Postmarketing safety evaluation: depside salt injection made from Danshen (Radix Salviae Miltiorrhizae)

IMR OpenIR

	Postmarketing safety evaluation: depside salt injection made from Danshen (Radix Salviae Miltiorrhizae)
其他题名	Postmarketing safety evaluation: depside salt injection made from Danshen (RadixSalviae Miltiorrhizae)
	Chang Yanpeng 1; Zhang Wen 1; Xie Yanming 1; Xu Xiangyang 3; Sun Rendi 3; Wang Zheng 3; Yan Ruihua 3
	2014
发表期刊	JOURNAL OF TRADITIONAL CHINESE MEDICINE
ISSN	0255-2922
卷号	34 期号:6 页码:749-753
摘要	OBJECTIVE: To systematically examine the post-marketing safety of depside salt injection made from Danshen (Radix Salviae Miltiorrhizae), identify the potential risk factors, and ensure its clinical safety.
其他摘要	OBJECTIVE: To systematically examine the postmarketing safety of depside salt injection made from Danshen (Radix SalviaeMiltiorrhizae), identify the potential risk factors, and ensure its clinical safety. METHODS: We examined a comprehensive series of studies on the production process, quality standards, pharmacology, population pharmacokinetics, and safety evaluation of depside salt injection made from Danshen (RodixSalvioeMiltiorrhizae). Data from I -IV clinical drug trials, hospital information systems (HIS), and spontaneous reporting systems (SRS) were also analyzed. RESULTS: The effective components of salvianolic acid salt content reached almost 100%, and the magnesium lithospermate B content reached more than 80%. The median lethal dose (LD50) calculated by the Bliss method was 1.49 g/kg, with 95% confidence intervals of 1.29-1.72 g/kg. Long-term tests on Beagle dogs indicated that doses of less than 80 mg/kg were safe and doses of 320 mg/kg were toxic. Adverse drug reactions (ADRs) included digestive disorders; drug-induced erythrocyte deformation in lung, liver, spleen, kidney, bone marrow, intestinal mucosa, lymph nodes, and other tissues; megakaryocytes in lung, liver, and spleen resulting from mild hemolysis; and mild hyperplasia in bone marrow hematopoietic tissue. Other studies indicated no irritative effect of the injection on local tissues and blood vessels, and no allergic reactions, erythrocyte coagulation, or hemolysis. SRS data showed that the most common ADRs were headache, head distention, dizziness, facial flushing, skin itching, thrombocytopenia, and the reversibility of elevated Aspartate transaminase. HIS data indicated no damage to renal function from using depside salt injection made from Danshen (Radix Salviae Miltiorrhizae) at a dosage higher than the recommended dose. CONCLUSION: This study analyzes the clinical characteristics of ADRs from depside salt injection made from Danshen (Radix Salviae Miltiorrhizae), and discusses the factors influencing such reactions. It provides scientific reference and recommendations for clinically safe medication of the Danshen injection.
关键词	MAGNESIUM LITHOSPERMATE-B Product surveillance postmarketing Chinese medicine Safety Danshen (Radix Salviae Miltiorrhizae) Depside salt injection
收录类别	CSCD
语种	英语
资助项目	[National Science and Technology Major Projects for "Major New Drugs Innovation and Development": Study on Key Technologies of Postmarketing Evaluation for Chinese Medicine]
CSCD记录号	CSCD:5305872
引用统计	被引频次：5[CSCD] [CSCD记录]
文献类型	期刊论文
条目标识符	http://ir.imr.ac.cn/handle/321006/151603
专题	中国科学院金属研究所
作者单位	1.中国科学院 2.中国科学院金属研究所 3.Shanghai Green Valley Pharmaceut Ltd, Shanghai 201203, Peoples R China
推荐引用方式 GB/T 7714	Chang Yanpeng,Zhang Wen,Xie Yanming,et al. Postmarketing safety evaluation: depside salt injection made from Danshen (Radix Salviae Miltiorrhizae)[J]. JOURNAL OF TRADITIONAL CHINESE MEDICINE,2014,34(6):749-753.
APA	Chang Yanpeng.,Zhang Wen.,Xie Yanming.,Xu Xiangyang.,Sun Rendi.,...&Yan Ruihua.(2014).Postmarketing safety evaluation: depside salt injection made from Danshen (Radix Salviae Miltiorrhizae).JOURNAL OF TRADITIONAL CHINESE MEDICINE,34(6),749-753.
MLA	Chang Yanpeng,et al."Postmarketing safety evaluation: depside salt injection made from Danshen (Radix Salviae Miltiorrhizae)".JOURNAL OF TRADITIONAL CHINESE MEDICINE 34.6(2014):749-753.