芙蓉膏治疗哺乳期急性乳腺炎的倾向性评分匹配研究

A propensity score matching study of Furong Ointment in the treatment of acute mastitis during lactation

目的采用倾向性评分匹配法评价芙蓉膏治疗哺乳期急性乳腺炎的疗效。方法回顾性分析2019年1月-2022年11月首都医科大学附属北京中医医院乳腺科487例哺乳期急性乳腺炎患者的病历资料,根据是否使用芙蓉膏分为芙蓉膏组404例和对照组83例。以倾向性评分匹配法按1∶1比例匹配均衡治疗前易混杂因素,最终2组各有46例匹配成功。芙蓉膏组外敷芙蓉膏,治疗3 d,随访(6±2)d;对照组观察期间不予药物治疗,观察3 d。观察记录2组患者治疗前后乳腺肿块大小、红肿范围;评估患者乳腺疼痛程度、乳汁通畅度、乳房张力,进行中医症状量化分级评分,根据随访结果整理评价芙蓉膏的药物安全性。结果芙蓉膏组治疗后肿块大小[1(1,4)cm^(2)比6(2,12)cm^(2)、4(2,9)cm^(2),Z=4.29]、红肿范围[0(0,0)cm^(2)比3(1,10)cm^(2)、4(0,4)cm^(2),Z=4.22]较同组治疗前及对照组观察后缩小(P<0.05)。芙蓉膏组治疗后VAS评分[1(0,3)分比2(2,4)分,Z=1.79]、乳汁通畅度评分[0(0,3)分比3(0,3)分,Z=3.05]及乳房张力评分[2(0,2)分比4(2,4)分,Z=2.77]较对照组观察后降低(P<0.05)。芙蓉膏组治疗后乳房胀痛[0(0,0)分比1(0,2)分、1(0,1)分,Z=1.12]、乳房肿块面积[2(0,2)分比3(2,3)分、3(2,3)分,Z=1.44]、乳房皮肤灼热[0(0,0)分比1(0,2)分、1(0,1)分,Z=1.00]、头痛/身痛程度[0(0,0)分比0(0,1)分、0(0,1)分,Z=0.60]、舌苔黄腻[0(0,0)分比0(0,1)分、0(0,1)分,Z=0.69]积分及总分[2(3,1)分比6(5,7)分、5(3,5)分,Z=3.79]较同组治疗前及对照组观察后降低(P<0.05)。芙蓉膏组随访期间、肿块大小评分[0(0,2)比1(1,4),Z=2.73]、乳房张力评分[0(0,2)分比2(0,2)分,Z=2.05]较同组治疗后降低(P<0.05)。芙蓉膏组观察期间未见明显药物不良反应。结论芙蓉膏可有效缩小哺乳期急性乳腺炎患者乳腺肿块及红肿范围,减轻乳腺疼痛程度,改善乳汁通畅度及乳房张力。

Objective To evaluate the clinical efficacy of Furong Ointment in the treatment of acute mastitis during lactation using propensity score matching.Methods The medical records of 487 patients with acute mastitis during lactation were retrospectively analyzed in the Department of Mammography,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,from January 2019 to November 2022,and were divided into 404 cases in the Furong Ointment group and 83 cases in the control group according to whether or not Furong Ointment was used.The propensity score matching method was used to match and equalize the pre-treatment confounding factors in a 1:1 ratio,and finally 46 cases in each of the 2 groups were successfully matched.In the Furong Ointment group,Furong Ointment external application or Furong Ointment mammary gland patch was applied for 3 d,and the follow-up period was(6±2)d.In the control group,no medication was given during the observation period,and the observation period was 3 d.Observations were made to record the size of the mammary gland lumps and the extent of redness and swelling before and after the treatment in the patients of the two groups;the degree of mammary gland pain,breast milk smoothness,and breast tension were evaluated,and the quantitative grading scores of TCM symptoms were performed;the safety of the Furong Ointment was evaluated based on the results of the follow-up period.Results The size of the lump[1(1,4)cm^(2)vs.6(2,12)cm^(2),4(2,9)cm^(2),Z=4.29]and the extent of redness and swelling[0(0,0)cm^(2)vs.3(1,10)cm^(2),4(0,4)cm^(2),Z=4.22]were reduced in the Furong Ointment group after treatment compared with those in the same group before treatment and the control group after observation(P<0.05).The VAS score[1(0,3)vs.2(2,4),Z=1.79],milk patency score[0(0,3)vs.3(0,3),Z=3.05]and breast tension score[2(0,2)vs.4(2,4),Z=2.77]in the Furong Ointment group were lower than those in the control group after observation(P<0.05).After treatment,breast swelling and pain[0(0,0)vs.1(0,2),1(0,1),Z=1.12],breast lump area[2(0,2)vs.3(2,3),3(2,3),Z=1.44],breast skin burning[0(0,0)vs.1(0,2),1(0,1),Z=1.00],and the degree of headache/bodyache[0(0,0)vs.0(0,1),0(0,1),Z=0.60],yellowish and greasy tongue coating[0(0,0)vs.0(0,1),0(0,1),Z=0.69]score and total score[2(3,1)vs.6(5,7),5(3,5),Z=3.79]in the Furong Ointment group were reduced compared with those of the same group before the treatment and after the observation of the control group(P<0.05).During the follow-up period,mass size score[0(0,2)vs.1(1,4),Z=2.73],breast tension score[0(0,2)vs.2(0,2)]of the Furong Ointment group were lower than those in the control group(P<0.05).No significant adverse drug reactions were observed in the Furong Ointment group during the observation period.Conclusion Furong Ointment can effectively reduce the extent of breast lumps and redness in patients with acute mastitis during lactation,reduce the degree of breast pain,and improve the degree of breast milk patency and breast tension.