The Clinical Study About Neiyi Dysmenorrheal Granule In The Treatment Of Dysmenorrheal Caused By Endometriosis

Objective:Observed the clinical efficacy and safety of Neiyi Dysmenorrheal granule in the treatment of Dysmenorrheal (the qi stagnation and blood stasis type) that caused by endometriosis, and to provide a scientific basis for the drug’s clinical application and promotion.Methods:The total of30patients were all come from Hubei Provincial Traditional Chinese Medical Hospital outpatients during April2009to October2010, and all of them were diagnosised as qi stagnation and blood stasis dysmenorrheal caused by Endometriosis. The all cases were randomly divided into two groups,20cases wrer selected for treatment group and placebo control group with10cases. Comparaison with the two groups of patients with age, disease duration, severity of disease, TCM syndrome integral, they have no obvious statistical difference (P>0.05). The treatment group were treated with Neiyi dysmenorrheal granule. Taking methods:to take it from seven days before menstruation and continuos use10days. Take3times daily and one bag every time. Use3consecutive menstrual cycles for a course of treatment. The placebo control group were given Neiyi dysmenorrhea granule simulated agent. Its education and treatment method are the same with the treatment group. Two groups of patients after treatment were followed up for3menstrual cycles.According to the dysmenorrheal pain symptom score, dysmenorrhea severity classification standard and concomitant symptom score standard score. Observation of Endometriosis Dysmenorrhea induced by pain severity improved efficac. Therapeutic efficacy of TCM Syndromes, Determination of the serum CA125and other clinical symptoms. Monitor the routine blood test, urine routine, Stool routine. Electrocardiogram and liver and kidney function before the treatment and after3month.Results:Three months after the treatment,compared the clinical comprehensive therapeutic effect,the effective rate in the treatment group was90%,compared to the control group in the total efficiency was30%. Between the two groups had significant difference (P<0.05).3months after the treatment comparison of TCM Syndrome, The treatment group total effective rate was85%, compared to the control group in the total efficiency was40%, there was significant difference between two groups. Two groups of patients had no adverse events during the treatment, and did not find any clinically significant abnormal changes with the drug related.Conclusion:Neiyi Dysmenorrheal granule can effectively treat the Qi stagnation and blood stasis type of dysmenorrheal which is caused by endometriosis, and can relieve the patients’pain safety without side effects. Its advantages are simple and convenient for taking. So it has significance to promote the use of the drug for the dysmenorrheal patients that caused by endometriosis.