科研之友
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摘要
Objective: To evaluate the effect and safety of Kangfuyan Capsules(抗妇炎胶囊) for treating pelvic inflammatory disease(PID) in patients with chronic pelvic pain(CPP) in a multicenter, randomized, controlled, double-blind, parallel-group clinical trial. Methods: Totally, 240 PID patients with CPP were randomized into 2 groups using a computer generated random number at a 1:1 ratio from 10 hospitals in China between September 2014 and November 2015. Patients received either oral Kangfuyan Capsules or Gongyanping Capsules(宫炎平胶囊, control); the regimen for both groups comprised 4 capsules(3 times daily) for 12 weeks, with follow-up visit 4 weeks after treatment. The visual analogue scale(VAS) scores, clinical responses, remarkable cure rates for each symptom, and quality of life scores were assessed at baseline, and after 1, 2, and 3 months. Adverse events were also recorded. Results: The VAS scores were significantly lower(P<0.05), whereas the clinical responses, remarkable cure rates for lower abdominal pain, uterine tenderness, adnexal mass, and adnexal tenderness, and health-related quality of life(EQ-5 D) scores were higher in the Kangfuyan group than in the control group at 3 months(P<0.05). Common treatment-related adverse events included high hepatic enzyme levels, reduced hemoglobin levels, and elevated platelet counts, although all the adverse events were either mild or moderate in severity. Conclusion: Compared with Gongyanping therapy, Kangfuyan therapy yielded markedly better analgesia effects for CPP caused by PID, with obvious long-term efficacy and good safety.(Registration No. ChiCTR190022732)
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