Objective:Compared with placebo further evaluation man pen kang using irrigation treatment of chronic pelvic inflammation (damp and hot accumulate knot poison and blood stasis syndrome) the safety and effectiveness, for its in the clinical application of scientific basis to provide a powerful.Methods:take randomized, double-blind, multicenter, placebo-controlled clinical trial, will meet the chronic pelvic inflammation (damp and hot accumulate knot poison and blood stasis syndrome diagnosis standard118patients divided into trial group and control group, and the basin filling kang group slow intestinal fluid therapy, the control group choose a placebo (slow basin filling simulation using Cornwall agent) treatment, drug treatment for two menstrual cycles. The two groups each observed before and after treatment and related symptoms and signs integral curative effect and the safety index changes.Results:(1) in the two groups of the chronic pelvic inflammation and damp and hot accumulate knot ZhuZheng curative effect of poison, the treatment group and greater rate was40%, the total effective rate was90.00%; The control group greater rate was18.97%, the total effective rate was75.86%, the treatment group compared with controls, a statistically significant (P<0.05);(2) the total curative effect in the two groups compare:treatment group and greater rate was37%, the total effective rate was90.00%; The control group greater rate was18.97%, the total effective rate was79.31%, the treatment group compared with controls, a statistically significant (P<0.05);(3) in the two groups of traditional Chinese medical syndrome compare the efficacy: treatment group and greater rate was63.33%, the total effective rate was91.67%; The control group greater rate was20.69%, the total effective rate was79.31%, the treatment group compared with controls, a statistically significant (P<0.05);(4) in two groups of local signs curative effect comparative:treatment group and greater rate was41.67%, the total effective rate was88.33%; The control group greater rate was20.69%, the total effective rate was63.79%, the treatment group compared with controls, a statistically significant (P<0.05);(5) the security:this experiment, the experimental total adverse events appear7times, of which appear in2cases mild liver function is unusual,5cases of mild digestive system and the relationship between anomalies may drugs, and1case slight cold adverse events, and drug relations have nothing to do. Was8.33%, and clinical application safer.Conclusion:man pen kang irrigation is using the honeysuckle, common cnidium fruit, dandelion, kindhearted YiRen, defeated sauce grass, wild chrysanthemum flowers, big blood cane, root, fumaric nine taste of Chinese traditional medicine. Has qingrejiedu, qushi adjustable gas, for activating blood circulation and eliminating stasis efficacy, used in the treatment of damp and hot accumulate knot poison stasis syndrome the chronic pelvic inflammation, can obviously improve the lower quadrant abdominal pain, pain and lumbar di ministry of color yellow gas down more smelly wait for a symptom, the greater rate and the total effective rate is better than a placebo, clinical use safety, convenient, is worth further promotion. |