| Objection:Observe the clinical efficacy of different doses of Guizhifuling capsule treatment of primary dysmenorrhea, and the safety of medication, the results of systematic analysis of its clinical precision to use, to provide a scientific theory and basis.Method:This study is a randomized, double-blind, placebo-controlled research methods, cases from the August2010March to2011in Hubei Province Hospital gynecological outpatient diagnosis of primary dysmenorrhea patients, a total of30patients aged18-30years old divided into Guizhifuling high dose group, low dose group and placebo control group, the ratio of1:1:1,10cases in each group. Based on the pain scale, pain intensity rating score, taking three menstrual cycles, pain scores were observed in three patients before and after treatment, the clinical symptom score, follow-up efficacy, as well as blood, urine, fecal three conventional, and blood biochemical laboratory tests results and statistical analysis to determine its clinical efficacy.Results:A primary efficacy endpoint:treatment and follow-up after high-dose group of the, Guizhifuling capsule in the treatment of primary dysmenorrhea efficiency, the total effective rate were70.00%,90.00%; Guizhifuling capsule low dose group, significant efficiency The total effective rate for the rate of60.00%,80.00%; the placebo group efficiency, the total effective rate was40.00%,60.00%, the statistical analysis, P<0.05, the difference was statistically significant, three groups of drugs can be effective in treating primary dysmenorrhea, which Guizhifuling high dose group was better than the low dose group and placebo group followed. In pain intensity after treatment and follow-up, three patients have varying degrees of decline in the high dose group was2.46±1.87, low dose group was2.64±1.98, placebo3.28±2.23, statistical analysis, P<0.05, statistically significant difference Guizhifuling high dose of pain intensity was most obvious, low-dose group second.(2) The secondary efficacy endpoint comparison:Clinical symptom score after treatment follow-up, a comparison of three groups of patients before and after treatment (P<0.05), indicating that each group of patients with medication, the clinical symptoms significantly improved. Three groups were compared in patients before and after treatment, clinical symptom score decreased value (P<0.05), symptom score decreased significantly; comparison between the clinical symptom score decreased value, P<0.05, that Guizhifuling capsules plus decreased dose group value is more commonly used dose group, the placebo group decreased the value of at least.After treatment follow-up, three groups were compared patient medication compliance and dosage, medication days, P values>0.05, not statistically significant, indicating that the three groups of patients with medication compliance and dosage of medication days are similar. In concomitant medication, the three groups were each one, the statistical analysis, P>0.05, not statistically significant, indicating that each group concomitant medication was similar.(3) Comparison of satisfaction with the overall efficacy assessment: placebo is very satisfied with the cases1cases, satisfied with the number of cases for the four cases, very satisfied with the rate of10.00%satisfaction+satisfaction rate of50.00%; Guizhifuling capsules low dose very satisfied with the group of patients for two cases, a satisfactory number of cases of four cases, very satisfied with the rate of20.00%satisfaction+satisfaction rate of60.00%; Guizhifuling high dose group is very satisfied with the number of cases for two cases, the number of satisfied patients five cases, very satisfied with the rate of20.00%, very satisfied+satisfaction rate of70.00%. All very satisfied with the rate, the statistical analysis, P<0.05, statistically significant, indicating that the three groups of treatment are patient satisfaction and Guizhifuling high dose group was higher than the low dose group, low-dose group than in the comfort agent group. The very satisfaction+satisfaction rate, the statistical analysis, P<0.05, statistically significant, higher than the low dose group and Guizhifuling high dose group, low-dose group than in the placebo group.(4) Security:The clinical study, three groups of patients had no adverse reactions occurred before treatment after treatment, laboratory test results showed no abnormal changes. That Guizhifuling capsule is safe to take. Conclusion:Guizhifuling high dose group and low dose group can be effective treatment of primary dysmenorrhea, can significantly relieve pain in patients taking the safe and reliable clinical, no significant adverse reactions, and the high dose group was significantly superior in reducing pain intensity in patients with in the low dose group, the doses of the drug is worthy of clinical application. |
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