乳痛愈药膜治疗肝郁气滞型乳腺增生病患者的疗效观察

Clinical Study of Rutongyu Medicine Membrane on Mammary Hyperplasia of Liver Stagnation and Qi Stagnation

目的 研究乳痛愈药膜对肝郁气滞型乳腺增生病的疗效及安全性。方法 选取2015年5月—2016年7月期间北京中医药大学东方医院乳腺科门诊收治的肝郁气滞型乳腺增生病患者100例,按1∶1的比例随机分为治疗组和对照组。100例入组病例中,共收集完整数据病例89例,对照组46例,治疗组43例,剔除11例。对照组采用荞麦面粉治疗,即在患者双侧乳房上敷荞麦面粉糊后,在面糊表面覆盖煅石膏糊;治疗组采用等量乳痛愈药膜治疗:在患者双侧乳房上敷乳痛愈药膜后,同样在药膜表面覆盖煅石膏糊;两组患者治疗时间均为20 min/次,隔天1次,每个月经周期治疗不少于10次,治疗周期为3个月经周期,经期不用药,治疗结束后随访1个月经周期。观察两组患者治疗前后乳房疼痛、乳房肿块等指标的变化。结果 治疗1周期、2周期、3周期后及随访期两组患者乳房疼痛积分均较治疗前降低,差异有统计学意义(P<0.01);且治疗组乳房疼痛程度积分下降程度优于对照组,差异有统计学意义(P<0.01)。治疗1周期、2周期、3周期后及随访期两组患者乳腺相关症状体征(疼痛、肿块)积分均较治疗前降低,差异有统计学意义(P<0.01);且治疗组乳腺相关症状体征(疼痛、肿块)积分下降程度优于对照组,差异有统计学意义(P<0.01)。治疗组治疗3周期后总有效率76.74%(33/43)、随访期总有效率79.07%(34/43)均较对照组治疗3周期后32.61%(15/46)、随访期32.61%(15/46)升高,差异有统计学意义(P<0.01)。治疗1周期、2周期、3周期后及随访期两组患者中医证候综合疗效总积分均较治疗前降低,差异有统计学意义(P<0.01);且治疗组中医证候综合疗效总积分下降程度优于对照组,差异有统计学意义(P<0.01)。治疗3周期后治疗组中医证候综合疗效总有效率76.74%(33/43)、随访期79.07%(34/43)均较对照组26.09%(12/46)、随访期28.26%(13/46)升高,差异有统计学意义(P<0.01)。两组患者治疗期间均未发生皮肤刺激、过敏相关的不良反应。结论 乳痛愈药膜治疗肝郁气滞型乳腺增生病能明显减轻乳房疼痛等症状,能够缩小肿块,疗效确切且安全,无皮肤刺激不良反应。

Objective To study the efficacy and safety of Rutongyu Medicine Membrane in the treatment of mammary hyperplasia with liver stagnation and qi stagnation.Methods A total of 100 patients with liver stagnation and qi stagnation type mammary hyperplasia admitted to the department of mammary gland of Oriental Hospital of Beijing University of traditional Chinese Medicine from May 2015 to July 2016 were selected and randomly divided into treatment group and control group according to a ratio of 1∶1.Among the 100 included cases, a total of 89 cases with complete data were collected, including 46 cases in the control group, 43 cases in the treatment group and 11 cases excluded.The control group was treated with buckwheat flour: after applying buckwheat flour paste on both breasts of the patient, the surface of the batter was covered with calcined gypsum paste;The treatment group was treated with the same amount of Rutongyu Medicine Membrane: after applying the Rutongyu Medicine Membrane on both breasts of the patient, the surface of the membrane was also covered with calcined plaster.The treatment duration of the two groups was 20 minutes, once every other day, no lessthan 10 times per menstrual cycle.The treatment cycle was 3 menstrual cycles, no medication was used during menstrual period, and the follow-up period was 1 menstrual cycle after the end of treatment.The changes of breast pain, breast lumps and other indexes were observed before and after treatment.Results After 1,2 and 3 cycles of treatment and in the follow-up period, the breast pain score of both groups was significantly decreased compared with that before treatment(P<0.01),and the reduction degree of breast pain score of the treatment group was significantly better than that of the control group(P<0.01).In addition, after 1,2,3 cycles of treatment and at the follow-up period, the scores of mammary gland related symptoms and signs(pain, mass)in both groups were significantly reduced compared with those before treatment(P<0.01),and the scores of mammary gland related symptoms and signs(pain, mass)in the treatment group were significantly reduced than those in the control group(P<0.01).After 3 cycles of treatment, the total effective rate of the treatment group was 76.74%(33/43),and the total effective rate of the follow-up period was 79.07%(34/43),which were significantly higher than that of the control group[32.61%(15/46)]and the follow-up period[32.61%(15/4),P<0.01].After 1,2 and 3 cycles of treatment and in the follow-up period, the total score of comprehensive efficacy of TCM syndrome in two groups was significantly decreased compared with that before treatment(P<0.01),and the decrease degree of total score of comprehensive efficacy of TCM syndrome in the treatment group was significantly better than that in the control group(P<0.01).The total effective rate of the comprehensive effect of TCM syndrome in the treatment group after 3 cycles was 76.74%(33/43),and that in the follow-up period was 79.07%(34/43),both of which were significantly higher than that in the control group after 3 cycles[26.09%(12/46)]and that in the follow-up period[28.26%(13/46),P<0.01].No adverse reactions related to skin irritation or allergy occurred in the two groups during treatment.Conclusion Rutongyu Medicine Membrane can significantly reduce breast pain and other symptoms of mammary hyperplasia of liver stagnation and qi stagnation, can narrow the lump, the curative effect is accurate and safe, without adverse reactions to skin irritation.