| Background:More than two consecutive spontaneous abortions occur once or twice, known as recurrent spontaneous abortions (RSA).5%of women of reproductive age have experienced two or more successive pregnancy losses, and RSA is a common gynaecological disease, is also a concerned difficulty disease of the whole world gynaecology realm. The incidence of the disease presents to a sharp upward trend in China, however prevention of recurrent spontaneous and protection of women’s reproductive health have a positive and important clinical and social significance.There are several problems in clinical medicine research of TCM treatment of RSA, such as:the number of researches is limited, low quality researches, level of evidence is not enough, lack of evaluation of the treatment efficacy of different causes (lack of luteal insufficiency, immune factors, unexplained recurrent spontaneous abortions, etc.). In the past, TCM clinical researches on the treatment of miscarriage have more reports. But, clinical researches on pregnancy intervention are obviously insufficient and few published data on this issue are available.For these reasons, my mentor conducted a comprehensively and systematically clinical research of RSA, by absorbing the former’s point of view, extracted her nearly50years of clinical experience, and combined with modern medical research theory. Upon completion of the Integrative Medicine and Chinese medicine fetus protection treatment of RSA (Bushenantai with progesterone), she highlighted the application of Chinese medicine intervention before pregnancy is essential treatment of RSA. And she has created the BuShenZhuYun side (Dodder, heterophylla, Placenta, turtle shell, etc.) which has the characteristics of invigorating kidney, coordinating spleen and stomach, and nourishing. The treatment of fetus protection which is based on the intervention before pregnancy is able to increase the probability of fetus protection significantly and also prevents the occurrence of spontaneous abortion effectively.Objective:Through this study, firstly the study analyze and summary the mentor’s academic experience. Secondly, the study objectively evaluates the clinical efficacy of BuShenZhuYun side and proves that it has an important role in the treatment of RSA. Thirdly, the study provides effective and practical ideas and methods of treating RSA caused by luteal phase deficiency. Finally, the study also hopes that improve deficiencies of previous studies of Chinese medicine intervention before pregnancy.Research:Part I:literature research, the study reviews and summarizes the understanding, treatment and research status of TCM for RSA; in particular, it summarizes the TCM theory of "preventive treatment of disease" and Zhang Jing Yue’s theory of "Prevention of disease damage". The study also sums up the progress of RSA pathogenesis and treatment of Western medicine.Part II:Clinical part:Select60cases recurrent miscarriage patients belong to endocrine luteal insufficiency, TCM for kidney-spleen deficiency syndrome, and then randomly divided into a treatment group of30patients,30patients in the control group. At3months before pregnancy oral medicine Bushenzhuyun preconception intervention, pregnant after oral Bushenantai preconception and progesterone capsules miscarriage to12weeks of pregnancy. The control group without Chinese intervention before pregnancy, sequential treatment in the control group and treatment group Pregnancy. Through the pregnancy outcomes after treatment, again threatened abortion during pregnancy symptom, serum progesterone, progesterone miscarriage Progesterone dosage after pregnancy, emotional psychological impact on the patient, such as comparing, scientific and objective evaluation method reflects the clinical efficacy BuShenZhuYun pregnancy intervention. Results:The two groups of patients comparing pregnancy outcomes:the treatment group,30cases were cured28cases,2cases of invalid, the total effective rate was93.3%. Control group of30patients were cured26cases,4cases of invalid, the total efficiency of86.6%, the difference was statistically significant (P<0.05).There are14cases within the treatment group has given birth and all the newborn babies are healthy, while the patients who are still in pregnancy haven’t shown any signs of spontaneous abortion. When patients were pregnant again comparing the severity of symptoms of threatened abortion:treatment groups:mild in24patients (80%), moderate in6patients (20%), in the control group:mild in18cases (60%), moderate12cases (36.67%), and severe in1case (3.33%), the degree of difference between the two groups was statistically significant disease (P<0.05). Vaginal bleeding, weak waist, abdominal pain and other individual symptoms, the treatment group than the control group, a significant difference (P<0.05) between the two groups. Patients were pregnant for4weeks,6weeks, serum β-HCG and progesterone comparison:treatment group than the control group, and after pregnancy a relatively fast growth in early fetus protection, the difference was statistically significant (P<0.05). Two pregnant after fetus protection progesterone dose comparison:treatment group,30patients in the treatment group,3patients with progesterone after progesterone capsules200mg/day treatment is still low, the amount of progesterone was added to300mg/day. Control group of30patients,6patients the same circumstances, there are differences between the two groups.Discussion:Discussions were made from some aspects, as mentioned below, which included the objective of this research and its theoretical basis, the academic experiences of my mentor, the method and features of the sequential treatment in protecting the fetus which is based on the intervention before pregnancy, the analysis of the clinical curative effect, the studies about the mechanism of Chinese herbal medicine, the analysis of the failure cases, the inadequateness and prospection etc.Conclusion:1. This study seizes the hotspot and weak links of the research field. This study has the innovation by using the Chinese medicine as a treatment to intervene before pregnancy as the breakthrough point, and doing the comparison of the stability during pregnancy between the intervention treatment and non-intervention treatment group before pregnancy.2. Systematically summarize the theoretical literature of the TCM theory about the "preventive treatment of disease" and "prevention of disease damage" for application in RSA, enriched the theory of preventive treatment of TCM, and have profound guiding significance to the clinical research.3." Nourishing source of embryos, the pre-pregnancy intervention" approach in TCM theory about "Treating disease","Pre-training its loss" to guide treatment of recurrent miscarriage. In addition, it is based on the50-years wide experiences of my mentor. BuShenZhuYun prescription is set up according to the etiology and diagnosis through the combination of syndrome and disease. This prescription is mainly in invigorating kidney, treating the kidney and spleen, maximize the function of invigorating. It is used to be a treatment of kidney deficiency, kidney and spleen deficiency caused by recurrent miscarriage.4. The comparing method is used by this clinical research, by observing the clinical curative effect of the sequential treatment which is fetus-protection treatment based on the intervention before pregnancy, and evaluate the clinical curative effect of BuShenZhuYun method in the intervention treatment scientifically and objectively. The result of this study is comparing through the pregnancy outcome, symptoms of threatened abortion during pregnancy again etc. Results:Traditional Chinese medicine pregnancy interventions can effectively prevent the recurrence of spontaneous abortion, increase the success rate of fetus protection and also prevents the occurrence of spontaneous abortion effectively.5. The clinical study of recurrent miscarriage provides a significance practical value.6. Due to the time for the study is limited, the time needed for the treatment and clinical observation is quite long and the collection of the cases is limited, we expect to increase the time for the study and increasing the sample size, in order to observe all the progress till the end of the pregnancy outcome after the sequential treatment of the intervention before pregnancy and fetus protection treatment. |
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