广防风胶囊治疗肾阴虚证围绝经期综合征的临床研究
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摘要
目的:在前期试验基础上,初步探讨不同剂量广防风胶囊治疗围绝经期综合征(肾阴虚证)的临床有效性及安全性,推荐临床用药剂量。
方法:1、研究对象
选择60例门诊诊断为围绝经期综合症(肾阴虚证)的患者,采用随机、双盲、阴性药平行对照的方法,分为广防风胶囊高剂量组、低剂量组与安慰剂对照组,三组例数相等均为20例。其中每组各剔除病例1例,故有效病例为高剂量组19例,低剂量组19例,安慰剂对照组19例。
2.观察指标
(1)疗效性观测指标:以潮热汗出、心烦易怒为观察主症,选取失眠多梦、腰膝酸痛、头晕、耳鸣、口干、性欲下降、阴道干涩、皮肤干燥、尿黄、大便干结等症为观察次症。
(2)安全性观察指标:一般体格检查、血尿粪常规、心电图、肝功能(ALT)、肾功能(BUN、Cr)、B超、乳腺检查(红外线透乳)。
3.治疗方法
高剂量组:广防风胶囊,口服,每次用药一袋即3粒,每天2次。(3粒均为试验药,其中每袋含广防风根1.2g)。低剂量组:广防风胶囊,口服,每次用药一袋即3粒,每天2次(3粒中2粒为试验药,1粒为模拟剂,其中每袋含广防风根0.8g,糊精0.4g)。安慰剂对照组:模拟安慰剂,口服,每次用药一袋即3粒,每天2次。(3粒均为模拟剂,其中含糊精1.2g)。连续服药,8周为一个疗程。
4.疗效判定标准
(1)中医证候疗效判定标准:
疗效指数=(治疗前积分-治疗后积分)/治疗前积分×100%
临床痊愈:治疗后临床症状基本消失,疗效指数≥95%
显效:治疗后临床症状明显减轻,70%≤疗效指数＜95%
进步:治疗后临床症状减轻,30%≤疗效指数＜70%
无效:治疗后临床症状无变化,疗效指数＜30%
(2)激素水平变化
评定治疗前后E_2、P、FSH、LH的变化
5.统计学处理
计量资料采用t检验,多组间比较采用方差分析,计数资料采用χ~2检验,等级资料采用Ridit分析,P＞0.05表示无显著性差异,P＜0.05表示有显著性差异。
结果:
(1)治疗肾阴虚证围绝经期综合征的中医证候疗效
高剂量组临床痊愈率15.8%,总显效率84.2%,总进步率100%。低剂量组临床痊愈率5.3%,总显效率78.9%,总进步率94.7%。对照组临床痊愈率5.3%,总显效率5.3%,总进步率36.8%。三组间中医证候疗效有显著性差异,高剂量与低剂量组疗效相似,高低剂量组与对照组疗效不同。
(2)治疗肾阴虚证围绝经综合征的激素水平变化
E_2:高剂量组、低剂量组治疗前后有显著性差异,对照组无显著性差异。P、FSH、LH三组治疗前后均无显著性差异。
(3)治疗肾阴虚证围绝经期综合征的中医单项症状疗效
潮热汗出、心烦易怒、失眠多梦、腰膝酸痛、头晕、耳鸣、口干、性欲下降、阴道干涩、大便干结等单项症状评分,高剂量组、低剂量组治疗前后有显著性差异;皮肤干燥、尿黄等评分,高剂量组、低剂量组治疗前后无显著性差异。对照组治疗前后所有症状评分均无显著性差异。
(4)安全性分析
三组患者治疗前后血尿粪常规、心电图、肝肾功能、B超、乳腺检查均无显著性差异。其中血常规WBC、RBC、HGB、PLT,B超、乳腺检查在治疗前有少数异常病例,治疗后无进一步恶化。尿常规WBC、RBC治疗前后有少数异常病例,复查后均正常。
结论:
高、低剂量广防风胶囊的中医证候疗效相似,均能明显改善肾阴虚证围绝经期综合征的中医证候如:潮热汗出、心烦易怒、失眠多梦、腰膝酸痛、头晕、耳鸣、口干、性欲下降、阴道干涩、大便干结等。且均可使血清E_2升高,故临床可选择低剂量广防风胶囊治疗。临床应用未出现任何不良反应,安全可靠,无毒副作用。
Objective:
on the basis of early test,to explore clinical effect and safety of different dose-shielding Guangfangfeng Capsule for perimenopausal syndrome(kidney-yin deficiency syndrome),and to make a preliminary assessment of clinical dose.
Method:
1,study of target 60 cases of out-patient perimenopausal syndrome(kidney-yin deficiency syndrome)patients were Chosen and divided into test high dose group,low dose group and the placebo control group with a randomized,double-blind,parallel negative drug control methods.3 Group cases are equal to the number of 20 cases.Each of group removed one case.Finally,the high dose group contained 19 cases,low-dose group contained 19 cases and the placebo control group contained 19 cases too.
2.Observation indexes
(1)efficiency of indicators:sweat in hot flashes,irritability upset for the observation of selected insomnia dream,Yaoxi pain,dizziness,tinnitus,dry mouth,decreased libido, vaginal dryness,dry skin,Sui Huang,and dry stool.
(2)safety of indicators:general medical examination,fecal conventional hematuria,ECG, liver function(ALT),renal function(BUN,Cr),the B-breast examination(infrared thoroughly milk).
3.Treatment The high dose group:Guangfangfeng capsule,oral,each a bag of medication that 3,2 times a day.(3 test were drug-shielding containing root 1.2 g).The low dose group: Guangfangfeng capsule,oral,each a bag of medication that 3,2 times a day(3 test contain root 0.8g,dextrin 0.4 g).control group:simulated placebo,oral,each a bag of medication that 3,2 times a day.(3 are simulated agents,which ambiguity fine 1.2 g).Continuous medication,eight weeks as a course.
4.Clinical criteria
(1)Clinical Syndrome criteria:
Clinical cure:clinical symptoms were disappeared,effective index≥95% Effective:clinical symptoms were alleviated,70%＜effective index 70%＜95% Progress:reduce clinical symptoms after treatment,30%≤effective index＜70% Ineffective:no changes in clinical symptoms after treatment,effective index＜30%
(2)changes in hormone levels
E2,P,FSH,LH were assessed before and after treatment.
5.Statistical treatment The measuement data had been analysed by t test,analysis F was used to compare in several,and the enumeration data had been analysed by chi-square test. While the ranked data had been tested by Ridit analysis.P＞0.05 demonstrate has no significant difference,P＜0.05 demonstrate has significant difference.
Results:
(1)The clinical curative effect of perimenopausal syndrome(kidney-yin deficiency syndrome)
High-dose group clinical,cure rate was 15.8%,the efficiency was 84.2%,the total progress rate was 100%.Low-dose group,clinical cure rate was 5.3%,the efficiency was 78.9%,the total progress rate was 94.7%.Placebo control group,clinical cure rate was 5.3%, the efficiency was 5.3%,the total progress rate was 36.8%.There is significant difference in the three groups.
(2)The hormone level changes of perimenopausal syndrome(kidney-yin deficiency syndrome)
There was significant difference between high-dose group and low dose group in E_2 before and after treatment.There was no significant difference in the control group.Three groups was no significant difference in P,FSH,LH.
(3)individual effects of perimenopausal syndrome(kidney-yin deficiency syndrome)
There was significant differences before and after treatment between high dose group and low dose group in Hot flushes sweat upset irritability,insomnia dream,Yaoxi pain, dizziness,tinnitus,dry mouth,decreased libido,vaginal dryness,dry stool guitar,and other symptoms,but indifferences in skin drying,Sui Huang.All symptoms was no significant difference in the control group.
(4)Safety Analysis There are no obvious changes for these three groups in three conventional, ECG,liver and kidney function,B-breast examination result.Although there were several abnormal terms before treatment,they were not aggravated.These show that GuangFangFeng Drug test groups were safe,reliable,non-toxic side effects.
Conclusion:
High and low-dose capsules precautions Syndrome have similar effect,which can significantly improve TCM symptoms such as:hot flashes sweat upset irriability,insomnia dream,Yaoxi pain,dizziness,tinnitus,dry mouth,decreased libido,vaginal dryness,dry stool guitar.High and low-dose capsules can increased E_2.The P,FSH,LH improvement was not obvious.It is safe,effective and non-toxic side effects in clinical applications.
方法:1、研究对象
选择60例门诊诊断为围绝经期综合症(肾阴虚证)的患者,采用随机、双盲、阴性药平行对照的方法,分为广防风胶囊高剂量组、低剂量组与安慰剂对照组,三组例数相等均为20例。其中每组各剔除病例1例,故有效病例为高剂量组19例,低剂量组19例,安慰剂对照组19例。
2.观察指标
(1)疗效性观测指标:以潮热汗出、心烦易怒为观察主症,选取失眠多梦、腰膝酸痛、头晕、耳鸣、口干、性欲下降、阴道干涩、皮肤干燥、尿黄、大便干结等症为观察次症。
(2)安全性观察指标:一般体格检查、血尿粪常规、心电图、肝功能(ALT)、肾功能(BUN、Cr)、B超、乳腺检查(红外线透乳)。
3.治疗方法
高剂量组:广防风胶囊,口服,每次用药一袋即3粒,每天2次。(3粒均为试验药,其中每袋含广防风根1.2g)。低剂量组:广防风胶囊,口服,每次用药一袋即3粒,每天2次(3粒中2粒为试验药,1粒为模拟剂,其中每袋含广防风根0.8g,糊精0.4g)。安慰剂对照组:模拟安慰剂,口服,每次用药一袋即3粒,每天2次。(3粒均为模拟剂,其中含糊精1.2g)。连续服药,8周为一个疗程。
4.疗效判定标准
(1)中医证候疗效判定标准:
疗效指数=(治疗前积分-治疗后积分)/治疗前积分×100%
临床痊愈:治疗后临床症状基本消失,疗效指数≥95%
显效:治疗后临床症状明显减轻,70%≤疗效指数＜95%
进步:治疗后临床症状减轻,30%≤疗效指数＜70%
无效:治疗后临床症状无变化,疗效指数＜30%
(2)激素水平变化
评定治疗前后E_2、P、FSH、LH的变化
5.统计学处理
计量资料采用t检验,多组间比较采用方差分析,计数资料采用χ~2检验,等级资料采用Ridit分析,P＞0.05表示无显著性差异,P＜0.05表示有显著性差异。
结果:
(1)治疗肾阴虚证围绝经期综合征的中医证候疗效
高剂量组临床痊愈率15.8%,总显效率84.2%,总进步率100%。低剂量组临床痊愈率5.3%,总显效率78.9%,总进步率94.7%。对照组临床痊愈率5.3%,总显效率5.3%,总进步率36.8%。三组间中医证候疗效有显著性差异,高剂量与低剂量组疗效相似,高低剂量组与对照组疗效不同。
(2)治疗肾阴虚证围绝经综合征的激素水平变化
E_2:高剂量组、低剂量组治疗前后有显著性差异,对照组无显著性差异。P、FSH、LH三组治疗前后均无显著性差异。
(3)治疗肾阴虚证围绝经期综合征的中医单项症状疗效
潮热汗出、心烦易怒、失眠多梦、腰膝酸痛、头晕、耳鸣、口干、性欲下降、阴道干涩、大便干结等单项症状评分,高剂量组、低剂量组治疗前后有显著性差异;皮肤干燥、尿黄等评分,高剂量组、低剂量组治疗前后无显著性差异。对照组治疗前后所有症状评分均无显著性差异。
(4)安全性分析
三组患者治疗前后血尿粪常规、心电图、肝肾功能、B超、乳腺检查均无显著性差异。其中血常规WBC、RBC、HGB、PLT,B超、乳腺检查在治疗前有少数异常病例,治疗后无进一步恶化。尿常规WBC、RBC治疗前后有少数异常病例,复查后均正常。
结论:
高、低剂量广防风胶囊的中医证候疗效相似,均能明显改善肾阴虚证围绝经期综合征的中医证候如:潮热汗出、心烦易怒、失眠多梦、腰膝酸痛、头晕、耳鸣、口干、性欲下降、阴道干涩、大便干结等。且均可使血清E_2升高,故临床可选择低剂量广防风胶囊治疗。临床应用未出现任何不良反应,安全可靠,无毒副作用。
Objective:
on the basis of early test,to explore clinical effect and safety of different dose-shielding Guangfangfeng Capsule for perimenopausal syndrome(kidney-yin deficiency syndrome),and to make a preliminary assessment of clinical dose.
Method:
1,study of target 60 cases of out-patient perimenopausal syndrome(kidney-yin deficiency syndrome)patients were Chosen and divided into test high dose group,low dose group and the placebo control group with a randomized,double-blind,parallel negative drug control methods.3 Group cases are equal to the number of 20 cases.Each of group removed one case.Finally,the high dose group contained 19 cases,low-dose group contained 19 cases and the placebo control group contained 19 cases too.
2.Observation indexes
(1)efficiency of indicators:sweat in hot flashes,irritability upset for the observation of selected insomnia dream,Yaoxi pain,dizziness,tinnitus,dry mouth,decreased libido, vaginal dryness,dry skin,Sui Huang,and dry stool.
(2)safety of indicators:general medical examination,fecal conventional hematuria,ECG, liver function(ALT),renal function(BUN,Cr),the B-breast examination(infrared thoroughly milk).
3.Treatment The high dose group:Guangfangfeng capsule,oral,each a bag of medication that 3,2 times a day.(3 test were drug-shielding containing root 1.2 g).The low dose group: Guangfangfeng capsule,oral,each a bag of medication that 3,2 times a day(3 test contain root 0.8g,dextrin 0.4 g).control group:simulated placebo,oral,each a bag of medication that 3,2 times a day.(3 are simulated agents,which ambiguity fine 1.2 g).Continuous medication,eight weeks as a course.
4.Clinical criteria
(1)Clinical Syndrome criteria:
Clinical cure:clinical symptoms were disappeared,effective index≥95% Effective:clinical symptoms were alleviated,70%＜effective index 70%＜95% Progress:reduce clinical symptoms after treatment,30%≤effective index＜70% Ineffective:no changes in clinical symptoms after treatment,effective index＜30%
(2)changes in hormone levels
E2,P,FSH,LH were assessed before and after treatment.
5.Statistical treatment The measuement data had been analysed by t test,analysis F was used to compare in several,and the enumeration data had been analysed by chi-square test. While the ranked data had been tested by Ridit analysis.P＞0.05 demonstrate has no significant difference,P＜0.05 demonstrate has significant difference.
Results:
(1)The clinical curative effect of perimenopausal syndrome(kidney-yin deficiency syndrome)
High-dose group clinical,cure rate was 15.8%,the efficiency was 84.2%,the total progress rate was 100%.Low-dose group,clinical cure rate was 5.3%,the efficiency was 78.9%,the total progress rate was 94.7%.Placebo control group,clinical cure rate was 5.3%, the efficiency was 5.3%,the total progress rate was 36.8%.There is significant difference in the three groups.
(2)The hormone level changes of perimenopausal syndrome(kidney-yin deficiency syndrome)
There was significant difference between high-dose group and low dose group in E_2 before and after treatment.There was no significant difference in the control group.Three groups was no significant difference in P,FSH,LH.
(3)individual effects of perimenopausal syndrome(kidney-yin deficiency syndrome)
There was significant differences before and after treatment between high dose group and low dose group in Hot flushes sweat upset irritability,insomnia dream,Yaoxi pain, dizziness,tinnitus,dry mouth,decreased libido,vaginal dryness,dry stool guitar,and other symptoms,but indifferences in skin drying,Sui Huang.All symptoms was no significant difference in the control group.
(4)Safety Analysis There are no obvious changes for these three groups in three conventional, ECG,liver and kidney function,B-breast examination result.Although there were several abnormal terms before treatment,they were not aggravated.These show that GuangFangFeng Drug test groups were safe,reliable,non-toxic side effects.
Conclusion:
High and low-dose capsules precautions Syndrome have similar effect,which can significantly improve TCM symptoms such as:hot flashes sweat upset irriability,insomnia dream,Yaoxi pain,dizziness,tinnitus,dry mouth,decreased libido,vaginal dryness,dry stool guitar.High and low-dose capsules can increased E_2.The P,FSH,LH improvement was not obvious.It is safe,effective and non-toxic side effects in clinical applications.
引文
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