Clinical Study On Electroacupuncture Treatment Of Constipation Related To Oral Oxycodone Hydrochloride Sustained-release Tablets

Objective:To observe the effect of electroacupuncture on constipation of qi deficiency related to oral oxycodone hydrochloride prolonged-release tablets,and to evaluate its safety,and to establish this clinical trial,so as to provide a basis for the follow-up study of electroacupuncture on OIC.Methods:Design a prospective,randomized,comparative clinical trial:44 patients were divided into treatment group(electroacupuncture group)and control group(western medicine group).The treatment group was treated with electroacupuncture at Zusanli,Tianshu,Zhigou and Shangjuxu acupoints every day for 20 minutes for 14 consecutive days;The control group was treated with lactulose oral solution 30 ml every day for 14 consecutive days.The constipation symptoms,traditional Chinese medicine symptoms,defecation times,quality of life,physical condition and cancer pain were observed and recorded before treatment,on the 7th and 14th day of treatment.Safety indexes were recorded on the 7th and 14th day of treatment.The results were statistically analyzed.Results:42 patients completed the clinical trial,including 22 in the electroacupuncture group and 20 in the western medicine group.?Baseline:Before the treatment,there were no significant differences in age,gender,cancer,constipation symptom score,traditional Chinese medicine symptom score,defecation frequency,QOL,ECOG,NRS,and the dosage of oxycodone hydrochloride prolonged-release tablets between the two groups(P>0.05).?Constipation symptoms:On the 7th day of treatment,10 cases were effective and 12 cases were ineffective in the electroacupuncture group,with a total effective rate of 45.45%;6 cases were effective and 14 cases were ineffective in the western medicine group,with a total effective rate of 30.00%;On the 7th day of treatment,the improvement of constipation symptoms in the two groups did not show a statistical difference(P=0.303).On the 14th day of treatment,4 cases in the electroacupuncture group were cured,5 cases had significant curative effect,11 cases were effective,2 cases were ineffective,the total effective rate was 90.91%;In the western medicine group,15 cases were effective,5 cases were ineffective,the total effective rate was 75.00%;On the 14th day of treatment,the improvement of constipation symptoms in the electroacupuncture group was better than that in western medicine group(P=0.009).The electroacupuncture group was more advantageous than the western medicine group in improving defecation difficulty,defecation feeling,defecation frequency and abdominal distention symptom(P<0.05),there was no significant difference between the two groups in improving fecal characteristics and defecation time(P>0.05).?Symptoms of traditional Chinese medicine:The time of improving symptoms of traditional Chinese medicine in electroacupuncture group(the 7th day of treatment)was earlier than that in western medicine group(the 14th day of treatment).Compared with western medicine group,electroacupuncture group can improve the symptoms of traditional Chinese medicine better(P<0.05).?Number of defecations:After treatment,the number of defecation in the two groups increased significantly(P<0.001).On the 7th day of treatment,there was no significant difference in the number of defecation between the two groups(P=0.360).On the 14th day of treatment,the effect of increasing the number of defecation in the electroacupuncture group was better than that in the western medicine group(P=0.028).?Quality of life:The improvement of the quality of life in the electroacupuncture group was better than that in the western medicine group(P<0.001),and the electroacupuncture group had more advantages than the western medicine group in improving food intake,spirit and fatigue(P<0.05).There was no statistical difference in the improvement of sleep between the two groups(P>0.05).?Cancer pain:There was no statistically significant difference in pain between the two groups of subjects before and after treatment,and there was no statistical difference in the amount of oxycodone hydrochloride prolonged-release tablets(P>0.05).?Safety:In the western medicine group,1 subject withdrew from the study due to the use of rescue defecation treatment,and 1 subject withdrew from the study due to mild diarrhea.All the subjects in the electroacupuncture group had no acupuncture related adverse events such as fainting,bending,stagnation,breaking and bleeding.There were no significant changes in blood routine,liver and kidney function,stool routine and ECG in the two groups.There were no other serious adverse events in the two groups.Conclusion:Electroacupuncture is better than lactulose in the treatment of qi deficiency constipation related to oxycodone hydrochloride prolonged-release tablets.It can significantly improve the symptoms of constipation,improve the symptoms of traditional Chinese medicine,increase the number of defecation,improve the quality of life.It is safe and effective.