舒肝胶囊治疗更年期妇女抑郁症的临床随机对照研究
摘要
研究背景:
更年期妇女抑郁症是一种严重危害女性生理心理健康的疾病,随着社会经济发展和生活节奏加快,工作压力竞争的增加,抑郁症的发病率、致残率和因抑郁导致的自杀率呈逐年递增趋势,对更年期妇女的身心健康及家庭和睦带来严重的影响。随着老年社会到来,人们对抑郁症的认识逐渐增强。关于该病的治疗,现代医学主要采用抗抑郁药物治疗,必要时配合激素替代或补充疗法,虽有一定的疗效,但需长期服药,费用昂贵,且副作用大,患者的依从性较差,治疗不彻底;心理治疗也是常见的方法,但因为个体化的原因,疗效不稳定,难以推广。抑郁症属于中医的“郁病”范畴,中医通过辩证论治,很好的发挥中医药的优势,在减少副反应和降低费用方面明显优于西药,且疗效稳定,不宜反弹,无成瘾性,患者容易接受。本研究就是论证中成药舒肝胶囊治疗此病的确切疗效和安全性。
研究目的:
本研究采用舒肝胶囊和抗抑郁药黛立新治疗更年期抑郁症妇女,观察舒肝胶囊治疗更年期妇女抑郁症的临床有效性和安全性,便于临床推广应用;探讨舒肝胶囊和黛立新治疗抑郁症的可能作用机理;观察PSQI量表作为抑郁症临床疗效评价指标的可行性。
研究方法:
本研究采用随机对照的临床试验设计,选择2007年10月至2009年2月广东省中医院妇科门诊就诊符合纳入标准的更年期抑郁症妇女53人,利用简单随机分组的方法将其分为治疗组(舒肝胶囊组)和对照组(黛立新组),各自口服药物治疗8周,并分别在治疗前、治疗4周后、8周后进行汉密尔顿抑郁量表(HAMD量表)、匹兹堡睡眠质量量表(PSQI)的评分;并在治疗前后检测血清5-HT,FSH,E_2的浓度,同时检测血、尿常规、肝肾功能、心电图等一般安全性项目,填写观察表,记录不良反应。
结果:
1.临床疗效比较:根据HAMD治疗前后的减分率计算临床疗效,以痊愈、显著进步、进步均为有效计算,得出治疗组的总有效率为81.5%,对照组总有效率为73.1%;组间比较,差异无显著性,P＞0.05,说明两种药物的疗效相当,均可以有效的改善抑郁症状。
2.HAMD量表评分比较:两组治疗8周后HAMD评分与治疗前相比:组内比较,差异均有显著性(P＜0.01),组间比较,差异无显著性(P＞0.05),说明在服药8周后,两组的HAMD评分均下降,但两组之间下降幅度无明显差异。
两组治疗4周后HAMD评分与治疗前相比:组内比较,差异均有显著性(P＜0.05),组间比较,差异也有显著性(P＜0.05),说明服药治疗4周后对照组的HAMD评分较治疗组下降明显。
在服药4周与8周的HAMD评分相比:治疗组内比较,差异有显著性(P＜0.01),对照组内比较,差异无显著性(P＞0.05),说明对照组服药8周的HAMD评分与服药4周的评分无明显差异,即在服药第4-8周阶段,HAMD评分无明显变化;两组间比较,差异有显著性(P＜0.01),提示在服药第4周至第8周阶段,治疗组的HAMD评分较对照组下降明显。
3.PSQI评分比较:两组治疗8周后PSQI评分各自与治疗前相比,差异均有显著性(P＜0.01),但两组之间差异无显著性(P＞0.05),提示两组治疗8周后PSQI评分均较治疗前明显下降。但治疗组在服药4周与治疗前的PSQI评分比较,比对照组下降更明显(治疗组P＜0.01,对照组P＜0.05)。
4.血清5-HT浓度,治疗组前后无明显改变(P＞0.05),而对照组治疗后低于治疗前(P＜0.05)。血清FSH、E2含量治疗前后相比,差异均无显著性(P＞0.05)提示两组治疗前后,血清性激素检测值均无明显变化。
5.两组治疗前后均未见明显(严重)不良反应,安全性检测均未见异常。
研究结论:
1.舒肝胶囊与黛立新对于更年期抑郁症患者的抑郁症状、植物神经功能紊乱症状和睡眠障碍均有显著改善,且两者疗效相当。
2.研究提示更年期抑郁症患者血清5-HT存在紊乱,其发病病因是多方面的,5-HT可能只是其中的一个影响因素,舒肝胶囊有抑制5-HT的下降趋势;同时治疗后FSH未见下降,E2未见上升,可以认为更年期抑郁症状的发生与性腺轴功能失调有关。舒肝胶囊可以改善神经内分泌的紊乱而起到抗抑郁作用。
3.PSQI评分与HAMD评分有高度一致性,可作为抑郁症临床疗效评价指标。
4.舒肝胶囊作用缓慢持久,不良反应较黛立新少,说明舒肝胶囊安全有效,可在临床推广。
Background:
Menopause depression affects the physiology and mental health of women severely.Nowadays,as the development of social economy,life rhythm getting faster and faster,and work pressure getting bigger and bigger,the incidence of depression,the disability rate and the suicide rate are in the trend of increasing year by year.It seriously affects the physical and mental health of menopausal women and breaks family harmony.With the coming of an aging society,people' sknowledge of depression is gradually strengthened.Current medicine mainly prescribes some antidepressant to cure the disease,if necessary assist with hormone replacement therapy or supplementary therapy. Though there are some curative effect,patients have to take medicine for a long period,and it costs a lot.The side effect is big.Patients' compliance is not so good,so patient can not totally recover from depression. Psychotherapy is also commonly used,but the effects are not steady because of the individuality,so it can not be used popularly.Depression belongs to melancholia of Chinese medicine.Chinese medicine use the method of syndrome differentiation.It takes advantage of Chinese medicine.It is better than the western medicine in the aspects of decreasing side-effects and expense. And the effect is steady.It' s not easy to rebound and It' s not addictive. It' s easy for patient to take.This study is to prove the exact effects and safety of the capsule of shugan on curing depression.
Research purpose:
Compare the method of taking capsule of shugan to the depressant Deanxit, and observe the clinical efficacy and safety of shugan capsule curing menopause depression.To make it easy to be used popularly.In this study,I will demonstrate the mechanism of shugan capsule and Deanxit on curing depression. Observing the results of the scale of PSQI reflects the feasibility of curing depression.
Methods:
This study used clinical randomized controlled trial.We chose 53 women who has menopause depression in Guangdong provincial hospital of Chinese medicine,and they all meets with the including criteria.We separate the patients into two groups in the way of simple random method.One of the group is treatment group which takes the capsule of shugan for 8 weeks.The other is the control group which takes Deanxit for 8 weeks.We let patients do the Hamilton depression scale and Pittsburgh sleep quality scale before the therapy and after 4 weeks,after 8 weeks.We detect the degree of serum 5-HT,FSH and E2.At the same time,we do some save examination,such as the blood routine, urine routine,hepatic and renal routine,electrocardiogram,et al.We make an observation table,and record the adverse effects.
Results:
1.Comparison of the clinical effects of the two groups:
The effective rate of the treatment group is 81.5%by calculating the result of Hamilton depression scale pre and post treatment.The effective rate of the control group is 73.1%.The recovery,significantly improvement and improvement are considered effective.Compare with each other,there was no significant difference between them(P>0.05).That is to say,the effects of the two treatments are nearly the same.They both can alleviate the symptoms of depression.
2.Comparison of the results of two groups with Hamilton depression scale:
Compare the results of Hamilton depression scale pre and after 8 weeks treatment:compare in the groups,there was significantly difference(P<0.01). But compare in two groups,there was no significant difference.That is to say,both of the results of Hamilton depression scale are reducing,but there was no remarkable difference in the decrease range.
3.Compare the result of taking medicine for 4 weeks to the result of taking medicine for 8 weeks,there are significant differences in the groups.But compare to the other group,there are no significant difference(P>0.05).That is to say,there are no differences in the results of Hamilton depression scale between 4 and 8 week taking medicine.So the result of treatment group decreased apparently than the control group.
4.Comparison of PSQI scale in the groups:
there are significant differences in the groups results compared with the pre and post treatment.But there are no significant differences between the two groups.It prompted that the results of post-treatments decrease than the results of pre-treatment.But the result after taking 4 weeks medicine decrease more apparently that the results of pre treatment.
There are no apparent difference between the degree of serum 5-HT pre and post treatment(P>0.05).But the results of post control group are lower than the pre treatment.There are no significant difference in the degree of serum FSH and E2 pre and post treatment.It hints that there are no differences in sexua]hormone examination pre and post treatments.
There are no abnormal results of safe examination pre and post treatment in the two groups.
Conclusions:
1.Both of the Shugan capsule and Deanxit can improve the symptoms of the depression and the symptoms of vegetative nerve functional disturbance,and the effects are nearly the same.
2.Shugan capsule can inhibit the decrease of 5-HT.It hints that there are disturbance of serum 5-HT.Menopause depression' s etiological factor related to a lot of factors.5-HT is only one of the reference factors.FSH doesn' tdecreaseandE2doesn' t increase,it is considered that the menopause depression is related to the functional disturbance of gonadal axis.Shugan capsule can improve the symptoms of disturbance of neuroendocrine and has the function of anti-depression.
3.The results of PSQI scale and Hamilton depression scale are nearly the same;they both can evaluate the clinical effects of depression.
4.Shugan capsule' s effect is slow and lasting,the expense is lower. And side effects are lesser than Deanxit.In conclusion,Shugan capsule is safe and effective;it can be popularly used in clinical.
更年期妇女抑郁症是一种严重危害女性生理心理健康的疾病,随着社会经济发展和生活节奏加快,工作压力竞争的增加,抑郁症的发病率、致残率和因抑郁导致的自杀率呈逐年递增趋势,对更年期妇女的身心健康及家庭和睦带来严重的影响。随着老年社会到来,人们对抑郁症的认识逐渐增强。关于该病的治疗,现代医学主要采用抗抑郁药物治疗,必要时配合激素替代或补充疗法,虽有一定的疗效,但需长期服药,费用昂贵,且副作用大,患者的依从性较差,治疗不彻底;心理治疗也是常见的方法,但因为个体化的原因,疗效不稳定,难以推广。抑郁症属于中医的“郁病”范畴,中医通过辩证论治,很好的发挥中医药的优势,在减少副反应和降低费用方面明显优于西药,且疗效稳定,不宜反弹,无成瘾性,患者容易接受。本研究就是论证中成药舒肝胶囊治疗此病的确切疗效和安全性。
研究目的:
本研究采用舒肝胶囊和抗抑郁药黛立新治疗更年期抑郁症妇女,观察舒肝胶囊治疗更年期妇女抑郁症的临床有效性和安全性,便于临床推广应用;探讨舒肝胶囊和黛立新治疗抑郁症的可能作用机理;观察PSQI量表作为抑郁症临床疗效评价指标的可行性。
研究方法:
本研究采用随机对照的临床试验设计,选择2007年10月至2009年2月广东省中医院妇科门诊就诊符合纳入标准的更年期抑郁症妇女53人,利用简单随机分组的方法将其分为治疗组(舒肝胶囊组)和对照组(黛立新组),各自口服药物治疗8周,并分别在治疗前、治疗4周后、8周后进行汉密尔顿抑郁量表(HAMD量表)、匹兹堡睡眠质量量表(PSQI)的评分;并在治疗前后检测血清5-HT,FSH,E_2的浓度,同时检测血、尿常规、肝肾功能、心电图等一般安全性项目,填写观察表,记录不良反应。
结果:
1.临床疗效比较:根据HAMD治疗前后的减分率计算临床疗效,以痊愈、显著进步、进步均为有效计算,得出治疗组的总有效率为81.5%,对照组总有效率为73.1%;组间比较,差异无显著性,P＞0.05,说明两种药物的疗效相当,均可以有效的改善抑郁症状。
2.HAMD量表评分比较:两组治疗8周后HAMD评分与治疗前相比:组内比较,差异均有显著性(P＜0.01),组间比较,差异无显著性(P＞0.05),说明在服药8周后,两组的HAMD评分均下降,但两组之间下降幅度无明显差异。
两组治疗4周后HAMD评分与治疗前相比:组内比较,差异均有显著性(P＜0.05),组间比较,差异也有显著性(P＜0.05),说明服药治疗4周后对照组的HAMD评分较治疗组下降明显。
在服药4周与8周的HAMD评分相比:治疗组内比较,差异有显著性(P＜0.01),对照组内比较,差异无显著性(P＞0.05),说明对照组服药8周的HAMD评分与服药4周的评分无明显差异,即在服药第4-8周阶段,HAMD评分无明显变化;两组间比较,差异有显著性(P＜0.01),提示在服药第4周至第8周阶段,治疗组的HAMD评分较对照组下降明显。
3.PSQI评分比较:两组治疗8周后PSQI评分各自与治疗前相比,差异均有显著性(P＜0.01),但两组之间差异无显著性(P＞0.05),提示两组治疗8周后PSQI评分均较治疗前明显下降。但治疗组在服药4周与治疗前的PSQI评分比较,比对照组下降更明显(治疗组P＜0.01,对照组P＜0.05)。
4.血清5-HT浓度,治疗组前后无明显改变(P＞0.05),而对照组治疗后低于治疗前(P＜0.05)。血清FSH、E2含量治疗前后相比,差异均无显著性(P＞0.05)提示两组治疗前后,血清性激素检测值均无明显变化。
5.两组治疗前后均未见明显(严重)不良反应,安全性检测均未见异常。
研究结论:
1.舒肝胶囊与黛立新对于更年期抑郁症患者的抑郁症状、植物神经功能紊乱症状和睡眠障碍均有显著改善,且两者疗效相当。
2.研究提示更年期抑郁症患者血清5-HT存在紊乱,其发病病因是多方面的,5-HT可能只是其中的一个影响因素,舒肝胶囊有抑制5-HT的下降趋势;同时治疗后FSH未见下降,E2未见上升,可以认为更年期抑郁症状的发生与性腺轴功能失调有关。舒肝胶囊可以改善神经内分泌的紊乱而起到抗抑郁作用。
3.PSQI评分与HAMD评分有高度一致性,可作为抑郁症临床疗效评价指标。
4.舒肝胶囊作用缓慢持久,不良反应较黛立新少,说明舒肝胶囊安全有效,可在临床推广。
Background:
Menopause depression affects the physiology and mental health of women severely.Nowadays,as the development of social economy,life rhythm getting faster and faster,and work pressure getting bigger and bigger,the incidence of depression,the disability rate and the suicide rate are in the trend of increasing year by year.It seriously affects the physical and mental health of menopausal women and breaks family harmony.With the coming of an aging society,people' sknowledge of depression is gradually strengthened.Current medicine mainly prescribes some antidepressant to cure the disease,if necessary assist with hormone replacement therapy or supplementary therapy. Though there are some curative effect,patients have to take medicine for a long period,and it costs a lot.The side effect is big.Patients' compliance is not so good,so patient can not totally recover from depression. Psychotherapy is also commonly used,but the effects are not steady because of the individuality,so it can not be used popularly.Depression belongs to melancholia of Chinese medicine.Chinese medicine use the method of syndrome differentiation.It takes advantage of Chinese medicine.It is better than the western medicine in the aspects of decreasing side-effects and expense. And the effect is steady.It' s not easy to rebound and It' s not addictive. It' s easy for patient to take.This study is to prove the exact effects and safety of the capsule of shugan on curing depression.
Research purpose:
Compare the method of taking capsule of shugan to the depressant Deanxit, and observe the clinical efficacy and safety of shugan capsule curing menopause depression.To make it easy to be used popularly.In this study,I will demonstrate the mechanism of shugan capsule and Deanxit on curing depression. Observing the results of the scale of PSQI reflects the feasibility of curing depression.
Methods:
This study used clinical randomized controlled trial.We chose 53 women who has menopause depression in Guangdong provincial hospital of Chinese medicine,and they all meets with the including criteria.We separate the patients into two groups in the way of simple random method.One of the group is treatment group which takes the capsule of shugan for 8 weeks.The other is the control group which takes Deanxit for 8 weeks.We let patients do the Hamilton depression scale and Pittsburgh sleep quality scale before the therapy and after 4 weeks,after 8 weeks.We detect the degree of serum 5-HT,FSH and E2.At the same time,we do some save examination,such as the blood routine, urine routine,hepatic and renal routine,electrocardiogram,et al.We make an observation table,and record the adverse effects.
Results:
1.Comparison of the clinical effects of the two groups:
The effective rate of the treatment group is 81.5%by calculating the result of Hamilton depression scale pre and post treatment.The effective rate of the control group is 73.1%.The recovery,significantly improvement and improvement are considered effective.Compare with each other,there was no significant difference between them(P>0.05).That is to say,the effects of the two treatments are nearly the same.They both can alleviate the symptoms of depression.
2.Comparison of the results of two groups with Hamilton depression scale:
Compare the results of Hamilton depression scale pre and after 8 weeks treatment:compare in the groups,there was significantly difference(P<0.01). But compare in two groups,there was no significant difference.That is to say,both of the results of Hamilton depression scale are reducing,but there was no remarkable difference in the decrease range.
3.Compare the result of taking medicine for 4 weeks to the result of taking medicine for 8 weeks,there are significant differences in the groups.But compare to the other group,there are no significant difference(P>0.05).That is to say,there are no differences in the results of Hamilton depression scale between 4 and 8 week taking medicine.So the result of treatment group decreased apparently than the control group.
4.Comparison of PSQI scale in the groups:
there are significant differences in the groups results compared with the pre and post treatment.But there are no significant differences between the two groups.It prompted that the results of post-treatments decrease than the results of pre-treatment.But the result after taking 4 weeks medicine decrease more apparently that the results of pre treatment.
There are no apparent difference between the degree of serum 5-HT pre and post treatment(P>0.05).But the results of post control group are lower than the pre treatment.There are no significant difference in the degree of serum FSH and E2 pre and post treatment.It hints that there are no differences in sexua]hormone examination pre and post treatments.
There are no abnormal results of safe examination pre and post treatment in the two groups.
Conclusions:
1.Both of the Shugan capsule and Deanxit can improve the symptoms of the depression and the symptoms of vegetative nerve functional disturbance,and the effects are nearly the same.
2.Shugan capsule can inhibit the decrease of 5-HT.It hints that there are disturbance of serum 5-HT.Menopause depression' s etiological factor related to a lot of factors.5-HT is only one of the reference factors.FSH doesn' tdecreaseandE2doesn' t increase,it is considered that the menopause depression is related to the functional disturbance of gonadal axis.Shugan capsule can improve the symptoms of disturbance of neuroendocrine and has the function of anti-depression.
3.The results of PSQI scale and Hamilton depression scale are nearly the same;they both can evaluate the clinical effects of depression.
4.Shugan capsule' s effect is slow and lasting,the expense is lower. And side effects are lesser than Deanxit.In conclusion,Shugan capsule is safe and effective;it can be popularly used in clinical.
引文
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