A Randomized,Double-blind,Controlled Clinical Study Of Maren Soft Capsule In The Treatment Of Opioid-related Constipation

Objective:Cancer pain is one of the common symptoms of cancer patients.Opioid drugs are the most important analgesic drugs.However,opioid drugs may cause gastrointestinal dysfunction in the course of treating cancer pain,and the secret is the most common adverse reaction.The purpose of this study was to observe the clinical efficacy and safety of maoren soft capsule in the treatment of opioid-related constipation by randomized,double-blind,and controlled methods.Methods:Fifty-three patients with opioid-associated constipation(OIC)were enrolled into the treatment group and the control group according to the randomized,double-blind principle.First,both groups of patients were included in the screening period,during which the patient needed to stop using all laxatives and other intestinal drugs;If there is no spontaneous defecation within 72 hours,10mg or Kaixelu is an acceptable rescue drug.If it does not work,it can be used repeatedly or enema.If it is still ineffective,it can use short-acting clostric drugs on its own.Then into the treatment period,the treatment group was given oral mahren soft capsule,twice a day,2 tablets each time;the control group;The patients in the control group were given placebo twice a day for 2 tablets each time.If there is no spontaneous defecation within 72 hours,the rescue method is the same as before.The pain score,constipation symptom score(PAC-SYM),quality of life score(PAC-QOL)of constipation patients before and aft:er treatment,and the interval time of defecation before and after treatment were observed.The scores of TCM syndromes and the adverse reactions of the patients were analyzed statistically after the patients completed the test,and then the conclusion was drawn.Results:In this study,60 patients were enrolled,7 patients fell off during the period,and 53 patients were finally treated,including 27 patients in the treatment group and 26 patients in the control group.After statistical analysis,before treatment,there was no significant difference in data between the two groups.After treatment,the scores of constipation symptoms and the interval of defecation in the treatment group were significantly higher than those in the control group(P<0.05),and the quality of life score and TCM syndrome score in the treatment group were also better than those in the control group.The difference was statistically significant(P<0.05).Before and after treatment,there was no significant difference in pain score,there was no statistical significance.Research process In the treatment group,1 case of loose stool,after the withdrawal of symptoms improved.Conclusion:Compared with placebo,maoren soft capsule has obvious curative effect on constipation caused by opioid drugs,and can relieve constipation symptoms and improve quality of life of patients to a certain extent.Maren soft capsule has no obvious effect on the analgesic effect of opioid drugs,and the probability of adverse events is low.It is a safe and effective treatment measure.