The Clinical Study Of Fufang Aitong Recipe In The Treatment Of Moderate To Severe Cancer Pain With Internal Nodules Of Blood Stasis By The Method Of Directed Medicine Penetration Of Traditional Chinese Medicine

Objective: To objectively evaluate the clinical efficacy and safety of Compound Cancer Pain Prescription joint traditional Chinese medicine(TCM)directional transdermal therapy in the treatment of moderate and severe cancer pain by collecting clinical data of Compound Cancer Pain Prescription joint TCM directional transdermal therapy in the adjuvant treatment of moderate and severe cancer pain,and to provide scientific basis for further promotion and application.Methods: A prospective single-blind randomized controlled clinical trial was conducted in this study.80 inpatients who met the research criteria were numbered 1~80 in order of visiting time.According to the principle of randomized control,they were divided into treatment group and control group with 40 cases each.After grouping,all patients were given the first stage of opioids titration for 1 to 3 days.According to the dosage of opioids determined after titration,the second stage of treatment was carried out.The control group was treated with opioid sustained-release agents,while the treatment group was treated with Compound Cancer Pain Prescription joint TCM directional transdermal therapy.Both groups were treated with immediate-release morphine symptomatic treatment when outbreak pain occurred,and the dosage of sustained-release opiates was adjusted in time according to the number of outbreaks of pain and the duration of pain relief.After treatment,pain intensity score,pain relief rate,dosage of opioid analgesics,number of outbreaks of pain,pain impact score,onset time of pain relief,duration of pain relief,quality of life,adverse reactions and safety were compared between the two groups before and after treatment.Result:1.Pain intensityAfter the treatment of the first stage,the average NRS score of the treatment group was reduced to(2.49±1.30),while that of the control group was reduced to(2.51±1.30).There was no statistical difference between the two groups(P=0.984).After the treatment of the second stage,the average NRS score of the treatment group continued to decline to(1.43±1.32),while that of the control group was(2.26 ± 1.41).The difference between the two groups was significant.Statistical significance(P = 0.003).2.Pain relief rateAfter the second stage treatment,the pain relief rate(CR+PR)of the treatment group was97.50%,and that of the control group was 92.31%.The pain relief rate of the treatment group was slightly higher than that of the control group,but there was no significant difference(P=0.231).3.Dosage of opioid analgesicsDuring the first stage of treatment,the 24-hour basic dose of morphine in the treatment group was(41.40±24.83)mg,while that in the control group was(41.31±25.54)mg,with no significant difference(P=0.984).During the second stage of treatment,the 24-hour basic dose of morphine in the treatment group decreased to(36.75±24.28)mg,while that in the control group increased to(44.23±28.76)mg.Compared with the first stage of treatment,the 24-hour basic dose of morphine in the treatment group decreased to(4.65±12.7)mg,while that in the control group increased to(2.92±12.18)mg),with a significant difference(P=0.000).4.Breakthrough pain controlDuring the second stage of treatment,Breakthrough pain occurred in the treatment group(1.72±0.63)and in the control group(3.20±1.04).The difference was significant(P=0.000).5.Pain affect scoreAfter treatment,the pain affect score of the treatment group was(20.30±6.16)and that of the control group was(25.48 ± 6.38).There was no significant difference between the two groups(P=0.565).6.Onset time of pain reliefDuring the second stage of treatment,the onset time of pain relief in treatment group was(58.89±5.61)minutes,while that in control group was(61.50±6.58)minutes.There was no significant difference between the two groups(P=0.087).7.The duration of pain reliefDuring the second stage of treatment,the duration of pain relief in the treatment group was(11.84 +0.68)hours,while that in the control group was(11.53 ±0.72)hours.There was no significant difference between the two groups(P=0.321).8.KPS scoreAfter treatment,the KPS score of the treatment group was(76.52±8.17)and that of the control group was(75.72±6.96).There was no significant difference between the two groups(P=1.000).9.Adverse reactions and safetyAfter treatment,there was no significant difference in nausea,vomiting and sleepiness between the treatment group and the control group(P > 0.05);in the degree of constipation,the treatment group was better than the control group and the difference was statistically significant(P=0.028).After treatment,no abnormal changes of blood pressure,heart rate,blood routine,liver and kidney function were observed in both groups.Conclusion: The treatment group can relieve the intensity of pain,reduce the intake of opioids,reduce the number of Breakthrough pain,and improve constipation and other adverse reactions when using Compound Cancer Pain Prescription joint TCM directional transdermal therapy to treat patients with moderate or severe cancer pain.In terms of pain relief rate,pain affect score,KPS score,onset and duration of pain relief,the treatment group was slightly better than the control group,but the effect was roughly the same.Therefore,the method of Compound Cancer Pain Prescription joint TCM directional transdermal therapy is worth popularizing among patients with moderate or severe cancer pain.