【目的】 观察丹归四味饮破壁饮片治疗气虚血瘀型退行性腰椎管狭窄症（DLSS）患者的临床疗效。【方法】 采用随机对照 设计，将2023年11月至2025年1月广东省第二中医院（黄埔医院）收治的72例气虚血瘀型DLSS患者按随机数字表法随机分 为破壁饮片组和传统饮片组，每组各36例。2组患者均给予口服艾瑞昔布片、甲钴胺片的西医常规治疗，在此基础上，破壁 饮片组给予口服丹归四味饮破壁饮片治疗，传统饮片组给予口服丹归四味饮传统饮片治疗，2组均连续治疗1周。观察2组 患者治疗前后疼痛视觉模拟量表（VAS）评分、Oswestry功能障碍指数（ODI）评分和腰椎功能日本骨科协会（JOA）评分的变化情 况，并评价 2 组患者的临床疗效及用药安全性。【结果】（1）临床疗效方面：治疗 1 周后，破壁饮片组的总有效率为 88.89% （32/36），传统饮片组为 75.00%（27/36），组间比较（χ2检验），破壁饮片组的疗效明显优于传统饮片组（P＜0.05）。（2）结局 指标方面：治疗后，2 组患者的 VAS 评分、ODI 评分均较治疗前明显降低（P＜0.05），JOA 评分均较治疗前明显升高（P＜ 0.05），且破壁饮片组对 VAS 评分、ODI 评分的降低幅度及对 JOA 评分的升高幅度均明显优于传统饮片组（P＜0.05）。（3）安 全性方面：破壁饮片组的不良反应率为 8.33%（3/36），传统饮片组为 11.11%（4/36），组间比较，差异无统计学意义（P＞ 0.05）。【结论】 相比丹归四味饮传统饮片，丹归四味饮破壁饮片在缓解气虚血瘀型DLSS患者腰腿疼痛、改善腰椎功能方面疗 效更好，该研究为中药破壁饮片的组方应用与进一步发展提供了循证医学证据。

Objective To evaluate the clinical efficacy of Dangui Siwei Yin cell-wall broken powder in the treatment of degenerative lumbar spinal stenosis （DLSS） with qi deficiency and blood stasis syndrome. Methods A randomized controlled trial was conducted on 72 patients with qi deficiency and blood stasis-typed DLSS admitted to Guangdong Second Traditional Chinese Medicine Hospital （Huangpu Hospital） from November 2023 to January 2025. Patients were randomly divided into a cell-wall broken powder group and a traditional midicinal slice group （36 cases each） using a random number table method. Both groups received conventional western treatment （oral administration of Etoricoxib Tablets and Mecobalamin Tablets）. Additionally，the cell-wall broken powder group was treated with Dangui Siwei Yin cell-wall broken powder，while the traditional midicinal slice group received traditional decoction of Dangui Siwei Yin. Both groups underwent a 1-week treatment course. Changes in Visual Analogue Scale （VAS） of pain scores， Oswestry Disability Index （ODI） scores， and Japanese Orthopaedic Association （JOA） lumbar function scores were observed before and after treatment. Clinical efficacy and medication safety were evaluated. Results （1） After one week of treatment，the total effective rate was 88.89% （32/36） in the cell-wall broken powder group and 75.00% （27/36） in the traditional midicinal slice group. The intergroup comparison （by chi-square test） showed that the efficacy in the cell-wall broken powder group was superior to the traditional midicinal slice group （P＜0.05）. （2） After treatment， VAS and ODI scores were significantly decreased in both groups （P＜0.05），while JOA scores significantly increased （P＜0.05）. The cell-wall broken powder group demonstrated superior improvements in VAS and ODI reduction and JOA elevation compared to the traditional midicinal slice group （P＜0.05）.（3） The adverse reaction rate was 8.33% （3/36） in the cell-wall broken powder group and 11.11% （4/36） in the traditional midicinal slice group，with no statistically significant difference （P＞0.05）. Conclusion Compared with traditional midicinal slice，Dangui Siwei Yin cell-wall broken powder exhibit better efficacy in alleviating low back and leg pain and improving lumbar function in qi deficiency and blood stasis-typed DLSS patients. This study provides evidence-based medical support for the clinical application and further development of cell-wall broken powder formulations in traditional Chinese medicine.

R274.9

中华中医药学会方剂学分会科研项目（编号：中会学术[2023]11号）；广东省基础与应用基础研究基金省企联合基金面上项目（编号： 2022A1515220093）