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术前放疗与使用非甾体类抗炎药预防全髋关节置换术后异位骨化的随机试验结果

Preoperative irradiation versus the use of nonsteroidal anti-inflammatory drugs for prevention of heterotopic ossification following total hip replacement: the results of a randomized trial.

作者信息

Kölbl O, Knelles D, Barthel T, Raunecker F, Flentje M, Eulert J

机构信息

Clinic and Policlinic for Radiotherapy of the University of Würzburg, Germany.

出版信息

Int J Radiat Oncol Biol Phys. 1998 Sep 1;42(2):397-401. doi: 10.1016/s0360-3016(98)00204-1.

DOI:10.1016/s0360-3016(98)00204-1
PMID:9788422
Abstract

PURPOSE

Previous studies showed the effectiveness of early preoperative (4 h before operation) irradiation for prevention of heterotopic ossification (HO) after total hip replacement. This procedure can result in logistic problems, if there is a great distance between the department of radiotherapy and the orthopedic clinic. To avoid these organizational problems a prospective study was undertaken to analyze the effectiveness of preoperative irradiation on the day preceding surgery (16-20 h before operation).

METHODS AND MATERIALS

Between 1995 and 1996, 100 patients were randomized to receive a prophylactic therapy for prevention of heterotopic ossification. Forty-six patients were irradiated with 7 Gy single dose within 16-20 h before operation. Fifty-four patients were treated with nonsteroidal anti-inflammatory drugs (NSAID) (Voltaren resinat 2 x 75 mg/day for 2 weeks). Heterotopic ossification was scored according to the Brooker Grading system. One hundred patients receiving no prophylactic therapy after total hip arthroplasty between 1988 and 1992 were analyzed and defined as the historical control group.

RESULTS

Incidence of heterotopic ossification was 47.8% in the 7 Gy preoperative group (Brooker Score I: 36.9%; II: 8.7%; III: 2.2%; IV: 0%) and 11.1% in the NSAID group (Brooker Score I: 9.3%; II: 1.8%; III: 0%; IV: 0%). Regarding overall heterotopic ossification there was a significant difference between the NSAID group and the 7 Gy group (p < 0.01). Analyzing the clinically significant heterotopic ossification (Brooker Score III and IV) there was no significant difference between the two treatment arms (p > 0.05). In the untreated historical control group the incidence of heterotopic ossification was 65% (Brooker Score I: 26%; II: 15%; III: 19%; IV: 5%). Referring to overall and to clinically relevant heterotopic ossification the incidence of HO was greater in the control group than in the prophylactically treated groups (p < 0.05).

CONCLUSION

Irradiation within 16-20 h before operation and use of NSAID (Voltaren resinat) can reduce the incidence of clinically relevant heterotopic ossification after total hip replacement.

摘要

目的

先前的研究表明,术前早期(手术前4小时)照射对于预防全髋关节置换术后异位骨化(HO)有效。如果放疗科与骨科门诊距离较远,此方法可能会导致后勤问题。为避免这些组织问题,我们进行了一项前瞻性研究,以分析手术前一天(手术前16 - 20小时)进行术前照射的有效性。

方法与材料

1995年至1996年期间,100例患者被随机分配接受预防异位骨化的预防性治疗。46例患者在手术前16 - 20小时内接受7 Gy单次剂量照射。54例患者接受非甾体抗炎药(NSAID)治疗(扶他林树脂2×75毫克/天,持续2周)。根据布鲁克分级系统对异位骨化进行评分。对1988年至1992年期间全髋关节置换术后未接受预防性治疗的100例患者进行分析,并将其定义为历史对照组。

结果

7 Gy术前照射组异位骨化发生率为47.8%(布鲁克评分I:36.9%;II:8.7%;III:2.2%;IV:0%),NSAID组为11.1%(布鲁克评分I:9.3%;II:1.8%;III:0%;IV:0%)。就总体异位骨化而言,NSAID组与7 Gy组之间存在显著差异(p < 0.01)。分析具有临床意义的异位骨化(布鲁克评分III和IV),两个治疗组之间无显著差异(p > 0.05)。在未治疗的历史对照组中,异位骨化发生率为65%(布鲁克评分I:26%;II:15%;III:19%;IV:5%)。就总体和临床相关的异位骨化而言,对照组中HO的发生率高于预防性治疗组(p < 0.05)。

结论

手术前16 - 20小时内照射以及使用NSAID(扶他林树脂)可降低全髋关节置换术后临床相关异位骨化的发生率。

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