| Objective: To observe the efficacy and safety of replenishing qi and nourishing blood method on peripheral neurotoxicity induced by taxanes in patients with breast cancer,in order to provide more effective treatment options for clinical treatment of this disease.Methods: Breast cancer patients with peripheral neurotoxicity due to the use of taxane chemotherapy drugs were selected,and a total of 70 patients were initially included according to the inclusion and exclusion criteria,signed informed consent,and divided into control and treatment groups using a random number table method,with 35 patients in each group.The control group was given mecobalamin tablets orally,0.5 mg each time,3 times a day;the treatment group was given replenishing qi and nourishing blood Chinese herbal medicine on the basis of the control group,taking in the morning and evening.The vital signs,laboratory indexes(blood routine,liver function,renal function,etc.),peripheral neurotoxicity grade,nerve conduction velocity,TCM syndrome score,quality of life score and NRS pain score were collected when the patients were enrolled.Relevant indicators were reviewed after 6 weeks of treatment,and the data were statistically analyzed.Results: A total of 67 patients in both groups completed the study per protocol,including 34 in the treatment group and 33 in the control group.(1)Baseline data: statistical analysis was performed on patient age,surgical approach,pathological type,clinical stage,molecular typing,drug type,chemotherapy cycles,grade of peripheral nerve toxicity,TCM syndrome scores,Karnofsky performance score,Pain scores,and nerve conduction velocities between the two groups,all with P > 0.05,showing no statistical difference and were comparable.(2)Grade of peripheral nerve toxicity: after treatment,17 cases of grade 0,11 cases of grade 1,5 cases of grade 2 and 1 case of grade 3 in the treatment group,6 cases of grade 0,16 cases of grade 1,8 cases of grade 2 and 3 cases of grade 3 in the control group,were better than before treatment.For intragroup comparisons,the grades of peripheral neurotoxicity were statistically analyzed before and after treatment in the two groups,respectively,with a significant statistical difference of P < 0.01.The grades of peripheral nerve toxicity after treatment were statistically analyzed between the two groups with P < 0.05.In terms of efficacy,the response rates were 82.35%,66.67% between the treatment and control groups,respectively,with a statistical difference by test,P <0.05.(3)TCM syndrome scores: after treatment,the TCM syndrome score in the treatment group decreased from 23.12 ± 4.44 to 10.21 ± 3.55,with a significant statistical difference by test,P < 0.01;The TCM syndrome score in the control group decreased from 23.33 ± 5.24 to 15.45 ± 5.39,with a significant statistical difference by test,P < 0.01.The TCM syndrome scores of the two groups after treatment were statistically analyzed with P < 0.01,a significant difference.In terms of efficacy,the response rates were 88.24%,69.70% between the treatment and control groups,respectively,with a significant difference by test,P < 0.01.(4)Karnofsky performance score: after treatment,the Karnofsky performance score of the treatment group increased from 70(70,80)to 80(77.5,90),which was significant by test,P < 0.01;The Karnofsky performance score of the control group increased from 70(70,80)to 80(70,80),which was significant by test,P < 0.01.The Karnofsky performance score after treatment was statistically significant at P < 0.05.(5)Pain scores: after treatment,the pain scores of the treatment group decreased from 4.68 ± 1.36 to 2.29 ± 1.29,which,by the test,was significantly different,P < 0.01;The pain score in the control group decreased from 4.94 ± 1.52 to 3.30 ± 1.85,which was significant by test,P < 0.01.The pain scores of the two groups after treatment were statistically analyzed at P < 0.05.(6)Nerve conduction velocities: after treatment,in the treated group,the MNCV of the median nerve was 51.29 ± 2.60m/s,the SNCV of the median nerve was 45.79 ± 2.36m/s,the MNCV of the common peroneal nerve was 45.17± 3.56m/s,and the SNCV of the common peroneal nerve was 44.35 ± 3.93m/s.In the control group,the median nerve MNCV was 47.03 ± 2.41m/s,the median nerve SNCV was 41.39 ± 1.92m/s,the common peroneal nerve MNCV was41.16 ± 3.39m/s,and the common peroneal nerve SNCV was 40.04 ± 3.31m/s.For intragroup comparison,the nerve conduction velocity of the two groups before and after treatment were statistically analyzed,P < 0.01,there were significant statistical differences.For the comparison between groups,the nerve conduction velocity of the two groups after treatment was statistically analyzed,P < 0.01,there was a significant statistical difference.(7)There were no adverse reactions in the two groups,and there were no obvious abnormalities in the safety observation indexes during the study period.Conclusion: The method of replenishing qi and nourishing blood can effectively reduce the symptoms of peripheral neurotoxicity caused by taxane chemotherapy drugs in breast cancer patients,improve the performance of TCM syndromes,the quality of life and nerve conduction velocity of patients.The therapeutic effect is better than that of mecobalamin alone,and there is no obvious adverse reaction.It is safe and worthy of clinical application. |