观察益气养阴降糖方（由黄芪、生地黄、白茅根、麦冬、葛根等中药组成）联合穴位注射治疗初发2型糖尿病的 临床疗效。【方法】将100例气阴两虚兼血瘀证的初发2型糖尿病患者随机分为治疗组和对照组，每组各50例。对照组给予盐 酸二甲双胍片口服治疗，治疗组在对照组的基础上给予益气养阴降糖方中药颗粒剂联合穴位注射（每次取足三里、肾俞、气 海单侧穴位）治疗，疗程为4周。观察2组患者治疗前后中医证候积分、空腹血糖（FPG）、餐后2 h血糖（2hPG）、糖化血红蛋 白（HbA1c）、总胆固醇（TC）、甘油三酯（TG）和血清炎症因子白细胞介素6（IL-6）、C反应蛋白（CRP）、肿瘤坏死因子α（TNF-α） 水平以及血液流变学指标（全血低切黏度和全血高切黏度）的变化情况，并评价2组患者的临床疗效及安全性。【结果】（1）脱 落情况方面：研究过程中，治疗组脱落5例，对照组脱落4例，最终共有91例患者纳入疗效统计，其中，治疗组45例，对 照组46例。（2）疗效方面：治疗4周后，治疗组的总有效率为93.33%（42/45），对照组为71.74%（33/46），组间比较（χ2检验）， 治疗组的疗效明显优于对照组（P＜0.01）。（3）中医证候评分方面：治疗后，2组患者的口干咽燥、夜尿频多、气短乏力、潮 热盗汗等各项中医证候评分及总评分均较治疗前明显降低（P＜0.05），且治疗组的降低幅度均明显优于对照组（P＜0.01）。（4）血 糖、血脂方面：治疗后，2组患者的FPG、2hPG、HbA1c、TC、TG水平均较治疗前降低（P＜0.05），且治疗组的降低幅度均 明显优于对照组（P＜0.05或P＜0.01）。（5）炎症因子方面：治疗后，2组患者的血清IL-6、CRP、TNF-α水平均较治疗前降低 （P＜0.01），且治疗组的降低幅度均明显优于对照组（P＜0.01）。（6）血液流变学方面：治疗后，2组患者的全血低切黏度、全 血高切黏度等血液流变学指标均较治疗前降低（P＜0.05），且治疗组的降低幅度均明显优于对照组（P＜0.05）。（7）安全性评价方面：治疗组的不良反应发生率为8.89%（4/45），明显低于对照组的21.74%（10/46），差异有统计学意义（P＜0.01）。【结论】 对于气阴两虚兼血瘀证的初发2型糖尿病患者，益气养阴降糖方联合穴位注射治疗疗效显著，能有效减轻患者早期临床表 现，降低患者血糖、血脂、炎症因子水平，改善患者的血液流变学指标，提高患者的生活质量。

To observe the clinical efficacy of Yiqi Yangyin Jiangtang Prescription（mainly composed of Astragali Radix，Rehmanniae Radix，Imperatae Rhizoma，Ophiopogonis Radix，and Puerariae Lobatae Radix） combined with acupoint injection in the treatment of newly-diagnosed type 2 diabetes mellitus（T2DM）. Methods One hundred patients with newly-diagnosed T2DM of qi-yin deficiency complicated with blood stasis type were randomly divided into a treatment group and a control group，with 50 patients in each group. The control group was given oral use of Metformin Hydrochloride Tablets，and the treatment group was given the granules of Yiqi Yangyin Jiangtang Prescription orally combined with acupoint injection at unilateral points of Zusanli（ST36）， Shenshu （BL23）and Qihai（CV6）on the basis of treatment for the control group. The course of treatment lasted for 4 weeks. Before and after the treatment， the two groups were observed in the changes of traditional Chinese medicine（TCM）syndrome scores，fasting plasma glucose（FPG），2-hour postprandial blood glucose（2hPG）， glycated hemoglobin（HbA1c）， total cholesterol（TC）， triglyceride（TG）， and serum levels of inflammatory factors of interleukin 6（IL-6），C-reactive protein（CRP），tumor necrosis factor α（TNF-α），as well as the hemorheology indicators of whole blood low-shear viscosity and whole blood high-shear viscosity. After treatment， the clinical efficacy and safety of the two groups were evaluated. Results（1）During the trial，5 cases fell off from the treatment group and 4 cases fell off from the control group，and a total of 91 patients were eventually included in the efficacy statistics，of which 45 cases were in the treatment group and 46 cases were in the control group. （2）After 4 weeks of treatment，the total effective rate of the treatment group was 93.33%（42/45），and that of the control group was 71.74%（33/46）. The intergroup comparison（tested by chi- square test） showed that the therapeutic effect of the treatment group was significantly superior to that of the control group（P＜0.01）.（3）After treatment， the scores of TCM symptoms of dry mouth and throat， frequent nocturia， shortness of breath and fatigue， hot flushes and night sweating as well as the total TCM syndrome scores in the two groups were significantly lower than those before the treatment（P＜0.05）， and the reduction of the scores in the treatment group was significantly superior to that of the control group（P＜0.01）.（4）After treatment，the levels of blood glucose and lipid indicators of FPG，2hPG，HbA1c，TC and TG of patients in the two groups were decreased compared with those before treatment（P＜0.05）， and the decrease in the treatment group was significantly superior to that in the control group（P＜0.05 or P＜0.01）.（5）After treatment，the serum levels of inflammatory factors of IL-6，CRP，and TNF-α in the two groups were all lower than those before treatment（P＜0.01），and the reduction in the treatment group was significantly superior to that in the control group（P＜0.01）.（6）After treatment，the levels of hemorheology indicators such as whole blood low-shear viscosity and high-shear viscosity in the two groups were all lower than those before treatment（P＜0.05），and the reduction in the treatment group was significantly superior to that in the control group（P＜0.05）.（7）The incidence of adverse reactions in the treatment group was 8.89%（4/45），which was significantly lower than that of the control group（21.74%，10/46）， and the difference was statistically significant （P＜0.01）. Conclusion Yiqi Yangyin Jiangtang Prescription combined with acupoint injection exerts certain effect in treating patients with newly-diagnosed T2DM of qi-yin deficiency complicated with blood stasis syndrome type. The combined therapy can effectively alleviate the early clinical manifestations， decrease the levels of blood glucose， blood lipids， and inflammatory factors， and improve the hematological indicators and the quality of life of the patients.

R259.871

三亚市高校及医疗机构科研专项（编号：2021GXYL08）