首页|基于真实世界的高强度聚焦超声联合中药二期双联疗法治疗子宫腺肌病的临床研究

基于真实世界的高强度聚焦超声联合中药二期双联疗法治疗子宫腺肌病的临床研究

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目的:评价高强度聚焦超声(high intensity focused ultrasound,HIFU)联合中药二期双联疗法治疗子宫腺肌病(adenomyosis,AM)的临床疗效.方法:收集2017 年9 月至2022 年12 月于成都中医药大学附属医院就诊,明确诊断为AM并进行HIFU治疗的 194 例患者为研究对象,其中试验组 102 例予以HIFU联合中药二期双联疗法治疗3 月,对照组92 例单纯行HIFU治疗,两组均随访至术后6 月.以中医药干预和预后影响因素为暴露和混杂因素,将真实医疗环境中的临床资料和随访数据采用倾向性评分法控制混杂因素,将两组临床基线资料进行倾向性匹配,得到每组61 例患者.比较两组患者治疗后的临床表现(痛经程度、月经量、子宫体积、病灶体积)、生活质量的改善情况(UFS-QOL、EQ-5D量表)、治疗满意度、术后不良反应等.结果:所有患者治疗后在痛经、月经量、子宫及病灶体积等临床表现方面得到有效改善(P<0.05),且试验组较对照组疗效更好(P<0.05).UFS-QOL、EQ-5D量表及治疗满意度比较显示,试验组在改善AM患者HIFU术后的生活质量和治疗满意度方面优于对照组(P<0.05).所有不良反应轻微,均不需临床处理.结论:HIFU治疗AM在改善痛经、减少月经量、促进子宫及病灶体积的缩小等方面取得较好临床疗效;HIFU术后联合中医药治疗可进一步增强疗效,可行性高,不良反应少,能有效提高患者生活质量,临床可根据患者病情推荐使用中医药治疗作为术后联合治疗方案.
Clinical Study of HIFU Combined with Chinese Medicine in Treatment of Adenomyosis Based on Real World
Objective:To evaluate the clinical efficacy of high intensity focused ultrasound combined with traditional Chinese medicine in the treatment of adenomyosis.Methods:A total of 194 patients diagnosed as AM and treated with HIFU in the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine(TCM)from September 2017 to December 2022 were selected as the study sub-jects.Among them,102 patients in the experimental group were treated with HIFU combined with traditional Chinese medicine phase Ⅱ double therapy for 3 months.The control group was treated with HIFU alone,and both groups were followed up to 6 months after op-eration.With TCM intervention and prognostic factors as exposure and confounding factors,the clinical data and follow-up data in the real medical environment were controlled by propensity score method,and the clinical baseline data of the two groups were matched by propensity,and 61 patients in each group were obtained.Clinical manifestations(dysmenorrhea,menstrual volume,uterine volume,lesion volume),improvement of quality of life(UFS-QOL,EQ-5D scale),treatment satisfaction,postoperative adverse reactions,etc.,were compared between 2 groups after treatment.Results:After treatment,all patients were effectively improved in alleviating dysmenorrhea,reducing menstrual volume,reducing the volume of lesions and uterine volume,and the efficacy of the experimental group was significantly higher than the control group,the difference was statistically significant(P<0.05).The Comparison of UFS-QOL,EQ-5D scale and satisfaction showed that the experimental group was superior to the control group in improving the quality of life and treatment satisfaction of AM patients after HIFU surgery,and the difference was statistically significant(P<0.05).All the pa-tients had no obvious abnormal safety indicators and minor adverse reactions,which did not require clinical treatment.Conclusion:HIFU in the treatment of AM has achieved good clinical efficacy in relieving dysmenorrhea,reducing menstrual flow,promoting uterine volume and shrinking lesions;HIFU combined with traditional Chinese medicine treatment can further enhance the efficacy,with high feasibility,and small adverse reactions.It can effectively improve the quality of life of patients,and the clinical use of traditional Chi-nese medicine can be recommended as a postoperative combined treatment method according to the patient's condition.

Second stage therapy of traditional Chinese medicineHigh intensity focused ultrasoundAdenomyosisReal world re-searchCurative effect evaluation

范玲秀、杨蕾蕾、黄叶芳、石玲、张丽叶、张颖、文怡

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成都中医药大学 附属医院/临床医学院,四川 成都 610072

中药二期双联疗法 高强度聚焦超声 子宫腺肌病 真实世界研究 疗效评价

四川省中医药管理局中医药科研专项课题成都中医药大学附属医院科技发展基金项目

2021MS06022ZL12

2024

成都中医药大学学报
成都中医药大学

成都中医药大学学报

影响因子:0.572
ISSN:1004-0668
年,卷(期):2024.47(4)