| Objective: The aim of this study was to observe the changes in pain score,pain relief rate,maintenance of oxycodone hydrochloride tablets,outbreak of pain,KPS score,Brief Pain Inventory(BPI)score,and adverse drug reactions in patients with mild to moderate bone metastasis cancer pain(BCP)before and after treatment with the "Kaihe Liuqi acupuncture".We also compared the changes of serum β-endorphin(β-EP)and substance P(SP)levels before and after the treatment,and preliminarily explored the possible mechanism of action of the Kaihe Liuqi acupuncture in the treatment of bone metastasis cancer pain in tumor patients.Methods: A total of 63 patients with mild and moderate BCP were included in the study,and a total of 3 patients were dislodged during the treatment process.In addition to radiotherapy,on the basis of conventional antitumor treatment,the treatment group:patients with mild BCP(1≦NRS≦3)were treated with "Kaihe Liuqi acupuncture";patients with moderate BCP(3<NRS<7)were treated with "Kaihe Liuqi acupuncture"based on oral administration of oxycodone hydrochloride extended-release tablets 10 mg q12 h,while the control group was treated with kaihe Liuqi acupuncture".In the"control group",patients with mild BCP were treated with celecoxib 0.2g bid.,and patients with moderate BCP were treated with oral oxycodone hydrochloride extended-release tablets 10 mg given every 12 h,and the initial dose of oxycodone was10 mg.The initial dose of oxycodone was 10 mg,and the individualized and differentiated doses were administered through dynamic assessment of the patients’ pain level.The pain scores,pain relief rate,daily maintenance of oxycodone hydrochloride tablets and frequency of pain outbreaks were measured before and after treatmentat at the 1st,2nd,3rd and 4th weeks respectively,and serum specimens were collected.Compare the changes of scale scores during the treatment process of the two groups to evaluate the efficacy of acupuncture in the treatment of bone metastasis cancer pain;detect and compare the differences of laboratory indexes between the two groups before and after treatment;record the adverse reactions,emergencies and responses of patients during the treatment process.The experimental data were compiled and counted,and the SPSS 25.0 software was used for statistical analysis after the experimental data were compiled.Results:General information,scale scores,β-endorphin(β-EP),and substance P(SP)levels were not statistically different between the two groups before treatment(P>0.05)and were comparable.Main observation indicators.(1)Pain indicators: A numerical NRS pain rating method was used to record patients’ NRS scores.Within-group comparisons showed that patients’ scale scores decreased in both groups before and at 1,2,3 and 4 weeks after treatment,with the difference being statistically significant(P<0.05).In between-group comparisons,NRS scores at the same time point before treatment and at weeks 1,2,3 and 4 weeks after treatment were lower in the treatment group than in the control group,and the difference was statistically significant(P <0.05).(2)Total effective rate: The overall analgesic efficacy rate at the end of week 4 was86.67% in the treatment group and 70.00% in the control group,a statistically significant difference(P<0.05).Secondary observation indexes.(1)Opioid use:After 4weeks of treatment,the single dose of oxycodone extended-release tablets was(11.85±4.15)mg in the treatment group and(13.24±3.27)mg in the control group,and the dosage of oxycodone extended-release tablets increased in both groups compared with that before treatment,but the dosage of oxycodone used in the treatment group was less than that in the control group,and P<0.05.(2)Outbreak pain: During treatment,the mean number of painful flares was(0.75 ± 0.82)in the main group and(1.54±0.97)in the control group,a statistically significant difference(P< 0.05).(3)KPS and BPI scores in each domain:Comparing the KPS and BPI scores in each domain,at the end of the fourth week,the treatment group demonstrated better performance than the control group in terms of improving overall health in the domains of activities of daily living,daily functioning,ability to walk,relationships with others,sleep,mood,and interest in life,with the difference being statistically significant(P<0.05).No serious adverse events occurred in either group during treatment,and safety parameters were within the normal range.(4)Adverse effects: Statistical analysis showed that the P value for constipation and nausea in the treatment group was less than 0.05 and the difference was statistically significant compared to the control group,while the difference was not statistically significant for vomiting,dizziness,and somnolence(P> 0.05).Laboratory indices.In intra-group comparison,there was a statistically significant difference in the levels of serum β-endorphin(β-EP)and substance P(SP)values at the end of week 4 treatment in the control group patients compared to pre-treatment(P<0.05).In comparison between groups,there was a statistically significant difference(P<0.05)in the changes of serumβ-endorphin and substance P levels at the end of week 4 in both groups.Conclusion:(1)The use of "Kaihe Liuqi acupuncture" alone for mild BCP or in combination with three-step analgesic drugs for moderate BCP can significantly reduce the pain level and effectively improve the pain relief rate.(2)The use of "Kaihe Liuqi acupuncture" can significantly reduce the amount of opioids used and the number of painful outbreaks.(3)The use of "Kaihe Liuqi acupuncture" can effectively improve the quality of life of patients compared with the simple three-step pain relief therapy.(4)"Kaihe Liuqi acupuncture" can reduce the side effects caused by opioids and has a good safety.(5)The use of "Kaihe Liuqi acupuncture" can significantly increase the level of serumβ-endorphin(β-EP)and decrease the level of substance P(SP),which can better relieve the pain state of patients. |
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