| Objective: This research aims to observe the clinical efficacy of external application of "Dingxiongxiaotong Prescription" applied to the treatment of pain caused by bone metastasis of malignant tumor,and to evaluate its safety.Raising the level of external treatment of Chinese medicine to a higher level,and playing a supporting role in the treatment of bone metastasis pain by the method of integrated traditional Chinese and western medicine.Methods: In this research,54 patients with malignant tumor and bone metastasis with negative TCM syndromes were selected.According to the principle of random double-blind control,the experiment was divided into two groups.Among them,27 cases in the experimental group received external application of "Dingxiongxiaotong Prescription " + conventional treatment(1 case dropped out,a total of 26 cases),and 27 cases in the control group received placebo + conventional treatment(2 cases dropped out,2 cases were excluded,a total of 23 cases),once a day,after 7 days of treatment,after that,the drug was discontinued and observed for 3 days.During the treatment period,both groups of subjects were given the best supportive care.Quantitative scores were performed on each index during the treatment period,and the pain behavior score,pain intensity score,24-hour opioid dosage,burst pain frequency,PGE2 level,quality of life evaluation,the safety and adverse reactions of both groups should be recorded at that time.After statistical analysis,efficacy evaluation and safety evaluation were completed.Results: 1.UBA pain behavior scale(PBS):(1)On the 7th day after treatment(D7),the PBS scores of the two groups were(1.94±0.75),(2.48±0.79),P<0.05,the difference can be statistically significant..(2)On the 10 th day after treatment(D10),the pain behavior scale score of the test group was(1.75±0.89),and the PBS score of the control group was(2.28±0.78).The pain behavior score of the experimental group group was lower than that of the control group,P < 0.05,suggesting that the difference was statistically significant.2.NRS pain intensity score:(1)The NRS score of the experimental group was(2.85±1.19)and the NRS score of the control group was(2.83±1.07)on the first day of enrollment(D1),and the difference was not statistically significant.(2)After the 4th day(D4)of acupoint application,the pain intensity scores of the experimental group and the control group were(1.69±0.93)and(2.00±0.74)respectively,with no statistical significance.After 7 days of treatment(D7),the NRS scores of the experimental group and the control group were(1.35±0.69)and(1.70±0.70),respectively,and the difference between the two groups was not statistically significant.(3)On the 10 th day of treatment(D10),the NRS scores of the experimental group and the control group were(0.85±0.78)and(1.39±0.78),respectively,P<0.05,By statistical analysis of the differences between the two groups,there is statistical significance.3.Frequency of pain outbreak: The frequency of D1,D4,D7 and D10 pain outbreak was compared between the experimental group and the control group,and the difference between the two groups was statistically analyzed,P>0.05,so there was no statistical significance.4.24-hour opioid dosage: 24-hour opioids dosage for two groups of subjects on the first day(D1),the fourth day(D4),the seventh day of treatment(D7),and the tenth day of treatment(D10)were analyzed and compared.During the treatment,the dosage of opioids in both groups has a decreasing trend,Statistical analysis shows that there is no difference between the two groups.5.KPS score: The KPS scores of the two groups on the first day before treatment(D0)and the seventh day after treatment(D7)were compared,and the result was: P>0.05,and there was no difference between the two groups.6.QOL score:(1)One day before treatment(D0),the QOL scores of the experimental group and the control group were(35.52 4.82)and(35.69 5.23),respectively.After statistical analysis,P>0.05,which showed that there was no significant difference between the two groups.(2)The QOL scores of the patients in the two groups after the 7th day(D7)were(40.54±4.62)and(35.61±4.56)respectively.Results: P<0.05,By statistical analysis of the differences between the two groups,there is statistical significance.7.PGE2 detection level: The PGE2 detection values of the two groups were analyzed and compared on the 1st day before enrollment(D0)and the 7th day after treatment(D7),P>0.05,indicating that the difference was not statistically significant.8.The comprehensive satisfaction evaluation:(1)After the treatment,the comprehensive satisfaction score of the physician in charge of the experimental group and the control group were(2.19±0.69)and(2.52±0.51),and the difference was not statistically significant.(2)The comprehensive satisfaction scores of experimental group and control group were(2.27 0.67)and(2.61 0.66)respectively,and there was no significant difference between the two groups.9.Pain relief rate: After treatment,the pain relief rate of the experimental group was 92.31% and that of the control group was 60.87%.The treatment group was significantly higher than the control group,and the statistical analysis showed that P<0.05,the difference is statistically significant.10.Evaluation of safety and adverse reactions:(1)After the treatment,there was no obvious abnormality in the blood routine,liver function and renal function indexes.(2)The occurrence of adverse reactions in the two groups was compared by Fisher’s exact probability method,after statistical analysis,it is concluded that P>0.05(P=1.000).(3)Compared with the control group,the patients in the experimental group are less prone to constipation adverse reactions.P<0.05,the difference is statistically significant.Conclusion:(1)The external application of Dingxiongxiaotong Prescription in the treatment of pain with bone metastases from malignant tumors can significantly improve the pain score,increase the pain relief rate,and improve the quality of life.It shows the advantages of external treatment of traditional Chinese medicine.(2)The external application of Dingxiongxiaotong Prescription has obvious clinical curative effect in the treatment of malignant tumor bone metastases pain,and can be clinically applied and promoted with... |
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