| Objective: To identify the therapeutic efficacy and safety of Heat-sensitive moxibustion combined with Qishe Tongluo Lotion for the prophylaxis and treatment of albumin paclitaxel-induced peripheral neurotoxicity.Methods: This study is a prospective cohort study.Patients who qualified for the enrollment criteria were from the third Department of Oncology of Weifang Hospital of Traditional Chinese Medicine,and randomly divided them into the control group(40 cases)and the treatment group(40 cases).On the first day of chemotherapy,the control group was given oral mecobalamin tablets 0.5mg tid,and the treatment group was given heat-sensitive moxibustion and Qishe Tongluo lotion,until the end of this cycle of chemotherapy,a total of 6 cycles of treatment.A total of 3 observation points were set up,and the data were counted within 24 hours after the end of each 2 cycles of treatment.PIPN occurrence,severity level and EORTCQLQ-CIPN20 score of the two groups at every observation point were counted to assess the degree of peripheral nerve damage.The TCM syndrome score was compared to evaluate the improvement of TCM symptoms.The Kamofsky Performance Status(KPS)score and the revised piper fatigue scale(PFS-R)score were monitored to compare the physical status and fatigue of the two groups.Focus on monitoring patients for bone marrow suppression and other adverse effects in order to assess their safety.SPSS26.0 software was used for data statistics and analysis,and bilateral tests were used for statistical tests,and P<0.05 was statistically significant.Results: 1.Completion: At the beginning of this study,a total of 80 patients eligible for the enrollment were included,and the final number of patients in this study was 64,including 30 patients in the control group and 34 cases in the treatment group.2.Comparison of baseline datas: Firstly,the dropout rate and baseline data of the two groups including gender,age,tumor type,pathological stage,treatment plan and TCM syndrome score were statistically tested and the differences wwere not statistically significant.3.Neurotoxic symptoms:(1)PIPN incidence and severity level: In the control group,the number of patients with PIPN during the 2nd,4th and 6th cycles were 5 cases {(16.67%),5 cases of Grade 1},20 cases {(66.67%),(12 cases of Grade 1,6 cases of Grade 2,2 cases of Grade 3)},24 cases {(80%),(11 cases of Grade 1,9 cases of grade 2,4 cases of Grade 3)}.The number of patients in the treatment group were 5 cases {(14.71%),5 cases of Grade 1},12 cases{(35.29%),(7 cases of Grade 1,4 cases of grade 2,1 case of grade 3)},17 cases {(50%),(9 cases of grade 1,6 cases of grade 2,2 cases of grade 3)},and the difference was not statistically significant at the 2nd cycle(P > 0.05).The difference was statistically significant at the 4th and 6th cycles(all P<0.05).(2)EORTC QLQ-CIPN20 score: At the 2nd,4th and 6th cycles of chemotherapy,the scores of the control group were 22.73±2.21,26.23±2.47 and 31.80±3.23,and the scores of the treatment group were 21.65±1.48,24.91±2.47 and 28.06±2.89,the difference was statistically significant(all P<0.05).4.Curative effect of TCM syndrome: The curative effect of TCM syndromes in two groups did not achieve recovery effect.The number of ineffective,effective and effective patients were 19 cases,11cases and 0cases in the control group and 14 cases,19cases and1 cases in the treatment group at the 2nd cycle,16 cases,13cases and 1cases in the control group and 9cases,22 cases and 3cases in the treatment group at the 4th cycle and 18 cases,11cases and 1cases in the control group and 10 cases,20cases and 4cases in the treatment group at the 2nd cycle.The differences between the two groups were statistically significant(all P<0.05).5.KPS scores: At the 2nd,4th and 6th cycles of chemotherapy,the KPS scores of the control group were 85.05±6.38,82.65±5.44 and 78.93±6.84,respectively,and those of the treatment group were 89.92±5.40,87.08±6.15 and 83.26±6.32,respectively.The differences between the two groups were statistically significant(all P<0.05).6.PFS-R scores: At the 2nd,4th and 6th cycles of chemotherapy,the total PFS-R scores of the control group were 90.89±4.13,105.91±9.35,125.27±8.67,and the PFS-R scores of the treatment group were 87.85±5.52,98.47±9.29,118.56±8.37,respectively.The differences between the two groups were statistically significant(all P<0.05).7.Myelosuppression: The total incidences of myelosuppression at each observation point in the control group were 33.33%,53.33% and 66.67%,and that in the treatment group were 29.41%,35.30% and 41.18%,respectively.The difference was not statistically significant at 2 cycles(P > 0.05),and at 4 and 6 cycles,The differences between the two groups were statistically significant(all P<0.05).Conclusion: Heat-sensitive moxibustion combined with Qishetongluo lotion can prevent and control the peripheral neurotoxicity caused by albumin-paclitaxel,alleviate the symptoms of peripheral neurotoxicity to a certain extent,improve the traditional Chinese medicine syndrome and physical condition of patients with Qi deficiency and blood stasis syndrome,reduce cancer fatigue,reduce bone marrow depression,and increase patients’ tolerance to chemotherapy. |
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