【目的】 观察自拟柴桂通脉方联合温针灸治疗寒凝血瘀型下肢动脉硬化闭塞症（LEASO）的临床疗效。【方法】 选取2022年 11月至2023年11月期间河北省沧州中西医结合医院疮疡脉管病科门诊及病房收治的90例明确诊断为寒凝血瘀型LEASO的 患者为研究对象。按随机数字表将患者随机分为观察组和对照组，每组各45例。2组患者均给予健康宣教及常规治疗。对照 组给予自拟柴桂通脉方口服治疗，观察组在对照组治疗的基础上，给予温针灸治疗。2组均治疗3周。治疗3周后，评价2组 临床疗效。观察 2组患者治疗前后中医证候积分和间歇性跛行距离的变化情况，以及踝肱指数（ABI）及趾肱指数（TBI）的情 况。比较2组患者治疗前后血流动力学指标和血清炎性因子水平的变化情况。并评价2组的安全性及不良反应的发生情况。 【结果】（1）观察组总有效率为 95.56%（43/45），对照组为 80.00%（36/45）。观察组疗效优于对照组，差异有统计学意义（P＜ 0.05）。（2）治疗后，2组患者的中医证候积分、间歇性跛行距离明显改善（P＜0.05），且观察组在改善中医证候积分、间歇性 跛行距离方面明显优于对照组，差异有统计学意义（P＜0.05）。（3）治疗后，2组患者的间歇性跛行距离明显改善（P＜0.05）， 且观察组在改善间歇性跛行距离方面明显优于对照组，差异有统计学意义（P＜0.05）。（4）治疗后，2组患者的ABI及TBI明显 改善（P＜0.05），且观察组在改善ABI及TBI方面明显优于对照组，差异有统计学意义（P＜0.05）。（5）治疗后，2组患者的全血 低切黏度、高切黏度、血浆黏度水平明显改善（P＜0.05），且观察组在改善全血低切黏度、高切黏度、血浆黏度水平方面明 显优于对照组，差异有统计学意义（P＜0.05）。（6）治疗后，2组患者的IL-18、hs-CRP、ICAM-1水平明显改善（P＜0.05），且 观察组在改善IL-18、hs-CRP、ICAM-1水平方面明显优于对照组，差异有统计学意义（P＜0.05）。（7）治疗期间，观察组不良 反应发生率为4.44%（2/45），对照组为6.66%（3/45）。观察组与对照组的不良反应发生率比较，差异无统计学意义（P＞0.05）。 【结论】 自拟柴桂通脉方联合温针灸治疗寒凝血瘀型LEASO患者，能促进患者临床症状的恢复，降低炎症反应，促进血流动 力学指标的恢复，从而提高患者生活质量，疗效显著，且安全性良好。

Objective To observe the clinical efficacy of self-prescribed Chaigui Tongmai Formula combined with warm needle moxibustion in treating lower extremity arteriosclerosis obliterans （LEASO） with cold coagulation and blood stasis syndrome. Methods A total of 90 patients diagnosed with LEASO of cold coagulation and blood stasis syndrome who were treated in the outpatient and inpatient departments of the Ulcer and Vascular Disease Department of Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine between November 2022 and November 2023 were selected as study subjects. Patients were randomly divided into an observation group and a control group using a random number table，with 45 cases in each group. Both groups received health education and conventional treatment. The control group was treated with oral administration of self-prescribed Chaigui Tongmai Formula，while the observation group received additional warm needle moxibustion based on the control group’s treatment. Both groups were treated for 3 weeks. After treatment， clinical efficacy was evaluated by observing changes in TCM syndrome scores， intermittent claudication distance， ankle-brachial index （ABI）， toe-brachial index （TBI）， hemodynamic parameters， and serum inflammatory factor levels before and after treatment in both groups. Safety and adverse reactions were also assessed. Results （1） The total effective rate was 95.56% （43/45） in the observation group and 80.00% （36/45） in the control group. The efficacy of the observation group was significantly superior to that of the control group，with a statistically significant difference （P＜0.05）. （2） After treatment，TCM syndrome scores and intermittent claudication distance were significantly improved in both groups （P＜0.05），and the improvement in the observation group was significantly greater than that in the control group，with a statistically significant difference （P＜0.05）.（3） After treatment，intermittent claudication distance was significantly improved in both groups （P＜0.05），and the improvement in the observation group was significantly greater than that in the control group，with a statistically significant difference （P＜0.05）.（4） After treatment， ABI and TBI were significantly improved in both groups （P＜0.05）， and the improvement in the observation group was significantly greater than that in the control group，with a statistically significant difference （P＜0.05）.（5） After treatment，whole blood low-shear viscosity，high-shear viscosity，and plasma viscosity levels were significantly improved in both groups （P＜0.05），and the improvement in the observation group was significantly greater than that in the control group，with a statistically significant difference （P＜0.05）.（6） After treatment，levels of IL-18，hs-CRP，and ICAM-1 were significantly improved in both groups （P＜0.05），and the improvement in the observation group was significantly greater than that in the control group，with a statistically significant difference （P＜0.05）.（7） During treatment，the incidence of adverse reactions was 4.44% （2/45） in the observation group and 6.66% （3/45） in the control group. There was no statistically significant difference in the incidence of adverse reactions between the two groups （P＞0.05）. Conclusion Self-prescribed Chaigui Tongmai Formula combined with warm needle moxibustion significantly promotes the recovery of clinical symptoms， reduces inflammatory responses，improves hemodynamic parameters，and enhances the quality of life in patients with LEASO of cold coagulation and blood stasis syndrome，demonstrating notable efficacy and good safety.

R246.9

河北省中医药管理局资助项目（编号：2025559）