Objective:The purpose of this study was to study the clinical effects of Jiaweibaiteng Mixture for treating sequelae of pelvic inflammatory disease with syndrome of damp-heat and blood stagnation.In order to evaluate the effectiveness and safety of this Mixture,evaluated by comparing the quantitative score, the changes of laboratory tests and tracking control of adverse events.Methods:Chose 60 patients included in the standard then using randomized controlled clinical trial design method according to the proportion of 1:1 randomly divided into two groups: treatment group (oral Jiaweibaiteng Mixture) and the control group (oral Kangfuyan capsules), 30 cases in each group,the two treatments are 4 weeks as a course of treatment immediately observed after two courses of treatment. Observe the changes of TCM syndrome, local signs,the efficiency of VAS score, hemorheology, CRP, platelet parameters and related inflammatory factors before and after treatment between both groups.Result:1. After treatment, the treatment group of TCM syndrome total effective rate was 96.7%, local signs of the total effective rate was 100%, the efficiency of VAS score was 100%, the total effective rate is 96.7%. The control group of TCM syndrome total effective rate was 83.3%, local signs of the total effective rate was 80%, the efficiency of VAS score was 96.7%, the total effective rate is 80%. The difference in the comprehensive effect of local signs of efficacy, the efficacy of TCM, were statistically significant compared to the two groups after treatment. The results show that each of the two groups of patients were observed after treatment were significantly improved than before.2.After treatment the hemorheology indexes (plasma viscosity, whole blood high and low shear whole blood, erythrocyte sedimentation rate, platelet aggregation rate)decreased in different degree(P<0.05 or P<0.01). The indexes of the treatment group improved more significantly, compared with control group, there was significant difference between the groups (P<0.05).Compare the D-value of two groups, high and low shear whole blood viscosity and platelet aggregation rate were significant different or extremely significant different (P<0.01). For improving the plasma viscosity and erythrocyte sedimentation rate, no significant difference between groups.3.The platelet count in the two groups after treatment was lower than before treatment, the difference was statistically significant (P<0.05). The MPV index of the treatment group rose significantly(P<0.01), the difference between the groups was statistically significant(P<0.05).4. After treatment, the two groups of patients with CRP indicators were significantly improved (P<0.05), the difference between the groups was not statistically significant.5.After treatment, treatment group patients with TNF-a, IL-6 than before were decreased, the difference is statistically significant (P<0.05 or P<0.01);Control group patients with TNF-a levels decreased (P<0.05), the differences before and after the treatment of IL-6 no statistical significance. Compared with the control group, there were significant differences between the two groups in treatment group (P<0.05 or P<0.01).6.A11 the patients did not have toxic side effects and other adverse reactions during the treatment, indicating that the use of the drug is safe and reliable.Conclusion:Jiaweibaiteng Mixture effectively worked for the treatment of damp heat and blood stasis type of pelvic inflammatory disease sequelae. In total efficiency, specific signs and symptoms score, blood rheology, platelet parameters, inflammatory factor aspects were.Jiaweibaiteng Mixture can significantly alleviate the local and systemic symptoms, improve the state of blood rheology, reduce the levels of inflammatory cytokines in patients, the mechanism may is by regulating the body immune factors, correct the immunity to treat the disorder. The effectiveness and safety of the parties are better, it is worth in clinical application and promotion. |