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.Optimizing expression of the capsid protein VP2 from human Bocavirus and establish it's seroepidemiology assying methord.
Ye-Xia HAO ; Ji-Min GAO ; Yu JIN ; Xiao-Le LI ; Jing-Song LI ; Zhi-Ping XIE ; Yuan-Yun AO ; Xi-Qian CHEN ; Ke-Na CHEN ; Zhao-Jun DUAN
Chinese Journal of Experimental and Clinical Virology 2012;26(1):18-21
OBJECTIVETo obtain sufficient recombinant VP2 protein of human Bocavirus and establish it's seroepidemiology assying metbord. METHORD: Tbe capsid protein VP2 DNA genes of HBoV1 and 2 were optimized in accordance with tbe usage of the favorite codons in K coil so as to enhance its protein expression in prokaryotic expressing system. The protein was purified by Ni-NTA column, and its antigenicity was determined by Western Blot. Then establish ELISA to detect the specific anti-VP2 IgG antibodies against HBoV1 and 2 in healthy children aged 3-6 years in Nanjing, China.
RESULTSThe recombinant protein 6 x His-VP2 was produced in a larger quantity at 25 degrees C induced by IPTG (1 mmol/L) over night and purified by Ni-NTA column. Seropositive rates of HBoV1 and 2 were 62.2% and 55.5% and their mixed seropositivity was 37%.
CONCLUSIONThe optimizing expression of the capsid protein VP2 from human Bocavirus constructed successfully and get a high yield under certain conditions. The established ELISA could be used to further analyze seroepidemiology of HBoV in China.
Capsid Proteins ; analysis ; genetics ; Child ; Child, Preschool ; Enzyme-Linked Immunosorbent Assay ; Female ; Human bocavirus ; isolation & purification ; Humans ; Male ; Polymerase Chain Reaction ; Seroepidemiologic Studies
9.Simultaneous multi-tear exclusion: an optimal strategy for type B thoracic aortic dissection initially proved by a single center's 8 years experience.
Liang-xi YUAN ; Jun-min BAO ; Zhi-qing ZHAO ; Xiang FENG ; Le-feng OU ; Rui FENG ; Qing-sheng LU ; Zhi-jun MEI ; Zai-ping JING
Chinese Medical Journal 2007;120(24):2210-2214
BACKGROUNDEndovascular stent-grafting is widely used to treat thoracic aortic dissection. However, little information is available regarding outcome following simultaneous exclusion of multiple tears. This report details eight years of experience using simultaneous multi-tear exclusion for treatment of Stanford type B thoracic aortic dissection resulting in successful aortic remodeling without adverse events.
METHODSFrom September 1998 to January 2006, 29 type B thoracic aortic dissection patients (24 men, 5 women; 27 chronic, 2 acute; mean age 58 years, range 45 - 77 years) were treated by simultaneous multi-tear exclusion in our center. Magnetic resonance angiography was used as the preoperative evaluation method. Different kinds of stent-grafts were used. The patients were followed up with contrast-enhanced spiral computed tomography at 6 months postoperatively and yearly thereafter.
RESULTSTwenty-nine surgeries were completed successfully using at least 2 stent-grafts per patient (range: 2 - 6, mean: 2.7). No major procedure-related complications, such as rupture, paraplegia, aortic branch ischemia or cerebral infarction, were observed. During follow-up, favorable remodeling of the aorta was observed.
CONCLUSIONSThe mid-term result of thoracic aortic dissection with simultaneous multi-tear exclusion was satisfactory. With the improvement of stent-grafts, simultaneous multi-tear exclusion should find wider application and become an optimal strategy for thoracic aortic dissection.
Aged ; Aneurysm, Dissecting ; pathology ; surgery ; Aortic Aneurysm, Thoracic ; pathology ; surgery ; Blood Vessel Prosthesis Implantation ; methods ; Female ; Humans ; Male ; Middle Aged ; Stents ; Treatment Outcome
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