A multicenter trial was conducted to evaluate the efficacy and safety of tacrolimus in the treatment of refractory renal allograft rejection. Renal transplant recipients experiencing biopsy-proven recurrent acute allograft rejection were eligible if the current rejection episode was refractory to corticosteroids. A total of 73 patients were enrolled, of whom 59 (81%) had previously received at least one course of antilymphocyte antibody as rejection therapy. One-year follow-up was available in 93% of patients. Median time to tacrolimus rescue therapy was 75 days after transplantation (range, 18-1448 days). Therapeutic responses to tacrolimus included improvement in 78% of patients, stabilization in 11%, and progressive deterioration in 11%. The risk of experiencing progressive deterioration was related to the pretacrolimus serum creatinine level: serum creatinine < or = mg/dl, 3%; 3.1-5 mg/dl, 16% (P < 0.04); > 5 mg/dl, 23% (P < 0.02). Twelve-month (from the time of initiation of tacrolimus therapy) actuarial patient and graft survival rates were 93% and 75%. Graft loss occurred in 19 patients (25%) at a median time of 108 days. Fourteen episodes of recurrent rejection were diagnosed in 10 patients (14%), at a median time of 101 days. Eleven episodes of recurrent rejection were treated (three patients underwent transplant nephrectomy), with resolution achieved in nine patients. Antilymphocyte antibody therapy was not used to treat recurrent rejection. Serum creatinine values improved during tacrolimus therapy: median serum creatinine level before tacrolimus, 3.2 mg/dl; median at 1 year after tacrolimus, 1.8 mg/dl. Twelve infections were documented in 11 patients (15%), including cytomegalovirus infection in three patients (4%). Posttransplant lymphoproliferative disorder was diagnosed in a single patient. Tacrolimus whole blood levels averaged 15.0 +/- 9.9 ng/ml at day 7 of tacrolimus therapy and 9.4 +/- 5.1 ng/ml at 1 year, and were consistent among individual centers. Treatment outcome did not correlate with tacrolimus blood levels. The most commonly observed adverse events were neurological and gastrointestinal. Seventy-four percent of patients received tacrolimus for at least 1 year. Tacrolimus therapy was discontinued in 18% of patients for rejection (11% for progressive, unrelenting rejection, and 7% for recurrent rejection). Tacrolimus therapy was discontinued in 8% of patients due to adverse events. In conclusion, tacrolimus rescue therapy provides (1) prompt, effective reversal of refractory renal allograft rejection, (2) good long-term renal allograft function, (3) a low incidence of recurrent rejection, and (4) an acceptable safety profile in renal allograft recipients experiencing refractory rejection.
BACKGROUND AND OBJECTIVES: Intrauterine devices (IUDs) are increasingly being used in adolescents and nulliparous women for contraception. Levonorgestrel IUDs also have beneficial effects on bleeding and pain. Although they are recommended for menstrual suppression in adolescents with disabilities, there are limited data on their use in this population. Our objective is to describe the characteristics and experiences of levonorgestrel IUD use in nulliparous children, adolescents, and young adults with physical, intellectual, and developmental disabilities.METHODS: A retrospective chart review was conducted for all nulliparous patients ages #22 with physical, intellectual, or developmental disabilities who had levonorgestrel IUDs placed between July 1, 2004, and June 30, 2014, at a tertiary-care children's hospital. Descriptive statistical analysis and survival analysis were performed.RESULTS: In total, 185 levonorgestrel IUDs were placed in 159 patients with disabilities. The mean age was 16.3 (3.3; range of 9-22) years. Only 4% had ever been sexually active; 96% of IUDs were inserted in the operating room. IUD continuation rate at 1 year was 95% (95% confidence interval: 93%-100%) and at 5 years was 73% (95% confidence interval: 66%-83%). The amenorrhea rate was ∼60% throughout the duration of IUD use among those with available follow-up data. Side effects and complications were #3%. CONCLUSIONS:In this study, we provide evidence for the therapeutic benefit and safety of levonorgestrel IUD use in adolescents and young adults with physical, intellectual, and developmental disabilities. It should be considered as a menstrual management and contraceptive option for this population.WHAT'S KNOWN ON THIS SUBJECT: Intrauterine devices (IUDs) reduce unintended pregnancies and improve bleeding, pain, and quality of life for women with heavy menstrual bleeding and dysmenorrhea. There are minimal data on IUD use for menstrual management and contraception in young women with disabilities.WHAT THIS STUDY ADDS: This is the largest study of IUD use in young women with physical, intellectual, and developmental disabilities. With these data, we provide evidence that IUDs are effective, well-tolerated, safe menstrual management and contraceptive options for this population.
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