清经胶囊治疗月经先期血分虚热证的临床研究
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摘要
研究课题 清经胶囊治疗血分虚热证月经先期的临床观察。
研究目的、研究设计、观察指标、诊断标准
研究目的:采用清经胶囊治疗血分虚热证月经先期,对清经胶囊的临床疗效进行评价,为清经胶囊的临床应用提供科学的依据。
研究设计:采用随机双盲、双模拟、阳性药平行对照法,将选用90例门诊诊断为月经先期血分虚热证(西医诊断为排卵型功血黄体不健)的患者,随机分为2组,每组45例,分为清经胶囊治疗组和固经丸对照组。通过观察结果评价清经胶囊的临床疗效,以及观察治疗前后中医血分虚热证证候的变化及月经周期、量、色、质的变化,比较研究其疗效。
观察指标:以妇检、基础体温测定、B型超声波检查为主要诊断性指标,同时选取月经的经期、量、色、质的变化以及其它中医血分虚热证证候如:口干咽燥、五心烦热、小便黄短、大便干结为次要疗效观察指针。以血常规、尿常规、大便常规、心电图、肝肾功能为主要的安全性指针。
诊断标准:符合西医排卵型功能失调性子宫出血黄体不健的诊断标准,以及中医辨证为血分虚热证月经先期的患者。
治疗和观察方法 受试者用药期间前停用与治疗本病有关的药物及疗法。治疗组:清经胶囊,每次4粒,每日3次,温开水冲服。对照组:固经丸,每次8g,每日2次,温开水冲服。于经净后服用14天药物,共两个月经周期。疗程:14天为一疗程,共两个疗程。
统计分析方法 数据以均数±标准差((?)±S)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。
疗效判定标准
月经先期疗效
痊愈:治疗后月经周期恢复正常,其它症状消失,停药三个月经周期未复发。
显效:治疗后月经周期较治疗前延长4-7天,经量小于80ml,其它症状消或减轻,停药三个月经周期未复发。
有效:治疗后月经周期、经量较治疗前改善,其它症状也较治疗前减轻。
无效:治疗后月经周期、经量无改变。
中医证候疗效判定标准
根据积分法判定证候疗效
疗效指数(n)=(疗前积分-疗后积分)/疗前积分×100%
痊愈:n=100%
显效:n≥70%
有效:n≥30%<70%
无效:n<30%
学位论文:清经胶囊治疗月经先期的临床观察
结果
1.清经胶囊治疗组治疗血分虚热证月经先期愈显率51.n%,临床总有效率
84.44%;固经丸对照组愈显率44.44%,临床总有效率73.33%。经统计学分析,
两组比较无显著性差异(P) 0.05),说明清经胶囊与固经丸临床疗效相似。
2.治疗前后两组间症状总积分比较均有非常显著性差异(P<0.01),说明清
经胶囊和固经丸均能明显改善中医症状。两组治疗前后组间积分比较无显著性
差异,说明两组对中医症候改善作用相似(P<0.05)。
3.两组药物均能在一定程度上改善相关临床症状。两组患者治疗后绝大多数
中医临床症状较治疗前明显改善,如:月经提前、出血量、经色、经质、口干
咽燥、大便干结,小便黄短,两组患者均有非常明显的差异(P<0.01)。说明
清经胶囊和固经丸治疗月经先期的疗效显著。
4.相关因素与疗效观察显示,本病的疗效与年龄、病情、病程无关。
5.治疗组治疗前后血常规、尿常规、大便常规、心电图、GPT、BUN、cr均
无异常变化(P>0.05)。其中血常规、心电图、GPT在治疗前有少数病例存在轻
度异常,治疗后未进一步恶化,未出现新发异常病例。表明治疗组所用药物无毒
副作用,安全可靠。
结论
清经胶囊为治疗月经先期血分虚热证的中药制剂,其清热凉血,滋肾养阴,
调经止血功效确切。能明显改善中医临床症状,对月经提前、月经量、色、质
及口干咽燥、大便干结、小便黄短等均有改善。通过进一步临床验证和安全性
检查,‘说明清经胶囊安全有效,未发现任何不良反应,值得进一步推广。
主题词
月经先期/中医药疗法
血分虚热证
临床研究
@清经胶囊
1.The subject of research: the clinical observation of QingJing Capsule(QC for short) on treating Advanced Menorrhea (AM for short) of Blood and Deficiency-heat syndrome.2. The objective of research, the design of research, observation indexex, Diagnosis StandardThe objective of research: QC was performed in treating of AM of Blood and Deficiency-heat syndrome, the clinical effect of QC was investigated, and provide scientific basis for the clinical application of it. The design of research: Double-blind, double-imitating, parallel-controlled and randomized trial was performed in 90 cases of AM with Blood and Deficiency-heat syndrome, which of it was diagnosed as ovulatory dysfunctional uterine fleeding. Those were divided into two groups randomly as QC group and Gujing pill group. The clinical effect of QC was evaluated through observation results, and observe the change of the clinical syndromes and signs, the menstrual cycle, color, quantity, texture before and after the treatment, compared with the treatment effect of its observation.Observation indexex: The gynecological inspect, basal boby temperature, B types of supersonic were served as the major diagnosis indexex. The change of the menstrual cycle, color, quantity, texture and the clinical syndromes and signs of AM with Blood and Deficiency-heat syndrome. The urine routine, blood routine, stool routine, liver function, kidney function were served as the major safety indexex.3. Treatment and Observation Methods: The experimented suspended the medicine and the therapy correlated with the disease during the treatingperiod. Treatment group: Qingjing capsule, each time 4 pills, T. i. d. orally taking by the warm water. Control group: Gujing pill, each time 8g, B. i. d. orally taking by the warm water. Both groups stated after the menstrual period and consecutively lasted 14 days. There are totally two menstrual cycles, We valuated the clinical effect of each group after each group after stopping three menstrual cycles. Course:A couse contains 14 days, consecutively taking two courses.4. Methods of statistical AnlaysisX ±S average value for statistical analysis. Analysis F was used tocampare in several. Analysis X2 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. Determined Standard of Curative Effect Indexex (l)the Curative Effect of AMRecovery: The menstrual cycle recovers normality, and the other symptoms diminish after treatment. Three menstrual cycles don't relapse after suspending medicine,,Very Effective: After treatment, the menstrual cycle extends 4-7 days, the menstrual quanlity is less than 80 ml, and the other symptoms diminish or shorten, Three menstrual cycles don't relapse after suspending medicine.Effective: The menstrual cycle and quantity after treatment improve much compared with before treatment, the other symptoms shorten much compared with before treatment.Invality: There is no change of the menstrual cycle, quantity after treatment.(2)the Determined Standard of Curative Effect on Clinical Symptom and Signsscore before treatment—score after treatmentCurative Effect Index(n)=score before treatmentRecovery: n=100%Very Effective: n≥70%Effective: n≥30%<70%Invality: n<30%6. Result(l)The recovery of QC is 51.11%, the total effective rate is 84. 44%;which of Gujing pill is 44. 44%, the total effective rate is 73. 33%. By means of statistics analysis ,there is no significant difference between these two groups on the clinical effect(P>0. 05). It states that of the control group.(2)There are very significant difference between the total scores of symptoms before and after treatment of the two groups(P<0. 01). It states QC and Gujing pill can evidently improve the symptoms. (3)Both groups can ameliorate correlate clinical symptoms in certain level. There are very significant difference between the symptoms of the advanced menorrhea, the quantity of fleeding, the menstrua
研究目的、研究设计、观察指标、诊断标准
研究目的:采用清经胶囊治疗血分虚热证月经先期,对清经胶囊的临床疗效进行评价,为清经胶囊的临床应用提供科学的依据。
研究设计:采用随机双盲、双模拟、阳性药平行对照法,将选用90例门诊诊断为月经先期血分虚热证(西医诊断为排卵型功血黄体不健)的患者,随机分为2组,每组45例,分为清经胶囊治疗组和固经丸对照组。通过观察结果评价清经胶囊的临床疗效,以及观察治疗前后中医血分虚热证证候的变化及月经周期、量、色、质的变化,比较研究其疗效。
观察指标:以妇检、基础体温测定、B型超声波检查为主要诊断性指标,同时选取月经的经期、量、色、质的变化以及其它中医血分虚热证证候如:口干咽燥、五心烦热、小便黄短、大便干结为次要疗效观察指针。以血常规、尿常规、大便常规、心电图、肝肾功能为主要的安全性指针。
诊断标准:符合西医排卵型功能失调性子宫出血黄体不健的诊断标准,以及中医辨证为血分虚热证月经先期的患者。
治疗和观察方法 受试者用药期间前停用与治疗本病有关的药物及疗法。治疗组:清经胶囊,每次4粒,每日3次,温开水冲服。对照组:固经丸,每次8g,每日2次,温开水冲服。于经净后服用14天药物,共两个月经周期。疗程:14天为一疗程,共两个疗程。
统计分析方法 数据以均数±标准差((?)±S)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。
疗效判定标准
月经先期疗效
痊愈:治疗后月经周期恢复正常,其它症状消失,停药三个月经周期未复发。
显效:治疗后月经周期较治疗前延长4-7天,经量小于80ml,其它症状消或减轻,停药三个月经周期未复发。
有效:治疗后月经周期、经量较治疗前改善,其它症状也较治疗前减轻。
无效:治疗后月经周期、经量无改变。
中医证候疗效判定标准
根据积分法判定证候疗效
疗效指数(n)=(疗前积分-疗后积分)/疗前积分×100%
痊愈:n=100%
显效:n≥70%
有效:n≥30%<70%
无效:n<30%
学位论文:清经胶囊治疗月经先期的临床观察
结果
1.清经胶囊治疗组治疗血分虚热证月经先期愈显率51.n%,临床总有效率
84.44%;固经丸对照组愈显率44.44%,临床总有效率73.33%。经统计学分析,
两组比较无显著性差异(P) 0.05),说明清经胶囊与固经丸临床疗效相似。
2.治疗前后两组间症状总积分比较均有非常显著性差异(P<0.01),说明清
经胶囊和固经丸均能明显改善中医症状。两组治疗前后组间积分比较无显著性
差异,说明两组对中医症候改善作用相似(P<0.05)。
3.两组药物均能在一定程度上改善相关临床症状。两组患者治疗后绝大多数
中医临床症状较治疗前明显改善,如:月经提前、出血量、经色、经质、口干
咽燥、大便干结,小便黄短,两组患者均有非常明显的差异(P<0.01)。说明
清经胶囊和固经丸治疗月经先期的疗效显著。
4.相关因素与疗效观察显示,本病的疗效与年龄、病情、病程无关。
5.治疗组治疗前后血常规、尿常规、大便常规、心电图、GPT、BUN、cr均
无异常变化(P>0.05)。其中血常规、心电图、GPT在治疗前有少数病例存在轻
度异常,治疗后未进一步恶化,未出现新发异常病例。表明治疗组所用药物无毒
副作用,安全可靠。
结论
清经胶囊为治疗月经先期血分虚热证的中药制剂,其清热凉血,滋肾养阴,
调经止血功效确切。能明显改善中医临床症状,对月经提前、月经量、色、质
及口干咽燥、大便干结、小便黄短等均有改善。通过进一步临床验证和安全性
检查,‘说明清经胶囊安全有效,未发现任何不良反应,值得进一步推广。
主题词
月经先期/中医药疗法
血分虚热证
临床研究
@清经胶囊
1.The subject of research: the clinical observation of QingJing Capsule(QC for short) on treating Advanced Menorrhea (AM for short) of Blood and Deficiency-heat syndrome.2. The objective of research, the design of research, observation indexex, Diagnosis StandardThe objective of research: QC was performed in treating of AM of Blood and Deficiency-heat syndrome, the clinical effect of QC was investigated, and provide scientific basis for the clinical application of it. The design of research: Double-blind, double-imitating, parallel-controlled and randomized trial was performed in 90 cases of AM with Blood and Deficiency-heat syndrome, which of it was diagnosed as ovulatory dysfunctional uterine fleeding. Those were divided into two groups randomly as QC group and Gujing pill group. The clinical effect of QC was evaluated through observation results, and observe the change of the clinical syndromes and signs, the menstrual cycle, color, quantity, texture before and after the treatment, compared with the treatment effect of its observation.Observation indexex: The gynecological inspect, basal boby temperature, B types of supersonic were served as the major diagnosis indexex. The change of the menstrual cycle, color, quantity, texture and the clinical syndromes and signs of AM with Blood and Deficiency-heat syndrome. The urine routine, blood routine, stool routine, liver function, kidney function were served as the major safety indexex.3. Treatment and Observation Methods: The experimented suspended the medicine and the therapy correlated with the disease during the treatingperiod. Treatment group: Qingjing capsule, each time 4 pills, T. i. d. orally taking by the warm water. Control group: Gujing pill, each time 8g, B. i. d. orally taking by the warm water. Both groups stated after the menstrual period and consecutively lasted 14 days. There are totally two menstrual cycles, We valuated the clinical effect of each group after each group after stopping three menstrual cycles. Course:A couse contains 14 days, consecutively taking two courses.4. Methods of statistical AnlaysisX ±S average value for statistical analysis. Analysis F was used tocampare in several. Analysis X2 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. Determined Standard of Curative Effect Indexex (l)the Curative Effect of AMRecovery: The menstrual cycle recovers normality, and the other symptoms diminish after treatment. Three menstrual cycles don't relapse after suspending medicine,,Very Effective: After treatment, the menstrual cycle extends 4-7 days, the menstrual quanlity is less than 80 ml, and the other symptoms diminish or shorten, Three menstrual cycles don't relapse after suspending medicine.Effective: The menstrual cycle and quantity after treatment improve much compared with before treatment, the other symptoms shorten much compared with before treatment.Invality: There is no change of the menstrual cycle, quantity after treatment.(2)the Determined Standard of Curative Effect on Clinical Symptom and Signsscore before treatment—score after treatmentCurative Effect Index(n)=score before treatmentRecovery: n=100%Very Effective: n≥70%Effective: n≥30%<70%Invality: n<30%6. Result(l)The recovery of QC is 51.11%, the total effective rate is 84. 44%;which of Gujing pill is 44. 44%, the total effective rate is 73. 33%. By means of statistics analysis ,there is no significant difference between these two groups on the clinical effect(P>0. 05). It states that of the control group.(2)There are very significant difference between the total scores of symptoms before and after treatment of the two groups(P<0. 01). It states QC and Gujing pill can evidently improve the symptoms. (3)Both groups can ameliorate correlate clinical symptoms in certain level. There are very significant difference between the symptoms of the advanced menorrhea, the quantity of fleeding, the menstrua
引文
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