Effectiveness and Safety of Recombinant Human Follicle-Stimulating Hormone (Follitrope™) in Inducing Controlled Ovarian Stimulation in Infertile Women in Real-World Practice: a Prospective Cohort Study.

To evaluate the safety and effectiveness of recombinant human follicle-stimulating hormone (rhFSH [Follitrope™]) in infertile women undergoing in vitro fertilization (IVF). To identify predictors of ovarian response that induce optimal clinical outcomes. This multicenter prospective study enrolled infertile women who were scheduled to undergo IVF after ovarian stimulation with rhFSH (Follitrope™) following the gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist protocol. Predictive factors for ovarian response were identified in the GnRH antagonist group based on the number of oocytes retrieved. A total of 516 infertile women were enrolled, among whom 136 (except one who withdrew before administration) received rhFSH using the GnRH agonist protocol and 379 using the antagonist protocol. The mean number of oocytes retrieved was 13.4 in the GnRH agonist group and 13.6 in the GnRH antagonist group. The clinical pregnancy rates were 32.3% (30/93) and 39.9% (115/288) in the GnRH agonist and antagonist groups, respectively. The incidence of ovarian hyperstimulation syndrome was 1.8% and 3.4% in the GnRH agonist and antagonist groups, respectively. No other significant safety risks associated with rhFSH administration were identified. Body mass index, basal serum FSH and anti-Müllerian hormone levels, and antral follicle count were identified as predictors of ovarian response by multiple regression with backward elimination, and the final regression model accounted for 26.5% of the response variability. In real-world practice, rhFSH (Follitrope™) is safe and effective in inducing ovarian stimulation in infertile women. Patient characteristics identified as predictors can be considered to be highly related to optimal clinical outcomes.

The Prevalence of Clostridium difficile Colitis and Effect on All-Cause Mortality in Elderly Patients after Hip Fracture Surgery: A Korean Nationwide Cohort Study.

Background: This study aimed to investigate the prevalence of Clostridium difficile colitis (CDC) in elderly patients with hip fractures using a nationwide cohort database and to analyze the effect of CDC on the all-cause mortality rate after hip fracture. Methods: This retrospective nationwide study identified subjects from the Korean National Health Insurance Service-Senior cohort. The subjects of this study were patients who were over 65 years old and underwent surgical treatment for hip fractures from January 1, 2002, to December 31, 2015. The total number of patients included in this study was 10,158. The diagnostic code used in this study was A047 of the International Classification of Diseases, 10th revision for identifying CDC. Procedure codes for C. difficile culture or toxin assay were BY021 and BY022. CDC patients were defined as follows: patients treated with oral vancomycin or metronidazole over 10 days and patients with procedure codes BY021 and BY022 or diagnostic code A047 after hip fracture. Incidence date (index date, time zero) of hip fracture for analyzing risk of all-cause mortality was defined as the date of discharge. A generalized estimating equation model with Poisson distribution and logarithmic link function was used for estimating adjusted risk ratios and 95% confidence intervals to assess the association between CDC and cumulative mortality risk. Results: The prevalence of CDC during the hospitalization period in the elderly patients with hip fractures was 1.43%. Compared to the non-CDC group, the CDC group had a 2.57-fold risk of 30-day mortality after discharge, and a 1.50-fold risk of 1-year mortality after discharge (p < 0.05). Conclusions: The prevalence of CDC after hip fracture surgery in elderly patients was 1.43%. CDC after hip fracture in the elderly patients significantly increased the all-cause mortality rate after discharge.

Dual mobility total hip arthroplasty in the treatment of femoral neck fractures.

AIMS: To evaluate the rate of dislocation following dual mobility total hip arthroplasty (DM-THA) in patients with displaced femoral neck fractures, and to compare rates of dislocation, surgical-site infection, reoperation, and one-year mortality between DM-THA and bipolar hemiarthroplasty (BHA). METHODS: Studies were selected based on the following criteria: 1) study design (retrospective cohort studies, prospective cohort studies, retrospective comparative studies, prospective comparative studies, and randomized controlled studies (RCTs)); 2) study population (patients with femoral neck fracture); 3) intervention (DM-THA or BHA); and 4) outcomes (complications during postoperative follow-up and clinical results). Pooled meta-analysis was carried out to evaluate the dislocation rate after DM-THA and to compare outcomes between DM-THA and BHA. RESULTS: A total of 17 studies (ten cohort studies on DM-THA and seven comparative studies of DM-THA and BHA) were selected. These studies included 2,793 patients (2,799 hips), made up of 2,263 DM-THA patients (2,269 hips) and 530 BHA patients (530 hips). In all, 16 studies were analyzed to evaluate dislocation rate after DM-THA. The cumulative dislocation rate was 4% (95% confidence interval (CI) 3 to 5). Seven studies were analyzed to compare the rates dislocation and surgical-site infection. The rate of dislocation was significantly lower in the DM-THA group than in the BHA group (risk ratio (RR) 0.3; 95% CI 0.17 to 0.53, p < 0.001, Z -4.11). There was no significant difference in the rate of surgical-site infection between the two groups (p = 0.580). Six studies reported all-cause reoperations. The rate of reoperation was significantly lower in the DM-THA group than in the BHA group (RR 0.5; 95% CI 0.32 to 0.78, p = 0.003, Z -3.01). Five studies reported one-year mortality. The mortality rate was significantly lower in the DM-THA group than in the BHA group (RR 0.58 95% CI 0.45 to 0.75, p < 0.0001, Z -4.2). CONCLUSION: While the evidence available consisted mainly of non-randomized studies, DM-THA appeared to be a viable option for patients with displaced fractures of the femoral neck, with better reported rates of dislocation, reoperation, and mortality than BHA. Cite this article: Bone Joint J 2020;102-B(11):1457-1466.

Endometrial osteopontin mRNA expression and plasma osteopontin levels are increased in patients with endometriosis.

PROBLEM: The aim of this study was to evaluate osteopontin (OPN) mRNA expression in eutopic endometrium and plasma OPN levels in patients with endometriosis. METHOD OF STUDY: A total of 79 patients with histologically confirmed endometriosis and 43 patients without endometriosis participated in this study. OPN mRNA expression in endometrial tissues was measured by real-time quantitative polymerase chain reaction (PCR) and plasma concentrations of OPN were quantified using a specific commercial sandwich enzyme-linked immunosorbent assays (ELISA). RESULTS: Osteopontin mRNA expression in endometrial tissue was significantly higher in women with endometriosis than in controls (P = 0.010). The mean plasma levels of OPN (mean +/- S.E.M.) in patients with endometriosis and controls were 407.31 +/- 37.80 ng/mL and 165.84 +/- 19.29 ng/mL, respectively (P < 0.001). Receiver operating characteristic (ROC) analysis for plasma OPN revealed an area under the curve (AUC) of 0.894, with a sensitivity of 93.0%, specificity of 72.4%, positive likelihood ratio of 3.37, and negative likelihood ratio of 0.1 using a cut-off value of 167.68 ng/mL. CONCLUSION: Osteopontin may be involved in the pathogenesis of endometriosis and plasma OPN may be a useful non-invasive marker for the diagnosis of endometriosis.