舒脉胶囊联合回阳生肌膏治疗2型糖尿病并发足部溃疡的临床疗效及对踝肱指数的影响分析

Clinical Efficacy of Shumai Capsules Combined with Huiyang Shengji Ointment in the Treatment of Type 2 Diabetes Complicated with Foot Ulcer and Their Effect on Ankle-Brachial Index

【目的】分析舒脉胶囊(由首乌藤、鸡血藤、当归、生黄芪等组成)联合回阳生肌膏(由肉桂、炮姜、人参、黄芪、当归、川芎、白芥子等组成)治疗气滞血瘀型2型糖尿病(T2DM)并发足部溃疡的临床疗效及对踝肱指数(ABI)的影响。【方法】通过盲法、便利抽样、对照原则回顾性研究首都医科大学附属北京中医医院2020年1月至2022年1月接诊的90例气滞血瘀型T2DM并发足部溃疡患者,根据治疗方法的不同分为观察组和对照组,每组各45例。对照组给予西医基础及局部清创治疗,观察组在对照组的基础上给予舒脉胶囊联合回阳生肌膏治疗,疗程为4周。观察2组患者治疗前后临床症状积分、ABI、溃疡面积、血清炎症因子[白细胞介素10(IL-10)、白细胞介素6(IL-6)、超敏C反应蛋白(CRP)]、足背动脉血流动力学指标的变化情况,并评价2组患者的临床疗效。【结果】(1)治疗4周后,观察组的总有效率为95.56%(43/45),对照组为71.11%(32/45),组间比较,观察组的疗效明显优于对照组(P<0.01)。(2)观察组患者治疗2周和4周后及对照组患者治疗4周后的足部溃疡的色泽、面积、疼痛、渗出积分均较治疗前明显降低(P<0.05),且观察组在治疗2周和4周后对足部溃疡的色泽、面积、疼痛、渗出积分的降低幅度均明显优于对照组(P<0.01)。(3)观察组患者治疗2周和4周后及对照组患者治疗4周后的ABI均较治疗前升高(P<0.05),溃疡面积均较治疗前缩小(P<0.05),且观察组在治疗2周和4周后对ABI的升高幅度及对溃疡面积的缩小幅度均明显优于对照组(P<0.05或P<0.01)。(4)观察组患者治疗2周和4周后及对照组患者治疗4周后的血清IL-10水平均较治疗前升高(P<0.05),血清hs-CRP、IL-6水平均较治疗前降低(P<0.05),且观察组在治疗2周和4周后对血清IL-10水平的升高幅度及对血清hs-CRP、IL-6水平的降低幅度均明显优于对照组(P<0.01)。(5)观察组患者治疗2周和4周后及对照组患者治疗4周后的足背动脉搏动指数、阻力指数、血管内径、血流速度均较治疗前改善(P<0.05),且观察组在治疗2周和4周后对各项足背动脉血流动力学指标的改善幅度均明显优于对照组,差异均有统计学意义(P<0.05或P<0.01)。【结论】舒脉胶囊联合回阳生肌膏可有效缓解气滞血瘀型T2DM并发足部溃疡患者的疼痛等症状,提高ABI,缩小溃疡面积,改善足背动脉血液循环,减轻炎症反应,疗效显著。

Objective To investigate the clinical efficacy and the effect on the ankle-brachial index(ABI)of patients with type 2 diabetes mellitus(T2DM)complicated with foot ulcer of qi stagnation and blood stasis type treated by Shumai Capsules(composed of Polygoni Multiflori Caulis,Spatholobi Caulis,Angelicae Sinensis Radix,raw Astragali Radix,etc.)combined with Huiyang Shengji Ointment(composed of Cinnamomi Cortex,Zingiberis Rhizoma Praeparatum,Ginseng Radix et Rhizoma,Astragali Radix,Angelicae Sinensis Radix,Chuanxiong Rhizoma,Sinapis Semen,etc.).Methods Ninety patients with T2DM complicated by foot ulcer of qi stagnation and blood stasis type who sought medical consultation in Beijing Hospital of Traditional Chinese Medicine from January 2020 to January 2022 were retrospectively studied by blinded,convenience-sampling and controlled principles,and the patients were divided into observation group and control group according to the treatment method,with 45 cases in each group.The control group was given basic western medicine treatment and local debridement treatment,while the observation group was treated with Shumai Capsules orally combined with external application of Huiyang Shengji Ointment on the basis of treatment for the control group.Both groups were treated for 4 weeks.The changes in clinical symptom score,ABI,ulcer area,serum inflammatory factors such as interleukin 10(IL-10),interleukin 6(IL-6)and hypersensitive C-reactive protein(hs-CRP),and hemodynamic indexes of dorsalis pedis artery in the two groups were observed before and after treatment.After treatment,the clinical efficacy of the two groups was evaluated.Results(1)After 4 weeks of treatment,the overall effective rate of the observation group was 95.56%(43/45)and the control group was 71.11%(32/45).The intergroup comparison showed that the efficacy of the observation group was significantly superior to that of the control group(P<0.01).(2)The scores of color,area,pain and exudation of foot ulcer in the observation group after 2 and 4 weeks of treatment and the scores in the control group after 4 weeks of treatment were all significantly decreased compared with those before treatment(P<0.05),and the degree of the decrease in scores of color,area,pain and exudation of foot ulcer in the observation group after 2 and 4 weeks of treatment was significantly superior to that of the control group(P<0.01).(3)In comparison with those before treatment,the ABI was increased and the ulcer area was reduced in the observation group after 2 and 4 weeks of treatment and in the control group after 4 weeks of treatment(P<0.05),and the degree of increase in ABI and the degree of reduction in ulcer area in the observation group were significantly superior to those in the control group after 2 and 4 weeks of treatment(P<0.05 or P<0.01).(4)In comparison with those before treatment,the serum IL-10 level was increased and serum hs-CRP and IL-6 levels were decreased in the observation group after 2 and 4 weeks of treatment and in the control group after 4 weeks of treatment(P<0.05),and the degree of increase in serum IL-10 level and the degree of decrease in serum hs-CRP and IL-6 level in the observation group were significantly superior to those in the control group after 2 and 4 weeks of treatment(P<0.01).(5)The pulsatility index,resistance index,intravascular diameter and flow velocity of the dorsalis pedis artery were improved in the observation group after 2 and 4 weeks of treatment and in the control group after 4 weeks of treatment compared with those before treatment(P<0.05),and the improvement of all dorsalis pedis artery hemodynamic indexes in the observation group was significantly superior to that in the control group after 2 and 4 weeks of treatment,the differences being statistically significant(P<0.05 or P<0.01).Conclusion The combination of Shumai Capsules and Huiyang Shengji Ointment exerts significant clinical efficacy for patients with T2DM complicated by foot ulcer of qi stagnation and blood stasis type through effectively relieving pain and other symptoms,increasing ABI,reducing ulcer area,improving blood circulation in the dorsal foot artery and alleviating inflammatory response.