| Objective:To evaluate the efficacy and safety of Wenyang Huoxue Decoction in the treatment of moderate to severe bone metastasis somatic pain with 58%cold coagulation and blood stasis,in order to provide evidence-based basis for further clinical promotion.Methods:Using a randomized controlled trial design,66 patients who met the inclusion criteria were randomly divided into control group(33 cases)and treatment group(33 cases).The treatment group was treated with opioid analgesics+Wenyang Huoxue decoction,the control group was only given oral opioid analgesics.This study took 7 days as a course of treatment.After the observation session,the effective pain relief rate,pain score,analgesic dose,analgesic dose reduction rate,TCM Symptom score,KPS score,the occurrence of burst pain and adverse drug reactions were compared between the two groups before and after treatment,and make statistical analysis.Results:①After treatment,both groups can alleviate the pain of bone metastasis to a certain extent.The pain effective rate in the control group was 81.82%,and the pain effective rate in the treatment group was 96.97%.There was a significant difference in the rate of pain relief between the two groups(p<0.001).②After treatment,the pain scores of the two groups were lower.However,the treatment group was more obvious than the control group,and there was a significant difference between the two groups(p<0.05).③After the course of treatment,the KPS scores of patients in the control group and the treatment group were improved.However,the difference between the two groups was not significant(p>0.05).④After the course of treatment,the dosage of opioids in the treatment group was significantly reduced compared with that before.The effective rate of reducing the dosage of analgesics in the control group was 87.88%,while that in the treatment group was 93.94%.Significant difference between the two groups(p<0.05).⑤During the treatment process,compared with the control group,the occurrence of burst pain in the treatment group decreased,and the difference between the two groups was significant(p<0.05).⑥After the treatment,both groups could improve the symptoms of cold blood stasis syndrome to a certain extent.The effective rate of TCM symptom remission in the control group was 54.55%,and the effective rate in the treatment group was 87.88%.There was a significant difference between the two groups(P<0.05).⑦After the treatment,compared with the control group,the treatment group had relatively few adverse reactions,but there was no significant difference between the two groups(P>0.05).There were no significant changes in vital signs,electrocardiogram,routine blood,liver and kidney function,and routine urine before and after treatment.Conclusion:Wenyang Huoxue Decoction combined with opioid analgesics can improve the remission rate of moderate-to-severe bone metastases somatic pain of cold blood coagulation stasis type,reduce pain intensity score,reduce the use of painkillers,improve patients’ TCM symptoms,and has good safety sex. |