Clinical efficacy of uterus myoma injection of lauromacrogol sclerotherapy by ultrasound-guided combined with postoperative mifepristone

doi:10.3877/cma.j.issn.1673-5250.2024.03.015

Objective

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.

Methods

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].

Results

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].

Conclusions

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.

Key words: Leiomyoma, uterus, Lauromacrogol, Sclerotherapy, Mifepristone, Carcinoembryonic antigen, Progesterone congeners, Luteinizing hormone, Estradiol, Follicle stimulating hormone, Interleukin-6, Vascular endothelial growth factors, Comparative effectiveness research

表1 2组UM患者一般临床资料比较

组别	例数	年龄(岁，±s)	病程(年，±s)	UM数量[例数(%)]		UM位置[例数(%)]
组别	例数	年龄(岁，±s)	病程(年，±s)	单发	多发	肌壁间	浆膜下	黏膜下
研究组	46	38.1±4.2	2.2±0.5	37(80.4)	9(19.6)	29(63.0)	13(28.3)	4(8.7)
对照组	46	37.2±4.1	2.1±0.4	40(87.0)	6(13.0)	26(56.5)	17(37.0)	3(6.5)
统计量		t＝1.07	t＝0.87	χ²＝0.72		χ²＝0.84
P值		0.289	0.386	0.397		0.657

表1 2组UM患者一般临床资料比较

组别	例数	年龄(岁，±s)	病程(年，±s)	UM数量[例数(%)]		UM位置[例数(%)]
组别	例数	年龄(岁，±s)	病程(年，±s)	单发	多发	肌壁间	浆膜下	黏膜下
研究组	46	38.1±4.2	2.2±0.5	37(80.4)	9(19.6)	29(63.0)	13(28.3)	4(8.7)
对照组	46	37.2±4.1	2.1±0.4	40(87.0)	6(13.0)	26(56.5)	17(37.0)	3(6.5)
统计量		t＝1.07	t＝0.87	χ²＝0.72		χ²＝0.84
P值		0.289	0.386	0.397		0.657

表2 2组UM患者治疗前、后，UM直径、体积组间与组内比较(

±s)

组别	例数	UM直径(cm)		UM体积(cm³)
组别	例数	治疗前	治疗后	治疗前	治疗后
研究组	46	3.5±0.5	1.3±0.3	25.7±4.3	11.4±2.3
对照组	46	3.6±0.5	1.5±0.3	26.6±4.4	12.8±2.5
t值		0.96	3.20	0.99	2.80
P值		0.340	0.002	0.324	0.006

表2 2组UM患者治疗前、后，UM直径、体积组间与组内比较(

±s)

组别	例数	UM直径(cm)		UM体积(cm³)
组别	例数	治疗前	治疗后	治疗前	治疗后
研究组	46	3.5±0.5	1.3±0.3	25.7±4.3	11.4±2.3
对照组	46	3.6±0.5	1.5±0.3	26.6±4.4	12.8±2.5
t值		0.96	3.20	0.99	2.80
P值		0.340	0.002	0.324	0.006

表3 2组UM患者治疗前、后，血清HE4、CEA水平组间与组内比较(

±s)

组别	例数	HE4(pmol/L)		CEA(μg/mL)
组别	例数	治疗前	治疗后	治疗前	治疗后
研究组	46	67.2±7.4	50.1±5.5	15.5±3.1	7.5±1.5
对照组	46	68.4±7.6	53.4±5.8	16.2±3.2	8.4±1.6
t值		0.77	2.80	1.07	2.78
P值		0.445	0.006	0.289	0.007

表3 2组UM患者治疗前、后，血清HE4、CEA水平组间与组内比较(

±s)

组别	例数	HE4(pmol/L)		CEA(μg/mL)
组别	例数	治疗前	治疗后	治疗前	治疗后
研究组	46	67.2±7.4	50.1±5.5	15.5±3.1	7.5±1.5
对照组	46	68.4±7.6	53.4±5.8	16.2±3.2	8.4±1.6
t值		0.77	2.80	1.07	2.78
P值		0.445	0.006	0.289	0.007

表4 2组UM患者治疗前、后，血清孕激素、雌二醇、LS与FSH水平组间与组内比较(

±s)

组别	例数	孕激素(pg/mL)		雌二醇(ng/mL)		LH(mIU/mL)		FSH(mIU/mL)
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
研究组	46	12.5±2.5	6.3±1.2	69.5±7.7	125.4±13.9	17.2±3.4	8.6±1.7	16.1±3.2	10.5±2.1
对照组	46	12.1±2.4	7.1±1.4	68.4±7.6	116.3±12.9	16.9±3.3	10.1±2.1	16.5±3.3	11.8±2.3
t值		0.78	2.94	0.69	3.26	0.43	3.77	0.59	2.83
P值		0.436	0.004	0.492	0.002	0.671	<0.001	0.557	0.006

表4 2组UM患者治疗前、后，血清孕激素、雌二醇、LS与FSH水平组间与组内比较(

±s)

组别	例数	孕激素(pg/mL)		雌二醇(ng/mL)		LH(mIU/mL)		FSH(mIU/mL)
组别	例数	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后	治疗前	治疗后
研究组	46	12.5±2.5	6.3±1.2	69.5±7.7	125.4±13.9	17.2±3.4	8.6±1.7	16.1±3.2	10.5±2.1
对照组	46	12.1±2.4	7.1±1.4	68.4±7.6	116.3±12.9	16.9±3.3	10.1±2.1	16.5±3.3	11.8±2.3
t值		0.78	2.94	0.69	3.26	0.43	3.77	0.59	2.83
P值		0.436	0.004	0.492	0.002	0.671	<0.001	0.557	0.006

表5 2组UM患者治疗前、后，血清IL-6、VEGF水平组间与组内比较(

±s)

组别	例数	IL-6(ng/L)		VEGF(pg/mL)
组别	例数	治疗前	治疗后	治疗前	治疗后
研究组	46	30.5±6.1	12.4±2.5	256.4±28.5	146.8±16.3
对照组	46	31.3±6.2	15.1±3.0	253.4±28.2	155.7±17.3
t值		0.62	4.69	0.51	2.54
P值		0.530	<0.001	0.613	0.013

表5 2组UM患者治疗前、后，血清IL-6、VEGF水平组间与组内比较(

±s)

组别	例数	IL-6(ng/L)		VEGF(pg/mL)
组别	例数	治疗前	治疗后	治疗前	治疗后
研究组	46	30.5±6.1	12.4±2.5	256.4±28.5	146.8±16.3
对照组	46	31.3±6.2	15.1±3.0	253.4±28.2	155.7±17.3
t值		0.62	4.69	0.51	2.54
P值		0.530	<0.001	0.613	0.013

表6 2组UM患者不良反应总发生率比较[例数(%)]

组别	例数	腹痛	乏力	恶心、呕吐	皮疹	胸闷	心慌	不良反应总发生率
研究组	46	2(4.3)	1(2.2)	3(6.6)	1(2.2)	2(4.3)	0(0)	9(19.6)
对照组	46	1(2.2)	0(0)	2(4.3)	0(0)	0(0)	1(2.2)	4(8.7)
χ²值		—	—	—	—	—	—	2.35
P值		—	—	—	—	—	—	0.126

表6 2组UM患者不良反应总发生率比较[例数(%)]

组别	例数	腹痛	乏力	恶心、呕吐	皮疹	胸闷	心慌	不良反应总发生率
研究组	46	2(4.3)	1(2.2)	3(6.6)	1(2.2)	2(4.3)	0(0)	9(19.6)
对照组	46	1(2.2)	0(0)	2(4.3)	0(0)	0(0)	1(2.2)	4(8.7)
χ²值		—	—	—	—	—	—	2.35
P值		—	—	—	—	—	—	0.126

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