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,pa...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-5D)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)展开更多
目的:观察健脾益肾祛湿丸治疗盆腔炎性疾病后遗症(Sequelae of Pelvic Inflammatory Disease,SPID)脾虚湿盛证患者的临床疗效及药物安全性,验证其相对优势所在,为该疾病的诊疗拓展更宽的思路,为该方用于临床患者治疗的有力手段提供理论...目的:观察健脾益肾祛湿丸治疗盆腔炎性疾病后遗症(Sequelae of Pelvic Inflammatory Disease,SPID)脾虚湿盛证患者的临床疗效及药物安全性,验证其相对优势所在,为该疾病的诊疗拓展更宽的思路,为该方用于临床患者治疗的有力手段提供理论依据。方法:通过随机对照临床研究方法,将满足纳入排除条件60例患者分成观察组(健脾益肾祛湿丸)、对照组(康妇炎胶囊),观察治疗前后中医证候积分、临床疗效、局部体征评分指标,并对其进行详细比较。结果:中医证候积分、局部体征评分上有统计学意义;2组经治疗有效率评价比较有统计学意义。结论:健脾益肾祛湿丸治疗盆腔炎性疾病后遗症脾虚湿盛证对腰骶胀痛、下腹疼痛、身倦乏力、带下异常改善效果极佳,效果优于对照组,彰显了健脾益肾祛湿丸治疗SPID的临床优势,为SPID患者的中医治疗提供了新的思路。展开更多
文摘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-5D)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)
文摘目的:观察健脾益肾祛湿丸治疗盆腔炎性疾病后遗症(Sequelae of Pelvic Inflammatory Disease,SPID)脾虚湿盛证患者的临床疗效及药物安全性,验证其相对优势所在,为该疾病的诊疗拓展更宽的思路,为该方用于临床患者治疗的有力手段提供理论依据。方法:通过随机对照临床研究方法,将满足纳入排除条件60例患者分成观察组(健脾益肾祛湿丸)、对照组(康妇炎胶囊),观察治疗前后中医证候积分、临床疗效、局部体征评分指标,并对其进行详细比较。结果:中医证候积分、局部体征评分上有统计学意义;2组经治疗有效率评价比较有统计学意义。结论:健脾益肾祛湿丸治疗盆腔炎性疾病后遗症脾虚湿盛证对腰骶胀痛、下腹疼痛、身倦乏力、带下异常改善效果极佳,效果优于对照组,彰显了健脾益肾祛湿丸治疗SPID的临床优势,为SPID患者的中医治疗提供了新的思路。
