| One of the most prevalent and terrifying signs for cancer patients is cancer pain,with a high incidence and difficult therapy.At present,opioids are widely used to treat moderate and severe cancer pain.However,long-term use of such medications can easily lead to drug tolerance or hyperalgesia,which is not conducive to the control of pain conditions,and patients are often plagued by their adverse reactions,which greatly threaten the quality of life and prognosis of patients.Cancer pain belongs to the category of "pain" in TCM.At present,a systematic and standardized TCM therapy plan for cancer pain has not yet been formed,and the advantages of TCM in treating cancer pain still need to be discovered.On the basis of preliminary experiments,taking lung cancer pain as an example,this study adopts a prospective,randomized,and controlled research method to explore the efficacy and safety of electroacupuncture encircling needling combined with external application of traditional Chinese medicine for encouraging blood flow and eliminating blood stasis in the therapy of cancer pain,in order to provide a practical and effective TCM comprehensive external therapy scheme for clinical therapy of moderate and severe cancer pain of blood stasis type.Objective:Through a prospective,randomized,controlled clinical study,assess the effectiveness and safety of electroacupuncture encircling needling in combination with external application of traditional Chinese medicine for encouraging blood flow and eliminating blood stasis in order to treat moderate and severe cancer pain of the blood stasis stagnation type of lung cancer,to offer evidence-based medical support for the clinical use of TCM comprehensive external therapy in conjunction with acupuncture and medicine in the management of cancer pain associated with blood stasis.Methods:From January 2022 to November 2022,The random number table method was used to randomly divide the 72 patients with moderate to severe cancer pain of the lung cancer stasis type who were hospitalized in the oncology ward of Wangjing Hospital,China Academy of Chinese Medical Sciences and met the inclusion criteria into the experimental group and the control group.Oral prolonged-release pills of oxycodone hydrochloride were administered to the control group.The experimental group received therapy with electroacupuncture encircling needling in conjunction with external application of traditional Chinese medicine for increasing blood circulation and reducing blood stasis,based on the course of therapy used in the control group.5 days constituted a cycle,and both groups were treated for two consecutive cycles.The primary curative effect evaluation index is the effective rate of pain relief,and the secondary curative effect evaluation indexes are NRS scores,average daily dose of oxycodone,average daily number of outbreaks of pain,serum PGE2 and β-EP levels,pain impact scores,KPS scores,and improvement rate.On this basis,conduct safety evaluation and observe the occurrence of adverse reactions.Results:In this study,there were no dropout instances throughout the trial,which involved a total of 72 patients with moderate to severe cancer pain of the lung cancer stasis type who were randomly assigned to the experimental group and the control group,with 36 cases in each group.According to the baseline analysis,there was no discernible difference between the two groups’ gender,ages,body mass indexes,pathological types,TNM stages,numbers of pain sites,and pain durations(P>0.05),which were comparable.In terms of effectiveness analysis,the effective rate of pain relief comparison,the total effective rate of pain relief in the experimental group was 91.67%(33/36),and that in the control group was 77.78%(28/36).The total effective rate of pain relief in the experimental group was higher than that in the control group(P<0.01);the effective rate of pain relief with moderate pain in the experimental group was higher than that in severe pain(P<0.01),and there was no significant difference between moderate and severe pain in the control group(P>0.05);compared between the moderate pain groups,the effective rate of pain relief in the experimental group was higher than that in the control group(P<0.01),and there was no significant difference between the severe pain groups(P>0.05).Comparison of NRS scores,There was no statistically significant difference in NRS scores between the two groups before therapy(P>0.05),which was comparable;after therapy,the NRS scores of the two groups were lower those before therapy(P<0.01),and the NRS scores of the experimental group were lower compared with the control group(P<0.01),the difference of NRS scores before and after therapy in the experimental group was greater than that in the control group(P<0.01).Comparison of the average daily dose of oxycodone,there was no significant difference in the average daily dose of oxycodone hydrochloride in the first cycle between the two groups(P>0.05),and the average daily dose of oxycodone in the experimental group in the second cycle was lower than that in the control group(P<0.05).Comparison of the daily average number of breakthrough pain,there was no significant difference between the two groups in the average number of breakthrough pain in the first three days before therapy(P>0.05),and the average number of breakthrough pain in the experimental group was lower than that in the control group during the entire therapy period(P<0.01).Comparison of serum PGE2 and β-EP levels,there was no statistically significant difference in serum PGE2 and β-EP levels between the two groups before therapy(P>0.05),and they were comparable;after therapy,the PGE2 levels in both groups were lower than those before therapy(P<0.01),and the experimental group was lower than the control group(P<0.05),the β-EP levels in the two groups were higher than those before therapy(P<0.01),and the experimental group was higher than the control group(P<0.05);The differences of serum PGE2 and β-EP levels before and after therapy in the experimental group were greater than those in the control group(P<0.01).Comparison of pain impact scores,there was no significant difference in the pain impact scores between the two groups before therapy in terms of general activities,emotions,walking ability,normal work,relationship with others,sleep,joy of life and total pain impact scores(P>0.05),which were comparable;There were statistically significant differences in general activities,emotions,walking ability,normal work,relationship with others,sleep scores and total pain impact scores between the two groups before and after therapy(P<0.01 or P<0.05),there was a statistically significant difference in the joy of life scores of the experimental group before and after therapy(P<0.01),and there was no statistically significant difference in the joy of life scores of the control group before and after therapy(P>0.05);after therapy,the emotions,sleep scores and total pain impact scores of the experimental group was lower than those of the control group(P<0.05 or P<0.01),and there was no statistically significant difference in the scores of other aspects between the groups(P>0.05);the differences in emotions,walking ability,normal work,sleep,joy of life scores and total pain impact scores in the experimental group before and after therapy were greater than those in the control group(P<0.01),there was no statistically significant difference in the scores of other aspects between the groups(P>0.05).Comparison of KPS scores and improvement rate,there was no statistically significant difference in KPS scores between the two groups before therapy(P>0.05),which was comparable;after therapy,the KPS scores of the experimental group was higher than those before therapy(P<0.01),and the KPS scores of the control group before and after therapy had no statistically significant difference(P>0.05);after therapy,there was no statistically significant difference in KPS scores between the two groups(P>0.05);the difference in KPS scores before and after therapy in the experimental group was greater than that in the control group(P<0.01).The improvement degree of KPS scores in the experimental group was mainly increased,while the improvement degree of KPS scores in the control group was mainly stable,and the difference in the average level of KPS scores improvement between the two groups was statistically significant(P<0.01).In terms of safety analysis,there was no significant difference in blood,urine,stool routine,liver and kidney function between the two groups before and after therapy(P>0.05).During the therapy,a total of 59 patients reported adverse reactions,including 24 cases of constipation,nausea and vomiting in the experimental group and 35 cases of constipation,nausea and vomiting and dizziness in the control group,the total incidence of adverse reactions in the experimental group was lower than that in the control group(P<0.01).Conclusion:The effect of oxycodone hydrochloride prolonged-release tablets combined with electroacupuncture encircling needling and external application of traditional Chinese medicine for encouraging blood flow and eliminating blood stasis is better than that of oxycodone hydrochloride prolonged-release tablets alone in the therapy of moderate and severe cancer pain of lung cancer stasis type,especially for patients with moderate pain,and can reduce the dosage of analgesic drugs and the number of breakthrough pain,and the analgesic mechanism may be related to the reduction of serum PGE2 content and the increase of serum β-EP content;at the same time,it can improve the degree of influence of cancer pain on daily activities to a certain extent,mainly reflected in emotions and sleep,and improve the overall functional status of patients;the safety is good,and can reduce the occurrence of opioid-related adverse reactions. |
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