莉芙敏改善妇科恶性肿瘤患者术后绝经综合征的临床研究
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摘要
目的:观察莉芙敏改善妇科恶性肿瘤患者术后的绝经症状的疗效;对骨代谢的影响;评估患者体内血雌二醇、黄体生成素、卵泡刺激素、血脂的水平;观察与药物有关的不良反应。
     方法:收集大连市妇产医院自2010年3月-2011年3月的因妇科恶性肿瘤切除双侧卵巢并且术前未绝经的患者,其中23名患者同意莉芙敏治疗绝经症状。患者年龄在43岁至54岁之间,其中子宫内膜癌12例,Ⅰ期8例、Ⅱ期2例、Ⅲ期2例;卵巢癌5例,Ⅰ期1例、Ⅱ期2例,Ⅲ期2例;宫颈癌2例,Ⅰ期2例(近绝经期故同时切除了双侧附件);卵巢交界性肿瘤2例,ⅠC期1例,Ⅱ期1例;乳癌术后2例(外科医生建议切除双侧卵巢,更改药物治疗方式)。患者自术后出现绝经症状且改良Kupperman评分》15时应用莉芙敏(黑升麻根茎的异丙醇提取物)40mg每天,治疗12周。改良kupperman评分包括潮热出汗、失眠、焦虑、抑郁等共13项,程度评分为0~3分,加权分:潮热出汗为4分,感觉异常、失眠、焦虑、泌尿系症状、性生活为2分,其余皆为1分。加权分乘以程度评分即为该项得分,总分为每项相加的总和。用药期间在0W、4W、8W、12W通过记录改良的Kupperman评分评价其疗效,改良的Kupperman评分<15分,认为有效的,计算治疗有效的患者的百分率;在用药0W及12W检测血清碱性磷酸酶、高密度脂蛋白、低密度脂蛋白、血清总胆固醇、血清甘油三酯、雌二醇、黄体生成素、卵泡雌激素。检测用药前后血常规及肝肾功的水平,记录患者出现的不良反应。
     结果:本实验可以观察到Kupperman评分由用药前的21.70±5降到用药12周后的8.65±4.97,有效率为85.7%;潮热出汗由6.78±3.06降到用药12周后的2.09±2.37 ;失眠4±1.6降到用药12周后的2.17±1.34;焦虑抑郁6.13±1.84降到用药12周后的3.39±1.16 ,用药前后的差异均有统计学意义的;患者体内的E2由用药前的16.17±3.93pg/ml到用药12周后15.75±3.80 pg/ml;FSH由65.23±16.24mIU/ml到用药12周后的66.14±17.29mIU/ml ;LH有用药前39.12±10.24mIU/ml到用药12周后的40.95±11.12mIU/ml;差异均无统计学意义(p>0.05)。碱性磷酸酶由48±10.93IU/L升高到用药12周后的57±17.80IU/L ,差异有统计学意义(p<0.05)。高密度脂蛋白HDL-C由1.37±0.35mmol/l升高到用药12周后的1.68±0.61mmol/l;低密度脂蛋白由3.18±0.86mmol/l降低到用药12周后的2.67±0.79mmol/l,用药前后有统计学差异;血清甘油三酯由1.41±0.9mmol/l到用药12周后的1.38±0.61mmol/l;血清总胆固醇CHOL由5.27±0.9mmol/l到用药12周后的5.23±0.83mmol/l,用药前后无统计学差异。血常规及血生化检验没有发生有临床意义的改变,不良反应出现4例胃肠道反应。
     结论:莉芙敏有效的改善恶性肿瘤患者术后的绝经症状,尤其是对潮热出汗、焦虑抑郁、失眠有明显的效果;不改变体内雌二醇(E2)、卵泡刺激素(FSH)、黄体生成素(LH)的水平;升高碱性磷酸酶;不影响血清总胆固醇、甘油三酯,增加高密度脂蛋白,减低低密度脂蛋白。不良反应少,且轻微。
Objective: Remifemin improve gynecological malignant tumor postoperative patients of menopause syndrome; The influence of bone metabolism; Evaluate the patients' estradiol, luteinizing hormone follicle stimulating hormone, lipids. Observation and drug related adverse reactions.
     Methods:Collect Dalian Maternity Hospitals from March 2010 to March 2011 by gynecologic malignant tumor resection of bilateral ovarian and preoperative not postmenopausal patients, 23 patients agree with Remifemin treatment postmenopausal symptoms. The patients between 43 to 54, 12 cases of endometrial carcinoma ,Ⅰperiod 8 cases,Ⅱperiod in 2 cases, 2 casesⅡperiod; Ovarian cancer in 5 patients, andⅠperiod 1 case ,in 2 casesⅡperiod ,2 casesⅡperiod; Cervical cancerⅠperiod in 2 cases, 2 cases (near menopause reason also removed the bilateral annex); borderline ovarian tumors in 2 casesⅠC period ,in 1 caseⅡperiod; 2 cases (postmastectomy breast surgeon suggest excision bilateral ovarian, change medications).
     Since the postoperatie patients with menopausal symptoms and improved Kupperman score》15 scores. Remifemin (an isopropanolic black cohosh extract) 40mg /d,treatment for 12 weeks. Improved kupperman score including hot perspire, insomnia, anxiety, depression, totaling 13 item, degree score of 0 ~ 3 points, weighted points: hot sweat is four points, cacesthesia、insomnia、anxiety、urinary tract symptoms、sex life weretwo points, the rest were for 1 minute. Weighted points for the multiply degree rating score, the total was the sum of the sum for each item. During the course of medication 0W 4W 8W and 12W by recording Kupperman score evaluatd its curative effect,( if improved Kupperman score < 15 points was effective), calculate the percentage of effective treatment for patients. For medication in 0W and12W detectd serum alkaline phosphatase, high-density lipoprotein cholesterol (hdl-c), low density lipoprotein, serum total cholesterol, serum triglyceride, estradiol, FSH, LH. Medication before and after detected blood routine and liver and kidney level, record patients experienced adverse reactions.
     Result:This experiment can be observed the Kupperman score dreased from21.70±5 to 8.65±4.97 after 12 weeks treatment, effective power was 85.7%.The hot sweat was reduced from 6.78±3.06 to 2.09±2.37 12 weeks treatment;Insomnia was reduced from4±1.6to 2.17±1.34after 12 weeks treatment;Anxiety depressed 6.13±1.84 to 3.39±1.16 after 12 weeks treatment; There were statistically significant differences(p < 0.05).E2 was 16.17±3.93pg/ml to 15.75±3.80 pg/ml after 12 weeks treatment;FSH was 65.23±16.24 mIU/ml to 66.14±17.29mIU/ml after 12 weeks treatment;LH was 39.12±10.24mIU/ml to 40.95±11.12mIU/ml after 12 weeks treatment, There were no statistically significant difference (p > 0.05). Serum alkaline phosphatase was ascended from 48±10.93IU/L to57±17.80IU/L, difference was statistically significant (p < 0.05). HDL-C was ascended from 1.37±0.35mmol/lto1.68±0.61mmol/l after 12 weeks treatment; LDL-C was ascended from 3.18±0.86mmol/l to 2.67±0.79mmol/l after 12 weeks treatment, difference was statistically significant (p < 0.05).TGL was from1.41±0.9mmol/lto 1.38±0.61mmol/lafter 12 weeks treatment ; CHOL from 5.27±0.9mmol/l to 5.23±0.83mmol/lafter 12 weeks treatment, there were no statistically significant difference (p > 0.05). Routine blood and blood biochemistry examines not happened clinically meaningful change, adverse effects weae 4 cases of gastrointestinal reaction.
     Conclusion: Remifemin was effective in relieving emotional symptoms,mainly hot flashes、insomnia and anxiety in patients,with no effect on E2、FSH、LH. Remifemin caused a slight but significant decrease of LDL-cholesterol,and increase of HDL-cholesterol, without affecting total cholesterol and triglycerdes. Fewer side effects, and light.
引文
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    11.贡联兵缓解围绝经期综合症的植物药-黑升麻的异丙醇提取物(Remifemin)临床应用与评价2010 08 1672-2124
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