以動物模式使用非侵入性震波治療人工義乳植入所造成的包膜性攣縮疤痕

Non-Invasive Shock Wave Treatment for Capsular Contracture after Breast Augmentation Implantation in Animal Mode

吳育全(Yu-Chiuan Wu)

指導教授 ： 陳博洲

共同指導教授 ： 黃蓮池(Lain-Chyr Hwang)

義守大學/電機資訊學院/電機工程學系/博士(2014年)

https://doi.org/10.6343/ISU.2014.00225

摘要

背景
包膜性疤痕攣縮(Capsular contracture) 為婦女患者接受乳房隆胸植入手術後的主要併發症。文獻報導包膜性疤痕攣縮之發生率大約在 1%到 47%之間。包膜性疤痕攣縮會造成病患前胸極度不適、極度疼痛、觸感不佳，並造成患者前胸負擔。在臨床應用上，包膜性疤痕攣縮併發症的預防方法包括： 1.使用紋理植入物，2。 將植入物植入表淺肌肉，3。 使用預防性抗生素藥物，4。 術後按摩 和5。使用Zafirlukast藥物治療。不幸地是，上述預防方法已外科醫生的觀點而言，往往是不成功的。因此，我們提出使用震波治療兔子接受模擬乳房隆胸植入之創新方法。本研究使用磁振成像和 H & E 染色法探討植入包膜的深度、乳房植入物的剛度和周圍組織病理。本研究的目的為尋找一種廉價、易於操作且有效的治療方法以軟化的包膜性疤痕攣縮進而解除患者之疼痛。
材料與方法
本實驗採單盲試驗設計使用十五隻紐西蘭大白兔。實驗兔接受植入物的光滑生理食鹽水袋植入手術（30 毫升矽膠組織擴張器），動物實驗係經動物照護機構核准進行。實驗兔經麻醉後，在無菌環境下執行剃毛與外科手術。依照製造商建議將矽膠袋注滿30 毫升蒸餾水以模擬乳房植入物。然後，將兩個膨脹的乳房植入袋分別植入實驗兔左右兩側接近臀部到脊椎旁之皮下區域。外科手術完成後，實驗兔即正常餵食，不施行任何進一步侵入性的程序，以避免在手術位置周圍形成包膜性疤痕攣縮。於手術後6 周進行檢查是否形成包膜性疤痕攣縮，如果包膜性疤痕攣縮形成，實驗兔即接受為期六周的單側包膜性疤痕攣縮之震波治療（2 Bar，每周施打1000發震波，指定為第一實驗組）。另一側包膜性疤痕攣縮為未接受任何震波治療之實驗兔則指定為控制組。除了上述治療方法，十八隻實驗兔亦使用上述的手術方法來產生類似的包膜性疤痕攣縮，但震波治療方法改變為（2.5 Bar，每周施打2000發震波，為期六周之治療，指定為第二實驗組）。震波治療完成後，使用 磁振成像和 H & E 染色法進行震波治療對包膜性疤痕攣縮之療效評估。

結果:
為期六周的震波治療後，實驗兔未出現任何嚴重的併發症。計算六個臨床參數以評估震波治療之療效，結果如下：控制組之平均包膜厚度為0.27 mm，第一實驗組為0.42 mm和第二實驗組則為0.50 毫米。此外，觀察到第一實驗組包膜之黏液改變，13隻呈正陽性(n = 15，86.6%，包括4隻呈強陽性)，第二實驗組為15隻呈正陽性 (n = 18，83.3%，包括四隻呈強陽性)，而控制組則為9隻呈正陽性， (n = 15，60%）；第一實驗組包膜之血管增生8隻呈正陽性，(n = 15，53.3%)，第二實驗組為9隻呈正陽性 (n = 18，50%) 和控制組則為4隻呈正陽性 (n = 15，26.7%)； 第一實驗組包膜之lymphoplasma 細胞浸潤6隻呈正陽性 (n = 15，40%），第二實驗組為7隻呈正陽性 (n = 18，38.9%） 和控制組則為5隻呈正陽性(n = 15，33.3%) ；第一實驗組包膜之內薄膠原蛋白層12隻呈正陽性 (n = 15，80%)，第二實驗組為13隻呈正陽性 (n = 18，72.2%) 和控制組則為15隻呈正陽性 (n = 15，100%）； 第一實驗組包膜壁之膠原蛋白沉積了6隻呈正陽性 (n = 15，40%），第二實驗組為6隻呈正陽性(n = 18，33.3%)，控制組則為12隻呈正陽性 (n = 15，80%，包括6隻呈強陽性）。從 MRI T1遲豫時間圖像分析結果發現 MRI T1-圖像中震波治療側包膜性疤痕攣縮周圍之疤痕的 T1 遲豫時間是約為 1053 ± 123 ms，而控制側則約為 996 ± 91 ms。在震波治療側疤痕的 T1 弛豫時間大於控制側。從 H & E 染色法和 MRI T1-圖像所獲得的結果發現，震波治療可能會引起結構或包膜性疤痕攣縮組成的變化。震波治療可使包膜性疤痕攣縮變鬆及減少膠原蛋白的置換（或形成），然後可減少永久疤痕的形成。然而，仍需更多詳細的實驗和設計以評估使用震波治療包膜性疤痕攣縮的可行性。

關鍵字

none

並列摘要

Background
Capsular contracture is the main complication in women after patients received breast augmentation implantation. In calculating incidence, some literatures reported that this capsular contraction is approximately at 1% to 47%. This capsular contracture caused patients front chest uncomfortable, severe pain, bad impression and had a big chest burden for patients. In clinical practices, the prevention procedures for this capsular contracture complication included as follows: 1. Use textured implants, 2. Implants implanted in the sub-muscular plane, 3. Use prophylaxis antibiotic drug, 4. Post-operation massage, and 5. Zafirlukast. But unfortunately, the above-mentioned prevention procedures are often unsuccessful from the view of surgeons. Thus, we intend to employ an innovative and new protocol by using shock wave in rabbit animal where is subjected to a simulated breast augmentation implantation in the rabbit. The depth of the capsule and stiffness of the implanted breast implants and the histology of surrounding tissues were examined by MRI imaging and H&E stains. The purpose of this study is want to find out a cheap and easy-to-operation and effective treatment to soften the capsular contraction and thereafter relief the pains from patients.
Methods
Fifteen New Zealand White rabbits were used in this experiment under blinded design. These rabbits underwent implantation with smooth saline implants (30 ml silicon tissue expander) and this operation was approved by an institutional animal care protocol. The rabbits were anesthetized and shaved under sterile environment and surgical technique. The breast implant was filled with 30 mL distilled water to inflate the implant under manufacture’s recommendation. And then, two inflated breast implants were implanted into each rabbit- each implant was implanted into the subcutaneous plane near the hip-to-perispine region (both sites). After the surgical operation, the rabbits were fed as usual and without any further invasive procedures to prevent the formation of capsular contracture around the surgical sites. After 6 weeks of post-operation, we checked the possible formation of capsular contracture, and then if capsular contracture formed, one site of capsular contracture in the rabbit underwent shock wave treatments for six weeks (2 Bar, 1000 shots of shock wave per week, assigned as first experimental groups). The other capsular contracture left without any shock wave treatments as control group. In addition to this treatment protocol, we also used eighteen rabbits and repeated the previous surgical protocols to create similar capsular contracture, but we changed the shock wave treatments protocol as 2.5 Bar, 2000 shots per week for six weeks (assigned as second experimental group). After the shock wave treatments, MRI imaging and H&E stains were utilized to evaluate the treatment efficiency of shock wave on the capsular contracture.
Results
After six weeks shock wave treatments, the rabbits were lived without any severe complications. Six clinical parameters were calculated to evaluate the treatment efficiency of shock wave and concluded as follows: the average capsular thickness was 0.27 mm in the control group, 0.42 mm in the first experimental group and 0.50 mm in the second experimental group. Besides, myxoid changed of capsule were observed in night positive and four strong positive in first experimental group (n=15, 86.6%), fifteen positive in second experimental group (n=18, 83.3%, included four strong positive), however, night positive in the control group (n=15, 60%); vascular proliferation were observed in eight in first experimental group (n=15, 53.3%), nine in second experimental group (n=18, 50%) and four in control group (n=15, 26.7%); lymphoplasma cells infiltration were six in first experimental group (n=6, 40%), seven in second experimental group (n=7, 38.9%) and five in control group (n= 5, 33.3%); inner thinner collagen layer were twelve in first experimental group (n=15, 80%), thirteen in second experimental group (n=18, 72.2%) and fifteen in control group (n=15,100%); capsule wall collagen deposition were six in first experimental group (n=15, 40%), six in second experimental group (n=18, 33.3%) but six positive and six strong positive in the control group (n=18, 80%).
From the examination of MRI T1-map imaging analyses, we found that the MRI T1-map images showed that the T1 relaxation time of scar around the capsular contracture was approximately at 1053  123 ms at shock wave treatment site, however, approximately 996  91 ms at the control site. The T1 relaxation time of scar at shockwave treatment site is larger than that of control site.
From the results obtained from H&E stains and MRI images, we interestingly found the shock wave can potentially cause the changes either on the structure or the composition of capsular contracture. These shock wave treatments can loosen the capsular contracture and decrease the replacement (or formation) of collagen and then decrease the formation of permanent scars. However, there still needs more detail experiments and designs to evaluate the feasibility of shock wave in the treatment of capsular contracture.

並列關鍵字

capsular contracture ； shock wave ； breast augmentation

參考文獻

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