清热解毒方治疗肉芽肿性乳腺炎急性期的前瞻性随机对照研究

A prospective randomized controlled study on the treatment of acute granulomatous mastitis with Qingre Jiedu Formula

目的评价清热解毒方治疗肉芽肿性乳腺炎急性期的临床疗效。方法纳入2021年8月—2023年2月于首都医科大学附属北京中医医院乳腺科门诊就诊的急性期肉芽肿性乳腺炎患者60例,采用随机数字法分为观察组和对照组,各30例。观察组予中药清热解毒方口服,对照组予头孢呋辛酯片口服,均治疗7 d、随访7 d。观察比较2组乳房肿物面积缩小有效率、乳房肿物面积缩小率、红肿面积缩小率、VAS疼痛评分、局部皮肤颜色改变、超声肿物总范围、超声最大病灶范围及白细胞总数(WBC)、中性粒细胞绝对值(NEUT#)、C-反应蛋白(CRP)、动态红细胞沉降率(ESR)等实验室指标水平。结果治疗7 d后,观察组肿物缩小有效率63.3%,对照组肿物缩小有效率59.3%;2组乳房肿物面积缩小率、红肿面积缩小率、疼痛VAS评分、超声肿物总范围、超声最大病灶范围、WBC、NEUT#均较治疗前改善(P<0.05),但2组间差异无统计学意义(P>0.05)。治疗7 d后,与对照组比较,观察组局部皮色评分、CRP均降低,差异有统计学意义(P<0.05)。2组治疗7 d后,ESR均较治疗前下降,但差异无统计学意义(P>0.05)。结论清热解毒方能明显缩小乳房肿块,减轻炎症反应,是一种疗效显著、简便易行的急性期肉芽肿性乳腺炎治疗方案。

Objective To evaluate the clinical efficacy of Qingre Jiedu Formula in the treatment of acute granulomatous mastitis.Methods 60 patients with acute granulomatous mastitis who visited the mammary clinic of Beijing Hospital of Traditional Chinese Medicine affiliated to the Capital Medical University from August 2021 to February 2023 were included.These cases were randomly divided into Qingre Jiedu Foumula Liquid group of 30 cases and Cefuroxime axetil control group of 30 cases.Both groups were treated for 7 days and follow-up for 7 days.The effective rate of breast tumor area reduction,the reduction rate of breast tumor area,the reduction rate of redness and swelling area,VAS pain score,local skin color change,total ultrasound tumor range,maximum ultrasound focus range,white blood cells(WBC),absolute value of neutrophils(NEUT#),C-reactive protein(CRP),Erythrocyte sedimentation rate(ESR)were compared.Results Seven days after the treatment,the effective rate of tumor reduction was 63.3%in the Qingre Jiedu Formula group,and 59.3%in the Cefuroxime axetil group.During the treatment period,the effective rate of breast tumor area reduction,the reduction rate of breast tumor area,the reduction rate of redness and swelling area,VAS pain score,total ultrasound tumor range,maximum ultrasound focus range,WBC,NEUT#(P<0.05)were significantly improved in both the Qingre Jiedu Decoction group and the Cefuroxime axetil group.And there was no significant difference compared with the Cefuroxime axetil group(P>0.05).There was statistical difference in the skin color score and CRP between Qingre Jiedu Formula group and the Cefuroxime axetil group(P<0.05).Conclusion Qingre Jiedu Formula can significantly reduce breast mass,alleviated inflammatory reaction and prevent anxiety and depression.So it is a simple and effective program for the treatment of granulomatous mastitis in acute phase.