, 145 outcomes were included in the first round of the Delphi survey. Then, a COS for clinical trials of TCM and WM was developed. The COS include clinical outcomes (recovery/improvement/progression/death), etiology (SARS-CoV-2 nucleic-acid tests, viral load), inflammatory factor (C-reactive protein), vital signs (temperature, respiration), blood and lymphatic-system parameters (lymphocytes, virus antibody), respiratory outcomes (Pulmonary imaging, blood oxygen saturation, PaO2/FiO2 ratio, arterial blood gas analysis, mechanical ventilation, oxygen intake, pneumonia severity index), clinical efficacy (prevalence of preventing patients with mild-to-moderate disease progressing to severe disease), symptoms (clinical symptom score). Outcomes were recommended according to different types of disease. Outcome measurement instrument/definition were also recommended. ConclusionA COS for COVID-19 may improve consistency of outcome reporting in clinical trials.

Outcome reporting from protocols of clinical trials of Coronavirus Disease 2019 (COVID-19): a review

ObjectivesTo examine heterogeneity of outcomes in protocols of clinical trials of Coronavirus Disease 2019 (COVID-19) and to identify outcomes for prioritization in developing a core outcome set (COS) in this field. DesignThis study is a review. Data sourcesDatabases of ICMJE-accepted clinical trial registry platform were searched on February 14, 2020. Eligibility CriteriaRandomized controlled trials (RCTs) and non-RCTs of COVID-19 were considered. Conditions of patients include common type, severe type or critical type. Interventions include traditional Chinese medicine (TCM) and Western medicine. We excluded trials that for discharged patients, psychological intervention and complications of COVID-19. Data extraction and synthesisThe general information and outcomes, outcome measurement instruments and measurement times were extracted. The results were analysed by descriptive analysis. Results19 registry platforms were searched. A total of 97 protocols were included from 160 protocols. For protocols of TCM clinical trials, 76 outcomes from 16 outcome domains were reported, and almost half (34/76, 44.74%) of outcomes were reported only once; the most frequently reported outcome was time of SARS-CoV-2 RNA turns to negative. 27 (27/76, 35.53%) outcomes were provided one or more outcome measurement instruments. 10 outcomes were provided one or more measurement time frame. For protocols of western medicine clinical trials, 126 outcomes from 17 outcome domains were reported; almost half (62/126, 49.21%) of outcomes were reported only once; the most frequently reported outcome was proportion of patients with negative SARS-CoV-2. 27 outcomes were provided one or more outcome measurement instruments. 40 (40/126, 31.75%) outcomes were provided one or more measurement time frame. ConclusionOutcome reporting in protocols of clinical trials of COVID-19 is inconsistent. Thus, developing a core outcome set is necessary. Strengths and limitations of this study1. This review is the first to describe variation in outcomes, outcome measurement instruments and outcome measurement time reporting in clinical trials for Coronavirus Disease 2019 (COVID-19). 2. All the database of ICMJE-accepted clinical trial registry platform were searched, and randomized controlled trials and observational studies were considered. 4. The aim of this review was to provide a list of outcomes for clinical trials of COVID-19, both interventions of Traditional Chinese Medicine and western medicine were considered. 5. When the searching was conducted, no clinical trials were registered by countries out of China, so all of included protocols were from China.

Effect of Xuebijing Injection on differentiation of bone marrow hematopoietic stem cells in septic mice / 中国中西医结合急救杂志

Objective To investigate the intervention effect of Xuebijing Injection on the differentiation of bone marrow hematopoietic stem cells (HSC) in septic mice. Methods Fifty-four male C57BL/6N mice were randomly divided into three groups: normal control group, model group and Xuebijing group, each group with 18 mice. The mouse models of sepsis were duplicated by intra-peritoneal injection of 10 mg/kg E. coli lipopolysaccharide (LPS) method. Starting from the day of modeling, Xuebijing Injection 20 mL/kg was intravenously injected into the tail vein in Xuebijing group, once a day for consecutive 4 days; the normal control and model groups were intravenously injected with normal saline at the same dose and site for 4 days. The bone marrow cells of the femur and tibia of the mice were isolated after 4 days of various treatments in the three groups, and the proportions of bone marrow HSC Lin-Sca-1+c-Kit+ (LSK) and hematopoietic progenitor cells Lin-Sca-1-c-Kit+ (LS-K) of each group were detected by flow cytometry. Results Finally, 14 mice were included in the normal control group, 17 in the model group, and 12 in the Xuebijing group. With the prolongation of time, the body weight of the normal control group gradually increased, the body masses of the model group and the Xuebijing group were decreased first and then increased, reaching a peak at 96 hours after the model was established, but they were still significantly lower than the body mass of normal control group (g: 19.81±0.27, 19.58±0.39 vs. 22.23±0.30, both P < 0.05). Compared with the normal control group, the proportions of LSK, LS-K, long-term HSC (LT-HSC), and megakaryocyte-erythroid progenitor cells (MEP) were all significantly increased in the model group [LSK: (16.62±1.28)% vs. (12.89±0.83)%, LS-K: (44.77±1.77)% vs. (30.34±0.90)%, LT-HSC: (6.88±0.48)% vs. (1.83±0.24)%, MEP: (13.89±1.26)% vs. (9.38±0.66)%, all P < 0.05], the proportion of multipotential progenitor cells (MPP) was significantly decreased [(2.41±0.34)% vs. (5.99±0.59)%, P < 0.05]. Compared with the model group, the LSK and myeloid progenitor (CMP) of the Xuebijing group were significantly reduced [LSK: (12.25±0.69)% vs. (16.62±1.28)%, CMP :(0.31±0.05)% vs. (0.55±0.13)%, both P < 0.05], and LS-K, LT-HSC, MEP showed a decreasing trend [LS-K: (42.75±2.48)% vs. (44.77±1.77)%, LT-HSC:(5.98±0.70)% vs. (6.88±0.48)%, MEP: (10.94±1.36)% vs. (13.89±1.26) %], but the differences were not statistically significant (all P > 0.05). There were no significant differences in the proportions of short-term HSC (ST-HSC) and granulocyte-macrophage progenitor cells (GMP) among the three septic groups (all P > 0.05). Conclusion Xuebijing Injection can improve the differentiation function of bone marrow cells in septic mice, which may be possibly related to the inhibition of pathological proliferation of bone marrow hematopoietic stem cells and progenitor cells in septic mice by Xuebijing Injection.

Interpretation of design ideas and implementation process of randomized controlled trial of Xuebijing injection in the treatment of severe community-acquired pneumonia / 中华危重病急救医学

A multicenter blinded randomized controlled trial (RCT) was conducted in accordance with international clinical trial standards to evaluate the efficacy and safety of Xuebijing injection in the treatment of severe community-acquired pneumonia (SCAP) under strict quality control condition. This article aims to illustrate key contents of the design ideas and implementation process of the RCT of Xuebijing injection in the treatment of SCAP, including the selection of research objects, design, implementation, and insights, etc., share experience with researchers of the respiratory and critical care, and provide reference for future studies in critical care.

Clinical Evidence and Effect Mechanism of Yiqi Fumai (Freeze-dried) for Treatment of Coronary Heart Disease with Heart Failure / 世界科学技术-中医药现代化

In review of recent literature on the treatment of heart failure with coronary heart disease by injection of Yiqi Fumai (freeze-dried), clinical evidence for the treatment of coronary heart disease with heart failure was reviewed from relevant systematic reviews, clinical randomized controlled trials, and safety evaluation, from the experiments in vivo and in vitro on its working mechanism of the treatment of coronary heart disease, heart failure, for more in-depth research on clinical and basic research in the future to lay the foundation.

Danhong Injection on Inflammatory Factors after Percutaneous Coronary Intervention in Patients with Coronary Heart Disease: A Meta-analysis / 世界科学技术-中医药现代化

Object: To systematically evaluate the effect of Danhong injection combined with conventional medication on inflammatory factors after percutaneous coronary intervention in coronary heart disease, and providing evidence for further research and design. Methods: PubMed, The Cochrane Library, EMbase, MEDLINE, CBM, VIP, CMCI, CNKI, Wanfang Medical Database and other Chinese and foreign medical databases collected the clinical study of Danhong injection in the treatment of inflammatory factors after coronary intervention, using Revman 5.3 software for analysis.Results: A total of 7 studies were included, including 831 patients. 1) Inflammatory response index: hs-CRP of danhong injection treatment group was significantly different from that of control group [RR=-0.86, 95％CI (-1.03, -0.69), P ＜0.0001]. There were significant differences in IL-6 test values between the danhong injection group and the control group[RR =-1.19, 95％CI (-1.41, -0.96), P ＜ 0.00001]. The MMP-9 test values of danhong injection group were significantly different from those of the control group [RR =-0.39, 95％CI (-0.78, -0.00), P = 0.05]. 2) Myocardial injury index:There were significant differences in the CK MB test values of danhong injection treatment group and control group[RR =-0.89, 95％ CI (-1.12, -0.67, P ＜ 0.00001) ]. The cTnT test values of the danhong injection group were significantly different from those of the control group [RR =-1.25, 95％CI (-1.51, -0.98), P ＜ 0.00001]. Conclusion:Current research indicates that Danhong injection can reduce inflammatory factors hs-CRP, IL-6 and MMP-9 and myocardial injury indicators creatine kinase-MB (CK-MB) and cardiac troponin T (cTnT) after coronary intervention. In other words, Danhong injection can reduce the levels of inflammatory factors such as hs-CRP, IL-6 and MMP-9 and improve the myocardial injury index such as CK-MB and cTnT after coronary intervention, and then have a certain protective effect on the myocardium. However, the above conclusions still need further research and verification.

Systematic Review of Danhong Injection on Endothelial Function after Percutaneous Coronary Intervention in Patients with Coronary Heart Disease / 世界科学技术-中医药现代化

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.

Prevention and Treatment of Traditional Chinese Medicine for Heart Failure Caused by Coronary Heart Disease Based on Endpoint Events: Ideas and Methods of Evidence-Based Optimization / 世界科学技术-中医药现代化

Objective: This paper analyzed the present clinical researches of traditional Chinese medicine (TCM) in the treatment of heart failure caused by coronary heart disease and discusses the ideas and methods of evidence-based optimization. Methods: PubMed, EMBASE, Cochrane Library, CNKI, WanFang, VIP and CBM were searched to screen the clinical studies of TCM for treating heart failure caused by coronary heart disease. The problems and solutions were discussed by evaluating the risk of bias of the studies and analyzing the outcomes compared with the Cochrane systematic reviews of chronic heart failure. Results: A total of 32 clinical researches were included and the methodological quality of the studies was generally low. In addition, few studies assessed the endpoint events, mortality and readmission, as the primary outcomes in their trials, which is significantly different from the outcomes concerned in the Cochrane systematic reviews. Conclusion: It is really critical to improve the methodological quality of the trials and to choose the endpoint events as the primary outcomes in the evidence-based optimization of the prevention and treatment of TCM for heart failure caused by coronary heart disease Chinese medicine.

Evidence-Based Optimization Research on the Timing of Traditional Chinese Medicine Intervention for Coronary Heart Disease: Trial Design and Thinking / 世界科学技术-中医药现代化

Traditional Chinese medicine (TCM) emphasizes treatment timing, and it believes that the timing of treatment is closely related to the curative effect. In the era of the Chinese and Western medicine combined application, it attaches new connotations on how to choose the timing of interventions. Defining the timing of intervention is one of the key links to make the best effect of Chinese medicine, and it is also the focus of clinical decision-making, which deserves research attention. This article expounded the significance of TCM intervention timing research, and pointed out that the alternative timing should be based on the baseline investigation and mechanism clues. This article also demonstrated some key points of intervention timing trial design, like the outcome indicators setting, sample size estimation, blinding and data analysis. With the examples of national key research and development program"evidence-based optimization and mechanism research of traditional Chinese medicine therapies for coronary artery disease (angina pectoris-myocardial infarction-heart failure) ", the timing of TCM intervention in myocardial infarction perioperative period and coronary heart disease related research cases aboard, we hope to provide reference for the intervention timing optimization research.

Evidence-based Optimization Design and Thinking on TCM Syndrome Differentiation and Treatment Protocol of Stable Angina / 世界科学技术-中医药现代化

Objectives: To strengthen the causal link between TCM syndrome differentiation and curative effect of stableangina through standardized evidence-based design, measurement and evaluation methods, so as to improve the clinicalevidence of TCM. Methods: Under the framework of the top-level parental design, this study aims at the research purposeof early intervention of TCM in patients with stable angina, and adopts a multicenter practical randomized controlled trial.This study adopts superior design and refines the design points of clinical trials in terms of subject selection, interventionsetting, index system construction, sample size estimation, safety observation, and quality control. Results: The nationalkey research and development plan project, "Study on Evidence-based Optimization of TCM Syndrome and TreatmentProtocol of Stable Angina Pectoris and Cross-Boundary Syndrome"indicated that the clinical research design ofevidence-based medicine and TCM differentiation and treatment was improved. Conclusions: The practical RCT designcan fully reflect the characteristics of TCM differentiation and treatment. The evidence-based design of TCM can providemethodological support for improving the quality of evidence.

Status Quo and Reflections of Development of Integrative Coronary Heart Disease Clinical Practice Guidelines / 世界科学技术-中医药现代化

Objective: Through analyzing development statue of integrative coronary heart disease clinical practice guidelines, we aim to provide a reference baseline for the future study. Methods: Databases including CBM, CNKI, WanFang, VIP were searched for published integrative coronary heart disease clinical practices. The website medlive.cn was also used as supplementary. The reporting tool for clinical practice guidelines RIGHT statement was used to evaluate the reporting quality. Results: A total of nine relevant clinical practice guidelines or experts consensuses were included, covering five integrative treatment therapy guidelines of PCI or CABG perioperative period, three myocardial infarction guidelines and one atherosclerosis guideline. Experts consensus methods were adopted in seven guidelines, the remining two guidelines used the evidence-based guidelines development methods. The evaluation of RIGHT statements showed that most guidelines reported complete information in"Basic information"and"Background"domain, however, they usually failed to provide enough description in"Evidence", "Recommendations", "Review and quality assurance", "Funding and declaration and management of interests"and"Other information"parts. Conclusion: Although some achievements have been reached in the development of integrative coronary heart disease clinical practice guidelines, the development methods and quality of reporting still needs further improvements. Researchers should explore more specific Chinese medicine guideline development methods and tools in the future.

Clinical Evidence Evaluation of Shexiang Tongxin Dropping Pill for Slow Blood Flow after PCI / 世界科学技术-中医药现代化

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.

The Clinical Study of Wenxin Keli in the Treatment of Atrial Fibrillation: a Systematic Review / 世界科学技术-中医药现代化

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.

Clinical Evidence Evaluation and Effect Characteristics of Shuxuening Injection / 世界科学技术-中医药现代化

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.