补肾活血汤治疗人工流产术后月经过少（肾虚血瘀型）的疗效观察
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摘要
目的：系统观察补肾活血汤治疗人工流产术后月经过少(中医辨证为肾虚血瘀型)的临床疗效并初步探讨其可能的作用机理。
方法：采用随机对照的设计方法,共收集肾虚血瘀型人流后月经过少患者57例,所有受试病例必须严格按照诊断标准、纳入标准和排除标准进行筛选,以上病例随机分为中药治疗组29例,,西药对照组28例。治疗组服用补肾活血汤治疗,对照组服用补佳乐治疗,从月经第5天开始服用,连服21天,3个月经周期为1疗程,用药一疗程后进行疗效评价。观察两组治疗前后月经及临床症状评分量、血清激素(FSH、LH、E2、PRL及P值)水平、子宫内膜厚度变化、BBT的改变及用药过程中有无不良反应,对观察结果进行统计分析以评价中药经验方的临床疗效和安全性。
结果：治疗组及对照组均能改善人流后月经过少患者月经情况。两组均能降低人流后月经过少患者临床症状积分,差异有统计学意义(P<0.05),可以认为治疗组在改善临床症状方面疗效优于对照组。两组总有效率分别为93.10%及82.14%,差异有统计学意义(P<0.05)。两组均能降低人流后月经过少患者LH水平,升高E2水平,但对FSH、PRL及P值影响不大,并且治疗后各激素水平仍在正常值范围,提示两组对于人流后月经过少患者血激素水平影响无明显差异(P>0.05)。两组均可改善子宫内膜情况,但治疗组优于对照组(P<0.05)。用药期间不良反应观察发现,中药治疗组均未出现不良反应,西药对照组用药期间有7例出现轻度胃肠道反应,提示补肾活血汤治疗人流后月经过少是比较安全的。
结论：补肾活血化瘀法是治疗肾虚血瘀型人流后月经过少的有效治疗方法,补肾活血汤能通过改善月经、临床症状、体内激素水平及子宫内膜达到治疗目的,无明显副作用,疗效优于补佳乐。
Objective:The purposes of the presents study are to investigate the clinical effects and mechanisms of bu shen huo xue Soup medicine on Hypomenorrhea after induced abortion (TCM for kidney deficiency and blood stasis type)through a clinical study.
Methods:In clinical research 57 women with Hypomenorrhea after induced abortion (kidney deficiency and blood stasis type) are chosen with a randomized and controlled interventional study.All were strictly brought into and removed line according to the diagnosis standard.Above examples were divided into two groups randomly as 29 cases of Traditional Chinese Medicine treatment group and 28 cases of western-medicine contrast group.The treatment group were mainly treated with bu shen huo xue Soup,and the controls were treated with bu jia le medicine.Two groups took medicine the first five days from menstruation for 21 days,and took three menstrual cycles as a treatment course,and carried on appraising the clinical effeet after a medicine treatment course.we observed its treatment in menstruation,the clinical symptoms score,the serum hormone levels of luteinzing hormone(LH)、 follicle stimulating hormone(FSH)、estradiol(E2)、prolactin(PRL)and Progesterone(P),the changes of endometrial thickness in differences the change of BBT,and the side effects in the medicine process between the treatment and control groups.At last,We dealt with observed result in terms of the statistical analysis and evaluated medicine treatment about the clinical effect and the security.
Results: Improved menstruation were revealed in both groups. Improved symptoms score were revealed in both groups and the treatment group showed significant improvement on the clinical symptoms than the control group(P<0.05).The total effect in treatment group was 93.10%, while that in control group was 82.14%.there was statistical difference between these two groups on the clinical effect(P<0.05).Both group can lower the content of serum LH,raising the content of serum E2,but the little effect on the content of serum FSH、PRL and P values,besides every hormone level after treatment was in normal range,these pointed out no significant difference on the impact of blood hormone level in patients of Hypomenorrhea after induced abortion between two groups.Improved endometrial thickness were revealed in both groups and the treatment group showed significant improvement than the control group(p>0.05).T-he treatment group showed no side effects of drugs in this investigation,and the same time the control group showed side effects of drugs on 7 patients.
Conclusions:Due to invigorating the kidney and simulating the circulation of blood,which is assumed that the therapy of treatment soup might be a good approach in treating Hypomenorrhea after induced abortion of kidney deficiency and blood stasis type.The bu shen huo xue Soup could effective benefit patients suffering from Hypomenorrhea after induced abortion via significant improvements in menstruation,clinical symptoms,serum hormones and endometrial thickness,and no significant side effects,The treatment group was superior to bu jia le medicine.
方法：采用随机对照的设计方法,共收集肾虚血瘀型人流后月经过少患者57例,所有受试病例必须严格按照诊断标准、纳入标准和排除标准进行筛选,以上病例随机分为中药治疗组29例,,西药对照组28例。治疗组服用补肾活血汤治疗,对照组服用补佳乐治疗,从月经第5天开始服用,连服21天,3个月经周期为1疗程,用药一疗程后进行疗效评价。观察两组治疗前后月经及临床症状评分量、血清激素(FSH、LH、E2、PRL及P值)水平、子宫内膜厚度变化、BBT的改变及用药过程中有无不良反应,对观察结果进行统计分析以评价中药经验方的临床疗效和安全性。
结果：治疗组及对照组均能改善人流后月经过少患者月经情况。两组均能降低人流后月经过少患者临床症状积分,差异有统计学意义(P<0.05),可以认为治疗组在改善临床症状方面疗效优于对照组。两组总有效率分别为93.10%及82.14%,差异有统计学意义(P<0.05)。两组均能降低人流后月经过少患者LH水平,升高E2水平,但对FSH、PRL及P值影响不大,并且治疗后各激素水平仍在正常值范围,提示两组对于人流后月经过少患者血激素水平影响无明显差异(P>0.05)。两组均可改善子宫内膜情况,但治疗组优于对照组(P<0.05)。用药期间不良反应观察发现,中药治疗组均未出现不良反应,西药对照组用药期间有7例出现轻度胃肠道反应,提示补肾活血汤治疗人流后月经过少是比较安全的。
结论：补肾活血化瘀法是治疗肾虚血瘀型人流后月经过少的有效治疗方法,补肾活血汤能通过改善月经、临床症状、体内激素水平及子宫内膜达到治疗目的,无明显副作用,疗效优于补佳乐。
Objective:The purposes of the presents study are to investigate the clinical effects and mechanisms of bu shen huo xue Soup medicine on Hypomenorrhea after induced abortion (TCM for kidney deficiency and blood stasis type)through a clinical study.
Methods:In clinical research 57 women with Hypomenorrhea after induced abortion (kidney deficiency and blood stasis type) are chosen with a randomized and controlled interventional study.All were strictly brought into and removed line according to the diagnosis standard.Above examples were divided into two groups randomly as 29 cases of Traditional Chinese Medicine treatment group and 28 cases of western-medicine contrast group.The treatment group were mainly treated with bu shen huo xue Soup,and the controls were treated with bu jia le medicine.Two groups took medicine the first five days from menstruation for 21 days,and took three menstrual cycles as a treatment course,and carried on appraising the clinical effeet after a medicine treatment course.we observed its treatment in menstruation,the clinical symptoms score,the serum hormone levels of luteinzing hormone(LH)、 follicle stimulating hormone(FSH)、estradiol(E2)、prolactin(PRL)and Progesterone(P),the changes of endometrial thickness in differences the change of BBT,and the side effects in the medicine process between the treatment and control groups.At last,We dealt with observed result in terms of the statistical analysis and evaluated medicine treatment about the clinical effect and the security.
Results: Improved menstruation were revealed in both groups. Improved symptoms score were revealed in both groups and the treatment group showed significant improvement on the clinical symptoms than the control group(P<0.05).The total effect in treatment group was 93.10%, while that in control group was 82.14%.there was statistical difference between these two groups on the clinical effect(P<0.05).Both group can lower the content of serum LH,raising the content of serum E2,but the little effect on the content of serum FSH、PRL and P values,besides every hormone level after treatment was in normal range,these pointed out no significant difference on the impact of blood hormone level in patients of Hypomenorrhea after induced abortion between two groups.Improved endometrial thickness were revealed in both groups and the treatment group showed significant improvement than the control group(p>0.05).T-he treatment group showed no side effects of drugs in this investigation,and the same time the control group showed side effects of drugs on 7 patients.
Conclusions:Due to invigorating the kidney and simulating the circulation of blood,which is assumed that the therapy of treatment soup might be a good approach in treating Hypomenorrhea after induced abortion of kidney deficiency and blood stasis type.The bu shen huo xue Soup could effective benefit patients suffering from Hypomenorrhea after induced abortion via significant improvements in menstruation,clinical symptoms,serum hormones and endometrial thickness,and no significant side effects,The treatment group was superior to bu jia le medicine.
引文
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[3]郑筱英主编.中药新药临床研究指导原则.北京：中国医药科技出版社,2002,第一版：239-243.
[4]国家中医药管理局.中医病症诊断标准[M].南京：南京大学出版社,1994: 66.
[5]国家中医药管理局主编.中华人民共和国行业标准—中医病证诊断疗效标准[M].南京：南京大学出版社,1995,第一版：263-264.
[6]袁萍,蒋荣超,翁双燕,等.补肾调经颗粒治疗人工流产手术后月经过少临床观察[J].中国中医急症,2007,16(6)：671,678.
[7]陈靓芬.归肾活血调经汤治疗人工流产术后月经过少疗效观察[D].广州中医药大学,2006.
[8]秦达念,佘白蓉；佘运初,等.菟丝子黄酮对实验动物及人绒毛组织生殖功能的影响[J].中药新药与临床药理,2000,11(6)：349-351.
[9]肖锦松,崔风军,宁廷选,等.玉竹、菟丝子醇提物对烧伤小鼠免疫功能的影响[J].中国中药杂志,1990,15(9)：45-47.
[10]柯江维,王建红,赵宏,等.菟丝子黄酮对心理应激雌性大鼠海马—下丘脑—垂体—卵巢轴性激素手提的影响[J].中草药,2006,37(1)：90-92.
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