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.Effects of valsartan on angiotensinⅡreceptor 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
Objective To investigate the effects of valsartan on expression of angiotensin Ⅱ receptors in different regions of heart after myocardial infarction(MI).Metbods Canines were divided into sham-operated control group(n=7),infarction group(n=7)and Valsartan group(10 mg·kg-1·day-1 for 4 weeks after MI operation,n=7).Four weeks after operation,Dopplor tissue imaging(DTI)was used to evaluate reglonal 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 down-regulated 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.Conclusion Both 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.
9.Study on graded therapy of hemophilic arthritis by integrative traditional Chinese and Western medicine.
Shan-Xi LIU ; Lin JIANG ; Xin LIANG ; Wei-wei KONG ; Jing CHEN ; Yi-guo LIU ; Le-qin HE
Chinese journal of integrative medicine 2007;13(4):301-305
OBJECTIVETo study the effect and safety of graded therapy featuring integrative traditional Chinese and Western medicine for the treatment of hemophilic arthritis.
METHODSForty patients with hemophilic arthritis were hospitalized randomly, with their blood coagulation factor activity determined by one-stage method and their arthritis classified into 4 stages. The treatment was applied according to the stage of arthritis and finding of intra-articular cavity puncture. For stage I, based on the principle of RICE (rest, ice, compression and elevation), 1.8 g of Xuefuda was medicated orally once per day, intravenous dripping of 250 mL of hemostasis mixture twice a day and 1.2 g of clindamycin per day were also given for hemostasis and anti-inflammation. For stage II-III, Kangyanling was additionally administered via intra-articular cavity injection twice a week, 2 mL every time, for 5-6 times in total. For stage IV, the drug for intra-articular cavity injection was replaced with 25 mg of sodium hyaluronate and the frequency of injection reduced to every two weeks, for 5-6 times in total. Coagulation factors III and IV as well as blood plasma were not given in the whole treatment course. Short-term therapeutic effects and adverse reaction in patients were evaluated, and the long-term effects were followed-up after patients left the hospital with 6-month consolidation therapy by Xuefuda.
RESULTSAfter a 3-week treatment, 33 patients (82.5%) were completely remitted; 5 (12.5%) were partially remitted and 2 (5.0%) un-remitted, setting the short-term effective rate at 95.0% (38 cases). The 6-month follow-up showed that except for a relapse in 2 and 4 patients of stage III and IV respectively, long-term remission displayed in all the other 34 patients, with the remission sustaining rate being 85.0%. No complication such as an infection, bleeding or aggravating pain occurred in the 215 times intra-articular puncturing conducted in the 40 patients. Normal figures were shown in liver and kidney function, electrolytes, ECG, blood glucose and routine test of blood and urine throughout the course.
CONCLUSIONThe graded treatment of integrative medicine for hemophilia with non-blood preparation has a favorable effect and is safe or without any adverse reaction, which opens a high efficacy and new safe path and thinking for the treatment of and deformity prevention in the hemophilic patients.
Acupuncture Therapy ; adverse effects ; Adolescent ; Adult ; Arthritis ; complications ; therapy ; Child ; Child, Preschool ; Combined Modality Therapy ; Follow-Up Studies ; Hemophilia A ; complications ; therapy ; Humans ; Male ; Medicine ; methods ; Medicine, Chinese Traditional ; methods ; Treatment Outcome ; Western World
10.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