| Background of the study The incidence of immune infertility is increasing day by day.AsAb positive infertility is the most common type of immune infertility.Traditional Chinese medicine has a long history of treating infertility with few side effects.Acupuncture has been widely used in reproductive field,which has the function of bidirectional regulating immune function,and has broad prospects in the research of treating AsAb positive infertility.Professor Chen Xinghua thinks that this disease is mostly caused by dysfunction of kidney,Tiangui,Chong Ren and uterus,and infertile women who suffer from multiple pressures from physiology,psychology and society for a long time are prone to breed negative emotions such as depression and anxiety.Therefore,he combined his own experience with the reproductive axis thought of "Kidney-Tiangui-Chong Ren-uterus" and the theory of "Jin San Zhen" to regulate brain and spirit to create Lingnan acupuncture for regulating spirit and helping pregnancy.Clinical findings show that it can relieve depression and anxiety of infertile patients,and there are many successful pregnancies,but relevant research and data are scarce.Objectives The purpose of this study is to explore the clinical efficacy and mechanism of Lingnan acupuncture for regulating mind and helping pregnancy in treating AsAb positive infertility through prospective randomized controlled trials,so as to develop the advantages of Chinese medicine,find an effective way for treating AsAb positive infertility,explore new research ideas for treating AsAb immune infertility and provide basic data for further research.Methods From January 2020 to December 2020,90 AsAb-positive infertility patients were randomly assigned to acupuncture group,western medicine group and control group.1.Clinical investigation.General data questionnaire,Self-rating Anxiety Scale(SAS)and Self-rating Depression Scale(SDS)were distributed to the subjects to investigate their basic situation and psychological status.Clinical investigation was conducted before treatment,after treatment and during the follow-up period.The scores of questionnaires in different periods of the three groups were calculated,the database was established,the psychological characteristics of immune infertility patients were analyzed,and the effects of the three groups on patients' psychological state and treatment outcome were compared.2.Clinical observation.The acupuncture group was treated with Lingnan acupuncture and condom isolation,the western medicine group was treated with prednisone tablets and condom isolation,and the control group was treated with condom isolation only.All three groups were treated with one menstrual cycle as a course of treatment.After each course of treatment,the scores of TCM syndromes and the quantification of serum AsAb,IL-2 and IL-6 were recorded.Those whose AsAb turned negative were instructed to share the same room during ovulation in the next month,while those whose serum AsAb had not turned negative continued the original treatment.Result 1.Serum AsAb:There were no antibody negative cases in the first course of treatment in the three groups,but there were 2 cases in acupuncture group and 0 cases in western medicine group and control group in the second course of treatment;In the third course of treatment,there were 24 cases(82.76%)in acupuncture group,17 cases(56.67%)in western medicine group and 6 cases(20%)in control group.The effect of reducing antibody content in acupuncture group was the most obvious(P<0.05),followed by western medicine group,and the effect of control group was the worst.The curative effects of all three groups increased with the increase of treatment time.2.Levels of IL-2 and IL-6:After a course of treatment,there was no significant difference in the changes of IL-2 and IL-6 among the three groups(P>0.05).After two courses of treatment,the improvement of serum IL-2 in the three groups had little difference(P>0.05),but there was significant difference in reducing serum IL-6 level(P<0.05).After three courses of treatment,the data of serum IL-2 and IL-6 in the three groups were significantly different from those in the previous period(P<0.05).The levels of IL-2 and IL-6 in acupuncture group were the most obvious,followed by western medicine group and the worst in control group.3.TCM symptom and sign score:The acupuncture group decreased after one course of treatment(P<0.05),and the scores in each stage were significantly different(P<0.05),and also significantly different from those in western medicine group and control group(P<0.05).Both the western medicine group and the control group have no obvious effect in improving the symptoms of patients in each treatment stage(P>0.05),and there is no significant difference between the two groups in each treatment stage(P>0.05).The curative effects of the three groups increased with the increase of treatment duration,among which the acupuncture group had the most obvious improvement effect,followed by western medicine group and the control group had the worst effect.4.Psychological indicators:(1)Before treatment,it was found that 7 people were severely depressed(7.87%),17 people were moderately depressed(19.1%),23 people were slightly depressed(25.84%),and the incidence of depression was 52.8%.There were 9 patients with severe anxiety(10.11%),14 patients with moderate anxiety(15.73%)and 20 patients with mild anxiety(22.47%),and the incidence of anxiety was 48.31%.There was no significant difference in depression and anxiety scores among the three groups(P>0.05).(2)After treatment,the scores of SDS and SAS in acupuncture group decreased most obviously(P<0.05),while there was no significant difference between western medicine group and control group compared with before treatment(P>0.05).There were significant differences in SDS and SAS scores between acupuncture group and western medicine group,acupuncture group and control group(P<0.05),while there was no significant difference in SDS scores between western medicine group and control group(P>0.05),but significant difference in SAS scores(P<0.05).After treatment,the number of depression decreased by 7 in acupuncture group and 3 in western medicine group,but remained unchanged in control group.Anxiety decreased by 5 in acupuncture group and 2 in western medicine group,but increased by 2 in control group.(3)During the follow-up period,the scores of SDS and SAS in acupuncture group still decreased significantly(P<0.05),while there was no significant difference between western medicine group and control group compared with the previous period(P>0.05).SDS and SAS scores showed significant differences between acupuncture group and western medicine group,acupuncture group and control group(P<0.05),but there was no significant difference between western medicine group and control group(P>0.05).During the follow-up,the number of depression decreased by one in acupuncture group,but there was no change between western medicine group and control group.The number of anxiety decreased by 2 in acupuncture group,but remained unchanged in western medicine group.Although the number of anxiety decreased by 2 in control group,it was the same as that before treatment.5.Pregnancy rate During the treatment and within 3 months of follow-up,6 cases(20.69%)were pregnant in acupuncture group,1 case(3.33%)was pregnant in western medicine group,and no patient was pregnant in control group.There were significant differences in pregnancy among the three groups(P < 0.05).At the end of the study,9 cases(31.03%)were pregnant in acupuncture group,5 cases(16.67%)in western medicine group and 4 cases(13.33%)in control group.6.Evaluation of curative effect:In acupuncture group,9 cases were cured(31.03%),15 cases were markedly effective(51.72%),4 cases were effective(13.79%),1 case was ineffective(3.45%),and the markedly effective rate was 82.76%.In the western medicine group,4 cases(13.33%)were cured,13 cases(43.33%)were markedly effective,11 cases(36.67%)were effective,2 cases(6.67%)were ineffective,and the markedly effective rate was 56.67%.In the control group,4 cases(13.33%)were cured,2 cases(6.67%)were markedly effective,9 cases(30%)were effective,15 cases(50%)were ineffective,and the effective rate was 50%.Among them,acupuncture group had the best curative effect,followed by western medicine group and the control group had the worst curative effect(P<0.05).7.Adverse reactions.In acupuncture group,2 patients had skin flush and slight bruise,which were relieved by themselves,and the incidence of adverse reactions was 6.9%.In western medicine group,there were 3 patients with facial edema,2 patients with nausea and stomach discomfort,1 patient with facial fever and 1 patient with slight rash on the chest.The incidence of adverse reactions was 23.33%.The incidence of adverse reactions in western medicine group was the highest,while that in acupuncture group and control group was lower(P< 0.05).Conclusion Immune infertility women have obvious psychological conditions of anxiety and depression.Lingnan acupuncture for regulating mind and helping pregnancy can nourish the mind,relieve liver depression,invigorate kidney and qi,strengthen the body resistance and eliminate evil,relieve depression and anxiety of infertility patients,regulate the immune function of the body,effectively reduce or even eliminate AsAb of the body,and also regulate the synthesis and secretion of cytokines,and improve the reproductive function so as to achieve the purposes of reducing antibodies and helping pregnancy.Compared with immunosuppressant therapy and isolation therapy commonly used at present,Lingnan acupuncture for regulating mind and helping pregnancy has obvious curative effect,little side effect and is not easy to relapse,which is worthy of clinical promotion. |
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