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自拟柴桂通脉方治疗下肢动脉硬化闭塞症寒凝血瘀证的有效性及安全性研究
邢宏青,闫磊,乔凯明
河北省沧州中西医结合医院疮疡脉管病科沧州 061000
摘要:
目的:探讨自拟柴桂通脉方治疗下肢动脉硬化闭塞症(LEASO)寒凝血瘀证的有效性及安全性。方法:选取本院在2022年10月—2024年10月收治的LEASO患者120例,采用随机数字表法分为西药组和中药组,每组60例。西药组患者给予贝前列素钠片治疗,中药组患者采用自拟柴桂通脉方治疗。比较两组患者治疗后的临床疗效、血液流变学指标、纤维蛋白原(FIB)、6-酮前列腺素F1α(6-Keto-PGF1α)水平,踝肱指数(ABI)、中医证候积分、安全性评价。结果:治疗后,中药组临床总有效率为95.00%(57/60),高于西药组的78.33%(47/60),差异有统计学意义(P <0.05);两组患者的全血高切黏度、全血低切黏度、红细胞刚性指数、红细胞聚集指数、血浆黏度(PV)、FIB水平、中医证候积分较治疗前降低,中药组低于西药组,差异有统计学意义(P <0.05);两组患者的ABI、6-Keto-PGF1α水平升高,中药组高于西药组,差异有统计学意义(P <0.05);两组的谷丙转氨酶(ALT)、谷草转氨酶(AST)、肌酐和尿素氮水平差异无统计学意义(P >0.05)。结论:采用自拟柴桂通脉方治疗LEASO寒凝血瘀证,能够提高患者的临床效果,改善血液流变学指标,具有较高的安全性。
关键词:  自拟柴桂通脉方  寒凝血瘀证  动脉硬化闭塞症  有效性  安全性
DOI:10.3969/j.issn.1007-6948.2026.04.011
投稿时间:2025-10-07
基金项目:河北省中医药管理局科学研究项目(2025559)
Effectiveness and security of Chaigui Tongmai formula in treating lower limb arteriosclerosis obliterans with cold coagulation and blood stasis syndrome
XING Hong-qing,YAN Lei,QIAO Kai-ming
Department of Ulcer and Vascular Diseases, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Cangzhou 061000, China
Abstract:
Objective To explore the effectiveness and security of self-formulated Chaigui Tongmai formula in treating lower limb arteriosclerosis obliterans (LEASO) with cold coagulation and blood stasis syndrome. Methods From October 2022 to October 2024, 120 LEASO patients who visited our hospital were recruited and assigned into western drug group (60 cases) and Formula group (60 cases) via random number table. The western drug group adopted bepronil sodium tablets, while the Formula group adopted self-designed Chaigui Tongmai formula. The clinical efficacy, hemorheology, fibrinogen, 6-keto-prostaglandin F1α (6-Keto-PGF1α), ankle brachial index (ABI), TCM syndrome score, and security were evaluated. Results The Formula group had a total clinical effective rate of 95.00% (57/60), and was conspicuously higher than western drug group, which was 78.33% (47/60) (P <0.05). Both groups showed clear reductions in whole blood high shear viscosity, whole blood low shear viscosity, erythrocyte rigidity index, erythrocyte aggregation index, plasma viscosity (PV), fibrinogen (FIB), and TCM syndrome scores after treatment (P <0.05), with the Formula group being clearly lower than the western drug group (P <0.05). Both groups showed a conspicuous increase in ankle brachial index (ABI) and level of 6-Keto-PGF1α, with the Formula group being conspicuously higher than the western drug group (P <0.05). The alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, and urea nitrogen between Formula group and western drug group (P >0.05). Conclusion The self-designed Chaigui Tongmai formula can improve the clinical efficacy of LEASO with cold coagulation and blood stasis syndrome, improve hemorheological indicators, and has high security.
Key words:  Self-designed Chaigui Tongmai formula  cold coagulation and blood stasis syndrome  arteriosclerosis obliterans  effectiveness  security

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