妇炎舒胶囊联合抗菌药物治疗盆腔炎性疾病的有效性及安全性：一项随机对照临床研究#br#

Effectiveness and safety of Fuyanshu capsule combined with antibiotics in the treatment of pelvic inflammatory diseases: a randomized controlled clinical study

【Abstract】?Objective?To evaluate the efficacy and safety of Fuyanshu capsule(FC) combined with antimicrobial agents in the treatment of dampness-heat stasis syndrome of pelvic inflammatory disease (PID). Methods?A prospective, multicenter, randomized, double-blind design was adopted. A total of 288 PID patients aged 20 to 50 years were enrolled in 5 hospitals from June 2017 to September 2018, and randomly assigned to study group (treated with Fuyanshu capsule) and control group (treated with placebo) according to a 1:1 ratio. 144 cases in both groups were additively given levofloxacin tablets + metronidazole tablets from the 1st to 14th day of admission. The score of McCormack scale and traditional Chinese medicine (TCM) syndromes were compared between the two groups after 8 weeks of treatment (after 2 menstrual cycles). Follow-up was performed one month after drug withdrawal. Results?The score of McCormack scale in the study group was lower than that before treatment [(7.65±2.21) points] and higher than that in the control group [(4.01±2.46) points] (P<0.0001). The effective rate of TCM syndrome in the study group [93.75% (135/144)] was higher than that in the control group [41.67% (60/144)] (P<0.0001).The recurrence rate of the study group was 3.50% (5/144) and the incidence of pelvic pain was 10.49% (15/144) within one month after drug withdrawal, both of which were lower than those of the control group (P<0.0001). Conclusions?Antibiotics combined with FC improved the score of McCormack scale, curative effect of TCM syndromes, disease recurrence and sequelae of pelvic pain in PID patients better than antibiotics alone.