| ObjectiveThis clinical study was a prospective study.By observing the effect of progesterone treatment and Ertian decoction combined with progesterone in the treatment of threatened abortion of spleen and kidney deficiency before 12 weeks of pregnancy(corresponding to the diagnosis of fetal unstability and fetal leakage in traditional Chinese medicine),the clinical efficacy of Ertian decoction in the treatment of early threatened abortion of spleen and kidney deficiency was explored.It provides a valuable clinical basis for the research and promotion of new drugs for Ertian decoction in the future,and brings practical effect and value to the treatment of early threatened abortion patients.MethodsPatients with early threatened abortion of spleen and kidney deficiency were recruited from the gynecological clinic of Dongzmen Hospital,Beijing University of Chinese Medicine.Following the principle of voluntary,after signing the informed consent form,the patients were randomly divided into two groups according to the ratio of 2:1,namely:Integrated traditional Chinese and western medicine treatment group,progesterone treatment group,the patients’ general conditions(age,gravidity,parity,menstrual history,related medical history before pregnancy,etc.),main syndrome and secondary syndrome scores were evaluated at the time of enrollment.After taking progesterone and integrated traditional Chinese and western medicine treatment for 1 month,the patients’ main syndrome and secondary syndrome scores were evaluated again.The early pregnancy outcome of the patients(12 weeks of pregnancy)was followed up,and the success rate of tocolysis treatment and the improvement of TCM syndromes were compared between the two groups,so as to evaluate the efficacy of Ertian decoction.The data obtained in this study were entered into EXCEL table,a database was established,and SPSS 26.0 system was used for statistical analysis.According to the difference of measurement,count,grade data,and whether the measurement data conformed to the normal distribution,corresponding test methods were adopted:Parametric test(such as independent sample t test,paired sample t test)was used for measurement data conforming to normal distribution.Non-parametric test was used for measurement data,count data and grade data that did not conform to the normal distribution.Results1 A total of 47 patients were included in this study,including 16 patients in the progesterone treatment group and 31 patients in the combined treatment group.2 Basic information of patients with early threatened abortion:①The age ranged from 23 to 42 years,with an average age of 32.70±3.59 years.The mean age was 32.19±3.35 years in the progesterone group and 32.97±3.74 years in the combination group.The proportion of each age group:21 to 25 years old accounted for 2.13%,26 to 30 years old accounted for 23.40%,31 to 35 years old accounted for 57.45%,36 to 40 years old accounted for 14.90%,≥41 years old 1,accounting for 2.13%.② The menstrual cycle span before pregnancy was from 25 days to 120 days,and the average menstrual cycle was more than 35 days.There were 12 women with postmenopausal malocclusion(6 in each group),accounting for 19.15%of the total population.③The number of natural pregnancies before pregnancy in the population was 0-3,the proportion of never pregnancy was 31.91%,the proportion of one pregnancy was 40.40%,the proportion of two pregnancies was 23.40%,the proportion of three pregnancies was 4.26%,the number of natural pregnancies was the least,and the average natural pregnancy history was 1.00±0.86.The number of natural abortions was 0-3 times,36.17%of them had no natural abortion history,40.40%had one natural abortion,19.10%had two natural abortions,4.26%had three natural abortions,and the average natural abortion history was 0.91±0.86 times.④There were 3 cases of polycystic ovary syndrome before pregnancy,accounting for 6.40%of the total number of patients,including 1 case in the progesterone group and 2 cases in the integrated traditional Chinese and western medicine group.⑤27 cases(57.40%)had a history of uterine operation before pregnancy,including 9 cases in progesterone group and 18 cases in integrated traditional Chinese and western medicine group.⑥Three cases had a history of endometrial polyps before pregnancy,accounting for 6.40%of the total number of patients,including 2 cases in progesterone group and 1 case in integrated traditional Chinese and western medicine group.⑦There were 5 cases of adenomyosis/endometriosis before pregnancy,accounting for 10.64%of the total number of patients,including 2 cases in the progesterone group and 3 cases in the integrated traditional Chinese and western medicine group.⑧There were 6 cases of uterine fibroids before pregnancy,accounting for 12.77%of the total number of patients,including 4 cases in the progesterone group and 2 cases in the integrated traditional Chinese and western medicine group.⑨There were 3 cases with ovarian cyst/surgery before pregnancy,accounting for 6.40%of the total number of patients,including 2 cases in the progesterone group and 1 case in the integrated traditional Chinese and western medicine group.⑩Four cases(8.51%)had fallopian tube disorders before pregnancy.All patients were in the combination group,including 1 case of unilateral salpingectomy history,2 cases of obstructed fallopian tube,and 1 case of ectopic pregnancy conservative treatment.3 There were no significant differences in age,menstrual history,natural pregnancy/abortion history,other related medical history before pregnancy and related syndrome scores before treatment between the two groups,which had comparable significance.4 TCM syndrome score:after treatment,there was a difference in the total score of syndrome score between the two groups,and the TCM combined with western medicine group was higher than the progesterone group(P<0.05).In terms of the scores of main syndrome rules in the two groups,the scores of abdominal pain before and after treatment were statistically significant(P<0.05).There was no significant difference in the amount of vaginal bleeding and the time of vaginal bleeding before and after treatment(P>0.05).There were significant differences in the scores of lower abdominal pain and waist soreness before and after treatment in the combination group(P<0.05),but there was no significant difference in the progesterone group(P>0.05).In terms of the score of minor syndrome rules,the test results of the progesterone group before and after treatment were P>0.05 except for less food and anorexia,and the difference was not statistically significant.The non-parametric test results of less food and anorexia were P<0.05,and the difference was statistically significant,but the mean value after treatment was higher than that before treatment.The scores of dizziness and tinnitus,sore and soft knees,fatigue,colorless face and loose stool in the combined treatment group before and after treatment were all P<0.05,and the differences were statistically significant.There was no statistically significant difference in the scores of nocturia,less food and anorexia before and after treatment in the combined treatment group(P>0.05).5 At 12 weeks of pregnancy,the embryo survival rate of the combined treatment group(90.32%)was slightly higher than that of the progesterone treatment group(81.25%),but there was no statistically significant difference(P>0.05).The total effective rate of the combined treatment group(87.10%)was higher than that of the progesterone treatment group(37.50%).The total effective rate of the integrated traditional Chinese and western medicine group was significantly different from that of the progesterone group(P<0.05).6 There was no significant difference in E2,P and HCG between the two groups at 4-9 weeks(P>0.05).There was no significant difference in the maximum diameter and average diameter of gestational sac measured by ultrasound at 5,7 and 9 weeks(P>0.05).In the group of embryo outcome before 12 weeks of pregnancy,there was a significant difference in the average cyst diameter between the survival group and the abortion group at 6 and 7 weeks of pregnancy(P<0.05).Conclusion1 The treatment of Ertian decoction combined with progesterone and progesterone alone can improve the pregnancy outcome and TCM syndrome,and the treatment of Ertian decoction combined with progesterone is superior to progesterone alone in improving the overall TCM syndrome and the overall effective rate of treatment.Both treatments have a therapeutic effect on abdominal pain,but the superiority and inferiority of the treatment are not clear.Ertian Decoction combined with progesterone improved the feeling of lower abdominal pain and waist pain,while the progesterone group had no improvement effect(statistically significant).Ertian Decoction had an improvement effect on the feeling of lower abdominal pain and waist pain.In the same way,Ertian decoction has curative effect on dizziness and tinnitus,sore and soft knees,fatigue,colorless complexion,loose stool and so on.However,there was no statistical evidence to show that the improvement of the volume of vaginal bleeding,vaginal bleeding time,frequent urination at night,less food and anorexia was significant.2 The significance of Ertian decoction in improving the examination and ultrasound results of patients with early threatened abortion needs further study.The guiding significance of E2,P and other test results in early pregnancy for the outcome of early threatened abortion needs to be further clarified,and the level of HCG at 7 weeks of pregnancy is meaningful for the prediction of pregnancy outcome to a certain extent.The ultrasound mean gestational sac diameter at 6 and 7 weeks of pregnancy has predictive value for the outcome.3 The modified medicine of Ertian decoction is safe and has no toxic side effects,and is recommended for clinical use. |
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