二仙汤合当归芍药散加减治疗围绝经期高脂血症的随机对照试验

Randomized Controlled Trial of Modified Erxian Decoction Plus Danggui Shaoyao Powder in the Treatment of Perimenopausal Women with Hyperlipemia

【目的】评价二仙汤合当归芍药散加减治疗围绝经期高脂血症(肾阴阳两虚型)的临床疗效。【方法】将68例围绝经期高脂血症(肾阴阳两虚型)患者随机分为对照组和治疗组,每组各34例。对照组给予口服阿托伐他汀治疗,治疗组在对照组基础上给予二仙汤合当归芍药散加减治疗,疗程为4周。观察2组患者治疗前后中医证候积分、更年期综合征自我评定量表Kupperman评分、激素水平、血脂水平的变化情况,并评价2组的安全性。【结果】(1)研究过程中,2组各有2例患者脱落,最终治疗组和对照组各有32例患者纳入统计。(2)治疗后,2组患者的中医证候积分和Kupperman积分均较治疗前明显降低(P<0.01),且治疗组对中医证候积分和Kupperman积分的降低作用均明显优于对照组,组间差值比较,差异均有统计学意义(P<0.01)。(3)治疗后,2组患者血清黄体生成素(LH)、卵泡刺激素(FSH)水平均较治疗前明显降低(P<0.01),血清雌二醇(E2)水平均较治疗前明显升高(P<0.01),且治疗组对血清LH、FSH水平的降低作用及对血清E2水平的升高作用均明显优于对照组,组间差值比较,差异均有统计学意义(P<0.05或P<0.01)。(4)治疗后,2组患者血清总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)水平均较治疗前明显降低(P<0.01),血清高密度脂蛋白胆固醇(HDL-C)水平均较治疗前明显升高(P<0.01),且治疗组对血清TC、TG、LDL-C水平的降低作用和对血清HDL-C水平的升高作用均明显优于对照组,组间差值比较,差异均有统计学意义(P<0.05或P<0.01)。(5)治疗过程中,2组患者均未出现恶心、呕吐等不良反应,患者的肝肾功能也均无明显异常变化。【结论】二仙汤合当归芍药散加减治疗围绝经期高脂血症(肾阴阳两虚型)患者疗效确切,可显著缓解患者临床症状,改善患者性激素和血脂水平,具有较高的安全性。

Objective To evaluate the clinical efficacy of modified Erxian Decoction plus Danggui Shaoyao Powder in the treatment of perimenopausal women with hyperlipemia differentiated as kidney yin and yang deficiency type.Methods Sixty-eight perimenopausal women with hyperlipidemia differentiated as kidney yin and yang deficiency type were randomly divided into the control group and the treatment group,34 cases in each group.The control group was given oral use of atorvastatin tablets,and the treatment group was given Erxian Decoction combined with modified Danggui Shaoyao Powder orally on the basis of the treatment for the control group.The course of treatment lasted 4 weeks.Before and after treatment,the changes of traditional Chinese medicine(TCM)syndrome scores,Kupperman self-rating climacteric syndrome scale scores,serum hormone level,and blood lipid level in the two groups were observed.After treatment,the safety of the two groups was evaluated.Results(1)During the trial,2 cases from each group fell-off,and finally 32 cases from each group were included in the analysis.(2)After treatment,TCM syndrome scores and Kupperman scores in the two groups were decreased compared with those before treatment(P<0.01),the effect on decreasing the scores in the treatment group was significantly superior to that in the control group,and significant difference was shown in the pre-and post-treatment differences between the two groups(P<0.01).(3)After treatment,the levels of serum luteinizing hormone(LH)and follicle-stimulating hormone(FSH)in the two groups were significantly decreased and the level of estradiol(E2)was significantly increased compared with those before treatment(P<0.01).Moreover,the effect on lowering serum LH and FSH levels and on increasing serum E2 level in the treatment group was significantly superior to that in the control group,and significant difference was shown in the pre-and post-treatment differences between the two groups(P<0.05 or P<0.01).(4)After treatment,the levels of serum total cholesterol(TC),triglyceride(TG)and low-density lipoprotein cholesterol(LDL-C)in the two groups were significantly decreased and the level of serum high-density lipoprotein cholesterol(HDL-C)was significantly increased compared with those before treatment(P<0.01).The effect on lowering serum TC,TG and LDL-C level and on increasing serum HDL-C level in the treatment group was significantly superior to that in the control group,and significant difference was shown in the pre-and post-treatment differences between the two groups(P<0.05 or P<0.01).(5)During the treatment,there were no adverse reactions such as nausea and vomiting occurring in the two groups,neither abnormal changes were shown in liver and kidney function of the two groups.Conclusion Modified Erxian Decoction plus Danggui Shaoyao Powder exerts certain efficacy in the treatment of perimenopausal women with hyperlipemia differentiated as kidney yin and yang deficiency type.The therapy is effective on significantly relieving the clinical symptoms of patients and improving the levels of sex hormones and blood lipids with a high safety.