Linda J. Goldsmith

A Randomized Controlled Trial Comparing Fascia Lata and Synthetic Mesh for Sacral Colpopexy

Objective: To compare the objective anatomic outcomes after sacral colpopexy performed with cadaveric fascia lata and polypropylene mesh. Methods: Patients undergoing a sacral colpopexy were randomized to receive either fascia lata or polypropylene mesh in a double-blinded fashion. Data were collected at 6 weeks, 3 months, 6 months, and 1 year postoperatively. The main outcome measures were pelvic organ prolapse quantification (POP-Q) system stage and individual POP-Q points over time. Objective anatomic failure was defined as POP-Q stage 2 or more at any point during the follow-up period. Proportions of patients with objective anatomic failure at 1 year in each group were compared using the &khgr;2 test. Mean POP-Q points and stage at 1 year were compared by using the independent samples t test. Results: One hundred patients were randomized to receive either fascia (n = 46) or mesh (n = 54). Of the 89 patients returning for 1-year follow-up, 91% (41/45) of the mesh group and 68% (30/44) of the fascia group were classified as objectively cured (P = .007). We found significant differences between the mesh and fascia groups with respect to the 1-year postoperative comparisons of points Aa, C, and POP-Q stage. There were no differences between the 2 groups with respect to points TVL (total vaginal length), GH (genital hiatus), PB (perineal body), Ap or Bp (2 points along the posterior vaginal wall). Conclusions: Polypropylene mesh was superior to fascia lata in terms of POP-Q points, POP-Q stage, and objective anatomic failure rates. Level of Evidence: I

Lung function in infants with wheezing and gastroesophageal reflux.

Eighty‐four otherwise healthy infants with daily wheezing underwent infant pulmonary function tests (IPFTs) and 24‐h esophageal pH probe studies. Fifty‐four (64%) infants had positive pH probe studies, and 30 infants had negative pH probe studies.

Human chorionic gonadotropin exhibits potent inhibition of preterm delivery in a small animal model

OBJECTIVE The purpose of this study was to test the capability of human chorionic gonadotropin to inhibit prostaglandin-induced preterm delivery in a murine model. STUDY DESIGN A preterm delivery model was developed by using intraperitoneal injection of 20 microgram of prostaglandin F(2)(alpha) to induce preterm labor in C3H/HeN inbred mice. Mice were then pretreated with human chorionic gonadotropin 4 hours before administration of prostaglandin F(2)(alpha), and time to delivery of the first pup was recorded. After initial promising results, mice were then given increasing intraperitoneal doses of human chorionic gonadotropin (100 IU, 250 IU, or 1000 IU or sodium chloride solution vehicle) 4 hours after administration of prostaglandin F(2)(alpha). The specificity of the human chorionic gonadotropin effect was assessed by treating mice with whole human chorionic gonadotropin, an equal mass dose of the beta-subunit or the alpha-subunit of human chorionic gonadotropin, or an equal mass dose of luteinizing hormone 4 hours after administration of prostaglandin F(2)(alpha). Delivery times between groups were compared by using the Mann-Whitney U test and the log-rank test. Survival estimates were computed by using the Kaplan-Meier method. RESULTS Pilot studies in 52 mice confirmed that a single intraperitoneal injection of 20 microgram of prostaglandin F(2)(alpha) on day 16 (80% gestation) consistently induced preterm delivery compared with the effect of sodium chloride solution on control mice (prostaglandin F(2)(alpha), 19.3 +/- 2.9 hours; sodium chloride solution, 53.5 +/- 13.6 hours; P <.0001). Mice pretreated with human chorionic gonadotropin (1000 IU) demonstrated significant delays in delivery times compared with the prostaglandin-only group (prostaglandin F(2)(alpha) only, 21.9 +/- 2. 0 hours; human chorionic gonadotropin pretreatment plus prostaglandin F(2)(alpha), 48.5 +/- 20 hours; P <.0001; n = 17). Mice treated with human chorionic gonadotropin (100 IU, 250 IU, 1000 IU) 4 hours after administration of prostaglandin F(2)(alpha) demonstrated significant dose-dependent inhibition of preterm delivery compared with the prostaglandin-only group (P <.00005; n = 34). Mice treated with the alpha-subunit or the beta-subunit of human chorionic gonadotropin after prostaglandin administration did not demonstrate delays in delivery times (P =.46; n = 27). Administration of luteinizing hormone delayed delivery compared with the effect of prostaglandin F(2)(alpha) on control animals (P <.05; n = 17); however, the effect was less pronounced than that seen with a mass equivalent of human chorionic gonadotropin. CONCLUSIONS Human chorionic gonadotropin exhibits potent inhibition of prostaglandin-induced preterm delivery in mice. The effect is dose-dependent, and whole human chorionic gonadotropin is required to elicit inhibition. Further studies are needed to determine the safety and efficacy of human chorionic gonadotropin as a potential therapy for preterm labor inhibition in human pregnancy.

Comparison of the efficacy of inhaled fluticasone propionate, 880 μg/day, with flunisolide, 1500 μg/day, in moderate-to-severe persistent asthma

Background Inhaled corticosteroids have become the mainstay of asthma therapy. Few studies however, have compared inhaled steroids in children. We compared the efficacy of inhaled fluticasone propionate (FP), 880 μg/day (2 puffs of 220 μg/puff, BID) with inhaled flunisolide (FLU), 1500 μg/day (3 puffs of 250 μg/puff, BID). Methods Thirty children with moderate to severe asthma, mean age 12.7 years (range 10 to 17 years), mean duration of asthma 8.4 years, initially received flunisolide 1500 μg/day for 1 year, and then were switched to fluticasone propionate 880 μg/day and followed for an additional year. Pulmonary function tests (PFTs) were monitored and analyzed before and after the switch for the duration of study. Mean percent predicted for age values for FVC, FEV 1 , FEF 25-75% , and FEFR were compared at 1 month, 2 to 6-month intervals, and 7 to 12-month intervals and during the same season of the year. Pulmonary function tests within 3 weeks of an exacerbation were not included in the study. The number of asthma exacerbations, emergency room visits, hospital admissions, and number of school days lost were also compared. Results There was significant improvement in mean asthma exacerbations/patient/year (1.7 ± 1.66 SD) versus (4 ± 2.6) ( P P = .004); mean hospital admissions for asthma/patient/year (0.2 ± 0.61) versus (1.13 ± 1.45) ( P P Also, the mean percent values predicted for age in all time-periods (at 1 month, 2 to 6 months, and 7 to 12 months) revealed significant improvement in FEV 1 and FEF 25-75% ( P 1 was observed in all seasons while patients were receiving fluticasone propionate (FP) compared with flunisolide (FLU) ( P 25-75% was observed only in spring and summer season. Conclusion Fluticasone propionate 880 μg/day improved lung function and quality of life in adolescents with moderate-to-severe asthma when compared with flunisolide 1500 μg/day.

Protracted results of dose-intensive therapy using cyclophosphamide, carmustine, and continuous infusion etoposide with autologous stem cell support in patients with relapse or refractory Hodgkin's disease: A phase II study from the North American Marrow Transplant Group

To determine the long-term results of high-dose chemotherapy and stem cell support in relapsed or primary refractory Hodgkin disease patients. One hundred and thirty-one patients with relapsed or primary refractory Hodgkins disease were treated with a dose-intensive therapy protocol consisting of etoposide (2400 mg/m2 continuous intravenous infusion) cyclophosphamide (7200 mg/m2 intravenously), and carmustine (300-600 mg/m2 intravenously) CBVi. All patients had previously failed conventional chemoradiotherapy. Severe toxicities were related to infectious, hepatic, and pulmonary complications. Fatal, regimen-related toxicity was 19%; liver and lung dysfunction, as well as infection, were the most frequent problems. Ninety-one (69%) of the patients achieved a complete response (CR) (95% CI = 59% to 75%) after CBVi and autologous stem cell infusion. With a median follow-up of 5.1 years (range 3.0 to 9.5 years), overall and event-free survival are 44% (95% CI = 33% to 47%) and 38% (95% CI = 28% to 46%) respectively. While univariate analysis did not reveal a statistically significant variable to predict a better response, responsiveness to therapy demonstrated a trend. We conclude that CBVi is an effective therapy for relapsed or refractory Hodgkins disease, producing long-term, durable remissions.

A randomized, controlled trial comparing fascia lata and synthetic mesh for sacral colpopexy

One hundred women with posthysterectomy vaginal vault prolapse who were scheduled for sacral colpopexy at the University of Louisville Health Sciences Center participated in this double-blind, randomized trial comparing the use of cadaveric fascia lata and polypropylene mesh. The Pelvic Organ Prolapse Quantification system (POP-Q) was used for patient evaluation preoperatively and at 3 months, 6 months, and 1 year postoperatively. Fascial lata was used in 46 patients and polypropylene mesh was used in 54. Eighty-nine women, 44 in the fascia group and 45 in the mesh group, completed the 1-year study period. The 2 groups were similar in social demographics, clinical characteristics, and operative data. Adverse events possibly related to the graft were experienced by 26% of women who received mesh and 15% of women who received fascia (P = .19). Other surgical procedures, in tension-free tape procedures, posterior repairs, and paravaginal repairs were performed frequently and at similar rates in the 2 groups. At the 1-year examination, the rate of objective anatomic failure, as defined by Weber et al, was greater in the women who received fascia (14 of 44; 32%) compared with those who received mesh (4 of 45; 9%) (P = .007). There were 15 instances of POP-Q point Aa (point along the distal anterior vaginal wall) and 3 of POP-Q point Ap (posterior vaginal wall) reaching at least the -1 position. There were no point C (vaginal cuff) failures. The results of the POP-Q evaluations changed over the year of observation. At the end of 12 months, significant differences in between the 2 groups were seen for the mean values of point Aa (P = .02), point C (P = .04), and prolapse stage (P = .03). No differences were seen in total vaginal length, genital hiatus, perineal body, or points Ap or Bp (points along the posterior vaginal wall). When risk factors for surgical failure of sacral colpopexy, other than graft material (age, body mass index, prior prolapse or continence surgery), were subjected to univariate analysis, no significant predictors of failure were seen.