论文标题:宫瘤消颗粒治疗气滞血瘀证子宫肌瘤的临床观察
Clinical Study of GanKang Ⅱ on Hepatic Fibrosis in Chronic Hepatitis B
论文作者 范妮娜
论文导师 周忠明,论文学位 硕士,论文专业 中医妇科学
论文单位 湖北中医学院,点击次数 268,论文页数 34页File Size1527k
2005-04-01论文网 http://www.lw23.com/lunwen_29624602/ 子宫肌瘤/中医药疗法;气滞血瘀证;临床研究;@宫瘤消颗粒
myoma of uterus/Chinese medcine therapy;Blood stasis due to Qi stugnancy;Clinical investigation;@ Gongliuxiao Granule
1.研究课题:宫瘤消颗粒治疗气滞血瘀证子宫肌瘤的临床观察 2.研究目的、研究设计、观察指针、诊断标准 (1)研究目的:采用不同剂量的宫瘤消颗粒治疗气滞血瘀证子宫肌瘤,对宫瘤消颗粒不同剂量的临床疗效及安全性进行评价,为宫瘤消的临床应用提供科学依据。 (2)研究设计:选用72例门诊及病房诊断为气滞血瘀证子宫肌瘤的患者,随机分为宫瘤消高剂量治疗组、低剂量治疗组、桂枝茯苓胶囊对照组,各组均为24例。实际完成有效病例为高剂量治疗组23例、低剂量治疗组22例、桂枝茯苓胶囊对照组23例。采用随机双盲双模拟对照方法,观察治疗前后三组患者的瘤体大小的变化,中医气滞血瘀证证候的变化及月经经期、量、色、质的变化,比较研究其疗效及安全性。 (3)观察指针:以子宫肌瘤瘤体的大小为主要疗效观察指针,同时选取月经的经期、量、色、质改变以及中医气滞血瘀证的证候如:下腹包块、小腹疼痛、下腹坠胀、乳房胀痛为次要疗效观察指针,以一般体检项目、血尿便常规、心电图、ALT、BUN、Cr作为安全性观察指针。 (4)诊断标准:符合子宫肌瘤的西医诊断标准,及中医辩证为气滞血瘀证的患者。 3.治疗和观察方法:受试者于用药前一个月停用与治疗本病有关的药物及疗法。高剂量治疗组:宫瘤消颗粒,口服,1次10g(其中每袋含宫瘤消颗粒10g),一日2次。低剂量治疗组:宫瘤消颗粒,口服,1次10g(其中每袋含宫瘤消颗粒5g,辅料5g),一日2次。高、低剂量治疗组均同时加用桂枝茯苓胶囊安慰模拟剂。阳性药对照组:桂枝茯苓胶囊,口服,1次3粒,1日3次。同时加用宫瘤消颗粒安慰模拟剂。月经期间第1至第7天停服药物。疗程:用药12周。 4.统计分析方法:数据以均数±标准差((?)±SD)表示,多组间比较采用方差分析,用q检验,计数资料采用X~2检验,等级资料采用R分析,P<0.05为有显著性差异,P<0.01为有非常显著性差异,P>0.05为无显著性差异。 5.疗效指数判定标准: (1)子宫肌瘤疗效判定标准: 痊愈:肌瘤消失。 显效;肌瘤缩小1/2以上者。 有效:肌瘤缩小1/3者。 无效:未达进步标准者。 (2)气滞血瘀疗效判定标准: 痊愈:证候积分减少≥90%。 显效;证候积分减少≥70%<90%。 有效:证候积分减少≥30%<70%。 无效:证候积分减少<30%。 6.结果: (1)治疗气滞血瘀证子宫肌瘤瘤体大小的疗效湖北中医学院临床硕士研究生学位论文 宫瘤消高剂量治疗组治愈率13.04%,显效率34.78%,有效率4.35%,总有效率86.96%。宫瘤消低剂量治疗组治愈率22.7304,显效率22.73y0,有效率9.0904,总有效率76.19%。桂枝获答胶囊对照组治愈率8.70%,显效率34.78%,有效率13.04%,总有效率90.91%。三组经过统计学处理,三组治疗前后均无显著性差异,三组间疗效经统计学处理无显著性差异,说明三组对于子宫肌瘤瘤体大小均无明显缩小作用。 (2)治疗气滞血疲证子官肌瘤的证候疗效 宫瘤消高剂量治疗组治愈率4.35%,显效率21.74%,有效率“.22%,总有效率95.65%。宫瘤消低剂量治疗组治愈率13.64%,显效率18.18%,有效率59.05%,总有效率86.36%。桂枝获芬胶囊对照组治愈率8.70%,显效率17.39%,有效率60.87%,总有效率91二30%。三组治疗前后经统计学处理,均有显著性差异,三组间证候疗效经统计学处理无显著性差异,说明三组对于气滞血疲证证候改善均有很好的疗效。 (3)安全性分析 三组治疗后血、尿、粪常规、心电图、ALT、BUN、Cr均无明显异常变化,治疗前虽有个别异常存在,但治疗后无加重,临床观察中各病例均未发现不良反应,表明宫瘤消颗粒治疗气滞血疲证子宫肌瘤安全可靠,无毒副作用。7.结论: 高、低剂量宫瘤消颗粒均能明显改善月经的经期、量、色、质改变以及除下腹包块外的中医气滞血疲证的证候如:小腹疼痛、下腹坠胀、乳房胀痛,两组间疗效无明显差异,对于子宫肌瘤瘤体的大小无明显缩小作用,临床应用安全有效,无毒副作用。主题词: 子宫肌瘤/中医药疗法 气滞血疲证 临床研究 m宫瘤消颗粒
l.Subject of Analysis: The use of gongliuxiao Granule in treating myoma of uterusof blood stasis due to Qi stugnancy .2.Aims of Analysis,Design of Analysis,Observation Methods,Tanget Group andStandard of Diagnosis:(l)Aims of Analysis:To observe the clinical effect and safety of Gongliuxiao Granule which was used to treat myoma of uterus of blood stasis due to Qi stugnancy,and supply scientific evidence for the clinical usage of Gongliuxiao Granule. (2)Design of Analysis:72 cases of patients of myoma of uterus of blood stasis due to Qi stugnancy which had been diagnosed in our outpatient department were shosed and divided randomly into high dose treatment group,low dose treatment group and control group(Guizhifuling Capsule). high dose treatment group contains 20 cases,low dose treatment group contains 20 cases, control group contains 20 cases. It was a random , double-blind , double - mock research.Observe the change of size of myoma of uterus,the change of the blood stasis due to Qi stugnancy symptoms,and the changes of themenstrual cycle,amount clour and quality.Compare the clinical effect and safety. (3)Observation Methods:The main of observation methods is the size of myoma of uterus.And selecting 4 secondary symptoms to obverse thecases.For exammple the masses of blow the navel,pain in the area blow the navel,distending in the blow the navel,diatending of the breast, themenstrual cycle,amount clour and quality.As for somatoscopy estrogen regular blood and urine,liver(ALT),the function of the kidneys(Cr,BUN)and ECG etc were taken into observe safety of the medicine. (4)Tanget Group:Woman aged between 18-45. (5)Standard of Diagnosis:Women who were diagnosed by westen doctors as and myoma of uterus by Chinese doctors as blood stasis due to Qi stugnancy.3.Treatment and Observation MethodsBefore one month,patient stop the use of drinking and treatment which was used to treat myoma of uterus.They were respectively given Gongliuxiao Granule and Guizhifulinf capsule.twenty weeks as a course. 4.Methords of Statistical AnalysisX ± SD average value for statistical analysis .Analysis F was used to compare in several.Analysis X was used in count data.Analysis R was used in grade data.Withed the result of the checked amount of analysis and the relative pvalue,using double test.P > 0.05 is ineffective, P < 0.05 is effective, P < 0.01 is very effective. 5.The effectiveness of The Prescription(1) Standard on evaluating in myoma of uterus Recovery:disappearance of myoma of uterus Very effective:contract 1/2 of myoma of uterus Effectivexontract 1/3 of myoma of uterus Ineffective:not lessened of myoma of uterus (2)The effectiveness of The Treatment by Chinese Doctors Recovery:% in improvement in clinical symption ≥ 90% Very effective: % in improvement in clinical symption 70% < 90% Effective: % in improvement in clinical symption 30% < 70% Ineffective: % in improvement in clinical symption < 30% 6.result(l)The effectiveness of myoma of uterus of blood stasis due to Qi stugnancy: In Gongliuxiao Granule high dose treatment group,the cured rate is 13.04%,markedly effective rate is 34.78%,effective rate is 4.35%,and the total effective rate is 86.96%. In Gongliuxiao Granule low dose treatment group,the cured rate is 22.73%,markedly effective rate is 22.73%,effective rate is 9.09%.and the total effective rate is 76.19%. In Guizhifuling Capsule control group,the cured rate is 8.07%,markedly effective rate is 34.78%,effective rate is 13.04%,and the total effective rate is 90.91%. There is no significant difference of pre-treatment and pos-treatment in the three groups.Three groups cannot contract myoma of uterus.(2)The clinical curative effect myoma of uterus of blood stasis due to Qistugnancy: In Gongliuxiao Granule high dose treatment group,the cured rate is 4.35%,markedly effective rate is 21.74%,effective rate is 65.22%,and the total effective rate is 95.65%. In Gongliuxiao Granule low dose treatment group,the cured rate is 13.64%,markedly effective rate is 18.18%,effective rate is 59.09%.and the total effective rate is 86.3
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