乳腺导管探查术治疗乳汁淤积的临床研究

Clinical study on ductal probing in treating milk stasis

目的探讨乳腺导管探查术治疗乳汁淤积的效果及可能的影响因素。方法选择2012年1月至2016年5月北京市海淀区妇幼保健院收治的乳汁淤积患者2 544例进行前瞻性研究。运用随机数字表法将患者分为研究组(1 159例)及对照组(1 385例),研究组采用乳腺导管探查术治疗,对照组采用乳腺物理综合治疗(包括乳腺按摩、半导体激光物理治疗、电动吸奶器吸乳、50%硫酸镁局部外敷30 min)。随访1个月,比较2组患者治疗效果及复发率的差异。根据研究组中乳汁淤积的病程、肿块距离乳头的距离以及肿块直径进行亚组分析,比较亚组间治疗效果的差异。复发率比较采用χ~2检验;治疗效果比较采用非参数检验,其中2组比较采用Wilcoxon检验,3组比较采用Kruskal-Wallis检验。结果治疗后,研究组847例治愈,156例好转,73例有效,65例无效,18例病情进展;对照组441例治愈,312例好转,291例有效,308例无效,33例病情进展,2组治疗效果差异有统计学意义(Z=-20.75,P<0.001)。2组复发率的差异无统计学意义[14.6%(169/1 159)比14.0%(194/1 385),χ~2=0.17,P=0.680]。亚组分析显示:不同病程组(<2 d组、2~3 d组及>3 d组)以及肿块距离乳头不同距离组(<3 cm组、3~5 cm组及>5 cm组)应用乳腺导管探查术的治疗效果比较,差异均有统计学意义(Z=116.14,P<0.001;Z=198.77,P<0.001)。不同肿块直径组(≤5 cm组和>5 cm组)治疗效果比较,差异无统计学意义(Z=-1.00,P=0.317)。结论与乳腺物理综合治疗相比,导管探查术可提高乳汁淤积患者的疗效,值得推广。该技术的治疗效果与病程及肿块到乳头的距离有关,与肿块直径无关。

Objective To evaluate the efficacy of ductal probing in treating milk stasis and the possible influencing factors. Methods A total of 2 544 patients with milk stasis in Haidian Maternal and Child Health Hospital from January 2012 to May 2016 were enrolled in this prospective study. They were divided into the study group（ n = 1 159） and the control group（ n = 1 385） using a random number table method. The patients in study group were treated by ductal probing and the patients in control group received comprehensive physiotherapy（ including local massage,semiconductor laser physical therapy,electric breast pump sucking and external application with 50% magnesium sulfate for 30 min）. The patients were followed up for 1 month. The efficacy and recurrence rate were compared between two groups. According to the course of milk stasis,the distance from the nipple to the lump and the lump diameter,all patients in study group were subdivided to compare the efficacy of ductal probing among subgroups. The recurrence rate was compared between two groups using χ~2 test. The non-parametric test was used to compare the treatment outcome. Two groups were compared using the Wilcoxon test,and three groups were compared using the Kruskal-Wallis test. Results After the treatment,there were 847 patients cured,156 improved,73 with clinical response,65 with no response,and18 with disease progression in the study group,441,312,291,308 and 33 in control group. The efficacy of ductal probing showed a significant difference（ Z =-20. 75,P〈0. 001）. The difference in the recurrence rate between two groups was not statistically significant [14. 6%（ 169/1 159） vs 14. 0%（ 194/1 385）,χ2= 0. 17,P = 0. 680]. Subgroup analysis showed that the efficacy of ductal probing was significantly different among the subgroups with different courses（ 〈2 d,2 - 3 d and〉 3 d） and different distance from the nipple to the lump（ 〈3 cm,3 - 5 cm and 〉5 cm）（ Z = 116. 14,P〈0. 001; Z = 198. 77,P〈0. 001）. The efficacy of ductal probing showed no significant difference between the patients with the lump ≤5 cm and the patients with the lump 〉5 cm（ Z =-1. 00,P = 0. 317）. Conclusions Compared with mammary physiotherapy,ductal probing is effective in patients with milk stasis,worthy of clinical application. The outcome of this operation is related to the disease course and the distance from the nipple to the lump,irrelevant of the lump diameter.