更年青胶囊治疗女性更年期综合征205例临床研究

按照《新药审批办法》，将405例女性更年期综合征患者随机分为治疗组205例，对照组100例，开放组100例。治疗组口服更年青胶囊、模拟淀粉片各4粒，日3次；对照组口服更年安片、模拟淀粉胶囊各4粒，日3次；开放组仅服更年青胶囊4粒，日3次；3组疗程均为30天，观察服药前和治疗结束当日临床症状和实验室变化。结果治疗组总有效率96.10%，愈显率65.36%，雌激素(E2)升高(P＜0.001)，卵泡刺激素(FSH)、黄体生成素(LH)略有下降(P＞0.05)，阴道脱落细胞成熟指数(MI)升高(P＜0.01)，临床症状积分明显下降(P＜0.01，P＜0.001)，安全性指标无异常；对照组总有效率86%，愈显率40%，E2升高(P＜0.05)，FSH、LH变化不明显(P＞0.05),MI升高(P＜0.01)，临床症状积分明显下降(P＜0.01)；开放组总有效率99%，愈显率66%，E2升高(P＜0.001)，FSH、LH变化不明显(P＞0.05),MI升高(P＜0.05)，临床症状积分明显下降(P＜0.001)；治疗组与对照组比较差异有显著性(P＜0.01)，治疗组与开放组比较差异无显著性(P＞0.05)。说明更年青胶囊能够提高E2水平，治疗更年期综合征有效而安全。

Clinical Study on 205 Cases of Female Climacteric Syndrome Treated with Geng Nian Qing Capsule

Four hundred and five cases of female climacteric syndrome were randomly divided into treatment group(205 cases),control group(100 cases) and open group(100 cases). The treatment group was administrated orally 4 Geng Nian Qing Capsules and 4 analog starch tablets,3 times each day.The control group,4 pieces of Geng Nian An and 4 analog starch tablets,3 times each day.The open group, only 4 Geng Nian Qing Tablets,3 time daily.The courses in the 3 groups were 30 days.Clinical symptoms and laboratory indixes were observed before and after treatment. Results showed that the total effective rate was 96.10%,the markedly effective rate was 65.36%,estradiol(E2) increased(P<0.001),follicule-stimulating hormone(FSH),luteotropic hormone(LH) decreased slightly(P>0.05),vaginal scaling cell mature index(MI) increased (P<0.01), and clinical symptom cumulative scores decreased significantly(P<0.01 or P<0.001).Abnormal safty index did not be found in the treatment group.The total effective rate was 86%,the markedly effective rate 40%,E2 increased(P<0.05),FSH and LH did not change significantly(P>0.05), MI increased (P<0.01), clinical symptom cumulative score decreased significantly(P<0.01) in the control group.The total effective rate was 99%,the markedly effective rate was 66%, E2 increased(P<0.001),FSH and LH did not have significant change(P>0.05),MI increased(P<0.05),clinical symptom cumulative score decreased significantly(P<0.001) in the open group.There was significantly difference between the treatment group and the control group(P<0.01), and no significant difference between the treatment group and the open group(P>0.05),suggesting that Geng Nian Qing Capsule can increase E2 level and it is effective and safe for treatment of female climacteric syndrome.