盆炎丸联合雷火灸治疗盆腔炎性疾病后遗症的随机对照试验  

Penyan pill combined with thunder fire moxibustion in patients with sequelae of pelvic inflammatory disease:a randomized controlled trial

作　　者：胡依 余艳兰[1] 唐丽 HU Yi;YU Yanlan;TANG Li(Department of Gynecology,the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine,Changsha 410007,China)

机构地区：[1]湖南中医药大学第一附属医院妇科,长沙410007

出　　处：《药物流行病学杂志》2025年第2期144-150,共7页Chinese Journal of Pharmacoepidemiology

基　　金：湖南中医药大学校院联合基金项目(202305)。

摘　　要：目的观察盆炎丸联合雷火灸(TFM)对盆腔炎性疾病后遗症(SPID)的临床疗效。方法招募2023年5月—2024年5月湖南中医药大学第一附属医院妇科就诊的SPID患者,随机均等分为A组(奥硝唑)、B组(奥硝唑联合盆炎丸)和C组(奥硝唑联合盆炎丸及TFM)。主要结局指标为治疗有效率;次要指标为中医证候积分(TCMSI)、视觉模拟量表(VAS)评分、健康状况调查量表(SF-36)评分、焦虑自评量表(SAS)评分、炎症因子[白细胞介素-6(IL-6)、肿瘤坏死因子(TNF-α)和C-反应蛋白(CRP)]、药品不良反应发生率。所有观察指标均在治疗前及治疗12周后评估。结果共纳入195例SPID患者,16例患者因依从性不佳而未能完成研究,故最终每组病例数分别为A组59例、B组60例、C组60例。C组治疗有效率为95.00%,显著高于B组(80.00%)和A组(71.19%)(P<0.017),而A组和B组的有效率差异无统计学意义(P>0.017)。治疗后,3组患者的TCMSI总分、VAS评分、SF-36评分、SAS评分、血清IL-6、TNF-α和CRP水平均较入组时显著改善(P<0.05),且C组各项指标均明显优于B组和A组(P<0.05)。3组患者均未见不良反应出现。结论盆炎丸联合TFM可改善SPID患者疼痛程度、生活质量和焦虑状态,提高有效率,可能与盆炎丸及TFM调控炎症因子表达有关。Objective To observe the clinical efficacy of Penyan pill combined with thunder fire moxibustion(TFM)in patients with sequelae of pelvic inflammatory disease(SPID).Methods This study was conducted at the department of gynecology,the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine from May 2023 to May 2024.Patients with SPID were recruited and randomly and equally divided into group A(treated with ornidazole),group B(treated with ornidazole combined with Penyan pill),and group C(treated with ornidazole combined with Penyan pill and TFM).The primary outcome was the treatment effective rate,the secondary indicators were the Traditional Chinese Medicine Syndrome Integral(TCMSI),Visual Analogue Scale(VAS)score,short-form 36 health survey(SF-36)score,Self-rating Anxiety Scale(SAS)score,inflammatory factors[interleukin-6(IL-6),tumor necrosis factor(TNF-α),and C-reactive protein(CRP)],and the incidence of adverse drug reactions.All observation indicators were evaluated before treatment and 12 weeks after treatment.Results A total of 195 patients with SPID were included,and 16 patients failed to complete the study due to poor compliance.Therefore,the final number of cases was 59 in group A,60 in group B,and 60 in group C.The treatment effective rate in group C was 95.00%,which was significantly higher than that in group B(80.00%)and group A(71.19%)(P<0.017).However,there was no significant difference in the effective rates between group A and group B(P>0.017).After treatment,the TCMSI total score,VAS score,SF-36 score,SAS score,and the levels of serum IL-6,TNF-α,and CRP in the three groups were significantly improved compared with those at enrollment(P<0.05).In addition,all the indicators in group C were significantly better than those in group B and group A(P<0.05).No adverse reactions were observed in the three groups.Conclusion Penyan pill combined with TFM can improve the pain degree,quality of life and anxiety state in SPID patients,which may be related to the regulation of inflammator

关 键 词：盆炎丸 雷火灸 盆腔炎性疾病后遗症 随机对照试验 

分 类 号：R969.4[医药卫生—药理学]