PDF(Pubmed)
Abstract：
Background: Chemonucleolysis is a minimally invasive treatment of lumbar disc herniation (LDH). However, the low specificity of the enzyme and the existence of serious adverse events limit the application of chemonucleolysis. Clinical studies in recent years have shown that Chondroitin sulfate ABC endolyase (condoliase) is a potential therapeutic enzyme for LDH. Aim. A meta-analysis was conducted to determine the efficacy and safety of condoliase in LDH treatment. Methods: We searched Web of Science, Embase, PubMed, and Cochrane Library databases. Two reviewers independently screened articles, extracted data, and assessed the risk of bias. The outcomes were the total effective rate, Oswestry Disability Index (ODI) score change, the proportion of lumbar surgery after condoliase treatment, herniated mass volume change, Pfirrmann grade change, and adverse events. Review Manager 5.3 and Stata 12.0 were used for meta-, sensitivity, and bias analysis. Results: Ten studies were included. A single-arm meta-analysis showed that the total effective rate was 78% [95% confidence interval (CI) 75%-81%], the proportion of surgery was 9% (95% CI 7%-12%), the proportion of Pfirrmann grade change was 43% (95%CI 38%-47%), and the adverse events were 4% (95% CI 2%-6%) after condoliase treatment. The two-arm meta-analysis showed that the ODI score change [standardized mean difference (SMD) -2.46, 95% CI -3.30 to -1.63] and the herniated mass volume change (SMD -16.97, 95% CI -23.92 to -10.03) of the condoliase treatment group were greater than those of the placebo control group, and there was no difference in adverse events between the two groups (OR 1.52, 95% CI 0.60-3.85). The results of sensitivity and publication bias analyses showed that the results were robust. Conclusion: Condoliase intradiscal injection has excellent eutherapeutic and safety for LDH, thus, has considerable potential as a treatment option besides conservative treatment and surgical intervention for LDH. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022375492, PROSPERO (CRD42022375492).
摘要：
背景：化学核溶解术是腰椎间盘突出症（LDH）的微创治疗方法。然而,酶的低特异性和严重不良事件的存在限制了化学核溶解术的应用。近年来的临床研究表明，硫酸软骨素ABC内溶酶（condoliase）是一种潜在的LDH治疗酶。瞄准.进行了荟萃分析，以确定condoliase在LDH治疗中的疗效和安全性。方法：我们搜索了WebofScience，Embase,PubMed,和Cochrane图书馆数据库。两名审稿人独立筛选文章，提取的数据，并评估了偏差的风险。结果是总有效率，Oswestry残疾指数(ODI)评分变化，腰椎手术治疗后的比例，突出的肿块体积变化，Pfirrmann等级改变,和不良事件。审查经理5.3和Stata12.0用于元-，灵敏度,和偏倚分析。结果：共纳入10项研究。单臂荟萃分析表明，总有效率为78％[95％置信区间（CI）75％-81％]，手术比例为9%(95%CI7%-12%)，Pfirrmann等级变化的比例为43%(95CI38%-47%)，并且在condoliase治疗后的不良事件为4%(95%CI2%-6%)。双臂荟萃分析显示,condoliase治疗组的ODI评分变化[标准化均差(SMD)-2.46,95%CI-3.30~-1.63]和突出肿块体积变化(SMD-16.97,95%CI-23.92~-10.03)均大于安慰剂对照组,两组之间的不良事件没有差异（OR1.52，95％CI0.60-3.85）。敏感性和发表偏倚分析的结果表明，结果是稳健的。结论:盘内注射Condoliase对LDH具有良好的治疗效果和安全性。因此，除了保守治疗和手术干预外，作为LDH的治疗选择还具有相当大的潜力。系统审查注册：https://www。crd.约克。AC.uk/prospro/display_record.php?ID=CRD42022375492,PROSPERO(CRD42022375492)。
