中药穴位贴敷辅助治疗乳腺增生多中心随机双盲安慰剂对照研究  

Acupoint Application of Chinese Herbs for Assistant Treatment of Mammary Hyperplasia:A Multi-center,Randomized,Double-blinded,Placebo-controlled Clinical Study

作　　者：刘晓菲[1] 房小芳 李湘奇 陈守华 徐春红[5] 李良[6] LIU Xiao-fei;FANG Xiao-fang;LI Xiang-qi;CHEN Shou-hua;XU Chun-hong;LI Liang(Department of Breast and Thyroid Surgery,Affiliated Hospital,Shandong University of Traditional Chinese Medicine,Jinan,250014;College of Traditional Chinese Medicine,Shandong University of Traditional Chinese Medicine,Jinan,250014;Department of Breast Surgery,Second Affiliated Hospital,Shandong First Medical University,Shandong,271099;Department of Breast Surgery,First Affiliated Hospital,Shandong First Medical University,Jinan,250013;Department of Thyroid and Breast Surgery,Weifang Hospital of Traditional Chinese Medicine,Shandong,261041;Department of Breast and Thyroid Surgery,Zibo Central Hospital,Shandong,255020)

机构地区：[1]山东中医药大学附属医院乳腺甲状腺外科,济南250014 [2]山东中医药大学中医学院,济南250014 [3]山东第一医科大学第二附属医院乳腺外科,山东271099 [4]山东第一医科大学第一附属医院乳腺外科,济南250013 [5]山东省潍坊市中医院甲状腺乳腺外科,山东261041 [6]山东省淄博市中心医院乳腺甲状腺外科,山东255020

出　　处：《中国中西医结合杂志》2024年第11期1301-1306,共6页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：中华中医药学会春播行动中医药贴敷疗法项目(No.H20210908-05);山东省自然科学基金面上项目(No.ZR2020MH356);2022年山东省优质专业学位教学案例库立项建设项目(No.SDYAL2022045)。

摘　　要：目的 观察中药穴位贴敷治疗乳腺增生(MH)改善乳房疼痛及中医证候积分、缓解焦虑抑郁状态、提高生活质量的临床疗效及对炎症因子的影响。方法 将176例MH患者中符合纳入标准的148例患者按数字生成的顺序将分组方案装入不透光的密封信封,按随机数字1:1的比例分为试验组(消肿止痛贴+中药粉末)和对照组(消肿止痛贴安慰剂+中药粉末安慰剂),每组74例。两组均选取阿是穴(双侧)、涌泉穴(双侧)、神阙穴进行隔日贴敷,每次6~8 h;腋十(双侧)进行贴敷,每次30 min;共治疗8周。比较两组患者治疗前后的乳房疼痛(VAS)评分、中医证候积分、焦虑自测量表(SAS)、汉密顿抑郁量表(HAMD)、生活质量量表(SF-36)评分及血清5-羟色胺(5-HT)、脑源性神经营养因子(BDNF)、白细胞介素(IL)-6、肿瘤坏死因子-α(TNF-α)水平变化。结果 治疗8周后,试验组乳房疼痛、乳房触痛VAS评分明显低于对照组(t_(1)=-7.262,t_(2)=-6.914,P<0.01);平均起效时间试验组为(8.81±4.06)天,短于对照组[(12.59±6.90)天],差异有统计学意义(t=-4.029,P<0.01);试验组中医证候积分、SAS量表及HAMD量表评分低于对照组,SF-36量表评分高于对照组(t_(1)=-6.882,t_(2)=-2.537,t_(3)=-2.864,t4=3.241,P<0.01);试验组IL-6、TNF-α水平低于对照组,5-HT、BDNF水平高于对照组(t_(1)=-3.155,t_(2)=-2.963,t_(3)=2.051,t4=6.631,P<0.05,P<0.01)。结论 消肿止痛贴联合中药粉穴位贴敷可减轻乳房疼痛、改善免疫环境及焦虑抑郁状态、提高生活质量。(中国临床试验注册中心No.Chi CTR 2200056568)Objective To observe the clinical efficacy of acupoint application of Chinese herbs(CHs)on mammary hyperplasia(MH)in improving breast pain and Chinese medical syndrome scores(CMSS),elevating patients'quality of life(QOL),and its effect on inflammatory factors.Methods A total of 148 patients in line with the inclusion criteria were placed into an opaque sealed envelope in a numerically generated sequence,and then assigned to the experimental group (Xiaozhong Zhitong Plaster + CHs powder) and the control group(Xiaozhong Zhitong Plaster placebo + CHs powder placebo) according to random digit ratio of 1:1, 74 cases ineach group. Ashi point (bilateral), Yongquan point (KI1, bilateral), and Shenque point (RN8) were applied everyother day for 6~8 h each time. CHs acupoints were applied at armpit_(1)0 points (bilateral) for 30 min each time. Thetreatment lasted for 8 weeks. Changes of breast pain Visual Analogue Score (VAS), CMSS, Self-rated AnxietyScale (SAS) score, Hamilton Depression (HAMD) score, QOL score (SF-36), and serum levels of 5-hydroxytryptamine (5-HT), brain-derived neurotrophic factor (BDNF), IL-6, and tumor necrosis factor-α (TNF-α)were compared between the two groups before and after treatment. Results After 8 weeks of treatment,the scores of breast pain and breast tenderness (VAS) were significantly lower in the experimental group than inthe control group (t_(1) =-7.262, t_(2) =-6.914, P<0.01), and the average onset time was shorter in the experimentalgroup than in control group [(8.81 ±4.06) days vs . (12.59 ±6.90) days;t =-4.029, P <0.01)]. CMSS, SASscore, and HAMD score were lower, and SF-36 score was higher in the experimental group than those in thecontrol group (t_(1)=-6.882, t_(2)=-2.537, t3=-2.864, t 4=3.241, P<0.01). IL-6 and TNF-α were lower, and 5-HTand BDNF were higher in the experimental group than in the control group (t_(1)=-3.155, t_(2)=-2.963, t_(3)=2.051,t 4=6.631, P<0.05, P<0.01). Conclusion Xiaozhong Zhitong Plaster combined with CHs powder acupointapplication alleviated breast

关 键 词：乳腺增生 5-羟色胺 中药 穴位贴敷 随机对照研究 双盲 

分 类 号：R269[医药卫生—中西医结合]