McLaren Alex C, Nugent Matt, Economopoulos Kostas, Kaul Himanshu, Vernon Brent L, McLemore Ryan
Arizona State University, Phoenix, AZ, USA.
Clin Orthop Relat Res. 2009 Jul;467(7):1693-8. doi: 10.1007/s11999-009-0847-1. Epub 2009 Apr 24.
Since low-dose antibiotic-loaded bone cement (ALBC) was approved by the FDA for second-stage reimplantation after infected arthroplasties in 2003, commercially premixed low-dose ALBC has become available in the United States. However, surgeons continue to mix ALBC by hand. We presumed hand-mixed ALBC was not as homogeneous as commercially premixed ALBC. We assessed homogeneity by determining the variation in antibiotic elution by location in a batch, from premixed and hand-mixed formulations of low-dose ALBC. Four hand-mixed methodologies were used: (1) suspension--antibiotic powder in the liquid monomer; (2) no-mix--antibiotic powder added but not mixed with the polymer powder before adding monomer; (3) hand-stirred--antibiotic powder stirred into the polymer powder before the monomer was added; and (4) bowl-mix--antibiotic powder mixed into polymer powder using a commercial mixing bowl before the monomer was added. Antibiotic elution was measured using the Kirby-Bauer bioassay. None of the mixing methods had consistently dissimilar homogeneity of antibiotic distribution from the others. Based upon our data we conclude hand-mixed low-dose ALBC is not less homogeneous than commercially premixed formulations.
自2003年低剂量载抗生素骨水泥(ALBC)被美国食品药品监督管理局(FDA)批准用于感染性关节置换术后的二期再植入以来,市售预混低剂量ALBC已在美国上市。然而,外科医生仍继续手工混合ALBC。我们推测手工混合的ALBC不如市售预混的ALBC均匀。我们通过测定低剂量ALBC预混和手工混合配方中一批产品不同位置的抗生素洗脱差异来评估均匀性。使用了四种手工混合方法:(1)悬浮法——抗生素粉末加入液态单体中;(2)不混合法——加入抗生素粉末但在加入单体前不与聚合物粉末混合;(3)手工搅拌法——在加入单体前将抗生素粉末搅拌到聚合物粉末中;(4)碗混法——在加入单体前使用商用搅拌碗将抗生素粉末混入聚合物粉末中。使用Kirby-Bauer生物测定法测量抗生素洗脱。没有一种混合方法在抗生素分布均匀性上与其他方法始终存在差异。基于我们的数据,我们得出结论,手工混合的低剂量ALBC在均匀性上并不亚于市售预混配方。