| Objectvie:To evaluate the curative effect and safety and inquire the mechanism of the traditional Chinese herb medicine "Tang-Kuei Phthalide capsule" on primary dysmenorrhea(qi stagnation and blood stasis,cold-damp stagnation),to explore the possible mechanism and provide scientific basis for the clinical application of it.Methord1.Case choose.Dvided randomly the 58 cases which are accord with primary dysmenorrheal diagnostic code ,and with traditional Chinese medicine differentiation of symptoms and signs that are qi-stagnancy and blood stasis cold hygrosis ,into treatment group (43 cases)and controlledgroup (15cases).Adopting continuously Medicine 3 menstruation cyclesas one course of treatment,then evaluate curative effect.two groups' demography distinction, course of disease and vital signs of ;prior treatment are all without significant differences.2.Treatment methord. Give the treatment Tang-Kuei Phthalide capsule,while giving the control group FutongningDiwan .Take medicine on the time of the 5 days before every month's menstrual ,Use three month. Follow up recovery patients.3. curative effect indexes. Observe the extent and time of the painful before treatmen,after treatmen,after every month's menstrual .Also write down the score of the pain palliation efficacy and TCM symptoms. Follow up recovery patients.4.Safety index . Observe the laboratory index and vital signs .Such as weight,blood press,heart rate,breath ;ECG,Liver Function(ALT,AST),Renal Function(BUN,Cr) andthe three large Conventional.5. The Stat. method: We analyze the data , the count materials are examined with X2, the measuring materials are examined with t-test and the grade materials with Ridit.Result:1. Both can significantly depress the integal of dysmenorrheal after treatmen (P<0.01).it states Tang-Kuei Phthalide capsule and FutongningDiwan can evidently impove the symptoms.There is no difference before and after on the symptom score of dysmenorrhea and tcm.2.both tang-Kuei Phthalide capsule and FutongningDiwan can allevaite the extent and time of the painful .Compared with those in the control group ,there is no difference.it states they all can allevaite the painful.3 .On the pain palliation efficacy ,the effctive rate of Tang-Kuei Phthalide capsule is 83.72%,while the control group is 73.33%.There is no statistical difference between those two group(P>0.05).It shows that the analgesic effect of Tang-Kuei Phthalide capsule is the same of FutongningDiwan.4.The total effective rate of TCM symptoms of Tang-Kuei Phthalide capsule is 95.34%,while the control group is 80%. We can find our there is no significant difference between these two groups on the clinical effect(P>0.05).5.There are no badness and side-effect in both groups. During the period of the research,two groups' laboratory results (the three large Conventional,Liver Function,Renal Function,ECG) were normal.ResultTang-Kuei Phthalide capsule can effecintly allevaite the painful of the dysmenorrheal(Qi stagnation and blood stasis,cold-damp stagnation). There are no badness and side-effect.It is worthily recommended in the clinical application. |