| Objective:This clinical study,progesterone injection as a positive control group of drugs, An evaluation of treatment of spleen and kidney deficiency type sub-decoction threatened abortion clinical drug efficacy and safety, and to explore its mechanism, clinical applications for the objective basis.Methods:80 cases of clinical study, were randomly divided into three groups:traditional Chinese medicine group of 30 patients given oral decoction of Chinese medicine An ZI; In group A,30 cases of oral decoction for Annprogesterone intramuscular;western group of 20 patients received intramuscular progesterone.4 weeks for a course of treatment. Three separate effect before and after treatment indicators and safety of observation, by comparing the observed three groups of patients before and after treatment the improvement of clinical symptoms, pelvic examination B-embryo development and serum estradiol (E2), progesterone ketone (P) and human chorionic gonadotropinβsubunit (β-HCG) level of dynamic change, to evaluate the safety and treatment of spleen and kidney deficiency type sub-decoction threatened abortion clinical efficacy and safety.Results:(1)Chinese medicine group 26.7% cure rate, improvement rate was 63.3%, total effective rate 90.0%; In group A 30.0% cure rate, improvement rate was63.3%, the total effective rate was 93.3%; WM group 25.0% cure rate, improvement rate of 60.0%,85% total efficiency. Integrated effect of the three groups, the difference was not significant (P> 0.05); three fairly comprehensive effect.(2) Three groups of patients compared efficacy of TCM, Chinese medicine group was 93.3%, in the western group and 90.0%, western group, the total effective rate was 70%, with Chinese and Western Medicines group, the effect rather, the difference was not statistical significance (P> 0.05);Chinese medicine group and western medicine group, traditional Chinese medicine than western medicine group, the difference was statistically significant (P<0.05); In group A, compared with western medicine, western medicine was superior to western medicine group differences statistically significant (P<0.05).(3)Three groups of hormones and drugs on pregnancy and development of gestational sac: three groups of drugs can improve the pregnancy hormone levels, and promote the growth of gestational sac, three groups after treatment, the difference was not statistically significant (P> 0.05). (4) The efficacy and related factors:age, gestational age and the effect was not related (P<0. 05); disease severity correlated with efficacy, the-more severe condition, the worse the effect of (P<0.05); spontaneous abortion was correlated with efficacy (P<0.05), a history of spontaneous abortion more the number of effects worse (P<0.05).(5) Security Analysis:The treatment group of 30 patients before and after treatment of blood, urine, stool, liver and renal function and ECG detected no abnormal clinical observation of the process has not found toxicity, suggesting clinical application of drug good safety.Conelusion:The clinical findings indicated the therapy of AnZi Decoction is effective and safe for early threatened abortion belongs in deficiency of the spleen and kindey, which can effectively improve the clinical symptoms, but also elevated serum levels of human chorionic gonadotropin, progesterone, estradiol levels, to promote uterine embryonic growth and development, and toxic side effects, safe and reliable clinical application. |