Huang Zeling, Xu Bo, Liu Yujiang, Chen Hua, Cai Xuefeng, Zhang Long, Shen Xiaofeng, Li Yuwei
Suzhou TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Suzhou, Jiangsu, China.
Front Pharmacol. 2023 Aug 21;14:1151998. doi: 10.3389/fphar.2023.1151998. eCollection 2023.
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. 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. 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. 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. https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022375492, PROSPERO (CRD42022375492).
化学髓核溶解术是一种治疗腰椎间盘突出症（LDH）的微创治疗方法。然而，该酶的低特异性以及严重不良事件的存在限制了化学髓核溶解术的应用。近年来的临床研究表明，硫酸软骨素ABC内切酶（condoliase）是一种治疗LDH的潜在治疗酶。目的。进行一项荟萃分析以确定condoliase治疗LDH的疗效和安全性。我们检索了Web of Science、Embase、PubMed和Cochrane图书馆数据库。两名 reviewers 独立筛选文章、提取数据并评估偏倚风险。结局指标为总有效率、Oswestry功能障碍指数（ODI）评分变化、condoliase治疗后腰椎手术的比例、突出肿块体积变化、Pfirrmann分级变化和不良事件。使用Review Manager 5.3和Stata 12.0进行荟萃分析、敏感性分析和偏倚分析。纳入了10项研究。单臂荟萃分析表明，condoliase治疗后的总有效率为78%[95%置信区间（CI）75%-81%]，手术比例为9%（95%CI 7%-12%），Pfirrmann分级变化比例为43%（95%CI 38%-47%），不良事件为4%（95%CI 2%-6%）。双臂荟萃分析表明，condoliase治疗组的ODI评分变化[标准化均数差（SMD）-2.46，95%CI -3.30至-1.63]和突出肿块体积变化（SMD -16.97，95%CI -23.92至-10.03）大于安慰剂对照组，两组不良事件无差异（OR 1.52，95%CI 0.60-3.85）。敏感性分析和发表偏倚分析结果表明结果具有稳健性。椎间盘内注射condoliase对LDH具有良好的治疗效果和安全性，因此，除了LDH的保守治疗和手术干预外，作为一种治疗选择具有相当大的潜力。https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022375492，PROSPERO（CRD42022375492）
