翻译：中南大学湘雅二院　黄添隆

　　

　　前言：对于前交叉韧带撕裂，通常可选择针对性的康复锻炼或者手术重建韧带。既往的KANNON研究采用随机对照方法对比了早期ACL重建和康复锻炼后延期重建的临床效果，发现两组间KOOS评分无明显差异。本研究针对早期ACL重建和康复锻炼后延期重建进行了成本效应分析。

　　方法：应用Markov决策模型对早期ACL重建（ER组）和康复锻炼后延期重建（DR组）进行成本效用分析。疗效的概率和效力分析来源于两大数据分析：其一是膝前交叉韧带非手术治疗及手术治疗(KANON)研究，其二为骨科多中心网络数据库中针对ACL重建的前瞻性纵向多中心研究。采用SF-6D进行效用分析。从整个社会角度按国家平均医疗保险赔偿总值（2011年美元价值）进行成本分析。成本和效用按国家医疗卫生成本效益协议专家组数据进行相应调整。使用质量调整寿命年衡量效力，质量调整寿命年用来测量生活的数量和质量，是评价效力的单位。主要疗效评价指标为平均增量成本、平均增量效力、平均增量质量调整寿命年以及健康净收益。本研究的愿付价格设定为50000美元，与目前国家可接受标准一致。

　　结果：本研究中ER组较DR组的增量收益为0.28质量调整寿命年。但ER组平均费用较DR组高1690美元。而增量成本效果比为5967美元/质量调整寿命年，该数据明显低于愿付价格阈值。敏感度分析表明，如果ACL重建费用降至1404美元或者在经过2年康复锻炼仍残留有临床不稳定症状的ACL撕裂患者（约32%）中，若超过58%患者最终选择行延期ACL重建术，那么早期ACL重建成本更低。在这些情况下，早期ACL重建将更加有效且成本更低，应成为治疗的首选。
　　讨论：尽管康复后延期ACL重建的成本效益与早期ACL重建相近，但由于早期ACL重建的增益效力低于愿付价格阈值，因此其成为目前的主流治疗方式。换而言之，早期ACL重建与康复后延期ACL重建相比，虽其医疗费用稍高，但仍在社会承受范围之内，成本较低且收益更高。

结论：研究显示为降低社会医疗保健负担，早期ACL重建为更好的治疗策略。

 

 

 

 

 

　　An initial anterior cruciate ligament (ACL) tear can be treated with focused rehabilitation or surgical reconstruction. The KANON randomized control trial compared early ACL reconstruction to rehabilitation and optional delayed reconstruction and found no difference in outcome by intention to treat analysis of KOOS scores. The purpose of this study was to compare the cost-effectiveness of early ACL reconstruction to rehabilitation and delayed reconstruction.
METHODS

　　Markov decision model was constructed for a cost-utility analysis of early reconstruction (ER) versus rehabilitation and optional delayed reconstruction (DR). Outcome probabilities and effectiveness were derived from two sources: The Knee Anterior Cruciate Ligament, Nonsurgical versus Surgical Treatment (KANON) Study and the Multicenter Orthopaedic Outcome Network (MOON) database of a prospective longitudinal cohort of anterior cruciate ligament reconstructions. Utilities were measured by the SF-6D. Costs were estimated from the societal perspective with use of the national average Medicare reimbursement for the procedures in 2011 U.S. dollars. Costs and utilities were discounted in accord with the United States Panel on Cost-Effectiveness in Health and Medicine. Effectiveness was expressed in quality-adjusted life years gained (QALYs). QALYs measure the quantity and quality of life and are a unit of utility. Principal outcome measures were average incremental costs, incremental effectiveness, incremental quality-adjusted life years (QALYs), and net health benefits. Willingness-to-pay was set at $50,000, the currently accepted standard in the U.S.
RESULTS

　　In the base case, early ACL reconstruction resulted in an incremental gain of 0.28 QALYs over rehabilitation and delayed reconstruction. However, early reconstruction cost, on average, $1,690 more than rehabilitation and delayed reconstruction. The incremental cost effectiveness ratio was $5,967/QALY. This number was well below the $50,000/QALY willingness-to-pay threshold. Sensitivity analysis revealed that if the cost of ACL reconstruction falls below $1,404 or 58% of the remaining 32% of patients with residual clinical instability at two years after rehabilitation eventually choose ACL reconstruction, the early reconstruction treatment strategy becomes less costly. At these thresholds, early reconstruction was both more effective and less costly, and therefore, a dominant treatment strategy.
DISCUSSION AND CONCLUSION

　　Early ACL reconstruction produced effectiveness gains below the willingness-to-pay threshold and is therefore, the preferred treatment compared to rehabilitation and delayed ACL reconstruction with cost effectiveness as the primary outcome. In other words, early ACL reconstruction provides a greater average benefit to the patient at a cost highly acceptable to society. Reasonable scenarios exist where early reconstruction would cost less than rehabilitation and delayed reconstruction. These findings suggest that when considering optimal societal healthcare delivery, early ACL reconstruction is a viable treatment option.