石举梅, 张永嘉, 杨新春, 韩倩, 王子衿, 赵瑞华. 活血消异颗粒抑制子宫内膜异位症保守术后复发的双中心、随机对照研究[J]. 南京中医药大学学报, 2024, 40(7): 733-739. DOI: 10.14148/j.issn.1672-0482.2024.0733
引用本文: 石举梅, 张永嘉, 杨新春, 韩倩, 王子衿, 赵瑞华. 活血消异颗粒抑制子宫内膜异位症保守术后复发的双中心、随机对照研究[J]. 南京中医药大学学报, 2024, 40(7): 733-739. DOI: 10.14148/j.issn.1672-0482.2024.0733
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SHI Jumei, ZHANG Yongjia, YANG Xinchun, HAN Qian, WANG Zijin, ZHAO Ruihua. Double Center, Randomized Controlled Study of Huoxue Xiaoyi Granule in Inhibiting Recurrence of Endometriosis after Conservative Surgery[J]. Journal of Nanjing University of traditional Chinese Medicine, 2024, 40(7): 733-739. DOI: 10.14148/j.issn.1672-0482.2024.0733
Citation: SHI Jumei, ZHANG Yongjia, YANG Xinchun, HAN Qian, WANG Zijin, ZHAO Ruihua. Double Center, Randomized Controlled Study of Huoxue Xiaoyi Granule in Inhibiting Recurrence of Endometriosis after Conservative Surgery[J]. Journal of Nanjing University of traditional Chinese Medicine, 2024, 40(7): 733-739. DOI: 10.14148/j.issn.1672-0482.2024.0733
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活血消异颗粒抑制子宫内膜异位症保守术后复发的双中心、随机对照研究

Double Center, Randomized Controlled Study of Huoxue Xiaoyi Granule in Inhibiting Recurrence of Endometriosis after Conservative Surgery

    摘要
  • 摘要:
    目的 评价活血消异颗粒抑制子宫内膜异位症(EMs)保守术后复发的有效性与安全性，为中药抑制EMs术后复发提供依据。
    方法 选取EMs术后气滞血瘀型患者72例作为研究对象，随机分为中药组和西药组，各36例，中药组予活血消异颗粒治疗，西药组予促性腺激素释放激素激动剂(GnRH-α)治疗。观察2组术后复发率、中医证候积分、糖类抗原125(CA125)、痛经评分、盆腔痛评分、妊娠率、血清性激素雌二醇(E2)、促黄体生成素(LH)、卵泡刺激素(FSH)水平及安全性指标变化情况。
    结果 术后9个月、术后12个月，2组患者中医证候总积分均显著降低(P<0.05)，中药组优于西药组(P<0.05)；术后12个月，中药组中医临床总有效率优于西药组；术后2组患者血清CA125水平、痛经评分及盆腔痛严重程度均显著降低(P<0.05，P<0.01)；治疗期间中药组总不良反应发生率低于西药组(P<0.01)；中药组复发率稍低于西药组，但无统计学差异(P>0.05)。
    结论 活血消异颗粒可明显改善EMs术后气滞血瘀证患者的中医证候，安全性较好，且与GnRH-α在预防EMs术后复发方面疗效相当，值得临床推广应用。

     

    Abstract:
    OBJECTIVE To evaluate the efficacy and safety of Huoxue Xiaoyi Granule in inhibiting the recurrence of endometriosis (EMs) after conservative operation, and to provide evidence for Chinese medicine in inhibiting the recurrence of EMs.
    METHODS A total of 72 patients with qi-stagnation and blood-stasis after EMs operation were selected as the study objects and randomly divided into the Chinese medicine group and the Western medicine group, 36 cases in each group. The Chinese medicine group was treated with Huoxue Xiaoyi Granule, and the Western medicine group was treated with GnRH-α. The postoperative recurrence rate, TCM syndrome score, carbohydrate antigen 125 (CA125), dysmenorrhea score, pelvic pain score, pregnancy rate, serum sex hormones estradiol (E2), luteinizing hormone (LH), follicle stimulating hormone (FSH) and safety indexes of the two groups were observed.
    RESULTS At 9 months and 12 months after surgery, the total TCM syndrome scores of the two groups of patients were significantly reduced (P<0.05), and the Chinese medicine group was better than the Western medicine group (P<0.05); 12 months later, the TCM total clinical curative rate in the Chinese medicine group was better than that in the Western medicine group; after surgery, the serum CA125 levels, dysmenorrhea scores and pelvic pain severity of the two groups of patients were significantly reduced (P<0.05, P<0.01); during treatment, the total incidence of adverse reactions in the Chinese medicine group was lower than that in the Western medicine group (P<0.01); the recurrence rate of the Chinese medicine group was slightly lower than that of the Western medicine group, but there was no statistical difference (P>0.05).
    CONCLUSION Huoxue Xiaoyi Granule can significantly improve TCM syndromes in patients with qi-stagnation and blood-stasis after EMs surgery. It is safe and has equivalent efficacy to GnRH-α in preventing postoperative recurrence of EMs, and worthy of clinical promotion and application.

     

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