| 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.
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