中医标本同治法治疗不同证型输卵管阻塞性不孕症的疗效分析

目的:前瞻性随机对照研究中医标本同治法治疗不同证型输卵管阻塞性不孕症的近期疗效。评价该治疗方案的临床应用价值。方法:91例输卵管阻塞性不孕症患者按照2∶1比例完全随机分为试验组和对照组。中医辨证分为气滞血瘀、湿热瘀结、寒湿瘀滞3个证型。试验组采用中医标本同治法,在输卵管再通术(fallopian tuberecanalization,FTR)术后行宫腔通液术和中医内外合治(内服、外敷、灌肠);对照组采用FTR和宫腔通液术治疗,灌注药物为常规西药组。术后随访1～2年,记录受孕情况或行子宫输卵管造影复查输卵管通畅情况。组间均衡性采用独立样本t检验或χ2检验,通畅度的对比采用Wilcoxon秩和检验,失访病例疗效进行意图治疗分析。结果:两组介入术后输卵管通畅度比较差异无统计学意义(P>0.05),随访期两组输卵管通畅度比较差异有显著意义(P<0.01)。两组随访期气滞血瘀证型的输卵管通畅度比较差异有统计学意义(P<0.05),湿热瘀结证型的输卵管通畅度比较差异无统计学意义(P>0.05),寒湿瘀滞证型的输卵管通畅度比较差异有显著意义(P<0.01)。结论:中医标本同治法对气滞血瘀证型的输卵管阻塞性不孕症有效。湿热瘀滞和寒湿瘀滞证型的疗效是否与治疗疗程或治疗方案有关还需进一步的大样本前瞻性随机对照研究证实。

Clinical Efficacy of The Treatment for Infertility Due to Fallopian Tube Obstruction on Relieving the Primary and the Secondary Aspects According to the Syndrome Differentiation of Traditional Chinese Medicine

Objective:To assess the short-term clinical efficacy of the protocol of treating both the primary and the secondary aspects for infertility induced by oviduct blockage,prospectively and randomly.Methods:91 consectuive patients with infertility induced by oviduct blockage defined according to the inclusion and exclusion criteria were divided into two groups:experimental group and controls by 2:1 ratio from Apr.2009 to Nov.2010,randomly.All of patients received HSG in the First Affiliated Hospital of Guangzhou University of Chinese Medicine.All of the patients were received fallopian tube recanalization.The patients of experimental group were received the treatment of Chinese herbs by oral,enema and external application according to syndrome differentiation of TCM about one week per month in 3 months after fallopian tuberecanalization.Perfuse the drugs which are different in two groups into uterine cavity about two times per month in 2 months after operation.The patients were regularly followed up for 2 years.The patient which is not perceived during follow-up will be tested on HSG.The findings before operation were compared between two groups by independent-samples t test and χ2 test.The statistic method was respectively adopted the matched t-test and of measurement data and the Wilcoxon test to analyse by SPSS 13.0 statistic software.Results:The patent rate of oviduct in experimental group was higher than that of the control group in the syndrome of qi stagnation and blood stasis and stagnation of cold and damp,the obvious significant between two groups was statistic(P<0.05).The patent rate of oviduct in two groups was not significantly different in the syndrome of stagnation of damp and heat.Conclusion:The treatment focusing on relieving the primary and the secondary aspects is quite effective for infertility due to tubal obstruction for the syndrome of qi stagnation and blood stasis.