J Bone Joint Surg Br. 1976 Nov;58-B(4):399-411. doi: 10.1302/0301-620X.58B4.1018027.
In two centres in Korea 350 patients with a diagnosis of tuberculosis of the thoracic and/or lumbar spine were allocated at random: in Masan to in-patient rest in bed (IP) for six months followed by out-patient treatment or to ambulatory out-patient treatment (OP) from the start; in Pusan to out-patient treatment with a plaster-of-Paris jacket (J) for nine months or to ambulatory treatment without any support (No J). All patients recieved chemotherapy with PAS with isoniazid for eighteen months, either supplemented with streptomycin for the first three months (SPH) or without this supplement (PH), by random allocation. The main analysis of this report concerns 299 patients (eighty-three IP, eighty-three OP, sixty-three J, seventy No J; 143 SPH, 156 PH). Pre-treatment factors were similar in both centres except that the patients in Pusan had, on average, less extensive lesions although in a greater proportion the disease was radiographically active. One patient (J/SPH) died with active spinal disease and three (all No J/SPH) with paraplegia. A fifth patient (IP/PH) who died from cardio respiratory failure also had pulmonary tuberculosis. Twenty-three patients required operation and/or additional chemotherapy for the spinal lesion. A sinus or clinically evident abscess was either present initially or developed during treatment in 41 per cent of patients. Residual lesions persisted in ten patients (four IP, two OP, one J, three No J; six SPH, four PH) at five years. Thirty-two patients had paraparesis on admission or developing later. Complete resolution occurred in twenty on the allocated regimen and in eight after operation or additional chemotherapy or both. Of the remaining four atients, all of whom had operation and additional chemotherapy, three died and one still had paraparesis at five years. Of 295 patients assessed at five years 89 per cent had a favourable status. The proportions of the patients responding favourably were similar in the IP (91 per cent) and OP (89 per cent) series, in the J (90 per cent) and No J (84 per cent) series and in the SPH (86 per cent) and PH (92 per cent) series.
在韩国的两个医疗中心，350名被诊断患有胸椎和/或腰椎结核的患者被随机分配：在马山，一部分患者接受为期6个月的住院卧床休息（IP），之后进行门诊治疗；另一部分患者从一开始就接受门诊治疗（OP）；在釜山，一部分患者使用巴黎石膏背心（J）进行为期9个月的门诊治疗，另一部分患者不使用任何支撑物进行门诊治疗（无J）。所有患者均接受对氨基水杨酸与异烟肼联合化疗18个月，随机分配，一部分患者在前三个月补充链霉素（SPH），另一部分患者不补充（PH）。本报告的主要分析涉及299名患者（83名IP、83名OP、63名J、70名无J；143名SPH、156名PH）。两个中心的治疗前因素相似，不过釜山的患者平均病变范围较小，尽管在更大比例的患者中疾病在影像学上呈活动状态。1名患者（J/SPH）死于活动性脊柱疾病，3名患者（均为无J/SPH）死于截瘫。第5名死于心肺功能衰竭的患者（IP/PH）也患有肺结核。23名患者因脊柱病变需要手术和/或额外化疗。41%的患者在治疗开始时就存在窦道或临床上明显的脓肿，或者在治疗过程中出现。5年后，10名患者（4名IP、2名OP、1名J、3名无J；6名SPH、4名PH）仍有残留病变。32名患者入院时或后来出现轻瘫。在分配的治疗方案下，20名患者完全康复，8名患者在手术后或接受额外化疗或两者兼施后康复。其余4名患者均接受了手术和额外化疗，其中3名患者死亡，1名患者在5年后仍有轻瘫。在295名接受5年评估的患者中，89%的患者状况良好。IP组（91%）和OP组（89%）、J组（90%）和无J组（84%）、SPH组（86%）和PH组（92%）中治疗反应良好的患者比例相似。
