双极射频阻抗控制系统联合左炔诺孕酮宫内节育系统治疗异常子宫出血的临床研究

doi:10.3877/cma.j.issn.1674-6899.2023.02.008

目的

比较双极射频阻抗控制系统联合左炔诺孕酮宫内节育系统治疗异常子宫出血(abnormal uterine bleeding，AUB)的临床疗效。

方法

回顾2011年1月至2018年12月期间在首都医科大学附属北京天坛医院妇科接受双极射频阻抗控制系统治疗的373例患者的临床资料，按照纳入、排除标准筛选出243例，治疗方式的决定需要根据手术医师对患者病情的评估、患者是否接受放置左炔诺孕酮宫内节育系统，其中157例纳入双极射频阻抗控制系统组、86例纳入联合治疗组，通过电话随访记录入组患者的术后情况，比较两组患者的闭经、疼痛改善、生活质量改善、满意和再次干预情况。

结果

比较两组患者之间术后1、12、48个月时的闭经率、疼痛改善率、生活质量改善率、满意率，联合治疗组高于双极射频阻抗控制系统组；比较再次干预率，联合治疗组低于双极射频阻抗控制系统组(P<0.05)。

结论

双极射频阻抗控制系统联合左炔诺孕酮宫内节育系统治疗AUB，对于月经、痛经、生活质量的改善更好，患者满意率更高，术后再次干预更少。

关键词: 异常子宫出血, 双极射频阻抗控制子宫内膜去除术, Novasure, 诺舒, 左炔诺孕酮宫内节育系统, 曼月乐

Objective

This study aims to evaluate the clinical efficacy of the combination of bipolar radiofrequency impedance-controlled endometrial ablation (Novasure) and levonorgestrel intrauterine system (LNG-IUS, Mirena) placement in comparison with Novasure endometrial ablation alone in women with abnormal uterine bleeding (AUB).

Methods

This study is a retrospective cohort study. A total of 373 patients with abnormal uterine bleeding underwent Novasure endometrial ablation at the Department of Gynaecology of Beijing Tiantan Hospital from Jan. 2011 to Dec. 2018. 243 women meeting the criteria were selected, and 86 of them offered Mirena simultaneously with Novasure were separated as combined therapy group, and the 157 women treated with Novasure alone as control group. The postoperative situation was recorded through the telephone follow-up. The situation on amenorrhea, dysmenorrhea, quality of life, satisfaction and re-intervention were compared beetween the two group.

Results

The combined therapy group had higher rates of amenorrhoea, pain relief, improvement of life′s quality and satisfaction than the control group after 1 months, 12 months, 48 months. However, the rate of re-intervention in the combined treatment group was lower than that in the control group (all P<0.05).

Conclusions

For women with AUB, the combination of Novasure combined with Levonorgestrel intrauterine system is more effective than Novasure alone in achieving amenorrhea, alleviating dysmenorrhea and reducing re-interventions.

Key words: Abnormal uterine bleeding, Bipolar radiofrequency impedance-controlled system, Novasure, Endometrial ablation, Levonorgestrel intrauterine system, Mirena

表1 两组异常子宫出血患者的基线特征分析(±s)

变量	联合治疗组(78例)	双极射频阻抗控制系统组(78例)	χ²/t值	P值
年龄(岁)	46.0±4.9	45.4±4.7	0.890	0.375
体质量指数(kg/m²)	25.4±3.0	25.2±2.6	0.229	0.819
孕(次)	3.0±1.4	2.8±1.3	0.418	0.676
产(次)	1.6±0.9	1.5±0.7	0.548	0.585
月经失血图评分(分)	378.3±245.7	312.9±247.3	1.651	0.101
疼痛视觉模拟评分(分)	3.6±3.3	3.1±2.9	0.895	0.372
血红蛋白(g/L)	102.0±24.9	101.6±25.1	0.097	0.923
子宫深度(cm)	8.9±0.8	8.9±1.0	0.649	0.518

表1 两组异常子宫出血患者的基线特征分析(±s)

变量	联合治疗组(78例)	双极射频阻抗控制系统组(78例)	χ²/t值	P值
年龄(岁)	46.0±4.9	45.4±4.7	0.890	0.375
体质量指数(kg/m²)	25.4±3.0	25.2±2.6	0.229	0.819
孕(次)	3.0±1.4	2.8±1.3	0.418	0.676
产(次)	1.6±0.9	1.5±0.7	0.548	0.585
月经失血图评分(分)	378.3±245.7	312.9±247.3	1.651	0.101
疼痛视觉模拟评分(分)	3.6±3.3	3.1±2.9	0.895	0.372
血红蛋白(g/L)	102.0±24.9	101.6±25.1	0.097	0.923
子宫深度(cm)	8.9±0.8	8.9±1.0	0.649	0.518

表2 两组异常子宫出血患者术后1、12、48个月的临床结局[例(%)]

组别	例数	闭经	痛经改善	生活质量改善	患者满意	子宫切除	再次干预
联合治疗组	78
术后1个月		47(60.2)	46(59.0)	65(83.3)	70(89.7)	0(0.0)	3(3.8)
术后12个月		55(70.5)	47(60.2)	68(87.2)	69(88.5)	1(1.3)	9(11.6)
术后48个月		61(78.2)	47(60.2)	74(94.9)	74(94.9)	3(3.8)	18(23.1)
双极射频阻抗控制系统组	78
术后1个月		40(51.3)	37(47.4)	65(83.3)	70(89.7)	0(0.0)	3(3.8)
术后12个月		44(56.4)	35(44.9)	64(82.1)	66(84.6)	1(1.3)	17(21.8)
术后48个月		48(61.6)	29(37.2)	60(76.9)	60(76.9)	7(9.0)	29(37.2)
P值¹		0.105	0.038	>0.999	>0.999	－	>0.999
P值²		0.006	0.005	0.309	0.287	>0.999	0.004
P值³		<0.001	<0.001	<0.001	<0.001	0.191	0.003

表2 两组异常子宫出血患者术后1、12、48个月的临床结局[例(%)]

组别	例数	闭经	痛经改善	生活质量改善	患者满意	子宫切除	再次干预
联合治疗组	78
术后1个月		47(60.2)	46(59.0)	65(83.3)	70(89.7)	0(0.0)	3(3.8)
术后12个月		55(70.5)	47(60.2)	68(87.2)	69(88.5)	1(1.3)	9(11.6)
术后48个月		61(78.2)	47(60.2)	74(94.9)	74(94.9)	3(3.8)	18(23.1)
双极射频阻抗控制系统组	78
术后1个月		40(51.3)	37(47.4)	65(83.3)	70(89.7)	0(0.0)	3(3.8)
术后12个月		44(56.4)	35(44.9)	64(82.1)	66(84.6)	1(1.3)	17(21.8)
术后48个月		48(61.6)	29(37.2)	60(76.9)	60(76.9)	7(9.0)	29(37.2)
P值¹		0.105	0.038	>0.999	>0.999	－	>0.999
P值²		0.006	0.005	0.309	0.287	>0.999	0.004
P值³		<0.001	<0.001	<0.001	<0.001	0.191	0.003

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Clinical study of bipolar radiofrequency impedance-controlled system combined with levonorgestrel intrauterine system in women with abnormal uterine bleeding

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Clinical study of bipolar radiofrequency impedance-controlled system combined with levonorgestrel intrauterine system in women with abnormal uterine bleeding