不同部位和途径注射胶原酶治疗腰椎间盘突出症有效性与安全性的系统评价

Effectiveness and Safety of Different Injection Sites of Collagenase for Lumbar Intervertebral Disc Protrusion: A Systematic Review

目的运用Cochrane系统评价的方法评价不同部位和不同途径注射胶原酶治疗腰椎间盘突出症的有效性和安全性,以期为临床合理选择注射部位和途径提供依据。方法计算机检索PubMed(1966-2006．5)、EMbase(1966～2006．5)、Cochrane图书馆(2006年第2期)、CRD(Center for Reviews and Dissemination,York University)和CBM(1978～2006．5)、CNKI (1994～2006)、VIP(1989～2006),同时筛检了纳入文献的参考文献。收集有关不同部位和途径注射胶原酶治疗腰椎间盘突出症的随机和半随机对照试验,由两名评价员独立评价文献质量。结果共纳入8个研究,1035例患者。由于纳入研究间存在异质性,未能进行合并分析。其中,4个研究为比较盘内、盘外及盘内外注射,结果显示胶原酶盘内、盘外和盘内外注射的近、远期有效率的差异均无统计学意义。另4个研究(436例)为盘外法注射中各间隙比较,其中1个研究结果(100例)显示,前间隙与侧间隙注射胶原酶均优于后间隙注射;其余研究(纳入病例数均小于50例)显示,三个间隙注射疗效相似(P值均大于0．05)。结论目前尚无证据证明不同部位注射胶原酶治疗腰椎间盘突出症的效果有何差异,但不同间隙注射的研究显示注射到前间隙与侧间隙均优于后间隙。由于每种注射部位和途径纳入的研究数少,质量不高,且诊断标准、随访时间、结果测量指标和判效标准等均不一致,因此需要开展大样本、多中心、方法科学、规范的高质量随机对照试验进一步验证。

Objective To evaluate the effectiveness and safety of different injection sites for collagenase chemonucleolysis for lumbar intervertebral disc protrusion （LIDP）. Methods We searched for randomized controlled trials （RCTs） and quasi-RCTs in the following electronic databases： Pubmed （1966 to May 2006）, EMBASE（1966 to May 2006）, The Cochrane library （Issue 2, 2006）, CRD（Center for Reviews and Dissemination）,York University, CBM （1978 to May 2006 ）, CNKI（1994-2006）and VIP（1989-2006）. Quality assessment and data extraction were conducted by two reviewers independently. Disagreement was resolved through discussion. Results Eight studies involving a total of 1035 participants met the inclusion criteria. Meta-analysis was not carried out because of apparent heterogeneity. Four studies made comparisons among intradisc, extradisc, and combined intra- and extra-disc injection. One study （62 participants） showed that intradisc injection was superior to extradisc injection （RR 3.71, 95% CI 1.19 to 11.58, P〈0.05）. Another study （240 participants） showed that intradisc injection was superior to combined intra- and extra-disc injection after 3 months and 6 months of follow-up （RR 0.88, 95% CI 0.80 to 0.98, P〈0.05）. The other two studies showed no significant difference among intradisc, extradisc, and combined intra- and extra-disc injection. Four studies （436 participants in total） showed that amongst three extradisc injections, both anterior epidural space injection and lateral epidural space injection were superior to posterior epidural space injection （P〈0.05）. Although one study indicated that anterior epidural space injection was superior to lateral epidural space injection （RR 1.24, 95% CI 1.03 to 1.51, P〈0.05）, no statistical significance was found between anterior epidural space injection and lateral epidural space injection in two other studies （P〉0.05）. Conclusions There is insufficient evidence to identify which injection site for collagenase is the most effective for lumbar intervertebral disc protrusion. The included studies showed that both anterior and lateral epidural space injection were superior to posterior epidural space injection. However, these studies are too small and poor quality, and have different diagnostic criteria, follow-up time points, outcome measures and efficacy parameters. Thus, more high quality and large-scale RCTs are needed.