HIRASAWA, Y.

LEIMBECK, R.

RABENSEIFNER, L.

Kyoto University Research Information Repository

TitleRefobacin Concentration in Blood Serum, Urine and WoundSecretion : A Comparative Study of Refobacin-Palacos andImplast-Gentamicin in Total Hip ReplacementAuthor(s)RABENSEIFNER, L.; LEIMBECK, R.; HIRASAWA, Y.Citation日本外科宝函 (1986), 55(6): 762-767Issue Date1986-11-01URL http://hdl.handle.net/2433/208656RightType Departmental Bulletin PaperTextversionpublisherKyoto UniversityArch Jpn Chir 5(6), 762～767, Nov., 1986 Refobacin Concentration in Blood Serum, Urine and Wound Secretion: A Comparative Study of Refobacin-Palacos and lmplast-Gentamicin in Total Hip Replacement L. RABENSEIFNER, R. LEIMBECKへY.HIRASAWA件Department of Orthopaedic Surgery, Konig-Ludwig-Haus University of Wi.irzburg, West Germany Received for Publication, July. 18, 1986. Introduction In the field of orthopaedic surgery the possibility of treatment for severe dysfunction of the joint can no longer be conceived without the innovation of alloarthroplasty. The value of an operation method is ultimately determined by the late results and specific possibilities of complica-tion. A critical complication in the case of total endoprosthesis is the eventuality of loosening. ¥Vith this in mind we carried out tests within a small area of the research on bone cement. Meterials and Methods The Gentamicin concentrations in serum, urine and wound secretions of 9 patients whose endoprostheses were implanted with Refobacin-Palacos were examined. These values were compared with the analyses of 8 patients whose endoprostheses were implanted with Implast-Gentamicin. The analysis of serum and urine tests was carried out by means of fluorescence-polarization with the TDX machine of the Abbott Company. The statistical indication limit was specified by the maker as 0.16 μg/ml which was corroborated in our testing. At the be-ginning of the testing we recalibrated the machine. Specifically for the urine tests, several analyses were necessary to reach the measuring range of the machine by adequate dilutions. All the results are mean values of double analysis. The wound secretion tests were checked microbiologically on Gentamicin activity by means of agar diffusion. The indication limit was 0.1 μg/ml. Results Figure 1 shows the mean values of Gentamicin concentration in the wound secretions. Key words: Total hip replacemant, Antibiotics concentration and excretion. 索引語：股関節全置換術，抗生物質生体内濃度．*Labor Dr. Leimbeck, Bad Kissingen, West Germany 料 VisitingProfessor (Present address: Dept. Orthopaedic Surgery, Kyoto Prefectural University of Medicine) Reprint request: Dr. L. Rabenseifner, K凸nig-Ludwig-Haus,BrettreichstraBe 1, 8700 Wi.irzburg, West Germany REFOBACIN IN TOTAL HIP REPLACEMENT 20 18 16 14 GENTAMICIN 12 CONCENTRATION 10 (ug/ml) 8 本meanvalues* ??Tota I Sub cut. Subcut. I ntart I ntart GM 24h 48h 24h 48h (mg/d) Fig. 1. Wound secretion 763 図 Group I 園 Group 2 Group 1 isthe Refobacin-Palacos group, and Group 2 shows those with Implast-Gentamicin. In Figure 2 the mean values of the total precipitation in the urine on each postoperative day are shown. Especially interesting were the mean values of the blood serum tests as they are shown in Figure 3. At al times the blood serum tests of the Implast-Gentamicin group were higher than those of the comparison group. In Figure 4 the blood serum tests are shown graphically in the median for both groups. Group 2 shows clearly higher values. In Group 1 the Gentamicin precipitation in the urine is, at al measured times, higher and reaches, on the first postoperative day, values nearly double those of Group 2 (Fig. 5). 25 201-1:::: .To↑al: GM/Day , .，ー15H訟，*mean values* (rng/d) 10 5 。3. 5. 2. TIME AFTER OPERATION Fig. 2. Total precipitation per day 図 Gro叩｜図 Group 2 ‘d O> *"' れ】? ???????? ????????（??? ?）???。?〈? ? ? ??（ ? ???? ．??? ．?? ．?? ? ?。??? ?????? ? ? ??↓『???????『? ? ????? ??????? ???7~ ? ．?? ． ????????（??????」?）?????-P> hコ。? 『 ? ?図図?『? ?? ? ? ? r0 ::T 。 ? ?????↓?????↓??? ???? ↓???????? ???。。?????． 、ー． 。『? ?x ?『? ? れ33ぽ ． 。 。 ? ???? ?↓?????↓? ? ? ? ? ?》↓?? （?『?）????????﹈。。? ????? ? ????。?。??〈。(J1 0 ?????。??????? ? ? ????? ? ??????????? ??????????? ? ? ??? ? ?? ????﹈）??????? ? ?????????????? ? ????????????? ????????? ） ? ??】????????? ?????? ? ? ??? ????? ??? ???????】?。?????????。?? ?。??。?????????（??? ????????『????）??????????????? ??? ??。???????﹈?。?? ? ? ﹈｛。??．。??｝?????????????? ?｝?? ? ? ???????? 『?『?????? ??????????????? ????????? ???????? ? ???? ???????〈???????? ????????（?????? ????。?????）??????? ???? ???????????????????? ? ? ?。 ??? ??〉??????（??????? ? ? ?。????????）?????????? 『????? ? ? ? ????? ? ? ????。??????Gentamicin concentration in 24 hrs. -urine *mean values* (ug/ml) 40 30~1> 2o*L 。REFOBACIN IN TOTAL HIP REPLACEMENT 2. 3. 5. TIME AFTER OPERATION Fig. 5. 臼Group I 園 Group 2 14 .. day 765 Many different ways have been tried to control the problem of prosthesis loosening3,4>. On one hand it is desirable to secure a stable anchorage without cement, and impaction of the bone and the implanted prosthesis by means of the best biomechanical design of the prosthesis. For this a biocompatible material for the prosthesis is also necessary. On the other hand, it should be attempted to advance closer to a solution of the problem by means of improvement in the operation technique as well as the improvement of the bone cement1，丸町（Table2). As in al other bone cements, the newly developed bone cement Implast-Gentamicin is a product made of pol戸nethylmethacrylate. Because of the special composition of Implast, the quality was improved in some areas compared to conventional bone cements. The maximum hardening temperature is lowered to 45°ー50°Cand the intrusion is increased to 5-9 mm . measured according to DIN-ISO 5833. The proportion of 23% monomeric methacrylic acid methyl ester is about 10% lower than that of comparable bone cements. The concentration of residuum monomers is reduced about 90% as compared with conventional bone cements. Type of Prosthesz's M tiller-Charnley Weller-Aesculap McKee-Farrar Weber-Huggler Ceramic Prosthesisー LindenhofShell Prosthesis (Wagner) Head Endoprosthesis (Moore) Others TOTAL Table 1. (1969 until 1975) (1975 until today) (1970 until 1973) (1971 until 1974) (1976 until 1978) (1976 until today) (1969 until today) 894 591 33 49 44 44 71 13 1, 729 766 日外宝第55巻第6号（昭和61年1且）Table 2. Loosening of Pγosthesis: Exchange Operation Removal Total Septic Loosening Aseptic Loosening 110 20 90 ????。?????The results of the Implast-Gentamicin Group (Group 2) reflect, in comparison to Group 1, a positive bioequivalence with an overall high Gentamicin concentration in wound secretions and blood serum. Iu Gronp 2 the relative bioavailability of the Gentamicin consisting of bone cement, amounts in the blood serum to 170.8%土46.54(median), respectively 179.9%土31.71(mean values) in comparison to the reference preparation. On the first day the renal elimination in Group 1 was much more distinct than in Group 2. In Group 2 the relative total precipitation amounts to 45.5%土11.52(median) and 45.9%士23.89(mean values) in comparison to the reference group. These optimistic data must be qualified since they show only provisional results, gained with only a small number of patients. Furthermore, al values must be cleared according to the individual Creatinin Clearance. However these provisional results allow a well-founded optimism for further testing. Conclusion The value of the Gentamicin concentrations in serum, urine and wound secretions of 9 patients whose total prosthesis were implanted with Refobacin-Palacos was compared with the analysis of 8 patients whose endoprostheses were implanted with Implast-Gentamicin. The following results were obtained. 1) The Implast-Gentamicin group reflected a positive bioequivalence with an overall high Gentamicin concentration in wound secretions and blood serum with relative bioavailability of the Gentamicin. 2) The renal elimination in Refobacin-Palacos group was much more distinct than in Implast-Gentamicin group, especially on the first day. References 1) Buchholz HW, Elson RA, Heinert, K: Antibiotic-loaded acrylic cement. Current concepts. Clinical Orthopaedics, 19v: 96-108, 1984. 2) Bayston R, Milner RDG: The sustained release of antimicrobial drugs from bone cement. J. Bone and Joint Surg., 64-B, 460 464, 1982. 3) Buchholz HW, Elson RA, Engelbrecht E, et al: Management of deep infection of total hip replacement. J. Bone and Joint Surg., 63-B, 342 353, 1981. 4) Elson RA, Jephcott AE, McGechie DB, et al: Bacterial infection and acrylic cement in the rat. J. Bone and Joint Surg., 59-B, 452 457, 1977. 5) Wahlig H, Dingeldein E: Antibiotics and bone cements. Acta Orthop. Scand., 51, 49-56, 1980. REFOBACIN IN TOTAL HIP REPLACEMENT 767 和文抄録股関節全置換術における Refobacin濃度に関する研究Department of Orthopaedic Surgery, Konig-Ludwig-Haus, University of Wiirzburg, West Germany Rabenseifner, L., Leimbeck, R., Hirasawa, Y. 股関節全置換術における合併症の 1っとして人工関節の looseningがある． 乙の人工関節のゆるみの原因として感染あるいはメカニカルな因子があげられている．人工関節の固定材料としての骨セメント使用に関しでも種々の議論がなされている．一方骨セメン ト剤も最近種々の改良が行われている．本論文ではその改良型である Implast-Gentamicinおよび Refobacin-Palacosを用いた会置換術について，血清・尿・創部における術後の Gentamicin濃度IL関して比較検討を行った．対象患者は Refobacin-Palacos使用例9例，lmplast-Gentamicin使用例8例である．それによるとは｝ Implast-Gentamicin群においては創部浸出液および血清に比較的高濃度の Gentamicinを検出し，良好な生体内当量と利用率を認めた.(2) Refobacin-Pa-lacos群においては術後第1日自に腎よりの高濃度の排出を認めた．今後なお生体力学的な骨セメ ントの効果の研究に加えて，とのような生化学的な性質の研究も進めていく必要がある．

股関節全置換術におけるRefobacin濃度に関する研究

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股関節全置換術におけるRefobacin濃度に関する研究

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