芍药止痛合剂治疗盆腔子宫内膜异位症的临床疗效及安全性观察

Clinical Observation on Effect and Safety of Shaoyaozhitong Mixture in the Treatment of Endometriosis

目的观察中药芍药止痛合剂治疗Ⅲ一Ⅳ期盆腔子宫内膜异位症（EMs）的临床疗效和安全性。方法采用随机、对照、单盲的研究方法，将符合入选标准的Ⅱ～Ⅳ期EMs保守性手术术后患者94例随机分为中药组、孕三烯酮组和期待组。中药组31例给予口服芍药止痛合剂，孕三烯酮组30例给予口服孕三烯酮，期待组33例不用任何药物治疗。比较三组治疗前后血清CA125、TNFα和VEGF水平变化和疼痛程度变化、临床总有效率、复发和不良反应情况。结果与本组治疗前相比，治疗后三组CA125、TNF-α及VEGF水平、疼痛程度评分均显著下降，差异有统计学意义（P〈0．05）。与期待组相比，中药组与孕三烯酮组CA125、TNF-α及VEGF水平、疼痛程度评分下降的速度和幅度均显著高于期待组（P〈0．05）。中药组临床总有效率为83．9％，孕三烯酮组为86．7％，期待组为60．6％，与期待组相比，中药组与孕三烯酮组的临床总有效率显著高于期待组，差异有统计学意义（P〈0．05）。而中药组与孕三烯酮组虽然复发率较低，但差异无统计学意义（P〉0．05）。三组术后首次复发距手术的间膈时间差异均无统计学意义（P〉0．05）。孕三烯酮组的不良反应发生率为60％，显著高于中药组与期待组（P〈0．05）。结论芍药止痛合剂能有效治疗盆腔子宫内膜异位症，且副作用小，值得进一步临床推广。

Objective To study the effect and safety of Shaoyaozhitong mixture on stage Ⅲ-Ⅳ endometriosis. Methods By the research methods of random, contrast and single-blind, 94 cases of patients who conformed to the standard were randomly divided into three groups： the traditional Chinese medicine（TCM） group included 31 cases were treated with Shaoyaozhitong Mixture,the gestrinone group included 30 cases were treated with gestrinone while the expectant group included 33 cases received no medications. The changes of CA125, TNFα and VEGF levels, visual pain score, total effective rate, recurrence and adverse effect were compared. Results There existed a statistical difference in CA125, TNFα and VEGF levels and visual pain score in the entire three group after treatment （ P 〈 0. 05 ）. The decline of CA125, TNFα and VEGF levels and visual pain score in the TCM group and gestrinone group were significantly faster and larger than that of the expectant group（P 〈 0.05）. The total effective rate of TCM group and gestrinone group were both higher than that of expectant group （83.9% , 86.7% and 60. 6% , respectively, P 〈 0.05）. The recurrence rate was lower in TCM and gestrinone group than that of expectant group, but there was no statistical difference （P 〉 0.05 ） ,and so was the time interval between recurrence and operation. The incidence of adverse effect in gestrinone group was 60% , which was significantly higher than that of TCM and expectant group （ P 〈 0. 05 ）. Conclusion Shaoyaozhitong Mixture was effective in the treatment of endometriosis and the side effect was small. It deserved further clinical promotion.