BACKGROUND: As the first long-acting atypical antipsychotics, the therapeutic effect and safety of risperidone microsphere have been proved. However, it may lead to serious pain due to the deep intramuscular injection.OBJECTIVE: To evaluate the pain levels by 12-week injection of rispeddone microsphere and to explore the relationship among dose and times of injection of risperidone microsphere and pain levels.METHODS: A total of 57 patients diagnosed as schizoprenia by DSM-Ⅳ, aged 18-65 years, were selected and injected risperidone microsphere once every 2 weeks with doses of 25, 37.5 and 50 mg. The pain levels were evaluated using 100 mm visual analogue scale during injection and at the injected sites. The effects of injected dose, injected frequency and injected sites on the pain were analyzed by the nurse questionnaire.RESULTS AND CONCLUSION: The pain levels among the different doses groups had no notable differences (F=1.35,P> 0.05), which demonstrated that the pain had no relationship with injected dose. However, the pain level of injected sites had correlation to injected doses. The pain level of the 50 mg group was greater than that of the 37.5 and 25 mg groups. Accordingly,patients who treated by high dose of risperidone microsphere should be intervened by nurses.

Purpose:To study the response and toxicity of the regimen of oxaliplatin combined with fluorouracil and calcium folinate in the treatment of consisting of advanced colorectal cancer.Methods:Thirty-seven patients with advanced colorectal cancer received chemotherapy of regimen:oxaliplatin 130 mg/m~2 2 hours iv on day 1,calcium folinate 200 mg/ m~2 iv 2 hours on days 1 to 5,followed by fluorouracil 300 mg/m~2(≤500 mg/d) iv 4 h on days 1 to 5,three or four weeks as one cycle.Results:The total response rate was 29.7%,the main toxicity was bone marrow suppression and neuro-sensory toxicity,leukopenia was observed in 45.9% of the patients,but grade Ⅲ and Ⅳ in only 8.1%,neuro-sensory toxicity was observed in 81.9.%,but grade Ⅲ and Ⅳ in only 5.4%.Conclusions:This study shows that the regimen of oxaliplatin combined fluorouracil and calcium folinate is effective and tolerable in advanced colorectal cancer therapy.

Objective To analyze the clinical features of organic damages in Kawasaki disease(KD),and to improve the diagnosis and treatment level.Methods Two hundred and two cases with KD admitted in Children's Hospital Affiliated to Capital Institute of Pediatrics from Jan.2000 to Oct.2007 were reviewed,and their blood routine,urine,stool routine,liver function,kidney function,chest X-ray,and so on,were investigated.The incidence of organic damages in KD was evaluated.Results Among the 202 KD children,137 were male and 65 were female,the male-female ratio was 2.11.0.Most of them were infants,and 71.3% of them were younger than 3 years old.The damages of hematological system were detected in 78/202 cases(38.6%),respiratory system 76/202 cases(37.6%),cardiovascalar system 68/202 cases(33.7%),urinary system 52/202 cases(25.6%),digestive system 23/202 cases(11.4%),and central nervous system 3/202 cases(1.5%).On the other hand,3 cases complicated with septemia,1 case with juvenile rheumatoid arthritis and 1 case with Henoch-Schonlein purpura.Conclusions The data indicate that the incidence of hematological system involvement in the sick-children with KD were highest,with more than 2 organs involved simaltaneously.Many organic damages were involved in KD and diverse clinical manifestation could be found.Physicians should understand not only the typical features but also the rare symptoms and organic damage so as to prevent misdiagnosis and improper treatment.J Appl Clin Pediatr,2009,24(1):31-32

Recently traditional Chinese medicine (TCM)-induced liver injury has been an unresolved critical issue which impacts TCM clinical safety. The premise and key step to reduce or avoid drug-induced liver injury (DILI) is to identify the drug source of liver injury in early stage. Then the timely withdrawal of drug and treatment can be done. However, the current diagnosis of DILI is primarily governed by exclusive method relying on administering history supplied by patients and experience judgment from doctors, which lacks objective and reliable diagnostic indices. It is obvious that diagnosis of TCM-induced liver injury is especially difficult due to the complicated composition of TCM medication, as well the frequent combination of Chinese and Western drugs in clinic. In this paper, we proposed construction of research pattern and method for objective identification of TCM-related DILI based on translational toxicology, which utilizes clinical specimen to find specific biomarkers and characteristic blood-entering constituents, as well the clinical biochemistry and liver biopsy. With integration of diagnosis marker database, bibliographic database, medical record database and clinical specimen database, an integrative diagnosis database for TCM-related DILI can be established, which would make a transformation of clinical identification pattern for TCM-induced liver injury from subjective and exclusive to objective and index-supporting mode. This would be helpful to improve rational uses of TCM and promote sustainable development of TCM industry.
Animals ; Biomarkers, Pharmacological ; metabolism ; Biopsy ; methods ; Chemical and Drug Induced Liver Injury ; diagnosis ; metabolism ; pathology ; Early Diagnosis ; Humans ; Liver ; drug effects ; pathology ; Medicine, Chinese Traditional ; adverse effects ; Rats

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

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

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

A rapid, sensitive and convenient LC-MS/MS method was developed for the determination of γ-aminobutyric acid (GABA) in human plasma. d2-γ-Aminobutyric acid (d2-GABA) was synthesized as internal standard (IS). After extraction from human plasma by protein precipitation with acetonitrile, all analytes were separated on a Luna HILIC column (100 mm x 3.0 mm, 3 μm) using an isocratic mobile phase of water: acetonitrile: formic acid (20 : 80 : 0.12) with a flow rate of 0.5 mL x min(-1). Acquisition of mass spectrometric data was performed in multiple reaction monitoring mode (MRM) in positive electrospray ionization using the transitions of m/z 104 --> 69 for GABA and m/z 106 --> 71 for d2-GABA. The method was linear in the concentration range of 5.00 to 1 000 ng x mL(-1). The intra- and inter-day precisions were within 9.9%, and accuracy ranged from 99.1% to 104%, within the acceptable limit across all concentrations. The method was successfully applied to a pharmacokinetic study of GABA tablets in healthy Chinese volunteers.
Chromatography, Liquid ; Humans ; Tandem Mass Spectrometry ; gamma-Aminobutyric Acid ; blood

Adult ; Eosinophilic Granuloma ; Humans ; Male