for the Foreign-Body Infection (FBI) Study GroupContext.-Rifampin-containing regimens are able to cure staphylococcal implant-related infections based on in vitro and in vivo observations. However, this evidence has not been proven by a controlled clinical trial.Objective.-To evaluate the clinical efficacy of a rifampin combination in staphylococcal infections associated with stable orthopedic devices.Design.-A randomized, placebo-controlled, double-blind trial conducted from 1992 through 1997.Setting.-Two infectious disease services in tertiary care centers in collaboration with 5 orthopedic surgeons in Switzerland.Patients.-A total of 33 patients with culture-proven staphylococcal infection associated with stable orthopedic implants and with a short duration of symptoms of infection (exclusion limit Ͻ1 year; actual experience 0-21 days).Intervention.-Initial debridement and 2-week intravenous course of flucloxacillin or vancomycin with rifampin or placebo, followed by either ciprofloxacinrifampin or ciprofloxacin-placebo long-term therapy.Main Outcome Measures.-Cure was defined as (1) lack of clinical signs and symptoms of infection, (2) C-reactive protein level less than 5 mg/L, and (3) absence of radiological signs of loosening or infection at the final follow-up visit at 24 months. Failure was defined as (1) persisting clinical and/or laboratory signs of infection or (2) persisting or new isolation of the initial microorganism.Results.-A total of 18 patients were allocated to ciprofloxacin-rifampin and 15 patients to the ciprofloxacin-placebo combination. Twenty-four patients fully completed the trial with a follow-up of 35 and 33 months. The cure rate was 12 (100%) of 12 in the ciprofloxacin-rifampin group compared with 7 (58%) of 12 in the ciprofloxacin-placebo group (P=.02). Nine of 33 patients dropped out due to adverse events (n=6), noncompliance (n=1), or protocol violation (n=2). Seven of the 9 patients who dropped out were subsequently treated with rifampin combinations, and 5 of them were cured without removal of the device.Conclusion.-Among patients with stable implants, short duration of infection, and initial debridement, patients able to tolerate long-term (3-6 months) therapy with rifampin-ciprofloxacin experienced cure of the infection without removal of the implant.
These findings do not support adding AA+DHA to formulas containing 10% energy as linoleic acid and 1% energy as alpha-linolenic acid to enhance growth, visual acuity, information processing, general development, language, or temperament in healthy, term infants during the first 14 months after birth.infant development, breast feeding, infant formula, long-chain polyunsaturated fatty acids, docosahexaenoic acid.
Context Increasing reports of pertussis among US adolescents, adults, and their infant contacts have stimulated vaccine development for older age groups.Objective To assess the immunogenicity and reactogenicity of a tetanus-diphtheria 5-component (pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae types 2 and 3) acellular pertussis vaccine (Tdap) in adolescents and adults.Design, Setting, and Participants A prospective, randomized, modified doubleblind, comparative trial was conducted in healthy adolescents and adults aged 11 through 64 years from August 2001 to August 2002 at 39 US clinical centers.Interventions A single 0.5-mL intramuscular dose of either Tdap or tetanusdiphtheria vaccine (Td).Main Outcome Measures Antibody titers to diphtheria and tetanus toxoids for Tdap and Td were measured in sera collected from subsets of adolescents and adults, before and 28 days after vaccination. For pertussis antigens, titers in sera from Tdap vaccinees were assessed vs those from infants who received analogous pediatric diphtheria-tetanus-acellular pertussis vaccine (DTaP) in a previous efficacy trial. Safety was assessed via solicited local and systemic reactions for 14 days and adverse events for 6 months following vaccination.Results A total of 4480 participants were enrolled. For both Tdap and Td, more than 94% and nearly 100% of vaccinees had protective antibody concentrations of at least 0.1 IU/mL for diphtheria and tetanus, respectively. Geometric mean antibody titers to pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbriae types 2 and 3 exceeded (by 2.1 to 5.4 times) levels in infants following immunization at 2, 4, and 6 months with DTaP. The incidence of solicited local and systemic reactions and adverse events was generally similar between the Tdap and Td groups.Conclusions This Tdap vaccine elicited robust immune responses in adolescents and adults to pertussis, tetanus, and diphtheria antigens, while exhibiting an overall safety profile similar to that of a licensed Td vaccine. These data support the potential routine use of this Tdap vaccine in adolescents and adults.
review reminds us that simple vaginal hysterectomy is often curative in women with endometrial cancer. In this series of 128 women over age 70 with endometrial cancer, the 5-year survival rate was 89.2% for stage I disease and a very respectable 67.4% for 33 women with stage II or III disease. All patients had a bilateral salpingo-oophorectomy, but only 8.6% of these women had a pelvic lymphadenectomy through an extraperitoneal approach. Others, including Chan et al from the University of California at Irvine, have also reported excellent results with minimal morbidity in a series of 51 medically compromised women with endometrial cancer (Obstet Gynecol 2001;97: 707). Most of these women were morbidly obese and many had 3 or more risk factors. Morbidity was minimal and 5-year survival was 88%.Although radiation therapy alone has been used to treat women with endometrial adenocarcinoma, older reports have indicated a worse outcome than when hysterectomy is part of the treatment, and there are no recent studies that have examined this question. In a study of 34 women over age 75 with endometrial cancer, Citron et al found minimal morbidity when pelvic radiation was added to surgery for high-risk disease (Int J Radiat Biol Phys 2004;59:1432). The 5-year disease-free survival was actually better in the women treated with radiation for deep myometrial invasion, cervical involvement, or poorly differentiated adenocarcinoma.Laparoscopically assisted hysterectomy has also been used for older women with endometrial cancer with good results (Scribner et al. Gynecol Oncol 2001;83:563). However, operative time and surgical morbidity are usually greater than with abdominal hysterectomy and staging. Once again, the value of lymphadenectomy in the survival of women with endometrial cancer is very much in question.-HWJ)
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