通脉宁方治疗动脉硬化性闭塞症脉络血瘀证的临床观察

Clinical observation of Tongmaining Formula in managing arteriosclerosis obliterans with the vessel collateral blood stasis pattern

摘要

目的 系统评价通脉宁方治疗动脉硬化闭塞症（arteriosclerosis Obliterans， ASO）脉络血瘀证患者的临床疗效与安全性。方法 采用随机对照设计，将104例ASO患者随机分为治疗组与对照组，每组52例。治疗组口服通脉宁方，对照组口服贝前列素钠片，疗程均为4周。观察临床疗效、下肢症状体征量表评分、足部皮肤温差、跛行距离及缓解时间、血脂水平、血常规及肝肾功能，并记录不良事件。结果 治疗组的临床疗效优于对照组（P＜0.05）。治疗后，治疗组的下肢症状评分、足部皮肤温差、跛行距离及缓解时间均较治疗前改善（P＜0.05）；对照组的下肢症状评分、足部皮肤温差较治疗前改善（P＜0.05）。2组治疗后下肢症状评分、跛行距离的改善程度比较，差异均有统计学意义（P＜0.05）。治疗后，2组血脂水平、血常规及肝肾功能均未见显著异常变化，且组间比较差异无统计学意义（P＞0.05）。2组均无药物相关不良反应发生。结论 通脉宁方治疗ASO（脉络血瘀证）安全、有效。

Abstract

Objective To systematically evaluate the clinical efficacy and safety of Tongmaining Formula in treating patients with arteriosclerosis obliterans presenting with vessel collateral blood stasis pattern. Methods A randomized controlled design was used. 104 ASO patients were randomly divided into a treatment group and a control group, with 52 cases in each group. The treatment group received oral TMNF formula, while the control group received oral Beraprost Sodium tablets. The treatment course was 4 weeks for both groups. Clinical efficacy, lower limb symptom and sign scale scores, foot skin temperature difference, claudication distance and relief time, lipid levels, routine blood tests, and liver and kidney function were observed, and adverse events were recorded. Results The clinical efficacy of the treatment group was superior to that of the control group (P＜0.05). After treatment, the scores of lower limb symptoms, foot skin temperature, claudication distance, and relief time in the treatment group were all significantly improved compared to those before treatment (P＜0.05). In the control group, the lower limb symptom scores and foot skin temperature were improved compared to those before treatment (P＜0.05). The degree of improvement in lower limb symptom scores and claudication distance after treatment was significantly greater in the treatment group than in the control group (P＜0.05). After treatment, no significant abnormal changes were observed in lipid levels, routine blood tests, or liver and kidney function in either group, and there were no statistically significant differences between the two groups (P＞0.05). No drug-related adverse reactions occurred in either group. Conclusion Tongmaining Formula is safe and effective in treating arteriosclerosis obliterans with the vessel collateral blood stasis pattern.

关键词

通脉宁方 / 动脉硬化性闭塞症 / 间歇性跛行 / 脉络血瘀证 / 中医药治疗

Key words

Tongmaining Formula / arteriosclerosis obliterans / intermittent claudication / vessel collateral blood stasis / Traditional Chinese Medicine treatment

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基金资助

北京市中医药科技发展资金项目(BJZYYB-2023-82)