| ObjectiveIn this study,warm acupuncture and moxibustion combined with oral administration of traditional Chinese medicine to treat patients with cold coagulation type of menstrual period,explore new clinical treatment plans,and provide more evidence-based information for the combination of acupuncture and medicine for gynecological diseases.Clinical treatment,so it is of positive clinical significance and value through the combination of traditional Chinese medicine and acupuncture.Through clinical randomized controlled trials,the clinical efficacy of Baliao point warm needle combined with Danggui Shaoyao San on patients with cold coagulopathy and’ late menstruation was observed to observe the effectiveness and safety of this therapy.MethodsResearch method90 cases were randomly divided into treatment group,30 cases,control group A,30 cases,and control group B,according to the number of random sequences generated by random sequence software.The specific methods are as follows:Using a random sequence software template,a set of 1-90 random sequences is generated(that is,a natural number of 1-90,but the order is randomly scrambled).Then each patient was assigned a random sequence number,the value of which was divided by 3,the remaining 1 into the treatment group,the remaining 2 into the control group A,and the remaining 0 into the control group B.If a patient is assigned a number of 32,divided by 3,the remaining is 2,the patient is assigned to the control group A.Fill in the random card according to the random sequence number and put it into the corresponding numbered envelope,and keep it in a special person.After the case meeting the inclusion criteria,the envelope number is opened in turn and the treatment on the random card is accepted.Treatment methodTreatment group interventions:(1)Chinese medicine orallyDanggui Shaoyao San:(Angelica 10g,white peony 30g,Chuanxiong 20g,Atractylodes 15g,Tuckahoe 15g,Alisma 20g,)Operation:1000 ml of water,first boil with high heat,then decoct for 30 minutes with a small fire,take 300 ml of the soup,and take warm soup 3 times.(2)Selection of acupoints:Baliao points,matching points:SanyinjiaoOperation:The patient takes the prone position and fully exposes the lumbosacral region.Use Suzhou Huaying brand disposable sterile acupuncture needle(produced by Suzhou Medical Products Factory Co.,Ltd.)to take(according to the patient’ s fat and thin,choose 0.30mm*50mm),routine 75%alcohol acupoint skin disinfection,use one-handed to quickly insert the needle.After needling with the lifting,thrusting,twisting and then arrival of qi,the Baliao points are all ignited with a 1.5cm long moxa stick and then left in the needle handle,and then withdraw the needles when the moxa sticks are burned out.(3)Course of treatment:Medicine oral administration and acupuncture treatment are once a day,continuous treatment 5 times(then rest for two days),continuous treatment for 4 weeks as a course of treatment,a total of 4 courses of treatment.Control group A intervention:(1)Chinese medicine orallyDanggui Shaoyao San:(Angelica 10g,white peony 30g,Chuanxiong 20g,Atractylodes 15g,Tuckahoe 15g,Alisma 20g,)Operation:1000 ml of water,first boil with high heat,then decoct for 30 minutes with a small fire,take 300 ml of the soup,and take warm soup 3 times.(2)Selection of acupoints:refer to the general acupuncture selection points in the later period of menstruation in the planning textbooks of Acupuncture and Moxibustion and the Acupuncture and Moxibustion in the New Century National College of Traditional Chinese Medicine:Guanyuan,Xuehai,Sanyinjiao,Taichong,Qimen.Operation:The patient is placed in a supine position to fully expose the lower abdomen and limbs.Use Suzhou Huaying brand disposable sterile acupuncture needle(produced by Suzhou Medical Products Factory Co.,Ltd.)to take(according to the patient’ s fat and thin,choose 0.30mm*50mm),routine 75%alcohol acupoint skin disinfection,use one-handed to quickly insert the needle.After needling with the lifting,thrusting,twisting and then arrival of qi,the 1.5cm long moxa stick is ignited and left in the needle handle,and then withdraw the needles when the moxa sticks are burned out.(3)Treatment:once a day,5 consecutive treatments(then rest for two days)for one course of treatment,continuous treatment for 4 weeks for a course of treatment,a total of 4 courses of treatment.Control group B intervention:(1)Chinese medicine orallyDanggui Shaoyao San:(Angelica 10g,white peony 30g,Chuanxiong 20g,Atractylodes 15g,Tuckahoe 15g,Alisma 20g,)Operation:1000 ml of water,first boil with high heat,then decoct for 30 minutes with a small fire,take 300 ml of the soup,and take warm soup 3 times.(2)Treatment:once a day,taking 5 consecutive days(then rest for two days)for a course of treatment,taking 4 weeks for a course of treatment,a total of 4 courses of treatment.Observation indicators and scoring standardsObserve the changes of the menstrual cycle,menstrual period,serum sex hormones(FSH,LH,E2,P,T,PRL)accompanied by symptom scores,objectively analyze and evaluate the efficacy of Baliao point warm needle combined with Danggui Shaoyao San in the treatment of late menstruation.Menstrual cycle days:Refer to the "Guidelines for Clinical Research of New Drugs in Traditional Chinese Medicine" in the irregular menstruation and the grading of the menstrual cycle in the "Integrated Chinese and Western Medicine Obstetrics and Gynecology".(See Table 1 for the rating scale)Standards for accompanying symptom evaluation:refer to the relevant standards in the Guiding Principles for Clinical Research of New Drugs in Traditional Chinese Medicine(see Attached Table 2)Because the rating scale involves multiple subjective index evaluations,a person with relevant knowledge of TCM is assigned to collect the patient-related symptoms at the time of evaluation,and the responsible evaluator does not know the number of random sequences and the corresponding patient grouping.Try to ensure the objectivity,scientificity and uniformity of the collected information.Efficacy criteriaThe comprehensive efficacy evaluation refers to the diagnostic efficacy standard of 2017 Chinese medicine.Note:Calculation formula:efficacy index=(pre-treatment score-post-treatment score)/pre-treatment score X 100%.Healing:the menstrual cycle returns to normal,other symptoms disappear,and the score is reduced by>95%;Significant effect:the menstrual cycle recovered 28+7 days,other symptoms disappeared or reduced,70%≤points decreased<95%;Effective:menstrual cycle is improved compared with before treatment,other symptoms are less than before treatment,30%≤integral reduction<70%;Invalid:There is no significant improvement in the menstrual cycle,and the score is reduced by<30%.Statistical methodThe data of this study were statistically analyzed using statistical software SPSS19.0.The measurement data were compared by t test,the X2 chi-square test was used for counting treatment,and the grade data was statistically processed by Ridit test method.Multiple independent samples were analyzed by one-way ANOVA.The Dunnett test was used in the treatment group and the control group.The non-parametric test(Kruskal-Wallis test)method was used for statistical analysis when the normal distribution was not satisfied.ResultsIn the income group,the researchers responsible for arranging the enrollment fully analyze and analyze the patient’ s past menstrual conditions,and combine the work and study environment,mental conditions,stress status and living conditions as a whole.From the source,the patient’ s enrollment was strictly controlled to ensure good compliance after enrollment.Therefore,at the end of the study,after analyzing the data,it was found that 90 patients in the income group participated in the whole research process without falling off.And the suspension situation,90 valid data were included in the statistical analysis.There were no significant differences in the distribution of age,disease duration,menstrual cycle,menstrual cycle,serum sex hormones FSH,LH,E2 and accompanying symptoms in the three groups before treatment(P>0.05),all of which were comparable.1.After the treatment,the total effective rate of the treatment group was 96.7%,the total effective rate of the control group A was 83.3%,and the total effective rate of the control group B was 66.7%.The cure rate was 76.7%in the treatment group,10%in the control group A,and 0 in the control group B.The overall efficacy of the treatment group was significantly better than that of the control group A and the control group B.The difference was statistically significant.(P<0.01).2.Many patients had normal menstrual period before enrollment,16 cases(53.3%)in the treatment group,16 cases(53.3%)in the control group A,and 13 cases(43.3%)in the control group B.The menstrual period was normal.Except for the influence of this cardinality,compared with the control group A and the control group B,the treatment group was significantly better than the control group A and the control group B in the improvement of menstrual period(P<0.01).For the improvement of menstrual cycle,the treatment group was significantly better than the control group A and the control group B,compared with the control group A and the control group B,the difference was statistically significant(P<0.01).3.In the second menstrual period,serum sex hormones were measured,and the changes of FSH,LH,E2,P,T and PRL in the three groups were compared with those before treatment.When serum sex hormones were detected in the second menstrual period,the FSH and LH values of the treatment group were significantly lower than those before treatment,and the difference was statistically significant(P<0.01).At the third menstrual period,serum sex hormones were measured,and the changes of FSH,LH,E2,P,T,and PRL were compared between the three groups.When the serum sex hormones were detected in the third menstrual period,the FSH,LH,E2,T and PRL values of the treatment group were significantly lower than those before treatment,and the difference was statistically significant(P<0.01);the FSH and LH of the control group A were significantly higher(P<0.01).Compared with before treatment,the difference was significantly lower(P<0.01).The T value of the control group A was significantly lower than that before the treatment,and the difference was statistically significant(P<0.05).4.After treatment,the symptom scores of the treatment group were significantly lower than those of the control group A and the control group B(P<0.01),and the control group A compared with the control group B.The difference was not statistically significant(P>0.05).The T-test was used to analyze the changes of the accompanying symptom scores before and after treatment in each group.The symptom scores of the three groups were significantly lower than those before treatment(P<0.01).ConclusionIn this study,patients with cold coagulation type of late menstruation were selected as subjects.By selecting a combination of acupoints and Sanyinjiao specific acupuncture points,local warm needles combined with oral Chinese medicine treatment,compared with ordinary acupuncture and single oral Chinese medicine,the former treatment was observed.The clinical efficacy of the method,the results show that this treatment can significantly improve the patient’ s main symptoms,regulate the menstrual cycle,can comprehensively adjust the serum sex hormone indicators,and can significantly improve the patient’s accompanying symptoms and improve the quality of life.This treatment is safe and effective,no adverse events and adverse reactions occur,and a reference to treatment options during clinical application provides a new approach.This study conducted a longitudinal analysis of the effectiveness of clinical trials,and later included in other syndrome patients,conducted a comparative analysis of lateral multiple syndrome types,and evaluated the efficacy characteristics of the treatment methods in this study from multiple angles.Through the study,we found that the clinical efficacy is better.Based on this,we can explore the mechanism of action and provide more scientific evidence-based medical data for the clinical efficacy. |
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