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[摘要]
【目的】探析补肾调经汤 (在《景岳全书》大营煎方的基础上加味而成) 联合人重组干扰素-α-2b治疗子宫内膜异位症 (endometriosis,EMs)疗效及其对体液免疫、血清糖类抗原 125(carbohydrate antigen,CA125)、抗子宫内膜抗体(anti- endometrial antibody,EMAb) 水平的影响。 【方法】将86例EMs肾虚血瘀证患者随机分为观察组和对照组,每组各43例。对照 组单纯给予人重组干扰素-α-2b治疗,观察组给予补肾调经汤联合人重组干扰素-α-2b治疗,疗程为1个月。观察2组患者 治疗前后体液免疫因子[免疫球蛋白A (immunoglobulin A,IgA) 、补体3 (complement 3,C3) 、补体4 (complement 4,C4) ]、子 宫内膜异位包块直径及病理相关因子 (CA125、EMAb) 水平的变化情况,并评价2组患者的临床疗效和安全性。 【结果】(1) 治 疗1个月后,观察组的总有效率为97.67% (42/43) ,对照组为81.40% (35/43) ,组间比较 (χ2 检验) ,观察组的疗效明显优于对 照组 (P<0.05) 。 (2) 治疗后,2组患者的血清IgA水平均较治疗前明显升高 (P<0.05) ,血清C3、C4水平均较治疗前明显降低 (P<0.05) ,且观察组对血清IgA水平的升高幅度及对血清C3、C4水平的降低幅度均明显优于对照组 (P<0.01) 。 (3) 治疗后, 2组患者的血清CA125、EMAb水平及子宫内膜异位包块直径均较治疗前明显降低 (P<0.05) ,且观察组对血清CA125、 EMAb水平及子宫内膜异位包块直径的降低幅度均明显优于对照组 (P<0.01) 。 (4) 观察组的不良反应总发生率为6.98% (3/43) , 对照组为11.63% (5/43) ,组间比较,差异无统计学意义 (P>0.05) 。 【结论】补肾调经汤联合人重组干扰素-α-2b治疗EMs肾 虚血瘀证患者临床疗效显著,可有效改善患者体液免疫因子及血清CA125、EMAb水平,缩小子宫内膜异位包块,且具有 较高的安全性。
[Key word]
[Abstract]
Objective To investigate the efficacy of Bushen Tiaojing Decoction, a prescription derived from Daying Decoction which recorded in Jing Yue Quan Shu (The Complete Works of ZHANG Jing-Yue) and with herbs added,combined with human recombinant interferon-α-2b for the treatment of endometriosis (EMs) and to observe its effects on humoral immunity, serum carbohydrate antigen 125 (CA125) and anti-endometrial antibody (EMAb) levels of EMs patients. Methods A total of 86 cases of EMs patients with kidney deficiency and blood stasis syndrome were randomly divided into observation group and control group,with 43 cases in each group. The control group was treated with human recombinant interferon- α -2b alone,and the observation group was treated with Bushen Tiaojing Decoction combined with human recombinant interferon- α -2b. The course o treatment covered one month. The changes of humoral immune factors of immunoglobulin A (IgA) ,complement 3 (C3) and complement 4 (C4) ,endometrial ectopic mass diameter,and the levels of pathology-relevant factors o CA125 and EMAb in the two groups before and after treatment were observed. Moreover,the clinical efficacy and safety of the two groups were evaluated. Results (1) After one month of treatment,the total effective rate of the observation group was 97.67%(42/43), and that of the control group was 81.40%(35/43) . The intergroup comparison (tested by chi-square test) showed that the efficacy of the observation group was significantly superior to that of the control group (P<0.05) . (2) After treatment,the serum IgA level of the two groups was significantly higher than that before treatment(P<0.05) ,and the serum C3 and C4 levels were significantly lower than those before treatment(P<0.05) . The increase of serum IgA level and the decrease of serum C3 and C4 levels in the observation group were significantly superior to those in the control group(P<0.01) . (3) After treatment,the serum CA125 and EMAb levels and the diameter of endometrial ectopic mass in the two groups were significantly lower than those before treatment (P<0.05) ,and the decrease of serum CA125 and EMAb levels and the diameter of endometriosis mass in the observation group was significantly superior to that in the control group (P<0.01) (4) The total incidence of adverse reactions in the observation group was 6.98% (3/43) and that in the contro group was 11.63% (5/43) ,and the difference between the two groups was not significant(P>0.05) . Conclusion Bushen Tiaojing Decoction combined with human recombinant interferon-α-2b has a significant clinical effect for the treatment of EMs patients with kidney deficiency and blood stasis syndrome. The combined therapy is effective on improving the levels of humoral immune factors,serum CA125 and EMAb,and reducing endometrial ectopic mass,with high safety.
[中图分类号]
R271.9
[基金项目]
中国中医科学院科技创新工程项目 (编号:CI2021A02401);石家庄市重点研发计划项目 (编号:20220607)