Li Tianshuo, Ye Pengfei, He Xinli, Li Chen, Xi Lanlan, Xi Zuowu
Department of Integrated Traditional Chinese and Western Medicine, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.
Department of Anorectal Medicine, Henan Provincial Hospital of Traditional Chinese Medicine, Zhengzhou, China.
Front Pharmacol. 2025 Aug 21;16:1642347. doi: 10.3389/fphar.2025.1642347. eCollection 2025.
Calcium channel blockers (CCBs) are first-line pharmacotherapy for chronic anal fissures (CAF), but the optimal administration route (oral vs. topical) remains unclear. This systematic review and meta-analysis compared efficacy and safety of oral vs. topical CCBs for CAF.
PubMed and Embase were systematically searched from inception through February 2025 for relevant randomized controlled trials (RCTs). Two reviewers independently performed study selection, quality assessment, and data extraction. Random-effects models were used to pool effect sizes, with sensitivity analyses to assess robustness. The quality of evidence was assessed using the GRADE approach.
Four RCTs (279 patients) were included. Topical CCBs significantly reduced unhealed fissure risk vs. oral CCBs (OR = 2.65, 95% CI = 1.50-4.69, moderate certainty evidence), with comparable recurrence rates (based on limited data from 3 studies). Initial side effect analysis showed no difference, but sensitivity analysis excluding a high-bias trial revealed fewer adverse events with topical CCBs (OR = 13.16, 95% CI = 5.05-34.3, moderate certainty evidence).
Based on limited evidence, topical CCBs may offer superior healing rates and safety profiles vs. oral formulations for CAF, with similar recurrence rates, though additional high-quality studies are needed to confirm these findings.
钙通道阻滞剂（CCBs）是慢性肛裂（CAF）的一线药物治疗方法，但最佳给药途径（口服与局部用药）仍不明确。本系统评价和荟萃分析比较了口服与局部应用CCBs治疗CAF的疗效和安全性。
从创刊至2025年2月，系统检索PubMed和Embase以获取相关随机对照试验（RCTs）。两名研究者独立进行研究筛选、质量评估和数据提取。采用随机效应模型汇总效应量，并进行敏感性分析以评估稳健性。使用GRADE方法评估证据质量。
纳入4项RCTs（279例患者）。与口服CCBs相比，局部应用CCBs显著降低了肛裂未愈合的风险（OR = 2.65，95%CI = 1.50 - 4.69，中等确定性证据），复发率相当（基于3项研究的有限数据）。初始副作用分析显示无差异，但排除一项高偏倚试验的敏感性分析显示，局部应用CCBs的不良事件较少（OR = 13.16，95%CI = 5.05 - 34.3，中等确定性证据）。
基于有限的证据，对于CAF，局部应用CCBs可能比口服制剂具有更高的愈合率和更好的安全性，复发率相似，不过需要更多高质量研究来证实这些发现。
