莪附顆粒治療子宮內(nèi)膜異位癥痛經(jīng)（寒凝血瘀證）的臨床療效觀察
發(fā)布時(shí)間：2018-07-31 06:12
【摘要】：研究背景:近年來,子宮內(nèi)膜異位癥(Endometriosis)發(fā)病率逐年上升,并且日益成為育齡期婦女的常見病。子宮內(nèi)膜異位癥是指子宮內(nèi)膜組織(腺體和間質(zhì))出現(xiàn)在子宮體以外的部位。子宮內(nèi)膜異位癥具有性激素依賴的特點(diǎn),多發(fā)生于育齡期女性,其主要癥狀為盆腔的疼痛,內(nèi)異灶侵犯特殊器官伴隨的癥狀,不孕,盆腔結(jié)節(jié)及包塊等。其發(fā)病具有病變類型多樣且廣泛,病灶具有侵襲性并且治療后易復(fù)發(fā)的特點(diǎn)。子宮內(nèi)膜異位癥以盆腔疼痛癥狀最為多見,主要包括繼發(fā)性痛經(jīng),進(jìn)行性加重,慢性盆腔痛,性交痛,肛門墜痛等。大部分子宮內(nèi)膜異位癥患者因痛經(jīng)癥狀嚴(yán)重導(dǎo)致生活質(zhì)量下降,而目前對(duì)子宮內(nèi)膜異位癥所引起的痛經(jīng)尚無規(guī)律性及療效較好的藥物治療,當(dāng)前的藥物治療均存在某些方面的不良反應(yīng),故本研究具有臨床研究?jī)r(jià)值,可望為子宮內(nèi)膜異位癥痛經(jīng)患者痛經(jīng)的緩解提供更好的藥物。中醫(yī)中無"子宮內(nèi)膜異位癥"的病名,根據(jù)其臨床表現(xiàn),可見于"痛經(jīng)","ve瘕","月經(jīng)不調(diào)","不孕"等疾病中。中醫(yī)認(rèn)為其發(fā)病機(jī)制主要為"瘀血阻滯沖任胞宮",而瘀血作為一種病理產(chǎn)物,可由多種病因?qū)е�。�?dǎo)師王樹林教授長(zhǎng)期的臨床經(jīng)驗(yàn)總結(jié),發(fā)現(xiàn)子宮內(nèi)膜異位癥痛經(jīng)患者中以寒凝血瘀證較為多見。治療多以溫經(jīng)散寒,活血止痛為主,臨證常應(yīng)用大黃附子湯合琥珀散合方加減進(jìn)行治療,療效顯著。研究目的:本研究旨在通過臨床觀察的方法,應(yīng)用莪附顆粒(方劑組成:三棱10g,莪術(shù)10g,肉桂5g,細(xì)辛3g,大黃6g,附子9g,北劉寄奴20g,鱉甲10g)對(duì)子宮內(nèi)膜異位癥痛經(jīng)寒凝血瘀證進(jìn)行治療,可望收到較好的臨床療效,為子宮內(nèi)膜異位癥痛經(jīng)患者提供更好的緩解癥狀及治療疾病的效果。研究方法:本研究采用隨機(jī)對(duì)照的研究方法,對(duì)60例子宮內(nèi)膜異位癥痛經(jīng)寒凝血瘀證患者進(jìn)行臨床觀察,將患者隨機(jī)分為治療組與對(duì)照組,其中治療組服用莪附顆粒(選用北京中醫(yī)藥大學(xué)東方醫(yī)院顆粒藥房生產(chǎn)的顆粒,每日兩次口服,早晚各一次,一次一袋,飯后服),對(duì)照組服用桂枝茯苓膠囊(選用江蘇康緣桂枝茯苓膠囊,每日兩次口服,每次五粒,飯后服),兩組患者均連續(xù)服藥三個(gè)月經(jīng)周期,自月經(jīng)周期第一天起開始服藥,經(jīng)期可服藥,如經(jīng)量明顯增多則經(jīng)期停藥。并于每個(gè)月經(jīng)周期后對(duì)患者疼痛總發(fā)作時(shí)間,疼痛平均嚴(yán)重程度,痛經(jīng)的嚴(yán)重程度,中醫(yī)證候的評(píng)分進(jìn)行評(píng)估,且于連續(xù)治療前后檢查血清CA125水平及婦科B超,以幫助評(píng)估病情。治療周期結(jié)束后收集臨床治療數(shù)據(jù),應(yīng)用SPSS 21.0對(duì)數(shù)據(jù)進(jìn)行統(tǒng)計(jì)分析,得出結(jié)論。研究結(jié)果:完成課題合格的受試者共57例,治療組29例,對(duì)照組28例,治療前兩組患者年齡,病程,病史,婚育情況,疼痛總發(fā)作時(shí)間COX評(píng)分,疼痛平均嚴(yán)重程度COX評(píng)分,痛經(jīng)嚴(yán)重程度VAS評(píng)分及中醫(yī)證候評(píng)分,血清CA125水平,婦科B超巧克力囊腫大小均無統(tǒng)計(jì)學(xué)差異(P0.05),具有可比性。經(jīng)治療三個(gè)月經(jīng)周期后疼痛總發(fā)作時(shí)間COX評(píng)分:經(jīng)治療三個(gè)月經(jīng)周期后,痛經(jīng)各癥狀中小腹痛,惡心,食欲不振,抑郁,易激惹,神經(jīng)質(zhì)六個(gè)癥狀方面,治療組治療效果優(yōu)于對(duì)照組,P均0.05,具有統(tǒng)計(jì)學(xué)差異。疼痛平均嚴(yán)重程度COX評(píng)分:經(jīng)治療三個(gè)月經(jīng)周期后,治療組與對(duì)照組疼痛平均嚴(yán)重程度均較治療前癥狀明顯好轉(zhuǎn),于第一個(gè)月經(jīng)周期結(jié)束后治療組與對(duì)照組在改善痛經(jīng)癥狀嚴(yán)重程度上無明顯差異,P0.05,無統(tǒng)計(jì)學(xué)差異;于第二個(gè)月經(jīng)周期結(jié)束后,治療組與對(duì)照組在改善疼痛平均嚴(yán)重程度上顯現(xiàn)出差異,P0.05,且具有統(tǒng)計(jì)學(xué)意義,治療三個(gè)月經(jīng)周期后,治療組在改善疼痛平均嚴(yán)重程度上明顯優(yōu)于對(duì)照組,P0.05,具有統(tǒng)計(jì)學(xué)意義。痛經(jīng)嚴(yán)重程度VAS評(píng)分:治療組在改善痛經(jīng)嚴(yán)重程度VAS評(píng)分方面,治愈7例,顯效12例,有效6例,無效4例,治愈率24.13%,顯效率41.38%,有效率20.69%,無效率13.79%,總有效率86.21%;對(duì)照組在改善痛經(jīng)嚴(yán)重程度VAS評(píng)分方面,治愈3例,顯效7例,有效12例,無效6例,治愈率10.71%,顯效率25%,有效率42.86%,無效率21.43%,總有效率78.57%。治療組與對(duì)照組療效評(píng)價(jià),P0.05,治療組在對(duì)痛經(jīng)嚴(yán)重程度VAS評(píng)分療效方面優(yōu)于對(duì)照組,具有統(tǒng)計(jì)學(xué)差異。中醫(yī)證候評(píng)分:在中醫(yī)證候改善方面,治療組無治愈患者,顯效5例,有效21例,無效3例,顯效率17.24%,有效率72.41%,無效率10.34%,總有效率89.66%。對(duì)照組無治愈及顯效患者,有效22例,無效6例,有效率78.57%,無效率21.43%,總有效率78.57%。治療組與對(duì)照組在中醫(yī)證候方面的療效,治療組優(yōu)于對(duì)照組,P0.05,具有統(tǒng)計(jì)學(xué)意義。婦科B超:經(jīng)治療后治療組與對(duì)照組在縮小卵巢巧克力囊腫大小方面均有治療效果,治療組與對(duì)照組P均0.05,具有統(tǒng)計(jì)學(xué)差異。但是治療后治療組與對(duì)照組在縮小卵巢巧克力囊腫大小方面無明顯差異,P0.05,無統(tǒng)計(jì)學(xué)差異。CA125:經(jīng)治療后治療組與對(duì)照組在降低血清CA125方面無明顯療效。安全性:此藥物用藥期間未出現(xiàn)明顯不良反應(yīng),藥物安全。研究結(jié)論:莪附顆粒在對(duì)子宮內(nèi)膜異位癥痛經(jīng)(寒凝血瘀證)治療過程中,具有減少疼痛發(fā)作時(shí)間,減輕疼痛平均嚴(yán)重程度,及緩解痛經(jīng)嚴(yán)重程度的作用,并且具有縮小卵巢巧克力囊腫大小的作用。并在臨床療效觀察中COX評(píng)分中惡心,食欲不振及其情緒相關(guān)指標(biāo)總發(fā)作時(shí)間明顯下降,提示此藥物在緩解痛經(jīng)癥狀的同時(shí),也緩解因痛經(jīng)造成的患者的惡心,食欲不振,抑郁,易激惹,神經(jīng)質(zhì)等問題,可間接提高患者生活質(zhì)量。此藥物療效穩(wěn)定,無副作用及不良反應(yīng),值得進(jìn)一步研究及探索。
[Abstract]:Background: in recent years, the incidence of endometriosis (Endometriosis) has risen year by year, and is increasingly becoming a common disease in women of childbearing age. Endometriosis refers to the appearance of endometriosis (glands and stroma) outside the uterus. Endometriosis is characterized by sexual hormone dependence, mostly in women of childbearing age. The main symptoms are the pain of pelvic cavity, the symptoms of special organs, infertility, pelvic nodules and masses. The disease is characterized by diverse and extensive pathological types, and the lesions are invasive and easy to relapse after treatment. Endometriosis is most common in pelvic pain and pain, mainly including secondary dysmenorrhea. Most of the patients with endometriosis have decreased the quality of life due to severe dysmenorrhea, but there is no regular and effective drug treatment for endometriosis, and there are some adverse reactions in the current drug treatment. The study is of clinical value. It is expected to provide better medicine for the relief of dysmenorrhea in patients with endometriosis. There is no "endometriosis" in traditional Chinese medicine. According to its clinical manifestations, it is seen in diseases such as "dysmenorrhea", "ve", "irregular menstruation," and "infertility". "Palace", and blood stasis as a pathological product, can be caused by a variety of causes. Professor Wang Shulin's long-term clinical experience summed up, found that endometriosis of dysmenorrhea patients with cold blood stasis syndrome more common. The purpose of this study is to use the method of clinical observation. The purpose of this study is to apply zedoary granules (composed of zedoary 10g, zedoary zedoary 10g, cinnamon 5g, asarum 3G, rhubarb 6G, Radix Aconiti 9g, North Liu slave 20g, turtle 10g) to treat endometriosis with dysmenorrhea and blood stasis syndrome, which can be expected to receive better clinical curative effect and be endometriosis. Patients with dysmenorrhea provide better relief of symptoms and treatment of disease. Methods: a randomized controlled study was used to observe 60 cases of endometriosis with dysmenorrhea and blood stasis syndrome. The patients were randomly divided into the treatment group and the control group. The treatment group took zedoi granules (Beijing University of Chinese Medicine). The granules produced in the granule pharmacy of the oriental hospital were taken orally two times a day, once in the morning and evening, one bag and after meals. The control group took the capsule of Guizhi Fuling (with Jiangsu Kang Guizhi Fuling Capsule, two times a day, five tablets each time, after meals), and the two groups were continued to take medicine for three menstrual cycles, starting from the first day of the menstrual cycle. During the menstrual period, the drug can be taken, such as the menstrual period, the duration of the pain, the severity of pain, the severity of the pain, the severity of the dysmenorrhea, the score of the TCM syndrome, and the examination of the serum CA125 level and the gynecologic B ultrasound before and after the continuous treatment to help assess the condition. The data of clinical treatment were collected and SPSS 21 was used to make a statistical analysis of the data, and the results were concluded. The results were as follows: 57 cases of qualified subjects were completed, 29 cases in the treatment group and 28 cases in the control group. The age of the two groups, the course of disease, the history of the disease, the situation of marriage and childbirth, the COX score of the total pain time, the average severity of pain COX score, and the severity of dysmenorrhea V AS score, TCM syndrome score, serum CA125 level, and the size of the gynecologic B-ultrasound chocolate cyst have no statistical difference (P0.05). The total time of pain is COX score after treatment of three menstrual cycles: after treatment of three menstrual cycles, there are six symptoms of small abdominal pain, nausea, anorexia, depression, irritability, and neuroticism in the symptoms of dysmenorrhea after treatment. In the treatment group, the therapeutic effect of the treatment group was better than the control group, P was 0.05, with statistical difference. The average severity of pain was COX score: after the treatment of three menstrual cycles, the average severity of pain in the treatment group and the control group improved obviously, and the treatment group and the control group improved dysmenorrhea after the first period of the first period. There was no significant difference in severity, no significant difference in P0.05. After the end of second menstrual cycles, the treatment group and the control group showed a difference in the average severity of pain, P0.05, and had statistical significance. After the treatment of three menstrual cycles, the treatment group was significantly better than the control group in the average severity of the pain improvement, P0.05, with the control group. Statistical significance. VAS score of severity of dysmenorrhea: in the treatment group, 7 cases were cured, 12 cases were cured, 6 cases were effective, 6 cases were effective and 4 cases were invalid, the cure rate was 24.13%, the effective rate was 41.38%, the effective rate was 20.69%, the inefficiency was 13.79%, the total effective rate was 86.21%, 3 cases were cured and 7 were cured in the control group in improving the VAS score of dysmenorrhea severity. 3 cases were cured and 7 markedly effective. 12 cases were effective, 6 cases were invalid, the cure rate was 10.71%, the effective rate was 25%, the effective rate was 42.86%, the inefficiency was 21.43%, the total effective rate of the 78.57%. treatment group and the control group was evaluated, P0.05, the treatment group was superior to the control group in the VAS score of the severity of dysmenorrhea, with statistical difference. 5 cases were cured, 21 cases were effective, 3 cases were invalid, the effective rate was 17.24%, the effective rate was 72.41%, and the inefficiency was 10.34%. The total effective rate of 89.66%. control group was no cure and effective patients, 22 cases were effective, 6 cases were invalid, the effective rate was 78.57%, no efficiency 21.43%, the total effective rate of the treatment group and the control group in TCM syndrome, the treatment group was superior to the control group. P0.05, with statistical significance. Gynecologic B ultrasound: after treatment, the treatment group and the control group have a therapeutic effect on reducing the size of ovarian chocolate cyst. The treatment group and the control group P are 0.05, with statistical difference. However, there is no significant difference between the treatment group and the control group in reducing the size of the ovarian chocolate cyst, P0.05, no statistical difference. The difference.CA125: treatment group and the control group had no obvious effect on reducing the serum CA125. Safety: there was no obvious adverse reaction and drug safety during the drug use. Conclusion: zedoi granules can reduce the pain attack time and relieve the pain during the treatment of Endometriosis Dysmenorrhea (cold coagulation and stasis syndrome) in the course of treatment. The effect of the severity of the dysmenorrhea, and the effect of reducing the severity of the dysmenorrhea, and the effect of reducing the size of the ovarian chocolate cysts. In the clinical observation, the COX score was nausea, anorexia and its emotional related indexes decreased significantly, suggesting that the drug could relieve the symptoms of pain and relieve the patients caused by dysmenorrhea. Nausea, loss of appetite, depression, irritability, neuroticism and other problems, can indirectly improve the quality of life of the patient. The drug has a stable effect, no side effects and adverse reactions. It is worth further research and exploration.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R271.113
本文編號(hào)：2154678
[Abstract]:Background: in recent years, the incidence of endometriosis (Endometriosis) has risen year by year, and is increasingly becoming a common disease in women of childbearing age. Endometriosis refers to the appearance of endometriosis (glands and stroma) outside the uterus. Endometriosis is characterized by sexual hormone dependence, mostly in women of childbearing age. The main symptoms are the pain of pelvic cavity, the symptoms of special organs, infertility, pelvic nodules and masses. The disease is characterized by diverse and extensive pathological types, and the lesions are invasive and easy to relapse after treatment. Endometriosis is most common in pelvic pain and pain, mainly including secondary dysmenorrhea. Most of the patients with endometriosis have decreased the quality of life due to severe dysmenorrhea, but there is no regular and effective drug treatment for endometriosis, and there are some adverse reactions in the current drug treatment. The study is of clinical value. It is expected to provide better medicine for the relief of dysmenorrhea in patients with endometriosis. There is no "endometriosis" in traditional Chinese medicine. According to its clinical manifestations, it is seen in diseases such as "dysmenorrhea", "ve", "irregular menstruation," and "infertility". "Palace", and blood stasis as a pathological product, can be caused by a variety of causes. Professor Wang Shulin's long-term clinical experience summed up, found that endometriosis of dysmenorrhea patients with cold blood stasis syndrome more common. The purpose of this study is to use the method of clinical observation. The purpose of this study is to apply zedoary granules (composed of zedoary 10g, zedoary zedoary 10g, cinnamon 5g, asarum 3G, rhubarb 6G, Radix Aconiti 9g, North Liu slave 20g, turtle 10g) to treat endometriosis with dysmenorrhea and blood stasis syndrome, which can be expected to receive better clinical curative effect and be endometriosis. Patients with dysmenorrhea provide better relief of symptoms and treatment of disease. Methods: a randomized controlled study was used to observe 60 cases of endometriosis with dysmenorrhea and blood stasis syndrome. The patients were randomly divided into the treatment group and the control group. The treatment group took zedoi granules (Beijing University of Chinese Medicine). The granules produced in the granule pharmacy of the oriental hospital were taken orally two times a day, once in the morning and evening, one bag and after meals. The control group took the capsule of Guizhi Fuling (with Jiangsu Kang Guizhi Fuling Capsule, two times a day, five tablets each time, after meals), and the two groups were continued to take medicine for three menstrual cycles, starting from the first day of the menstrual cycle. During the menstrual period, the drug can be taken, such as the menstrual period, the duration of the pain, the severity of pain, the severity of the pain, the severity of the dysmenorrhea, the score of the TCM syndrome, and the examination of the serum CA125 level and the gynecologic B ultrasound before and after the continuous treatment to help assess the condition. The data of clinical treatment were collected and SPSS 21 was used to make a statistical analysis of the data, and the results were concluded. The results were as follows: 57 cases of qualified subjects were completed, 29 cases in the treatment group and 28 cases in the control group. The age of the two groups, the course of disease, the history of the disease, the situation of marriage and childbirth, the COX score of the total pain time, the average severity of pain COX score, and the severity of dysmenorrhea V AS score, TCM syndrome score, serum CA125 level, and the size of the gynecologic B-ultrasound chocolate cyst have no statistical difference (P0.05). The total time of pain is COX score after treatment of three menstrual cycles: after treatment of three menstrual cycles, there are six symptoms of small abdominal pain, nausea, anorexia, depression, irritability, and neuroticism in the symptoms of dysmenorrhea after treatment. In the treatment group, the therapeutic effect of the treatment group was better than the control group, P was 0.05, with statistical difference. The average severity of pain was COX score: after the treatment of three menstrual cycles, the average severity of pain in the treatment group and the control group improved obviously, and the treatment group and the control group improved dysmenorrhea after the first period of the first period. There was no significant difference in severity, no significant difference in P0.05. After the end of second menstrual cycles, the treatment group and the control group showed a difference in the average severity of pain, P0.05, and had statistical significance. After the treatment of three menstrual cycles, the treatment group was significantly better than the control group in the average severity of the pain improvement, P0.05, with the control group. Statistical significance. VAS score of severity of dysmenorrhea: in the treatment group, 7 cases were cured, 12 cases were cured, 6 cases were effective, 6 cases were effective and 4 cases were invalid, the cure rate was 24.13%, the effective rate was 41.38%, the effective rate was 20.69%, the inefficiency was 13.79%, the total effective rate was 86.21%, 3 cases were cured and 7 were cured in the control group in improving the VAS score of dysmenorrhea severity. 3 cases were cured and 7 markedly effective. 12 cases were effective, 6 cases were invalid, the cure rate was 10.71%, the effective rate was 25%, the effective rate was 42.86%, the inefficiency was 21.43%, the total effective rate of the 78.57%. treatment group and the control group was evaluated, P0.05, the treatment group was superior to the control group in the VAS score of the severity of dysmenorrhea, with statistical difference. 5 cases were cured, 21 cases were effective, 3 cases were invalid, the effective rate was 17.24%, the effective rate was 72.41%, and the inefficiency was 10.34%. The total effective rate of 89.66%. control group was no cure and effective patients, 22 cases were effective, 6 cases were invalid, the effective rate was 78.57%, no efficiency 21.43%, the total effective rate of the treatment group and the control group in TCM syndrome, the treatment group was superior to the control group. P0.05, with statistical significance. Gynecologic B ultrasound: after treatment, the treatment group and the control group have a therapeutic effect on reducing the size of ovarian chocolate cyst. The treatment group and the control group P are 0.05, with statistical difference. However, there is no significant difference between the treatment group and the control group in reducing the size of the ovarian chocolate cyst, P0.05, no statistical difference. The difference.CA125: treatment group and the control group had no obvious effect on reducing the serum CA125. Safety: there was no obvious adverse reaction and drug safety during the drug use. Conclusion: zedoi granules can reduce the pain attack time and relieve the pain during the treatment of Endometriosis Dysmenorrhea (cold coagulation and stasis syndrome) in the course of treatment. The effect of the severity of the dysmenorrhea, and the effect of reducing the severity of the dysmenorrhea, and the effect of reducing the size of the ovarian chocolate cysts. In the clinical observation, the COX score was nausea, anorexia and its emotional related indexes decreased significantly, suggesting that the drug could relieve the symptoms of pain and relieve the patients caused by dysmenorrhea. Nausea, loss of appetite, depression, irritability, neuroticism and other problems, can indirectly improve the quality of life of the patient. The drug has a stable effect, no side effects and adverse reactions. It is worth further research and exploration.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R271.113
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