滋肾健脾方联合淋巴细胞免疫治疗复发性流产脾肾两虚证临床研究
Clinical Study on ZiShen Jianpi Formula Combined with Lymphocyte Immunotherapy for Recurrent Abortion of Deficiency of Both the Spleen and Kidney
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摘要: 目的 观察滋肾健脾方联合淋巴细胞免疫治疗复发性流产（RSA）脾肾两虚证的疗效及安全性。方法 将120例复发性流产脾肾两虚证患者随机分为对照组和治疗组，各60例。对照组采用淋巴细胞免疫，观察组在对照组治疗基础上给予滋肾健脾方，观察患者中医证候评分，血清封闭抗体（CD3+、CD4+、CD8+、CD4+/CD8+）和炎症因子（IFN-γ、TNF-α、IL-1β、IL-10）水平；比较2组患者有效率和不良反应发生率。结果 研究期间对照组脱落3例，治疗组脱落2例。治疗组生产率89.7%，高于对照组的71.9%（P<0.05）。治疗组总有效率94.8%，高于对照组的80.7%（P<0.05）。治疗组患者的中医证候评分、血清封闭抗体和炎症因子水平均明显改善，优于对照组（P<0.05~0.01）。治疗组不良反应发生率10.3%（6/58）低于对照组的28.1%（16/57）（P<0.05 )。结论 滋肾健脾方联合淋巴细胞免疫治疗复发性流产脾肾两虚证能明显提高足月分娩率，其机理可能与调节血清封闭抗体及炎症因子水平有关。Abstract: OBJECTIVE To observe the efficacy and safety of Zishen Jianpi Formula combined lymphocyte immunotherapy for recurrent abortion of deficiency of both the spleen and kidney syndrome. METHODS 120 patients with recurrent abortion of deficiency of both the spleen and kidney were randomly divided into control group and experimental group， 60 cases in each group. The control group was treated with lymphocyte immunotherapy， and the experimental group was given Zishen Jianpi Formula on the basis of the treatment of control group. The TCM syndrome scores， serum blocking antibodies (CD3+， CD4+， CD8+， CD4+/CD8+) and inflammatory factors (IFN-γ， TNF-α， IL-1β， IL-10) were observed. The effective rate and adverse reaction rate of the two groups were compared. RESULTS 3 patients in control group and 2 patients in experimental group were fell off during the study. The term birth rate of experimental group was 89.7%， which was higher than that of control group 71.9%(P<0.05). The total effective rate of experimental group was 94.8%， which was higher than that of control group 80.7% (P<0.05). The TCM symptom scores， serum blocking antibody and inflammatory factor levels in experimental group were higher than the control group (P<0.05). The incidence of adverse reaction in treatment group was 10.3% (6/58)， which was lower than that of control group 28.1% (16/57) (P<0.05). CONCLUSION Zishen Jianpi Formula combined with lymphocyte immunotherapy for recurrent abortion of deficiency of both the spleen and kidney syndrome can significantly improve the rate of full-term delivery. The mechanism may be related to improving blood coagulation function， regulating serum blocking antibody and inflammatory factor levels.
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