Abstract:The relevant information of ADRs for Ciwujia injection was insufficiently reported in included studies. The ADR type distribution between clinical studies and ADR reports was inconsistency. Most of the reported ADRs were mild, and were treated successfully by slowing down the drip velocity or by withdrawing the drug and treating the symptoms. As Ciwujia injection was one of the highest numbers of ADR reports of traditional Chinese medicine injections, high quality ADR monitoring, standardized ADR reporting, an… Show more
“…Fig. 3 shows that the number of common peaks decreased to 15 (peak numbers 1,8,9,11,12,15,19,21,22, 25 (S), 28, 29, 30, 31, 33) when compared with six batches of abnormal YZHI samples and 10 batches of normal samples. Fig.…”
Section: Similarity Analysesmentioning
confidence: 89%
“…This has been a problem in the QC of herbal injections because unknown substances have resulted in adverse drug reactions and adverse drug events [13]. These include pyrogenic reactions, anaphylactic reactions, allergic shock, or even death [14,15]. Hence, it has become necessary to establish novel approaches for the QC of herbal injections from a biological viewpoint [16][17][18].…”
“…Fig. 3 shows that the number of common peaks decreased to 15 (peak numbers 1,8,9,11,12,15,19,21,22, 25 (S), 28, 29, 30, 31, 33) when compared with six batches of abnormal YZHI samples and 10 batches of normal samples. Fig.…”
Section: Similarity Analysesmentioning
confidence: 89%
“…This has been a problem in the QC of herbal injections because unknown substances have resulted in adverse drug reactions and adverse drug events [13]. These include pyrogenic reactions, anaphylactic reactions, allergic shock, or even death [14,15]. Hence, it has become necessary to establish novel approaches for the QC of herbal injections from a biological viewpoint [16][17][18].…”
“…Standardized protocols are essential to avoid deterioration, reduction in essential oils content, bacterial, fungal or chemical contaminations. Bad practice resulted in high nicotine levels in Chinese dried mushrooms (Anastassiades and Fernandez-Alba, 2009) and bacterial contamination of Ciwujia injection (Du et al, 2008;Hu et al, 2010).…”
Section: Risk Factors Arising From the Drugmentioning
confidence: 98%
“…Through this network the National ADR Monitoring Center identified a series of drug safety problems, such as the Clindamycin Phosphate Glucose Injection (Xinfu) event (Jing et al, 2007;Du et al, 2008) or the Ciwujia Herbal Injectable event (Du et al, 2008;Hu et al, 2010).…”
The model of safety monitoring and risk management of TCM drugs is still under exploration. Indeed, the characteristics and risk factors associated with these drugs require both proper understanding and control of the risk by strengthening standardization of clinical applications, basic science research, quality control in manufacturing, exploration of the actives monitoring methodology and enhancement of international communication and cooperation.
“…However, the basic research on its security is defective, especially the sensitivity of allergy test. Over the past ten years, many severe allergic reactions of herbal injection had been reported in China which made great limits of its usage in the clinic 4,5 . Allergic reaction is the most common adverse reaction of herbal injections 6 .…”
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