手术并超短程化疗治疗脊柱结核的5年以上疗效观察

Efficacy of ultra-short-course chemotherapy on spinal tuberculosis after surgery, an over 5-year clinical outcome

中文关键词:  脊柱结核  超短程化疗  疗效  彻底病灶清除术

英文关键词:Spine tuberculosis  Ultra-short-course chemotherapy  Efficacy  Thorough focus debridement

中文摘要:

  【摘要】 目的：观察手术并超短程化疗治疗脊柱结核的5年以上疗效，探讨脊柱结核彻底病灶清除术后超短程化疗方案治疗的可行性。方法：采用前瞻性队列研究设计，按照随机对照原则，对1998年1月～2007年1月经手术治疗的226例脊柱结核患者，根据化疗疗程不同分为：超短程化疗组（A组），137例，疗程4~6个月，平均5.5个月，化疗方案为2SHRZ/2~4HRZ；标准化疗组（B组），89例，疗程9～18个月，平均12个月，化疗方案为2SHRZ/7~16HRZ。术前年龄、性别、病灶部位、累及脊椎节段数、出现脓肿例数、后凸Cobb角、血沉（ESR）、C反应蛋白（CRP）、神经功能ASIA评分及合并脊柱外结核，两组比较均无统计学差异（P＞0.05）。两组病例均行彻底病灶清除、植骨融合及内固定手术。在治疗过程中，严格执行改良的督导下化疗（DOTS）方案。末次随访时，观察ESR、CRP、神经功能ASIA评分、生活与工作能力恢复情况、后凸Cobb角矫正与丢失情况、植骨愈合情况及抗结核药物不良反应发生情况。结果：随访时间，A组73～86个月、平均79.4个月；B组64～87个月，平均70.3个月。末次随访时，ESR、CRP降至正常者两组间比较无统计学差异（P＞0.05）。末次随访时神经功能ASIA评分两组间比较无统计学差异（P＞0.05），但组内末次随访时与术前比较有统计学差异（P<0.05）。末次随访时，A组后凸Cobb角矫正率为70.3%，丢失率8.0%；B组矫正率为68.2%，丢失率为7.6%，两组比较无统计学差异（P＞0.05）。植骨愈合时间，A组平均4.6（3.0～5.0）个月，B组平均4.1（3.0～5.0）个月，两组比较无统计学差异（P＞0.05）。末次随访时，A组融合率为100%，B组为98.9%，两组间比较无统计学差异（P＞0.05），B组未愈合的1例为严重急性肾功能衰竭未能按要求化疗者。生活、工作能力恢复正常，A组为129/137（94.2%），B组为85/89（95.5%），两组间比较无统计学差异（P＞0.05）。术后出现抗结核药物不良反应，A组11例（8.0%），B组18例（20.2%），两组间比较有统计学差异（P<0.05）。两组按各自设计化疗方案治疗结束时疗程还需延长者，A组19例（13.9%），B组6例（6.7%），两组间比较有统计学差异（P<0.05）。结论：脊柱结核患者彻底病灶清除术后采用超短程化疗的5年以上疗效与标准化疗相似；在严格超短程化疗适应证、彻底病灶清除的基础上，脊柱结核超短程化疗是可行的，超短程化疗可减少药物不良反应的发生。

英文摘要:

  【Abstract】 Objectives: To explore the feasibility of over 5-year clinical outcome of ultra-short-course chemotherapy for spinal tuberculosis after thorough focus debridement. Methods: A prospective cohort study design, in accordance with the principles of randomized controlled trial was perfomed, from January 1998 to January 2007, 226 patients with spinal tuberculosis and indicated for surgery were included in this series. According to the duration of the chemotherapy, the patients were divided into two groups. The ultra-short-course chemotherapy group(group A, 137 cases) was treated for 4-6 months(average, 5.5 months) of 2SHRZ/2-4HRZ. The standard chemotherapy group(group B, 89 cases) was treated for 9-18 months(average, 12 months) of 2SHRZ/7-16HRZ. The age, sex, lesion site, number of spinal segments involving abscess, kyphosis Cobb angle, erythrocyte sedimentation rate(ESR), C-reactive protein(CRP), ASIA score and the combined non-spinal tuberculosis showed no statistically significant difference between two groups(P>0.05). The same surgery was performed on patients in two groups. The DOTS program was adopted during treatment. The ESR, CRP, nerve function ASIA score, life quality and ability to work, loss of correction, bone graft and use of anti-TB drugs, the incidence of complications were observed at final follow-up. Results: The follow-up lasted 73-86 months(average, 79.4 months) for group A and 64-87 months(average, 70.3 months) for group B. ESR, CRP value and ASIA scores showed no significant difference between two groups before or after treatment. However, the aforementioned indexes showed significant difference(P<0.05). At final follow-up, the correction rate was 70.3%, while the loss rate of correction of 8.0% in group A and 68.2% and 7.6% in group B respectively, which showed no difference between two groups(P＞0.05). The average bone healing time for group A and group B was 4.6 months(range, 3.0-5.0 months) and 4.1 months(range, 3.0-5.0 months) respectively, which showed no difference between two groups(P＞0.05). At final follow-up, the bone healing rate was 100% in group A and 98.9% in group B, which showed no significant difference between two groups(P＞0.05). One patient abandoned chemotherapy because of acute renal dysfunction and had protracted disease. At final follow-up, 129/137 patients(94.2%) in group A, and 85/89 patients(95.5%) in group B returned to normal life and recovered the ability to work, which showed no difference between two groups(P＞0.05). Drug side effects occurred in 11(8.0%) patients in group A and 18(20.2%) patients in group B, which showed significant difference between two groups(P<0.05). 19 patients(13.9%) in group A and 6 patients(6.7%) in group B had chemotherapy extended, which showed significant difference between two groups(P<0.05). Conclusions: Ultra-short-course chemotherapy present the similar efficacy as standard chemotherapy for the spinal tuberculosis after a clinical observeration of more than 5 years. Ultra-short-course chemotherapy after thorough debridement for spinal tuberculosis is feasible and less side effects.