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Similar to 1100205-HIFU海扶刀子宮保衛戰~肌瘤永退
Similar to 1100205-HIFU海扶刀子宮保衛戰~肌瘤永退 (20)
1100205-HIFU海扶刀子宮保衛戰~肌瘤永退
- 2. 無創手術 ~海扶刀 子 宮 肌 瘤
- 3. 子 宮 肌 瘤 ★ 子宮肌瘤是在骨盆腔中，最常見的腫瘤。 ★ 確切病因仍不明確。可能與女性性激素有關。
- 5. 子宮肌瘤
- 6. 子宮肌瘤分類
- 9. 子宮肌瘤會有些什麼症狀？ * 大部分的子宮肌瘤並沒有症狀，也不須治療。 * 35 -- 50 %有症狀決定於肌瘤的位置、大小、是否懷孕及變性。
- 10. Medical therapy ● Estrogen-progestin contraceptives – ● Progestin-releasing intrauterine devices (IUDs) – ● Tranexamic acid – ● NSAIDS : Ponstan
- 11. Medical therapy ● Progesterone receptor modulators (PRM) — Ulipristal acetate (Esyma) and Mifepristone (RU486) ● GnRH analogs — agonists, antagonists ● Androgenic compounds — Danazol and gestrinone (Gestrin) ● Aromatase inhibitors — Letrozole (Femara) ● Selective estrogen reuptake modulators (SERMs) — Raloxifene (Evista)
- 12. Surgical therapy ● Endometrial ablation ● Uterine artery embolization ● Traditional surgery Focused ultrasound surgery H I F U
- 14. Diseases that harm require therapies that harm less. 傷害人體的疾病需要 對人體傷害更小的治療方法。 —— Sir William Osler, (1849- 1919), the Father of Modern Medicine 醫學發展趨勢
- 15. 手術 --- 損傷 ---- “雙刃劍” 自20 世紀70 年代，軟質內鏡的出現，便開始了微創技術向 傳統外科的滲入。 1983 年，英國醫生Wickham 首先提出微創外科 （minimally invasive surgery）的概念。 1987 年,法國醫生Mouret 完成了世界上第一例電視腹腔鏡 膽囊切除術，微創外科的概念才逐漸被廣泛接受。 20世紀以來，外科學朝向專業化、最小損傷、程式化發展。 醫學的發展歷程
- 17. 醫學發展趨勢 大創 微創 無創
- 18. FUAS技術原理 聚焦超音波消融手術 （Focused Ultrasound Ablation Surgery） 高強度聚焦超音波技術（High Intensity Focused Ultrasound）
- 22. Tumour HIFU Treatment Principle Treatment head Ultrasonic Target area
- 26. HIFU技術的發展史 • 1940s, Lynn首先提出HIFU; • 1950s, Fry實驗表明HIFU能有效消融靶區組織， 而對周圍結構不會造成影響。
- 27. History • 1956 Burov for malignant tumors in animal and humans • 1959 Parkinsons and Neurologic Conditions • 1964 Breast Cancer and Thyroid Cancer • 1990s Pancreatic Cancer • 1990s HIFU for Fibroids • 1993 Liver Cancer
- 28. • 1999 Chongqing USgHIFU for Malignant Tumors • 2000 Bone Cancer • 2004 FDA approved MRgFUS for Fibroid Treatment • 2005 CE approved UsgHIFU for Uterine Fibroid • 2013 TFDA approved UsgHIFU for Uterine Fibroid • 2018 CE approved UsgHIFU for Adenomyosis History
- 33. 患者數量 10078 年齡 40.4± 5.8 每種適應症的患者數量 子宮肌瘤 7439（74%） 子宮腺肌症 2549（25%） 陰道分娩後胎盤植入 25（0%） 子宮內膜異位症 60（1%） 剖腹產後瘢痕妊娠 5（0%） SI R 描述 Complicatio n Rate (%) A 無需治療，無後續 12.7 0.45 B 觀察，無後續 C 幾乎不需治療， 住院時間短(＜48小時) 0.06 0.06 D 需治療，細心照料， 長期住院(＞48小時) E 永久性反應， 需後續處理 0 F 死亡 10家中心有關HIFU治療的安全性和有效性的回顧性研究: 9988例(2006-2013) 關於FUAS臨床應用 Safety of ultrasound-guided ultrasound ablation for uterine fibroids and adenomyosis: A review of 9988 cases CrossMark jinyun Chen a, Wenzhi Chen a,b,*, Lian Zhang b, Kequan u c, Song Penga, Min He c, Liang Hu a Ultrasonics Sonochemistry 27 (2015) 671-676
- 34. FUAS學術平臺打造
- 35. FUAS消融原理
- 36. Instant Ultrasound Image Monitoring HIFU Before treatment HIFU After treatment Immediately after HIFU treatment, real-time ultrasound images of liver coagulation necrosis in live pigs
- 38. M-S雙影三維導航 ① 雙影融合：超音波,MRI影像精准融合，MRI軌跡同 步跟蹤 ② 三維識別：智能識別與分割 ③ 三維重建：立體重建病灶 ，FUAS進入3D時代 ④ 三維導航：顯示刀尖、腫瘤、毗鄰正常組織和人 體解剖座標四者之間空間結構關係 B超圖像 MRI圖像 B超MRI影像精准融合 立體重建病灶 三維模擬導航 三維影像處理軟體
- 40. Uterine Fibroids
- 41. Prospective study of multi-center (20 Hospitals: 2011.03-2013.12) A prospective multi-center study with a volume of 2411 patients compared the differences between HIFU, myomectomy and hysterectomy for uterine fibroids Dr. P Mc Culloch Professor of Surgical Science and Practice Chair, IDEAL Collaboration Deputy Director, Surgical and Interventional Trials Unit (SITU) University of Oxford, Nuffield Department of Surgical Sciences John Radcliffe Hospital Dr. Lang Jinghe President of Chinese Obstetricians and Gynecologists Association
- 42. Follow up (6-month & 12-month)
- 44. Conclucions
- 45. FIGO Staging of Uterine Fibroids Munro MG, Critchley HOD , Broder MS , et al. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age[J]. Int J Gynaecol Obstet, 2011, 113(1):0-13. ✥Type 2, 3, 4, 5, 6 are indications for HIFU ✥70-80% of fibroids that require surgical interventions can benefit from HIFU
- 46. MRI-based treatment planning and post-HIFU assessment Pre-treatment Day 14 post-HIFU 4.5 months post-HIFU 10 months post-HIFU Pre-treatment 1-Day Post-treatment Average annual absorption rate: 67%
- 47. Effectiveness of FUS Before treatment After treatment Single uterine fibroid Multiple uterine fibroids Before treatment After treatment
- 50. 海扶醫療市場部
- 51. 1月 3月 6月 1年 1.5年 2年 标准差 20.8% 23.0% 21.2% 22.3% 21.3% 12.8% 平均缩小 39.4% 50.0% 58.4% 66.7% 66.3% 83.8% 66.3% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% 120.0% 子宮肌瘤縮小率（隨訪2246人次） 平均缩小 标准差 肌瘤縮小率（2年）
- 52. Adenomyosis
- 53. 子宮腺肌病治療方式 對症治療 NSAIDS Progestins 藥 物 治 療 手 術 治 療 手 術 治 療 腺肌瘤挖除 子宮切除 子宮內膜切除 手 術 治 療 GnRHa 骶前/骶骨神經切斷術
- 55. 202 patients with adenomyosis (120 focal, 82 diffuse). MRI taken before and after USgHIFU to evaluate the treatment effectiveness, 18m follow-up. March 2014
- 56. 18-month Follow-up Post FUS Treatment
- 57. FUS Treatment Improves Sexual Life Quality in Adenomyosis Patients - 51 patients with symptomatic adenomyosis were treated for HIFU, - 2 were pregnant - 47 were followed for 12 months with improved symptoms and improved sexual quality.
- 59. Female Sexual Function Index
- 61. FUS Treatment of Focal Adenomyosis
- 62. Sigittal view of MR images from a 47-year-old woman with diffuse adenomyosis. (A) Pre-treatment T2 weighted image shows the invading endometrium causes a generalized expansion of the uterine walls. (B) Pre-treatment T1-weighted contrast- enhanced MR image shows perfusion of the adenomyotic lesion. (C) Post-treatment T1-weighted contrast-enhanced MR image shows the fractional ablation was 83.5% A B C FUS Treatment of Diffused Adenomyosis A B C
- 63. Pre- and post-HIFU MRI images obtained from a 39 years old adenomyosis patient Before HIFU 1-day post-HIFU 4-m post-HIFU MRI-based treatment planning and post-HIFU assessment
- 64. 術後3月 術後12月 術後24月 完全緩解 111(28.8%) 65(24.7%) 37(28.0%) 明顯緩解 168(43.5%) 125(47.5%) 49(37.1%) 部分緩解 66(17.1%) 31(11.8%) 12(9.1%) 無效 37(9.6%) 34(12.9%) 30(22.7%) 加重 4(1.0%) 8(3.0%) 4(3.0%) 臨床有效 345（89.4%） 221（84.1%） 98 (74.3%) HIFU治療子宮腺肌症後痛經緩解情況
- 66. Baseline Characteristics of Uterine Fibroid Patients Characteristics KMUH KMSH No. of patients 404 69 Age range(y) 40.7 ± 5.9 42.1 ± 6.5 Body mass index(kg/m2) 22.7 ± 3.8 22.9 ± 3.7 Uterine fibroids Multiple fibroid (%) 61.9 (250/404) 49.3(34/69) Solitary fibroid (%) 25.0 (101/404) 50.7(35/69) Complicated with adenomyosis (%) 13.1(53/404) 14.5(10/69) Size of uterus(cm3) 599.6 ± 546.5 557 ± 383 Size of fibroids lesion (cm3) 193.9 ± 458.0 195 ± 235
- 67. Treatment results KMUH KMSH Sonication power (W) 366.2 ± 56.4 380 ± 29 Total treatment time (min) 120.2 ± 63.0 114 ± 24 Sonication time (s) 908.0 ± 519.9 794 ± 350 Sonication time/hour (s/h) 453.4± 135.4 428 ± 124 Exposure energy(J) 346331.9 ± 281401.9 320922 ± 151677
- 68. Changes in the Size of the Uterus and Fibroid Group N Size of uterus(cm3) P Uterine reduction rate (%) Size of fibroid lesion (cm3) P Fibroid reduction rate (%) Before treatment 404 599.6 ± 546.5 193.9 ± 458.0 KMSH 53 596 ± 412 210 ± 257 3m post- treatment 379 440.5 ± 401.7 <0.05 25.5 ± 16.1 118.7 ± 240 <0.05 40.2 ± 21.6 KMSH (6m) 53 440 ± 442 108 ± 109 48.6 ± 23.7
- 69. Shrinkage Rate of Adenomyosis Volume (134 case) Percentage
- 70. Patient Symptoms Before Treatment
- 71. Symptoms Reduction Rate (%) at 3 Months After Treatment 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% adenomyosis fibroids+adenomyosis fibroids reduction rate ()% Menorrhagia Dysmenorrhoea Frequent of Urination Constipation Anemia
- 72. Fibroids Fibroids & Adenomyosis Adenomyosis Symptom Score Baseline 3 mo Baseline 3 mo Baseline 3 mo UFS-QOL 63.9 44.8 74.5 61.6 84.8 55.5 VAS 3.5 2.1 7.5 5.7 8.1 3.8 POPDI-6 16 9.7 66.0 37.2 44.3 41.4 ICIQ-SF 57.9 34.3 19.3 16.6 17.5 16.3 UDI-6 14.6 9.1 20.2 13.6 15.8 12.8 IIQ-7 10.6 5.8 7.9 6.6 9.8 9.4 OABSS 27.1 19.6 48.9 20.0 25.9 19.8 FSFI 32 39.3 44.2 50.4 43.9 38.0 POPDI-6、ICIQ-SF、UDI-6、IIQ-7、OABSS -Total score (average × 33⅓, scale of 0–100) Symptomatic Improvement: Mean Scores at Baseline and 3 Months After Treatment
- 73. Pregnancy outcomes Fibroids Fibroids & Adenomyosis Adenomyosis Vaginal delivery 4 0 0 Cesarean section 1 1 0 Ongoing pregnancy 5 0 0 Spontaneous abortion 1 0 1 Pregnancy After HIFU Treatment
- 74. Comparison of adverse effects between KMUH, Chongqing, KMSH HIFU 高醫 (500 cases) 重慶海扶(9988 cases) 小港 KMSH (69 cases) Description Number (% of patients experiencing adverse effects) Vaginal secretion 30(6.00) 874 (8.75) 5(7.2) Lower abdominal pain 11(2.20) 225 (2.25) 36 Leg pain 2 (0.40) 76(0.76) 1(1.4) Hematuria 4 (0.80) 52(0.52) 0 Massive uterine bleeding 0(0) 24 (0.24) 0 Blurred vision 0(0) 2 (0.02) 0 Skin burns 0(0) 26 (0.26) 0 Urinary retention 1(0.20) 16 (0.16) 0 Fever 0(0) 4 (0.04) 0 Acute renal failure 1(0.20) 3 (0.03) 0 Intestinal perforation 0(0) 2 (0. 02) 0 Hernia in abdominal wall 0(0) 1 (0.01 0 Thrombocytopenia 1 (0.20) 0(0) 0 Major complications: 4(0.80) 0 0
- 75. KMUH HIFU Chongqing HIFU SIR Class Description Number of patients Percentage of patients with complications Number of patients Percentage of patients with complications A No therapy, no consequences 45 9.00% 1228 12.29% B Nominal therapy, observation, no consequences 2 0. 40% 45 0.45% C Required therapy, minor hospitalization(<48 h) 1 0.20% 26 0.26% D Major therapy, unplanned increase in level of care, prolonged hospitalization (>48 h) 2 0.40% 6 0.26% E Permanent adverse sequelae 0 0 0 0 F Death 0 0 0 0 Definitions of SIR AE Class and percentage incidence (KMUH HIFU N = 500 ; Chongqing HIFU N = 9988 ) SIR AE = Society of Interventional Radiology Adverse Event
- 76. Conclusion • Uterine fibroids and adenomyosis lesion reduction rates : 40.2% and 46.2% at 3 months after HIFU • Patient symptoms have significant improvement at 3 months after treatment • Adverse effects are not often
- 77. 24歲女性，未婚，治療2個月後
- 79. 治療前 治療後
- 80. 術前：明顯灌注 術後：無灌注
- 81. 術前 術後1天 術後3月 術前：6.4× 5.6× 5.6cm，術後：4.4× 3.9× 3.8cm，縮小率55%。
- 82. •磁共振檢查圖像 • pre- HIFU 14 d post-HIFU •HIFU治療前 HIFU治療後2周 •病灶吸收，子宮逐漸恢復，貧血糾正 •HIFU治療後4.5月 HIFU治療後10月
- 86. 海扶刀的治療方式
- 87. JC Model • JC tumor therapeutic system, Chongqing Haifu (HIFU) Tech Co., Ltd., Chongqing, China. • 12cm diameter PZT transducer of focal length 10-16cm at 0.8 or 1.6 MHz.
- 91. *禁忌症 * 有不能控制的高血壓。 * 肌瘤有惡性之可能。 * 有膠原結締組織病史(膠原纖維容易增生) 。 * 有腹部放療病史。 * 多次下腹部手術史，腸粘連史，下腹部聲通 道上有異物置入者。 * 下腹壁有質地較硬的手術疤痕，寬度>1cm者, 對顯像超聲有明顯衰減者。 * 不能堅持持續俯臥1小時以上者。 * 治療相關區域存在皮膚破潰或感染時
- 92. HIFU治療時機 1. 非月經期，排除早期妊娠 2. 有症狀的慢性盆腔炎患者，給予抗生素1-2周 。 急性盆腔炎在症狀控制後3個月。 3. 避孕器取出3天后 ，無陰道流血 4. 人工流產術後至少一次正常月經（HCG正常） 5. 下腹部手術3個月後