| Objective: Clinical trials were conducted to observe the clinical efficacy of Yishen-Huoxuestong prescription combined with oxycodone hydrochloride sustained release tablets in the treatment of bone metastatic cancer pain patients with kidney Yang deficiency and blood stasis type,and to study whether the combination has significant advantages in the treatment of bone metastatic cancer pain,and to make a preliminary discussion on the mechanism of action of Yishen-Huoxuestong prescription.Methods:This project adopted a single-blind,randomized,parallel placebo-controlled trial method,and used SAS software to generate random sequences and divide them into treatment group(Yishenhuoxuetong prescription + oxycodone hydro-chloride sustained-release tablet group)and control group(placebo +oxycodone hydrochloride sustained-release tablet group).A total of112 patients were included in this experiment,12 of whom fell off during treatment.Finally,100 patients were included and evaluated in the following two aspects after 4 weeks of treatment:(1)To observe the analgesic effect of Yishen Huoxuetong decoction combined with oxycodone hydrochloride sustained release tablets on patients with bone metastatic cancer pain,that is,the improvement degree of clinical symptoms,the specific evaluation indicators include pain numerical score(NRS),card functional status score(KPS),the use of painkillers,the incidence of adverse reactions,etc.,and scientifically evaluate the clinical efficacy and safety of Yishenhuoxuetong decoction.(2)To detect the changes of Yishen Huoxuetong decoction combined with oxycodone hydrochloride sustained-release tablets on peripheral blood of patients with bone metastatic cancer pain,that is,the release and changes of bone metabolic factors and tumor metastasis factors.These include fibroblast growth factor 23(FGF23),matrix metalloproteinase-2(MMP-2),matrix metalloproteinase-9(MMP-9),and macrophage inflammatory protein-1 α(MIP-1 α).The above factors can affect the absorption of bone substances or destroy the balance between osteogenic and osteoclastic functions in bone,increase the probability of bone events,and preliminarily explore the mechanism of action of this prescription,so as to provide an objective basis for the treatment of kidney Yang deficiency and blood stasis type bone metastasis cancer pain.Results:1.There were no significant differences in gender,age,NRS score before treatment,KPS score before treatment,number of people taking painkillers before treatment and dosage(P > 0.05),which were comparable and had statistical significance.2.After treatment,NRS score of both groups was significantly decreased(P < 0.05),NRS score of the treatment group was significantly decreased compared with the control group(P < 0.05),and the curative effect evaluation of treatment group was better(P < 0.05).3.There were no differences in the onset time and dose of oxycodone hydrochloride sustained-release tablets between the two groups(P > 0.05),and the maintenance dose in the treatment group was significantly lower than that in the control group after treatment(P < 0.05).4.After treatment,the quality of life of both groups was significantly improved(P <0.05),the quality of life of the treatment group was better than that of the control group(P < 0.05),and the curative effect evaluation of treatment group was better(P < 0.05).5.After treatment,the adverse reactions such as fatigue and constipation in the treatment group were less than those in the control group(P < 0.05),and there was no significant difference in the remaining adverse reactions(P > 0.05).6.After treatment,the contents of FGF23,MMP-2 and MMP-9 in peripheral blood of the two groups were significantly decreased in the treatment group(P < 0.05),while the contents of MIP-1 α had no significant difference(P > 0.05).The contents of FGF23 and MIP-1 αin peripheral blood of control group showed an increasing trend(P <0.05),while the contents of MMP-2 and MMP-9 had no significant difference(P > 0.05).Conclusion:1.Yishen Huoxuetong Decoction combined with oxycodone hydrochloride sustained-release tablets can improve clinical symptoms,improve quality of life,reduce maintenance dose of oxycodone hydrochloride sustained-release tablets and reduce adverse reactions(constipation and fatigue)of opioids in patients with bone metastasis cancer pain of kidney Yang deficiency and blood stasis type.2.Yishen Huoxuetong Decoction combined with oxycodone hydrochloride sustained release tablets can reduce the contents of FGF23,MMP-2 and MMP-9 in peripheral blood of patients with kidney Yang deficiency and blood stasis type bone metastasis cancer pain,but has no significant change in the content of MIP-1 α.The mechanism of action of this formula may be related to the inhibition of the release of tumor metastasis factors and bone metabolic factors. |
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