| Objective: To evaluate the efficacy and safety of Fuyanqing Granule in treating pelvic inflammatory disease sequelae of damp-heat stagnation type through clinical trials,and to provide scientific basis for clinical application and promotion of drugs.Methods:A randomized double-blind control method was used to select30 patients with SPID dampness-heat-stasis syndrome who visited Jingzhou hospital of traditional Chinese medicine,Hubei provincial maternal and child health hospital,Wuhan hospital of integrated traditional Chinese and western medicine,Jingmen hospital of traditional Chinese medicine and Shiyan hospital of traditional Chinese medicine from October 2016 to June 2017,a total of 150 patients.The patients were divided into treatment group and control group.Patients in the treatment group were given oral fuyanqing granules(1 bag at a time,3 times a day)and jinggang teng capsule simulant(4tablets at a time,3 times a day).Patients in the control group were given oral jingangteng capsule(4 capsules at a time,3 times a day)and fuyanqing granule simulation agent(1 bag at a time,3 times a day),and the course of treatment in both groups was one month.After one course of treatment,the efficacy was evaluated,and the changes of damp-heat stasis syndrome,localsigns and VAS pain score in each group were observed and compared.Statistical analysis was performed on the relevant data to evaluate the efficacy 、safety and draw conclusions.Result:1.There was no statistical difference between the two groups in age,pregnancy,abortion frequency and disease grade(P > 0.05),which was comparable.2.There was no significant difference between the treatment group and the control group in the improvement of pelvic mass,volume and cervical secretion culture(P > 0.05),but both groups could improve the results of pelvic mass,effusion and cervical secretion culture.3.Comparison of pelvic pain efficacy: the effective rates of pelvic pain in the treatment group and the control group were respectively 85.92% and75.34%,with statistically significant differences(P > 0.05).Fuyanqing granule is better than jingangteng capsule in treating pelvic pain.4.The efficacy of TCM syndromes was compared.The effective rates of the treatment group and the control group were 74.65% and 69.86%respectively,and the difference was not statistically significant(P>0.05).The therapeutic effect of TCM syndromes in the treatment group was similar to that of the control group,but the therapeutic effect of the treatment group was slightly better than that of the control group.5.Comparison of the efficacy of local signs: the effective rates of the treatment group and the control group were 77.46% and 72.60%,respectively,and the difference was not statistically significant(P>0.05),indicating that the efficacy of the treatment group was similar to that of the control group,but the efficacy of the treatment group was slightly better than that of the control group.6.Compared with the comprehensive efficacy:the effective rates of thetreatment group and the control group were 76.06% and 71.23% respectively,and the difference was not statistically significant(P>0.05),indicating that the comprehensive efficacy of the treatment group was similar to that of the control group,but the efficacy of the treatment group was slightly lower than that of the control group.7.Safety comparison: Before and after treatment,there were no statistically significant differences in blood routine,liver and kidney function,electrocardi-ogram and other indicators between the two groups(P >0.05),and the drugs in the two groups were safe and reliable.Conclusion:Fuyanqing granule is safe and effective in treating pelvic inflammatory disease sequelae with damp-heat stasis.Fuyanqing granule has the same curative effect as jingangteng capsule in comprehensive curative effect,TCM symptom curative effect,local physical effect and so on.It is suitable to apply fuyanqing granule to treat pelvic inflammatory disease sequelae. |
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