| Objectives To observe clinical efficacy of jian-pi-tong-luo recipe on diabetic gastroparesis patients, to provide some concrete ideas and reference bases for the traditional Chinese medicine treatment of DGP. To elucidate clinical evidence for TCM syndrome differentiation and treatment on DGP of spleen and stomach combined with blood stasis type.Methods From June 2013 to June 2014 in Endocrine department of Tangshan Chinese Medicine Hospital, 60 patients(from 30 to 70 years old) were select who meeting the diagnostic criteria for diabetic gastroparesis and inclusion criteria, and were randomly divided into treatment group(n=30) and control group(n=30). The selected cases were established on the basis of original effective therapy. Control group use domperidone tablets,10 milligram, three times a day. Treatment group use jian-pi-tong-luo Recipe on the basis of control group therapy, every 4 weeks for a course of treatment for patients.The following aspects were collected and analyzed comprehensively involving symptoms and signs of diabetic gastroparesis,gastric emptying rate,TCM syndromes,FPG,2h PG,Hb A1 c, lipid and liver and kidney function,the relapse rate before and after treatment to judge its efficacy and safety.Results By clinical observation, the total efficiency of the treatment group was 90.0% and the control group was 66.7%.Both treatments was effective. The treatment group to improve the clinical symptoms and physical signs was better than the control group(P<0.05). The treatment group was better than the control group on improving patients’ TCM syndromes(P<0.05).After treatments, the patients in treatment group had lower FPG, 2h PG and higher gastric emptying rate than the patients in control group(P<0.05).The treatment and control groups were not significantly lower in patients with Hb A1 c. Both groups of patients had no adverse reactions, and blood, urinary and stool routine test, liver and kidney function were all within the normal range both before and after treatment. After 12 weeks the relapse rate of treatment group was 33.3%,while the control group was 60.0%,the relapse rate between the two groups was different significantly(P<0.05).Conclusions Jian-pi-tong-luo decoction combined with domperidone is effective. Deficiency of spleen and stomach combined with blood stasis is the basic pathogenesis for the development of diabetic gastroparesis. Deficiency of spleen and stomach combined with blood stasis syndrome is one of important TCM type of diabetic gastroparesis. |
