Chang Yuchiao, Singer Daniel E, Wu Yen A, Keller Robert B, Atlas Steven J
General Medicine Division and the Clinical Epidemiology Unit, Medical Services, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114, USA.
J Am Geriatr Soc. 2005 May;53(5):785-92. doi: 10.1111/j.1532-5415.2005.53254.x.
To assess the relative effect of initial surgical and nonsurgical treatment on longitudinal outcomes of patients with lumbar spinal stenosis over a 10-year follow-up period.
A prospective observational cohort study.
Enrollment from community-based specialist practices throughout Maine.
One hundred forty-four patients with lumbar spinal stenosis who had at least one follow-up: 77 initially treated surgically and 67 initially treated nonsurgically.
Initial surgical or nonsurgical treatment.
Clinical data were obtained at baseline and outcomes followed at regular intervals over 10 years with mailed questionnaires including patient-reported symptoms of back pain, leg symptoms, back-specific functional status, and satisfaction. Longitudinal data were analyzed using general linear mixed models. In addition to treatment (initial surgical or nonsurgical care), time period, and the interaction between treatment and time, the models included baseline score, patient age and sex, and a time-varying general health status score. The effects of these covariates in explaining differences between treatment groups were also examined. The effect of subsequent surgical procedures was assessed using different analysis strategies.
The 10-year rate of subsequent surgical procedures was 23% and 38% for patients initially treated surgically and nonsurgically, respectively, and the overall 10-year survival rate was 69%. Patients undergoing initial surgical treatment had worse baseline symptoms and functional status than those initially treated nonsurgically. For all outcomes and at each time point, surgically treated patients reported greater improvement in symptoms and functional status and higher satisfaction scores, indicative of better outcomes, than nonsurgically treated patients. However, the relative magnitude of the benefit diminished over time such that the relative differences for low back pain and satisfaction were no longer significant over long-term follow-up (both P=.08 for treatment effect between 5 and 10 years after controlling for covariates). Regardless of initial treatment received, patients undergoing subsequent surgical procedures reported less improvement in outcomes over time than patients who did not undergo subsequent procedures, but the relative differences between treatment groups were similar in analyses that controlled for outcomes after subsequent procedures.
After controlling for covariates, patients initially treated surgically demonstrated better outcomes on all measures than those initially treated nonsurgically. Although outcomes of initial surgical treatment remained superior over time, the relative benefit of surgery diminished in later years, especially for low back pain and satisfaction. Patients undergoing subsequent surgery had worse outcomes regardless of initial treatment received, but excluding them did not change overall treatment group comparisons. The analytical methods described may be helpful in the design and analysis of future studies comparing treatment outcomes for patients with lumbar spinal stenosis.
评估初始手术治疗和非手术治疗对腰椎管狭窄症患者10年随访期纵向预后的相对影响。
一项前瞻性观察队列研究。
从缅因州各地的社区专科诊所招募患者。
144例腰椎管狭窄症患者,至少进行了一次随访:77例最初接受手术治疗,67例最初接受非手术治疗。
初始手术或非手术治疗。
在基线时获取临床数据,并在10年期间定期通过邮寄问卷随访预后情况,问卷包括患者报告的背痛症状、腿部症状、背部特定功能状态和满意度。使用一般线性混合模型分析纵向数据。除了治疗方式(初始手术或非手术治疗)、时间段以及治疗与时间的交互作用外,模型还包括基线评分、患者年龄和性别以及一个随时间变化的总体健康状况评分。还研究了这些协变量在解释治疗组之间差异方面的作用。使用不同的分析策略评估后续手术的影响。
最初接受手术治疗和非手术治疗的患者,后续手术的10年发生率分别为23%和38%,总体10年生存率为69%。最初接受手术治疗的患者基线症状和功能状态比最初接受非手术治疗的患者更差。对于所有预后指标以及每个时间点,手术治疗的患者在症状和功能状态改善方面以及满意度评分方面均高于非手术治疗的患者,表明手术治疗的预后更好。然而,随着时间的推移,获益的相对程度逐渐减小,以至于在长期随访中,下腰痛和满意度的相对差异不再显著(在控制协变量后,5至10年的治疗效果P值均为0.08)。无论最初接受何种治疗,接受后续手术的患者随着时间推移在预后改善方面均不如未接受后续手术的患者,但在控制后续手术预后的分析中,治疗组之间的相对差异相似。
在控制协变量后,最初接受手术治疗的患者在所有测量指标上的预后均优于最初接受非手术治疗的患者。虽然初始手术治疗的预后随时间推移仍保持优势,但手术的相对获益在后期有所减少,尤其是在下腰痛和满意度方面。无论最初接受何种治疗,接受后续手术的患者预后更差,但排除这些患者并未改变总体治疗组的比较结果。所描述的分析方法可能有助于未来比较腰椎管狭窄症患者治疗预后的研究的设计和分析。