Realization on the decision No 178/1999/Q§-TTg dated 30/8/1999 of Prime Minister about the promulgation of the regulation on labelling of commodities that domestic circulate and import-export. The circular letter No 34/1999/TT-BTM dated 15/12/1999 of Ministry of Trade. Ministry of Health have been regulated specifically about labels of drugs and cosmetic influence directly on the human health.
Pharmaceutical Preparations ; Drug Labeling

Drug Contamination ; Staining and Labeling ; methods

PURPOSE: To identify causative agents of the drug-induced anaphylaxis (DIA) by using the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System (KIDS-KAERS) database (Ministry of Food and Drug Safety) in Korea and to check their labeling information regarding anaphylaxis.METHODS: Among Individual Case Safety Reports from January, 2008 to December 2017, cases of DIA were analyzed for demographics, causative agents and fatal cases resulting in death. The domestic drug labeling, Micromedex and U.S. Food and Drug Administration (FDA) drug package insert, were reviewed to check if the labeling information on suspected causative agents contains anaphylaxis.RESULTS: A total of 4,700 cases of DIA were analyzed. The mean age was 49.85±18.32 years, and 2,642 patients (56.2%) were females. Among 8,664 drugs reported as causative agents, antibiotics (27.4%) accounted for the largest portion. There were 18 fatal cases: antibiotics (7 cases), antineoplastic agents (4 cases) were the major causative drugs for the mortality cases. Of 513 drugs reported as suspected causative agents, 103 (20.1%) did not list anaphylaxis as an adverse effect on domestic drug labeling and 16 (3.1%) did not reflect anaphylaxis in any of 3 adverse drug information.CONCLUSION: Analysis of 10-year data showed that antibiotics were the main cause of DIA and the mortality rate was 0.7%. In 3.1% of suspected drugs, there was no description of anaphylaxis in any of the drug labeling.
Anaphylaxis ; Anti-Bacterial Agents ; Antineoplastic Agents ; Demography ; Drug Labeling ; Female ; Humans ; Korea ; Mortality ; Pharmacovigilance ; United States Food and Drug Administration

OBJECTIVETo observe the effects of dexamethasone on proliferation, differentiation and apoptosis of adult human osteoblasts in vitro.

METHODSIliac trabecular bone specimens were obtained from adult patients undergoing necessary surgery. After the bone pieces were digested with collagenase-trypsin, osteoblasts were released and incubated at 37 degrees C in a relative humidity of 95% and 5% CO2. Then, the cells were purified, and their passages were given DMEM-F12 and fetal bovine serum medium. Subsequently, 10(-8) mol/L dexamethasone was added into the culture medium to incubate the osteoblasts for three days, and the cells from control groups were incubated without any drugs. All cells were observed continually with phase contrast microscope and transmission electron microscope. Finally, apoptosis was detected by the use of terminal deoxynucleotidyl transferase (TdT)-mediated dUTP nick end labeling (TUNEL) and biochemical indices, alkaline phosphatase (ALP) and osteocalcin (OCN) were used to determine the effects of dexamethasone on proliferation, differentiation and apoptosis of adult osteoblasts in vitro.

RESULTSIn the adult osteoblasts obtained by collagenase-trypsin digestion, it achieved high survival, stable biochemical indices and excellent purification. Under the condition of dexamethasone 10(-8) mol/L and osteoblasts 10,000/ml, there was significant promotion of ALP and OCN secretion without cell apoptosis.

CONCLUSIONSDexamethasone has a significant effect on the proliferation and differentiation of adult osteoblasts in vitro without apoptosis, and dexamethasone at the suggested concentration can be used as positive control in drug studies for osteoporosis treatment.

Adult ; Apoptosis ; drug effects ; Cell Differentiation ; drug effects ; Cell Division ; drug effects ; Cells, Cultured ; Dexamethasone ; pharmacology ; Humans ; In Situ Nick-End Labeling ; Osteoblasts ; cytology ; drug effects

OBJECTIVE: To observe pathological changes and apoptosis in rats myocardial cells after Macleaya cordata total alkaloids poisoning, and to provide some references for Macleaya cordata total alkaloids poisoning detection. METHODS: An experimental model of Macleaya cordata total alkaloids poisoning was established, and the technology of TUNEL staining was used.The results were analyzed by computer image analysis competitive system. RESULTS: Quantities of apoptosis in myocardial cells in poisoning groups were much more than those in the control groups at different tages (P<0.01). In addition the quantities of apoptosis were different after different poisoning duration. CONCLUSION Although clinical symptoms was not obvious and could not be detected by poison analysis. Pathological changes induced by Macleaya cordata total alkaloids could be found through the apoptosis detection.
Acute Disease ; Animals ; Apoptosis/drug effects* ; Cell Count ; Disease Models, Animal ; Female ; Immunohistochemistry ; In Situ Nick-End Labeling ; Male ; Myocardium/pathology* ; Myocytes, Cardiac/drug effects* ; Papaveraceae/chemistry* ; Papaverine/poisoning* ; Random Allocation ; Rats ; Rats, Sprague-Dawley ; Staining and Labeling ; Time Factors

OBJECTIVETo investigate the toxic effects of n-hexane on the Ganod of female mice.

METHODSn-Hexane was administered to four groups of mice by inhalation at doses of 0, 3.0, 15.1, and 75.8 mL/m3 respectivelyfor five weeks. Each group consisted of 10 mice, of which half were injected in first with 10 IU of pregnant mare serum gonadotrophin (PMSG) on the 33rd days, and then with 10 IU of human chorionic gonadotrophin (HCG) 48 hrs later. After the treatment, mouse sera were sampled and ovulating hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2), and progesterone (P4) levels were measured by electrochemiluminescence immunoassays (ECLIA). In each group, the right ovaries of the non-super-ovulated mice were stained with hematoxylin and eosin while ovaries on the left side were prepared with the TUNEL method in order to detect apoptotic cells.

RESULTSThe duration of the diestrus stage decreased significantly (P < 0.05) in the 75.8 mL/m3 group. All super-ovulated mice in each treatment group produced fewer eggs than those in the control group (P < 0.05). The number of follicles in ovaries in the 75.8 mL/m3 group was smaller compared with the control group (P < 0.05).The serum P4 levels in each treatment group were lower than those in the control group (F = 6.196, P < 0.01). The cell apoptotic rate in the 75.8 mL/m3 group was higher (P < 0.05).

CONCLUSIONn-Hexane may have directly mediated via alterations hormone secretion and promoted granulosal cell apoptotic, which may be one of the important mechanisms for n-hexane induced mouse ovary impairment.

Animals ; Female ; Gonadal Steroid Hormones ; metabolism ; Hexanes ; administration & dosage ; toxicity ; In Situ Nick-End Labeling ; Inhalation Exposure ; Mice ; Ovary ; drug effects

The use of psychotropic medications in lactating women is controversial. Despite widely accepted advantages of human milk, patients and professionals hesitate to use medications during breastfeeding. Package inserts written by manufacturers routinely discourage breastfeeding to prevent law suits. Here we conducted a review to help professionals to decide medication for lactating women on an evidence-based risk-benefit analysis. First, we reviewed lactational pharmacology. The relative infant dose (RID) was defined to give an objective measure for infant exposure to medication, and drugs with RID lesser than 10% were considered quite safe. Subsequently, we reviewed each category of psychotropic medications which were commonly used in mental illness. We provided information for each drug such as Dr. Hale's lactation risk category, RID, half-life, and time to peak plasma level as references for the risk analysis. There was no contraindicated psychotropic medication during breastfeeding, but for lithium, close monitoring of infant serum levels is warranted. In conclusion, most of medications used to treat mental illness in lactating women were usually safe. Nevertheless, medication use in lactating women should always be considered on an individualized risk-benefit analysis, and untoward adverse effects on the infant should be monitored.
Breast Feeding ; Drug Combinations ; Female ; Half-Life ; Humans ; Infant ; Jurisprudence ; Lactation ; Lithium ; Milk, Human ; Piperonyl Butoxide ; Plasma ; Product Labeling ; Pyrethrins

Animals ; DNA Damage ; Dose-Response Relationship, Drug ; Isotope Labeling ; Male ; Phosphorus Radioisotopes ; analysis ; Rats ; Rats, Sprague-Dawley ; Trichloroethylene ; toxicity

OBJECTIVETo find a convenient and exact method for evaluating acrosome reaction in human spermatozoa.

METHODSThe semen of the normal male was mixed and then divided into 6 groups. Coomassie brilliant blue (CBB) staining, chlortetracycline (CTC) fluorescence staining and acid phosphatase (ACP) detection were used for morphological observation and data analysis of the acrosome status of the human sperm treated with or without progesterone.

RESULTSThere were obvious morphological differences between the acrosome-reaction and acrosome-intact spermatozoa in CBB staining and CTC fluorescence staining, and significant differences were observed between the experimental and control spermatozoa by the three methods (P < 0.05).

CONCLUSIONAll the three methods can be used to assess acrosome reaction in human spermatozoa, but Coomassie brilliant blue (CBB) staining is much more convenient and stable.

Acid Phosphatase ; Acrosome Reaction ; drug effects ; Cells, Cultured ; Chlortetracycline ; Humans ; Male ; Progesterone ; pharmacology ; Rosaniline Dyes ; Spermatozoa ; cytology ; Staining and Labeling ; methods

OBJECTIVETo investigate the role of neuronal apoptosis in organophosphorus poisoning-induced delayed neuropathy (OPIDN) and its dynamic pathological changes.

METHODSTo establish OPIDN animal model, triorthocresyl phosphate (TOCP)was given to hens with a single dose (1 000 mg/kg, im). Changes of neuropathology, number of neurons and apoptotic cells in the third lumbar spinal cord were observed by HE, Nissl and TUNEL methods 3, 5, 7, 10, 14, 18 days after injection.

RESULTSThe hens showed OPIDN typical signs (progressive ataxia and hypotonia) about 9 days after TOCP exposure. HE staining revealed dark red nucleus in neurons of anterior horn of lumbar spinal cord 5 days after exposure, but this phenomenon disappeared 18 days later. Nissl method showed that the number of neurons in anterior horn of spinal cord decreased [from (82 +/- 4) cell/mm(2) to (66 +/- 6) cell/mm(2)]. TUNEL positive cells began to appear [(22 +/- 2) cell/mm(2)] 5 days after TOCP exposure, and reached the peak [(27 +/- 3) cell/mm(2)] 7 days later, and disappeared 18 days later.

CONCLUSIONNeuronal apoptosis in anterior horn of spinal cord of hens appeared in OPIDN, suggesting that cellular apoptosis may play an important role in the pathogenesis of OPIDN.

Animals ; Apoptosis ; drug effects ; Chickens ; Female ; In Situ Nick-End Labeling ; Insecticides ; toxicity ; Models, Animal ; Neurons ; drug effects ; Spinal Cord ; drug effects ; Tritolyl Phosphates ; toxicity