【作者】 魏方方；

【导师】 陆启滨；

【作者基本信息】 南京中医药大学 ， 中医妇科学， 2010， 硕士

【摘要】 目的：本临床研究以黄体酮针剂为阳性对照组药,评价安子汤剂治疗脾肾两虚型先兆流产的临床疗效及临床用药安全性,并初步探讨其作用机制,为临床推广应用提供客观的依据。方法：将临床研究病例80例,随机分为三组：中药组30例,给予中药安子汤剂口服；中西药组30例,给予安子汤剂口服+黄体酮肌注；西药组20例,给予黄体酮肌注。4周为一个疗程。三组在治疗前后分别进行疗效性指标和安全性指标的观察,通过比较观察三组病例治疗前后中医临床症状的改善情况、盆腔B超检查的胚胎发育情况、血清雌二醇(E2)、孕酮(P)及人绒毛膜促性腺激素β亚单位(β-HCG)水平的动态变化,来评价安子汤剂治疗脾肾两虚型先兆流产的临床疗效和安全性。结果：(1)中药组痊愈率26.7%,好转率63.3%,总有效率90.0%；中西药组痊愈率30.0%,好转率63.3%,总有效率93.3%；西药组痊愈率25.0%,好转率60.0%,总有效率85%。三组综合疗效比较,差异无统计学意义(P>0.05)；三组综合疗效相当。(2)三组患者中医证候疗效的比较,中药组有效率93.3%,中西药组有效率90.0%,西药组总有效率70%,中药组与中西药组比较,疗效相当,差异无统计学意义(P>0.05)；中药组与西药组比较,中药组优于西药组,差异有统计学意义(P<0.05)；中西药组与西药组比较,中西药组优于西药组差异有统计学意义(P<0.05)。(3)三组药物对妊娠激素及孕囊发育的影响：三组药物均能提高妊娠激素水平,促进孕囊的生长发育,三组治疗后比较,差异无统计学意义(P>0.05)。(4)疗效与相关因素分析：患者年龄、孕周与疗效无明显相关性(P<0.05)；病情程度与疗效具有相关性,病情越重,疗效越差(P<0.05)；自然流产史与疗效有相关性(P<0.05),有自然流产史次数越多,疗效越差(P<0.05)。(5)安全性分析：治疗组30例患者用药前后的血、尿、大便常规、肝、肾功能及心电图检测均无异常,临床治疗观察过程中亦未发现毒副反应,提示该药临床应用安全性良好。结论：安子汤剂汤治疗脾肾两虚型先兆流产的临床疗效显著,既能有效改善临床症状,又能升高血清人绒毛膜促性腺激素、孕酮、雌二醇的水平,促进宫内胚胎的生长发育,且无毒副作用,安全可靠,值得临床推广应用。更多还原

【Abstract】 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.更多还原