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【Human】腹腔镜联合己酮可可碱疗法治疗子宫内膜
BACKGROUND: Surgical treatment has modest efficacy for the treatment of infertility associated with early-stage endometriosis. Immunomodulation with pentoxifylline is considered as a new strategy potentially useful in treating endometriosis. Thus, this study investigated the usefulness of combined laparoscopic surgery and pentoxifylline therapy in the treatment of infertility associated with minimal to mild endometriosis.
METHODS: A prospective, randomized, controlled blind trial was conducted. Patients entered the study immediately after laparoscopic surgery and were randomly assigned to the treatment with either oral pentoxifylline (800 mg/day) (pentoxifylline group, n = 51) or an oral placebo (placebo group, n = 53). Patients were then observed for pregnancy for 6 months.
RESULTS: Among 98 patients finally considered in the evaluation of the results, the 6 month overall pregnancy rates were 28 and 14% in the pentoxifylline and placebo groups, respectively. Thus, an absolute difference of 14% (95% CI –2 to 30) (Chi-squared test, P = 0.1) in the cumulative probability of pregnancy in 6 months after laparoscopic surgery in patients receiving pentoxifylline versus placebo post-operatively was observed.
CONCLUSION: Our findings provide preliminary clinical evidence to suggest the new experimental treatment approaches, toward endometriosis, that are based on immunomodulation deserve further attention. Well-designed multicenter trials are warranted to confirm or refute our results.
The ClinicalTrials.gov Identifier is NCT00632697 [ClinicalTrials.gov] .
Key words: endometriosis/immunomodulation/infertility/laparoscopic surgery/pentoxifylline
Submitted on November 24, 2007; resubmitted on March 17, 2008; accepted on April 8, 2008.
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背景：外科治疗对于早期子宫内膜异位症相关性不孕症的疗效并不是很理想，己酮可可碱免疫调节治疗被认为是对子宫内膜异位症具有潜在疗效一种新的的策略。因此，本文研究了腹腔镜手术联合己酮可可碱疗法在治疗轻微子宫内膜异位症相关性不孕症的疗效。
方法：采用前瞻性随机对照盲法试验，患者在腹腔镜手术后即随机分为两组：己酮可可碱组，51人，每天口服己酮可可碱800毫克；安慰剂组，53人，口服安慰剂。所有病人随后都进行了为期六个月的妊娠观察。
结果：最终收集了98位患者进行结果的评价。六个月后，己酮可可碱组和安慰剂组总的妊娠率分别为28%和14%。由此可见，腹腔镜手术六个月后，患者接受己酮可可碱与安慰剂相比，累计妊娠率有14%(95% 可信区间–2 到 30)的绝对性差异 (卡方检验，P = 0.1)。
结论：我们的发现为子宫内膜异位症新的实验性的治疗方法提供了初步的临床证据，这种基于免疫调节的治疗方法是值得进一步研究的。应保证有精心设计的多中心临床试验证实或反驳我们的结果。
临床试验：政府标识NCT00632697 [ClinicalTrials.gov]
关键词：子宫内膜异位症，免疫调节，不孕症，腹腔镜手术，己酮可可碱
收稿日期：2007-11-24；修回日期：2008-3-17；发表日期：2008-4-8。 [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-04-06 17:14
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