摘要
目的评价妇炎清颗粒对盆腔炎性疾病后遗症(湿热瘀结证)的临床疗效。方法采用随机对照、双盲双模拟临床研究设计方法,5个试验中心300例盆腔炎性疾病后遗症(湿热瘀结证)患者随机分为试验组(150例)与对照组(150例)。试验组予妇炎清颗粒及金刚藤胶囊模拟剂口服,对照组予金刚藤胶囊及妇炎清颗粒模拟剂口服,疗程4周。将治疗前、治疗后及治疗结束后12周两组的临床总疗效、中医症状积分、盆腔疼痛评分疗效、盆腔积液及包块的恢复、宫颈分泌物恢复、复发率等情况进行比较。结果300例患者中,符合方案有效病例282例,试验组145例,对照组137例。疗程结束后,试验组、对照组总有效率分别为91.03%(132/145)、67.88%(93/137),试验组优于对照组(P<0.05);试验组治疗后的中医症状积分减少程度对比对照组更佳(P<0.05);试验组与对照组盆腔疼痛疗效有效率分别为93.10%(135/145)和75.91%(104/137),试验组优于对照组(P<0.05);两组盆腔内积液、包块恢复情况比较,试验组优于对照组(χ^(2)=15.633,P<0.05);宫颈分泌物恢复情况试验组优于对照组(χ^(2)=8.560,P<0.05);治疗结束后12周进行对比,试验组治疗有效患者的临床症状复发率较对照组更低(P<0.05);两组不良反应发生率在治疗过程中对比差异无统计学意义(P>0.05),两组药物均有较高安全性。结论妇炎清颗粒治疗盆腔炎性疾病后遗症(湿热瘀结证)临床疗效确切,在临床综合总疗效、中医症状总积分和单个症状积分的疗效等方面均优于金刚藤胶囊。
Objective To analyze the clinical efficacy of Fuyanqing Granule(妇炎清颗粒)on sequelae of pelvic inflammatory diseases(damp-heat and blood stasis syndrome).Methods Using a randomized controlled,double-blind and double-simulation clinical study design method,300 patients with sequelae of pelvic inflammatory disease(damp-heat and blood stasis syndrome)from 5 trial centers were randomly divided into an experimental group(150 cases)and a control group(150 cases).The experimental group was given oral administration of Fuyanqing Granule and Jingangteng Capsule(金刚藤胶囊)mimetics,while the control group was given oral administration of Jingangteng Capsule and Fuyanqing Granule mimetics,with a course of 4 weeks.The total clinical efficacy,traditional Chinese medicine symptom scores,pelvic pain score,recovery of pelvic fluid and mass,recovery of cervical secretions and recurrence rate were compared between the two groups before and after treatment and 12 weeks after treatment.Results Among the 300 patients,there were 282 effective cases that met the protocol,145 in the experimental group and 137 in the control group.After the end of the treatment course,the total effective rates of the experimental group and the control group were 91.03%(132/145)and 67.88%(93/137),respectively,and the rate of the experimental group was better than that of the control group(P<0.05).The reduction in traditional Chinese medicine symptom scores in the experimental group after treatment was better than that in the control group(P<0.05).The effective rates of pelvic pain treatment in the experimental group and the control group were(135/145)and 75.91%(104/137),respectively,and that of the experimental group was better than that of the control group(P<0.05).The recovery of pelvic fluid accumulation and mass of the experimental group was better than that of the control group(χ^(2)=15.633,P<0.05).The recovery of cervical secretions in the experimental group was better than that in the control group(χ^(2)=8.560,P<0.05).After 12 weeks of treatment,the clinical symptom recurrence rate in the experimental group was lower than that in the control group(P<0.05).There was no statistically significant difference in the incidence of adverse reactions between the two groups during the treatment process(P>0.05)and both groups had high safety.Conclusion The clinical efficacy of Fuyanqing Granule in treating sequelae of pelvic inflammatory diseases(damp-heat and blood stasis syndrome)is definite,and it is superior to Jingangteng Capsule in terms of overall clinical efficacy,total scores of traditional Chinese medicine symptoms and single symptom score.
作者
陈怡
张家玮
黄缨
彭宣文
陈宜斌
贺漪
黄晓艳
胡文金
CHEN Yi;ZHANG Jiawei;HUANG Ying;PENG Xuanwen;CHEN Yibin;HE Yi;HUANG Xiaoyan;HU Wenjin(Jingzhou Hospital of Traditional Chinese Medicine,Jingzhou 434000,Hubei,China;Maternal and Child Health Hospital of Hubei Province,Wuhan 430000,Hubei,China;Shiyan Hospital of Traditional Chinese Medicine,Shiyan 442000,Hubei,China;Wuhan No.1 Hospital,Wuhan 430000,Hubei,China;Jingmen Hospital of Traditional Chinese Medicine,Jingmen 448000,Hubei,China)
出处
《辽宁中医杂志》
CAS
北大核心
2024年第3期116-120,共5页
Liaoning Journal of Traditional Chinese Medicine
基金
湖北省自然科学基金项目(2020CFB718)
湖北省医学领军人才培养工程专项经费项目(鄂卫通[2019]47号)。
关键词
妇炎清颗粒
湿热瘀结证
盆腔炎性疾病后遗症
Fuyanqing Granules(妇炎清颗粒)
type of damp-heat and blood stasis syndrome
sequelae of pelvic inflammatory disease
