摘要
目的探讨莉芙敏治疗妇女围绝经期综合征的疗效及安全性。方法选取我科门诊就诊的符合围绝经期综合征诊断标准的150例患者随机分配入两组:莉芙敏组(治疗组)100例,给予莉芙敏口服治疗,1片/次,2次/d,连续服用3个月;维生素B6组(对照组)50例,给予维生素B6口服治疗,1片/次,1次/d,连续服用3个月。经检查无子宫、卵巢的恶性病变,子宫内膜<5mm,乳腺检查无异常。治疗前后填写Kupperman Index(KMI)和Men-opause Rating Scale(MRS)量表并评分,对比治疗前后围绝经期综合征妇女的临床症状、性激素水平〔促卵泡生成素(FSH)、黄体生成素(LH)、雌二醇(E2)〕、肝肾功能〔丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、肌酐(Cr)〕、脂代谢〔三酰甘油(TG)、胆固醇(TC)、高密度脂蛋白(HDL)、低密度脂蛋白(LDL)〕及空腹血糖(FBG)的变化,同时行妇科B超、乳腺B超、宫颈细胞学涂片及乳房触诊等检查及观察药物不良反应。结果应用莉芙敏治疗3个月后,围绝经期综合征患者的症状明显缓解,部分患者潮热、多汗、睡眠障碍消失,总有效率为92.3%;用药前后KMI及MRS量表评分差异显著,与对照组比较及治疗前后比较差异有统计学意义(P<0.001);治疗组用药前后血FSH、LH、E2水平无明显变化,差异无统计学意义(P>0.05);用药后FBG与用药前相比无明显变化,差异无统计学意义(P>0.05);脂代谢中TG、TC含量较用药前降低,差异有统计学意义(P<0.05),HDL较用药前升高,LDL较用药前降低,差异有统计学意义(P<0.05);用药前后患者的肝肾功能无明显变化(P>0.05);用药前后的宫颈涂片均未发现有不典型增生细胞及癌细胞;用药过程中6例患者在治疗1月后出现胃部不适,4例在治疗2个月后出现乳房胀痛,继续服药后症状消失,仅1例在治疗1个月后头痛,未出现异常阴道流血、腹痛、水肿、乳房包块等严重不良反应。结论莉芙敏治疗围绝经期综合征有较好的临床疗效,能有效改善围绝经期综合征妇女的临床症状,安全性高且不良反应少,患者易于接受,值得临床进一步研究。
Objective To investigate the clinical efficacy and safe of Remifemin in treating perimenopause syndrome.Methods 150 perimenopausal women with perimenopause syndrome from outpatient were divided into 2 groups randomly：100 cases in Remifemin group（therapy group） were treated with Remifemin tablets（one tablet each time,two times a day）orally for 3 months;50 cases in control group were treated with vitamin B6 tablets（one tablet each time,one time a day）orally for 3 months;None of them had evidences of ovarian or uterine malignant tumors,endometrial thickness was5mm,breast physical examination was normal.During the medication,the females fill in diaries（fill in the scores of KMI and MRS）.Comparing the variance of theirs clinical symptoms,physical signs,the sexual hormone（follicle stimulating hormone,luteinizing hormone,estradiol）,liver and kidney function（alanine aminotransferase,aspartate aminotransferase,creatinine）,lipid metabolism（triglyeride,total cholesterol,high-density lipoprotein,low-density lipoprotein）and fasting blood glucose to explore the clinical curative effects.Testing the variance of B-ultrasound in pelvic cavity,B-ultrasound in breast,the palpation of breast and cervical smear and observing the poisonous side effects and adverse effects to evaluate the safe of Remifemin.Results Three months after Remifemin treatment,symptoms of perimenopause syndrome were significantly relieved,sweat,hot flash and sleep disorders disappeared in some of these patients,clinical total effective rate reaches 92.3 percent.Clinical trials show that the scores of KMI and MRS have both greatly statistical significance as compared with control group and the values before treatment（P0.001）;In therapy group,the levels of females serum FSH,LH,E2 after the treatment have no greatly changes compared with those before the treatment,the difference has no statistical significance（P0.05）;The levels of fasting blood glucose after the treatment have no greatly changes compared with those before the treatment（P0.05）;The levels of lipid metabolism after the treatment have greatly changes compared with those before the treatment,the difference has statistical significance（P0.05）,triglyeride,total cholesterol,low-density lipoprotein and fasting blood glucose drop which have statistical discrepancy（P0.05）and high-density lipoprotein rises which has statistical discrepancy（P0.05）.The liver function and kidney function,the thickness of endometrium have no significant variance before and after the treatment.Atypical hyperplasia and malignant cells in cervical smear were not discovered before and after the treatment.Six patients experienced stomach upset during Remifemin treatment,four patients felt breast tenderness two months after the treatment,which disappeared without withdrawal of Remifemin,only one patient felt slight headache one month after the medication,there were no serious adverse effects as abnormal vaginal bleeding,bellyache,edema,breast nodus,et al.Conclusion Remifemin has great clinical curative effects and can greatly improve the clinical symptoms of perimenopause syndrome.It was easily accepted by patients for its higher safety and lower side-effects.It is worth further research.
出处
《临床合理用药杂志》
2012年第9期17-20,共4页
Chinese Journal of Clinical Rational Drug Use
关键词
莉芙敏
围绝经期综合征
黑升麻
Remifemin
Perimenopause Syndrome
Black cohosh root
Clinical research
