补肾调经膏方治疗肾虚型卵巢早衰的疗效及对性激素及免疫功能的影响
|
摘要
目的:分析补肾调经膏方治疗肾虚型卵巢早衰的疗效及对患者性激素及免疫功能的影响,探讨其临床适用性。方法:78例18～35岁肾虚型卵巢早衰患者,采用随机数字表法分为对观察组39例和对照组39例,对照组患者给予人工周期疗法,戊酸雌二醇片1 mg,每天1次,连服21 d;于服雌激素后第12天加服黄体酮胶囊200 mg,每日2次,连续10 d。观察组患者采用补肾调经膏方治疗,每次20 mL口服,每天2次。1个月为1个疗程,共治疗3个疗程。疗程结束后随访10个月,比较两组患者治疗前后月经改善、妊娠情况、中医症状积分、性激素(LH, E2,FSH及P)、免疫功能指标(lgA、lgG、CD4及CD8)的改善情况。结果:观察组患者治疗后月经改善率为94.87%(37/39),对照组患者为79.49%(31/39),两组患者月经改善率比较,差异有统计学意义(χ~2=4.129 4,P=0.042 1)。观察组患者的月经改善时间明显短于对照组,差异也有统计学意义(t=2.329 4,P=0.022 9)。观察组患者的停经复发率为2.56%(1/39),对照组患者为15.38%(6/39),两组患者停经复发率比较,差异也有统计学意义(χ~2=3.923 5,P=0.047 6)。两组患者治疗前月经异常,腰膝酸软,潮热汗出,畏寒肢冷,性欲减退,阴道干涩积分比较,差异均无明显统计学意义(P>0.05),治疗后上述积分均显著降低,差异有统计学意义(P<0.05),且观察组患者治疗后月经异常,腰膝酸软,潮热汗出,畏寒肢冷,性欲减退,阴道干涩积分均显著低于对照组患者,差异有统计学意义(P<0.05)。两组患者治疗前LH, E_2,FSH及P水平均无明显统计学差异(P>0.05),治疗后E_2及P明显升高,LH和FSH回落,差异有统计学意义(P<0.05),且观察组患者各项激素水平均优于对照组患者,差异有统计学意义(P<0.05)。两组患者治疗后lgA、lgG、CD4及CD8免疫指标与治疗前相比,均显著升高,差异均有统计学意义(P<0.05),且观察组患者的lgA、lgG、CD4及CD8均明显高于对照组,差异有统计学意义(P<0.05)。观察组患者治疗后10个月内妊娠率为82.05%(32/39),对照组患者的妊娠率为58.97%(23/39),两组患者的妊娠率比较,差异也有统计学意义(χ~2=4.994 5,P=0.025 4)。结论:补肾调经膏方治疗肾虚型卵巢早衰的临床效果显著,有效改善患者的临床症状,还可以有效调节性激素水平和免疫功能,提高妊娠预后。
Objective:To analyze the clinical effect of Bushen Tiaojing Cream in the treatment of premature ovarian failure(kideny deficiency) and its influence of sex hormone and immune function and explore its clinical applicability.Methods:Seventy-eight patients(18～35 years old) of premature ovarian failure(kideny deficiency) were simple randomly by hospitalized number divided into the observation group 39 cases and the control group 39 cases, The control group were treated with the artificial cycle therapy, including Estradiol Valerate Tablets 1 mg, once a day, and even served 21 days. On the twelfth day,patients took estrogen progesterone capsules 200 mg, twice daily for 10 consecutive days, while the observation group patients were treated with Bushen Tiaojing Cream therapy, 20 mL every day, twice a day. One month was 1 course of treatment, a total of 3 courses of treatment. The follow-up period was 10 months after the end of the course. The scores of TCM symptoms, sex hormones(LH, E_2, FSH and P), immune function indexes(lgA, lgG, CD4 and CD8) were compared before and after treatment in the two groups. Results: The improvement rate of menstruation in the observation group after treatment was 94.87%(37/39), while that in the control group was 79.49%(31/39). The difference was statistically significant(χ~2=4.129 4,P=0.042 1). The menstrual improvement time of the patients in the observation group was significantly shorter than that of the control group and the difference was statistically significant(t=2.329 4,P=0.022 9). The rate of menopause recurrence in the observation group was 2.56%(1/39)and the control group was 15.38%(6/39) and the difference was statistically significant(χ~2=3.923 5,P=0.047 6). The differences of symptom score(abnormal menstruation, lumbar and wasit pain, hot flashes sweating, aversion to cold, loss of libido, vaginal dryness) of two groups were statistically significant after treatment(P>0.05). The scores were remarkably reduced and the difference was statistically significant(P<0.05), and those of the observation group were significantly lower than those of the control group(P<0.05). Two groups' LH,E_2,FSH and P were no statistically significant before treatment(P>0.05). After treatment, E_2 and P were significantly increased,LH and FSH decreased(P<0.05) and the patients in the observation group were better than those of the control group(P<0.05). Two groups' lgA,lgG,CD4 and CD8 before treatment were no statistically significant(P>0.05). After treatment, lgA,lgG,CD4 and CD8 were significantly increased(P<0.05) and the patients in the observation group were higher than those of the control group(P<0.05). The observation group's pregnancy rate after treatment was 82.05%(32/39)and that was 58.97%(23/39)of the control group(χ~2=4.994 5,P=0.025 4). Conclusions:The clinical effect of Bushen Tiaojing Cream in the treatment of premature ovarian failure(kidney deficiency) is remarkable. It can effectively improve the patients' irregular menstruation and the clinical symptoms and also can effectively regulate the levels of sex hormone and immune function and improve the pregnancy outcome.
Objective:To analyze the clinical effect of Bushen Tiaojing Cream in the treatment of premature ovarian failure(kideny deficiency) and its influence of sex hormone and immune function and explore its clinical applicability.Methods:Seventy-eight patients(18～35 years old) of premature ovarian failure(kideny deficiency) were simple randomly by hospitalized number divided into the observation group 39 cases and the control group 39 cases, The control group were treated with the artificial cycle therapy, including Estradiol Valerate Tablets 1 mg, once a day, and even served 21 days. On the twelfth day,patients took estrogen progesterone capsules 200 mg, twice daily for 10 consecutive days, while the observation group patients were treated with Bushen Tiaojing Cream therapy, 20 mL every day, twice a day. One month was 1 course of treatment, a total of 3 courses of treatment. The follow-up period was 10 months after the end of the course. The scores of TCM symptoms, sex hormones(LH, E_2, FSH and P), immune function indexes(lgA, lgG, CD4 and CD8) were compared before and after treatment in the two groups. Results: The improvement rate of menstruation in the observation group after treatment was 94.87%(37/39), while that in the control group was 79.49%(31/39). The difference was statistically significant(χ~2=4.129 4,P=0.042 1). The menstrual improvement time of the patients in the observation group was significantly shorter than that of the control group and the difference was statistically significant(t=2.329 4,P=0.022 9). The rate of menopause recurrence in the observation group was 2.56%(1/39)and the control group was 15.38%(6/39) and the difference was statistically significant(χ~2=3.923 5,P=0.047 6). The differences of symptom score(abnormal menstruation, lumbar and wasit pain, hot flashes sweating, aversion to cold, loss of libido, vaginal dryness) of two groups were statistically significant after treatment(P>0.05). The scores were remarkably reduced and the difference was statistically significant(P<0.05), and those of the observation group were significantly lower than those of the control group(P<0.05). Two groups' LH,E_2,FSH and P were no statistically significant before treatment(P>0.05). After treatment, E_2 and P were significantly increased,LH and FSH decreased(P<0.05) and the patients in the observation group were better than those of the control group(P<0.05). Two groups' lgA,lgG,CD4 and CD8 before treatment were no statistically significant(P>0.05). After treatment, lgA,lgG,CD4 and CD8 were significantly increased(P<0.05) and the patients in the observation group were higher than those of the control group(P<0.05). The observation group's pregnancy rate after treatment was 82.05%(32/39)and that was 58.97%(23/39)of the control group(χ~2=4.994 5,P=0.025 4). Conclusions:The clinical effect of Bushen Tiaojing Cream in the treatment of premature ovarian failure(kidney deficiency) is remarkable. It can effectively improve the patients' irregular menstruation and the clinical symptoms and also can effectively regulate the levels of sex hormone and immune function and improve the pregnancy outcome.
引文
[1] Blumenfeld, Zeev,Evron, Ayelet.Preserving fertility when choosing chemotherapy regimens-the role of gonadotropin-releasing hormone agonists[J].Expert opinion on pharmacotherapy,2015,16(7):1009-1020.
[2] AlAsiri, Saleh,Basit, Sulman,Wood-Trageser, Michelle A. et al.Exome sequencing reveals MCM8 mutation underlies ovarian failure and chromosomal instability[J].The Journal of Clinical Investigation: The Official Journal of the American Society for Clinical Investigation,2015,125(1):258-262.
[3] Ott J,Pecnik P,Promberger R, et al.Dehydroepiandrosterone in women with premature ovarian failure and Hashimoto’s thyroiditis[J].Climacteric: the journal of the International Menopause Society,2014,17(1):92-96.
[4] 徐碧红,李茂清,熊思艺.补肾调经膏方对肾虚型卵巢早衰患者性激素水平的影响[J].广州中医药大学学报,2017,34(2):167-172.
[5] 徐苓,宋亦军.卵巢早衰的临床表现和诊断标准[J].实用妇产科杂志,2003,19(4):195-196.
[6] 国家药品食品监督管理局.中药新药临床研究指导原则(试行)[S].北京:中国医药科技出版社,2002:352-354.
[7] 国家中医药管理局.中医病证诊断疗效标准[S].南京:南京大学出版社,1994:45-47.
[8] 滕秀香,姚海洋.益肾疏肝汤治疗卵巢早衰肾虚肝郁证小样本前瞻性临床研究[J].中国临床医生杂志,2017,45(11):104-106.
[9] Sahmay S,Usta TA,Erel T, et al.Elevated LH levels draw a stronger distinction than AMH in premature ovarian insufficiency[J].Climacteric: the journal of the International Menopause Society,2014,17(2):197-203.
[10] 张秀,鲁雅,王佩娟.卵巢早衰的病因研究进展[J].湖北中医药大学学报,2017,19(1):118-120.
[11] 杨晓慧,沈兰.补肾调冲方联合西药人工周期治疗卵巢早衰肾虚冲任失调证临床观察[J].浙江中西医结合杂志,2015,25(12):1131-1133.
[12] 姬霞,傅金英,王冰玉.补肾养血方对卵巢早衰大鼠中抗苗勒氏管激素的影响[J].中国比较医学杂志,2017,27(1):49-53.
[13] 刘慧萍,曾柳庭,胡立娟,等.补肾活血方对卵巢早衰小鼠颗粒细胞TGF-β1、TGF-βRⅡ、Smad2/3表达的影响[J].中成药,2017,39(9):1782-1788.
[14] 陈思,王佩娟.补肾活血法防治免疫性卵巢早衰的研究进展[J].环球中医药,2014,7(3):237-240.
[15] 巫珏艳,吴忠新,路永新,等.坤泰胶囊联合激素替代法治疗卵巢早衰的效果观察[J].中国妇幼保健,2016,31(21):4425-4427.
[16] 孙晓峰,阳松威,贺又舜.左归丸对化疗性卵巢早衰小鼠卵巢组织中缝隙连接蛋白43表达的影响[J].中国药房,2017,28(22):3044-3047.
[17] 徐碧红,李茂清,熊思艺,等.补肾调经膏方对肾虚型卵巢早衰患者性激素水平的影响[J].广州中医药大学学报,2017,34(2):167-172.
[18] 赵明芝.巨噬细胞移动抑制因子和T淋巴细胞亚群在自身免疫性卵巢早衰患者中的应用价值[J].中国妇幼保健,2017,32(19):4678-4680.
[19] 叶娜,董晓英,李冬华,等.卵巢早衰的颗粒细胞凋亡机制研究进展[J].首都医科大学学报,2014,9(3):379-383.
[20] 徐晓琴,徐向荣.补肾中药对卵巢早衰患者卵巢储备功能及免疫调节影响的研究[J].中华全科医学,2014,12(12):2004-2006.
[2] AlAsiri, Saleh,Basit, Sulman,Wood-Trageser, Michelle A. et al.Exome sequencing reveals MCM8 mutation underlies ovarian failure and chromosomal instability[J].The Journal of Clinical Investigation: The Official Journal of the American Society for Clinical Investigation,2015,125(1):258-262.
[3] Ott J,Pecnik P,Promberger R, et al.Dehydroepiandrosterone in women with premature ovarian failure and Hashimoto’s thyroiditis[J].Climacteric: the journal of the International Menopause Society,2014,17(1):92-96.
[4] 徐碧红,李茂清,熊思艺.补肾调经膏方对肾虚型卵巢早衰患者性激素水平的影响[J].广州中医药大学学报,2017,34(2):167-172.
[5] 徐苓,宋亦军.卵巢早衰的临床表现和诊断标准[J].实用妇产科杂志,2003,19(4):195-196.
[6] 国家药品食品监督管理局.中药新药临床研究指导原则(试行)[S].北京:中国医药科技出版社,2002:352-354.
[7] 国家中医药管理局.中医病证诊断疗效标准[S].南京:南京大学出版社,1994:45-47.
[8] 滕秀香,姚海洋.益肾疏肝汤治疗卵巢早衰肾虚肝郁证小样本前瞻性临床研究[J].中国临床医生杂志,2017,45(11):104-106.
[9] Sahmay S,Usta TA,Erel T, et al.Elevated LH levels draw a stronger distinction than AMH in premature ovarian insufficiency[J].Climacteric: the journal of the International Menopause Society,2014,17(2):197-203.
[10] 张秀,鲁雅,王佩娟.卵巢早衰的病因研究进展[J].湖北中医药大学学报,2017,19(1):118-120.
[11] 杨晓慧,沈兰.补肾调冲方联合西药人工周期治疗卵巢早衰肾虚冲任失调证临床观察[J].浙江中西医结合杂志,2015,25(12):1131-1133.
[12] 姬霞,傅金英,王冰玉.补肾养血方对卵巢早衰大鼠中抗苗勒氏管激素的影响[J].中国比较医学杂志,2017,27(1):49-53.
[13] 刘慧萍,曾柳庭,胡立娟,等.补肾活血方对卵巢早衰小鼠颗粒细胞TGF-β1、TGF-βRⅡ、Smad2/3表达的影响[J].中成药,2017,39(9):1782-1788.
[14] 陈思,王佩娟.补肾活血法防治免疫性卵巢早衰的研究进展[J].环球中医药,2014,7(3):237-240.
[15] 巫珏艳,吴忠新,路永新,等.坤泰胶囊联合激素替代法治疗卵巢早衰的效果观察[J].中国妇幼保健,2016,31(21):4425-4427.
[16] 孙晓峰,阳松威,贺又舜.左归丸对化疗性卵巢早衰小鼠卵巢组织中缝隙连接蛋白43表达的影响[J].中国药房,2017,28(22):3044-3047.
[17] 徐碧红,李茂清,熊思艺,等.补肾调经膏方对肾虚型卵巢早衰患者性激素水平的影响[J].广州中医药大学学报,2017,34(2):167-172.
[18] 赵明芝.巨噬细胞移动抑制因子和T淋巴细胞亚群在自身免疫性卵巢早衰患者中的应用价值[J].中国妇幼保健,2017,32(19):4678-4680.
[19] 叶娜,董晓英,李冬华,等.卵巢早衰的颗粒细胞凋亡机制研究进展[J].首都医科大学学报,2014,9(3):379-383.
[20] 徐晓琴,徐向荣.补肾中药对卵巢早衰患者卵巢储备功能及免疫调节影响的研究[J].中华全科医学,2014,12(12):2004-2006.