益气健脾化痰方治疗多囊卵巢综合征脾虚痰阻证的临床研究
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摘要
目的：探讨中医学对多囊卵巢综合征的认识,通过临床研究,采用益气健脾化痰方治疗多囊卵巢综合征脾虚痰阻证,客观评价益气健脾化痰方对多囊卵巢综合征脾虚痰阻证患者的治疗效果,尤其是对中医证候积分、体质量指数、排卵情况、妊娠情况、月经恢复情况、性激素水平及B超等方面所产生的影响,并评价其临床疗效及安全性,为临床应用提供客观依据。
方法：临床研究采用随机、对照的研究方法,将符合多囊卵巢综合征脾虚痰阻证的患者,按1：1对照原则,随机分为对照组和治疗组。在基础治疗和西药常规治疗的基础上,对照组给予达英-35,2mg,每天1次,治疗组给予中药水煎剂每日1剂,分早晚两次服用。以3个月经周期为1个疗程,连续观察2个疗程。治疗前后两组分别评价其临床症状、体征的变化,治疗前后观测中医证候积分、体质量指数、排卵情况、妊娠情况、月经恢复情况、性激素水平及B超等指标。全部数据以SPSS16.0统计软件进行统计学分析。
结果：多囊卵巢综合征脾虚痰阻证患者60例随机分为2组,治疗组30例,对照组30例,治疗前两组患者在年龄、病程、婚况及不孕年限分布、BMI、实验室检查指标、中医症状等方面均无显著性差异。1、两组疾病疗效比较：治疗组30例,总有效率90.00%。对照组30例,总有效率73.33%。治疗总有效率优于对照组,有统计学意义(P<0.05)。2、对症状体征的改善作用：治疗组患者治疗后症状有明显改善,治疗组中医症状改善情况优于对照组(P<0.01)。3、肥胖指标方面：治疗后两组患者BMI有所降低,与治疗前比较均有显著性差异(P<0.01)；治疗组BMI改善较对照组有差异(P<0.05)。4、临床症状及体征：两组患者月经周期均有显著改善,差异有显著性(P<0.01),治疗组改善月经周期优于对照组,差异有统计学意义(P<0.05)；治疗组治疗后有3例妊娠,对照组无妊娠。两组多毛均有明显改善作用(P<0.01),治疗组疗效优于对照组(P<0.05)；两组治疗后对痤疮均有明显改善作用(P<0.01),治疗组疗效优于对照组(P<0.05)。5、性激素水平方面：两组对降低雄激素均有显著效果(P<0.01),治疗组降低雄激素效果优于对照组(P<0.05)；两组治疗前后E2无显著性差异(P>0.05)。两组对降低LH、LH/FSH值均有显著效果(P<0.01),治疗组效果优于对照组(P<0.05),两组治疗前后FSH均无显著性差异(P>0.05)。6、B超影像学方面：两组治疗后卵巢体积均较治疗前下降(P<0.01),治疗组与对照组无显著性差异(P>0.05)。两组治疗后基础体温双相率分别为36.67%和10.00%,治疗组优于对照组(P<0.05)。7、安全性指标：治疗组患者血、尿、粪常规及肾功能检查均在正常范围。两组均未见不良反应。
结论：从初步临床研究来看,益气健脾化痰方治疗多囊卵巢综合征脾虚痰阻证,治疗组总有效率优于对照组,可明显改善患者的临床症状；在西医学指标方面,可以改善月经周期及妊娠情况,降低体重指数,改善多毛F-G评分、痤疮评分,改善性激素水平,减小卵巢体积,改善基础体温,且无肝肾功能损害,治疗本病安全、有效,有广泛的应用前景。但由于条件限制,本研究病例数相对较少,观察指标较简单,需进一步深入研究。
Purpose:Discussion TCM on Polycystic Ovary Syndrome of awareness, through clinical research, used YiQiJianPiHuaTan Decoction treatment more SAC ovarian integrated levy spleen virtual phlegm resistance card, objective evaluation Yi gas health spleen phlegm party on more SAC ovarian integrated levy spleen virtual phlegm resistance card patients of treatment effect, especially on TCM card waiting integral, and body quality index, and ovulation situation, and pregnancy situation, and menstrual recovery situation, and sexual hormone level and the b Super-equal-area by produced of effect, and evaluation its clinical effect and the security, for clinical application provides objective pursuant to.
Methods:Clinical study on a randomized, controlled study of methods, consistent with polycystic ovarian syndrome in patients with spleen-deficiency syndrome of phlegm blocking, according to1:1control principles, randomly divided into a control group and treatment group. In primary care and Western medicine on a regular basis for treatment, control group given Daeng-35,2mg,1daily,1a day treatment group given water decoction of traditional Chinese medicine agent, sooner or later, take it twice.3for1course of menstrual cycle, continuous observation of2courses. Evaluation of each of the two groups before and after treatment the clinical symptoms and signs of change, observation points of TCM syndromes before and after treatment, body mass index, ovulation, pregnancy, menstruation recovery situation, sex hormones and b Super-equal-index. Statistical software for statistical analysis of all data to SPSS16.0.
Results:Polycystic ovary syndrome in patients with spleen-deficiency and phlegm stagnation syndrome in60cases randomly divided into2groups,30cases of the treatment group, control group of30cases, two groups of patients before treatment in the course of ages, and infertility, legitimate condition indicators for age, BMI, laboratory examination, symptoms are not of significant differences.1.Treatment30cases, total effective rate90%. Control group of30cases, total effective rate73.33%. Treatment of total effective rate is better than the control group, statistically significant (P<0.05).2.Symptoms and signs improvement:the treated group after treatment had a significant improvement. The symptoms improvement of the treated group was better than the controlled group (P<0.01).3.Obesity indicators:decreased after treatment of two groups of patients with BMI, compared with before treatment had significant difference (P<0.01), differences in BMI to improve treatment group compared with the control group (P<0.05).4.Clinical symptoms and signs:two groups of patients with the menstrual cycle have significantly improved, differences significant (P<0.01), the treatment group improved menstrual cycle better than the control group, statistically significant differences (P<0.05); treatment of3cases of pregnancy after treatment, control group no pregnancy. Two hairy has improved significantly (P<0.01), the treatment effect is better than the control group (P<0.05), two groups of treatment for acne has significant improvement (P<0.01), the treatment effect is better than the control group (P<0.05).5.Sex hormone levels:both groups are have a significant effect on decreasing androgen (P<0.01), lower androgen treatment group than the control group (P<0.05), two sets of E2is no significant differences before and after treatment (P>0.05). Two groups shall have a significant effect on lower LH, LH/FSH (P<0.01), the treatment group than the control group (P<0.05), two sets of FSH no significant differences before and after treatment (P>0.05).6.B-mode ultrasound imaging:two sets of declining ovarian volume after treatment than before treatment (P<0.01), the treatment group and the control group without significant difference (P>0.05). Basal body temperature after treatment in two sets of double rate per cent and36.67%per cent respectively, the treatment group than the control group (P<0.05).7.safety index:The routine blood/urine/feces test, and the liver and kidney function tests of treated group were within the normal range. two groups had no unhealthy response.
Conclusion:From preliminary clinical research view, YiQiJianPiHuaTan Decoction treatment polycystic ovary syndrome spleen virtual phlegm resistance card, treatment group total has efficiency better than controlled group, may obvious improve patients of clinical symptoms; in West medical indicators aspects, can improve menstrual cycle and the pregnancy situation, reduced weight index, improve more hair F-G scoring, and acne scoring, improve sexual hormone level, reduces ovarian volume, improve Foundation temperature, and no liver kidney function damage, treatment this disease security, and effective, has widely of application prospects. But because of the conditions, the relatively few number of cases studied, outcome measures is relatively simple, requires further in-depth study.
方法：临床研究采用随机、对照的研究方法,将符合多囊卵巢综合征脾虚痰阻证的患者,按1：1对照原则,随机分为对照组和治疗组。在基础治疗和西药常规治疗的基础上,对照组给予达英-35,2mg,每天1次,治疗组给予中药水煎剂每日1剂,分早晚两次服用。以3个月经周期为1个疗程,连续观察2个疗程。治疗前后两组分别评价其临床症状、体征的变化,治疗前后观测中医证候积分、体质量指数、排卵情况、妊娠情况、月经恢复情况、性激素水平及B超等指标。全部数据以SPSS16.0统计软件进行统计学分析。
结果：多囊卵巢综合征脾虚痰阻证患者60例随机分为2组,治疗组30例,对照组30例,治疗前两组患者在年龄、病程、婚况及不孕年限分布、BMI、实验室检查指标、中医症状等方面均无显著性差异。1、两组疾病疗效比较：治疗组30例,总有效率90.00%。对照组30例,总有效率73.33%。治疗总有效率优于对照组,有统计学意义(P<0.05)。2、对症状体征的改善作用：治疗组患者治疗后症状有明显改善,治疗组中医症状改善情况优于对照组(P<0.01)。3、肥胖指标方面：治疗后两组患者BMI有所降低,与治疗前比较均有显著性差异(P<0.01)；治疗组BMI改善较对照组有差异(P<0.05)。4、临床症状及体征：两组患者月经周期均有显著改善,差异有显著性(P<0.01),治疗组改善月经周期优于对照组,差异有统计学意义(P<0.05)；治疗组治疗后有3例妊娠,对照组无妊娠。两组多毛均有明显改善作用(P<0.01),治疗组疗效优于对照组(P<0.05)；两组治疗后对痤疮均有明显改善作用(P<0.01),治疗组疗效优于对照组(P<0.05)。5、性激素水平方面：两组对降低雄激素均有显著效果(P<0.01),治疗组降低雄激素效果优于对照组(P<0.05)；两组治疗前后E2无显著性差异(P>0.05)。两组对降低LH、LH/FSH值均有显著效果(P<0.01),治疗组效果优于对照组(P<0.05),两组治疗前后FSH均无显著性差异(P>0.05)。6、B超影像学方面：两组治疗后卵巢体积均较治疗前下降(P<0.01),治疗组与对照组无显著性差异(P>0.05)。两组治疗后基础体温双相率分别为36.67%和10.00%,治疗组优于对照组(P<0.05)。7、安全性指标：治疗组患者血、尿、粪常规及肾功能检查均在正常范围。两组均未见不良反应。
结论：从初步临床研究来看,益气健脾化痰方治疗多囊卵巢综合征脾虚痰阻证,治疗组总有效率优于对照组,可明显改善患者的临床症状；在西医学指标方面,可以改善月经周期及妊娠情况,降低体重指数,改善多毛F-G评分、痤疮评分,改善性激素水平,减小卵巢体积,改善基础体温,且无肝肾功能损害,治疗本病安全、有效,有广泛的应用前景。但由于条件限制,本研究病例数相对较少,观察指标较简单,需进一步深入研究。
Purpose:Discussion TCM on Polycystic Ovary Syndrome of awareness, through clinical research, used YiQiJianPiHuaTan Decoction treatment more SAC ovarian integrated levy spleen virtual phlegm resistance card, objective evaluation Yi gas health spleen phlegm party on more SAC ovarian integrated levy spleen virtual phlegm resistance card patients of treatment effect, especially on TCM card waiting integral, and body quality index, and ovulation situation, and pregnancy situation, and menstrual recovery situation, and sexual hormone level and the b Super-equal-area by produced of effect, and evaluation its clinical effect and the security, for clinical application provides objective pursuant to.
Methods:Clinical study on a randomized, controlled study of methods, consistent with polycystic ovarian syndrome in patients with spleen-deficiency syndrome of phlegm blocking, according to1:1control principles, randomly divided into a control group and treatment group. In primary care and Western medicine on a regular basis for treatment, control group given Daeng-35,2mg,1daily,1a day treatment group given water decoction of traditional Chinese medicine agent, sooner or later, take it twice.3for1course of menstrual cycle, continuous observation of2courses. Evaluation of each of the two groups before and after treatment the clinical symptoms and signs of change, observation points of TCM syndromes before and after treatment, body mass index, ovulation, pregnancy, menstruation recovery situation, sex hormones and b Super-equal-index. Statistical software for statistical analysis of all data to SPSS16.0.
Results:Polycystic ovary syndrome in patients with spleen-deficiency and phlegm stagnation syndrome in60cases randomly divided into2groups,30cases of the treatment group, control group of30cases, two groups of patients before treatment in the course of ages, and infertility, legitimate condition indicators for age, BMI, laboratory examination, symptoms are not of significant differences.1.Treatment30cases, total effective rate90%. Control group of30cases, total effective rate73.33%. Treatment of total effective rate is better than the control group, statistically significant (P<0.05).2.Symptoms and signs improvement:the treated group after treatment had a significant improvement. The symptoms improvement of the treated group was better than the controlled group (P<0.01).3.Obesity indicators:decreased after treatment of two groups of patients with BMI, compared with before treatment had significant difference (P<0.01), differences in BMI to improve treatment group compared with the control group (P<0.05).4.Clinical symptoms and signs:two groups of patients with the menstrual cycle have significantly improved, differences significant (P<0.01), the treatment group improved menstrual cycle better than the control group, statistically significant differences (P<0.05); treatment of3cases of pregnancy after treatment, control group no pregnancy. Two hairy has improved significantly (P<0.01), the treatment effect is better than the control group (P<0.05), two groups of treatment for acne has significant improvement (P<0.01), the treatment effect is better than the control group (P<0.05).5.Sex hormone levels:both groups are have a significant effect on decreasing androgen (P<0.01), lower androgen treatment group than the control group (P<0.05), two sets of E2is no significant differences before and after treatment (P>0.05). Two groups shall have a significant effect on lower LH, LH/FSH (P<0.01), the treatment group than the control group (P<0.05), two sets of FSH no significant differences before and after treatment (P>0.05).6.B-mode ultrasound imaging:two sets of declining ovarian volume after treatment than before treatment (P<0.01), the treatment group and the control group without significant difference (P>0.05). Basal body temperature after treatment in two sets of double rate per cent and36.67%per cent respectively, the treatment group than the control group (P<0.05).7.safety index:The routine blood/urine/feces test, and the liver and kidney function tests of treated group were within the normal range. two groups had no unhealthy response.
Conclusion:From preliminary clinical research view, YiQiJianPiHuaTan Decoction treatment polycystic ovary syndrome spleen virtual phlegm resistance card, treatment group total has efficiency better than controlled group, may obvious improve patients of clinical symptoms; in West medical indicators aspects, can improve menstrual cycle and the pregnancy situation, reduced weight index, improve more hair F-G scoring, and acne scoring, improve sexual hormone level, reduces ovarian volume, improve Foundation temperature, and no liver kidney function damage, treatment this disease security, and effective, has widely of application prospects. But because of the conditions, the relatively few number of cases studied, outcome measures is relatively simple, requires further in-depth study.
引文
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