3.Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine.
Xiao-Xi DU ; Hai-Bo SONG ; Jing-Tian REN ; Le YANG ; Xiao-Xin GUO ; Yu PANG
China Journal of Chinese Materia Medica 2014;39(18):3427-3429
Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.
Drug Evaluation
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methods
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Drugs, Chinese Herbal
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Humans
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Medicine, Chinese Traditional
4.Safety and risk factor analysis on Polygoni Multiflori Radix base on ancient traditional Chinese medicine literatures.
Hai-bo SONG ; Xiao-xi DU ; Xiao-xin GUO ; Jing-tian REN ; Le YANG ; Yu PANG
China Journal of Chinese Materia Medica 2015;40(5):985-988
Traditional Chinese medicine Polygoni Multiflori Radix is dried roots of Polygonaceae Polygortum multiflorum Thunb. Its clinical application records were first discovered in literatures of the Tang dynasty. The origins, efficacy, toxicity, processing and taboos of Polygoni Multiflori Radix have been discussed in many ancient herb literatures. In recent years, with the increase in the public awareness in health, Polygoni Multiflori Radix admits preparations have been more widely applied in the treatment and prevention of diseases. However, there have been more and more reports about Polygoni Multiflori Radix induced liver injury, the safety of Polygoni Multiflori Radix has increasingly attracted attention of the society. In this paper, the authors summarized and analyzed the toxicity and medication risk factors of Polygoni Multiflori Radix recorded in ancient herb literatures, and proposed that more attention shall be given to the effect of the planting and processing methods on the components and toxicity of Polygoni Multiflori Radix in safety studies, which provides clues for the further studies.
China
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Drugs, Chinese Herbal
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adverse effects
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history
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History, Ancient
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Humans
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Medicine in Literature
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Medicine, Chinese Traditional
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history
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Polygonum
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adverse effects
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Risk Assessment
5.Advance in studies on toxicity of aristolochic acid and analysis on risk factors.
Hai-Bo SONG ; Jing-Tian REN ; Le YANG ; Xiao-Xin GUO ; Xiao-Xi DU
China Journal of Chinese Materia Medica 2014;39(12):2246-2250
The renal toxicity and mutagenicity of aristolochic acid (AA) as well as its carcinogenicity on upper urinary tract transitional epithelial cells have been widely known. Since 2003, drug regulatory departments have successively cancelled the quality standards for AA-containing medicines such as Aristolochiae Radix, Aristolochiae Manshuriensis Caulis and Aristolchiae Fangchi Radix, and adopted measures for strengthening regulation and revising package insert or quality standards for other AA-containing medicines, including Aristolochia Cinnabarina Radix, Aristolochiae Fructus, Aristolochiae Mollissimae Herba, in order to control its safety risk. In recent years, domestic and foreign studies on AA have mainly involved action mechanism and clinical performance of AA toxicity, early-stage diagnosis and treatment method. In this paper, authors gave a brief summary and evaluation on risk factors for using AA-containing medicines, and offered measures and suggestions for preventing and controlling AA toxicity.
Animals
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Aristolochia
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adverse effects
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chemistry
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Aristolochic Acids
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analysis
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therapeutic use
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toxicity
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Drug Therapy
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Drug-Related Side Effects and Adverse Reactions
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epidemiology
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etiology
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Drugs, Chinese Herbal
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analysis
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therapeutic use
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toxicity
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Humans
6.Enlightenment of adverse reaction monitoring on safety evaluation of traditional Chinese medicines.
Hai-bo SONG ; Xiao-xi DU ; Jing-tian REN ; Le YANG ; Xiao-xin GUO ; Yu PANG
China Journal of Chinese Materia Medica 2015;40(8):1620-1623
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
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epidemiology
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Drug Evaluation
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Drug-Related Side Effects and Adverse Reactions
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epidemiology
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etiology
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Drugs, Chinese Herbal
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adverse effects
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therapeutic use
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Humans
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Product Surveillance, Postmarketing
7.On angiotensin II receptor distribution after myocardial infarction in dogs.
Xiu-fen QU ; Jing-jie LI ; Yang XI ; Jing-xia SHEN ; Chun-hong XIU ; Le YUE ; Gui-zhao WANG ; Yong-lin HUANG
Chinese Journal of Cardiology 2009;37(4):358-362
OBJECTIVETo investigate the effects of valsartan on expression of angiotensin II receptors in different regions of heart after myocardial infarction (MI).
METHODSCanines were divided into sham-operated control group (n=7), infarction group (n=7) and Valsartan group (10 mg x kg(-1) x day(-1) for 4 weeks after MI operation, n=7). Four weeks after operation, Doppler tissue imaging (DTI) was used to evaluate regional ventricular function in the noninfarcted myocardium (apical and basal near to the infarction region). The mRNA and protein expressions of angiotensin II type 1 receptor (AT1-R) and angiotensin II type 2 receptor (AT2-R) on the corresponding regions were detected by competitive reverse-transcriptase polymerase chain reaction technique and immunohistochemical technique respectively. Results The protein and mRNA expressions of AT1-R were significantly increased in both apical and basal regions near to the infarction in dogs with MI compared with those in control group (P < 0.05) which could be downregulated by valsartan (P < 0.05). AT2-R expressions were significantly upregulated in infarction group in both apical and basal regions compared with those in control group and valsartan further increased AT2-R expressions in both areas (P < 0.05). Myocardial peak systolic velocity (Sm), myocardial peak early diastolic velocity (Em) and myocardial peak late diastolic velocity (Am) at both apical and basal regions near to the infarction regions were significantly lower in MI group than those in the control group which could be significantly improved by valsartan.
CONCLUSIONBoth mRNA and protein expressions of AT1-R and AT2-R are upregulated in noninfarcted regions near MI, valsartan improved myocardial function via inhibiting AT1-R upregulation and enhancing AT2-R upregulation.
Angiotensin II Type 1 Receptor Blockers ; pharmacology ; therapeutic use ; Animals ; Dogs ; Female ; Male ; Myocardial Infarction ; drug therapy ; metabolism ; physiopathology ; Myocardium ; metabolism ; RNA, Messenger ; metabolism ; Receptor, Angiotensin, Type 1 ; metabolism ; Receptor, Angiotensin, Type 2 ; metabolism ; Tetrazoles ; pharmacology ; therapeutic use ; Valine ; analogs & derivatives ; pharmacology ; therapeutic use ; Valsartan
8.Three-dimensional low-dose CT volume reconstruction based on non-local weights optimization and GPU acceleration.
Xi-le ZHANG ; Ling-ling TIAN ; Jing HUANG ; Jian-hua MA ; Hua ZHANG ; Qian-jin FENG ; Wu-fan CHEN
Journal of Southern Medical University 2011;31(12):1974-1980
Concerns have been raised over x-ray radiation dose associated with repeated computed tomography (CT) scans for tumor surveillance and radiotherapy planning. In this paper, we present a low-dose CT image reconstruction method for improving low-dose CT image quality. The method proposed exploited rich redundancy information from previous normal-dose scan image for optimizing the non-local weights construction in the original non-local means (NLM)-based low-dose image reconstruction. The objective 3D low-dose volume and the previous 3D normal-dose volume were first registered to reduce the anatomic structural dissimilarity between the two datasets, and the optimized non-local weights were constructed based on the registered normal-dose volume. To increase the efficiency of this method, GPU was utilized to accelerate the implementation. The experimental results showed that this method obviously improved the image quality, as compared with the original NLM method, by suppressing the noise-induced artifacts and preserving the edge information.
Algorithms
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Artifacts
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Humans
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Imaging, Three-Dimensional
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methods
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Phantoms, Imaging
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Radiation Dosage
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Radiation Protection
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standards
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Radiographic Image Interpretation, Computer-Assisted
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methods
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standards
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Tomography, X-Ray Computed
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methods
9.Avastin combined with cisplan inhibits malignant ascites production in nude mice bearing transplanted ovary carcinoma with high VEGF expression.
Yan-jun CAI ; Da-yong ZHENG ; Rong-cheng LUO ; Jin-zhang CHEN ; Ai-ming LI ; Jing-le XI ; Xue-mei DING
Journal of Southern Medical University 2007;27(5):647-649
OBJECTIVETo establish a nude mouse model of malignant ascites with human ovarian carcinoma cell line OVCAR3 which highly expresses VEGF and evaluate the therapeutic of Avastin combined with cisplan.
METHODSForty-eight nude mice with malignant ascites resulting from intraperitoneal transplantation of human ovarian carcinoma cell line OVCAR3 were treated with intraperitoneal injection of Avastin, cisplan, their combination, and PBS, respectively, to observe the effect on ascites development, VEGF content in the ascites, peritoneal permeability, development of new vessels and number of tumor cells in the ascites.
RESULTSAvastin obviously inhibited ascites accumulation and peritoneal capillary permeability, reduced VEGF protein level and microvascular density in the tumor tissues and the number of red cells and tumor cells in the malignant ascites, and prolonged the survival of the mice. The combination of Avastin and cisplan further enhanced the therapeutic efficacy of Avastin.
CONCLUSIONThe bio-chemotherapeutic strategy with Avastin combined with cisplan can be a promising method for treatment of malignant ascites.
Animals ; Antibodies, Monoclonal ; administration & dosage ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Ascites ; etiology ; metabolism ; prevention & control ; Bevacizumab ; Cell Line, Tumor ; Cisplatin ; administration & dosage ; Drug Synergism ; Enzyme-Linked Immunosorbent Assay ; Female ; Gene Expression Regulation, Neoplastic ; Humans ; Mice ; Mice, Inbred BALB C ; Mice, Nude ; Neovascularization, Pathologic ; pathology ; prevention & control ; Ovarian Neoplasms ; complications ; genetics ; pathology ; Reverse Transcriptase Polymerase Chain Reaction ; Treatment Outcome ; Vascular Endothelial Growth Factor A ; genetics ; metabolism ; Xenograft Model Antitumor Assays
10.Effect of the size of abdominal aortic aneurysm on endovascular exclusion and its results.
Liang-xi YUAN ; Jun-min BAO ; Zhi-qing ZHAO ; Le-feng QU ; Xiang FENG ; Qing-sheng LU ; Rui FENG ; Zhi-jun MEI ; Yi-fei PEI ; Zai-ping JING
Chinese Journal of Surgery 2008;46(6):420-422
OBJECTIVETo evaluate the effect of the diameter of abdominal aortic aneurysm (AAA) on endovascular exclusion (EVE) and its results.
METHODSFrom March 1997 to June 2007, 429 AAA patients were treated with endovascular stent-graft exclusion. According to the maximal diameter of abdominal aortic aneurysm, the patients were divided into two groups: group A (diameter < 55 mm, n = 274) and group B (diameter > or = 55 mm, n = 155). The diameter of AAA, involvement of iliac artery, length, diameter and distortion of aneurismal neck in the two groups were recorded and compared retrospectively.
RESULTSPatients in group B were significantly older than group A (73.7 vs 71.1 years, P < 0.05). More patients in group B was complicated with coronary artery disease than those in group A (P < 0.05). The mean diameter of AAA in group A was (46.6 +/- 6.8) mm, and (66.8 +/- 11.2) mm in group B (P < 0.05). Proximal aneurysmal necks were shorter, wider and more tortuous in group B than those in group A (P < 0.05). Extraperitoneal approach, embolism of inner iliac artery and reconstruction of another inner iliac artery and stretch technique were more applied in group B. There were more endoleak during operation in group B and more stent-grafts were used. There was significant difference in morbidity rate between the two groups, while no statistic difference in mortality. And in group B, there were a high rate of endoleak and secondary intervention post operation.
CONCLUSIONSThe diameter of AAA affects EVE and its results. In small aneurysms, EVE carries better outcome than in big aneurysms.
Aged ; Aged, 80 and over ; Aortic Aneurysm, Abdominal ; pathology ; surgery ; Blood Vessel Prosthesis Implantation ; methods ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Prognosis ; Retrospective Studies ; Stents ; Treatment Outcome