| Objective: to observe the efficacy and safety of Chinese patent medicine kuntai capsule in the treatment of postoperative menopausal syndrome of gynecological malignant tumor,and to provide a new safe and effective treatment scheme for patients with contraindicated hormone replacement therapy,so as to improve the postoperative quality of life of patients with gynecological malignant tumor.Methods: a total of 90 cases of premenopausal or perimenopausal women who underwent radical tumor resection and bilateral ovarian resection in our hospital due to gynecological malignant tumors from August 2016 to January2019 were selected.The patients were divided into the experimental group(TCM kuntai capsule group)with 60 cases,including 30 cases of cervical squamous cell carcinoma,2 cases of cervical adenocarcinoma,18 cases of endometrial carcinoma and 10 cases of ovarian cancer.The control group(lvai group)had 30 cases of cervical squamous cell carcinoma.Among them,60 cases were in the experimental group(kuntai capsule group),with the age range of 31-50 years old and the median age of 45 years old.The control group(lvai group)consistedof 30 patients,whose age ranged from 32 to 49 years old,with a median age of43 years old.The duration of postoperative menopausal symptoms in the two groups fluctuated from 1 week to 4 weeks,with a median duration of 2weeks.Part I: 60 patients in the experimental group(Chinese medicine kuntai capsule group)were treated with oral Chinese medicine kuntai capsule for 3months by using the self-controlled study method.The observation indexes were divided into efficacy indexes,safety indexes,adverse reactions and side effects.The indexes of efficacy included main symptoms of menopause(hot flashes and sweating),improved Kupperman symptom score,efficacy index,and qol score of tumor patients.Safety indexes included serum estradiol(E2)level,hematuria routine,liver and kidney function,electrocardiogram,B ultrasound of abdominal urinary system,and B ultrasound of gynecology.Part ii: 30 cases of cervical squamous cell carcinoma were selected from the experimental group(traditional Chinese medicine kuntai capsule group)and the control group(Livial group),and were given oral treatment of kuntai capsule and Livial until 3months after surgery,and the above observation indexes were also compared.Results:1.Improvement of the main symptoms of menopause(hot flashes and sweating)In the self-controlled study,the symptoms of hot flashes and sweating were significantly improved compared with that before treatment,and the score of main symptoms of menopause(hot flashes and sweating)was significantly decreased 3 months after surgery(p < 0.01),and the difference was statistically significant.In the comparative study of the two groups,it was suggested that there was no significant difference between the two groups in the score of treating mainsymptoms of premenopause(p > 0.05).There was no significant difference in the scores of main symptoms of menopause between the two groups 1 month after surgery and 3 months after surgery(p > 0.05).2.Variations of modified Kupperman scoresIn the self-controlled study,the symptom scores of modified Kupperman in the experimental group were lower than that before treatment,in which the effect was most significant three months after surgery(p < 0.01).In the comparison of the two groups,there was no distinct difference in Kupperman symptom scores before treatment between the two groups(p >0.05).The Kupperman symptom scores of the control group were significantly lower than those of the experimental group 1 month after surgery,and the two groups were significantly different(p < 0.05).Three months after surgery,there was no significant difference in Kupperman symptom scores between the two groups(p > 0.05).3.Determination of total clinical efficacyIn the self-controlled trial,the total efficacy of 60 patients in the experimental group at 1,2 and 3 months after surgery was 36.6%,81.6% and91.6%,respectively.At 3 months after surgery,14 patients showed significant effect,41 were effective,and 5 were invalid.A comparative study between the two groups showed that the total efficacy of 30 patients in the experimental group at 1 month,2 months and 3 months after surgery was 40%,83.3% and 90%,respectively.At 3 months after surgery,5 patients showed significant effect,22 were effective and 3 were invalid.The total efficacy of 30 patients in the control group at 1 month,2 months and 3months after surgery was 46.7%,76.7% and 86.7%,respectively.Three months after surgery,there were 2 cases with significant effect,24 cases with effectiveeffect and 4 cases with invalid effect.There was no significant difference in the total effective rate between the two groups at 1 month,2 months and 3 months after surgery(p > 0.05).4.Quality of life scale score of tumor patientsIn the self-controlled study,60 patients in the experimental group showed significantly lower qol scores after treatment than before treatment,and the difference before and after treatment was statistically significant(p < 0.05).In the comparison study between the two groups,there was no significant difference in qol score between the experimental group and the control group(p> 0.05).After treatment,scores in the qol scale of tumor patients in the experimental group decreased significantly compared with the control group,and the comparison between the two groups was statistically significant(p <0.05).5.Changes in serum estradiol(E2)levelsExperimental group in serum estradiol levels before using this drug is 26.93pg/ml,postoperative 1 month in serum estradiol level of 21.88 pg/ml,2 months after the serum level of estradiol in 16.12 pg/ml,3 months after the median level of serum levels of estradiol showed < 10 pg/ml(estradiol levels below 10 pg/ml,the hospital clinical laboratory assay sheet shows only < 10 pg/ml,don’t show the specific number),still showed a trend of gradual decline in estrogen levels after medication.The median estradiol level in the control group was 26.65pg/ml before treatment,27.75pg/ml one month after treatment,35.54pg/ml two months after treatment,and 39.31pg/ml three months after treatment.6.Adverse reactions and side effectsNo serious adverse reactions were observed in patients of the two groups during the course of medication,including nausea and vomiting in 3 patients and headache in 1 patient in the control group,with an incidence of adverse reactions of 13.3%.During the treatment period,patients in the two groups were regularly reviewed for hematuria routine examination,liver and kidney function,electrocardiogram,b-ultrasound and other examinations,and no obvious abnormalities were found.Conclusion:1.Proprietary Chinese medicine kuntai capsule can effectively improve the patients with gynecology malignant tumor occurred after menopause symptoms,and can improve the quality of the survival of patients with postoperative.Had no significant effect in improving serum estradiol,thus can avoid estrogen to bring in patients with hormone-dependent tumor recurrence.2.Compared with the Livial,its for the improvement of main symptoms of menopause,menopausal syndrome,as well as the improvement in no difference between the total effective rate,efficacy and its equivalent;But for improving the quality of life in cancer patients kuntai capsule significantly superior to Livial.In improving patient serum estradiol,Livial can effectively supplement the body exogenous estrogen,therefore Livial work faster than kuntai capsule,but use taboo for hormone-dependent tumor patients.3.Kuntai capsule has less incidence of adverse reactions compared with Livial. |
PDF Full Text Request