Evidence body is defined as an evidence complex incorporating the evidence obtained from various research methods and various resources. As one of common parenterally administered Chinese medicines, Shuxuetong's safety drew high concern from doctors. However, we only have grasped several but less systematic evidence on the safety of Shuxuetong. To build a safety evidence body of Shuxuetong injection. Review and evaluate the evidence related to the safety of Shuxuetong injection after accumulating, searching and classfying related literature. Accoeding to levels of evidence from high to low, the evidence related to the safety of Shuxuetong injection was classified as following: the evidence from a long-term, prospective, large-sample-size and intensive hospital monitoring study was the strongest; the evidence of hospital information system (HIS) data analysis; the evidence of spontaneous reporting system (SRS) data analysis; the evidence of adverse drugreactions (ADRs)/adverse drug events (ADEs) reported in systematic evaluation, ADRs case report, toxicological tests, pharmacological tests were weakest. Based on the evidence body, Shuxuetong Injection was proved to be safe, and its ADRs were mainly allergic reactions, and more often happened among the old patients.
Adverse Drug Reaction Reporting Systems ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Prospective Studies

Statement of the REporting of studies conducted using routinely collected data (RECORD) and evaluating checklist of good research for comparative effectiveness (GRACE) were translated and introduced in this paper. The two evaluation tools would help researchers of Chinese medicine to conduct real world study in future. RECORD statement focus on unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues. Researchers of comparative effectiveness research could refer to GRACE checklist. It was believed that researchers of Chinese medicines who were keen on real world studies would be benefited from the two tools.
Biomedical Research ; Checklist ; Medicine, Chinese Traditional

Drug safety has always been a global focus. Discovery and accurate information acquisition of adverse drug reaction have been the most crucial concern. Terminology of adverse drug reaction makes adverse reaction medical report meaningful, standardized and accurate. This paper discussed the domestic use of the terminology WHOART and MedDRA in terms of content, structure, and application situation. It also analysed the differences between the two terminologies and discusses the future trend of application in our country
Dictionaries, Medical ; Drug-Related Side Effects and Adverse Reactions ; Terminology as Topic ; World Health Organization

There has been much difference between effectiveness and harm in evidence evaluation. Many evidence ranking or grading systems have been developed'by researchers in the world. However, no evidence ranking or grading systems are based on safety research reality. Those existing evidence ranking or grading systems are prone to evaluating effectiveness evidence not proper for harm evidence. It is necessary to develop a new system for harm evidence. We put forward to establishing the body of evidence for harm for postmarketing traditional Chinese medicine as required by our daily research work. We do hope such an ideal could be helpful and indicative for evidence evaluation for harm.
Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing

The paper is to systematically evaluate the effect and safety of Shenqi Fuzheng injection (SFI) combined with first-line chemotherapy for non-small cell lung cancer (NSCLC). Randomized controlled trials (RCTs) on Shenqi Fuzheng injection (SFI) combined with first-line chemotherapy (experiment group) and chemotherapy alone group ( control group) were electronically retrieved from Medline, EMbase, Clinical Trials, Cochrane Library, CBM, CNKI, VIP, and Wanfang Data base. All trials were assessed for quality according to the Cochrane Reviewer's Handbook for Systematic Reviews of Intervention and then Meta-analysis was performed withRevMan5. 2 Software. A total of 43 RCTs (3433 patients) were included after screening and selecting. Results of Meta-analysis showed that: Objective remission rate (ORR): ORR of experimental group was about 20% higher than that of control group [RR = 1.23, 95% CI (1.11,1.35), P < 0.0001]. Disease control rate (DCR):DCR of SFI combined with first-line chemotherapy was 11% higher than that of first-line chemotherapy alone [RR = 1.11, 95% CI (1.07, 1.16), P < 0.000 01]. Life quality evaluated by Kosovan performance status (KPS) showed that: life quality improvement rate of experimental group was about twice of that in control group [RR = 2.02, 95% CI (1.81, 2.26), P < 0.000 01]. Toxic and side reaction analysis showed that: the incidence of side reactions in experimental group was about 50% lower than that in control group [RR = 0.59, 95% CI (0.53, 0.66), P < 0.000 01]. Immune function test showed that: the function of experimental group was 3.2 (standard deviations) times greater than that of control group [MD = 3.23, 95% CI (2.86, 3.60), P < 0.000 01]. We can see that SFI combined with first-line chemotherapy for NSCLC can increase objective efficacy, improve life quality, decrease toxic and side reactionsinduced by chemotherapy, and improve the immune functions. As most of the included studies in this systematic evaluation had poor quality, the evidence to support conclusion was weak, so it was necessary to conduct more multi-center clinical trials with high quality methods and rigorous design.
Adult ; Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols ; administration & dosage ; Carcinoma, Non-Small-Cell Lung ; drug therapy ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Lung Neoplasms ; drug therapy ; Male ; Middle Aged ; Randomized Controlled Trials as Topic ; Young Adult

Good clinical practice should be based on evidence. Evidence quality should be based on critical appraisal in evidence based medicine (EBM). Evaluation of evidence quality plays an important role in evidence level clarifying, which is the core of EBM. Different recommendations for clinical practice often derive from evidence levels. Thus evidence quality evaluation is the first and most important step in EBM. There are lots of standards to evaluate evidence quality in the world. However there are two aspects of the evaluation, one is methodological evaluation and the other is reporting evaluation. This article collected a series of standards for clinical trials quality evaluation according to different research designs. It is hoped that the resource and introduction about the quality evaluation of clinical trials be helpful for medical researchers in China. Only being familiar with all kinds of standards of methodology and reporting, researchers could publish high quality scientific papers.
Biomedical Research ; Evidence-Based Medicine ; Guidelines as Topic ; Humans ; Meta-Analysis as Topic ; Randomized Controlled Trials as Topic

In recent years a number of qualitative research methods have gained popularity within the health care arena. Despite this popularity, different qualitative analysis methods pose many challenges to most researchers. The present paper responds to the needs expressed by recent Chinese medicine researches. The present paper is mainly focused on the concepts, nature, application of framework analysis, especially on how to use it, in such a way to assist the newcomer of Chinese medicine researchers to engage with the methodology.
Humans ; Medicine, Chinese Traditional ; Qualitative Research ; Research ; Research Design

There is a new research model named 'registry study/patient registry' in Western medicine, which could be referred to by Chinese medicine researchers, such as active safety surveillance. This article will introduce registry study from different aspects as the developing history, features, and application in order to inform Chinese medicine researchers of future studies.
Marketing ; Medicine, Chinese Traditional ; adverse effects ; economics ; Phytotherapy ; adverse effects ; economics ; Registries ; Safety Management ; methods

The paper is to systematically evaluate the efficacy and safety of Deng Zhan Xi Xin injection ( DZXXI) as an adjuvant treatment for patients with angina pectoris. The Cochrane Library, Medline, EMbase, CBM, CNKI, VIP, and Wan fang Data base were searched. Randomized controlled trials (RCTs) of DZXXI combined with western medicine routine treatment versus western medicine routine treatment alone for angina pectoris patients were all included. All trials were assessed according to the Cochrane Reviewer' s Handbook 5.1 for Systematic Reviews of Intervention and Meta analyses were performed by RevMan 5. 2 Software. A total of 30RCTs (3 086 patients including 1 572 patients of treatment group and 1 514 patients of control group) were included. Meta-analysis of treatment group compared with control group showed superior effect over reducing cardiovascular events ( OR = 0.33; 95% CI: [0.16, 0.67], P = 0.002, improving effective rate of DZXXI as adjuvant treatment for angina pectoris patients (OR = 3.97; 95% CI: [3.15, 5.02]; P < 0.000 010 and electrocardiogram curative effect (OR = 2.21; 95% CI; [1.83, 2.68]; P < 0.000 010. Funnel figure seemed that there was publication bias. The current limited evidence showed that when compared with the control group, treatment group was superior in improving patients with angina pectoris. But based on the limitations of the study, rigorous design with long follow up clinical trials are necessary for further evidence.
Adjuvants, Pharmaceutic ; Adult ; Aged ; Angina Pectoris ; drug therapy ; physiopathology ; Drugs, Chinese Herbal ; administration & dosage ; Electrocardiography ; Female ; Heart ; physiopathology ; Humans ; Injections ; Male ; Middle Aged ; Randomized Controlled Trials as Topic

To systematically review the incidence rate of adverse drug reaction/event by Qingkailing injection. Such databases as the PubMed, EMbase, the Cochrane library, CNKI, VIP WanFang data and CBM were searched by computer from foundation to July 30, 2015. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data and cross check data. Then, Meta-analysis was performed by using the R 3.2.0 software, subgroup sensitivity analysis was performed based on age, mode of medicine, observation time and research quality. Sixty-three studies involving 9,793 patients with Qingkailing injection were included, 367 cases of adverse reactions/events were reported in total. The incidence rate of adverse reaction in skin and mucosa group was 2% [95% CI (0.02; 0.03)]; the digestive system adverse reaction was 6% [95% CI(0.05; 0.07); the injection site adverse reaction was 4% [95% CI (0.02; 0.07)]. In the digestive system as the main types of adverse reactions/events, incidence of children and adults were 4.6% [0.021 1; 0.097 7] and 6.9% [0.053 5; 0.089 8], respectively. Adverse reactions to skin and mucous membrane damage as the main performance/event type, the observation time > 7 days and ≤ 7 days incidence of 3% [0.012 9; 0.068 3] and 1.9% [0.007 8; 0.046 1], respectively. Subgroup analysis showed that different types of adverse reactions, combination in the incidence of adverse reactions/events were higher than that of single drug, the difference was statistically significant (P < 0.05). This study suggested the influence factors of adverse reactions occur, and clinical rational drug use, such as combination, age and other fators, and the influence factors vary in different populations. Therefore, clinical doctors for children and the elderly use special care was required for a clear and open spirit injection, the implementation of individualized medication.
Adolescent ; Adult ; Aged ; Child ; Child, Preschool ; Drugs, Chinese Herbal ; adverse effects ; Female ; Humans ; Incidence ; Infant ; Infant, Newborn ; Injections ; Male ; Middle Aged