In order to ensure the authenticity and accuracy of traditional Chinese medicine injection safety monitoring data, Chinese medicine injection safety monitoring quality control indicators, including the monitoring center, monitoring personnel, hardware conditions, monitoring progress and the number of patients into the group, original documents and archives management, electronic data, adverse events, quality management were constructed. Its application in the creation of major new drugs technology major projects, 10 kinds of traditional Chinese medicine injections clinical safety monitoring quality control work, found the missing case surveillance, not reported adverse events, only reported adverse reactions, electronic data reporting lag, lack of level of efforts to control the problem, and corrected, the traditional Chinese medicine injection safety monitoring of quality control and quality assurance, and subsequent Chinese medicine safety monitoring quality control to provide the reference.
Humans ; Injections ; Medicine, Chinese Traditional ; adverse effects ; standards ; Quality Control

OBJECTIVETo analyze irrational clinical application of Houttuynia Injection (HI) and the risk of adverse event (AE) occurrence, thus providing references for after-sales reevaluation and rational clinical application of HI.

METHODSLiteratures concerning unreasonable application of HI were searched (terminated by June 2010) from PubMed, EMBASE, Chinese Biomedical Disc (CBMdisc), Chinese National Knowledge Infrastructure (CNKI), Chinese Science and Technology Journal Full-text Database (VIP), and etc. for case report, cross-sectional study, and clinical control study.

RESULTSA total of 342 papers with a total of 416 AE cases were retrieved. Of them, AE happened to 294 cases (including 290 children) of the 132 papers concerning contraindications, and 48 with allergic shock; AE happened to 57 cases in 9 papers reporting over-dose, and 6 with high risk combined medication. Sixteen irrational administration ways were reported in 195 papers. Of them, AE happened to 59 cases of seven administration ways (twenty cases by intracavitary injection, thirteen by aerosol inhalation, ten by rinse, eight by oral administration, one by enema, one by acupoint injection, and one by rectal administering). AE was not reported in the rest ten reports.

CONCLUSIONThe risk of AE occurrence was increased by changing clinical administration ways of HI without authorization, over-dose medication, high risk combined medication, and application in people with contraindications.

Databases, Factual ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; therapeutic use ; Houttuynia ; adverse effects ; Humans ; Injections

OBJECTIVETo evaluate the sensitization effect of polysorbate 80 and polysorbate 80 contained Houttuynia cordata Injection in different concentrations on Beagle.

METHODSBeagles, a kind of animal highly sensitive to sensitizing agents, were randomly divided into 18 groups, 3 in each group. They received respectively the intravenous infusion of polysorbate 80 made by different factories in different concentrations (0.25%, 0.10%, 0.05%), and Houttuynia cordata Injection containing polysorbate 80 in concentration of 0.25% or 0.30%, with the constant infusing speed of 5 mL/min and volume of 10 mL/kg. Changes of animals' condition were observed before infusion and in the 24 h after infusion, time of symptom appearance and disappearance was recorded, and the grade of response was determined. Moreover, blood samples of animals were collected before infusion and 10 min after ending infusion for measuring histamine content in plasma using ELISA. Then the sensitization effect was comprehensively estimated by combined consideration of the responding grade and histamine level.

RESULTSNo typical symptom of anaphylactoid reaction and over 1-fold increase of histamine level was found in all groups that received intravenous infusion of polysorbate 80 or polysorbate 80 contained Houttuynia cordata Injection in different concentrations. Estimation showed that all test solutions didn't induce typical anaphylactoid reaction on Beagle.

CONCLUSIONSConsidering both the appearance of symptoms and the elevation of blood content of histamine could be taken as the criteria for comprehensive diagnosis of anaphylactoid reactions. The solubilization effect and safety (for foreclose anaphylactoid reaction) of polysorbate 80 could be ensured by controlling its quality and concentration below 0.25% or 0.30%.

Anaphylaxis ; chemically induced ; Animals ; Dogs ; Houttuynia ; adverse effects ; Injections ; Polysorbates ; administration & dosage ; adverse effects

Alprostadil ; administration & dosage ; adverse effects ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Humans ; Injections, Intravenous

OBJECTIVETo investigate the complications in 16 patients who had breast augmentation with polyacrylamide hydrogel injection. The distribution and late changes of the injected material was observed.

METHODSThe physical signs and symptoms of the 16 patients were classified. Ultrasound and infrared examinations or MRI were used in some cases.

RESULTSTwo patients had operations for extraction. The injection material was distributed in the muscles diffusely, or existed in the breast and subcutaneous tissue as many masses.

CONCLUSIONThe reliability of this injection method for breast augmentation is in doubt.

Acrylic Resins ; adverse effects ; Adult ; Breast Implants ; adverse effects ; Female ; Humans ; Injections

Since the safety re-evaluation of traditional Chinese medicine(TCM) injections began in 2009, some TCM injection companies and research institutes have done a lot of work. And with the increase of drug development and drug production technology levels in China, the safety of some TCM injections has been greatly improved. There are safety risks in TCM injections, which are mainly reflected in unclear basis of medicinal materials, simple production process, poor controllability of quality standards, nonstan-dard drug instructions and irrational medication in the use process. This paper describes the research progress of the above-mentioned aspects of TCM injections. In addition, the author team found that adverse reactions of TCM injections are mainly pseudo-allergic reactions. Therefore, a lot of work has been done in detection of pseudo-allergic reactions, mechanism research and risk control. This part of the work is also described in this article.
China ; Drugs, Chinese Herbal/adverse effects* ; Humans ; Hypersensitivity/etiology* ; Injections ; Medicine, Chinese Traditional/adverse effects*

Humans ; Consensus ; Hypersensitivity ; Desensitization, Immunologic/adverse effects* ; Immunotherapy/adverse effects* ; Injections, Subcutaneous ; Allergens

As a modern dosage form drug with rapid effect, traditional Chinese medicine (TCM) injection has been more and more used in clinical practice. Meanwhile the safety of TCM injection has attracted more and more attention. The retrospective analysis on 74 cases of adverse reaction of TCM injections collected from 2007 to 2016 in the Third Affiliated Hospital of Beijing University of Chinese Medicine showed that the proportion of men and women with adverse reactions was 0.54:1; the average age was 62.5 years old; 21 kinds of TCM injections were involved. Among them, the most reported were blood-regulating agents. The top four kinds of TCM injections with highest adverse drug reactions (ADRs) were Tanreqing injection, Danhong Injection, Shuxuening Injection and Xuesaitong for injection. The top three clinical manifestations of adverse reactions were lesions of skin and its appendages, damage of circulatory system and damage of nervous system. The potential causes of the adverse reactions of TCM injections were analyzed, and it was believed that individual difference, medicine, pharmaceutical excipients, solvent and TCM syndrome differentiation may be the main five causes for the adverse reactions of TCM injections. In order to reduce the adverse reactions of TCM injections, it is suggested that the clinical pharmacists should participate in the application management of TCM injections in the hospital; the production enterprises shall strengthen the whole life cycle management of the drugs; and at the same time, the drug control and administration authorities should improve the drug management methods constantly and encourage the development of TCM injections to the high quality level.
Drugs, Chinese Herbal ; adverse effects ; Female ; Humans ; Injections ; adverse effects ; Male ; Medicine, Chinese Traditional ; adverse effects ; Middle Aged ; Retrospective Studies

Aged ; Astragalus Plant ; adverse effects ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; Humans ; Injections, Intravenous ; adverse effects ; Low Back Pain ; etiology ; Male ; Phytotherapy ; adverse effects

In this study, chemistry, biology and pharmacology were combinated to screen pseudoallergenic substances of Shuang-huanglian injection (SHLI) so that to establish a scientific and systematic approach to screen pseudoallergenic substances of traditional Chinese medicine injections. The mouse pseudoallergic reaction models were used to screen the pseudoallergic reaction of SHLI's intermediate extract and the intermediate extract's component or ingredient. Among the three intermediates of Shuanghuanglian injection (extract of Scutellaria baicalensis, extract of Lonicera japonica, extract of Forsythia suspensa) , pseudoallergic action of Forsythia suspensa was the strongest, Forsythia suspesnsa's pseudoallergic reaction mainly associated with the composition with largerchemical polarity. Further it was found that forsythiaside A and arctiin which existed in the the composition with largerchemical polarity caused obvious pseudoallergic reactions. SHLI with removal forsythoside A with the technology of HPLC-MS displayed reduced pseudoallergic reaction and a significant improved safety. This study provided a scientific basis for SHLI process improvements and also offered idea and research foundation for screening pseudoallergenic substances injections in other TCM injections.
Animals ; Drug Hypersensitivity ; etiology ; Drugs, Chinese Herbal ; adverse effects ; analysis ; Furans ; adverse effects ; Glucosides ; adverse effects ; Glycosides ; adverse effects ; Injections ; Male ; Mice ; Mice, Inbred ICR