| 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... |
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