曲普瑞林治疗子宫肌瘤的临床疗效及安全性研究

Clinical trial on the effectiveness and safety of triptorelin in treatment of uterine leiomyoma

目的观察曲普瑞林治疗子宫肌瘤的临床疗效及安全性。方法采用多中心的前瞻性随机对照临床研究,于2002年12月—2004年3月,将确诊的125例子宫肌瘤患者随机分为研究组,63例,接受臀部肌内注射曲普瑞林3.75mg治疗;和对照组,62例,接受前臂皮下注射亮丙瑞林3.75mg治疗。两组均为每28d注射药物1次,共治疗3个月。观察月经情况、子宫与子宫肌瘤体积以及血清雌二醇水平等变化。结果125例均完成治疗。两组治疗前子宫及最大子宫肌瘤体积比较,差异均无统计学意义(P>0.05)。但两组治疗后子宫及最大子宫肌瘤体积较治疗前均明显缩小,两组组内治疗前后比较,差异均有统计学意义(P<0.01)。研究组和对照组治疗后子宫体积较治疗前分别平均缩小51%(中位数,下同)和49%,最大子宫肌瘤体积分别平均缩小50%和48%,两组间比较,差异均无统计学意义(P>0.05)。研究组和对照组治疗后血清雌二醇达到去势水平(<183pmol/L)的比例均为94%(59/63,58/62)。研究组和对照组治疗3个月时的闭经率分别为97%(61/63)和95%(59/62)。患者治疗后痛经、非经期下腹痛和压迫症状等均迅速缓解,两组比较,差异均无统计学意义(P>0.05)。两组药物副反应总的发生率均为71%(45/63,44/62);主要副反应为注射药物后2周左右发生阴道出血及低雌激素症状;研究组和对照组分别有9例和6例因症状明显给予替勃龙1.25～2.50mg/d口服治疗。结论曲普瑞林治疗子宫肌瘤3个月的临床疗效确切,无严重副反应。

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 (P<0.01) in both groups, with a median decrease rate of 51% and 49%, respectively, without significant difference between two groups ((P>0.05).) The volumes of the largest leiomyoma decreased significantly after drug therapy (P<0.01) in both groups, with a median decrease rate of 50% and 48% in the triptorelin and leuprorelin groups, respectively, without significant difference between them (P>0.05). Patients with serum level of 17β-estradiol < 183 pmol/L accounted for 94% in both groups. The hemoglobin and serum ferrum levels were both significantly increased in the two groups after treatment (P<0.05). The amenorrhea rates after 3 months of treatment were 97% in the triptorelin group and 95% in the leuprorelin group (P>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.