摘要
目的验证自制新型“乳核散”凝胶的临床疗效及安全性。方法选择2018年7月-2021年7月收治的以乳腺小叶增生性肿块为主的良性肿瘤及乳腺结节微创消融术后患者300例,其中行微创消融术治疗和未行微创消融术治疗的患者均为150例。按照随机数字表法将行消融术治疗的患者分为治疗1组、对照1组,将未行微创消融术治疗的患者分为治疗2组、对照2组。治疗组给予“乳核散”凝胶贴敷治疗,对照组给予乳腺宁贴贴敷治疗,1次/d,1个疗程30 d,连续治疗2个疗程。对比2组疗效,治疗前及第1、2疗程结束时视觉模拟评分法(VAS)评分、症状体征积分及结节最大直径、体积、不良反应。结果治疗1组总有效率高于对照1组(P<0.05),治疗2组总有效率高于对照2组(P<0.05)。与治疗前比较,第1、2疗程结束时各组VAS评分均降低(P<0.05);第1、2疗程结束时,治疗组VAS评分均低于对照组(P<0.05)。与治疗前比较,第1、2疗程结束时各组乳房疼痛积分、总积分均降低(P<0.05);第2疗程结束时各组乳房肿块积分均降低(P<0.05)。第1、2疗程结束时,治疗组乳房疼痛积分、总积分均低于对照组(P<0.05)。与治疗前比较,第1、第2疗程结束时治疗1组、对照1组乳腺结节最大直径及体积均缩小(P<0.05)。第1、2疗程结束时,治疗1组结节最大直径及体积均小于对照1组(P<0.05)。治疗期间各组均未出现严重不良反应,对照组1例出现用药局部皮肤颜色轻度变红及瘙痒,3例对贴布轻度过敏,敷贴部位出现皮肤瘙痒、少许疱疹,予以氯地霜局部外用后症状改善。结论新型“乳核散”凝胶可改善乳腺小叶增生患者临床症状,促进术后肿块吸收,临床使用安全。
Objective To verify the clinical efficacy and safety of self-made Ruhe Powder Gel.Methods A total of 300 patients with benign tumors and breast nodules mainly characterized by lobular proliferative masses of the breast who underwent minimally invasive ablation were admitted to Shanghai Traditional Chinese Medicine Hospital from July 2018 to July 2021 were selected,among whom,150 patients were treated with minimally invasive ablation and 150 patients were not treated with minimally invasive ablation.According to the random number table,the patients who underwent ablation were divided into treatment group 1 and control group 1,and the patients who did not receive minimally invasive ablation were divided into treatment group 2 and control group 2.The treatment group was given Ruhe Powder Gel for external application on the affected breast,and the control group was given external application of Mammalin Paste for 2 consecutive courses,all once a day and 30 days as one course.The curative effect,visual analogue scale(VAS)score,symptoms and signs score,the maximum diameter,volume and adverse reactions of nodules were compared between the two groups.Results The total effective rate of treatment group 1 was higher than that of control group 1(P<0.05),and that of treatment group 2 was higher than that of control group 2(P<0.05).Compared with before treatment,the VAS scores of each group decreased at the end of the first and second courses(P<0.05).At the end of the first and second courses,the VAS scores of the treatment group were lower than those of the control group(P<0.05).Compared with before treatment,at the end of the first and second courses,the scores of breast pain and total scores in each group were decreased(P<0.05).At the end of the second course of treatment,the integral of breast lump in each group decreased(P<0.05).At the end of the first and second courses,the score and total score of breast pain in the treatment group were lower than those in the control group(P<0.05).Compared with before treatment,the ma
作者
李家磊
王小平
蔡慧群
邓佳琳
朱小雨
LI Jia-lei;WANG Xiao-ping;CAI Hui-qun;DENG Jia-lin;ZHU Xiao-yu(Department of External Surgery,Affiliated Hospital of Shanghai University of Traditional Chinese Medicine,Shanghai 200040,China)
出处
《北京中医药》
2023年第4期385-389,共5页
Beijing Journal of Traditional Chinese Medicine
基金
国家中医药管理局科研项目(2018ZY03005)
上海市科学技术委员会项目(18401904300)
上海市中医医院“未来计划”项目(WLJH2021ZY-MZY009)。
关键词
乳腺小叶增生
“乳核散”凝胶
乳腺宁贴
中医外治
Lobular hyperplasia of breast
Ruhe Powder Gel
Mammalin
self made
External treatment of TCM
