| Objective To analyze the clinical effect of shenfu injection on the prevention and treatment of peripheral neurotoxicity of paclitaxel and to explore its mechanism.Method1)clinical trial: patients with paclitaxel chemotherapy regimen who met the inclusion criteria in the department of oncology of sichuan provincial hospital of traditional Chinese medicine and west China hospital of China were treated with chemotherapy alone.Patients with traditional Chinese medicine were in the experimental group,and shenfu injection was used in combination with 100ml/d in the same period of chemotherapy.Peripheral nerve injury with CIPN20 score was evaluated at the 2nd,4th and 6th cycles of chemotherapy.The onset time of peripheral neurotoxic symptoms was observed and compared between the two groups.To evaluate and compare the pain scores of the two groups before chemotherapy and the second,fourth and sixth cycles..2)in vitro animal experiments: 20 Wistar rat dorsal root ganglion cells were isolated and cultured in vitro,divided into MOCK group,sf-treated group,chemotherapy group(PT),chemotherapy + low-dose traditional Chinese medicine(PT+LD),and chemotherapy + high-dose traditional Chinese medicine(PT+HD).The MOCK group received 10% blank serum,SF group received 10% drug-containing serum,PT group received 0.73(IC30)umol/L paclitaxel +10% blank serum,and the high-dose and low-dose groups received 10% and 5% drug-containing serum and the same amount of paclitaxel,respectively.After co-culture for 24 h,the following detection was performed:(1)cell proliferation was detected by cck-8 and enzyme marker.(2)the axon length: to beta tubulin ? antibodies to cellular immune dyeing and test analysis.(3)mitochondrial membrane potential changes were analyzed by jc-1 probe immunofluorescence staining.Results1)By the end of the follow-up in January 2020,a total of 117 patients with paclitaxel chemotherapy regimen were enrolled,including 62 in the experimental group and 55 in the control group.(1)CIPN20 score: after 2,4 and 6 cycles of chemotherapy,the scores of the experimental group were 21.92±1.42,23.23±2.35,and 24.84±4.09,respectively,which were significantly lower than those of the control group(P<0.01)and statistically significant differences.The score analysis after further age stratification showed that the difference between the control group and the experimental group in the scores of patients whose age ?60y was greater than that of patients whose age was > 60 y.(2)time of first PIPN: the time of first PIPN in the experimental group was(88.00±12.27)days,which was significantly longer than that in the control group(61.23±19.07)(P<0.05).(3)pain score: at the 2nd,4th and 6th cycles of chemotherapy,the pain score of the experimental group was 1.47±0.68,1.61±1.02 and 1.97±1.44,respectively,which was significantly lower than that of the control group(P < 0.01),and the difference between the 4th and 6th cycles of the control group and the 2nd cycle was statistically significant.(4)grade of bone marrow suppression: the total incidence of bone marrow suppression in the experimental group was 23.7%,26.1% and 49.3% in the second cycle of chemotherapy,compared with the control group(40.2%,59.6% and 64.3%),P value <0.05,among which there was no grade III or IV bone marrow suppression in the experimental group in the second and sixth cycles.(5)KPS score: in the second cycle of chemotherapy,the KPS score of the experimental group was 91.27±8.40,which was not statistically significant compared with the control group.At cycle 4 and cycle 6,the pain scores of the experimental group were 88.33±9.07 and 84.87±7.56,respectively,with P<0.05 compared with the control group,showing statistically significant differences.2)animal in vitro experiments:(1)cell proliferation: the OD values of the MOCK group and the PT group were 0.43±0.02 and 0.25±0.03,respectively(P<0.05).OD values of PT+LD and PT+HD were 0.41±0.05 and 0.46±0.03,respectively,which were both higher than that of PT group(P<0.05).(2)axon length: the MOCK group and the PT group were respectively(171.19±9.2)um and(59.2±6.1)um(P<0.05).The results of PT+LD and PT+HD groups were(124.2±18.3)um and(154.5±22.9)um,respectively,which were both higher than that of PT group(P<0.05).(3)mitochondrial membrane potential change: the MOCK group showed red fluorescence.Compared with the MOCK group,the PT group showed enhanced green fluorescence and decreased red fluorescence.The red fluorescence of PT+LD and PT+HD group was enhanced compared with that of PT group.Conclusion Shenfu injection can prevent and cure peripheral nerve injury caused by paclitaxel chemotherapy. |
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