Current status of outcome reporting in randomized controlled trials of traditional Chinese medicine for mammary gland hyperplasia: A systematic review

Objective:To assess outcome indicators in clinical trials and provide a reference for establishing a core outcome set to treat hyperplasia of mammary gland(HMG)with traditional Chinese medicine(TCM).Methods:Eight online databases were searched from their inception to December 31,2022,to assess outcomes reported in randomized controlled trials(RCTs)of HMG treated with TCM.The quality of the included studies was assessed according to the Cochrane Risk of Bias Assessment Tool.All outcomes were extracted,classified,and described.Results:A total of 8249 articles were initially retrieved.Of these,70 articles were eligible and involved 10618 participants with HMG.A total of 17 outcome indicators with a frequency of 271 times were involved and were collected according to six outcome domains.Conclusions:The core outcomes of RCTs of HMG treated with TCM are large and divergent.There are problems in evaluation standards,primary and secondary outcomes,TCM characteristic indicators,long-term prognosis,and standardization of reporting.It is recommended to strengthen the trial design and actively construct the core outcome sets with TCM characteristics for HMG.

Effect of Lirukang Oral Liquid(利乳康口服液) on Neurotransmitters and Estrogen in Rats with Hyperplasia of Mammary Gland

Objective: To investigate the effects of Lirukang oral liquid (LRK, 利乳康口服液) on release of neurotransmitter in rats with hyperplasia of mammary glands (HMG) and to explore its mechanism. Methods: Sixty rats were divided into six groups, the normal control group, the model control group, the large dosage (3.6g/kg) and the small dosage (1.8g/kg ) LRK groups, the Ruzengning (乳增宁, RZN, 2.5g/kg) group and the tamoxifen (TAM, 5mg/kg) group, 10 in each group. Except those in the normal control group, all the animals were made into rat model of HMG by intraperitoneal injection of estradiol benzoate. Levels of dopamine (DA) and 5-hydroxytryptamine (5-HT) in hypothalamus and mammary gland in rats were detected by fluorescence luminosity assay, and level of prolactin (PRL) in serum was detected by radioimmunoassay. Results: In the model group, the level of DA reduced significantly ( P<0. 01), and 5-HT and PRL increased obviously ( P<0.01). Compared with the model group, the LRK groups of both dosages and the TAM group had their level of DA significantly increased (P<0. 01), and level of 5-HT significantly decreased ( P<0.01). The serum PRL in both LRK groups was significantly decreased ( P<0. 01). No obvious changes in DA, 5-HT and PRL were found in the RZN group. Conclusion: LRK and TAM have similar effects in regulating the release of neurotransmitter in hypothalamus and mammary gland and serum content of estrogen in the animal models of HMG.

Differential Acupuncture Treatment of Hyperplasia of Mammary Glands

Hyperplasia of mammary glands is a common disease in the middle-aged women, and it is a precancerous lesion of mammary glands. For many years, the author has used Rugen (ST 18) of the Stomach Meridian of Foot-Yangming as the main point withcertain auxiliary points chosen on basis of the differentiation types to treat the disease and obtained satisfactory therapeutic effects. A report follows. ……

Core acupoints of acupuncture for hyperplasia of mammary gland: a network analysis

Backgroud:Clinical studies on acupuncture treatment of hyperplasia of mammary gland(HMG)have proved its effectiveness,but most studies have paid little attention to acupoints prescription and acupoint compatibility.The clinical prescription is not identical,the curative effect also has the difference.Therefore,through data mining and network analysis,this study explored the core acupoints and the compatibility law of acupoints in acupuncture treatment of HMG.Methods:To search and select qualified literature according to inclusion and exclusion criteria for relevant clinical research literature on acupuncture treatment of HMG in CNKI,VIP database,WanFang database and PubMed,etc.Then extract relevant information and establish a database.Using the method of statistical and complex network analysis,this paper studies the core acupoints and the law of acupoint compatibility.Results:A total of 104 Chinese literatures and 0 English literatures were included and 106 acupuncture prescriptions were extracted.The core acupoints in the treatment of HMG are Danzhong(CV 17),Wuyi(ST 15),Zusanli(ST 36),Jianjing(GB 21).Danzhong(CV 17)and Zusanli(ST 36),Danzhong(CV 17)and Wuyi(ST 15),Jianjing(GB 21)and Tianzong(SI 11),Jianjing(GB 21)and Wuyi(ST 15)have the highest correlation degree.The method of acupoint matching mainly consists of local-remote acupoints,upper-lower acupoints and front-rear acupoints.Conclusion:The results of a network analysis substantially accord with the general rules of acupuncture theories in traditional Chinese medicine,able to reflect the points-selection principles and features in acupuncture treatment of HMG and provide evidence for the acupoints selection in the treatment of HMG in acupuncture clinic.

ELECTROACUPUNCTURE TREATMENT OF 30 CASES OF HYPERPLASIA OF MAMMARY GLANDS

In the present paper,30 cases of hyperplasia of mammary glands were treated withelectroacupuncture in different times following menstruation,showing satisfactory results.The totaleffective rate was up to 96.67％.In addition,the symptom of mastalgla abated abviously after treat-ment.

Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland:A meta-analysis and trial sequential analysis

Objective:To evaluate the efficacy and safety of Rupi Sanjie(RPSJ)capsule plus the conventional surgical operation for treatment of hyperplasia nodule of mammary gland.Methods:A meta-analysis was conducted on randomized controlled trials(RCT)related to RPSJ capsule plus surgical operation in the treatment of hyperplasia nodule of mammary gland.The methodological quality of eligible RCTs was assessed according to the criteria from the Cochrane Handbook for Systematic Reviews of Interventions.RevMan5.3 and Stata14.0 were used for data analyses.Trial sequential analysis was performed to estimate the sample size of systematic review base on TSA software v0.9.Results:Twenty-two RCTs were totally included in this study,involving 2135 patients.The result showed the clinical recurrence rate of RPSJ capsule plus surgical treatment group was significantly lower than surgical treatment alone group(RR:0.25,95%CI[0.17,0.37],P<0.01).The clinical cure rate and total effective rate were higher in RPSJ capsule plus surgical treatment group than the conventional surgical treatment group(RR:1.63,95%CI[1.46,1.82],P<0.01);(RR:1.29,95%CI[1.22,1.37],P<0.01).Application of RPSJ capsule decreased the occurrence of adverse events including nausea,vomiting,irregular menstruation,constipation,dizziness,and headache etc.(RR:0.90,95%CI[0.54,1.49],P=0.68).The results of trial sequential analysis demonstrated that the current available data did not reach the expected value.Conclusion:RPSJ capsule plus the conventional surgical treatment was more effective in reducing the clinical recurrence rate,and improving the total clinical effective rate and clinical cure rate,with a decrease in the occurrence of adverse events.

Network meta-analysis of acupuncture treatment for mammary gland hyperplasia

Objective: To evaluate the efficacy of acupuncture for the treatment of mammary gland hyperplasia. Methods: Randomized controlled trials before December 2017 in CNKI, China Biology Medicine disc, Chinese sci-tech periodical full-text database, Wanfang database, Cochrane Library, Pubmed, Embase and Web of Science were searched. The risks were evaluated by two investigators according to the Cochrane Handbook 5.1.0 criteria. Evaluation GeMTC was used for network-meta analysis. Results: A total of 43 articles were included, involving 5531 patients. Network meta-analysis results showed that there were differences in the comparison before and after treatment: acupuncture + Chinese herbal medicine vs acupuncture, acupuncture + Chinese herbal medicine vs Chinese herbal medicine, acupuncture + Chinese herbal medicine v s acupoint embedding, acupuncture + western medicine vs acupuncture, acupuncture + western medicine vs western medicine, acupuncture + western medicine vs Chinese herbal medicine, fire needle vs acupuncture, fire needle vs Chinese herbal medicine, moxibustion vs acupuncture, moxibustion vs Chinese herbal medicine, acupoint embedding line + Chinese herbal medicine vs Chinese herbal medicine, acupoint embedding line + Chinese herbal medicine vs western medicine, acupoint embedding line + Chinese herbal medicine vs acupuncture, acupoint embedding line + Chinese herbal medicine vs acupuncture + Chinese herbal medicine, acupoint embedding line + Chinese herbal medicine vs acupuncture + western medicine, acupoint embedding line + Chinese herbal medicine vs fire needle, acupoint embedding line + Chinese herbal medicine vs fire needle + Chinese herbal medicine, acupoint embedding line + Chinese herbal medicine vs electroacupuncture, acupoint embedding line + Chinese herbal medicine vs acupoint embedding line, Acupoint embedding line + Chinese herbal medicine vs ear acupuncture, acupoint embedding line + Chinese herbal medicine vs moxibustion, acupoint embedding line + Chinese herbal medicine vs moxibustion + Chinese herbal medicine. Conclusion: Acupoint embedding + traditional Chinese medicine, acupuncture + western medicine is the best treatment for mammary gland hyperplasia, but the exact conclusion still needs high-quality clinical research to further verify.

300 CASES OF HYPERPLASIA OF MAMMARY GLANDS TREATED WITH RED-HOT NEEDLE PLUS FILIFORM NEEDLE

Clinical observations on 300 cases of hyperplasia of mammary glands (group A) treated by red hot needle plus filiform needle are reported in the present study. "Ashi" points were used as the main acupoints. For comparison, other 300 cases (group B) were treated with routine acupuncture method, and Rugen (ST 18) was used as the main acupoint. In addition, other auxiliary acupoints were supplemented in the light of the concrete syndromes in these two groups. The treatment was given once daily, with 10 sessions being a therapeutic course. Of the 300 cases in group A, 240 were clinically cured, amounting to 80%; 58 were effective, amounting to 19.3%; 2 were failed, with a total effective rate of 99.3%. Of the 300 cases in group B, 113 were clinically cured, 165 effective, 22 were failed, with a total effective rate of 92.7%. The therapeutic effect of group A is significantly superior to that of group B (P<0.05).

CLINICAL OBSERVATION ON THE ACUPOINT INTRADERMAL EMBEDDING OF RINGHEADED THUMBTACK-NEEDLE THERAPY FOR HYPERPLASIA OF MAMMARY GLANDS

In the present paper, the author used acupoint intradermal embedding of ringheaded thumbtack-needle therapy combined with herbal medicine therapy to treat 110 cases of hyperplasia of mammary glands, and compared its therapeutic effect with that of herbal therapy alone. The observed indexes of the treatment were pain relief degree, the size of hyperplasic glands and the time of occurrence of marked effect. Following 3 courses of treatment,the results showed the therapeutic effect of the ringheaded thumbtack-needle needle plus herbal medicine therapy was superior to that of herbal medicine therapy alone in the above-mentioned 3 indexes (P ＜ 0.01 ).

ACUPUNCTURE FOR TRERTING 120 CASES OF HYPERPLASIA OF MAMMARY GLANDS

Objective: To observe the therapeutic effect of acupuncture therapy for 120 cases of hyperplasia of mammary glands. Methods: These patients were classified into liver-qi-stagnation type (n=53), phlegm-coagulation type (n=30) and Thoroughfare-Conception vessel maladjustment type (n=37). Acupoints used were Qimen (期门 LR 14), Wuyi (屋翳 ST 15), Weishu (胃俞 BL 21), etc.. Acupuncture treatment was conducted once daily and 30 treatments constituted one therapeutic course. Results: After 3 courses of treatment, of the 53, 30 and 37 cases of the liver-qi-stagnation, phlegm-coagulation and Thoroughfare-Conception vessel maladjustment types, 43 (81.1%), 24 (80.0%) and 29 (78.4%) were cured, 7 (13.2%), 5 (16.7%)and 5 (13.5%) markedly improved, 3 (5.7%), 1 (3.3%) and 2 (5.4%) improved respectively, and 1 (2.7%) of Thoroughfare-Conception vessel maladjustment type failed. A two-years’ follow-up showed that 3 of the cured 92 cases had a relapse, and after 2 more courses of treatment, they were cured again. Conclusion: Acupuncture therapy is effective for the treatment of hyperplasia of mammary glands.

Research Progress on Classical Prescriptions in Treating Mammary Glands Hyperplasia

According to Zhongjing Zhang's academic thought,gynecological diseases mostly result from deficiency,accumulated cold,and qi stagnation,so the treatment of gynecological miscellaneous diseases should take qi and blood as the general principle,and focus on the liver.The pathogenesis of mammary glands hyperplasia(MGH)is liver and kidney deficiency,disharmony of the thoroughfare vessel and the conception vessel,the causes of which are emotional imbalance,liver qi depression,and failure of transportation due to spleen deficiency.The superficial causes include qi stagnation,phlegm coagulation,and blood stasis,which are mainly related to the liver,spleen,kidney,the thoroughfare vessel,and the conception vessel.In clinical treatment of MGH,Xiaochaihu Decoction or Sini Powder can be used for qi stagnation syndrome,Xiao Xianxiong Decoction for phlegm coagulation syndrome,Guizhi Fuling Pill or Dahuang Zhechong Pill for spleen deficiency syndrome,and Wenjing Decoction for the deficiency-cold syndrome.

柴芍乳增胶囊对肝郁气滞型乳腺增生大鼠神经递质和胃肠激素的影响

目的观察柴芍乳增胶囊对肝郁气滞型乳腺增生模型大鼠的治疗作用及机制。方法采用注射苯甲酸雌二醇加不可预知的应激刺激方法,复制肝郁气滞型乳腺增生大鼠模型。模型大鼠给予柴芍乳增胶囊高、中、低剂量(1.2、0.6、0.3 g·kg^(-1))。连续28天。观察大鼠一般状态及行为学指标,乳头直径、乳头高度及乳腺组织病理形态学变化,测血清孕酮(P)、黄体生成素(LH)、促卵泡生成素(FSH)、雌二醇(E2)、5-羟色胺(5-HT)、去甲肾上腺素(NE)、多巴胺(DA)、胃动素(MTL)、血管活性肠肽(VIP)、P物质(SP)。结果与空白对照组比较,模型组大鼠脱毛、倦怠、反应迟钝、易激怒,自主活动次数减少、蔗糖水偏嗜度降低,体质量明显降低(P<0.01);乳头直径增加,乳头高度增大(P<0.01);乳腺小叶增生程度增大(P<0.01)。血清中E2、LH、5-TH、NE、DA、MTL、SP含量升高,P、VIP含量降低(P<0.01)。与模型组比较,柴芍乳增胶囊各剂量组脱毛、倦怠、反应迟钝、易激怒等症状明显改善,自主活动次数增加、蔗糖水偏嗜度升高(P<0.05或P<0.01);乳头直径和乳头高度明显减少(P<0.05或P<0.01);乳腺小叶增生程度降低(P<0.05或P<0.01);血清中P、FSH、VIP含量明显升高,E2、LH、5-TH、NE、DA、MTL、SP含量显著降低(P<0.05或P<0.01)。结论柴芍乳增胶囊能缓解肝郁气滞型乳腺增生模型大鼠性激素紊乱,调节神经递质水平,改善胃肠激素异常,减轻肝郁气滞症状,抑制乳腺增生。

乳腺增生症的中西医认识及治疗研究进展

乳腺增生症(hyperplasia of mammary gland,HMG)中医病名为乳癖,是一种乳腺组织增生的疾病,其中医基本病机为情志失常,病机以肝内气机郁滞为主,兼有脾肾不足等,由此导致气滞、血瘀、痰凝。气、血、痰、瘀于乳络互结。西医病因病理尚未完全明确。西药目前尚无特异性疗法,中药治疗具有良好效果。文章将对乳癖的中西医病因病机进行论述,并结合临床案例及经验总结中医药治法治则及常用药物,以临床为角度基础,提出治疗乳癖的方法,并为乳癖病因病机的研究与探讨提供新思路。

穴位埋线治疗中重度乳腺增生病临床研究

目的:观察穴位埋线治疗中重度乳腺增生病(MGH)的疗效。方法:选取72例中重度MGH患者,按随机数字表法分为对照组及观察组各36例。对照组采用小金丸口服,观察组采用聚对二氧环己酮(PPDO)对折旋转穴位埋线治疗。2组均连续治疗8周,随访3个月。比较2组临床疗效,比较2组治疗前后乳房疼痛评分、乳房肿块大小、情绪评分[汉密尔顿焦虑量表-14项(HAMA)、汉密尔顿抑郁量表-17项(HAMD)]的变化。结果:观察组总有效率为90.63%,对照组为63.64%,2组比较,差异有统计学意义(P<0.05)。2组不同时间点乳房疼痛评分在时间因素、时点交互因素方面比较,差异有统计学意义(P<0.05)。治疗后及随访期,2组乳房疼痛评分均较治疗前下降(P<0.05),观察组治疗后及随访期的乳房疼痛评分均低于同一时间段的对照组(P<0.05)。2组不同时间点乳房肿块大小在时间因素、组间因素、时点交互因素方面比较,差异有统计学意义(P<0.05)。治疗后及随访期,2组乳房肿块大小均较治疗前缩小(P<0.05),观察组治疗后及随访期乳房肿块均小于同一时间段的对照组(P<0.05)。2组不同时间点HAMA评分、HAMD评分在时间因素、组间因素、时点交互因素方面比较,差异有统计学意义(P<0.05)。治疗后及随访期,2组HAMA、HAMD评分均较治疗前下降(P<0.05);观察组治疗后及随访期HAMA评分、HAMD评分均低于同一时间段的对照组(P<0.05)。结论:穴位埋线治疗中重度MGH疗效较好,可减轻乳房疼痛程度,缩小肿块大小,改善患者情绪。

香樟精油对大鼠乳腺增生的影响

目的分析香樟精油的化学成分,并探讨其对乳腺增生的影响。方法采用气相色谱-质谱联用技术(GC-MS)分析香樟精油的化学成分。将大鼠随机分为对照组、模型组和模型+香樟精油组,评估香樟精油对乳腺组织增生的影响。同时采用ELISA法检测大鼠血清中的性激素水平。结果GC-MS分析揭示了香樟精油中含有51种化学成分,主要包括冰片、D-樟脑、D-柠檬烯、乙酸龙脑酯、α-蒎烯、桉叶油醇、α-松油醇和莰烯。动物实验结果显示,与模型组相比,模型+香樟精油组大鼠的乳腺增生程度减轻,且雌二醇(E2)、促黄体生成素(LH)、促卵泡素(FSH)和催乳素(PRL)水平降低,而孕酮(PROG)和睾酮(T)水平则上升,提示香樟精油可能通过调节性激素水平抑制乳腺增生。结论香樟精油通过调节性激素水平有效抑制乳腺增生,显示出治疗和预防乳腺增生的潜在应用价值。

中药穴位贴敷治疗对冲任失调型乳腺增生患者的有效性及安全性

目的探究中药穴位贴敷治疗冲任失调型乳腺增生症(MGH)的有效性及安全性。方法选择阜阳市人民医院2021年8月—2023年8月收治的180例冲任失调型MGH患者为研究对象,按随机数字表法将其分为对照组和观察组,每组90例。对照组采用乳康舒胶囊治疗,观察组在对照组基础上采用中药穴位贴敷治疗。比较两组患者的临床疗效、中医证候积分、乳房疼痛程度及不良反应发生情况。结果观察组的治疗总有效率为93.33%,高于对照组的83.33%,差异有统计学意义(P<0.05)。治疗后,观察组的各项中医证候积分均低于对照组,组间差异有统计学意义(P<0.05);观察组的疼痛视觉模拟评分为(2.56±0.94)分,低于对照组的(3.61±1.28)分,差异有统计学意义(P<0.05)。两组的不良反应发生率比较,差异无统计学意义(P>0.05)。结论中药穴位贴敷能够有效缓解冲任失调型MGH患者的症状,减轻乳房疼痛,疗效显著,且未明显增加不良反应,安全可靠。

蒲公英对乳腺疾病治疗作用机制的研究进展

乳腺疾病是我国常见的危害女性心理及健康的最主要因素,蒲公英在治疗乳腺疾病方面疗效确切,深入研究其药理作用及临床应用尤为必要。基于此,就近年来关于蒲公英对乳腺疾病的药理作用和临床应用的相关文献进行归纳分析,发现可通过含蒲公英的复方治疗乳腺增生病;其主要有效成分可通过调控核因子κB(nuclear factor-kappa B,NF-κB)信号通路和微生物相关分子模式(microbe-associated molecular patterns,MAMPs)信号通路,下调肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)、白细胞介素-1β(interleukin-1β,IL-1β)和白细胞介素-6(interlukin-6,IL-6)等炎性因子的表达治疗哺乳期乳腺炎;通过中药复方合理配伍治疗非哺乳期乳腺炎;通过调控细胞周期以抑制增殖、促进凋亡、抗侵袭转移、调节自噬、影响雌激素、提高免疫力、抑制相关代谢途径等抗乳腺癌。总结梳理的关于蒲公英作用于乳腺疾病的药理作用及临床应用,可为进一步研究蒲公英在乳腺疾病的治疗提供新的思路和科学依据。

基于数据挖掘探讨针刺治疗乳腺增生症选穴规律

目的 采用数据挖掘技术探讨针刺治疗乳腺增生症(MGH)选穴规律,为规范临床针刺治疗MGH选穴提供理论依据。方法 检索中国知识资源总库(CNKI)、中国学术期刊数据库(万方数据)、中文科技期刊数据库(VIP)、PubMed 2013年8月27日-2023年8月27日收录的针刺治疗MGH临床研究文献,提取针刺处方并录入Excel2019建立数据库,运用SPSS25.0、SPSS Modeler 18.0、R studio4.2.2对数据进行描述性分析、聚类分析和关联规则分析并绘制关联网络图,运用Cytoscape3.9.1软件将网络图可视化。结果 共纳入95篇文献,提取针刺处方95条,涉及腧穴65个,总使用频次为658。高频腧穴有膻中、足三里、乳根等,常用经脉为足阳明胃经、任脉和足厥阴肝经,腧穴分布部位以胸腹胁部和下肢部为主,高频特定穴为募穴、五输穴、八会穴。聚类分析得到2个有效聚类群,关联规则分析得到膻中-足三里、膻中-乳根、膻中-三阴交3个核心组合。结论 针刺治疗MGH选穴集中在胸腹胁部,以肝经、任脉、胃经腧穴为主,重视特定穴使用,遵循“远近配穴”原则,重视从肝、脾、胃论治。

雌激素和孕激素诱导的乳腺增生大鼠血清代谢组学研究

目的:基于液相色谱-质谱联用法(LC-MS)的血清代谢组学探究大鼠乳腺增生的发生机制以及潜在差异代谢物。方法:将12只SPF级8周龄Wistar雌性大鼠随机分为正常组(n=6)和模型组(n=6),模型组给予肌肉注射苯甲酸雌二醇(0.5 mg·kg^(−1)·d^(−1)),连续注射21 d,随后肌肉注射黄体酮(4 mg·kg^(−1)·d^(−1)),连续注射7 d,制备乳腺增生模型。测定大鼠体重和乳头直径,并观察乳腺组织病理形态变化。造模成功后,利用大鼠血清进行LC-MS代谢组学分析,采用主成分分析(PCA)和正交偏最小二乘判别分析法(PLS-DA)筛选正常组与模型组血清中的差异代谢物,并通过京都基因与基因组百科全书(KEGG)开放数据库对差异的标志物进行代谢通路分析。结果:与正常组大鼠相比,模型组大鼠体重无显著变化(P>0.05);乳头直径显著扩大(P<0.01);乳腺HE切片表现出典型的乳腺增生形态,表明造模成功。正常组与模型组血清样本的代谢模式存在显著差异,基于变量投影重要性(VIP)≥2.0和P<0.05的原则鉴定出30个差异代谢物,并且进一步进行ROC分析显示13种差异代谢物的AUC均大于0.9,表明这13种代谢物可能对乳腺增生的诊断具有较高的敏感度。经过KEGG通路富集分析显示,大部分差异代谢物主要富集在醛固酮的合成与分泌、鞘磷脂代谢、花生四烯酸代谢、细胞凋亡和胆固醇代谢等。结论:雌激素和孕激素诱导的乳腺增生大鼠的发病机制可能与改变胆汁酸及其衍生物代谢和脂质代谢途径有关。血清代谢组学鉴定出的13种敏感度较高的差异代谢物,可为乳腺增生疾病的诊断提供参考。

消乳散结胶囊治疗乳腺增生临床观察

目的:观察消乳散结胶囊治疗乳腺增生的疗效。方法:80例按随机数字表法分为两组,对照组用三苯氧胺治疗,观察组用消乳散结胶囊治疗。结果:总有效率观察组较对照组高(P<0.05)。治疗后两组乳房肿块大小与乳房疼痛评分均下降(P<0.05),且观察组下降更明显(P<0.05)。随访6个月复发率观察组低于对照组(P<0.05)。观察组不良反应率低于对照组(P<0.05)。结论:消乳散结胶囊治疗乳腺增生效果较好,并可减少复发。