| objective: The purpose of this study was to research the effect of Fuzheng Granule on immune function and quality of life of pat ients,who treated with radio-chemotherapy in advanced cervical cancer,an d to evaluate the effectiveness and safety of this treatment..Methods : W estern medicine diagnosis accords with patients with advanced cervical ca ncer and syndrome differentiation of spleen and kidney yang deficiency i n traditional Chinese medicine.At least 84 patients should be enrolled in the calculation sample size group.The third party random number plus envelope method divides the patients into treatment group and control gr oup.Both groups are treated with standardized radio-chemotherapy.On th e first day of radio-chemotherapy,the treatment group was given Fuzhen g granule orally,10 g/time,three times a day.Age,number of pregnanci es,body weight,BMI,tumor stage,pathological type and KPS score wer e recorded at the time of admission.After treatment,patients were follo wed up regularly and quantified after 28 days.The scores of TCM syndr omes,immune function,tumor markers,side effects,quality of life and s afety indicators before and after treatment were compared.Results: From November 2016 to October 2018,90 hospitalized patients in the oncolog y department of our hospital were enrolled,including 45 in the treatment group and 45 in the control group.The baseline data such as age,num ber of pregnancies,weight,BMI,tumor stage,pathological type and KPS score were comparable between the two groups.The main results were as follows:(1)TCM syndromes: the effective rate of TCM syndromes in the treatment group was significantly higher than that in the control gro up(92% vs 56%,P = 0.004);the TCM syndromes score in the treatment group was significantly improved(7.40 ± 2.00 vs 8.24± 1.88,p =0.034). (2)Cellular immune function: Although the levels of T lymphocyte subs ets(CD3+,CD4+,CD4+/CD8+)decreased in both groups after treatment,the percentage of CD3+(64.64±10.84 vs 61.96±10.62,p=0.015),CD4+(35.37±5.21 vs 32.77±5.33,p=0.040)and the ratio of CD4+/CD8+ were s ignificantly higher in the treatment group(1.52±0.53 vs 1.39±0.46,p=0.032)than in the control group.(3)Tumor markers: Because of the short fol low-up time,there was no significant change in the tumor markers betwe en the two groups;(4)Peripheral blood routine: After radio-chemotherapy,the white blood cell count and hemoglobin concentration in both groups decreased slightly,then gradually increased.In 7 days after treatment,the total number of WBC in the treatment group was significantly higher tha n that in the control group(3.51±0.86 vs 2.94 ±0.80,p=0.025);After rad io-chemotherapy,the PLT of the two groups decreased after 14 days,and the total PLT of the treatment group was significantly higher than that of the control group(154.20 ±42.39 vs 143.72 ±50.16,p=0.033).(5)Sid e effects: After treatment,the number of side effects in the two groups was higher than that in the control group.The number and degree of na usea and vomiting in the control group increased significantly(36 vs 18,P = 0.009).There was no significant difference in the other two groups.(6)Quality of life: The quality of life was used to evaluate the quality of life of patients with cervical cancer.After treatment,the physical func tion,psychological function,specific module,common symptoms and side effects all reflected the loss of quality of life.The QOL total score of l oss in the treatment group was significantly lower than that in the contro l group(45.24 ±13.52 vs 33.08 ±13.83,p=0.001).(7)Safety indicators:In 7 days after treatment,there was no significant change in AST?ALT?BUN?Cr between the two groups.Conclusion:Fuzheng Granule may improve th e TCM syndromes and patients' immune function,alleviate the side effects such as nausea or vomiting.Fuzheng Granule may improve the quality of life of patients after radio-chemotherapy,and can reflect the advantag es of integrated traditional Chinese and Western medicine in reducing tox icity and increasing efficiency.However,the mechanism of influencing pa tients' immune function deserves further study and clinical practice deserv es further optimization. |
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