| Objective:By contrasting the Wen Yang and Strengthen Spleen prescription combined progesterone and the pure progesterone in the therapeutic effects of recurrent spontaneous abortion with type of spleen-kidney-yang deficiency, the paper aims to explore the mechanism of Wen Yang and Strengthen Spleen prescription and evaluate the clinical effects and safety of the two methods, providing scientific references to the treatment of recurrent spontaneous abortion.Methods:The study randomly divided the 72 recurrent spontaneous abortion cases, who met the inclusion criteria, into two groups. There were 36 cases in control group, who were treated by oral progesterone capsule, and 36 cases in trail group, who were treated by the progesterone capsule and Wen Yang and Strengthen Spleen prescription.All of the cases started to take the medicine when they were confirmed in gestation.Both groups’ treatment persisted for the 12 th weeks of their pregnancy.The paper observed the major symptoms improvement, and adverse reaction of the two groups in their treatment, as well as the change of serum P, β-h CG, E2 level after 1 week, 2weeks, and 12 weeks respectively, and the embryonic development through B-ultrasound, and detection of hepatorenal function index(ALT, AST, GGT, Cr and BUN) level.The paper comprehensively compared the differences between the two groups after the different treatment schedule to evaluate the clinical effects and safety of Wen Yang and Strengthen Spleen prescription.Results:During the study, there were 2 cases were excluded from trail group and 4cases were excluded from control group, and finally the data of 34 cases in trail group and 32 cases in control group were statistically analyzed. Evaluation criteria of therapeutic effect: as the national teaching material “Obstetrics and Gynecology” and“Guidance of Chinese New Medicine Clinical Research”.(1)General therapeutic effects: for trail group, there were 11 cases healed, 11 cases rather better, 8 cases better, and 4 cases null, total efficiency rate 88.23%. For control group, there were 5 healed, 8 cases rather better, 8 cases better, and 9 cases null, total efficiency rate 65.63%. There was statistically significant difference between the two groups(P<0.05).(2)Syndrome of Chinese Medicine: for trail group, there were 13 cases healed,12 cases rather better, 6 cases better, and 3 cases null, total efficiency rate 91.18%. For control group, there were 6 healed, 9 cases rather better, 8 cases better, and 9 cases null, total efficiency rate 71.88%. There was statistically significant difference between the two groups(P<0.05).(3)Symptoms score: after treatment, the general symptoms score and the single symptoms score had decreased for both groups, furthermore, Compared before and after treatment within the group and after treatment between the two groups, the general symptoms was statistically significant(P<0.01). The therapeutic effects of single symptoms score, like colprrhagia, vaginal bleeding, backache, fear of cold,abdominal pain and distension, fatigue, pale face and thin sloppy stool, of trial group was better than that of control group, the difference was statistically significant(P<0.05).(4)Reproductive hormone: after the treatment, the serum P, β-h CG, E2 level of the two groups improved than before, the difference was statistically significant(P<0.05). Moreover, the cases in trail group had more improvement in the serum P, β-h CG, E2 level than the cases in control group, the difference was statistically significant(P<0.05).(5)Embryonic development through B-ultrasound: after the treatment, in trail group, there were 30 cases’ embryonic development were coincide with normal condition and 4 cases stopped growth, success rate 88.23%. In control group, there were 21 cases’ embryonic development were coincide with normal condition and 11 cases stopped growth, success rate 65.63%. There was significant difference between the two groups(P<0.05). It indicated that the treatment of trail group could promote the embryonic development better than the treatment of control group.( 6) Observation of Security Index:every detection of hepatorenal function index(ALT, AST, GGT, Cr and BUN) were within the normal ranges. Compared before and after treatment within the group and between the two groups, there were no statistical significance( P> 0.05). It showed the two treatment methods are non-toxic or side effects.Conclusion:Wen Yang and Strengthen Spleen prescription could remarkably improve the clinical symptoms of recurrent spontaneous abortion with type of spleen-kidney-yang deficiency and promote Embryonic development, and enhance patient’s serum P,β-h CG, E2 level. The paper thought Wen Yang and Strengthen Spleen prescription treated this disease through promoting the serum P, β-h CG, E2 secretion and relieving endocrine disorder. The therapeutic effects of Wen Yang and Strengthen Spleen prescription is excellent. This treatment schedule has no obvious adverse reaction,worth clinical application and expansion. |
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