| Objective: To objectively evaluate prescription of supplementing qi and nourishing yin combined with metoclopramide treating diabetic gastroparesis(DGP) of the efficacy, safety and recurrence rate, and provide the basis for clinical practice.Methods: Choose 62 patients conformed to the syndrome of Qi-Yin deficiency with DGP, randomly divide them into two groups: 31 cases in the test group,31 cases in the control group. Two groups were treated with diabetes foundation treatment, to make blood glucose control in a good level, all the patients shouldn’t use other prokinetic drugs since one week before the subjects. Test group: all the patients were given my tutor ’ s clinical experience prescription, which contains: codonopsis pilosula, poria cocos, fried hovenia dulcis, bupleurum, dendrobium, rhizoma coptidis from Sichuan of China, scrophulariae, yam, salviae miltiorrhizae, etc. Meanwhile treated with metoclopramide tablets. Control group: all the patients were given metoclopramide tablets. Treatment course was four weeks.Observe the improvement of main clinical syndrome integral and the half gastric emptying of solid food time before and after the therapy, then calculate the total clinical efficiency for each group. Observe adverse reactions to evaluate drug safety.Follow up for 4 weeks after the end of the therapy to calculate the recurrence rate. Finally use statistical methods to analyze the results and evaluate the clinical efficacy of each group.Results:(1)The practical completed number:there was 1 case dropped in test group,1 case eliminated in control group.So the final number was 60,30 cases in test group,30 cases in control group.(2)The clinical efficiency comparison: after the therapy, 5 patients had basically recovered, 4 patients significantly effective, 15 patients effective and 6 patients ineffective in test group, and the total clinical efficiency was 80%. However, there were 1 patients basically recovered, 3 patiets significantly effective, 1 patients effective and 15 patients ineffective in control group, the total clinical efficiency was 50%. The statistical test indicated that the total efficiency of test group was better than control group after the therapy(P<0.05).(3)The main clinical syndrome integral comparison: Compared before and after the treatment, the main symptoms were significantly improved in test group(P < 0.01).That of control group were also significantly improved(P<0.01), except syndrome as body tired fatigue, dry mouth and throat, tongue picture, pulse condition.(P>0.05) Compared two groups after treatment, the improvement of syndrome integral as nausea, vomiting and sour regurgitation was no statistically significant difference;( P>0.05) While test group was superior to control group in terms of the rest syndrome integral(P<0.01 or P<0.05).(4)The half gastric emptying of solid food time comparison:The time of two groups were both significantly improved after treatment(P < 0.01). Two groups compared to the degree of improvement,the test group was better than the control group(P<0.01).(5)Safety comparison: After 14 days of therapy, two cases in control group appeared adverse reactions which were manifested as mild diarrhea. The security level of the two cases was class two and the discomfort can be tolerated, so the adverse reactions had little influence on continued treatment. No adverse reactions appeared in test group. During the course of therapy, all the patients was detected no anomaly in blood, urine, stool, liver function, renal function and ECG.(6)The recurrence rate comparison: During 4 weeks of follow-up, the recurrence rate was 16.67% in the test group, while was 53.33% in the control group. The rate of test group was obviously lower than control group, which indicated a statistically significant differerence between two groups(P<0.05).Conclusion:(1)Qi-Yin Enriching Formula combined with metoclopramide in the treatment of DGP with Qi-Yin deficiency syndrome has a good clinical effect, which can significantly improve the clinical symptoms of the patients.(2)Qi-Yin Enriching Formula combined with metoclopramide in the treatment of DGP with Qi-Yin deficiency syndrome can obviously decrease the half gastric emptying of solid food time of the patients, which significantly facilitates gastric emptying.(3) Qi-Yin Enriching Formula combined with metoclopramide in the treatment of DGP with Qi-Yin deficiency syndrome has little side effects, good security and lower recurrence rate than western medicine, and offers a certain reference value for the combination of traditional Chinese and Western medicine in the treatment of DGP. |
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