Postmarketing safety evaluation: depside salt injection made from Danshen (RadixSalviae Miltiorrhizae)
查看参考文献10篇
|
文摘
|
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. |
|
来源
|
Journal of Traditional Chinese Medicine
,2014,34(6):749-753 【核心库】
|
|
DOI
|
10.1016/s0254-6272(15)30091-1
|
|
关键词
|
Product surveillance, postmarketing Chinese medicine
;
Safety
;
Danshen (Radix Salviae Miltiorrhizae)
;
Depside salt injection
|
|
地址
|
1.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700
2.
Shanghai Green Valley Pharmaceutical Ltd., Shanghai, 201203
|
|
语种
|
英文 |
|
文献类型
|
综述型 |
|
ISSN
|
0255-2922 |
|
学科
|
医药、卫生;外国民族医学 |
|
基金
|
Supported by National Science and Technology Major Projects for "Major New Drugs Innovation and Development": Study on Key Technologies of Postmarketing Evaluation for Chinese Medicine
|
|
文献收藏号
|
CSCD:5305872
|
参考文献 共
10
共1页
|
|
1.
National Pharmacopoeia Committee.
Chinese Pharmacopoeia 2010,2010:70-71
|
CSCD被引
1
次
|
|
|
|
|
2.
Wu X J. Free radical scavenging and inhibition of lipid peroxidation by magnesium lithospermate B.
Acta Pharmacol Sin,2000,21(9):855-858
|
CSCD被引
12
次
|
|
|
|
|
3.
Wang W. Effects of magnesium lithospermate B on aggregation and 5-HT release in rabbit washed platelets.
Acta Pharmacol Sin,2000,21(9):859-863
|
CSCD被引
14
次
|
|
|
|
|
4.
Luo W B. Effect of magnesium lithospermate B on calcium and nitric oxide in endothelial cells upon hypoxia/reoxygenation.
Acta Pharmacologica Sinica,2002,23(10):930-936
|
CSCD被引
14
次
|
|
|
|
|
5.
Miao Y. Clinical observation on salvianolate for the treatment of angina pectoris in coronary heart disease with heart-blood stagnation syndrome.
Zhong Yao Xin Yao Yu Lin Chuang Yao Li,2006,17(2):140-144
|
CSCD被引
3
次
|
|
|
|
|
6.
Song Y Q. A summary of clinical application of salvianolate injection.
Chin J Pharmacoepidemiol,2012,21(8):404-407
|
CSCD被引
2
次
|
|
|
|
|
7.
Zhang Y. Pharmacokinetic study of lithospermata B on patients with blood-stasis syndrome of CHD.
Zhong Yao Yao Li Yu Lin Chuang,2010,26(6):22-24
|
CSCD被引
2
次
|
|
|
|
|
8.
Lu P F. Pharmacovigilance of parenterally administered salvianolate based on analysis of spontaneous reporting system data.
Zhong Guo Zhong Yao Za Zhi,2013,38(18):3003-3007
|
CSCD被引
1
次
|
|
|
|
|
9.
Chang Y P. Analysis of salvianolate injection combined with usual drugs in treatment of coronary heart disease in real world.
Zhong Guo Zhong Yao Za Zhi,2013,38(18):3186-3189
|
CSCD被引
1
次
|
|
|
|
|
10.
Chang Y P. Real world study of affect on liver function of overdose of salvianolate extract injection.
Zhong Guo Zhong Yao Za Zhi,2013,38(18):3092-3098
|
CSCD被引
1
次
|
|
|
|
|
了解气象卫星更多信息，请访问