子宫肿瘤%平滑肌瘤%高强聚焦超声消融术%生活质量%问卷调查%前瞻性研究
子宮腫瘤%平滑肌瘤%高彊聚焦超聲消融術%生活質量%問捲調查%前瞻性研究
자궁종류%평활기류%고강취초초성소융술%생활질량%문권조사%전첨성연구
Uterine neoplasms%Leiomyoma%High-intensity focused ultraseund ablation%Quality of life%Questionnaires%Prospective studies
目的 探讨MRI引导的聚焦超声术(MRgFUS)治疗育龄期妇女症状性子宫肌瘤的安全性和有效性.方法 选择2010年4月至2012年4月在北京协和医院门诊自愿接受MRgFUS治疗的子宫肌瘤患者80例,对其中已完成生育且有症状、可以清晰地表达治疗中的感受、子宫体积<16孕周、子宫肌瘤直径为2.5~10.0 cm、数量<10个的23例患者进行MRgFUS治疗.记录治疗参数、非灌注体积率(NPVR)和不良反应.并于术后l周,l、3、6个月,1年及2年随访.术前筛查及术后每次随访时均填写子宫肌瘤症状与生命质量问卷(UFS-QOL),该问卷包括症状严重程度评分(SSS)和健康相关生命质量(HRQL)评分两部分,分别比较治疗前后各问卷的评分变化.术后半年及1年时行MRI检查,比较肌瘤及子宫体积变化.术前所有患者均行血常规检查,贫血者于术后3个月、1年时复查血常规.结果 (1)治疗参数及不良反应:平均治疗温度为(69±7)℃,平均治疗时间为(144±62) min,平均NPVR为(62±23)%;主要出现的不良反应有皮肤红斑(1/23)、下腹部痉挛性疼痛(8/23)、阴道血性分泌物(5/23)、下肢酸胀或麻木感(4/23),程度均较轻且能白行缓解.(2)治疗后再手术率:1年内选择手术治疗的患者1例,两年内选择手术治疗的患者共4例(包括肌瘤剔除或子宫切除).(3)治疗前后肌瘤及子宫体积变化:术前、术后半年及1年时子宫肌瘤体积分别为75.6(P25 =43.8,P75=128.9)、52.3(P25 =23.8,P75 =111.2)、45.9(P25=26.3,P75=71.7) cm3,子宫体积分别为270.0(P25=208.4,P75=390.3)、216.4(P25=151.1,P75=290.0)、200.0(P25=149.1,P75=267.6) cm3,术后肌瘤及子宫体积均呈缩小趋势,差异均有统计学意义(P<0.01).(4)治疗前后UFS-QOL测评结果:术前、术后3个月、术后1年的SSS分别为(34±13)、(22±ll)、(19±12)分,术后较术前显著降低,差异有统计学意义(P<0.01).术前、术后3个月、术后1年的HRQL评分分别为(74±15)、(82±13)、(89±10)分,术后较术前明显提高,差异也有统计学意义(P<0.01).(5)治疗前后血红蛋白水平变化:治疗前11例患者贫血,平均血红蛋白为(87±6) g/L,治疗后3个月及1年时的血红蛋白含量分别为(106±14)、(112±10) g/L,术后较术前血红蛋白含量明显升高,差异有统计学意义(P<0.01).结论 MRgFUS是治疗症状性子宫肌瘤安全的无创疗法,其短期疗效确定,术后1年时子宫肌瘤症状及患者生命质量均明显改善,但两年内有一定的再手术率.
目的 探討MRI引導的聚焦超聲術(MRgFUS)治療育齡期婦女癥狀性子宮肌瘤的安全性和有效性.方法 選擇2010年4月至2012年4月在北京協和醫院門診自願接受MRgFUS治療的子宮肌瘤患者80例,對其中已完成生育且有癥狀、可以清晰地錶達治療中的感受、子宮體積<16孕週、子宮肌瘤直徑為2.5~10.0 cm、數量<10箇的23例患者進行MRgFUS治療.記錄治療參數、非灌註體積率(NPVR)和不良反應.併于術後l週,l、3、6箇月,1年及2年隨訪.術前篩查及術後每次隨訪時均填寫子宮肌瘤癥狀與生命質量問捲(UFS-QOL),該問捲包括癥狀嚴重程度評分(SSS)和健康相關生命質量(HRQL)評分兩部分,分彆比較治療前後各問捲的評分變化.術後半年及1年時行MRI檢查,比較肌瘤及子宮體積變化.術前所有患者均行血常規檢查,貧血者于術後3箇月、1年時複查血常規.結果 (1)治療參數及不良反應:平均治療溫度為(69±7)℃,平均治療時間為(144±62) min,平均NPVR為(62±23)%;主要齣現的不良反應有皮膚紅斑(1/23)、下腹部痙攣性疼痛(8/23)、陰道血性分泌物(5/23)、下肢痠脹或痳木感(4/23),程度均較輕且能白行緩解.(2)治療後再手術率:1年內選擇手術治療的患者1例,兩年內選擇手術治療的患者共4例(包括肌瘤剔除或子宮切除).(3)治療前後肌瘤及子宮體積變化:術前、術後半年及1年時子宮肌瘤體積分彆為75.6(P25 =43.8,P75=128.9)、52.3(P25 =23.8,P75 =111.2)、45.9(P25=26.3,P75=71.7) cm3,子宮體積分彆為270.0(P25=208.4,P75=390.3)、216.4(P25=151.1,P75=290.0)、200.0(P25=149.1,P75=267.6) cm3,術後肌瘤及子宮體積均呈縮小趨勢,差異均有統計學意義(P<0.01).(4)治療前後UFS-QOL測評結果:術前、術後3箇月、術後1年的SSS分彆為(34±13)、(22±ll)、(19±12)分,術後較術前顯著降低,差異有統計學意義(P<0.01).術前、術後3箇月、術後1年的HRQL評分分彆為(74±15)、(82±13)、(89±10)分,術後較術前明顯提高,差異也有統計學意義(P<0.01).(5)治療前後血紅蛋白水平變化:治療前11例患者貧血,平均血紅蛋白為(87±6) g/L,治療後3箇月及1年時的血紅蛋白含量分彆為(106±14)、(112±10) g/L,術後較術前血紅蛋白含量明顯升高,差異有統計學意義(P<0.01).結論 MRgFUS是治療癥狀性子宮肌瘤安全的無創療法,其短期療效確定,術後1年時子宮肌瘤癥狀及患者生命質量均明顯改善,但兩年內有一定的再手術率.
목적 탐토MRI인도적취초초성술(MRgFUS)치료육령기부녀증상성자궁기류적안전성화유효성.방법 선택2010년4월지2012년4월재북경협화의원문진자원접수MRgFUS치료적자궁기류환자80례,대기중이완성생육차유증상、가이청석지표체치료중적감수、자궁체적<16잉주、자궁기류직경위2.5~10.0 cm、수량<10개적23례환자진행MRgFUS치료.기록치료삼수、비관주체적솔(NPVR)화불량반응.병우술후l주,l、3、6개월,1년급2년수방.술전사사급술후매차수방시균전사자궁기류증상여생명질량문권(UFS-QOL),해문권포괄증상엄중정도평분(SSS)화건강상관생명질량(HRQL)평분량부분,분별비교치료전후각문권적평분변화.술후반년급1년시행MRI검사,비교기류급자궁체적변화.술전소유환자균행혈상규검사,빈혈자우술후3개월、1년시복사혈상규.결과 (1)치료삼수급불량반응:평균치료온도위(69±7)℃,평균치료시간위(144±62) min,평균NPVR위(62±23)%;주요출현적불량반응유피부홍반(1/23)、하복부경련성동통(8/23)、음도혈성분비물(5/23)、하지산창혹마목감(4/23),정도균교경차능백행완해.(2)치료후재수술솔:1년내선택수술치료적환자1례,량년내선택수술치료적환자공4례(포괄기류척제혹자궁절제).(3)치료전후기류급자궁체적변화:술전、술후반년급1년시자궁기류체적분별위75.6(P25 =43.8,P75=128.9)、52.3(P25 =23.8,P75 =111.2)、45.9(P25=26.3,P75=71.7) cm3,자궁체적분별위270.0(P25=208.4,P75=390.3)、216.4(P25=151.1,P75=290.0)、200.0(P25=149.1,P75=267.6) cm3,술후기류급자궁체적균정축소추세,차이균유통계학의의(P<0.01).(4)치료전후UFS-QOL측평결과:술전、술후3개월、술후1년적SSS분별위(34±13)、(22±ll)、(19±12)분,술후교술전현저강저,차이유통계학의의(P<0.01).술전、술후3개월、술후1년적HRQL평분분별위(74±15)、(82±13)、(89±10)분,술후교술전명현제고,차이야유통계학의의(P<0.01).(5)치료전후혈홍단백수평변화:치료전11례환자빈혈,평균혈홍단백위(87±6) g/L,치료후3개월급1년시적혈홍단백함량분별위(106±14)、(112±10) g/L,술후교술전혈홍단백함량명현승고,차이유통계학의의(P<0.01).결론 MRgFUS시치료증상성자궁기류안전적무창요법,기단기료효학정,술후1년시자궁기류증상급환자생명질량균명현개선,단량년내유일정적재수술솔.
Objective To evaluate the safety and efficacy of magnetic resonance-guided focused ultrasound surgery (MRgFUS) in treatment of symptomatic uterine leiomyoma among Chinese reproductive age women.Methods From April 2010 to April 2012,80 premenopausal women with symptomatic leiomyoma volunteered to participate in this prospective study in Department of Outpatient of Peking Union Medical College Hospital.Among 23 reproductive aged patients with size of uterus less than 16th gestational weeks,2.5 to 10 cm of diameter of myoma,less than 10 myomas and expressing symptoms clearly were treated by MRgFUS.Treatment data,non-perfused volume ratio (NPVR) and adverse events were recorded.After treatment,patients were followed up at 1 week,1,3,6,12 and 24 months,respectively.Patients at initial screening and each time of the follow-up filled out uterine fibroid symptoms quality of life (UFS-QOL),which include symptoms severity score (SSS) and health-related quality of life (HRQL).The volumes of leiomyoma and uterine were evaluated on MRI before and after the treatment (at 6 and 12 months,respectively).Before operation,routine blood test were performed on all patients,anemia patients at 3 months and 1 year after treatment were checked with blood test.Results (1) Treatment data and adverse events:the mean therapeutic temperature was (69 ± 7) ℃,the mean treatment time was (144 ±62) min,the mean NPVR was (62 ±23)%.Adverse events included mild erythema(1/23),abdominal cramp(8/23),vaginal discharge (5/23),and leg numbness (4/23).(2) The rate of secondary surgery:one patient was treated by myoectomy and hysterectomy within one year following up and 4 patients chose surgical treatment during the second-year follow-up.(3) Volume change:the volumes of leiomyoma before the treatment and 6,12 months after the treatment are 75.6 (P25 =43.8,P75 =128.9),52.3 (P25 =23.8,P75 =111.2),45.9 (P25 =26.3,P75 =71.7) cm3,respectively; and the volumes of uterine before the treatment and 6,12 months after the treatment are 270.0 (P25 =208.4,P75 =390.3),216.4 (P25 =151.1,P75 =290.0),200.0 (P25 =149.1,P75 =267.6) cm3,respectively.Both leiomyoma and uterine volumes decreased significantly after treatments (P < 0.01).(4) UFS-QOL change:the symptoms severity score (SSS) before the treatment and 3,12 months after the treatment are (34 13),(22 ± 11),(19 ± 12),which decreased significantly (P < 0.01).The health-related quality of life (HRQL) before the treatment and 3,12 months after the treatment are (74 ± 15),(82 ± 13),(89 ± 10),which increased dramatically (P <0.01).(5) Hemoglobin(HGB) change:eleven patients suffered from anemia before treatments,the mean HGB before treatment was (87 ±6) g/L and were (106 ± 14) g/L 3 months after treatment,(112 ± 10) g/L 12 months after treatment.The HGB was increased significantly after treatments (P<0.01).Conclusions MRgFUS is a safe and effective non-invasive management for symptomatic uterine leiomyoma in short-term follow up.But there is additional treatment ratio after MRgFUS.