己酮可可碱治疗子宫内膜异位症随机对照研究.docVIP

己酮可可碱治疗子宫内膜异位症随机对照研究 　　摘要：目的 探讨己酮可可碱治疗子宫内膜异位症相关不孕和痛经等症状的有效性。方法 前瞻性纳入2009年1月至2009年12月于我院行腹腔镜联合GnRH-α治疗EMS的不孕症患者150例，并随机分为实验组（n=75）和对照组（n=75）。实验组术后服用己酮可可碱，对照组术后服用安慰剂。评估术后随访期间的妊娠率、妊娠时间、EMS相关症状缓解程度以及复发率，并比较两组间的差异。结果 本研究实际纳入病例137例，其中实验组69例，对照组68例，两组患者基线情况一致。所有纳入患者均无明显不良反应事件。己酮可可碱可以明显提高EMS患者术后的妊娠率（53.6% vs. 30.9%, P=0.007），患者的平均妊娠时间也得以明显提前（P=0.002）。并且己酮可可碱可以有效缓解EMS患者术后痛经和性交痛症状（P 　　[Abstract]Objective: To determine the effectiveness of pentoxifylline in the treatment of endometriosis-related infertility and pelvic pain. Methods: Prospectively enrolled 150 patients underwent laparoscopic surgery combined with GnRH-α treatment from January 2009 to December 2009, were randomly assigned into two groups. The patients in experimental group (n=75) were given pentoxifylline postoperatively, while placebo were given to control group (n=75). The pregnancy rate were evaluated during the postoperative follow-up, as well as intervals from surgery to pregnancy, endometriosis-related symptoms and the recurrence rate, which were compared between two groups. Results: Finally 137 patients were enrolled in experimental group (n=69) and control group (n=68). The baselines characteristics of two groups were statistically similar. All included patients had no significant adverse events. Pentoxifylline could significantly improve the pregnancy rate of patients with endometriosis after surgery (53.6% vs. 30.9%, P=0.007), and shorten the intervals from surgery to pregnancy (P=0.002). Moreover, pentoxifylline could relieve the endometriosis-related symptoms, such as dysmenorrheal and dyspareunia (P 　　1.3 结局测量 　　 本研究的主要指标为术后随访期间的妊娠率以及妊娠时间。次要指标包括痛经、盆腔疼痛、性交痛等相应症状的缓解程度以及复发率。所有时间从手术结束作为零点。在每次门诊随访时，均会要求患者做妇科检查，以及询问症状，使用VAS量表（Visual Analogue Scale， VAS）评估症状缓解程度。 　　1.4 统计学方法 　　所有数据资料均使用SPSS 16.0统计软件处理。计数资料比较采用χ2检验，计量资料比较采用t检验，检验水准α＝0.05。 　　2 结果 　　2.1 两组患者一般情况比较 　　从2009年1月至2009年12月于我院治疗的EMS患者324例，根据纳入排除标准本研究选择病例150例，随访期间失访13例（实验组6例，对照组7例），实际纳入病例137例，其中实验组69例，对照组68例。两组患者的基线情况见表1，两组间基线特征