Laneh

作者：Deborah Brauser  
出處：WebMD醫學新聞

　　March 24, 2010（佛州坦帕市）－根據一項發表在國際放射學會第35屆年會的研究結果，一種使用核磁共振造影導引聚焦超音波（MRgFUS）的微創侵入性治療，可以有效地移除子宮肌瘤，且提供持續地症狀緩解，也可以免於進行侵入性的外科治療，例如子宮肌瘤切除或子宮移除手術。
　　
　　Gina Hesley醫師在她的發表會上表示，一位明尼蘇達州羅徹斯特梅約診所的放射學家，以MRgFUS進行的結果，與在子宮纖維瘤栓塞（UFE）的治療效果相當。
　　
　　她在新聞稿中表示，今天，女性們有不用使用手術刀剖開的介入性放射學選擇。女性們應該諮詢可以從核磁共振造影結果決定她們是否是MRgFUS或UFE適當人選的介入放射學家意見。
　　
　　【35歲以上女性常見纖維肌瘤】
　　大約有20%~40%的35歲以上美國女性有顯著大小的子宮肌瘤。雖然不會致癌，但是這些肌瘤經常生長在子宮肌肉層上，且會造成導致貧血的大量經血、令人難以忍受的經痛、頻尿、流產、與生殖相關問題。
　　
　　Hesley醫師解釋，當UFE是一種廣為採用阻斷肌瘤血流的治療，MRgFUS使用高能量超音波對單一特定部位產生熱能來摧毀子宮肌瘤組織而緩解症狀。
　　
　　她表示，這可以在門診進行，並不會牽涉到放射線，在最後一次治療結束後約一個小時，病患就可以離開，通常只有輕微的術後疼痛。
　　
　　她的團隊們收納了19位罹患子宮肌瘤的女性，這些女性的肌瘤一般大於3公分，且在2005年3月到2008年8月之間於梅約診所完成MRgFUS。這些病患中，100位接受12個月的電話追蹤訪談，因此可以評估纖維肌瘤相關症狀與症狀緩解。
　　
　　【症狀緩解持續】
　　在12個月的後續追蹤，97%女性表示她們的症狀獲得改善。這些女性中，74%評估症狀改善是卓越的，16%評估為相當多的，9%評估為中等的，僅有1%評估為不明顯的。
　　
　　總共有8位女性需要額外的術後治療（6位接受子宮切除術，2位接受子宮肌瘤切除術）。Hesley醫師表示，這個機率與接受子宮肌瘤切除和UFE的相差不多。
　　
　　Hesley醫師在記者會被問到時表示，這個治療方法與UFE的經濟效益比較時，MRgFUS的費用，在梅約診所，大約是子宮切除術的一半，UFE的三分之一。
　　
　　Hesley醫師認為，對病患來說，有多一點選擇是好的，因為每位女性的經驗都是不同的。典型地，UFS對於罹患多個體積較小的肌瘤來說是比較好的，而聚焦超音波是比較肌瘤專一性的治療，然而，你可能寧願肌瘤數目較少、或是較為集中。
　　
　　她表示，在梅約診所的團隊將會繼續追蹤這些女性，以評估2到3年後症狀緩解的研究結果。除此之外，她也已經發起國家衛生研究院贊助的一項研究，對等地比較MRgFUS與UFE的好處。她們未來也希望研究MRgFUS用於其他子宮相關疾病的效果，例如腺肌瘤。
　　
　　Hesley醫師表示，雖然她們的治療已經由美國食品藥物管理局於2004年10月核准，但是仍然被認為是新技術，且不是所有保險公司都有給付這項技術。
　　
　　【另一個選擇的結果令人驚奇】
　　這些研究結果是令人驚奇的。然而，在我們的經驗中，我們發現MRgFUS的一個議題是目前並不是所有保險公司都給付這項技術。記者會引言人、喬治亞州亞特蘭大Emory Adventist醫院介入性放射學部門主任John Lipman醫師表示，這在廣泛使用這項技術上是非常重要的關鍵。
　　
　　當被問到比較這兩項技術時，Lipman醫師表示，我不認為這是聚焦超音波與UFE比較的問題。它們並非要取代彼此的定位。UFE是一種全面性治療，治療子宮內各種囊腫，而聚焦超音波雖然可以用於治療一種以上囊腫，但是比較像是局部治療。
　　
　　未參與這項研究的Lipman醫師的結論是，整體來說，我會說這是項非常創新的技術，且我認為該技術將不僅應用於子宮肌瘤而已，而是全身適用。我想梅約診所在這項研究的努力應該值得讚賞。
　　
　　這項研究並未接受外部贊助。Hesley醫師表示過去參與由InSightec公司贊助的研究，該公司製造目前由FDA唯一核准的MRgFUS儀器。Lipman醫師表示已無相關資金上的往來。


Durable Symptom Relief With MR-Guided Ultrasound Removal of Uterine Fibroids

By Deborah Brauser
Medscape Medical News

March 24, 2010 (Tampa, Florida) — A minimally invasive treatment using magnetic-resonance-guided focused ultrasound (MRgFUS) is effective in removing uterine fibroids, provides lasting symptom relief, and eliminates the need for invasive surgical treatments such as myomectomy and hysterectomy, according to a study presented here at the Society of Interventional Radiology 35th Annual Scientific Meeting.

Results with MRgFUS were comparable with those seen with uterine fibroid embolization (UFE), said Gina Hesley, MD, a radiologist from the Mayo Clinic in Rochester, Minnesota, during her presentation of the results.

"Today, women have interventional radiology options that do not involve the use of a scalpel incision," she said in a release. "Women should ask for a consult with an interventional radiologist who can determine from [magnetic resonance] imaging whether they are candidates for [MRgFUS] or UFE."

Fibroids Common in Women Over 35

Approximately 20% to 40% of American women older than 35 years of age have uterine fibroids of a significant size. Although noncancerous, these commonly develop in the muscular wall of the uterus and can cause prolonged heavy menstrual bleeding that can lead to anemia, disabling pelvic pain, urinary frequency, miscarriage, and fertility problems.

"While UFE is a widely available treatment that blocks blood flow to fibroid tumors, [MRgFUS] uses high-energy ultrasound waves to generate heat at a specific point to destroy uterine fibroid tissue and relieve symptoms," explained Dr. Hesley.

"It is performed on an outpatient basis, it involves no radiation, patients leave the hospital about 1 hour after the last treatment is performed, and they report very mild postprocedural pain," she said.

Her team enrolled 119 premenopausal women with fibroids typically greater than 3?cm in size who completed MRgFUS at the Mayo Clinic between March 2005 and September 2008. Of these patients, 100 were available for 12 months of telephone follow-up interviews so that fibroid-related symptoms and symptomatic relief could be assessed.

Long-Lasting Relief

During the 12-month follow-up period, 97% of the women reported an improvement in their symptoms. Of these, 74% rated their improvement as excellent, 16% as considerable, 9% as moderate, and only 1% as insignificant.

A total of 8 of the women needed additional postprocedure treatments (6 hysterectomies and 2 myomectomies). "This rate is within values reported for myomectomy and [UFE]," reported Dr. Hesley.

When asked during a press conference about the cost difference between this procedure and UFE, Dr. Hesley said that MRgFUS is about half the cost of hysterectomies at the Mayo Clinic and a third the cost of UFE.

"I think it's important for patients to have lots of options, as each woman's experience is unique," said Dr. Hesley. "Typically, UFE is better for patients who have numerous similar-sized fibroids, and focused ultrasound is more of a fibroid-specific therapy, where you'd rather have fewer fibroids or more dominant fibroids."

She reported that the Mayo Clinic team will continue to follow these women to assess 2- and 3-year results for symptom relief. In addition, they've started a National Institutes of Health–sponsored trial comparing MRgFUS with UFE in a head-to-head design. They also hope to investigate the effectiveness of MRgFUS in other uterine conditions, such as adenomyosis, in the future.

Dr. Hesley noted that, although this treatment was approved by the US Food and Drug Administration in October 2004, it is still considered new and not all insurance companies cover it.

Exciting Results for Another Option

"The results are exciting. However, the issue with [MRgFUS] that we've found in our experience is that it's not currently covered by insurance. That is a very important impediment to its more widespread use," said press conference moderator John Lipman, MD, director of the Interventional Radiology Department at Emory Adventist Hospital in Atlanta, Georgia.

When asked to compare the 2 procedures, Dr. Lipman said: "I don't think it's an issue of focused ultrasound vs UFE. One isn't going to replace the other. UFE is a global therapy, treating all the fibroids in the uterus, whereas focused ultrasound, although it can treat more than 1 fibroid, is more of a localized treatment."

"Overall, I'd say this is very innovative and I think the technology will be applicable not only in fibroids but all over the body," concluded Dr. Lipman, who was not involved in the study. "I think the Mayo Clinic's efforts with this study are to be congratulated."

This study had no outside funding. Dr. Hesley reports participating in previous work supported by InSightec, "the company that makes the only MRgFUS device currently approved by the FDA." Dr. Lipman has disclosed no relevant financial relationships.

Society of Interventional Radiology (SIR) 35th Annual Scientific Meeting: Abstract?56. Presented March?14, 2010.