| Background:"Gynecologic tumor-related depression" refers to the pathological emotional changes that occur during the diagnosis and treatment of gynecologic tumors,which may not only have a profound impact on the quality of life and psychological health of tumor patients,but also affect the smooth implementation of anti-tumor therapy.Animal experiments and clinical studies have shown that Chaihu-jia-Longgu-Muli-Decoction is effective in relieving tumor-related depression and has unique advantages,but its mechanism of action is not yet clear.Objective:A pragmatic randomized controlled clinical study was used to further observe the efficac y of Chaihu-j ia-Longgu-Muli-Decoction on depression associated with gynecological maligna ncies;to explore the correlation between the mechanism and 5-hydroxytryptamine(5-HT)andβ-endorphin(β-EP).Research significance:At present,the research on depression associated with gynecological malignancies at home and abroad is still in the exploration stage,and its causative mechanism is still unclear,and there are no targeted drugs in Western medicine.This study aims to further explore the above problems,relieve patients’ physical and psychological disorders,provide more options for patients with gynecological malignancy-related depression,and benefit more patients,which is of great practical significance and value to bring into play the characteristic treatment of traditional Chinese medicine.Methods:The study was ethically reviewed by the Ethics Committee of Dongzhimen Hospital of BeijingUniversity of Chinese Medicine,and the cases were obtained from 67 patients who attended the outpatient clinic and ward of the Department of Hematology Oncology,Dongzhimen Hospital,between September 2021 and January 2023 and met the enrollment criteria of this study,and all patients had signed the informed consent form.The 67 patients were randomly divided into control group and treatment group according to the ratio of 1:1 using the random number table method.34 patients in the control group and 33 patients in the treatment group were randomly divided into control group and treatment group,among which 1 patient in the control group was lost due to personal reasons and refused to receive follow-up.Two patients in the treatment group had poor compliance and were unable to follow the prescribed protocol,making it difficult to judge the efficacy of the treatment.The final 62 cases entered the statistical analysis,31 cases each in the control and treatment groups.Control group:oral Escitalopram oxalate(Sichuan Kelun Pharmaceutical Co.,LTD.,National drug approval number H20080788)10mg per tablet,once a day,1 tablet each treatment.Treatment group:On the basis of control group,Chaihu-jia-Longgu-Muli-Decoction was used as the base formula,with the increase and decrease of the disease.Recipe basic composition:bupleurum 15g,raw keel 30g,raw oyster 30g,codonopsis 20g,wine rhubarb 10g,ginger pinellia 10g,Radix Baicalensis 10g,Paeony 15g,cassia branch 10g,poria cocos 10g,peach kernel 10g.Add or subtract according to common symptoms of gynecological tumors,such as abnormal bleeding:add madder and sanguisorba charcoal 10g each for dark red blood color;Light red blood plus crane grass 20g,Angelica 10g.Leucorrhea anomaly:multi-color yellow,foul odor plus thunberg fritillary bulb,flavescens 10g each;Add 15g atractylodes and 30g psyllium for multicolor white and clear.Less abdominal pain:less abdominal tingling,swelling pain plus frankincense,myrrh 10g each;Abdominal pain,dull pain,empty pain plus white peony 30g,scorched licorice 10g.Abdominal mass:Jiatuya 10g,leech 6g(Beijing Kangrentang Pharmaceutical Co.,LTD.).Take one dose a day with 150ml water,warm twice in the morning and evening.The primary diseases of the two groups were treated according to tumor related treatment norms.PHQ-9 score,TCM syndrome score evaluation and adverse reactions were observed on the 1st,15th and 30th day respectively.At day 1,30,5-HT and β-EP in peripheral blood of the two groups were measured,and the changes of 5-HT and β-EP in peripheral blood were compared.Results:1.PHQ-9 score analysis:In terms of PHQ-9 score distribution,at the first and 15th days,the PHQ-9 score distribution of the treatment group had significant statistical difference(P<0.01),while the control group had no statistical difference(P>0.05).At the first and 30th day,the PHQ-9 score distribution of the two groups was significantly different(P<0.01).At the 15th and 30th day,the PHQ-9 score distribution of the treatment group was significantly different(P<0.01),while the control group was significantly different(P<0.05).The distribution of PHQ-9 scores in both groups showed a trend of decreasing the number of patients with 10-14 scores and increasing the number of patients with 0-4 scores with the extension of observation time.On the 15th day of treatment,there was no significant difference in the distribution of PHQ-9 scores between the two groups(P>0.05).On the 30th day of treatment,there were statistically significant differences in the distribution of PHQ-9 scores between the two groups(P<0.01).In terms of PHQ-9 scores,both groups showed a gradually decreasing trend with the progress of time.On the 15th day of treatment,PHQ-9 scores were statistically different between the two groups(P<0.05).On the 30th day of treatment,PHQ-9 scores were significantly different between the two groups(P<0.01).In terms of curative effect,compared with the 30th day in the treatment group and the control group,the curative effect was improved.On the 15th day of treatment,the effective rate was statistically different between the two groups(P<0.05).On the 30th day of treatment,there was a statistically significant difference in the effective rate between the two groups(P<0.01).2.TCM syndrome score analysis:As for the integral distribution of TCM syndromes,at the first and 15th days,there were statistically significant differences in the integral distribution of TCM syndromes in the treatment group(P<0.01),but not in the control group(P>0.05).At the first and 30th day,there were statistically significant differences in the integral distribution of TCM syndromes in the treatment group and the control group(P<0.01).At the 15th and 30th day,there was statistical difference in the integral distribution of TCM syndrome in the treatment group(P<0.05),while there was no statistical difference in the control group(P>0.05).Between the two groups,on the 15th day of treatment,there was no statistical difference in the integral distribution of TCM syndrome between the two groups(P>0.05).On the 30th day of treatment,there were statistically significant differences in the integral distribution of TCM syndromes between the two groups(P<0.01).In terms of TCM syndrome scores,both groups showed a trend of decreasing gradually with the advance of time.On the 15th day of treatment,there were statistical differences in TCM syndrome scores between the two groups(P<0.05).On the 30th day of treatment,there were statistically significant differences in TCM syndrome scores between the two groups(P<0.01).The single score comparison of TCM syndrome,on the 15th day of treatment,the treatment group compared with the control group,in the aspect of fatigue and idling score improvement has significant statistical difference(P<0.01),in the aspect of depression,bitter mouth and dry throat,insomnia and dreaminess score improvement has statistical difference(P<0.05).On the 30th day of treatment,compared with the control group,there were significant statistical differences in the score improvement of depression,irritability and desire to cry(P<0.01),and statistical differences in the score improvement of god fatigue,bitter mouth and dry throat,dizziness,insomnia and dreaminess(P<0.05).In terms of curative effect,compared with the 30th day in the treatment group and the control group,the curative effect was improved.On the 15th day and the 30th day of treatment,there were statistically significant differences in the effective rate between the two groups(P<0.01).3.5-HT,β-EP levels analysis:There was no statistical difference in serum 5-HT levels between the treatment group and the control group before treatment(P>0.05),and after treatment,serum 5-HT levels in both groups were significantly higher than before(P<0.01),and serum 5-HT levels in the treatment group were significantly higher than those in the control group(P<0.01).There was no statistical difference between the serum β-EP levels of patients in the treatment group and control group before treatment(P>0.05),and after treatment,the serum β-EP levels in both groups were significantly lower than before(P<0.01),and the serum β-EP levels in the treatment group were significantly lower than those in the control group(P<0.01).4.Adverse reactions:There were minor adverse reactions in both groups,and there was no statistical difference between the treatment group and the control group(P>0.05).Conclusions:1.Chaihu-jia-Longgu-Muli-Decoction was effective in treating gynecological tumorrelated depression.2.The mechanism of the treatment of gynecological tumor-related depression with Chaihujia-Longgu-Muli-Decoction subtraction may be upregulation of peripheral blood 5-HT and reduction of peripheral blood β-EP. |
PDF Full Text Request