Heterogeneity of Outcomes Reporting in Trials Evaluating Traditional Chinese Medicine Breast Massage for Stasis Acute Mastitis: A Methodological Review

Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.Methods We searched CNKI,Wanfang,VIP,Sino Med,Pub Med,Web of Science,Embase,Cochrane library,JBI,CINAHL,Psyc INFO,Clinical Trials Registry Platform portal,Clinical Trials Registry,Australian New Zealand Clinical Trials Registry,Center Watch Registry from inception to May 15,2022 to find randomized controlled trials,non-randomized controlled trials,case series and cohort studies which reported the outcomes of stasis acute mastitis managed with Traditional Chinese Medicine breast massage,with search terms of mastitis,acute mastitis,lactation mastitis,puerperal mastitis,breast problem,breast engorgement,milk stasis,blocked ducked,breast pain,breast massage,and acupoint massage.Outcomes and the measurement schemes(measurement methods,timing of assessing outcome,frequency of assessing outcome,measurers)were extracted from the included studies.We used the Management of Otitis Media with Effusion in Children with Cleft Palate(MOMENT)to assess the quality of each study,then categorized outcomes derived from the included studies into different domains according to the Outcome Measures in Rheumatology Arthritis Clinic Trials(OMERACT)Filter 2.1 framework.Results We identified 85 clinical trials,in which 54 different outcomes were reported.A total of 81.2%(69/85)of studies were assessed as medium quality with a mean score of 2.6,and 18.8%(16/85)as low quality with a mean score of 0.9.These outcomes were organized in three core areas.Lump size(89.4%,76/85)was the most frequently reported outcome,followed by breast pain(69.4%,59/85)and milk excretion(68.2%,58/85).Five methods were used to assess lump size and four methods to assess breast pain.Conclusions The outcomes reported in clinical trials regarding stasis acute mastitis treated by Traditional Chinese Medicine breast massage are heterogeneous.Developing a core outcome set to achieve consistent standards for reporting outcomes and modalities for validation of the outcomes is clearly warranted.

ANALYSIS ON THE TREATMENT OF ACUTE MASTITIS WITH ACUPOINT LIEQUE

Remarkable curative effects were obtained in the treatment of acute mastitiswith acupoint Lieque(LU 7).202 cases out of 230 patients were cured and 20 cases were basicallycured,occupying 96.4％of the total.The manipulation was simple and easy to master.The crux layin controlling the time of treatment.The shorter the course of the disease,the better the curative ef-feet.The cure rate was 51.5％after one treatment if the patients were treated within 24 hours of theoccurrence of the disease.

Clinical Efficacy of Acupoint Massage Versus Normal Treatments for Acute Mastitis:A Systematic Review

Objective:To systematically review the effectiveness of acupoint massage versus normal treatments for acute mastitis.Methods:Databases including CNKI,Wanfang database,VIP,Pubmed,Web of science and Cochrane were searched to collect randomized controlled trials(RCTs)about acupoint massage versus normal treatments for acute mastitis from inception to October 2018.Two reviewers independently screened literature,extracted data,and assessed the risk of bias of included studies.Then meta-analysis was performed using RevMan 5.3.3 software.Results:A total of 16 RCTs involving 2056 patients were included.The results of meta-analysis showed that,compared with normal treatments,acupoint massage could improve the efficiency of clinical treatment[RR=1.18,95%CI(1.13,1.22),P<0.00001],shorten onset time[MD=-1.69,95%CI(-1.89,-1.41),P<0.00001],decrease the lump size[MD=-2.64,95%CI(-4.46,-0.82),P=0.005],and decrease the score of symptoms and signs[MD=-3.88,95%CI(-7.50,-0.27),P=0.04].However,there was no significant difference in recurrence rate[RR=0.41,95%CI(0.11,1.57),P=0.19]and cure rate[RR=11.82,95%CI(0.50,282.04),P=0.13].Conclusion:The current evidence shows that,compared with normal treatments,acupoint massage can improve the efficiency of clinical treatment,shorten the onset time,and decrease the lump size.Due to the limited quality of included studies,more high quality studies are needed to verify the above conclusion.

Studies of nursing in acute mastitis in China:Bibliometric analysis

Objective:To analyze the research hotspots of nursing related to lactation acute mastitis in China and provide guidance and reference for nursing researchers.Methods:Papers from China National Knowledge Infrastructure,Wanfang Data,VIP Data,and SinoMed are collected.All papers were imported into Noteexpress software in the form of bibliography to check again and delete duplicate references.The remaining literature was screened by reading the title and abstract and finally included by reading the full text.The paper’s information was analyzed using SPSS 22.0.Results:1275 papers are searched and 531 papers are included at last.Periodical literature accounted for the highest proportion,96.80%.Moreover,the journal with the largest number of entries is China Health Care and Nutrition.In 2007,the number of literatures related to acute mastitis nursing began to increase rapidly,and the most articles were published in Henan.Among the literature types,the majority are literatures expert experience.Only 18 literature reports were funded.Conclusions:Papers on acute mastitis nursing are increasing year by year and gradually become a research hotspot.However,the development of this study is uneven in different regions,with little financial support,and randomized controlled trials are still to be carried out.

Traditional Chinese Medicine Nursing Protocols for Mammary Abscess (Acute Mastitis)

Mammary abscess,also termed acute mastitis,is an acute suppurative disease characterized by breast lumps,redness,swelling,heat,and pain. It is commonly seen in primiparous lactating women 3-4 weeks after parturition. It is believed that the occurrence of acute mastitis is closely associated with stress,a surplus of nutrients during pregnancy,overreliance on breast pumps and lack of breastfeeding experience. In recent years,traditional Chinese medicine( TCM)has been extensively applied in the treatment of acute mastitis because of its low cost and high safety,and has been considered to be the first-choice treatment of acute mastitis in China. Therefore,this article mainly explored the key points of common syndromes,TCM nursing methods and health guidance of acute mastitis in order to further develop the advantages of TCM,improve its efficacy and standardized its nursing behavior.

A Systematic Review and Meta-Analysis on Gualou Niubang Decoction for Acute Mastitis

Objective:To systematically evaluate the clinical efficacy of Gualou Niubang decoction in the treatment of acute mastitis.Methods:Randomized controlled trials of Gualou Niubang decoction in the treatment of acute mastitis included in PubMed,Springer,Embase,Cochrane Library,CNKI,Wanfang,Weipu,and China Biomedical Literature Database from January 2016 to present.The Cochrane risk bias assessment tool was used to evaluate the risk of bias.Used Revman 5.3 software for Meta analysis.Results:There are 8 articles that meet the inclusion criteria,comprising 919 subjects,the test group were 462,cases and control group were 457 cases.The results of statistical analysis showed that the clinical efficacy of the experimental group was significantly higher than which of the control group,[RR=1.19,95%CI(1.07,1.33),P=0.002],the difference was statistically significant.Among the secondary outcome indicators,compared to the control group,Gualou Niubang decoction can effectively relieve the main symptoms of acute mastitis[MD=-1.96,95%CI(-2.27,-1.65),P<0.0001].Gualou Niubang decoction combined with antibiotics can shorten the length of hospital stay[MD=-5.23,95%CI(-6.02,-4.44),P<0.00001]and reduce white blood cell count[MD=-2.40,95%CI(-4.71,-0.08),P=0.04]are better than antibiotics.Conclusion:The use of Gualou Niubang decoction to treat acute mastitis can not only improve clinical efficacy,but also effectively relieve clinical symptoms,shorten hospital stay and reduce white blood cell count.

针刺联合循经按摩及中药外敷治疗哺乳期急性乳腺炎患者的疗效观察

目的探讨针刺联合循经按摩、中药外敷治疗哺乳期急性乳腺炎患者的临床疗效。方法回顾性分析2021年1月—2022年12月期间唐山市妇幼保健院中医科门诊收治的360例早期哺乳期急性乳腺炎患者,按随机数字表法分为对照A组(循经按摩+中药外敷)77例、对照B组(针刺+循经按摩)82例、对照C组(针刺+中药外敷)98例、治疗组(针刺+循经按摩+中药外敷)113例。对照A组患者循经按摩+中药外敷治疗,对照B组患者针刺+循经按摩治疗,对照C组患者针刺+中药外敷治疗,治疗组患者针刺+循经按摩+中药外敷治疗。治疗2个疗程后,观察比较4组患者临床疗效、临床症状、体征消退时间、疼痛及体温变化及复发率,治疗前后血清炎性指标[白细胞计数(White blood cell,WBC)、中性粒细胞百分比(Neutrophilicgranulocyte,NE%)、C-反应蛋白(Creactiveprotein,CRP)]水平。结果治疗后治疗组患者临床总有效率68.14%(77/113)明显高于对照A组患者53.25%(41/77)、对照B组患者51.22%(42/82)、对照C组患者53.06(52/98),差异有统计学意义(P<0.05)。治疗后治疗组患者疼痛消退时间、肿块消失时间、皮肤发红消退时间、体温恢复时间均明显优于对照A组、对照B组、对照C组患者,差异有统计学意义(P<0.05)。治疗后4组患者外周血WBC、NE%、CRP水平均较治疗前明显降低,差异有统计学意义(P<0.05);且治疗组患者外周血WBC、NE%、CRP水平均明显低于对照A组、对照B组、对照C组患者,差异有统计学意义(P<0.05)。治疗后治疗组患者哺乳意愿、哺乳行为率明显高于对照A组、对照B组、对照C组患者,差异有统计学意义(P<0.05);复发率明显低于对照A组、对照B组、对照C组患者,差异有统计学意义(P<0.05)。结论针刺联合循经按摩、中药外敷治疗哺乳期急性乳腺炎患者能有效提高临床疗效,降低患者炎症因子水平及疼痛感,增加哺乳意愿及哺乳行为,降低复发率。

消痈汤联合手法通乳治疗哺乳期郁滞型急性乳腺炎的效果分析

目的 探讨消痈汤联合手法通乳治疗哺乳期郁滞型急性乳腺炎患者的效果。方法 前瞻性选取2023年1月至10月丽水市中医院收治的80例哺乳期郁滞型急性乳腺炎患者,按随机数字表法分为消痈汤组和联合组,每组40例。消痈汤组患者口服消痈汤治疗,联合组患者在口服消痈汤的基础上进行手法通乳。比较两组患者的临床疗效及治疗前、治疗1个疗程及治疗2个疗程后的疼痛、肿块大小、肿块数量评分及炎症因子水平;比较两组患者的脓肿、停乳及复发远期疗效。结果 消痈汤组的临床总有效率为80.00%,联合组为95.00%,联合组高于消痈汤组,差异有统计学意义(χ^(2)=4.114,P=0.043)。治疗2个疗程后,联合组患者的视觉模拟评分法评分、肿块大小及肿块数量评分低于消痈汤组,差异有统计学意义(P<0.05);联合组患者的降钙素原、C反应蛋白均低于消痈汤组,差异有统计学意义(P<0.05);联合组患者的白细胞及中性粒细胞计数均低于消痈汤组(P<0.05);联合组的复发率为5.00%低于消痈汤组的20.00%(χ^(2)=4.114,P=0.043)。结论 哺乳期郁滞型急性乳腺炎患者经消痈汤联合手法通乳治疗可显著提高近期及远期疗效,可减轻疼痛、消除肿块、抑制炎症、减少复发,值得临床推广应用。

清热解毒汤治疗哺乳期急性乳腺炎的回顾性研究

[目的]探讨清热解毒汤治疗哺乳期急性乳腺炎的临床疗效。[方法]回顾性分析2019年1月至2020年12月就诊于首都医科大学附属北京中医医院乳腺科的哺乳期乳腺炎患者的临床资料,其中治疗组80例,内服清热解毒汤;对照组90例,无内服汤药。观察两组治疗前后乳腺炎的严重程度指数、疾病改善率、体温、乳房疼痛评分、乳汁通畅情况、乳头皲裂情况、中医全身症状评分等指标。[结果]在乳腺炎的严重程度指数、疾病改善率、乳房疼痛评分、乳汁通畅情况、中医全身症状方面组间差异有统计学意义(P<0.05),治疗组疗效优于对照组。[结论]清热解毒汤可有效改善哺乳期急性乳腺炎疼痛、肿块、红肿、乳汁堵塞等情况,疗效确切。

消痈散外敷联合砭石熨摩在急性乳腺炎患者中的应用

目的 探讨消痈散外敷联合砭石熨摩在急性乳腺炎患者中的应用效果。方法 选取2020年1月至2023年1月泰安市中医医院收治的80例急性乳腺炎患者为研究对象,以随机数字表法分为对照组和研究组,每组各40例。对照组给予砭石熨摩,研究组给予消痈散外敷联合砭石熨摩,比较两组疼痛评分、睡眠指数、舒适度及生活质量。结果 干预3、5 d后,研究组疼痛评分均低于对照组(P <0.05);干预后,研究组睡眠指数低于对照组,舒适度评分和生活质量评分均高于对照组(P <0.05)。结论 消痈散外敷联合砭石熨摩在急性乳腺炎患者中的应用效果显著,可减轻疼痛、改善睡眠、提高舒适度和生活质量,值得临床推广。

通乳消痈方联合中医手法排乳治疗哺乳期急性乳腺炎临床研究

目的:观察通乳消痈方联合中医手法排乳治疗哺乳期急性乳腺炎的临床疗效。方法:采用随机数字表法将138例哺乳期急性乳腺炎患者分为中药组、排乳组、联合组各46例。中药组给予通乳消痈方治疗,排乳组给予中医手法排乳治疗,联合组给予通乳消痈方联合中医手法排乳治疗,3组各治疗5 d。比较3组治疗前后临床症状评分、炎症指标水平;比较3组临床疗效、通乳时间、临床症状消除时间、体温恢复正常时间及不良反应发生率。结果:联合组总有效率97.83%,高于中药组82.61%、排乳组86.96%(P<0.05);联合组通乳时间、临床症状消除时间、体温恢复正常时间均较中药组、排乳组缩短(P<0.05),中药组、排乳组总有效率、通乳时间、临床症状消除时间、体温恢复正常时间比较,差异无统计学意义(P>0.05)。治疗后,3组临床症状评分、白细胞计数(WBC)、白细胞介素-6(IL-6)、C-反应蛋白(CRP)水平均较治疗前降低(P<0.05),且联合组治疗后临床症状评分及各炎症指标低于中药组、排乳组(P<0.05);中药组、排乳组临床症状评分及各炎症指标比较,差异无统计学意义(P>0.05)。3组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:通乳消痈方联合中医手法排乳治疗哺乳期急性乳腺炎效果良好,能够减轻患者临床症状,降低炎症因子水平,安全性较高。

中药与西药治疗急性乳腺炎疗效差异的Meta分析

目的通过Meta分析,对比中药与西药治疗急性乳腺炎的疗效和安全性方面的差异。方法确定相关中、英文检索词,通过计算机从Web of Science、Embase、PubMed、Cochrane Library、万方数据知识服务平台、维普网数据库、CNKI和中国生物医学文献数据库(CBM)中检索中药对比西药治疗急性乳腺炎的随机对照试验(RCT),检索时间区间为自建库起至2021年12月,对所获得文献和数据、文献质量评价参照Cochrane系统评价员手册(5.3版)的偏倚风险评估工具,应用RevMan 5.3软件进行Meta分析。结果共纳入41个RCT,4321例患者。试验组接受中药治疗,对照组接受西药治疗。分析结果显示中药治疗急性乳腺炎的总有效率和痊愈率均高于西药方案(P<0.05);中药组不良反应发生率低于西药组(P<0.05)。结论中药治疗急性乳腺炎的总体疗效优于西药方案,安全性更高,且不会影响哺乳。

中医药治疗非哺乳期乳腺炎

非哺乳期乳腺炎是一组发生在女性非哺乳期的良性炎症性疾病。该病病因不明,易漏诊、误诊,目前临床尚无统一有效的治疗方案,仍属乳腺疑难杂症,因其易反复发作、迁延不愈,也被称之为“不死的癌症”,对患者身心健康造成了极大的影响。西医以手术为主,药物为辅,但疗效不一,且复发率高,易致乳房畸形。近年来中医药治疗该病疗效显著,通过内治、外治及内外合治等手段发挥其优势。现将相关文献进行梳理,以期为临床治疗提供一定参考。

哺乳期急性乳腺炎初期中医综合治疗的研究进展

本文对近五年来关于哺乳期急性乳腺炎初期的中医综合治疗方法及效果的研究进行总结。在中医辨证理论指导下,分为中药内服,中药外敷,以及手法排乳、火龙罐综合灸、刮痧、刺络放血拔罐等干预为主,且研究以临床观察为主,个案形式展现居多,样本量小,缺乏规范统一的方式方法。

柴胡清肝汤加减治疗急性进展期肉芽肿性乳腺炎(肝郁化热证)患者的临床效果

目的探讨柴胡清肝汤加减治疗在急性进展期肉芽肿性乳腺炎(GM)(肝郁化热证)患者中的应用效果。方法选取2021年8月至2023年4月济宁市中医院收治的92例急性进展期GM患者,按随机数表法分为两组,每组各46例。对照组采用常规治疗,观察组加用柴胡清肝汤加减治疗,持续治疗3个月。比较两组疼痛程度、中医证候积分、肿块大小、炎症水平及不良反应发生情况。结果治疗前两组疼痛程度及中医证候积分、肿块大小、炎症水平比较,差异无统计学意义(P>0.05);治疗后观察组视觉模拟评分量表(VAS)评分(1.32±0.38)分、中医证候积分(8.63±1.76)分、白细胞介素-6(IL-6)水平(35.13±4.76)pg/L、C反应蛋白(CRP)水平(9.63±1.81)mg/L、白细胞计数(WBC)水平(7.02±0.86)×10^(9)/L、肿瘤坏死因子-α(TNF-α)水平(20.02±2.47)ng/L,低于对照组的(1.75±0.42)分、(11.22±2.03)分、(40.58±4.39)pg/L、(12.45±2.03)mg/L、(7.96±0.75)×10^(9)/L、(25.64±3.19)ng/L,观察组体表肿块(2.05±0.33)cm、B超测量的靶肿块(1.61±0.25)cm,小于对照组的(2.67±0.40)cm、(2.03±0.32)cm,差异有统计学意义(P<0.05);两组不良反应总发生率比较,差异无统计学意义(P>0.05)。结论柴胡清肝汤加减治疗能提高急性进展期GM治疗效果,降低炎症水平,加快疼痛肿胀消退,且不良反应少。

雷火灸足三里联合乳房按摩对剖宫产后泌乳及母乳喂养率的影响

目的观察雷火灸足三里联合乳房按摩对剖宫产后乳腺不通患者泌乳及母乳喂养率的影响。方法选取剖宫产后乳腺不通患者100例为研究对象,以干预方式的不同分为对照组、观察组,各50例。两组均给予常规护理,对照组加用乳房按摩干预,观察组在对照组基础上联合雷火灸足三里干预。比较两组泌乳量、母乳喂养自我效能简化量表(BSES-SF)评分、视觉模拟量表(VAS)评分、匹兹堡睡眠质量指数(PSQI)评分、生活质量综合评定问卷(GQOLI-74)评分及纯母乳喂养率。结果干预后,观察组泌乳量、BSES-SF评分、GQOLI-74评分均高于对照组,VAS评分、PSQI评分均低于对照组(P<0.05);观察组纯母乳喂养率为92.00%(46/50),高于对照组的74.00%(37/50)(P<0.05)。结论对于剖宫产术后乳腺不通患者,雷火灸足三里联合乳房按摩的通乳效果显著,可提高泌乳量、纯母乳喂养率和母乳喂养自我效能,缓解疼痛,改善睡眠质量和生活质量。

疏肝理气方对浆细胞性乳腺炎患者术后恢复及免疫因子的影响

目的:分析浆细胞性乳腺炎(PCM)患者应用疏肝理气、清热解毒法对其术后恢复及免疫因子的影响。方法:选取PCM术后患者88例,以随机方式分为两组。对照组采用常规西医疗法,研究组在对照组基础上应用中药疏肝理气、清热解毒法治疗,比较两组患者恢复情况、免疫因子指标变化及不良反应、并发症发生情况。结果:研究组治疗总有效率高于对照组(P<0.05)。与对照组比较,研究组的术后引流时间、拆线时间、切口愈合时间、住院时间更短(P<0.05)。两组换药时间比较,差异无统计学意义(P>0.05)。两组术后当天疼痛视觉模拟评分(VAS)比较,差异无统计学意义(P>0.05)。研究组术后3 d及术后7 d的VAS评分低于对照组,差异有统计学意义(均P<0.05)。与对照组比较,研究组术后7 d的血清分化簇3(CD3^(+))、分化簇4(CD4^(+))、CD4^(+)/分化簇8(CD8^(+))CD8^(+)更高,而CD8^(+)更低,差异有统计学意义(均P<0.05)。两组不良反应、并发症发生率比较,差异无统计学意义(均P>0.05)。结论:对PCM术后患者应用中药疏肝理气、清热解毒法较单纯西药治疗更利于促进患者恢复,减轻疼痛,促进免疫功能恢复,且安全性较好。

木犀草素全载药可溶性微针的制备及其透皮性能

为了提高木犀草素的生物利用度,改善急性乳腺炎治疗顺应性,以期给乳腺炎患者提供一种新型的用药选择,采用浇注法成功制备了木犀草素全载药可溶性微针(LUT-DMN)。单因素考察可溶性微针的基质种类、基质比例、溶剂种类及用量、干燥条件,正交优选微针基质比例、溶剂用量,最终确定微针的最佳制备工艺参数,从外观形态、机械强度、溶解性能、皮肤屏障恢复性能等方面对其进行评价;采用高效液相色谱(HPLC)法测定LUT-DMN载药量,利用Franz扩散池对载药微针进行体外透皮释药性能考察。得到最优处方:PVA与Gantrez S-97质量比为1∶3,溶剂用量9 mL。每片载药量为(1.068 3±0.037 0)mg,机械性能良好。作用于大鼠皮肤2 h时针尖几乎完全溶解,2 h后皮肤恢复情况良好。体外透皮试验结果显示,48 h时LUT-DMN累积透过率达87.14%。LUT-DMN的成型和机械性能良好,相比于药物基质溶液组,其具有显著透皮性能,可促进药物透皮吸收。

中药外敷联合推拿手法在产褥期急性乳腺炎中的应用价值

目的探究中药外敷联合推拿手法对产褥期急性乳腺炎的干预效果。方法选择2021年9月—2022年9月郑州大学第五附属医院收治的100例产褥期急性乳腺炎患者,按随机数字表法将其分为对照组和试验组各50例。对照组在常规护理基础上采用乳腺疏导推拿进行干预,试验组在对照组基础上给予中药外敷,比较两组干预前后症状体征积分;疼痛消失时间,体温恢复时间及通乳时间及干预前后炎症因子水平。结果干预后,试验组乳房肿痛、乳房肿块及乳汁分泌各项积分均低于对照组(P<0.05);试验组疼痛消失时间、体温恢复时间及通乳时间均短于对照组(P<0.01);干预后试验组WBC及CRP水平均低于对照组(P<0.05)。结论中药外敷联合推拿手法可以提高产褥期急性乳腺炎干预效果,缓解患者疼痛、缩小肿块,同时还可以有效抑制炎症。

透脓散加减联合乳痈散外敷治疗肉芽肿性小叶性乳腺炎的效果分析

目的:分析透脓散加减联合乳痈散外敷治疗肉芽肿性小叶性乳腺炎的效果。方法:选取2020年1月—2021年12月江阴市中医外科医院收治的肉芽肿性小叶性乳腺炎患者85例作为研究对象,采用抽签法随机分为对照组(n=42)、观察组(n=43)。对照组采用透脓散加减治疗,观察组采用透脓散加减联合乳痈散外敷治疗。比较两组治疗效果。结果:治疗2、4周后,两组肿块质地、病灶皮肤温度、病灶皮肤颜色、疼痛症状、脓液渗出量、脓液性质评分逐渐降低,且观察组低于对照组,差异有统计学意义(P<0.05)。观察组治疗有效率高于对照组,差异有统计学意义(P=0.012)。结论:透脓散加减联合乳痈散外敷治疗肉芽肿性小叶性乳腺炎的效果显著,可改善患者临床症状。