Clinical Research In The Jingshuning Particles In The Treatment Of Primary Dysmenorrhea (Qi Stagnation And Blood Stasis Type Of Dysmenorrhea)

Objective To observe the clinical efficacy of the JingShuNing particles to treat the qi stagnation and blood stasis type of Primary Dysmenorrhea and the change of the blood and PGF2a level, to prove its effectiveness and safety, in order to provide the scientific basis for clinical medication.Methods Randomly selected64outpatients who meet the diagnostic criteria for Primary Dysmenorrhea both in western medicine and traditional Chinese medicine, then divided them into treatment group and control group, each group has34patients. Treatment group received oral administration of JingShuNing grain,1bag each (5g), blunt the medicine with boiled water three times a day after every meal,at the seven days before began to use, then served10days for a menstrual cycle; The control group took ibuprofen capsule,1grain(0.2g) every time and3times a day after every meal,1day before menstruation began to take medicine, then served four days for a menstrual cycles. Two groups of patients were continuous treated of three menstrual cycles for a period of treatment, after the course judge curative effect, withdrawal of three menstrual cycles after a visit. Observe both groups of patients before and after treatment, symptoms improved clinical curative effect and the changes of blood prostaglandin PGF2a level.Results1. Treatment group and control group in age, duration, dysmenorrhea degree, show symptoms of integral, each single main symptoms of traditional Chinese medicine, compares, all is no statistical difference (P>0.05), comparable.2. Clinical curative effect the total effective rate:treatment group was94.12%, to88.24%in the placebo group, between two qol curative effect more, no statistical difference (P>0.05).3. The two groups of patients syndromes curative effect comparison: treatment group total effectiveness97.06%, the control group total effectiveness76.47%, explain the curative effect of treatment group was better than control (P<0.05).4. The treatment of three menstrual cycles TCM symptoms after total score change, two groups are more before treatment significant difference (P<0.01); After treatment, the comparison between two qol, statistically significant (P<0.05).5. The withdrawal of three menstrual cycles TCM symptoms after total score change:(1) in the two groups were compared with before treatment significant difference (P<0.01); Between group with significant difference (P<0.01).(2) and treatment after a period of treatment is, the treatment group is no statistical difference (P>0.05); The control group statistically significant (P<0.05).6. Between the two groups the main symptoms of traditional Chinese medicine (the line quantity is little, the line, and the dark purple color with piece, breast pain, bosom is frowsty not comfortable) improve the situation is more, statistically significant (P<0.05), indicating that the treatment group in the improvement of clinical symptoms of primary period (the line quantity is little, the line, and the dark purple color with piece, breast pain, bosom is frowsty not comfortable) better than control group.7. The two groups of patients before treatment PGF2a blood level is, no statistical difference (P>0.05). After treatment, the two groups of patients PGF2a blood levels decreased, and treatment is before, all significant difference (P<0.01), and the treatment group than in control group (P<0.01).8. In the clinical observation, the treatment of primary period pain patients JingShuNing particles during this period no significant side effects, safe and reliable.Conclusion This subject adopts the random, single blind, the posi-tive control of test methods, the study showed that the treatment of primary dysmenorrhea JingShuNing particles (qi stagnation and blood stasis type) can improve the clinical curative effect of traditional Chinese medicine and sickness curative effect,3months after treatment and withdrawal of three menstrual cycles of TCM symptoms after total score can be improved dramatically, can alleviate the primary period pain symptoms (the line quantity is little, the line, and the dark purple color with piece, breast pain, bosom is frowsty not comfortable), and can reduce the level of PGF2a in blood. The results indicated that, the JingShuNing particles in the treatment of primary period pain (qi stagnation and blood stasis type) has remarkable curative effect, high safety, deserved further study and promotion of use.