| This dissertation is composed of two parts:the review article and a clinical research.literature review is the first part,which is composed of two parts:"Pathogenesis and Treatment Progress of Paclitaxel-induced Peripheral Neuropathy" and "TCM1 Treatment Progress of Paclitaxel-induced Peripheral Neuropathy".The first part of the literature review introduces the pathogenesis,clinical manifestations,diagnosis criteria,and treatment progress of paclitaxel-induced CIPN(Chemotherapy-induced peripheral neuropathy).At present,western medicine treatment of CIPN is mainly symptomatic treatment,supplemented by etiological treatment with understanding possible pathogenesis of CIPN.The treatment methods include physical therapy and drug therapy.Physical therapy in clinical includes exercise therapy,acupuncture therapy and compression therapy.In terms of drug therapy,there are glutathione and amifostine which can reduce the toxicity of chemotherapy drugs;calcium magnesium mixture which can change the ion permeability of nerve cell membrane and reduce the excitability of nerve cells;methylcobalamin and neurotropin which can promote the repair of damaged nerve cells;gabapentin which can relieve neuralgia;but there is no effective drug.In conclusion,for the treatment of paclitaxel-introduced CIPN,there is no effective drugs that recommended by international guidelines,and there is a lack of drugs with good effect,safety,convenience and high cost performance.The second part of the literature review introduces the understanding and treatment progress of CIPN in TCM,and makes a retrospective study on five aspects of TCM treatment of paclitaxel-introduced CIPN:etiology and pathogenesis,syndrome type,treatment principle,external treatment and internal treatment.There are various forms of external treatment of TCM,such as acupuncture,electroacupuncture(EA),blood-letting puncture,herb soaking,etc.In the aspect of internal treatment of TCM,clinical doctors mainly treat patients with adjusted classical formulas or self-made formulas according to the actual clinical situation of patients.Common formulas include "Buyang Huanwu Decoction","Danggui Sini Decoction","Decoction of Five Drugs Including Astragalus and Cinnamon",etc.TCM treatment fully presents the advantages of"simplicity,convenience,efficacy and low cost",and is widely used in clinical practice.The second part of-the paper is clinical research.Objective:to reevaluate the effect of Wenluotong Granules with matured pharmaceutical technology and clear quality standard for external use before clinical treatment,and to observe the clinical therapeutic effect and safety of Wenluotong Granules.To provide superior TCM treatment for clinical treatment by reducing the symptoms of CIPN,improving life quality of patients and the effect of chemotherapy.Methods:78 cases of CIPN caused by chemotherapy were included in the study.51 cases of paclitaxel-introduced CIPN were analyzed by subgroup analysis.There were1 TCM(Traditional Chinese Medicine)27 cases in the experimental group and 24 cases in the control group.The experimental group was treated with external application of Wenluotong Granules and the control group was treated with placebo.At the same time,all patients took Mecobalamin(0.5mg tid).Before and after treatment,physical examinations were done,the main outcome measure was peripheral neuropathy grading(refer to NCI-CTCAE version 5.0),the secondary outcome measures were peripheral neurotoxicity symptom score(FACT/GOG Scale),NRS pain score,Brief Pain Inventory(BPI),and the safety measures including blood routine test,liver and kidney function test.SPSS 22.2 software was used for case grouping,data management and statistical analysis,and two-sided test was used for statistical test.If P<0.05,the difference was considered statistical significant.Results:the above observation indexes were all actual values,and SPSS 22.2 was used to process data.Therapeutic Effect Index Results:(1)completion:51 patients were enrolled with 5 males and 46 females,27 in the experimental group and 24 in the control group.The tumor distribution was mainly breast cancer(41/51),chemotherapy drug distribution was paclitaxel(PTX)(19/51),docetaxel(DOC)(14/51),Abraxane(5/51),paclitaxel liposome(13/51),peripheral neuropathy was mainly grade ?(38/51).(2)All the patients were treated with external application of Wenluotong Granules for one week.(3)main outcome measures:?peripheral neuropathy grading:at the end of the treatment cycle,the CIPN grading of the test group was mainly grade ?(23/27),while that of the control group was mainly grade ?(16/24),the difference was statistically significant(P<0.001);? comparison of NRS scores of pain between the two groups after treatment for one treatment cycle,there was a very significant difference between the experimental group and the control group(P<0.001);? Brief Pain Inventory(BPI),there was a very significant difference between the experimental group and the control group(P<0.001);? the FACT/GOG Scale,there was a very significant difference between the experimental group and the control group(P<0.001);? Onset time:from the beginning of to the end of treatment,Wenluotong Granules was 100%effective to the experimental group,the average onset time was 4.47 days,placebo was only 46%effective to the control group,the difference was statistically significant(P<0.01).There were no adverse reactions in the two groups before or after treatment.Conclusion:(1)Paclitaxel drugs are widely used in the treatment of breast cancer and are also one of the common chemotherapy drugs that cause peripheral neurotoxicity.(2)Peripheral neurotoxicity caused by paclitaxel drugs is mainly grade I and II.Common clinical symptoms include numbness at the ends of hands and feet,abnormal temperature sensation,and pain.Syndrome differentiation can be cold resistance meridian,qi deficiency and blood stasis syndrome.(3)Wenluotong granules can reduce the CIPN grade and significantly alleviate its symptoms.It has good consolidation effect,Good security,easy to use,and has obvious advantages. |
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