Objective: : This study aimed to determine the incidence and analyze trends of the herniated lumbar disc (HLD) based on a national database in the Republic of Korea (ROK) from January 2008 to December 2016. Methods: : This study was a retrospective analysis of data obtained from the national health-claim database provided by the National Health Insurance Service for 2008–2016 using the International Classification of Diseases. The crude incidence and age-standardized incidence of HLD were calculated, and additional analysis was conducted according to age and sex. Changes in trends in treatment methods and some treatments were analyzed using the Korean Classification of Diseases procedure codes. Results: : The number of patients diagnosed with HLD was 472245 in 2008 and increased to 537577 in 2012; however, it decreased to 478697 in 2016. The pattern of crude incidence and the standardized incidence were also similar. Overall, the incidence of HLD increased annually for the 30s, 40s, 50s, and 70s until 2012 and then decreased. However, the incidence of HLD for the 80s continued to increase. The crude incidence of HLD in female patients exceeded that of male patients in their middle age (30s or 40s) and was 1.5–1.6 times higher than in male patients in their 60s. The total number of open discectomy (OD) increased from 71598 in 2008 to 93942 in 2012 and then decreased to 85846 in 2016. The rate of younger patients (the 20s, 30s, and 40s) who underwent OD was decreased, and the rate of younger patients who underwent percutaneous endoscopic lumbar discectomy was increased. However, the rate of older patients (the 70s and 80s) who underwent OD was continuously increased. Conclusion : This nationwide data on HLD from 2008 to 2016 in the ROK demonstrated that the crude incidence and the standardized incidence increased until 2012 and then decreased. The annual crude incidence was different according to age and sex. These findings may be considered when deciding future health policy, especially in countries with a similar national health insurance system (or with plans to adopt).

BACKGROUND: Letrozole is an oral non-steroidal inhibitor of the aromatase enzyme, which has proven to be a useful drug against breast cancer. METHODS: This single-dose, randomized 2 x 2 crossover study was conducted in healthy male volunteers. Participants of each sequence group (each 13 volunteers for sequence group) received, in randomized sequence, a single oral 2.5-mg dose of generic letrozole (test) or branded letrozole (reference). Each treatment period was separated by a 5-week washout period. Blood samples were collected for up to 312 hours after drug administration, and drug concentrations were determined using validated LC/MS-MS. Pharmacokinetic properties were obtained using noncompartmental analysis. Drug tolerability was assessed throughout the study, using measurements of vital signs, physical examination, clinical chemistry testing, EKG, and interviews. RESULTS: A total of 26 subjects completed the study. The geometric mean ratios (90% CI) of Cmax and AUClast were 0.92 (0.85 - 0.99) and 1.01 (0.97 - 1.04), respectively. No serious AEs were reported, and there were no clinically significant differences between test and reference groups. CONCLUSION: The findings from this study suggest bioequivalence between two formulations of letrozole in healthy male volunteers. The safety profile of two formulations had similar characteristics.
Aromatase ; Breast ; Clinical Chemistry Tests ; Cross-Over Studies ; Electrocardiography ; Humans ; Male ; Nitriles ; Physical Examination ; Therapeutic Equivalency ; Triazoles ; Vital Signs

Busulfan is an antineoplastic agent with a narrow therapeutic window. A post-hoc population pharmacokinetic analysis of a prospective randomized trial for comparison of four-times daily versus once-daily intravenous busulfan was carried out to search for predictive factors of intravenous busulfan (iBu) pharmacokinetics (PK). In this study the population PK of iBu was characterized to provide suitable dosing recommendations. Patients were randomized to receive iBu, either as 0.8 mg/kg every 6 h or 3.2 mg/kg daily over 4 days prior to hematopoietic stem cell transplantation. In total, 295 busulfan concentrations were analyzed with NONMEM. Actual body weight and sex were significant covariates affecting the PK of iBu. Sixty patients were included in the study (all Korean; 23 women, 37 men; mean [SD] age, 36.5 [10.9] years; weight, 66.5 [11.3] kg). Population estimates for a typical patient weighing 65 kg were: clearance (CL) 7.6 l/h and volume of distribution (Vd) 32.2 l for men and 29.1 L for women. Inter-individual random variabilities of CL and Vd were 16% and 9%. Based on a CL estimate from the final PK model, a simple dosage scheme to achieve the target AUC0-inf (defined as median AUC0-inf with a once-daily dosage) of 26.18 mg/lxhr, was proposed: 24.79xABW0.5 mg q24h, where ABW represents the actual body weight in kilograms. The dosing scheme reduced the unexplained interindividual variabilities of CL and Vd of iBu with ABW being a significant covariate affecting clearance of iBU. We propose a new simple dosing scheme for iBu based only on ABW.
Body Weight ; Busulfan ; Female ; Hematopoietic Stem Cell Transplantation ; Humans ; Male ; Prospective Studies ; Retrospective Studies

Atypical antipsychotics have replaced conventional antipsychotics in the treatment of schizophrenia because they have less of a propensity to cause undesirable neurologic adverse events including extrapyramidal symptoms, tardive dyskinesia, and neuroleptic malignant syndrome (NMS). However, atypical antipsychotics have been known to result in various metabolic complications such as impaired glucose tolerance, diabetes and even diabetic ketoacidosis (DKA). In addition, a number of NMS cases have been reported in patients treated with atypical antipsychotics, although the absolute incidence of neurologic side effects is currently significantly low. Here, we report a patient who simultaneously developed DKA, acute renal failure and NMS with rhabdomyolysis after olanzapine treatment. Olanzapine-induced metabolic complications and NMS were dramatically improved with cessation of the olanzapine treatment and initiation of supportive management including fluid therapy, hemodialysis, and intensive glycemic control using insulin. At short-term follow-up, insulin secretion was markedly recovered as evidenced by a restoration of serum C-peptide level, and the patient no longer required any hypoglycemic medications. Despite the dramatic increase in the use of atypical antipsychotics treatment, individualized treatments along with careful monitoring may be prudent for high risk or vulnerable patients in order to avoid the development of metabolic side effects.
Acute Kidney Injury ; Antipsychotic Agents ; Benzodiazepines ; C-Peptide ; Diabetic Ketoacidosis ; Fluid Therapy ; Follow-Up Studies ; Glucose ; Humans ; Incidence ; Insulin ; Movement Disorders ; Neuroleptic Malignant Syndrome ; Renal Dialysis ; Rhabdomyolysis ; Schizophrenia