A Prospective Randomized Comparative Study To Evaluate The Efficacy And Safety Of Hydromorphone In Opioid-tolerance Cancer Patients With Breakthrough Pain

Background: Currently,only morphine hydrochloride is clinically used for the treatment of breakthrough cancer pain(BTcP).Hydromorphone hydrochloride is a new type of strong opioid analgesic drug.It is fast and effective in analgesic effect,but it has not been routinely applied to the treatment of BTcP.This study was to analyze the efficacy and safety of hydromorphone hydrochloride in the treatment of pain in patients with opioid-tolerant cancer pain.Methods: According to the criteria for the study,patients with opioid-tolerant were randomly divided into Group A: morphine group,Group B: hydromorphone group,by the alphabet method.Using NCCN Adult Cancer Pain Guide(V2.2017)for pain control.The analgesic effect was assessed using a numerical rating scale and quality of life scale.Adverse reactions were assessed according to the International Clinical Trial Standard CTCAE V5.0.And clinical data were processed using SPSS 25.0 statistical analysis software.Results: The drug remission rate in group A was 26.2±10.9%,and that in group B was 43.2±10.2%,after taking the medicine for 15 minutes.And the difference was statistically significant(P<0.001).There were no significant differences between groups in the adverse events(P>0.05).There was no difference QOL before administration in both two groups(one-sided P=0.07).After taking the medicine for 15 minutes,the QOL of group B was higher than that of group A(one-sided P=0.028).Conclusion: This study demonstrates that hydromorphone hydrochloride is more effective than morphine hydrochloride and can be used in the treatment of BTcP without significant uncontrollable adverse effects.Therefore,hydromorphone hydrochloride is expected to be a new type of opioid for opioid tolerant patient with BTcP.However,it will still need to be further confirmed by large samples in the future.