本文選題：骨髓炎 + 清創(chuàng)術(shù)�。� 參考：《廣西醫(yī)科大學》2017年博士論文

【摘要】：背景慢性創(chuàng)傷性骨髓炎通常是指由創(chuàng)傷原因(包含開放性骨折、閉合性骨折、火器傷和骨科手術(shù)污染等)導致的慢性骨髓炎,主要分為慢性創(chuàng)傷后骨髓炎和慢性術(shù)后骨髓炎。慢性創(chuàng)傷后骨髓炎和慢性術(shù)后骨髓炎是一種難治性的疾病,一直是創(chuàng)傷骨科的一個重大挑戰(zhàn)。慢性創(chuàng)傷后骨髓炎和慢性術(shù)后骨髓炎通常需要進行抗生素治療和清創(chuàng)手術(shù)治療,然而,在治療后可發(fā)生持續(xù)感染或者出現(xiàn)感染復發(fā)。近年來,盡管在抗生素治療和手術(shù)治療方面已經(jīng)取得顯著的進展,但是慢性骨髓炎的長期復發(fā)率仍然高達20%。萬古霉素硫酸鈣緩釋系統(tǒng)和萬古霉素聚甲基丙烯酸甲酯(Polymethylmethacrylate PMMA)緩釋系統(tǒng)都被廣泛應用于治療慢性創(chuàng)傷性骨髓炎,并且獲得了相當不錯的治療效果。然而,隨著它們的廣泛應用,兩者各自的缺點均已顯露出來,但是它們也均具有各自固有的優(yōu)點。目前,在進行慢性骨髓炎的基礎研究以及臨床研究時,萬古霉素硫酸鈣緩釋系統(tǒng)或者萬古霉素PMMA緩釋系統(tǒng)往往被單獨使用。有關(guān)通過應用萬古霉素硫酸鈣緩釋系統(tǒng)和萬古霉素PMMA緩釋系統(tǒng)的各自優(yōu)點,制備萬古霉素硫酸鈣與萬古霉素PMMA聯(lián)合緩釋系統(tǒng)并使用該聯(lián)合緩釋系統(tǒng)治療慢性創(chuàng)傷性骨髓炎的研究尚未見報道。目的本臨床研究的主要目的是通過與萬古霉素PMMA緩釋系統(tǒng)比較,評價萬古霉素硫酸鈣與萬古霉素PMMA緩釋系統(tǒng)聯(lián)合治療慢性創(chuàng)傷后骨髓炎及慢性術(shù)后骨髓炎的可行性、安全性及有效性。方法本臨床研究共納入77例下肢慢性創(chuàng)傷后或骨折術(shù)后骨髓炎的患者。這些患者被分配到萬古霉素硫酸鈣與萬古霉素PMMA緩釋系統(tǒng)聯(lián)合治療研究組或萬古霉素pmma緩釋系統(tǒng)治療對照組。在手術(shù)治療前,兩組患者均接受兩種抗生素治療1周以便能更好地控制感染,而不管是否獲得細菌培養(yǎng)結(jié)果。經(jīng)過術(shù)前抗生素治療1周后,兩組患者均行接受兩階段的手術(shù)治療。在第一階段的治療中,骨感染的外科治療在共同遵循一個標準的方案下進行。該外科手術(shù)治療方案包括多個連續(xù)的操作步驟:去除內(nèi)固定材料,對感染性壞死骨組織及軟組織進行清創(chuàng),使用高速磨鉆清除骨感染部位的硬化骨,使用高壓脈沖沖洗系統(tǒng)沖洗創(chuàng)口,在清創(chuàng)術(shù)后的骨缺損區(qū)植入萬古霉素pmma緩釋系統(tǒng)或者萬古霉素硫酸鈣與萬古霉素pmma聯(lián)合緩釋系統(tǒng)以消滅骨死腔,創(chuàng)口內(nèi)置入引流管,然后縫合關(guān)閉切口。必要時采取穩(wěn)定骨骼的適當外固定措施。在第一階段手術(shù)治療后的隨訪期間,對血液學指標、微生物檢查、感染控制率、持續(xù)感染率、感染復發(fā)率和由于持續(xù)感染、復發(fā)感染導致的再次手術(shù)率進行評價。在第一階段治療后6周至8周,對獲得感染控制的患者進行第二階段治療。在進行第2階段治療時,切開皮膚并且逐層分離軟組織后,細心地縱形切開masquelet誘導膜,移除pmma骨水泥,在masquelet誘導膜腔里僅僅植入自體松質(zhì)骨顆�；蛘呋旌现踩胱泽w松質(zhì)骨顆粒和同種異體骨或人工骨替代物以重建骨缺損,植骨后細心縫合masquelet誘導膜,創(chuàng)口內(nèi)置入引流管,逐層縫合關(guān)閉切口。必要時使用接骨板內(nèi)固定或者外固定支架外固定。第二階段植骨重建外科手術(shù)后的有效性主要通過對植骨區(qū)感染復發(fā)率、骨缺損區(qū)移植骨的愈合及鄰近關(guān)節(jié)功能康復情況進行評估。結(jié)果第一階段手術(shù)治療后的平均隨訪期為24個月(范圍:15個月~48個月)。在萬古霉素硫酸鈣與萬古霉素pmma緩釋系統(tǒng)聯(lián)合治療研究組中,所有患者在術(shù)后平均6周(范圍,30天~60天)內(nèi)影像學檢查均表現(xiàn)出完全的硫酸鈣吸收;第一階段手術(shù)治療后的感染控制率為87.18%(34/39)和再次手術(shù)率為12.82%(5/39);感染復發(fā)的5例患者需要進行了進一步的外科手術(shù)治療,其中3例患者獲得感染控制,總的感染控制率達94.87%(37/39)。第一階段手術(shù)治療后,治療研究組無持續(xù)感染的患者。在萬古霉素pmma緩釋系統(tǒng)治療對照組,i期手術(shù)治療后的感染控制率68.42%(26/38),再次手術(shù)率為31.58%(12/38);i期手術(shù)治療后,12例發(fā)生持續(xù)感染或者復發(fā)感染的患者需行再次手術(shù)治療,其中4例患者獲得感染控制,總的感染控制率為78.95%(30/38)。在第一階段手術(shù)治療后,萬古霉素硫酸鈣與萬古霉素pmma聯(lián)合治療組的感染控制率高于萬古霉素pmma緩釋系統(tǒng)治療對照組的感染控制率(萬古霉素硫酸鈣與萬古霉素pmma緩釋系統(tǒng)聯(lián)合治療研究組,87.18%vs萬古霉素pmma緩釋系統(tǒng)治療對照組,68.42%;p0.05)。在經(jīng)過由于持續(xù)感染或者復發(fā)感染導致的再次手術(shù)治療后,萬古霉素硫酸鈣與萬古霉素pmma緩釋系統(tǒng)聯(lián)合治療研究組的總感染控制率仍然高于萬古霉素pmma緩釋系統(tǒng)治療對照組的總感染控制率(萬古霉素硫酸鈣與萬古霉素pmma聯(lián)合緩釋系統(tǒng)治療研究組,94.87%vs萬古霉素pmma緩釋系統(tǒng)治療對照組,78.95%;p0.05)。在第一階段手術(shù)治療后,萬古霉素硫酸鈣與萬古霉素pmma緩釋系統(tǒng)聯(lián)合治療組的持續(xù)感染或者復發(fā)感染的總發(fā)生率低于萬古霉素pmma治療對照組的持續(xù)感染或者復發(fā)感染的總發(fā)生率(萬古霉素硫酸鈣與萬古霉素pmma聯(lián)合治療組,12.82%vs萬古霉素pmma緩釋系統(tǒng)治療對照組,31.56%;p0.05)。在再次手術(shù)率方面,萬古霉素pmma治療對照組比萬古霉素硫酸鈣與萬古霉素pmma緩釋系統(tǒng)聯(lián)合治療組更高(萬古霉素pmma緩釋系統(tǒng)治療對照組,31.56%vs萬古霉素硫酸鈣與萬古霉素pmma緩釋系統(tǒng)聯(lián)合治療研究組,12.82%;p0.05)。在i期手術(shù)治療后,萬古霉素pmma治療對照組的總并發(fā)癥發(fā)送率高于萬古霉素硫酸鈣與萬古霉素pmma緩釋系統(tǒng)聯(lián)合治療組(萬古霉素pmma緩釋系統(tǒng)治療對照組,28.95%vs萬古霉素硫酸鈣與萬古霉素pmma聯(lián)合治療組,10.26%;p0.05)。通過血液學檢查顯示,萬古霉素硫酸鈣與萬古霉素pmma緩釋系統(tǒng)聯(lián)合治療組和萬古霉素pmma治療對照組均無肝毒性及腎毒性。在第二階段治療中,獲得感染控制的兩組患者65例中共有48例患者接受植骨重建手術(shù)治療,采用接骨板內(nèi)固定30例,使用外固定支架外固定10例,不需要進行內(nèi)固定或者外固定8例。術(shù)后平均隨訪期間為18個月(范圍,12個月~24個月),骨缺損植骨區(qū)無感染復發(fā),影像學檢查顯示骨缺損區(qū)植骨愈合平均時間為6個月,末次隨訪時,患肢均能完全或者部分負重行走和步態(tài)基本正常,骨缺損植骨區(qū)無疼痛。結(jié)論與萬古霉素PMMA緩釋系統(tǒng)比較,通過萬古霉素硫酸鈣緩釋系統(tǒng)和萬古霉素PMMA緩釋系統(tǒng)的協(xié)同作用,萬古霉素硫酸鈣與萬古霉素PMMA緩釋系統(tǒng)聯(lián)合治療可更有效治療慢性創(chuàng)傷性骨髓炎,能有效提高感染控制率、降低持續(xù)感染或者復發(fā)感染發(fā)生率、降低由于持續(xù)感染或者復發(fā)感染導致的再次手術(shù)率及降低并發(fā)癥癥發(fā)送率。在慢性創(chuàng)傷性骨髓炎的治療中,可生物降解性材料和非生物降解性材料的聯(lián)合應用也許能夠?qū)崿F(xiàn)感染局部的即刻結(jié)構(gòu)穩(wěn)定和較高濃度的抗生素,從而能更有效治療慢性創(chuàng)傷性骨髓炎。
[Abstract]:Background chronic traumatic osteomyelitis usually refers to chronic osteomyelitis caused by the cause of trauma (including open fracture, closed fracture, firearm injury, and Department of orthopedics pollution). It is mainly divided into chronic posttraumatic osteomyelitis and chronic postoperative osteomyelitis. Chronic posttraumatic osteomyelitis and chronic postoperative osteomyelitis are a refractory disease. It is a major challenge in the trauma department of orthopedics. Chronic posttraumatic osteomyelitis and chronic postoperative osteomyelitis are usually treated with antibiotic and debridement. However, persistent infection or recurrence of infection can occur after treatment. In recent years, although significant progress has been made in the treatment and surgical treatment of antibiotics, it is slow but slow The long-term recurrence rate of osteomyelitis is still high up to 20%. vancomycin calcium sulphate slow release system and vancomycin polymethyl methacrylate (Polymethylmethacrylate PMMA) sustained-release system, which are widely used in the treatment of chronic traumatic osteomyelitis, and have obtained considerable therapeutic effect. However, with their extensive application, both of them have been widely used. The shortcomings of the self have been revealed, but they also have their own inherent advantages. At present, in the basic research and clinical study of chronic osteomyelitis, vancomycin sulfate sustained-release system or vancomycin PMMA sustained-release system is often used alone. The study of the combined slow release system of vancomycin sulfate and vancomycin for the treatment of chronic traumatic osteomyelitis has not been reported. The purpose of this clinical study is to evaluate vancomycin calcium sulphate by comparison with the slow release system of vancomycin PMMA and the PMMA release system of vancomycin. The feasibility, safety and effectiveness of the combined treatment of chronic posttraumatic osteomyelitis and chronic postoperative osteomyelitis with vancomycin PMMA system. Methods a total of 77 patients with osteomyelitis after chronic trauma or fracture of the lower extremities were included in this clinical study. These patients were assigned to the combined treatment of vancomycin calcium sulphate and vancomycin PMMA sustained release system. The treatment study group or the vancomycin PMMA sustained-release system treated the control group. Before the operation, the two groups were treated with two antibiotics for 1 weeks in order to better control the infection, regardless of whether the bacterial culture was obtained. After 1 weeks of preoperative antibiotic treatment, the two group received two stages of surgical treatment. In the first stage In treatment, surgical treatment of bone infection is carried out under a common standard program. The surgical treatment includes a number of continuous procedures: removal of internal fixation materials, debridement of necrotic bone tissue and soft tissue, high speed drill to remove the hardened bone in the bone sensing site, and high pressure pulse irrigation system In the bone defect area after debridement, the vancomycin PMMA sustained-release system or vancomycin sulfate and vancomycin PMMA combined with the vancomycin slow-release system is used to eliminate the bone dead cavity, the wound is inserted into the drainage tube, and then the incision is sutured and closed. During the visit, the Hematology Index, microbiological examination, infection control rate, persistent infection rate, infection recurrence rate, recurrent infection and recurrent infection were evaluated. 6 to 8 weeks after the first stage of treatment, second stages of treatment for patients with infection control were treated. The skin was cut during the second stage treatment and the skin was cut. After separating the soft tissue layer by layer, the masquelet induced membrane was carefully cut and the PMMA bone cement was removed. The autologous cancellous bone particles were implanted in the masquelet induced membrane cavity, or the autograft of autogenous cancellous bone particles and the allograft bone or artificial bone substitute were used to reconstruct the bone defect. The masquelet induced membrane was sutured carefully after the bone graft, and the wound was built in. The effectiveness of the second stage bone graft reconstruction is mainly through the recurrence rate of infection in the bone graft region, the healing of the bone graft in the bone defect area and the rehabilitation of the adjacent joint function. Results first stage surgical treatment. The average follow-up period was 24 months (range: 15 months ~48 months). In the combined treatment group of vancomycin calcium sulfate and vancomycin PMMA sustained release system, all patients showed complete calcium sulfate absorption within 6 weeks (range, 30 days ~60 days) after the operation; the infection control rate after the first stage operation was 87.18%. (34/39) and reoperation rate of 12.82% (5/39); 5 patients with recurrent infection needed further surgical treatment, of which 3 patients received infection control, the total infection control rate was 94.87% (37/39). After the first stage of the operation, the study group was treated with no continued infection. In the vancomycin PMMA sustained release system, the control group was treated with the control group The infection control rate after I was 68.42% (26/38) and the reoperation rate was 31.58% (12/38); after the I operation, 12 patients with persistent infection or recurrent infection needed reoperation, of which 4 patients received infection control, the total infection control rate was 78.95% (30/38). After the first stage of operation, vancomycin sulfur The rate of infection control in the combined treatment group of calcium acid and vancomycin PMMA was higher than that of the control group with vancomycin PMMA sustained release system (vancomycin calcium sulfate and vancomycin PMMA sustained-release system combined treatment group, 87.18%vs vancomycin PMMA sustained-release system for control group, 68.42%; P0.05). The total infection control rate of the combined treatment group of vancomycin calcium sulfate and vancomycin PMMA sustained release system was still higher than that of the vancomycin PMMA sustained-release system (vancomycin sulfate and vancomycin PMMA combined slow-release system treatment group, 94.87%vs million) The total incidence of persistent infection or recurrent infection in the combined treatment group of vancomycin calcium sulfate and vancomycin PMMA sustained release system was lower than that of vancomycin PMMA treatment group (vancomycin PMMA). The total incidence of vancomycin in the control group (vancomycin) was lower than that of vancomycin PMMA control group. Calcium sulfate and vancomycin PMMA combined treatment group, 12.82%vs vancomycin PMMA sustained release system for the control group, 31.56%; P0.05). In the reoperation rate, vancomycin PMMA treatment control group was higher than vancomycin calcium sulfate and vancomycin PMMA slow release system combined treatment group (vancomycin PMMA sustained-release system treatment control group, 31.56%vs million, 31.56%vs million) The total complication rate of vancomycin PMMA treatment group was higher than that of vancomycin calcium sulfate and vancomycin PMMA sustained-release system (vancomycin PMMA) group (vancomycin PMMA sustained-release system treatment group, 28.95%vs vancomycin, 12.82%; 12.82%; P0.05). After I operation, the total complication rate was higher than that of vancomycin calcium sulfate and vancomycin PMMA slow release system. Calcium sulfate and vancomycin PMMA combined treatment group, 10.26%; P0.05). Through hematological examination, there were no hepatotoxicity and renal toxicity of vancomycin calcium sulfate combined with vancomycin PMMA sustained-release system combined with vancomycin PMMA treatment control group. In the second stage treatment, two groups of patients who received infection control had 48 patients. There were 30 cases of internal fixation with bone grafting and 10 cases with external fixation with external fixation. No internal fixation or external fixation was needed in 8 cases. The average follow-up period was 18 months (range, 12 months ~24 months). No infection recurrence was found in bone defect area. The average time of bone graft healing in bone defect area was revealed by imaging examination. For 6 months, all the limbs were completely or partially weight-bearing walking and gait basically normal at the last follow-up, and there was no pain in the bone defect area. Conclusion compared with vancomycin PMMA sustained-release system, vancomycin sulfate calcium sulfate and vancomycin PMMA sustained-release system were used by the combined use of vancomycin calcium sulfate slow release system and vancomycin PMMA sustained release system. Combined therapy can be more effective in the treatment of chronic traumatic osteomyelitis. It can effectively improve the infection control rate, reduce the incidence of persistent infection or recurrent infection, reduce the reoperation rate due to persistent infection or recurrent infection and reduce the incidence of complications. Biodegradable materials can be used in the treatment of chronic traumatic osteomyelitis. The combined application of non biodegradable materials may be able to achieve immediate structural stability and high concentrations of antibiotics, which can be more effective in the treatment of chronic traumatic osteomyelitis.
【學位授予單位】：廣西醫(yī)科大學
【學位級別】：博士
【學位授予年份】：2017
【分類號】：R681.2

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