Clinical trial on the effectiveness and safety of triptorelin in treatment of uterine leiomyoma / 中华妇产科杂志

ABSTRACT

Objective To evaluate the effectiveness and safety of triptorelin in the treatment of uterine leiomyoma. Methods A multi-center, prospective, randomly controlled clinical trial was carried out from Dec. 2002 to Mar. 2004 in three university hospitals. A total of 125 qualified patients with uterine leiomyoma were randomly divided into either triptorelin group (63 cases) treated with 3.75 mg triptorelin injected intramuscularly or leuprorelin group (62 cases) treated with 3.75 mg leuprorelin injected subcutaneously. Both drugs were injected every 28 days for a total of 3 months. Results All 125 patients finished the trial. The uterine volumes were similar before treatment between the triptorelin group and the leuprorelin group and were decreased significantly after drug therapy (P0.05).) The volumes of the largest leiomyoma decreased significantly after drug therapy (P0.05). Patients with serum level of 17?-estradiol 0.05). Dysmenorrhea, noncyclic pelvic pain and pressure-like symptoms were relieved quickly and remarkably in both groups after treatment. The rates of adverse event occurred in 71% of patients in both groups. The main side effects included flare-up effects and hypoestrogenic symptoms. Nine patients in the triptorelin group and 6 in the leuprorelin group received add-back therapy with tibolone 1.25-2.50 mg/d because of remarkable climacteric-like symptoms. Conclusion Treatment of uterine leiomyoma with triptorelin for 3 months is both effective and safe in Chinese women.