加味青蒿鳖甲汤治疗女性更年期综合征临床疗效的研究
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摘要
更年期是指妇女从生殖、生育旺盛时期的性成熟期过渡到老年期的一段较长时期,也是人体衰老过程中生理变化最明显的阶段,是妇女生命过程的重要转折点。更年期综合症是由此期雌激素水平下降而引起的一系列症状,如月经变化、面色潮红、心悸、失眠、乏力、抑郁、多虑、情绪不稳定,易激动,注意力难于集中等,称为“更年期综合症”。这些病变给妇女的健康与精神、生活带来很大影响,直接关系到更年期和绝经后妇女的身心健康和生活质量,由此可引起家庭和社会的双重负担日益加重。因此,预防和及时治疗更年期综合征,使妇女能顺利渡过这一过渡时期,对提高妇女的健康水平具有重大的现实意义和社会意义。针对女性更年期综合征出现的明显低雌激素水平,西医目前主要采用激素替代疗法(HRT)对更年期综合征进行治疗,但HRT的长期使用又存在着潜在的危险性,如增加人群患子宫内膜癌、乳腺癌的危险度,体重增加,阴道不规则出血,深部静脉血栓的形成等。这些均使更年期妇女对激素替代治疗的顺应性降低,大大地限制了HRT在临床的广泛运用。更年期综合症为中医“经断前后诸证”范畴,中医药相比西医有其很好的优势,避免了西药治疗所带来的许多不良反应,因此,对中医药治疗更年期综合征的疗效观察具符合临床需要,且具有良好的社会效益和经济效益。
目的
采用临床观察的方法,通过观察加味青蒿鳖甲汤对女性更年期综合征的症状、生化指标及临床疗效的影响情况,并与西药对照组比较,以暨探讨加味青蒿鳖甲汤治疗女性更年期综合征的优势及机理。
方法
研究对象为符合中医主证为阴虚内热辨证标准,同时符合西医女性更年期综合征诊断标准的患者。随机分为两组,一组服用加味青蒿鳖甲汤方药,另一组常规激素替代疗法,以临床综合疗效、Kupperman症状积分、雌二醇(E2)、促卵泡成熟激素(FSH)、黄体生成激素(LH)等为观察指标,评价加味青蒿鳖甲汤的有效性和安全性。统计方法：分类资料用χ2检验,等级资料用两样本比较Wilcoxon秩和检验(校正),两样本均数比较用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。
结果
本研究最后符合纳入排除标准参与分析的有100例,分为加味青蒿鳖甲汤治疗组和激素替代对照组各50例。患者的平均年龄为48.75±3.6岁；平均病程为37.8±7.2月。从临床治疗总效果看,加味青蒿鳖甲汤的愈显率为74%,而对照组为28%,差别有统计学意义(P<0.05),说明加味青蒿鳖甲汤对于治疗更年期综合征有显著疗效。两组治疗前后Kupperman症状积分均有所降低,但治疗组分值更低于对照组(P<0.05),可认为治疗组加味青蒿鳖甲汤在改善更年期综合征症状方面要优于对照组激素替代。两组治疗前后客观指标(雌二醇(E2)、促卵泡成熟激素(FSH)、黄体生成激素(LH)等为观察指标,)积分均下降(P<0.05),但治疗组加味青蒿鳖甲汤在调节雌二醇(E2)、促卵泡成熟激素(FSH)、黄体生成激素(LH)及烘热汗出方面要更具优势(P<0.05)。对女性更年期综合征的主要临床症状和体征消失率进行比较,提示治疗组加味青蒿鳖甲汤在改善各种症状和体征方面要优于对照组(P<0.05)。治疗期间两组患者均无明显的不良反应,治疗前后血、尿、便及肝肾功能检测结果均未见异常改变及毒副反应。临床观察表明两药均具有较高的安全性。
结论
本课题的临床研究表明运用中医加味青蒿鳖甲汤施治,此法有如下优势：明显改善烘热汗出等症状体征及激素检查指标；对于治疗女性更年期综合征有其独特的优势与特点,未见明显的副作用；在提高女性更年期综合征病人生活质量上优于对照组,并且安全有效。本课题研究提示中医药加味青蒿鳖甲汤为女性更年期综合征的重要治疗法则,为中医中药治疗该病症的新途径。
Menopause is the period in which woman transits from sexual maturity to old age and physical change is the most obvious. It's the most important transition in woman's life. Climacteric syndrome includes a series of symptoms which result from estrogen's decrease, such as menses change, face redness, palpitate, loss sleep, etc. Those affect women's health, mind and life and are related to their sound in body and mind and life's quality after menopause, which maybe lead to increase dual burden of family and society. So the prevention and timely treatment of menopause can let women pass this period favorably and have momentous current and social significance.
It's treated by HRT against obvious low estrogen's decrease in menopause, but long-use of HRT has patent danger, such as increased risk of endometrium and galactophore cancer, gaining in weight, irregular bleeding in vagina and so on, which decrease women's acclimatization of HRT in menopause.
Climacteric syndrome is included in "menopausal syndrome" in China Medicine, tradition Chinese medicine and pharmacy have advantages against WM, because of averting a great deal of untoward reactions from therapy of WM. So the curative effect observation on treating climacteric syndrome by tradition Chinese medicine and pharmacy answers for clinical need and will have good social and financial benefits.
Objective
To study modified Qinghaobiejia dectotion'mechanism and advantages in the treatment of women'climacteric syndrome through the observation of symptoms, experimental index and efficacy and comparison with control group with WM.
Method
Objects meet both the differentiation standard of yin asthenia generating intrinsic heat and diagnostic criteria of climacteric syndrome. Out-patients were devided into control group with HRT and treatment group with modified Qinghaobiejia dectotion. Examined and compared the clinical efficacy,Kupperman Menopause Index score, estradio, lfollicle-stimulating hormone and luteotropic hormone. Then evaluate the efficacy and sfety of modified Qinghaobiejia dectotion. Grouped data was analyzed by χ2test and ranked data was analyzed by rank sum test. Two sample means and were compared by t test or rank sum test. Self circa were compared by matched-pairs t test or rank sum test.
Result
100cases is included and devided into2group averagely. Patients'mean age is48.75±3.6years and mean course is37.8±7.2months. The more explicit rate of treatment group is74%and control group is28%. The difference were significant (P<0.05), which meaned that the modified Qinghaobiejia Decoction had significant effect in climacteric syndromes. Kupperman Menopause Index scores of two groups had decreased after treatment, but treatment group's was lower than control group's. So the former had advantages over the latter. Two groups of E2,FSH and LH increased in both before and after treatment, but treatment group's was more obvious than control group's. The treatment group had more effective than the control group in meliorating symptoms and signs. All pai tents had no side effects and abnormal changes in the index of blood, urina, excrement and liver and kidney function. Clinical research showed that both of drugs had high safty.
Conclusion
In treating woman's climacteric syndrome, the Modified Qhaobiejia Decoction can meliorate symptoms, signs and hormone index without apparent side effects. It can incease patients' quality of life safely, supassing the contol group. This study showed the Modified Qinghaobiejia Decoction has its advantages and features in treating woman's climacteric syndrome and will be a new method.
目的
采用临床观察的方法,通过观察加味青蒿鳖甲汤对女性更年期综合征的症状、生化指标及临床疗效的影响情况,并与西药对照组比较,以暨探讨加味青蒿鳖甲汤治疗女性更年期综合征的优势及机理。
方法
研究对象为符合中医主证为阴虚内热辨证标准,同时符合西医女性更年期综合征诊断标准的患者。随机分为两组,一组服用加味青蒿鳖甲汤方药,另一组常规激素替代疗法,以临床综合疗效、Kupperman症状积分、雌二醇(E2)、促卵泡成熟激素(FSH)、黄体生成激素(LH)等为观察指标,评价加味青蒿鳖甲汤的有效性和安全性。统计方法：分类资料用χ2检验,等级资料用两样本比较Wilcoxon秩和检验(校正),两样本均数比较用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。
结果
本研究最后符合纳入排除标准参与分析的有100例,分为加味青蒿鳖甲汤治疗组和激素替代对照组各50例。患者的平均年龄为48.75±3.6岁；平均病程为37.8±7.2月。从临床治疗总效果看,加味青蒿鳖甲汤的愈显率为74%,而对照组为28%,差别有统计学意义(P<0.05),说明加味青蒿鳖甲汤对于治疗更年期综合征有显著疗效。两组治疗前后Kupperman症状积分均有所降低,但治疗组分值更低于对照组(P<0.05),可认为治疗组加味青蒿鳖甲汤在改善更年期综合征症状方面要优于对照组激素替代。两组治疗前后客观指标(雌二醇(E2)、促卵泡成熟激素(FSH)、黄体生成激素(LH)等为观察指标,)积分均下降(P<0.05),但治疗组加味青蒿鳖甲汤在调节雌二醇(E2)、促卵泡成熟激素(FSH)、黄体生成激素(LH)及烘热汗出方面要更具优势(P<0.05)。对女性更年期综合征的主要临床症状和体征消失率进行比较,提示治疗组加味青蒿鳖甲汤在改善各种症状和体征方面要优于对照组(P<0.05)。治疗期间两组患者均无明显的不良反应,治疗前后血、尿、便及肝肾功能检测结果均未见异常改变及毒副反应。临床观察表明两药均具有较高的安全性。
结论
本课题的临床研究表明运用中医加味青蒿鳖甲汤施治,此法有如下优势：明显改善烘热汗出等症状体征及激素检查指标；对于治疗女性更年期综合征有其独特的优势与特点,未见明显的副作用；在提高女性更年期综合征病人生活质量上优于对照组,并且安全有效。本课题研究提示中医药加味青蒿鳖甲汤为女性更年期综合征的重要治疗法则,为中医中药治疗该病症的新途径。
Menopause is the period in which woman transits from sexual maturity to old age and physical change is the most obvious. It's the most important transition in woman's life. Climacteric syndrome includes a series of symptoms which result from estrogen's decrease, such as menses change, face redness, palpitate, loss sleep, etc. Those affect women's health, mind and life and are related to their sound in body and mind and life's quality after menopause, which maybe lead to increase dual burden of family and society. So the prevention and timely treatment of menopause can let women pass this period favorably and have momentous current and social significance.
It's treated by HRT against obvious low estrogen's decrease in menopause, but long-use of HRT has patent danger, such as increased risk of endometrium and galactophore cancer, gaining in weight, irregular bleeding in vagina and so on, which decrease women's acclimatization of HRT in menopause.
Climacteric syndrome is included in "menopausal syndrome" in China Medicine, tradition Chinese medicine and pharmacy have advantages against WM, because of averting a great deal of untoward reactions from therapy of WM. So the curative effect observation on treating climacteric syndrome by tradition Chinese medicine and pharmacy answers for clinical need and will have good social and financial benefits.
Objective
To study modified Qinghaobiejia dectotion'mechanism and advantages in the treatment of women'climacteric syndrome through the observation of symptoms, experimental index and efficacy and comparison with control group with WM.
Method
Objects meet both the differentiation standard of yin asthenia generating intrinsic heat and diagnostic criteria of climacteric syndrome. Out-patients were devided into control group with HRT and treatment group with modified Qinghaobiejia dectotion. Examined and compared the clinical efficacy,Kupperman Menopause Index score, estradio, lfollicle-stimulating hormone and luteotropic hormone. Then evaluate the efficacy and sfety of modified Qinghaobiejia dectotion. Grouped data was analyzed by χ2test and ranked data was analyzed by rank sum test. Two sample means and were compared by t test or rank sum test. Self circa were compared by matched-pairs t test or rank sum test.
Result
100cases is included and devided into2group averagely. Patients'mean age is48.75±3.6years and mean course is37.8±7.2months. The more explicit rate of treatment group is74%and control group is28%. The difference were significant (P<0.05), which meaned that the modified Qinghaobiejia Decoction had significant effect in climacteric syndromes. Kupperman Menopause Index scores of two groups had decreased after treatment, but treatment group's was lower than control group's. So the former had advantages over the latter. Two groups of E2,FSH and LH increased in both before and after treatment, but treatment group's was more obvious than control group's. The treatment group had more effective than the control group in meliorating symptoms and signs. All pai tents had no side effects and abnormal changes in the index of blood, urina, excrement and liver and kidney function. Clinical research showed that both of drugs had high safty.
Conclusion
In treating woman's climacteric syndrome, the Modified Qhaobiejia Decoction can meliorate symptoms, signs and hormone index without apparent side effects. It can incease patients' quality of life safely, supassing the contol group. This study showed the Modified Qinghaobiejia Decoction has its advantages and features in treating woman's climacteric syndrome and will be a new method.
引文
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