CN103006826A - Chinese medicinal compound for treating insomnia in female climacteric - Google Patents
Chinese medicinal compound for treating insomnia in female climacteric Download PDFInfo
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- CN103006826A CN103006826A CN2012105755704A CN201210575570A CN103006826A CN 103006826 A CN103006826 A CN 103006826A CN 2012105755704 A CN2012105755704 A CN 2012105755704A CN 201210575570 A CN201210575570 A CN 201210575570A CN 103006826 A CN103006826 A CN 103006826A
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Abstract
The invention discloses a Chinese medicinal compound for treating insomnia in female climacteric, which consists of the following components by weight: 30g of glossy privet fruit, 15g of eclipta alba, 30g of raw astragalus, 15g of radix pseudostellariae, 15g of roasted bighead atractylodes rhizome, 20g of Chinese angelica, 30g of raw oyster, 30g of spina date seed, 20g of white peony root, 12g of thinleaf milkwort root bark, 20g of red-rooted salvia root, and 6g of costustoot. According to the Chinese medicinal compound, the sleeping situation of a patient suffering insomnia in climacteric can be remarkably improved. The Chinese medicinal compound is used for treating both heart and kidney, regulating qi and blood and restoring normal coordination between heart and kidney, and has an exact treatment effect to insomnia in climacteric.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of Chinese medicine compound for the treatment of the Women’s climacteric insomnia.
Background technology
Insomnia is can not obtaining ortho sleep, and the length of one's sleep, the degree of depth and allaying tiredness effect deficiency are main disease.Climacteric insomnia disease is a kind of prolonged sleep matter relevant with climacteric or measures unsatisfied physiological barrier.Because the disorder of hormone secretion of hypothalamus one Pituitary-ovary Axis, it is the ovarian secretion estrogen decrease, and hypothalamus secretion promoting sexual gland hormone increases and cause endocrine and autonomic nervous dysfunction, climacteric insomnia is more easily occured, degree is even more serious, and about 60% climacteric women suffers from serious insomnia.Primary disease is a kind of commonly encountered diseases, frequently-occurring disease, doctor trained in Western medicine thinks because climacteric sex hormone secretion in vivo minimizing, the cerebral cortex control ability weakens, and to the shortage of climacteric physiological knowledge, live in addition, work, the increase of social equal pressure, patients ' psychological is changed, even produces mental maladjustment, thereby cause autonomic nervous dysfunction, cause insomnia.Long-term insomnia brings very large psychic pain to the patient, even formation is to the dependence of the medicine of sleeping peacefully, the patient is psychentonia more because excessive worry insomnia increases the weight of, form vicious cycle, so that climacteric insomnia disease is shown effect repeatedly, it is difficult to control for a long time, is having a strong impact on women's physical and mental health, quality of life and normal operation, but is lacking at present effective treatment means.
The traditional Chinese medical science is by determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, and treating both the principal and secondary aspects of a disease recovering equilibrium between yin and yang, improves the ovary partial function, delays the ovary decline, improves estrogen level, mitigation symptoms, and the aspect such as improve the quality of living has clear superiority.The traditional Chinese medical science thinks, the women is about 49 years old, the kidney qi degradation, and a deficiency of vital energy is appointed in punching, asthenia of essence and blood, damage of kidney-YIN, heart kidney is not good, and the symptoms such as emotional lability, insomnia appear in the kidney failing to nourish the liver, so that stagnation of liver-QI yang hyperactivity.Therefore, kidney water virtual loss be climacteric insomnia this, hyperactivity of hesrt-fire and liver-fire be its mark, treatment is many to be had in mind from the five internal organs, or from Liver and kidney, or controls from heart spleen opinion, or the five internal organs and accent.This research is under the theoretical direction of the traditional Chinese medical science " heart kidney loses the key that Ji is the morbidity of climacteric insomnia disease " and " The heart controls mental activities; the essence of kidney governing reproduction ", in conjunction with the ERZHI WAN with nourishing kidney-YIN effect with have the tranquilizing by nourishing the heart effect and have the dual drug effect that delays hypothalamus one hypophysis one gonad axis decline and promote this s function, draft have supplementing QI and nourishing YIN, the Fructus Ligustri Lucidi side of calming the nerves of tranquilizing the mind, restoring normal coordination between the heart and kidney carries out clinical research.Therefore, the positive control of climacteric insomnia become public's medical science problem anxious to be resolved.Climacteric insomnia is often treated with controversies in hormone replacement in the elderly and anxiolytic drugs by western countries at present, and in China, the difference owing on race, syndrome, the understanding is more prone to Chinese medicine.ERZHI WAN and GUIPI TANG are effective prescriptions for the treatment of climacteric insomnia, and two sides are carried out addition or subtraction of changes, form compound recipe---the Fructus Ligustri Lucidi soup of calming the nerves, treatment climacteric insomnia.
Summary of the invention
In order to solve the problems of the technologies described above, the invention provides a kind of Chinese medicine compound for the treatment of the Women’s climacteric insomnia, under the theoretical direction of the traditional Chinese medical science " heart kidney loses the key that Ji is the morbidity of climacteric insomnia disease " and " The heart controls mental activities; the essence of kidney governing reproduction ", in conjunction with the ERZHI WAN with nourishing kidney-YIN effect with have a GUIPI TANG of tranquilizing by nourishing the heart effect, draft have supplementing QI and nourishing YIN, the Chinese medicine compound-Fructus Ligustri Lucidi of tranquilizing the mind, the restoring normal coordination between the heart and kidney soup of calming the nerves carries out clinical observation on the therapeutic effect, to form the compound recipe technology that effectively to treat the Women’s climacteric insomnia, be used for the control of primary disease.
Its technical scheme is as follows:
A kind of Chinese medicine compound for the treatment of the Women’s climacteric insomnia comprises following constituent: Fructus Ligustri Lucidi 30g, Herba Ecliptae 15g, Radix Astragali 30g, Radix Pseudostellariae 15g, Rhizoma Atractylodis Macrocephalae (parched) 15g, Radix Angelicae Sinensis 20g, Concha Ostreae 30g, Semen Ziziphi Spinosae 30g, Radix Paeoniae Alba 20g, Radix Polygalae 12g, Radix Salviae Miltiorrhizae 20g, Radix Aucklandiae 6g.14d was 1 course for the treatment of.
Compound recipe forms: Fructus Ligustri Lucidi 30g, and Herba Ecliptae 15g, Radix Astragali 30g, Radix Pseudostellariae 15g, Rhizoma Atractylodis Macrocephalae (parched) 15g, Radix Angelicae Sinensis 20g, Concha Ostreae 30g is decocted first, Semen Ziziphi Spinosae 30g, Radix Paeoniae Alba 20g, Radix Polygalae 12g, Radix Salviae Miltiorrhizae 20g, Radix Aucklandiae 6g.The decoction method: upper square toes are fried in shallow oil and are added water 500ml, and Concha Ostreae is decocted first.Soak 30min, intense fire is boiled, and is at a simmer to 200ml, and two fry in shallow oil and add water 350ml, and slow fire takes 200ml, two fry in shallow oil mutually and, before sleeping in lunch break and night, service once.14d was 1 course for the treatment of, serve on post-evaluation 2 courses for the treatment of curative effect.
Research is all withdrawn other Western medicine sleeping pill and hormone medicine and health product take SHULE ANDING PIAN as matched group for two groups during the treatment.Carry out efficacy evaluation according to " new Chinese medicine guideline of clinical investigations ", calculate total effective rate; (PSQI) measures with the Pittsburgh index, with the sleep quality after the form observation treatment of questionnaire.
Beneficial effect of the present invention:
Research is take SHULE ANDING PIAN as matched group, finds that calm the nerves soup treatment Women’s climacteric insomnia's total effective rate of Fructus Ligustri Lucidi that compound recipe of the present invention is made obviously increases (90.00% vs 64.58%) than matched group; The PQSI score value all significantly reduces (P＜0.01) before the treatment behind two groups of patient treatments, the PQSI of observation group score value has extremely significantly than matched group and reduces (P＜0.01), illustrates to calm the nerves Fructus Ligustri Lucidi to improve Women’s climacteric insomnia's effect more remarkable than estazolam for soup.Fructus Ligustri Lucidi, Herba Ecliptae are monarch drug in the side, and with nourishing the liver and kidney, the treatment fidgets due to deficiency is not peaceful; The Radix Astragali, Radix Pseudostellariae, Rhizoma Atractylodis Macrocephalae invigorating spleen and nourishing heart are ministerial drug altogether, with the caused restlessness of asrhenia type and insomnia for the treatment of blood failing to tonify the heart, palpitation with fear palpitation with a distress feeling; The Concha Ostreae tranquillization with heavy prescription, Semen Ziziphi Spinosae and Radix Paeoniae Alba nourishing blood to suppress the hyperactive liver, Chinese Angelica blood replonishing is invigorated blood circulation, Radix Salviae Miltiorrhizae removing heat from blood and promoting blood circulation, Radix Polygalae restoring normal coordination between the heart and kidney; The Radix Aucklandiae is tonify without causing stagnation, helps drug absorption.Fructus Ligustri Lucidi calm the nerves can make climacteric insomnia disease patient sleep state be improved significantly, our heart kidney is also controlled, QI and blood is also transferred, restoring normal coordination between the heart and kidney has clear and definite therapeutical effect to climacteric insomnia disease.
The specific embodiment
Below in conjunction with the specific embodiment technical scheme of the present invention is described in more detail.
1. data and method
1.1 the case Source Study is cured the patient of 108 climacteric insomnia diseases of the hospital of traditional Chinese hospital, Ningxia Medical University attached hospital general attached time to go to a doctor during year December in January, 2010-2011 in Ningxia Medical University's traditional Chinese medical science clinic, Ningxia Medical University.Age is in the 41-60 women in year, all cases except insomnia is arranged, all with the confusion of the menstrual cycle, the time clinical manifestation of the climacteric syndromes such as hectic fever night sweat, cardiopalmus, anxiety, agitation arranged.
1.2 diagnostic criteria
1.2.1 the diagnostic criteria of tcm diagnosis disease is with reference to " traditional Chinese medical science disease Standardization of diagnosis and curative effect "
[5]: 1. main suit's sleep physiology dysfunction; 2. due to the symptom system such as daytime fatigue and weak, feeling of fullness in the head, giddy is disturbed by sleep disorder; 3. only have amount of sleep to reduce and without daytime uncomfortable (short sleep) person be not considered as insomnia.
1.2.2 the Western medicine diagnose standard is diagnosed according to " CCMD-3 Chinese Spirit Obstacles classification and diagnostic criteria " that psychiatric department branch of Chinese Medical Association works out
[6], the accumulative total that meets 7 factor compositions of Pittsburgh index (PSQI) was divided greater than 7 minutes.
1.3 case is included in and exclusion standard
1.3.1 inclusive criteria 1. the age at 41-60 between year; 2. the Western medicine diagnose standard that meets the climacteric sleep disorder; 3. meet traditional Chinese medical science menopausal syndrome heart deficiency of the kidney yin, syndrome of disharmony between heart and kidney diagnostic criteria.
1.3.2 1. the case exclusion standard does not meet the disease diagnostic criteria of primary disease tcm diagnosis and Western medicine diagnose standard person; 2. excision bilateral ovaries or through radiation damage ovarian function person; 3. the age is below 41 years old or more than 60 years old, allergic constitution or to the multi-medicament allergy sufferers; 4. be associated with the patient of severe cardiac, liver, kidney and the diseases such as hemopoietic system, immune system or affect the serious disease of its existence, such as malignant tumor etc.; 5. once took in the recent period similar drugs or gonadal hormone person.
1.3.3 1. coming off of case included rear discovery in and do not meet climacteric insomnia disease and do not included in the person by mistake with rejecting; 2. occur anaphylaxis, aggravation etc. in the observation process, need immediately drug withdrawal person; 3. do not take medicine in accordance with regulations in the observation process, or terminator voluntarily, or on larger calm the nerves tranquilizer or hormone drugs or the health product person of trial drug impact; 4. finish the course for the treatment of of taking medicine, but refusal further consultation (check E
2, FSH) person; 5. surpass 2 courses for the treatment of of further consultation person not medicine time.
1.4 grouping and administration
108 routine patients are divided into matched group (estazolam group) 54 examples, observation group's (the Fructus Ligustri Lucidi side of calming the nerves group) 54 examples at random 1.4.1 divide into groups; All cases is diagnosed as this patient for Western medicine diagnose standard and the diagnostic criteria of traditional Chinese medical science disease according to climacteric insomnia disease; Harmony to two groups of patients' Baseline Data before the treatment is carried out χ
2Check, P＞0.05 has comparability.
1.4.2 medication observation group gives the treatment of the Fructus Ligustri Lucidi side of calming the nerves, square medicine forms: Fructus Ligustri Lucidi 30g, Herba Ecliptae 15g, Radix Astragali 30g, Radix Pseudostellariae 15g, Rhizoma Atractylodis Macrocephalae (parched) 15g, Radix Angelicae Sinensis 20g, Concha Ostreae 30g (being decocted first), Semen Ziziphi Spinosae 30g, Radix Paeoniae Alba 20g, Radix Polygalae 12g, Radix Salviae Miltiorrhizae 20g, Radix Aucklandiae 6G.The decoction method: upper square toes are fried in shallow oil and are added water 500ml, (Concha Ostreae is decocted first).Soak 30min, intense fire is boiled, and is at a simmer to 200ml, and two fry in shallow oil and add water 350ml, and slow fire takes 200ml, two fry in shallow oil mutually and, before sleeping in lunch break and night, service once.14d was 1 course for the treatment of, serve on post-evaluation 2 courses for the treatment of curative effect.
Matched group gives SHULE ANDING PIAN (Shanghai and one-tenth pharmaceutical factory; Lot number: 990601) treatment, each 2mg, the front 30min that sleeps every night is oral, serve on 28.All withdraw other Western medicine sleeping pill and hormone medicine and health product for two groups during the treatment.
1.5 observation index
1.5.1 curative effect judging standard carries out efficacy evaluation [7] according to " new Chinese medicine guideline of clinical investigations ".Clinical recovery: recover normal the length of one's sleep, or Nighttime sleep is more than 6h, sleep is dull, and is hale and hearty after waking up; Produce effects: sleep is clearly better, and increases the length of one's sleep more than the 3h, and Depth of sleep increases; Effectively: sx↓, the not enough 3h of the front increase length of one's sleep; Invalid: insomnia is without obviously improving or increasing the weight of after the treatment.Calculate total effective rate, computing formula: total effective rate=(cure+effectively+stable) routine number/total routine number * 100%.
The sleep quality after 1.5.2 Pittsburgh index (PSQI) is treated with the form observation of questionnaire.Wherein the 19th self-appraisal clauses and subclauses and 5 he comment clauses and subclauses not participate in score, front 18 self-appraisal clauses and subclauses are pressed sleep quality, time for falling asleep, the length of one's sleep, Sleep efficiency, sleep disorder, hypnotic drug, 7 compositions of daytime function obstacle composition, each composition is by the score of 0～3 grade, accumulate each composition score and add up to the PSQI total mark, the total points scope is 0～2], score is higher, and the expression sleep quality is poorer.The subjects finishes questionnaire to be needed about 10min.
1.5.3 serum FSH and E
2The level determination radio immunoassay is measured two groups for the treatment of front and back serum follicule-stimulating hormone (FSH) (FSH) and estradiol (E
2) level.Reagent adopts the Beijing North biotechnology research to provide; Full-automatic two probe radioimmunity Y calculating instrument carries out (Shanghai nuclear spoke photoelectric instrument company's day ring factory produces the SN-697B type).
1.6 the statistical procedures experimental data is processed with SPSS 13.0 statistical analysis softwares.Measurement data with
The t check is adopted in expression; The relatively employing χ of rate
2Check.Significance level is got α=0.05.
2. result
2.1 physical data reclaims 98 routine clinical cases altogether, observation group's 50 examples wherein, matched group 48 examples; Matched group is the oldest to be 58 years old, and minimum is 42 years old, and the mean age is 48.32 ± 3.56, and the course of disease is the longest to be 2 years, and the shortest is 2 months, and average course of disease is 10.74 ± 5.95 months; Observation group is the oldest to be 60 years old, and minimum is 42 years old, and the mean age is 47.95 ± 4.57, and the course of disease is the longest to be 3 years, and the shortest is 1 month, and average course of disease is 11.24 ± 7.13 months.
2.2 mistake visit rate is controlled this research and received altogether 98 parts of case report form, always losing visit rate case is 10 parts, and losing the visit rate is 9.26%.Observation group reclaims 50 examples, and 4 examples are lost and visited; Matched group reclaims 48 examples, and 6 examples are lost and visited.Lose visit rate＜15%, control is good.
2.3 curative effect relatively according to curative effect judging standard, is calculated total effective rate, observation group obviously increases than matched group, has significant difference (P＜0.05).See Table 1.
The Clinical efficacy comparison (%) of sleep improvement behind the table 1 liang group patient treatment
| Group | The example number | Cure | Produce effects | Effectively | Invalid | Total effective rate |
| Matched group | 48 | 6/48 | 10/48 | 15/48 | 17/48 | 64.58％ |
| Observation group | 50 | 9/50 | 21/50 | 16/50 | 5/50 | 90.00％# |
Annotate: compare with matched group,
#P＜0.05.
2.4 the PQSI score value all significantly reduced (P＜0.01) before the treatment after the PQSI score value changed two groups of patient treatments before and after the treatment; The PQSI of observation group score value has extremely significantly reduction (P＜0.01) than matched group.See Table 2.
The PQSI score value changes relatively before and after the table 2 liang group patient treatment
| Group | Example number (n) | Before the treatment (dividing) | After the treatment (dividing) |
| Matched group | 48 | 17.75±3.14 | 11.42±3.56^^ |
| Observation group | 50 | 18.12±3.58 | 8.13±2.77^^ ## |
Annotate: relatively front with treatment, ^^P＜0.01; Compare with matched group,
##P＜0.01.
2.5 the serum FSH level was treated front remarkable reduction (P＜0.01) after the serum FSH level changed observation group's patient treatment before and after the treatment; The FSH of observation group level has extremely significantly reduction (P＜0.01) than matched group.See Table 3.
The serum FSH level changes relatively before and after the table 3 liang group patient treatment
| Group | Example number (n) | Before the treatment (IU/L) | After the treatment (IU/L) |
| Matched group | 48 | 71.32±15.21 | 65.40±11.05 |
| Observation group | 50 | 72.14±15.94 | 46.52±12.47^^ ## |
Annotate: relatively front with treatment, ^^P＜0.01; Compare with matched group,
##P＜0.01.
2.6 serum E before and after the treatment
2Level changes serum E behind two groups of patient treatments
2Level all significantly increases (P＜0.01, P＜0.05) before the treatment; The E of observation group
2Level has extremely significantly than matched group and increases (P＜0.01).See Table 4.
Serum E before and after the table 4 liang group patient treatment
2Level changes relatively
| Group | Example number (n) | Before the treatment (ng/L) | After the treatment (ng/L) |
| Matched group | 48 | 24.65±10.14 | 33.21±10.45^ |
| Observation group | 50 | 25.42±10.36 | 49.57±12.85^^ ## |
Annotate: relatively front with treatment, ^^P＜0.01, ^P＜0.05; Compare with matched group,
##P＜0.01.
The above; it only is best mode for carrying out the invention; compound recipe of the present invention can be made into other dosage forms such as pill, tablet etc.; anyly be familiar with those skilled in the art in the technical scope that the present invention discloses, the simple change of the technical scheme that can obtain apparently or equivalence are replaced and are all fallen within the scope of protection of the present invention.
Claims (1)
1. a Chinese medicine compound for the treatment of the Women’s climacteric insomnia is characterized in that, comprises following constituent: Fructus Ligustri Lucidi 30g, Herba Ecliptae 15g, Radix Astragali 30g, Radix Pseudostellariae 15g, Rhizoma Atractylodis Macrocephalae (parched) 15g, Radix Angelicae Sinensis 20g, Concha Ostreae 30g, Semen Ziziphi Spinosae 30g, Radix Paeoniae Alba 20g, Radix Polygalae 12g, Radix Salviae Miltiorrhizae 20g, Radix Aucklandiae 6g.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104645005A (en) * | 2015-03-13 | 2015-05-27 | 青岛云天生物技术有限公司 | Traditional Chinese medicine composition for treating menopausal somnipathy and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1358508A (en) * | 2000-12-12 | 2002-07-17 | 陈宝贵 | Capsule for tonifying kidney and tranquilization |
| CN102357177A (en) * | 2011-10-18 | 2012-02-22 | 文登市口腔医院 | Traditional Chinese medicine for curing climacteric metancholia |
| CN102406838A (en) * | 2011-12-06 | 2012-04-11 | 赵英霖 | Traditional Chinese medicine for treating menopausal syndrome |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1358508A (en) * | 2000-12-12 | 2002-07-17 | 陈宝贵 | Capsule for tonifying kidney and tranquilization |
| CN102357177A (en) * | 2011-10-18 | 2012-02-22 | 文登市口腔医院 | Traditional Chinese medicine for curing climacteric metancholia |
| CN102406838A (en) * | 2011-12-06 | 2012-04-11 | 赵英霖 | Traditional Chinese medicine for treating menopausal syndrome |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104645005A (en) * | 2015-03-13 | 2015-05-27 | 青岛云天生物技术有限公司 | Traditional Chinese medicine composition for treating menopausal somnipathy and preparation method thereof |
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