| Objective:The first part of the retrospective clinical study reviewed the clinical cases,analyzed the distribution pattern of TCM Syndromes of patients with BCRL,and explored the good certificate type of the disease.The second part is a prospective clinical study to observe the efficacy and safety of Yiqi Wenjing Huoxue Method on patients with BCRL with Qi deficiency and blood stasis,and provide reference information for clinical treatment.Methods:The first part is a retrospective clinical study.The research direction is determined according to the literature records and the guidance and suggestions of tutors and experts.Taking March 2016 as the starting point and March 2021 as the time node,the past patients in the oncology department of the First Teaching Hospital and the Second Teaching Hospital of Tianjin University of traditional Chinese medicine and were collected,which must meet the BCRL inclusion criteria.Based on the review of previous case data,relevant literature research results,combined with clinical practice and widely soliciting the opinions of professional experts,this study collected relevant TCM symptoms,including tongue and pulse,established a database,analyzed the distribution characteristics of TCM syndromes,and obtained the TCM syndrome types of the disease through cluster analysis.The second part of the prospective clinical study collected patients who were treated in the outpatient or inpatient department of the oncology department of the First Teaching Hospital and the Second Teaching Hospital of Tianjin University of traditional Chinese medicine from March 1,2021 to December 31,2021,who met the BCRL inclusion criteria and the TCM syndrome differentiation was Qi deficiency and blood stasis.The patients could be divided into 2 groups,which contains experimental group and control group.The experimental group was treated with Yiqi Wenjing Huoxue Decoction Combined with mild moxibustion and functional exercise,and the control group was treated with mild moxibustion and functional exercise.After treatment,the relevant observation indexes on the 1st and 28th days were recorded for efficacy evaluation and safety evaluation.The two sets of data were compared to analyze the clinical efficacy of Yiqi Wenjing Huoxue Method on upper limb lymphedema after breast cancer operation and related safety indicators.Results:The first part of the retrospective clinical study included 103 cases of BCRL,including67 cases of qi deficiency and blood stasis syndrome,accounting for 65%.The second part of the prospective clinical study is to study the patients who met the BCRL inclusion criteria in the outpatient or inpatient department of the oncology department of the First Teaching Hospital and the Second Teaching Hospital of Tianjin University of traditional Chinese medicine from March 1,2021 to December 31,2021.A total of 60 patients were included,including 30 patients in the experimental group and 30 patients in the control group.1.Comparison and analysis of baseline information: analyze the general conditions of the two groups of patients before treatment.The P > 0.05,indicating that there is no significant difference between the two groups,which can be used for comparison of follow-up studies.2.The results of clinical intervention test show that:(1)arm circumference of affected side upper limb: the patients in the two groups recorded the arm circumference of their upper limb before and after treatment,and recorded the arm circumference of their healthy side upper limb.By calculating the difference between the healthy side and the affected side and the arm circumference of the affected side upper limb before and after treatment,it was found that the two groups had therapeutic benefits for reducing the arm circumference of upper limb(P < 0.01).It was also found that in the two groups,The recovery degree of the affected upper limb in the experimental group was greater than that in the control group(P < 0.05).(2)Pain score(VAS score): by recording the VAS scores of the two groups before and after treatment,it was found that the VAS scores of the two groups showed a downward trend after treatment(P < 0.01),but through the comparison between the two groups,it was found that the effect of the experimental group after treatment was more prominent(P < 0.05).(3)Dash upper limb function score: by comparing the changes and trend analysis of DASH scores of the two groups before and after treatment,it is found that the DASH scores of the two groups are reduced after treatment(P < 0.01),while comparing the two groups,it can be found that the decline of the scores of the test group is greater(P < 0.05),so the recovery effect of the test group on upper limb function is more prominent.(4)Muscle strength grading: by comparing the changes of muscle strength before and after treatment,it was found that there was no significant change in muscle strength between the two groups(P > 0.05).(5)Edema degree:comparing the changes of edema degree between the two groups before and after treatment,it is found that the experimental group and the control group have the recovery change of edema degree after treatment(P < 0.01).The comparison between the two groups can find that the improvement effect of the experimental group is more obvious(P < 0.05),the change of edema degree of the affected upper limb is greater,and the recovery effect is better.(6)Efficacy index: after treatment,the calculation found that 3.33% of the patients in the experimental group had significant improvement,70% of the patients had effective improvement,the patients in the control group had no significant improvement after treatment,and 53.33% of the patients had effective improvement,which had significant clinical effect.(7)Safety: no safety events occurred in the two groups during the whole study.It represents the method of Supplementing Qi,warming meridians and activating blood circulation,which is safe and reliable.Conclusion:1.the upper extremity lymphedema of breast cancer occurs in patients with Qi deficiency and blood stasis.2.The method of Supplementing Qi,warming meridians and activating blood circulation has a better curative effect on patients with BCRL(Qi deficiency and blood stasis type).It can more reduce the arm circumference of the edematous upper limb on the affected side,better alleviate the feeling of swelling and pain,and restore the upper limb function to a greater extent.At the same time,it can effectively reduce the degree of edema and help patients improve their quality of life.It also proves the excellent diagnosis and treatment effect and good safety of the method of Supplementing Qi,warming meridians and activating blood circulation. |