【作者】 杨凌；

【导师】 许丽绵；

【作者基本信息】 广州中医药大学 ， 中医妇科学， 2005， 硕士

【摘要】 目的: 本研究客观地评价了清湿化瘀合剂、益肾活血Ⅰ号丸对女性抗精子免疫性不孕患者治疗的临床疗效;从临床角度探讨慢性生殖道炎症与女性抗精子免疫性不孕的相关性,并分析其中可能的影响因素。 方法: 1.通过前瞻性随机对照实验,临床采用随机原则选择200例不孕患者为受试对象,了解AsAb阳性合并慢性生殖道炎症的不孕患者在不孕症患者人群中的分布情况。 2.将合格受试者按随机原则分配到治疗组和对照组。治疗组按中医辨证分型分为肾虚血瘀组和湿热瘀结组。肾虚血瘀组以益肾活血Ⅰ号丸治疗病人18例,湿热瘀结组以清湿化瘀合剂治疗病人20例,对照组以抗生素+强的松治疗病人20例。 3.观察治疗前后血清、宫颈粘液AsAb,淋巴细胞亚群,白细胞介素6（IL—6）,宫颈病原微生物培养的变化,最后观察各组妊娠情况。 结果: 1.受试的200例女性不孕症患者中原发性不孕91例,其中AsAb阳性36例,发病率为39.56%,AsAb阳性合并生殖道炎症15例,占总数的16.48%;继发性不孕109例,其中AsAb阳性60例,发病率为55.05%,AsAb阳性合并生殖道炎症40例,占总数的36.69%。炎症组122例不孕症患者中,AsAb的阳性率为50.8%,非炎症组78例中AsAb的阳性率为34%,两组比较有差异（p<0.05）。 2.经过治疗后肾虚血瘀组AsAb总有效率为77.8%,妊娠率为11.1%,湿热瘀结组总有效率为75%,妊娠率为10%,对照组总有效率为70%,妊娠率为5%。治疗前后各组疗效比较有显著差异性（p<0.05）。组间比较湿热瘀结组与对照组疗效有差异（p>0.05）。肾虚血瘀组和对照组比较差异不明显（p>0.05）。 3.免疫性不孕症的患者普遍存在机体免疫功能紊乱,表现为:治疗前湿热瘀结组的CD⁸⁺降低,CD⁴⁺、CD⁴⁺/CD⁸⁺、NK升高,而肾虚血瘀组为CD⁴⁺、CD⁸⁺针降低,CD⁴⁺/CD⁸⁺、NK升高。治疗后两组的CD⁸⁺升高,CD⁴⁺/CD⁸⁺、NK下降。治疗前后及组间比较有差异（p<0.05）。 4.治疗前湿热瘀结组和对照组的血清IL-6升高,肾虚血瘀组血清IL-6降低,治疗后湿热瘀结组和对照组的血清IL-6降低,而肾虚血瘀组中的血清IL-6却有一定程度的升高。治疗前后比较各组有显著性差异（p<0.01）,组间比较各组也有差异（p<0.05）。更多还原

【Abstract】 Objective:The study was an objective evaluation to assess Qing Shi Hua Yu Mixture 、 Yi Shen Huo Xue I Pill through the connection between the female immune infertility and positive anti-sperm antibody (AsAb). On the view of clinical science, the research explored the possible factors through the connect with the inflammation of genital system and female immune infertility. Methods:1. The study was pre-assumed that kidney deficiency plus blood stasis, damp heat plus blood stasis group were the main factors to cause the infertility. The treatment was stressed on the above.2. The clinical cases were applied the methods of prospective contrasted experiment and doctrine randomly. There were 200 clinical cases sorted randomly. Firstly, those patients detected both the level of AsAb (positive) in blood serum and inflammation of genitalia system.3. The result might indicate a primary distribution pattern in the mass.4. These patients were divided into two groups in random — therapy group and controlled group. The therapy group was based on the doctrine of diagnosis and treatment of Traditional Chinese Medicine.5. The treatment groups were classified into kidney deficiency plus blood stasis, damp heat plus blood stasis group. 20 cases of damp heat group were given Qing Shi Hua Yu Mixture. On the other hand, 18 cases of kidney deficiency group were treated by Yi Shen Huo Xue I Pill at the same time. Lastly, 20 cases of controlled group were taken in prednisone combined with antibiotics. In prospect to discover whether it existed any changes among 58 cases - comparing before treatment and after treatment.6. The observations were focused on AsAb in blood serum and cervical mucus, pathogenic microorganism. The index selected CT/UU in cervical mucus, T-cells subsets CD3+、 CD4+、 CD8+、 NK, IL-6 in the external blood serum and lastly pregnant evaluation.7. The duration was 3 months with 1-2 courses.Results:1. The data showed that there were 48% of AsAb positive rate found(96 cases out of 200 sterility cases), combining with genital inflammation was 27.5%. Spontaneous rate of sterility was 39.56% detected AsAb positive, combining genital inflammation was 16.48%. Secondary sterility infertility was 39.56 % detected AsAb positive, combining genital inflammation was 36.69%.According to the above study, the secondary sterility was than Primary one.2. The total effective rate of kidney deficiency, damp heat and controlled group were recorded 77.8%, 75% and 70% respectively. Thus, the result showed a significant difference in negative transformation rates of AsAb compared with before treatment and after treatment (p<0.05).3. Before treatment: The level of CD8+cells obviously declined, T cell subsets CD4+、 CD4+、 CD8+、 NK increased in the cases of damp heat group; After treatment in the cases of kidney deficiency group ,The level of CD8+、 CD4+ cells obviously increased, T cell subsets CD4+/ CD8+、 NK declined. There were great significance difference ( p<0.05) between before treatment and after treatment. But no finding difference inter-blocks. ( p>0.05).4. Before treatment the activity of IL-6 in damp heat group and controlled groups increased, and the kidney deficiency group declined. After treatment the level of IL-6 declined, respectively .The kidney deficiency group’s increased on the contrary. There was great significance difference (p<0.01) between before and after treatment. But there were no difference (p>0.05) inter-blocks.Conclusion:1. The affect of the inflammation of genitalia was remarkably related to the dissectingsituation of genital organs in pelvic cavity, the inflammation of internal genitalia has the more influence on the reproduce than external. It also implied that there were positive correlation between the AsAb in the external blood serum and in cervical mucus 、 history of the inflammation、 radio of CD4+/ CD8+ . However, the study showed that it might be no association with IL-6.2. The level of AsAb was dropped after the treatment of Qing Shi Hua Yu Mixture. There existed regulation of AsAb to enhance pregnancy. The result showed that the curative effect had association with the level of AsAb in blood serum. The higher the titer, the less the pregnancy. It also implied that there were positive correlation between the AsAb titer in the external blood serum and AsAb in cervical mucus. Though the level of AsAb in cervical mucus was lower than the AsAb in blood.3. Inflammation of CT/UU in cervical mucus was no correlation with immune infertility of kidney difference group, on the other hand, it’s was closely correlation with damp heat group. Now we had no enough proof to confirm that the IL-6 was related to AsAb in blood serum.更多还原