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 ; methods ; Drugs, Chinese Herbal ; Humans ; Medicine, Chinese Traditional

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 ; Drugs, Chinese Herbal ; adverse effects ; history ; History, Ancient ; Humans ; Medicine in Literature ; Medicine, Chinese Traditional ; history ; Polygonum ; adverse effects ; Risk Assessment

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 ; Aristolochia ; adverse effects ; chemistry ; Aristolochic Acids ; analysis ; therapeutic use ; toxicity ; Drug Therapy ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; analysis ; therapeutic use ; toxicity ; Humans

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 ; epidemiology ; Drug Evaluation ; Drug-Related Side Effects and Adverse Reactions ; epidemiology ; etiology ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Humans ; Product Surveillance, Postmarketing

More than 80 strains producing lipases were screened from oily soil of vegetable oil plant, meat processing factory and dairy factory in Jinan city, Shandong Province, which included bacteria, moulds and yeast. Conditions for lipase production and properties of some enzymes were studied. One drug-resistant mutant strain Y-11 with higher lipase activity was from Trichosporon sp. Y-1. In addition, Optimization of lipase production and characterization of enzymes were carried out. On the basis of above experiments, a characteristic library of stains producing lipases was established.

Objective To discuss the short-term currative effect of horizontal osteotomy across injured vertebral forⅤdegree old frac-ture-dislocations of thoracolumbar spine.Methods The data of 4 patients who received horizontal osteotomy across injured vertebral internal fixation in our hospital from April 2010 to October 2012 were retrospectively analyzed,of which 1 case with T8-9 fracture dislocation,2 cases with T10-11 fracture dislocation,1 case with T11-12 fracture dislocation.The Franke1 classification of all patients were grade A.Results All 4 cases were achieved completely fracture reduction and followed-up for 2-14 months(an average of 7.4 months),who could get sitting posi-tion with the support of brace 1 week after operation.The postoperative follow-up indicated that all 4 cases got fusion,but there was no improve-ment for Franke1 classification.Conclusion The method of horizontal osteotomy across injured vertebral forⅤdegree old fracture-dislocations of thoracolumbar spine has good short-term clinical effect,with the advantages of shorter operation time,less bleeding and good reduction effect.

Objective To learn the prevalence and trends of Brucella disease in Ningxia, in order to provide scientific basis for effective control of the disease. Methods Data of Brucella cases reported through city network from 2004 to 2009 in Yinchuan city, Shizuishan city, Wuzhong city, Guyuan city and Zhongwei city of Ningxia were reviewed and retrospectively analyzed. The data included demographic characteristics, treatment conditions and medical history so on related information. Analytical indicators include reported incidence;with patients' gender, age, regional distribution, urban and rural distribution;become chronic and associated factors;distribution of the cases reporting unit and so on. Results From 2004 to 2009, Ningxia had reported 349 cases of Brucellosis, no deaths, the annual incidence rates reported were 0.017/10 million, 0.543/10 million, 0.151/101 (295/54);The proportion of 34- to 40-year-old age group was higher than other age groups(27.5%, 96/349);Occupational distribution of patients was mainly farmers and herdsmen(70.2% ,245/349), in regional distribution of the patients, the highest percentage was Wuzhong city(61.9%,216/349), followed by Yinchuan city(22.9%,80/349);The proportion of patients in rural areas(97.4% ,340/349) was higher than urban(2.6% ,9/349);the proportion of patients converted to chronic was 11.2% (39/349). With age, the chance of patients converted to chronic was in a decreasing trend(odds ratio was 0.966);cases reported by Centre for Disease Control and Prevention accounted for 74.8%(261/349), by hospital accounted for 25.2%(88/349). Conclusions The reported incidence of Brucellosis in Ningxia is in a rapid upward trend year by year, the patients is mainly young men, the rate of converted to chronic is higher and the ability of hospital in founding and reporting of the cases is weaker.Comprehensive measures should be taken to increase funding, strengthen monitoring, and continuously improve the level of awareness and diagnosis of medical personnel for further strengthen the prevention and control of Brucellosis.

OBJECTIVE:To provide reference for vancomycin-induced neutropenia adverse reactions/adverse events in clinical diagnosis. METHODS:With a case of children with neutropenia treated by long-course and large-dose vancomycin,PubMed and CNKI were retrieved to collect related literature and the literature was analyzed. RESULTS:Neutropenia may be associated with vancomycin,based on causality criterion of adverse reaction in China. CONCLUSIONS:Vancomycin-induced neutropenia in chil-dren is most likely associated with prolonged exposure induced by infusion,vancomycin dosage should be reduced or stopped,and routine blood and plasma concentration should be closely monitored.

OBJECTIVETo investigate the effects of traditional transmyocardial laser revascularization (T-TMLR) and non-transmural myocardial laser revascularization (N-TMLR) on myocardial ischemic and necrotic areas and angiogenesis.

METHODSIn 30 rabbit models, Evans blue -TTC staining and HE staining were used for measuring ischemic and necrotic areas and observing angiogenesis.

RESULTSThe ischemic areas in the MI + T-TMLR (30.6 +/- 1.0)% and the MI + N-TMLR group (30.2 +/- 0.4)% were significantly decreased compared with the MI group (37.2 +/- 0.2)% (F = 21.04, P < 0.01). The necrotic areas in the MI + T-TMLR (17.0 +/- 0.7)% and the MI + N-TMLR group (16.9 +/- 0.6)% was not different from that in the MI group (17.9 +/- 0.5)% (F = 1.73, P > 0.05). The angiogenesis in the MI + T-TMLR (1.8) and the MI + N-TMLR (1.6) was significantly increased compared with that in the MI group (0.6) (F = 15.32, P < 0.01).

CONCLUSIONSMI + N-TMLR can achieve the same effects of MI + T-TMLR. Inducing angiogenesis via laser channels and decreasing ischemic area may be one of the predominant mechanisms of TMLR, whereas whether laser channels themselves are patent is not relation to the effects of TMLR.

Angioplasty, Balloon, Laser-Assisted ; Animals ; Disease Models, Animal ; Laser Therapy ; Male ; Myocardial Infarction ; surgery ; Myocardial Revascularization ; Neovascularization, Physiologic ; Rabbits