2.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
3.A retrospective study of Schatzker III tibial plateau--fracture using minimally invasive fixation and bone grafting through medial side.
Zhi-dan LING ; Jian-feng WANG ; Hai-bo SONG ; Hao-jie GU
China Journal of Orthopaedics and Traumatology 2015;28(12):1114-1116
OBJECTIVETo investigate clinical effects of minimally invasive fixation and bone grafting througn medial side for the treatment of Schatzker III tibial plateau fracture.
METHODSFrom April 2009 to August 2011, 18 patients with Schatzker III tibial plateau fracture were treated with minimally invasive fixation and bone grafting through medial side. There were 15 males and 3 females ranging in age from 64 to 73 years, with an average of (69.75 ± 1.22) years. Sixteen patients were caused by falling down, 2 cases were caused by traffic accident. Operative time and length of incision were be recorded. Clinical and radiological follow-up was performed after operation. Hospital for Special Surgery (HSS) score and Kellgren-Lawrence score were used to evaluate clinical effects.
RESULTSThe mean operative time was (45.32 ± 1.58) min, and the mean length of incision was (5.21 ± 0.65) cm. Postoperative X-ray showed excellent reduction. Eighteen patients were followed up for 10 to 13 months with an average of (11.5 ± 1.35) months. The mean HSS score was 86.51 ± 2.71, 12 cases got excellent results,4 good and 2 fair. Three patients were developed mild osteoarthritis according to the Kellgren-Lawrence system.
CONCLUSIONMinimally invasive fixation and bone grafting through medial side, not only could reduce surgical invasive, but also guarantee early function activities. It has advantages of keeping well after reduction. So it has the favorable future in clinic.
Aged ; Bone Transplantation ; Female ; Fracture Fixation, Internal ; methods ; Humans ; Male ; Middle Aged ; Minimally Invasive Surgical Procedures ; methods ; Retrospective Studies ; Tibial Fractures ; surgery
4.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
5.Rectal and perianal inflammatory myofibroblastic tumor: report of 3 cases
Bo SONG ; Yangchun ZHENG ; Jin YAN ; Hai HU ; Lin XU ; Chao LIU ; Baoshan LIU
Chinese Journal of General Surgery 2011;26(12):1016-1018
Objective To analyze the clinical features of rectal and perianal inflammatory myofibroblastic tumor and evaluate its diagnosis and treatment.Method Clinicopathological data of 3 cases diagnosed as inflammatory myofibroblastic tumor from January,2005 to June,2011 were retrospectively reviewed.Results Inflammatory myofibroblastic tumor presents as infiltrative growth mass with rich vascularization on CT or MRI,and is difficult to distinguish from hemangioma and other rectal tumors.Preoperative biopsy usually fails to ascertain the entity of mass,and pathological examination of the whole resected specimen with immunohistochemical staining is needed to make final diagnosis.All 3 cases underwent sphincter preserving surgery.One case received a second radical operation 16 months after primary resection because of local recurrence.All patients are followed up to now,with a survival time of 67 months,55 months,and 35 months respectively.Conclusions Rectal and perianal inflammatory myofibroblastic tumor is difficult to diagnose on preoperative imaging examinations or biopsy.Immunohistochemical staining is needed to make final diagnosis.Sphincter preserving surgery with complete tumor removal could achieve long term survival.
6.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
7.Epidemiological analysis of human brucellosis in Ningxia from 2004 to 2009
Xiao-jia, SONG ; Feng, JIN ; Xing-zhong, HU ; Tian-bo, MA ; Hai-hong, WANG ; Li, LI
Chinese Journal of Endemiology 2011;30(1):92-95
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.
8.Clinical evaluation of naloxone used in the postoperation of cerebral tumor
Zhen-Hua YU ; Hua-Wei JIN ; Zhen CHEN ; Hai LAN ; Zhi-Bo XIA ; Zheng-Song HUANG
Chinese Journal of Microsurgery 2000;0(02):-
Objective To evaluate the efficacy of naloxone used in the postoperation of cerebral tumor.Methods Eighty patients were randomly assigned to receive (treated group:40 patients) or not re- ceive (control group:40 patients) naloxone.Both the two groups accepted the conventional therapy.Re- sults After operation,the content of?-EP,ET decreased continuously but the one of the treated groups was more obviously than that of the control groups (P
9.Case-control study on cancellous screw and compression bolt in the treatment of calcaneal fractures wih minimally invasive plate.
Hai-Hong WANG ; Jin WANG ; Xiao-Qian SONG ; Li-Zhuang WANG ; Bo LI
China Journal of Orthopaedics and Traumatology 2013;26(2):134-137
OBJECTIVETo evaluate percutaneous reduction by Kirschner pin and internal fixation with cancellous screw and plate through minimal incision at the lateral side of heel for the treatment of intra-articular displacement fracture of calcaneus.
METHODSFrom September 2009 to June 2012, 80 patients with close intra-articular displacement fractures of calcaneus were divided into treatment group and control group. There were 40 patients in the control group, including 21 males and 19 females, ranging in age from 23 to 64 years old, averaged (39.1 +/-11.7) years old; and the patients were treated with fixation by compress screws and plates of self-broken type. There were 40 patients in the treatment group, including 24 males and 16 females,ranging in age from 21 to 67 years old, averaged (39.6+/-14.3) years old;and the patients were treated with full thread cancellous screws and plates fixation. The fixation time,intra-operative blood loss and the number of injured medial plntar nerve were compared between the two groups. The Böhler angle, Gissane angle and the correction degree of calcaneal width were measured at 1 year after operation. The internal fixators were taken out after 1 year. The AOFAS ankle-hindfoot score was used to evaluate therapeutic effects.
RESULTSAll the patients were followed up,and the duration ranged from 9 to 32 months, with a mean of 16 months. There were shorter operation time, less injury, satisfactory postoperative Böhler angle and calcaneal width in treatment group compared with control group,which reduced the medial neurovascular injuries, and the plate was easily removed after fracture healing.
CONCLUSIONFull thread cancellous screws and plate fixation for the treatment of calcaneal fractures could get same therapeutic effects as compress screws and plate of self-broken type fixation, and also has follow advantages: shortening the operation time, reducing blood loss, easily to be removed, avoiding the medial neurovascular damage, reducing the incidence of complications.
Adult ; Aged ; Bone Plates ; Bone Screws ; Calcaneus ; injuries ; Case-Control Studies ; Female ; Fracture Fixation, Internal ; methods ; Fractures, Bone ; surgery ; Humans ; Male ; Middle Aged
10.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