| Objective:To observe the effect of Sancai Lianmei Granule on blood sugar fluctuation in patients with type 2 diabetes mellitus(Qi-Yin deficiency type),and to provide new effective drugs and treatment ideas for clinical improvement of blood sugar fluctuation and prevention of complications.Methods:A randomized,controlled study was conducted in this clinical trial.64 cases were collected according to the inclusion criteria,and randomly divided into control group or treatment group according to the random table.The control group: treatment group= 1:1.Treatment group drugs:the original hypoglycemic program+Sancai Lianmei Granules,Sancai Lianmei Granules warm water flushing,one dose a day,three times a day;control group to maintain the original hypoglycemic program.The course of treatment was 12 weeks.At the beginning and end of the experiment,the total score of TCM syndromes and the self-blood glucose monitoring(SMBG)were assessed to obtain seven blood glucose values(including the changes of HbA1 c,CRP and LDL-C before and after three meals,2 hours before sleep)for three days.The standard deviation(SDBG)of blood glucose level,postprandial blood glucose fluctuation(PPGE)and maximum blood glucose fluctuation(LAGE)were calculated.To evaluate the clinical efficacy and safety of Sancai Lianmei Granule in the treatment of type 2 diabetes mellitus(deficiency of both Qi and Yin)with blood sugar fluctuation.Results:(1)A total of 64 patients were included in this study,including32 in the treatment group and 32 in the control group.At the end of the experiment,60 cases were completed,32 cases in the treatment group,2cases in the abscission group,32 cases in the control group and 2 cases in the absence of follow-up.(2)Evaluation of curative effect of TCM:There were significant differences in the total score of TCM syndromes between the treatment group and the control group before and after intervention(P<0.05).In the treatmentgroup,the marked effective rate was 16.7%,the effective rate was70.0%,and the total effective rate was 86.7%;in the control group,the marked effective rate was 0%,the effective rate was 70.0%,and the total effective rate was 70.0%.The total effective rate of the treatment group was higher than that of the control group.(3)Blood sugar fluctuation indicators:before and after intervention,there were significant differences in SDBG,PPGE and LAGE between the treatment group and the control group(P<0.05),and after treatment,there were significant differences between the two groups(P<0.05).SDBG,PPGE and LAGE in the treatment group decreased more significantly than those in the control group.(4)Changes of blood sugar and HbA1c: There were significant differences in blood sugar values at 7:00 and HbA1 c before and after intervention in the treatment group and the control group(P<0.05),and there were significant differences between the two groups after treatment(P<0.05).The blood sugar and HbA1 c in the treatment group decreased more significantly than those in the control group at 7 o'clock.(5)Changes of CRP: There were significant differences in CRP before and after intervention between treatment group and control group(P<0.05),and there were significant differences between treatment group and control group(P<0.05).CRP in the treatment group decreased more significantly than that in the control group.(6)Changes of LDL-C:There were significant differences in LDL-C between the treatment group and the control group before and after intervention(P<0.05),and there was no significant difference between the two groups after treatment(P>0.05).(7)Safety evaluation: There were no abnormalities in blood cell analysis,stool routine,urine routine,liver function,renal function and electrocardiogram before and after intervention in the control group and treat-ment group.There were no adverse reactions in both groups.Conclusion:(1)Sancai Lianmei Granule in the treatment of blood sugar fluctuation of type 2 diabetes with deficiency of both Qi and Yin conforms to the thinking of syndrome differentiation and treatment of traditional Chinese medicine,significantly improves the symptoms and signs of patients,and the curative effect is better than that of the control group.(2)Western medicine combined with Sancai Lianmei Granule significantly reduced SDBG,PPGE,LAGE,and improved the fluctuation of blood sugar than the control group treated with western medicine alone.(3)Western medicine combined with Sancai Lianmei Granule has more significant hypoglycemic effect,significantly reducing the level of HbA1 c,which is better than the control group treated with western medicine alone.(4)Western medicine combined with Sancai Lianmei Granule can significantly reduce CRP,which is better than the control group.Sancai Lianmei Granule can inhibit inflammation in patients with type 2 diabetes mellitus(deficiency of both Qi and Yin).(5)In improving LDL-C,the effect of Western medicine combined with Sancai Lianmei Granule is similar to that of the control group treated with western medicine alone.(6)Western medicine combined with Sancai Lianmei Granule is superior to the control group in lowering blood sugar and improving blood sugar fluctuation.It may be related to the hypoglycemic effect of Chinese medicine and inhibiting inflammation reaction,which can prevent chronic complications of diabetes mellitus.(7)Sancai Lianmei Granule in the treatment of type 2 diabetes mellitus(deficiency of both Qi and Yin)blood glucose fluctuation enriches the clinical experience of traditional Chinese medicine in the treatment of diabetes mellitus,and provides new treatment ideas for Chinese medicinein stabilizing blood sugar and preventing complications.(8)Sancai Lianmei Granule is safe for patients with type 2 diabetes mellitus(deficiency of both Qi and Yin)with blood sugar fluctuation,and no adverse reactions occur. |
PDF Full Text Request