红花如意丸治疗女性更年期综合征的临床对照试验

Clinical controlled trial of Honghua Ruyi pill in the treatment of female climacteric syndrome

目的评估红花如意丸联合替勃龙治疗更年期综合征(CLS)疗效及其对患者内分泌激素、植物神经功能的影响。方法选取60例CLS患者,应用单双号法分为A组与B组,每组30例。A组采用替勃龙治疗,B组在A组基础上联合红花如意丸治疗。比较两组临床疗效及治疗前后内分泌激素水平、植物神经功能。结果治疗后4周,B组总有效率为73.3%,A组为60.0%,比较差异无统计学意义(Х^(2)=1.20,P>0.05);治疗后8周,B组总有效率为83.3%,明显高于A组的60.0%,差异具有统计学意义(Х^(2)=4.02,p<0.05);治疗后12周,B组总有效率为90.0%,明显高于A组的66.7%,差异具有统计学意义(Х^(2)=4.81,P<0.05)。治疗前,两组雌二醇(E_(2))、促黄体生成素(LH)及卵泡刺激素(PSH)水平比较,差异无统计学意义(P>0.05);治疗后12周,两组Ez水平均较治疗前升高,B组明显高于A组,差异有统计学意义(P<0.05),两组FSH及LH水平均较治疗前降低,B组明显低于A组,差异有统计学意义(P<0.05)。治疗前,两组植物神经功能状态评分比较,差异无统计学意义(P>0.05);治疗后4、8、12周,两组植物神经功能状态评分均低于治疗前,且B组明显低于A组,差异有统计学意义(P<0.05)。治疗后4周,B组有1例患者出现少量阴道出血,持续2 d后自行消失。整个治疗过程中,所有患者无其他不适。结论激素替代治疗联合红花如意丸可进一步提高CLS患者疗效,并显著改善患者内分泌激素水平及植物神经功能,值得临床推广与应用。

Objective To evaluate the efficacy of Honghua Ruyi pill comhined with tiburon in the treatment of climacteric syndrome(CLS)and its effects on endocrine hormone and vegetative nerve function.Methods 60 patients with CLS were divided into group A and group B with 30 patients in each group.Group A was treated with tihlon,group B was treated with Honghua Ruyi pill on the basis of group A.The clinical efficacy,endocrine hormone levels and vegetative nerve function were compared between the two groups before and after treatment.Results 4 weeks after treatment,the total effective rate of group B was 73.3%and group A was 60.0%,with no statistical significance(Х^(2)=1.20,T3>0.05).8 weeks after treatment,the total effective rate of group B was 83.3%,which was significantly higher than that of group A(60.0%),the difference was statistically significant(Х^(2)=4.02,P<0.05).Twelve weeks after treatment,the total effective rate of group B was 90.0%,significantly higher than that of group A(66.7%),the difference was statistically significant(Х^(2)=4.81,P<0.05).Before treatment,there were no significant differences in the levels of estradiol(E_(2)),luteinizing hormone(LH)and follicle stimulating hormone(FSH)between 2 groups(P>0.05).Twelve weeks after treatment,E2 levels in both groups were increased compared with before treatment,and group B was significantly higher than group A,the difference was statistically significant(P<0.05).FSH and LH levels in both groups were decreased compared with before treatment,and group B was significantly lower than group A,the difference was statistically significant(P<0.05).Before treatment,there was no significant difference in scores of vegetative neurological function between the two groups(P>0.05).At 4,8 and 12 weeks after treatment,scores of vegetative neurological function in both groups were lower than before,and group B was significantly lower than group A,the difference was statistically significant(P<0.05).4 weeks after treatment,1 patient in group B showed a small amount of vaginal bleeding,which disappeared spontaneously after 2 days.All patients had no other discomfort during the whole treatment.Conclusion Hormone replacement therapy combined with Honghuaruyi pill can further improve the curative effect of CLS patients,and significantly improve the level of endocrine hormone and plant nerve function,which is worthy of clinical promotion and application.