Farley John H, Truong Vu, Goo Elwin, Uyehara Catherine, Belnap Christina, Larsen Wilma I
Division of Gynecologic Oncology, Tripler Army Medical Center, 1 Jarrett White Road TAMC, HI 96859-5000, USA.
Gynecol Oncol. 2006 Nov;103(2):425-30. doi: 10.1016/j.ygyno.2006.03.036. Epub 2006 May 3.
The objective of the study was to evaluate the efficacy of daily Celecoxib in the regression of moderate and severe cervical dysplasia, when compared to placebo.
Women, over the age of 18, with the histologic diagnosis of moderate or severe cervical dysplasia were enrolled in this IRB approved study. Women were randomized to receive either Celecoxib 200 mg twice a day or placebo. Both examining physician and patients were blinded to treatment option. Follow-up colposcopy with cervical cytology was obtained at 2-month intervals for 6 months, with cytologic and histologic specimens.
From June 2002 until October 2003, a total of 25 patients were enrolled in this randomized phase II study. There was no statistical difference in screening entry criteria, clinical histologic and cytologic variables between the two groups. 60% of patients enrolled had an overall response in the trial. The mean time to response was 72 days. 75% of patients who received Celecoxib had a clinical response. This was significantly higher than the 31%, of the placebo patients that had a clinical response, P<0.03. 33% of patients in the Celecoxib group had complete pathologic response to therapy, which was higher than the placebo group 15%.
We have observed that Celecoxib could have activity in the treatment of high-grade cervical dysplasia. As a result, medical treatment of cervical dysplasia with Celecoxib could offer a minimally invasive treatment with minor morbidity and time constraints. Further trials with larger numbers are needed to confirm these results.
本研究的目的是评估与安慰剂相比，每日服用塞来昔布对中重度宫颈发育异常消退的疗效。
年龄超过18岁、经组织学诊断为中重度宫颈发育异常的女性纳入了这项经机构审查委员会批准的研究。女性被随机分为两组，分别接受每日两次200毫克塞来昔布或安慰剂治疗。检查医生和患者均对治疗方案不知情。在6个月内，每隔2个月进行一次宫颈阴道镜检查及宫颈细胞学检查，并采集细胞学和组织学标本。
从2002年6月至2003年10月，共有25名患者纳入了这项随机II期研究。两组在筛查入选标准、临床组织学和细胞学变量方面无统计学差异。60%的入选患者在试验中出现总体反应。平均反应时间为72天。接受塞来昔布治疗的患者中有75%出现临床反应。这显著高于安慰剂组有临床反应的31%，P<0.03。塞来昔布组33%的患者对治疗有完全病理反应，高于安慰剂组的15%。
我们观察到塞来昔布在治疗高级别宫颈发育异常方面可能有活性。因此，用塞来昔布治疗宫颈发育异常可提供一种微创治疗，其发病率低且时间限制少。需要进行更多数量的进一步试验来证实这些结果。
