| Objective To observe the clinical efficacy of Jianpi Tongluo Recipe in treating diabetic gastroparesis,objectively analyze its clinical safety,preliminarily explore its principle and theoretical basis,and look for the modern pharmacological research of its compatibility with traditional Chinese medicine,so as to provide further clinical basis for TCM syndrome differentiation.Methods from October 2018 to September 2019,62 patients were randomly divided into control group(31 cases)and treatment group(31 cases).The treatment group was treated with Jianpi Tongluo decoction combined with Domperidone Tablets,while the control group was treated with Domperidone Tablets.The treatment lasted for 4 weeks.The gastric solid half emptying time(get1g2),TCM syndrome score,blood glucose and related safety indexes were observed before and after treatment in the treatment group and the control group.After the treatment,the patients were followed up for 8 weeks to observe the recurrence.The results were statistically analyzed by software to evaluate the clinical efficacy of the two groups.Results(1)the number of cases actually completed: there was 1 case of discharge in the treatment group and 1 case of prolapse in the control group,so the total number of cases actually completed was 60 cases,30 cases in the treatment group and 30 cases in the control group.(2)Comparison of clinical efficacy: after treatment,in the control group,1 patient was basically cured,3 patients were markedly effective,12 patients were effective,14 patients were ineffective,and the total effective rate was 53.33%;in the treatment group,5 patients were basically cured,4 patients were markedly effective,16 patients were effective,and 5 patients were ineffective,and the total effective rate was 83.33%.After treatment,the total effective rate by chi square test(P<0.05),the use of traditional Chinese medicine decoction treatment group than simple western medicine control group of clinical curative effect is better.(3)Comparison of main clinical symptom scores:(1)intra group comparison: in the control group,the symptom scores before and after the test were not significantly improved by t test(P > 0.05);in the other symptom scores(P<0.05),the difference was statistically significant;in the treatment group,all symptom scores before and after the treatment were statistically significant by t test(P<0.05).(2)Comparison between groups: two groups of patients in abdominal distension,nausea and vomiting,early satiety,belching acid symptom score,by t test(P > 0.05),no statistical significance,the rest of the symptoms(P<0.05),the difference was statistically significant.(4)Comparison of GET1/2: before the test,the GET1 / 2 of the two groups had no statistically significant difference(P > 0.05),indicating that the data were comparable;after the test,the GET1/2 of the two groups was significantly shorter than that before the test(P < 0.01);after the test,the GET1/2 of the two groups had significant difference(P <0.01),The increase of gastric emptying rate in the treatment group was more obvious than that in the control group.(5)Safety comparison: after 6 days of treatment,one case in the control group developed a local punctate skin rash in the upper abdomen,which was tolerable and did not affect the continued use of drugs;there was no obvious adverse reaction in the treatment group.During the whole course of the test,the three routine(blood routine,urine routine,stool routine),liver and kidney function,ECG and other safety indicators of the two groups were normal.(6)Comparison of recurrence: during the 8-week follow-up,the recurrence rate of the experimental group was 20.00%,and that of the control group was 55.56%.Compared with the two groups,the recurrence rate of the treatment group was better than that of the control group,with statistical difference(P < 0.05).Conclusion(1)Jianpi Tongluo decoction combined with domperidone has obvious clinical effect in the treatment of diabetic gastroparesis of spleen deficiency and blood stasis type,and can significantly improve the clinical symptoms of patients.(2)Conclusion: Jianpi Tongluo decoction combined with domperidone can significantly shorten the half emptying time of gastric solid and enhance gastric motility in DGP patients with spleen deficiency and blood stasis.(3)For DGP of spleen deficiency and blood stasis type,the application of Jianpi Tongluo decoction combined with Domperidone Tablets has less adverse reactions,high safety,and the recurrence rate is significantly less than that of Western medicine alone,which is worthy of further clinical exploration in the future. |