CAJ | 학술논문

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。
안조《신약심비판법》，장405례녀성경년기종합정환자수궤분위치료조205례，대조조100례，개방조100례。치료조구복경년청효낭、모의정분편각4립，일3차；대조조구복경년안편、모의정분효낭각4립，일3차；개방조부복경년청효낭4립，일3차；3조료정균위30천，관찰복약전화치료결속당일림상증상화실험실변화。결과치료조총유효솔96.10%，유현솔65.36%，자격소(E2)승고(P＜0.001)，란포자격소(FSH)、황체생성소(LH)략유하강(P＞0.05)，음도탈락세포성숙지수(MI)승고(P＜0.01)，림상증상적분명현하강(P＜0.01，P＜0.001)，안전성지표무이상；대조조총유효솔86%，유현솔40%，E2승고(P＜0.05)，FSH、LH변화불명현(P＞0.05),MI승고(P＜0.01)，림상증상적분명현하강(P＜0.01)；개방조총유효솔99%，유현솔66%，E2승고(P＜0.001)，FSH、LH변화불명현(P＞0.05),MI승고(P＜0.05)，림상증상적분명현하강(P＜0.001)；치료조여대조조비교차이유현저성(P＜0.01)，치료조여개방조비교차이무현저성(P＞0.05)。설명경년청효낭능구제고E2수평，치료경년기종합정유효이안전。
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.