探讨超声引导下子宫肌瘤(UM)注射聚桂醇硬化术(uterus myoma injection of lauromacrogol sclerotherapy by ultrasound-guided)联合术后米非司酮(Mife)治疗UM患者的临床疗效。

采用简单随机抽样法，选择2019年3月至2022年3月上海大学附属南通医院(南通市第六人民医院)收治的92例UM患者为研究对象。采用随机数字表法，将其分为研究组(n＝46，采取超声引导下UM注射聚桂醇硬化术联合术后Mife治疗)和对照组(n＝46，仅采取超声引导下UM注射聚桂醇硬化术治疗)。采用成组t检验，比较2组患者治疗前、后UM直径与体积，血清肿瘤标志物[人附睾蛋白(HE)4、癌胚抗原(CEA)]，内分泌功能指标[血清孕激素、雌二醇、促黄体激素(LH)与卵泡刺激素(FSH)]，炎症指标[血清白细胞介素(IL)-6与血管内皮生长因子(VEGF)]。2组组内治疗前、后比较，采用配对t检验。2组患者不良反应率比较，采用χ²检验。本研究遵循的程序符合上海大学附属南通医院(南通市第六人民医院)医学伦理委员会制定的伦理学标准，并获得该伦理委员会批准[审批文号：(2022年)伦理批第(NTLYLL2022045)号]。

①2组患者年龄、病程，UM单发与多发、位置构成比等临床资料比较，差异均无统计学意义(P>0.05)。②治疗前、后UM直径及体积组内比较，研究组与对照组均较治疗前缩小，差异均有统计学意义(研究组：t＝23.59、17.89，对照组：t＝21.43、15.50，均为P<0.001)。治疗后，研究组患者UM直径及体积，均显著小于对照组，差异亦均有统计学意义(t＝3.20、2.80，P＝0.002、0.006)。③治疗后，2组患者血清HE4、CEA水平，均显著低于组内治疗前，并且研究组均显著低于对照组，差异均有统计学意义(P<0.05)。④治疗后，2组患者血清孕激素、LH、FSH水平，均显著低于组内治疗前，并且研究组均显著低于对照组，而2组血清雌二醇水平，则均显著高于治疗前，并且研究组高于对照组，差异均有统计学意义(P<0.05)。⑤治疗后，2组患者血清IL-6、VEGF水平，均显著低于组内治疗前，并且研究组均显著低于对照组，差异均有统计学意义(P<0.05)。⑥研究组患者不良反应率为19.6%(9/46)，与对照组的8.7%(4/46)比较，差异无统计学意义(χ²＝2.35，P＝0.126)。

采取超声引导下UM注射聚桂醇硬化术联合术后Mife治疗UM患者，可缩小患者UM体积，改善其内分泌功能，减轻炎症及肿瘤指标水平，并且安全性较高。由于本研究仅为单中心研究，纳入样本量较小，该方案治疗UM患者疗效，仍有待进一步研究、证实。

To investigate the clinical efficacy of uterus myoma (UM) injection of lauromacrogol sclerotherapy by ultrasound-guided combined with postoperative mifepristone (Mife) in treatment of patients with UM.

A total of 92 patients with UM admitted to Affiliated Nantong Hospital of Shanghai University (The Sixth People′s Hospital of Nantong) from March 2019 to March 2022 were selected as the research subjects by simple random sampling method. They were divided into study group (n=46, treated with ultrasound-guided UM injection of lauromacrogol sclerotherapy by ultrasound-guided combined with postoperative Mife) and control group (n=46, treated with UM injection of lauromacrogol sclerotherapy by ultrasound-guided only) by random digit table method. The diameter and volume of UM, serum tumor markers levels [human epididymis protein (HE)4, carcinoembryonic antigen (CEA)], endocrine function indicators [serum progestogen, estradiol, luteinizing hormone (LH) and follicle stimulating hormone (FSH)], inflammatory indicators [serum interleukin (IL)-6 and vascular endothelial growth factor (VEGF)] were compared between two groups before and after treatment by independent-samples t test, and intra-group comparisons before and after treatment were conducted by paired samples t test. Chi-square test was used to compare the incidence of adverse reactions between two groups. The procedures followed in this study complied with the ethical standards set by the Medical Ethics Committee of Affiliated Nantong Hospital of Shanghai University (The Sixth People′s Hospital of Nantong), and have been approved by this ethics committee [Approval No. NTLYLL2022045].

①There were no significant differences in the general clinical data, such as age, course of disease, constituent ratio of single and multiple UM, constituent ratio of UM location between two groups (P>0.05). ②After treatment, the diameter and volume of UM in study group and control group all were smaller than those before treatment of intra group, and all the differences were statistically significant (study group: t=23.59, 17.89; control group: t=21.43, 15.50; all P<0.001). After treatment, the diameter and volume of UM in study group were significantly smaller than those in control group, and both the differences were statistically significant (t=3.20, 2.80; P=0.002, 0.006). ③After treatment, the serum levels of HE4 and CEA in two groups were significantly lower than those before treatment of intra group, and those in study group were significantly lower than those in control group, and the differences were statistically significant (P<0.05). ④After treatment, the serum levels of progestogen, LH, and FSH in two groups were significantly lower than those before treatment of intra group, and those in study group were significantly lower than those in control group, while serum estradiol levels in two groups were significantly higher than those before treatment of intra group, and serum estradiol level after treatment in study group was significantly lower than that in control group, and all the differences were statistically significant (P<0.05). ⑤After treatment, the serum levels of IL-6 and VEGF in two groups were significantly lower than those before treatment of intra group, and those in study group were significantly lower than those in control group, and all the differences were statistically significant (P<0.05). ⑥There was no statistical differences in the incidence of adverse reactions between study group and control group [19.6% (9/46) vs 8.7% (4/46), χ²=2.35, P=0.126].

UM injection of lauromacrogol sclerotherapy by ultrasound-guided combined with postoperative Mife in treatment of patients with UM can reduce the volume of UM, improve the endocrine functions, reduce the levels of inflammation and tumor indicators, and has high safety. Because this study is only a single-center study, and the sample size is relatively small, the efficacy of this treatment regimen for patients with UM remains to be further research and confirmed.