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韩国和香港脊柱结核治疗对照试验的15年评估。医学研究委员会脊柱结核工作小组的第十三份报告。

A 15-year assessment of controlled trials of the management of tuberculosis of the spine in Korea and Hong Kong. Thirteenth Report of the Medical Research Council Working Party on Tuberculosis of the Spine.

出版信息

J Bone Joint Surg Br. 1998 May;80(3):456-62. doi: 10.1302/0301-620x.80b3.8544.

DOI:10.1302/0301-620x.80b3.8544
PMID:9619936
Abstract

The final results up to 15 years are reported of clinical trials of the management of tuberculosis of the spine in Korea and Hong Kong. In Korea, 350 patients with active spinal tuberculosis were randomised to ambulatory chemotherapy or bed rest in hospital (in Masan) or a plaster-of-Paris jacket for nine months (in Pusan). Patients in both centres were also randomised to either PAS plus isoniazid for 18 months or to the same drugs plus streptomycin for the first three months. In Hong Kong, all 150 patients were treated with the three-drug regime and randomised to either radical excision of the spinal lesion with bone graft or open debridement. On average, the disease was more extensive in Korea, but at 15 years (or 13 or 14 years in a proportion of the patients in Korea) the great majority of patients in both countries achieved a favourable status, no evidence of CNS involvement, no radiological evidence of disease, no sinus or clinically evident abscess, and no restriction of normal physical activity. Most patients had already achieved a favourable status much earlier. The earlier results of these trials are confirmed by the long-term follow-up with no late relapse or late-onset paraplegia. The results of chemotherapy on an outpatient basis were not improved by bed rest or a plaster jacket and the only advantage of the radical operation was less late deformity compared with debridement. A second series of studies has shown that short-course regimes based on isoniazid and rifampicin are as effective as the 18-month regimes: ambulatory chemotherapy with these regimes should now be the main management of uncomplicated spinal tuberculosis.

摘要

本文报告了韩国和香港脊柱结核治疗临床试验长达15年的最终结果。在韩国,350例活动性脊柱结核患者被随机分为两组,一组接受门诊化疗,另一组在马山的医院卧床休息,或在釜山使用石膏背心固定九个月。两个中心的患者还被随机分为两组,一组接受对氨基水杨酸(PAS)加异烟肼治疗18个月,另一组在最初三个月使用相同药物加链霉素治疗。在香港,所有150例患者均接受三联药物治疗,并随机分为两组,一组接受脊柱病灶根治性切除并植骨,另一组接受开放清创术。平均而言,韩国患者的病情更为严重,但在15年时(韩国部分患者为13或14年),两国绝大多数患者均达到良好状态,无中枢神经系统受累迹象,无疾病的影像学证据,无窦道或临床明显脓肿,且正常身体活动不受限。大多数患者在此之前就已达到良好状态。这些试验的早期结果通过长期随访得到证实,无晚期复发或迟发性截瘫。门诊化疗的结果并未因卧床休息或石膏背心而改善,根治性手术的唯一优势是与清创术相比,晚期畸形较少。第二项系列研究表明,基于异烟肼和利福平的短程治疗方案与18个月的治疗方案同样有效:现在,采用这些方案的门诊化疗应成为单纯性脊柱结核的主要治疗方法。

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