射频微创术治疗子宫腺肌病的临床研究
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摘要
第一部分超声引导下经腹射频术治疗子宫腺肌病临床疗效研究
背景及目的子宫腺肌病是妇科常见病,好发于育龄女性,较严重影响着患者的正常生活和工作,目前寻找一种无创或微创治疗方法已成为现今研究热点。本研究初步探讨超声引导下经腹射频消融(RFA)微创术治疗子宫腺肌病的可行性、安全性及近期临床疗效。
方法2006年10月至2007年10月在第四军医大学附属第一医院确诊的32例子宫腺肌病患者,行超声引导下经腹RFA。详细记录患者术前月经史,包括痛经程度、月经量及经期天数;术后1、3、6、10个月随访,记录患者痛经程度、月经量改善情况及并发症。同时检测术前及术后1个月CA125、3个月Hb。描述分析患者术后痛经程度、经量的治疗有效率和各种并发症的发生率;采用t检验比较术前后经期天数、CA125及Hb的变化。
结果32例子宫腺肌病患者均成功进行了超声引导下经腹RFA治疗。术后随访各时间点,32例患者中,有87.5%(其中9例后壁弥漫型、5例前壁弥漫型和14例局限性)达到治疗有效标准,另外1例全子宫弥漫型、1例前壁弥漫型合并右侧卵巢巧克力囊肿和2例后壁弥漫型术后临床症状改善不佳。患者的痛经程度、经量均较术前明显改善,其治疗有效率分别为72%、80%,术后10个月经期天数较术前下降(P<0.05)。随访期间,30例(93.7%)患者出现少量淡粉色阴道分泌物,28例(87.5%)患者出现术后短暂性下腹疼痛,5例(15.6%)患者出现术后麻醉反应,1例(3.1%)患者出现低热,全部病例均未出现严重并发症。另外,术后1个月血清CA125水平较术前明显下降(P<0.05);而术后3个月血清Hb水平较术前明显升高(P<0.05),并恢复至正常指标内。
结论超声引导下经腹RFA微创术治疗子宫腺肌病具有操作简便、治疗时间短、见效快、可以多次重复治疗、并发症较少等特点,且能够保全女性内生殖器的完整。作为一种新型治疗手段,射频微创术在子宫腺肌病的保守治疗中具有广阔的发展前景,值得进行深入探索研究。
第二部分射频术治疗子宫腺肌病疗效评价方法的研究
目的本研究重点探讨了通过超声检查在经腹RFA治疗子宫腺肌病早期疗效中的应用价值。
方法对2006年10月至2007年10月在我科自愿行超声引导下经腹RFA术治疗的32例子宫腺肌病患者,进行术前后超声二维(2DUS)、彩色多普勒(CDFI)检查,及使用第二代超声造影剂Sono Vue通过肘前静脉注射进行子宫CEUS;于术后1、3、6、10个月随访测量子宫体积,并通过描述分析术前后2DUS、CDFI、CEUS的变化情况,采用t检验比较术前后子宫体积的变化,以P<0.05为差异有显著性意义。
结果(1)术前2DUS图像显示32例患者子宫增大,内膜线偏移;病灶组织内回声分布不均匀,较正常肌壁增粗,内回声增强、减弱或强弱不等,其中14例腺肌瘤2DUS图像均可见到较清楚的病变范围,其余18例弥漫型病变范围不明确。术后随访10个月,2DUS图像示32例患者术后各月子宫体积呈进行性缩小,与术前比较差异均具有统计学意义(P<0.01);同时,消融区内回声均不同程度变强,边界尚清晰。(2)术前CDFI显示,18例弥漫型病变子宫肌层内血流信号丰富,呈树枝状分布15例,短线状3例;14例局限型病灶区周边无明显环状血流包绕,内部彩色血流信号呈树枝状4例,短线状10例。术后CDFI示所有患者消融区内血流信号完全消失。(3)术前患者子宫CEUS显示病灶内可见到较正常子宫肌层组织丰富、粗大或正常的血管显影;术后CEUS检查可见所有患者消融病灶内未见造影剂灌注。
结论与二维和彩色多谱勒超声图像相比,实时超声造影检查更能直观的反映子宫腺肌病行射频微创术后的治疗区域组织凝固范围及残余病灶的情况,为评估早期临床疗效提供了一种较客观、有效的方法。
Part One Clinical efficacy of ultrasound-guided transabdominal radiofrequency ablation for adenomyosis
Background and Objective Adenomyosis is a common gynecological disease prevalent in women of reproductive age. It has great impact on patients’normal life and work. Now we are searching a way of minimally invasive therapy. Our study investigated the feasibility, safety and short-term efficacy of ultrasound- guided transabdominal RFA for adenomyosis.
Methods Thirty-two patients with adenomyosis in the first affiliated hospital of the Fourth Military Medical University were followed up at 1,3,6,10 months after RFA procedures. Menstrual history, childbearing history and miscarriage history were recorded before RFA procedures. Clinical symptom such as menorrhalgia, volume of menstrual blood and days of menstruation were recorded. The effective rate of clinical symptoms and complications were evaluated by descriptive method. The changes of days of menstruation, serum- CA125 and Hb level were analyzed by Student's t-test.
Results The patients were followed up at 1, 3, 6 and 10 month after treatment. Clinical symptoms including menorrhalgia and volume of menstrual improved significantly at all follow-up time point. And days of menstruation shortened (P<0.05).Effective rate of symptoms improvement was 72%, and 80%, respectively. And clinical effective power is 87.5%. During follow-up, 28 patients(87.5%)show up transient bellyache, 30 patients (93.7%) had small pink vaginal secretions, 5 patients (15.6%) had postop anesthesia reaction, and 1 patient (13.1%) had low-grade fever. None of the severe complications was observed. One month after treatment CA125 level was significantly decreased, while Hb level was significantly increased compared with preoperative time (P<0.05).
Conclusions Ultrasound-guided transabdominal RFA is a safety and technically feasible treatment for adenomyosis. Advantages of RFA in the treatment of adenomyosis include short time of therapy, short time to become effective, reproducibility and to assure the safety of female internal genital organs. As a newly developed therapy, it promised further research in the future.
Part two Evaluative method of short-term efficacy of ultrasound-guided transabdominal radiofrequency ablation for adenomyosis
Objective Clinical symptoms are key index to evaluate the efficacy of RFA therapy in gynecological diseases at present. However, a lot of factors have effect on clinical symptoms reported by patients. Thus, it is very important to establish a evaluation system with much accuracy and objection. In this study, the evaluative value of ultrasonography for RFA treatment in adenomyosis was investigated emphatically.
Methods Thirty-two patients with adenomyosis in the first affiliated hospital of the Fourth Military Medical University were followed up at 1,3,6,10 months after RFA procedures. All patiernts were investigated with 2DUS, CDFI and CEUS before and after RFA treatment. The changes of Uterine volume by Student's t-test,and ablation area of uterus investigated by 2DUS、CDFI or CEUS were compared.
Results (1)Befor RFA treatment, 2DUS image displayed that uterus were increscent , line of endometria had excursion, echo of focal zone emerged maldistribution, boundary of 14 patients’local focus could be distinguish.Ten months after RFA treatment, 2DUS image displayed that the echo of ablation area have been enhanced in 32 patients. And uterine volume had gradually grown down (P<0.01). (2)CDFI displayed that blood flow of 18 widespread focus in myometrium were affluent befor treatment. There were not blood flow in periphery of 14 local focus, those of inside were arborization or nematoid shape. After RFA, the blood flow in focal zone disappeared in 29(90.63%) cases. Three cases had remaining blood flow, decreased than preoperative state. (3)Compared with those before treatment, CEUS displayed that constrast medium were not observed in ablation areas after treatment.
Conclusions Compare with 2DUS and CDFI, CEUS can reflect the remaining ablation areas and blood flow is with a much more direct and accurate way. Thus, we recommend that CEUS should be combined to evaluate the therapeutic efficacy after RFA treatment for adenomyosis.
背景及目的子宫腺肌病是妇科常见病,好发于育龄女性,较严重影响着患者的正常生活和工作,目前寻找一种无创或微创治疗方法已成为现今研究热点。本研究初步探讨超声引导下经腹射频消融(RFA)微创术治疗子宫腺肌病的可行性、安全性及近期临床疗效。
方法2006年10月至2007年10月在第四军医大学附属第一医院确诊的32例子宫腺肌病患者,行超声引导下经腹RFA。详细记录患者术前月经史,包括痛经程度、月经量及经期天数;术后1、3、6、10个月随访,记录患者痛经程度、月经量改善情况及并发症。同时检测术前及术后1个月CA125、3个月Hb。描述分析患者术后痛经程度、经量的治疗有效率和各种并发症的发生率;采用t检验比较术前后经期天数、CA125及Hb的变化。
结果32例子宫腺肌病患者均成功进行了超声引导下经腹RFA治疗。术后随访各时间点,32例患者中,有87.5%(其中9例后壁弥漫型、5例前壁弥漫型和14例局限性)达到治疗有效标准,另外1例全子宫弥漫型、1例前壁弥漫型合并右侧卵巢巧克力囊肿和2例后壁弥漫型术后临床症状改善不佳。患者的痛经程度、经量均较术前明显改善,其治疗有效率分别为72%、80%,术后10个月经期天数较术前下降(P<0.05)。随访期间,30例(93.7%)患者出现少量淡粉色阴道分泌物,28例(87.5%)患者出现术后短暂性下腹疼痛,5例(15.6%)患者出现术后麻醉反应,1例(3.1%)患者出现低热,全部病例均未出现严重并发症。另外,术后1个月血清CA125水平较术前明显下降(P<0.05);而术后3个月血清Hb水平较术前明显升高(P<0.05),并恢复至正常指标内。
结论超声引导下经腹RFA微创术治疗子宫腺肌病具有操作简便、治疗时间短、见效快、可以多次重复治疗、并发症较少等特点,且能够保全女性内生殖器的完整。作为一种新型治疗手段,射频微创术在子宫腺肌病的保守治疗中具有广阔的发展前景,值得进行深入探索研究。
第二部分射频术治疗子宫腺肌病疗效评价方法的研究
目的本研究重点探讨了通过超声检查在经腹RFA治疗子宫腺肌病早期疗效中的应用价值。
方法对2006年10月至2007年10月在我科自愿行超声引导下经腹RFA术治疗的32例子宫腺肌病患者,进行术前后超声二维(2DUS)、彩色多普勒(CDFI)检查,及使用第二代超声造影剂Sono Vue通过肘前静脉注射进行子宫CEUS;于术后1、3、6、10个月随访测量子宫体积,并通过描述分析术前后2DUS、CDFI、CEUS的变化情况,采用t检验比较术前后子宫体积的变化,以P<0.05为差异有显著性意义。
结果(1)术前2DUS图像显示32例患者子宫增大,内膜线偏移;病灶组织内回声分布不均匀,较正常肌壁增粗,内回声增强、减弱或强弱不等,其中14例腺肌瘤2DUS图像均可见到较清楚的病变范围,其余18例弥漫型病变范围不明确。术后随访10个月,2DUS图像示32例患者术后各月子宫体积呈进行性缩小,与术前比较差异均具有统计学意义(P<0.01);同时,消融区内回声均不同程度变强,边界尚清晰。(2)术前CDFI显示,18例弥漫型病变子宫肌层内血流信号丰富,呈树枝状分布15例,短线状3例;14例局限型病灶区周边无明显环状血流包绕,内部彩色血流信号呈树枝状4例,短线状10例。术后CDFI示所有患者消融区内血流信号完全消失。(3)术前患者子宫CEUS显示病灶内可见到较正常子宫肌层组织丰富、粗大或正常的血管显影;术后CEUS检查可见所有患者消融病灶内未见造影剂灌注。
结论与二维和彩色多谱勒超声图像相比,实时超声造影检查更能直观的反映子宫腺肌病行射频微创术后的治疗区域组织凝固范围及残余病灶的情况,为评估早期临床疗效提供了一种较客观、有效的方法。
Part One Clinical efficacy of ultrasound-guided transabdominal radiofrequency ablation for adenomyosis
Background and Objective Adenomyosis is a common gynecological disease prevalent in women of reproductive age. It has great impact on patients’normal life and work. Now we are searching a way of minimally invasive therapy. Our study investigated the feasibility, safety and short-term efficacy of ultrasound- guided transabdominal RFA for adenomyosis.
Methods Thirty-two patients with adenomyosis in the first affiliated hospital of the Fourth Military Medical University were followed up at 1,3,6,10 months after RFA procedures. Menstrual history, childbearing history and miscarriage history were recorded before RFA procedures. Clinical symptom such as menorrhalgia, volume of menstrual blood and days of menstruation were recorded. The effective rate of clinical symptoms and complications were evaluated by descriptive method. The changes of days of menstruation, serum- CA125 and Hb level were analyzed by Student's t-test.
Results The patients were followed up at 1, 3, 6 and 10 month after treatment. Clinical symptoms including menorrhalgia and volume of menstrual improved significantly at all follow-up time point. And days of menstruation shortened (P<0.05).Effective rate of symptoms improvement was 72%, and 80%, respectively. And clinical effective power is 87.5%. During follow-up, 28 patients(87.5%)show up transient bellyache, 30 patients (93.7%) had small pink vaginal secretions, 5 patients (15.6%) had postop anesthesia reaction, and 1 patient (13.1%) had low-grade fever. None of the severe complications was observed. One month after treatment CA125 level was significantly decreased, while Hb level was significantly increased compared with preoperative time (P<0.05).
Conclusions Ultrasound-guided transabdominal RFA is a safety and technically feasible treatment for adenomyosis. Advantages of RFA in the treatment of adenomyosis include short time of therapy, short time to become effective, reproducibility and to assure the safety of female internal genital organs. As a newly developed therapy, it promised further research in the future.
Part two Evaluative method of short-term efficacy of ultrasound-guided transabdominal radiofrequency ablation for adenomyosis
Objective Clinical symptoms are key index to evaluate the efficacy of RFA therapy in gynecological diseases at present. However, a lot of factors have effect on clinical symptoms reported by patients. Thus, it is very important to establish a evaluation system with much accuracy and objection. In this study, the evaluative value of ultrasonography for RFA treatment in adenomyosis was investigated emphatically.
Methods Thirty-two patients with adenomyosis in the first affiliated hospital of the Fourth Military Medical University were followed up at 1,3,6,10 months after RFA procedures. All patiernts were investigated with 2DUS, CDFI and CEUS before and after RFA treatment. The changes of Uterine volume by Student's t-test,and ablation area of uterus investigated by 2DUS、CDFI or CEUS were compared.
Results (1)Befor RFA treatment, 2DUS image displayed that uterus were increscent , line of endometria had excursion, echo of focal zone emerged maldistribution, boundary of 14 patients’local focus could be distinguish.Ten months after RFA treatment, 2DUS image displayed that the echo of ablation area have been enhanced in 32 patients. And uterine volume had gradually grown down (P<0.01). (2)CDFI displayed that blood flow of 18 widespread focus in myometrium were affluent befor treatment. There were not blood flow in periphery of 14 local focus, those of inside were arborization or nematoid shape. After RFA, the blood flow in focal zone disappeared in 29(90.63%) cases. Three cases had remaining blood flow, decreased than preoperative state. (3)Compared with those before treatment, CEUS displayed that constrast medium were not observed in ablation areas after treatment.
Conclusions Compare with 2DUS and CDFI, CEUS can reflect the remaining ablation areas and blood flow is with a much more direct and accurate way. Thus, we recommend that CEUS should be combined to evaluate the therapeutic efficacy after RFA treatment for adenomyosis.
引文
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37. Jiao LR,Hansen PD,Halpern DF,et al. Clinical short-term results of radiofrequency ablation in primary and secondary liver tumors. Am J Surg, 1999,177: 303-306.
38. Dickso J,Calder wood S,Storm F,et al. Thermosensitivity of neoplastic tissues in vivo. Hall Medical Publisher,1983,63-140.
39. Hoey MF,Mulier PM,Leveillee RJ,et al. Transuret hralprostate ablation with saline elect rode allows cont rolled production of larger lesions than conventional methods. J Endourol,1997,11:279-284.
40. Goldberg SN. Radiof requency tumor ablation:principles and techniques. Eur J Ult rasound,2001,13:129-147.
41. Goldberg SN,Hahn D,Halpern EF,et al. Reaiofrequency tissue ablation: effect of pharmacologic modulation of blood flow on coagulation diameter. Radiology,1998,209: 761-767.
42. Raj GV,Reddan DJ,Hoey MB,et al. Management of small renal tumors with radiof- requency ablation. Urology,2003,61:23-29.
43. 宋雯霞,罗新.医用射频消融技术的发展进程及其在妇科领域中的应用.中国妇产科临床杂志,2003,4(2):156-158.
44. Rossi S,Fornari F,Paties C,et al. Thermal lesions induced by 480kHz localized current field in guinea pig and in pig livers. Tumori,1990,76:54-57.
45. McGahan JP,Browning PD,Brock JM,et al. Hepatic ablation usingradiofrequency electrocautery. Invest Radiol,1990,25:267-270.
46. Rossi S,Buscarini E,GarbagnatiF,et al. Percutaneous treatment of small hepatic tumors by an expandable RF needle electrode. AJR,1998,170:1015.
47. Krishnamurthy VN,Casillas VJ,Latorre L. Radiofrequency ablation of hepatic lesions:a review. Appl Radiol,2003,10:11-26.
48. Goldberg SN,Dupuy DE. Image-guided radiofrequency tumor ablation- challenges and opportunities:part II. J Vasc lnterv Radiol, 2001, 12:1135-1148.
49. Dodd GD,Soulen MC,Kane RA,Livraghi T,et al. Minimally invasive treatment of malignant hepatic tumors:at the threshold of a major breakthrough. Rsdiographics,2000,20:9-27.
50. Cuschieri A,Bracken J,Boni L,et al. Initial experience with laparoscopic ultrasound-guided radiofrequency thermal ablation of hepatic tumors. Endoscopy, 1999,31(4):318-321.
51. McGahan JP,Griffery SM,Schneider PD,et al. Radiofrequency electrocautery ablation ofmammary tissue in swine. Radiology,2000, 217:471-476.
52. Walther MM,Shawker TH,Libutti SK,et al. A phase 2 study of radio- frequency interstitial tissue ablation of localized renal tumors. J Urol,2000, 163:1424.
53. Garrean S,Hering J,Saied A,et al. Radiofrequency ablation of primary and metastatic liver tumors:a critical review of the literature. The American Journal of Surgery.2008,195:508–520.
54. Zaza M,Grassi C,Mardjonovic A,et al. The use of electrosurgery in the treatment of extra-cervical genital condylomatosis. Minerva Ginecol, 1998, 50: 367-371.
55. 刘念稚,徐岚,魏利杰.射频加外涂5-氟脲嘧啶治疗尖锐湿疣的临床分析.中国妇幼保健, 2004,19(10):66.
56. 李庆丰,区海,钟绍涛,等.应用射频治疗子宫颈糜烂.中华妇产科杂志,2000,35(3):184-185.
57. Phipps JH,Lewis BV,Roberts T,et al. Treatment of functional menorrhagia by radiofrequency-induced thermal endometrial ablation. Lancet,1990,335 (8686): 374-376.
58. Lewis BV. Radiofrequency induced endometrial ablation. Baillieres Clin Obstet Gynaecol,1995,9:347-355.
59. 邱学华,赵巧.子宫内膜消融术治疗功能失调性子宫出血34例.第四军医大学学报,1999, 20(10):863-886.
60. Goldfarb HA. Myoma coagulation(myolysis). Obstet Gynecol Clin North Am,2000,27:421-430.
61. Milic A,Asch MR,Hawrylyshyn PA,et al. Laparoscopic Ultrasound-Guided Radiofrequency Ablation of Uterine Fibroids. Cardiovasc Intervent Radiol.2006, 29:694-698.
62. 罗新,宋文霞,吴秀芝,等.射频消融技术对子宫肌瘤组织中ER、PR表达影响的临床试验研究.现代妇产科进展,2003,12(3):204-206.
63. 罗新,沈媛,宋雯霞,等。射频消融术靶位治疗子宫肌瘤临床疗效研究.中国实用妇科与产科杂志,2007,23(8):605-608.
64. 尹格平,陈铭,朱彤宇.射频热凝固微创治疗子宫肌腺瘤和腺肌病.中国妇产科临床杂志,2003,4(6):410-412.
65. 徐又先,濮德敏.超声引导下射频消融治疗子宫腺肌病的研究.中国医师进修杂志,2006,29(8):26-28.
66. Barbieri RL. CA125 in patients with endometriosis. Fertil Steril,1986,45(6):767.
67. 戚瑞珍,李亚里,关峥.子宫内膜异位症与CA125值相关性探讨.医学研究通讯,2003,32(3):29-31.
68. Krasnicki D. Serum and peritoneal fluid CA125 concentration in women with endometriosis.Ginekol pol,2001,72(12A):1365-1369.
69. Takahashi K,Kijima S,Yoshino K,et al. Serum CA125 as a marter for patients with endometriosis. In J pertil,1989,34:143.
70. Kauppila L,Telimaa S,Rornbers L,et al. Placebo-controlled study on serum concertration of CA125 before and after treatment of endometriosis with danazol or high dose medoxyprogeterone acetate alone or after surgery. Fertil Steril,1988,49:37.
71. Koninckx PR,Muylemans M,Meuleman C,et al. CA125 in the management of endometriosis. Pepro Biol,1993,49:109.
72. 王伟娟,朱荫芝.子宫腺肌病与子宫肌瘤的临床实验室比较分析.中国实用妇科与产科杂志,1999,15(10):608-610.
73. Kurjak A,Sanja K. Scoring system for prediction of ovarian endometriosis based on transvaginal color and pulsed Doppler sonography. Fertil Steril, 1994, 62:81.
74. Gramiak R,Shah PM. Echocardiography of the aortic root. Invest Radiol, 1968,3(5): 356-366.
75. Hohmann J,Albrecht T,Hoffmann CW,et al. Ultrasonographic detection of focal lesion :increased sensitivity and specificity wit h microbubble cont rast agents. Eur J Radiol,2003,13:147-159.
76. Albrecht T,Hoffmann CW,Schettler S,et al. Improved detection of liver metastases with phase inversion ultrasound during the late phase of levovist. Acad Radiol,2002,9(suppl1):236-239.
77. 齐青,王文平,魏瑞雪,等.彩色多普勒超声造影在诊断肝肿瘤中的应用.中华超声影像学杂志,2004,13(7):807.
78. Quaia E,Bertolotto M,Forgacs B,et al. Detection of liver metastases by conventional ultrasound and helical CT in 160 patients. Eur J Radiol,2003, 13:475-483.
79. Brecht T,Oldenberg A,Hohmann J,et al. Imaging of liver metastases with contrast-specific low-MI real-time ultrasound and SonoVue. Eur Radiol, 2003, 13(s3):79-86.
80. 甘玲,叶真,郑秀,等.灰阶超声造影在子宫肌瘤和子宫腺肌瘤鉴别诊断中的应用.中华医学超声杂志,2005,2(6):372-374.
81. 任小龙,周晓东,郑敏娟,等.超声造影在子宫肌瘤与腺肌瘤鉴别诊断中的价值.中华超声影像学杂志,2006,15(10):770-772.
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