Clinical study of Jiedu Tongmai Granule for the treatment of lower extremity arteriosclerosis obliterans
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摘要:
目的 评价解毒通脉颗粒治疗下肢动脉硬化闭塞症的治疗效果,为开发院内制剂提供临床资料。 方法 选择2018年6月—2019年10月期间吉林省中医药科学院第一临床医院心血管病科住院及门诊的下肢动脉硬化闭塞症患者共计72例,采用计算机随机数字法分成研究组与对照组,每组36例。2组患者在西药口服的同时,研究组加服解毒通脉颗粒,1袋(10 g)/次,2次/d,疗程为4周。观察2组患者治疗前与治疗后中医证候疗效、踝臂指数、血管硬度的变化。 结果 研究组改善中医证候总有效率为83.3%,对照组改善中医证候总有效率为58.3%,研究组优于对照组,差异有统计学意义(P < 0.05)。在踝臂指数方面,2组患者治疗后均有不同程度的升高,组内及组间比较差异均有统计学意义(均P < 0.05),研究组优于对照组。在血管硬度方面,2组患者治疗后均降低,组内及组间(右侧)比较,差异均有统计学意义(均P < 0.05),研究组优于对照组,组间左侧比较,差异无统计学意义(P>0.05)。 结论 对于下肢动脉粥样硬化闭塞症患者,在西药治疗基础上加用解毒通脉颗粒能够升高踝臂指数,降低血管硬度水平,从而减轻患者的症状,改善生活质量,可在临床广泛应用。 Abstract:Objective To evaluate the clinical efficacy of Jiedu Tongmai Granule for the treatment of lower extremity arteriosclerosis obliterans (ASO) and provide clinical case data for the development of hospital preparations. Methods Seventy-two patients with ASO were randomly divided into a treatment group and a control group, with 36 cases in each group. The treatment group was administered with Western medicine and additionally received Jiedu Tongmai Granules (1 bag, 10 g) twice a day for 4 weeks. Before and after the treatment, ankle-brachial index (ABI), brachial-ankle pulse wave velocity (baPWV) and TCM syndrome scores were observed and the clinical efficacy was evaluated. Results With regard to the curative effects of TCM syndrome, the total effective rate was 83.3% in the treatment group and 58.3% in the control group. Results of rank sum test showed that the treatment group was superior to the control group, and the difference was statistically different (P < 0.05). After the treatment, ABI in both groupswassignificantly improved (P < 0.05). After the treatment, baPWV decreased with varying degrees in both groups, and the difference was statistically significant (all P < 0.05). After the treatment, the difference between the two groups on the right side was statistically significant (P < 0.05). The clinical efficacy of Jiedu Tongmai Granule for the treatment of ASO was better in the treatment group than that in the control group. However, the difference between the two groups on the left side was not statistically significant (P>0.05). Conclusion For patients with ASO, the addition of Jiedu Tongmai Granule to the standardised treatment using Western medicines can alleviate the clinical symptoms, increase ABI index and decrease baPWV level, thereby reducing the clinical symptoms, improving the clinical signs, and enhancing the quality of life of patients. This study provides guidance for further research on and wide clinical applications of Jiedu Tongmai Granule. -
表 1 2组下肢动脉硬化闭塞症患者中医证候疗效比较[例(%)]
组别 例数 显效 有效 无效 总有效 对照组 36 6(16.7) 15(41.7) 15(41.7) 21(58.3) 研究组 36 9(25.0) 21(58.3) 6(16.7) 30(83.3) 注:2组疗效比较,U=-2.044,P=0.041。 表 2 2组下肢动脉硬化闭塞症患者ABI比较(x±s)
组别 例数 ABI t值 P值 治疗前 治疗后 对照组 36 0.85±0.06 0.98±0.05 9.987 < 0.001 研究组 36 0.83±0.07 1.02±0.05 13.252 < 0.001 t值 1.302 3.394 P值 0.197 0.001 表 3 2组下肢动脉硬化闭塞症患者baPWV比较(x±s, cm/s)
组别 例数 侧别 baPWV t值 P值 治疗前 治疗后 对照组 36 右侧 2 315±231 2 043±344 3.939 < 0.001 左侧 2 250±315 1 937±297 4.991 < 0.001 研究组 36 右侧 2 297±249 1 752±349 7.627 < 0.001 左侧 2 298±309 1 845±328 6.032 < 0.001 t值a 0.318 8.071 P值a 0.752 < 0.001 t值b 0.747 1.248 P值b 0.458 0.216 注:a为2组治疗后右侧比较;b为2组治疗后左侧比较。 -
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