OBJECTIVE: To compare the safety differences between Chinese medicine (CM) and Western medicine (WM) based on Chinese Spontaneous Reporting Database (CSRD). METHODS: Reports of adverse events (AEs) caused by CM and WM in the CSRD between 2010 and 2011 were selected. The following assessment indicators were constructed: the proportion of serious AEs (PSE), the average number of AEs (ANA), and the coverage rate of AEs (CRA). Further comparisons were also conducted, including the drugs with the most reported serious AEs, the AEs with the biggest report number, and the 5 serious AEs of interest (including death, anaphylactic shock, coma, dyspnea and abnormal liver function). RESULTS: The PSE, ANA and CRA of WM were 1.09, 8.23 and 2.35 times higher than those of CM, respectively. The top 10 drugs with the most serious AEs were mainly injections for CM and antibiotics for WM. The AEs with the most reports were rash, pruritus, nausea, dizziness and vomiting for both CM and WM. The proportions of CM and WM in anaphylactic shock and coma were similar. For abnormal liver function and death, the proportions of WM were 5.47 and 3.00 times higher than those of CM, respectively. CONCLUSION Based on CSRD, CM was safer than WM at the average level from the perspective of adverse drug reactions.
China ; Drug-Related Side Effects and Adverse Reactions/epidemiology* ; Humans ; Injections ; Medicine, Chinese Traditional

OBJECTIVETo analyze the literature about clinical efficacy of Shenmai injection for tumor treatment, and understand preliminarily the medicine law and effect of Shenmai injection.

METHODThe included and excluded rules are built, and the literatures about cancer treatment by "Deng feng" Shenmai injection are classified by the rules. Many kinds of information are analyzed such as published years, research types, sample size, sex and age of test-takers, dosage and evaluated parameters.

RESULTThe 54 literatures are brought into analysis. The small scale research below 100 people is the main type and lung cancer is the most. The evaluated parameters in these literatures include KPS improvement rate, reduction of toxicity reaction, improvement of total efective rate, improvement of clinical symptoms, improvement of one year survial rate, NK activity, LAK activity, TH/TS value and so on.

CONCLUSIONThe application of Shenmai injection for tumor treatment is increasingly extensive and some effect is got. But the quality of literature about clinical efficacy is not enough good and it cannot be adopted as evidence. It can support post-marketing reevaluation and improve the research combined with prospective experiment.

Clinical Trials as Topic ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Female ; Humans ; Male

OBJECTIVETo study Danhong injection adverse reactions (ADR) incidence, nature and clinical performance, provide the basis for the clinical safety of drugs.

METHODMulti-center, a large sample of hospitals focused on monitoring method.

RESULTDanhong injection ADR for the rapid onset and ease the quick recovery, the rate was 0. 682% , the newly discovered ADR constipation, sweating, tinnitus, irritability, joint disease, erythema, venous pain, phlebitis, local numbness, pain, weakness, gastrointestinal ulcer bleeding, vasospasm, cyanosis.

CONCLUSIONDanhong injection adverse reactions are type A adverse reactions occasionally, centralized monitoring of hospital medicine injection method is to carry out post-marketing safety re-evaluation of appropriate methods.

Drug-Related Side Effects and Adverse Reactions ; epidemiology ; Drugs, Chinese Herbal ; adverse effects ; Hospitals ; Humans ; Injections ; Product Surveillance, Postmarketing ; methods

This study aimed to comprehensively analyze and compare the differences of different clinical study types currently published in the safety evaluation of Xuebijing Injection. Six databases, namely the Cochrane Library, PubMed, EMbase, CNKI, VIP and Wanfang database, were electronically retrieved to collect all types of studies on the safety of Xuebijing Injection, including randomized controlled trials, case-controlled studies, cohort studies, systematic reviews, and centralized monitoring studies of clinical safety(hospital), in order to comprehensively and objectively evaluate the safety of Xuebijing Injection, and analyze the differences of different research results. A total of 211 literatures were included, involving a total of 46 384 patients treated with Xuebijing Injection, and 423 adverse reactions(ADRs) occurred. They included 191 randomized controlled trials, 3 cohort studies, 15 systematic reviews, and 2 centralized monitoring studies of clinical safety(hospital), and the incidence of adverse reactions was 2.54%(common), 2.31%(common), 0.95%(occasionally), and 0.50%(occasionally). More than half of the 423 cases of ADRs occurred in skin and adnexal system(151 cases) and gastrointestinal system(65 cases), including such manifestations as rash, skin itching, nausea and vomiting, diarrhea. The degree of ADRs was mild. Randomized controlled trials showed that the incidence of ADR was the highest when Xuebijing Injection was used for malignant tumor and multiple organ failure. And the systematic evaluation showed that the incidence of ADR was the highest when Xuebijing Injection was used for spontaneous peritonitis of liver cirrhosis. In conclusion, different study types could lead to significant differences in the results of drug safety evaluation. Sample size, study type, and quality control are the main factors for biased results. Due to large sample size and high-quality, centralized monitoring studies become the better clinical safety evaluation model of drugs at present, and full life cycle management could more objectively reflect drug safety and guide clinical rational drug use.
Case-Control Studies ; Drug-Related Side Effects and Adverse Reactions/epidemiology* ; Drugs, Chinese Herbal/adverse effects* ; Humans ; Injections

Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.
Adverse Drug Reaction Reporting Systems ; Books ; Drug-Related Side Effects and Adverse Reactions/epidemiology* ; European Union ; Humans ; Medicine, Chinese Traditional ; Pharmacovigilance

Parenterally administered Chinese medicine is widely applied in clinic. It particularly plays an important role in the treatment of cardiovascular and cerebrovascular disease, acute infectious diseases and malignant tumors. With the expansion of the scope of the clinical application of parenterally administered Chinese medicine adverse event reports also increase day by day. Thus, parenterally administered Chinese medicine has come to the attention of management departments, medical staff and the public. By the end of 2012, the national adverse drug reaction monitoring database has collected more than 5 million adverse drug reactions/events reports. Parenterally administered Chinese medicine accounted for more than half of the total number of adverse reactions to Chinese medicine. Therefore, it is essential that epidemiological methods are used to analyze the national database for all references to parenterally administered Chinese medicine. Our research aims to analyze the advantages and disadvantages of various safety monitoring methods for parenterally administered Chinese medicine and offer guidance in safety evaluation analysis.
China ; epidemiology ; Clinical Trials as Topic ; Drug Monitoring ; methods ; Drug Therapy ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Humans ; Infusions, Parenteral

Reviewing the literatures about adverse reactions induced by traditional Chinese medicine injections (TCMI) reported on CNKI from 1983 to 2013. Analyzing the causes of adverse reactions induced by TCMI from its quality standards. Provide ideas for improving security of TCMI and completing its quality standards. This review indicates that TCMI-induced adverse reactions have little relationship with the number of compositions, but have tight connection with chemical ingredients and solvents. Adverse reactions can be decreased by perfecting the quality standards of TCMI.
Adverse Drug Reaction Reporting Systems ; Drug Therapy ; standards ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; standards ; Humans ; Injections ; Quality Control

The adverse reaction monitoring is important in warning the risks of traditional Chinese medicines at an early stage, finding potential quality problems and ensuring the safe clinical medication. In the study, efforts were made to investigate the risk signal mining techniques in line with the characteristics of traditional Chinese medicines, particularly the complexity in component, processing, compatibility, preparation and clinical medication, find early risk signals of traditional Chinese medicines and establish a traditional Chinese medicine safety evaluation system based on adverse reaction risk signals, in order to improve the target studies on traditional Chinese medicine safety, effective and timely control risks and solve the existing frequent safety issue in traditional Chinese medicines.
China ; epidemiology ; Drug Evaluation ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Humans ; Product Surveillance, Postmarketing

OBJECTIVETo investigate the risk factors of vaginal dilators by 567 adverse event reports, and to provide a reference for the reasonable use.

METHODSWith retrospective case study, analyzed 567 reports induced by vaginal dilators by National Adverse Drug Reaction Monitoring Center in 2012.

RESULTSExpected treatment of disease might be relevant with severity of adverse events, while age was not the related factor; the influencing factor of consequences of grading was the classification of the cause of adverse events.

CONCLUSIONMonitoring should be strengthen in order to reduce or avoid the vaginal dilator adverse events.

Adverse Drug Reaction Reporting Systems ; Dilatation ; adverse effects ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; Female ; Humans ; Retrospective Studies ; Risk Factors ; Vagina ; pathology

To understand the characteristics of adverse reactions and find early warning signs after intake of Guizhi Fuling Capsules. The 1 500 adverse reaction(ADR) cases of Guizhi Fuling Capsules obtained by spontaneous reporting system(SRS) from 2008 to 2017 were analyzed by proportional reporting ratios method(PRR), Bayesian confidence propagation neural network method(BCPNN) and propensity score method. The number of ADR reports increased year by year, and reached the peak in the fourth quarter of 2014. A total of 1 500 ADR cases were monitored, including 10 severe ADR cases. There were a total of 934 cases aged between 18-44 years old, accounting for 62.27%. All patients were orally administered. Among them, 1 398 patients received a single dose according to the package insert, and 57.4% had ADR within 24 h. The top five clinical manifestations of ADR were gastric dysfunction, abdominal pain, nausea, vomiting and rash, which mainly damaged the digestive system. The ADR signals were analyzed. PRR suggested that "gastric dysfunction" and "abdominal pain" were the early warning signals of Guizhi Fuling Capsules. BCPNN suggested that "nausea" and "abdominal pain" were the early warning signals of Guizhi Fuling Capsules. After the propensity score weighting method was used to control the confounding factors, the warning signals remained unchanged. The results show that Guizhi Fuling Capsules has fewer adverse reactions and is relatively safe. This study provides a basis for studying ADR of Guizhi Fuling Capsules, and guidance for drug vigilance and risk management of Guizhi Fuling Capsules.
Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems ; Bayes Theorem ; Capsules ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; Drugs, Chinese Herbal ; adverse effects ; Humans ; Risk Management ; Young Adult