补益心脾法治疗产后抑郁症的临床疗效评价研究
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摘要
背景：产后抑郁症(Postpartum Depression, PPD)是抑郁症的一种,指产褥期内的抑郁症状,主要在产后2周内出现,4～6周症状明显,其病程可持续3～6个月。产后抑郁症发病率国外大致为10%～20%,国内2002～2009的文献调查显示发生率大致在11%～23.25%。其发病率高,不但影响产妇的健康,还会危及婴儿、家人,给家庭及社会带来沉重的负担。目前对PPD的治疗,西医常用的方法主要包括药物治疗和心理治疗,药物治疗副作用大、价格昂贵以及产后哺乳问题,致使患者依从性差。心理疗法根据患者个体心理状况而进行即时选择和调整,可控性、一致性均较差。近年来,随着产后抑郁症发病率的逐年升高,中医药治疗产后抑郁症的研究取得一定疗效,在药效及安全性方面都显示出了中医药治疗明显的优势,容易被患者接受。但目前中医对本病的治疗尚缺乏统一认识,且本病具有自愈性,大多数研究未设安慰剂组,直接与西药对照,缺乏严谨性,因此选取产后抑郁心脾两虚证患者作为研究对象,设安慰剂对照组,进行随机、对照、双盲的临床研究具有一定研究意义和价值。
目的：以符合纳入标准的60例产后抑郁心脾两虚证患者为研究对象,进行随机、对照、盲法研究,完成产后抑郁症的中药治疗疗效评价及安全性分析,进一步明确中医药治疗抑郁症的疗效、优势和安全性以及其治疗的适应范围。
方法：本项研究的所有产后抑郁患者,来源于2011年1月至2012年3月北京中医药大学第三附属医院及其下属的三个社区。本研究观察产后抑郁心脾两虚证的患者共60例,设治疗组30例,安慰剂组30例。治疗组采用参芪解郁颗粒,每日一剂。安慰组采用淀粉糊精颗粒,每日一剂。两组疗程均为6周。分别于治疗前、治疗后1周、2周、4周、6周,应用爱丁堡产后抑郁量表(Edinburgh Postnatal Depression Scale, EPDS)、抑郁症中医证候评分量表进行疗效评定,测定治疗前后血清雌二醇及孕酮水平。
结果：1.EPDS减分率评估临床疗效：在治疗6周时,治疗组的总有效率为86.67%其中临床控制率为26.67%,安慰剂组的总有效率为70.00%,其中临床控制率为0.00%；两组在治疗2、4、6周时的EPDS减分率差异均具有统计学意义(P<0.05)。2.中医疗效指数评估临床疗效：治疗组的总有效率为86.67%,其中临床控制率为26.67%,安慰剂组的总有效率为73.33%,其中临床控制率为10.00%；两组在治疗2、4、6周时的中医证候减分率差异均具有统计学意义(P<0.05)。3.治疗组及安慰剂组治疗后雌二醇水平均有上升趋势,治疗6周后,治疗组及安慰剂组与自身治疗的差异有统计学意义(P<0.05)。治疗组与安慰剂组对比其上升水平有统计学意义(P<0.05)。4.治疗组及安慰剂组治疗后血清孕酮水平均有下降趋势,治疗6周后,治疗组及安慰剂组与自身治疗的差异有统计学意义(P<0.05)。治疗组与安慰剂组对比其上升水平无统计学意义(P>0.05)。
结论：1.补益心脾法治疗产后抑郁的疗效评价
通过对符合纳入标准的60例患者进行随机、对照、盲法研究,比较参芪解郁方与安慰剂治疗产后抑郁心脾两虚证患者的疗效差异。结果表明参芪解郁方干预下的治疗组疗效高于安慰剂组,进一步明确中医药治疗产后抑郁的疗效、优势和安全性。
2.探讨中医药干预产后抑郁的作用机制
检测患者治疗前后血清中雌激素、孕激素水平。进一步阐释参芪解郁方治疗产后抑郁症的作用机制,本研究说明参芪解郁方可以提高产后抑郁心脾两虚证患者雌二醇水平,进一步丰富中医药治疗产后抑郁症的理论及临床内容。
3.参芪解郁方治疗产后抑郁临床疗效好,副作用小,依从性高,具有明显的优势,是一种比较安全有效的中药方剂。
Background:Postpartum Depression(PPD) is one form of depression, which refers to the depressive symptoms during puerperium, mainly emerge in the first two weeks after labor, with obviously symptoms in the4th to6th week, duration can be3-6months. Incidence of PPD in other countries is approximately11%-23.25%. With such a high incidence, PPD not only affects matenals'health, but also endanger infants, family, bringing heavy burden to family and society. The current treatment to PPD, western medical approaches mainly include drug treatment and psychological treatment. Drug treatment is expensive and it also has side-effects and lactation feed issues. For psychological treatment, it needs choice and adjustment timely according to the patients'psychological situation, with poor controllability and consistency. In recent years, as the incidence of PPD increased year by year, Traditional Chinese Medicine treatment achieve certain effect on PPD's research, Traditional Chinese Medicine has distinct advantages in efficacy and safety, likely to be accepted by patients. But Traditional Chinese Medicine treatment lack of a unified understanding for PPD treatment, and PPD's self-healing feature, most researches had not set placebo group, comparing with western medicine directly, lacking of rigor. So to select postnatal patients with depression of heart and spleen deficiency syndrome as objects of study, conduct random, comparative, double-blind clinical research has certain significance and value.
Purpose:Take60postnatal patients with depression of heart and spleen deficiency syndrome who meet the standards as objects of study, conduct random, comparative, double-blind clinical research. Complete Traditional Chinese Medical treatment's clinical evaluation and safety analysis for PPD, further clarify Traditional Chinese Medical treatment's efficacy, advantages, safety and range of treatment for PPD.
Methods:All the PPD patients in this research from Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine and three subordinate communities from January2011to March2012. This research observed total60postnatal patients with depression of heart and spleen deficiency syndrome, set30cases in treatment group and30cases in placebo group. Patients in treatment group took Shenqijieyu Particles1dose/day. Patients in placebo group took Starch Particles1dose/day. Both group adopted6weeks'treatment. Distributed in before treatment,1st week,2nd week,4th week,6th week after treatment, used in Edinburgh Postnatal Depression Scale, EPDS and TCM Depression Scale to evaluate the efficacy, measure the serum estradiol and progesterone levels before and after treatment.
Results:
1EPDS deducted rate Clinical efficacy evaluation:in the6weeks'treatment. The total effective rate in treatment group was86.67%, with26.67%Clinical control rate. The total effective rate in placebo group was70.00%, with0%Clinical control rate; EPDS deducted rate difference in2group's2nd week,4th week,6th week's treatment was statistically significant(P<0.05).
2Use TCM therapeutic index clinical efficacy:The total effective rate in treatment group was86.67%, with26.67%Clinical control rate. The total effective rate in placebo group was70.00%, with10%Clinical control rate. Traditional Chinese Medical syndrome deducted rate in2group's2nd week,4th week,6th week's treatment was statistically significant(P<0.05).
3Both treatment group and placebo group have shown upward trend in estradiol levels, after6weeks'treatment, the difference between treatment group, placebo group and Self-healing was statistically significant(P<0.05).
4Both treatment group and placebo group shown downward trend in serum progesterone levels, after6weeks'treatment, the difference between treatment group, placebo group and Self-healing was statistically significant(P<0.05). Level rised Contradistinction between treatment group, placebo group and Self-healing has no statistically significant (P>0.05)
Conclusion:
1. Clinical assessment of postpartum depression with heart and spleen method treatment60patients who conform to the standard with random, comparative, double-blind research. Compare the differences in efficacy of Shenqijieyu Particles and placebo treat to postpartum depression of heart and spleen deficiency syndrome. The results show that Shenqijieyu Particles treatment group's efficacy better than placebo group's. To further defined the efficacy, advantages and security of Chinese Medical treatment of postpartum depression.
2. Discusses the mechanism of Chinese Medical interventions for postpartum depression
Detected estrogen and progesterone level in patients'serum before and after treatment. To further explain the mechanism of Shenqijieyu Particles treat to postpartum depression, the research shows that Shenqijieyu Particles could improve estradiol level of postpartum depression of heart and spleen deficiency syndrome, and further enrich the theory of Traditional Chinese Medicine for postpartum depression and clinical contents.
3. Shenqijieyu Particles treatment in postpartum depression has better clinical efficacy, less side effects and higher compliance. The particle has obvious advantage, it is a more safe and effective Chinese Medicine formula.
目的：以符合纳入标准的60例产后抑郁心脾两虚证患者为研究对象,进行随机、对照、盲法研究,完成产后抑郁症的中药治疗疗效评价及安全性分析,进一步明确中医药治疗抑郁症的疗效、优势和安全性以及其治疗的适应范围。
方法：本项研究的所有产后抑郁患者,来源于2011年1月至2012年3月北京中医药大学第三附属医院及其下属的三个社区。本研究观察产后抑郁心脾两虚证的患者共60例,设治疗组30例,安慰剂组30例。治疗组采用参芪解郁颗粒,每日一剂。安慰组采用淀粉糊精颗粒,每日一剂。两组疗程均为6周。分别于治疗前、治疗后1周、2周、4周、6周,应用爱丁堡产后抑郁量表(Edinburgh Postnatal Depression Scale, EPDS)、抑郁症中医证候评分量表进行疗效评定,测定治疗前后血清雌二醇及孕酮水平。
结果：1.EPDS减分率评估临床疗效：在治疗6周时,治疗组的总有效率为86.67%其中临床控制率为26.67%,安慰剂组的总有效率为70.00%,其中临床控制率为0.00%；两组在治疗2、4、6周时的EPDS减分率差异均具有统计学意义(P<0.05)。2.中医疗效指数评估临床疗效：治疗组的总有效率为86.67%,其中临床控制率为26.67%,安慰剂组的总有效率为73.33%,其中临床控制率为10.00%；两组在治疗2、4、6周时的中医证候减分率差异均具有统计学意义(P<0.05)。3.治疗组及安慰剂组治疗后雌二醇水平均有上升趋势,治疗6周后,治疗组及安慰剂组与自身治疗的差异有统计学意义(P<0.05)。治疗组与安慰剂组对比其上升水平有统计学意义(P<0.05)。4.治疗组及安慰剂组治疗后血清孕酮水平均有下降趋势,治疗6周后,治疗组及安慰剂组与自身治疗的差异有统计学意义(P<0.05)。治疗组与安慰剂组对比其上升水平无统计学意义(P>0.05)。
结论：1.补益心脾法治疗产后抑郁的疗效评价
通过对符合纳入标准的60例患者进行随机、对照、盲法研究,比较参芪解郁方与安慰剂治疗产后抑郁心脾两虚证患者的疗效差异。结果表明参芪解郁方干预下的治疗组疗效高于安慰剂组,进一步明确中医药治疗产后抑郁的疗效、优势和安全性。
2.探讨中医药干预产后抑郁的作用机制
检测患者治疗前后血清中雌激素、孕激素水平。进一步阐释参芪解郁方治疗产后抑郁症的作用机制,本研究说明参芪解郁方可以提高产后抑郁心脾两虚证患者雌二醇水平,进一步丰富中医药治疗产后抑郁症的理论及临床内容。
3.参芪解郁方治疗产后抑郁临床疗效好,副作用小,依从性高,具有明显的优势,是一种比较安全有效的中药方剂。
Background:Postpartum Depression(PPD) is one form of depression, which refers to the depressive symptoms during puerperium, mainly emerge in the first two weeks after labor, with obviously symptoms in the4th to6th week, duration can be3-6months. Incidence of PPD in other countries is approximately11%-23.25%. With such a high incidence, PPD not only affects matenals'health, but also endanger infants, family, bringing heavy burden to family and society. The current treatment to PPD, western medical approaches mainly include drug treatment and psychological treatment. Drug treatment is expensive and it also has side-effects and lactation feed issues. For psychological treatment, it needs choice and adjustment timely according to the patients'psychological situation, with poor controllability and consistency. In recent years, as the incidence of PPD increased year by year, Traditional Chinese Medicine treatment achieve certain effect on PPD's research, Traditional Chinese Medicine has distinct advantages in efficacy and safety, likely to be accepted by patients. But Traditional Chinese Medicine treatment lack of a unified understanding for PPD treatment, and PPD's self-healing feature, most researches had not set placebo group, comparing with western medicine directly, lacking of rigor. So to select postnatal patients with depression of heart and spleen deficiency syndrome as objects of study, conduct random, comparative, double-blind clinical research has certain significance and value.
Purpose:Take60postnatal patients with depression of heart and spleen deficiency syndrome who meet the standards as objects of study, conduct random, comparative, double-blind clinical research. Complete Traditional Chinese Medical treatment's clinical evaluation and safety analysis for PPD, further clarify Traditional Chinese Medical treatment's efficacy, advantages, safety and range of treatment for PPD.
Methods:All the PPD patients in this research from Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine and three subordinate communities from January2011to March2012. This research observed total60postnatal patients with depression of heart and spleen deficiency syndrome, set30cases in treatment group and30cases in placebo group. Patients in treatment group took Shenqijieyu Particles1dose/day. Patients in placebo group took Starch Particles1dose/day. Both group adopted6weeks'treatment. Distributed in before treatment,1st week,2nd week,4th week,6th week after treatment, used in Edinburgh Postnatal Depression Scale, EPDS and TCM Depression Scale to evaluate the efficacy, measure the serum estradiol and progesterone levels before and after treatment.
Results:
1EPDS deducted rate Clinical efficacy evaluation:in the6weeks'treatment. The total effective rate in treatment group was86.67%, with26.67%Clinical control rate. The total effective rate in placebo group was70.00%, with0%Clinical control rate; EPDS deducted rate difference in2group's2nd week,4th week,6th week's treatment was statistically significant(P<0.05).
2Use TCM therapeutic index clinical efficacy:The total effective rate in treatment group was86.67%, with26.67%Clinical control rate. The total effective rate in placebo group was70.00%, with10%Clinical control rate. Traditional Chinese Medical syndrome deducted rate in2group's2nd week,4th week,6th week's treatment was statistically significant(P<0.05).
3Both treatment group and placebo group have shown upward trend in estradiol levels, after6weeks'treatment, the difference between treatment group, placebo group and Self-healing was statistically significant(P<0.05).
4Both treatment group and placebo group shown downward trend in serum progesterone levels, after6weeks'treatment, the difference between treatment group, placebo group and Self-healing was statistically significant(P<0.05). Level rised Contradistinction between treatment group, placebo group and Self-healing has no statistically significant (P>0.05)
Conclusion:
1. Clinical assessment of postpartum depression with heart and spleen method treatment60patients who conform to the standard with random, comparative, double-blind research. Compare the differences in efficacy of Shenqijieyu Particles and placebo treat to postpartum depression of heart and spleen deficiency syndrome. The results show that Shenqijieyu Particles treatment group's efficacy better than placebo group's. To further defined the efficacy, advantages and security of Chinese Medical treatment of postpartum depression.
2. Discusses the mechanism of Chinese Medical interventions for postpartum depression
Detected estrogen and progesterone level in patients'serum before and after treatment. To further explain the mechanism of Shenqijieyu Particles treat to postpartum depression, the research shows that Shenqijieyu Particles could improve estradiol level of postpartum depression of heart and spleen deficiency syndrome, and further enrich the theory of Traditional Chinese Medicine for postpartum depression and clinical contents.
3. Shenqijieyu Particles treatment in postpartum depression has better clinical efficacy, less side effects and higher compliance. The particle has obvious advantage, it is a more safe and effective Chinese Medicine formula.
引文
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[4]吴仕萍,汤艳清.产后抑郁症患者血清中雌三醇与孕酮的变化[J].中国临床康复,2006,9(24)：12-15.
[5]陆竹梅,林文秀.产后抑郁症患者雌、孕激素及催乳素变化的研究[J].华夏医学,2006,19(2)：188-189.
[6]方积屹主编.现代医学统计学[M].第二版.北京：人民卫生出版社,2005：162-174.
[7]罗阳,何国平.性激素及神经递质与产后抑郁症关系的Meta分析[J].中国妇幼保健,2007,22(8)：1022-1025.
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