重组人骨形态形成protein-2治疗开放性胫骨骨折的前瞻性,控制,随机研究的四百五十名患者。

文章的细节

引用

Govender年代,Csimma C,问题港元,Valentin-Opran,阿米特Y, Arbel R, Aro H,阿塔尔D, Bishay M,波尔纳MG,凯龙星P,忠P, Cinats J, B,中标价Feibel R, Geulette B, C砾石,哈斯N, Raschke M,凉帽E·范德·D,哈迪P,霍尔特M, Josten C, Ketterl RL, Lindeque B, Lob G,以及H,麦考伊克,沼泽D,米勒R,非洲黑人E, Oevre年代,Nordsletten L,帕特尔,波尔,兰尼W, Reynders P, Rommens点,Rondia J,罗索乌WC, Daneel PJ,飞边,拉特,Santavirta年代,Schildhauer助教,Gekle C, Schnettler R,西格尔D,西勒H, Snowdowne RB, Stapert J, Taglang G, Verdonk R, Vogels L, Weckbach, Wentzensen, Wisniewski T

重组人骨形态形成protein-2治疗开放性胫骨骨折的前瞻性,控制,随机研究的四百五十名患者。

中华骨科杂志。2002年12月,84,(12):2123 - 34。

PubMed ID
12473698 (在PubMed
]
文摘

背景:治疗胫骨开放性骨折的轴通常是复杂的延迟愈合和不愈合。本研究的目的是评估使用的安全性和有效性重组人骨形态形成protein-2 (rhBMP-2;dibotermin阿尔法)加速开放胫骨轴骨折的愈合和减少二次干预的必要性。方法:前瞻性、随机、对照、盲试验,450年开放的胫骨骨折患者被随机分配接受标准治疗(髓内钉固定和常规软组织管理(对照组)),标准的护理和植入含0.75毫克/毫升的rhBMP-2(总剂量的6毫克),或者标准的护理和植入含1.50毫克/毫升的rhBMP-2(总剂量为12毫克)。rhBMP-2植入(rhBMP-2应用于一个可吸收胶原蛋白海绵)被放置在断裂的伤口的时候关闭。随机化是伤口的严重程度分层的。主要结果测量指标是病人需要二级干预的比例,因为在术后12个月延迟愈合或不愈合。结果:四百二十一例(94%)患者可用的十二个月的随访。1.50毫克/毫升rhBMP-2组有一个失败的风险(即减少44%。二次干预,因为延迟愈合;相对危险度= 0.56; 95% confidence interval = 0.40 to 0.78; pairwise p = 0.0005), significantly fewer invasive interventions (e.g., bone-grafting and nail exchange; p = 0.0264), and significantly faster fracture-healing (p = 0.0022) than did the control patients. Significantly more patients treated with 1.50 mg/mL of rhBMP-2 had healing of the fracture at the postoperative visits from ten weeks through twelve months (p = 0.0008). Compared with the control patients, those treated with 1.50 mg/mL of rhBMP-2 also had significantly fewer hardware failures (p = 0.0174), fewer infections (in association with Gustilo-Anderson type-III injuries; p = 0.0219), and faster wound-healing (83% compared with 65% had wound-healing at six weeks; p =0.0010). CONCLUSIONS: The rhBMP-2 implant was safe and, when 1.50 mg/mL was used, significantly superior to the standard of care in reducing the frequency of secondary interventions and the overall invasiveness of the procedures, accelerating fracture and wound-healing, and reducing the infection rate in patients with an open fracture of the tibia.

beplay体育安全吗DrugBank数据引用了这篇文章

药物
药物靶点
药物 目标 生物 药理作用 行动
Dibotermin阿尔法 骨形态形成蛋白受体2型 蛋白质 人类
是的
配位体
细节