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莪附颗粒治疗子宫内膜异位症痛经(寒凝血瘀证)的临床疗效观察

发布时间:2018-07-31 06:12
【摘要】:研究背景:近年来,子宫内膜异位症(Endometriosis)发病率逐年上升,并且日益成为育龄期妇女的常见病。子宫内膜异位症是指子宫内膜组织(腺体和间质)出现在子宫体以外的部位。子宫内膜异位症具有性激素依赖的特点,多发生于育龄期女性,其主要症状为盆腔的疼痛,内异灶侵犯特殊器官伴随的症状,不孕,盆腔结节及包块等。其发病具有病变类型多样且广泛,病灶具有侵袭性并且治疗后易复发的特点。子宫内膜异位症以盆腔疼痛症状最为多见,主要包括继发性痛经,进行性加重,慢性盆腔痛,性交痛,肛门坠痛等。大部分子宫内膜异位症患者因痛经症状严重导致生活质量下降,而目前对子宫内膜异位症所引起的痛经尚无规律性及疗效较好的药物治疗,当前的药物治疗均存在某些方面的不良反应,故本研究具有临床研究价值,可望为子宫内膜异位症痛经患者痛经的缓解提供更好的药物。中医中无"子宫内膜异位症"的病名,根据其临床表现,可见于"痛经","ve瘕","月经不调","不孕"等疾病中。中医认为其发病机制主要为"瘀血阻滞冲任胞宫",而瘀血作为一种病理产物,可由多种病因导致。导师王树林教授长期的临床经验总结,发现子宫内膜异位症痛经患者中以寒凝血瘀证较为多见。治疗多以温经散寒,活血止痛为主,临证常应用大黄附子汤合琥珀散合方加减进行治疗,疗效显著。研究目的:本研究旨在通过临床观察的方法,应用莪附颗粒(方剂组成:三棱10g,莪术10g,肉桂5g,细辛3g,大黄6g,附子9g,北刘寄奴20g,鳖甲10g)对子宫内膜异位症痛经寒凝血瘀证进行治疗,可望收到较好的临床疗效,为子宫内膜异位症痛经患者提供更好的缓解症状及治疗疾病的效果。研究方法:本研究采用随机对照的研究方法,对60例子宫内膜异位症痛经寒凝血瘀证患者进行临床观察,将患者随机分为治疗组与对照组,其中治疗组服用莪附颗粒(选用北京中医药大学东方医院颗粒药房生产的颗粒,每日两次口服,早晚各一次,一次一袋,饭后服),对照组服用桂枝茯苓胶囊(选用江苏康缘桂枝茯苓胶囊,每日两次口服,每次五粒,饭后服),两组患者均连续服药三个月经周期,自月经周期第一天起开始服药,经期可服药,如经量明显增多则经期停药。并于每个月经周期后对患者疼痛总发作时间,疼痛平均严重程度,痛经的严重程度,中医证候的评分进行评估,且于连续治疗前后检查血清CA125水平及妇科B超,以帮助评估病情。治疗周期结束后收集临床治疗数据,应用SPSS 21.0对数据进行统计分析,得出结论。研究结果:完成课题合格的受试者共57例,治疗组29例,对照组28例,治疗前两组患者年龄,病程,病史,婚育情况,疼痛总发作时间COX评分,疼痛平均严重程度COX评分,痛经严重程度VAS评分及中医证候评分,血清CA125水平,妇科B超巧克力囊肿大小均无统计学差异(P0.05),具有可比性。经治疗三个月经周期后疼痛总发作时间COX评分:经治疗三个月经周期后,痛经各症状中小腹痛,恶心,食欲不振,抑郁,易激惹,神经质六个症状方面,治疗组治疗效果优于对照组,P均0.05,具有统计学差异。疼痛平均严重程度COX评分:经治疗三个月经周期后,治疗组与对照组疼痛平均严重程度均较治疗前症状明显好转,于第一个月经周期结束后治疗组与对照组在改善痛经症状严重程度上无明显差异,P0.05,无统计学差异;于第二个月经周期结束后,治疗组与对照组在改善疼痛平均严重程度上显现出差异,P0.05,且具有统计学意义,治疗三个月经周期后,治疗组在改善疼痛平均严重程度上明显优于对照组,P0.05,具有统计学意义。痛经严重程度VAS评分:治疗组在改善痛经严重程度VAS评分方面,治愈7例,显效12例,有效6例,无效4例,治愈率24.13%,显效率41.38%,有效率20.69%,无效率13.79%,总有效率86.21%;对照组在改善痛经严重程度VAS评分方面,治愈3例,显效7例,有效12例,无效6例,治愈率10.71%,显效率25%,有效率42.86%,无效率21.43%,总有效率78.57%。治疗组与对照组疗效评价,P0.05,治疗组在对痛经严重程度VAS评分疗效方面优于对照组,具有统计学差异。中医证候评分:在中医证候改善方面,治疗组无治愈患者,显效5例,有效21例,无效3例,显效率17.24%,有效率72.41%,无效率10.34%,总有效率89.66%。对照组无治愈及显效患者,有效22例,无效6例,有效率78.57%,无效率21.43%,总有效率78.57%。治疗组与对照组在中医证候方面的疗效,治疗组优于对照组,P0.05,具有统计学意义。妇科B超:经治疗后治疗组与对照组在缩小卵巢巧克力囊肿大小方面均有治疗效果,治疗组与对照组P均0.05,具有统计学差异。但是治疗后治疗组与对照组在缩小卵巢巧克力囊肿大小方面无明显差异,P0.05,无统计学差异。CA125:经治疗后治疗组与对照组在降低血清CA125方面无明显疗效。安全性:此药物用药期间未出现明显不良反应,药物安全。研究结论:莪附颗粒在对子宫内膜异位症痛经(寒凝血瘀证)治疗过程中,具有减少疼痛发作时间,减轻疼痛平均严重程度,及缓解痛经严重程度的作用,并且具有缩小卵巢巧克力囊肿大小的作用。并在临床疗效观察中COX评分中恶心,食欲不振及其情绪相关指标总发作时间明显下降,提示此药物在缓解痛经症状的同时,也缓解因痛经造成的患者的恶心,食欲不振,抑郁,易激惹,神经质等问题,可间接提高患者生活质量。此药物疗效稳定,无副作用及不良反应,值得进一步研究及探索。
[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.
【学位授予单位】:北京中医药大学
【学位级别】:硕士
【学位授予年份】:2017
【分类号】:R271.113

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