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中药复方联合西药治疗浆细胞性乳腺炎:系统评价与Meta分析方案

Chinese herbal compound combined with western medicine therapy in the treatment of plasma cell mastitis: A protocol for systematic review and meta-analysis.

作者信息

Zhang Jindan, Xu Jianzhong, Zhang Jiao, Ren Yun

机构信息

Changzhi City People's Hospital, Changzhi, Shanxi province, China.

出版信息

Medicine (Baltimore). 2020 Oct 30;99(44):e22858. doi: 10.1097/MD.0000000000022858.

Abstract

BACKGROUND

Plasma cell mastitis (PCM) is a benign suppurative disease of the breast based on the expansion of mammary ducts and infiltration of plasma cells. It is relatively rare clinically, and its main manifestations include nonperiodic breast pain, nipple discharge, areola lump, nipple depression, nipple fistula, among others. Modern medicine is mainly surgical treatment, which is easy to recur. The clinical practice shows that the overall treatment of patients with TCM syndrome differentiation using oral medicine combined with western medicine therapy, combined internal and external treatment, can significantly improve the curative effect, prevent recurrence, has a certain therapeutic advantage, but lack of evidence of evidence-based medicine. The purpose of this study is to study the efficacy and safety of oral traditional Chinese medicine (TCM) combined with western medicine therapy in the treatment of PCM.

METHODS

Use computer to retrieve English databases (PubMed, Embase, Web of Science, the Cochrane Library) and Chinese databases (CNKI, Wan Fang, VIP, Chinese biomedical database), from the establishment of database to September 2020, for randomized controlled trials(RCTs) of oral TCM combined with western medicine therapy in the treatment of PCM, two researchers independently extracted the data and evaluated the quality of the included research, and meta-analysis was conducted on the included literatures using RevMan5.3 software.

RESULTS

This study evaluated the efficacy and safety of oral TCM combined with western medicine therapy in the treatment of PCM from the aspects of effective rate, symptom score, recurrence rate, adverse reaction rate, and patient satisfaction.

CONCLUSION

This study will provide reliable evidence-based evidence for the clinical application of oral TCM combined with western medicine therapy in the treatment of PCM.

ETHICS AND DISSEMINATION

The purpose of this study is to sort out and analyze the literature. This systematic review also does not involve endangering participant rights. Ethical approval was not required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences. OSF REGISTRATION NUMBER:: doi 10.17605/OSF.IO/K9A78.

摘要

背景

浆细胞性乳腺炎(PCM)是一种以乳腺导管扩张和浆细胞浸润为基础的乳腺良性化脓性疾病。临床上相对少见,主要表现为非周期性乳房疼痛、乳头溢液、乳晕肿块、乳头凹陷、乳头瘘管等。现代医学主要采用手术治疗,术后易复发。临床实践表明,运用中医辨证口服药物结合西医治疗,内外同治,能显著提高疗效,预防复发,具有一定的治疗优势,但缺乏循证医学证据。本研究旨在探讨口服中药联合西医治疗PCM的疗效及安全性。

方法

利用计算机检索英文数据库(PubMed、Embase、Web of Science、Cochrane Library)和中文数据库(CNKI、万方、维普、中国生物医学数据库),检索时间从各数据库建库至2020年9月,查找口服中药联合西医治疗PCM的随机对照试验(RCT),两名研究者独立提取数据并评价纳入研究的质量,采用RevMan5.3软件对纳入文献进行Meta分析。

结果

本研究从有效率、症状评分、复发率、不良反应率及患者满意度等方面评价了口服中药联合西医治疗PCM的疗效及安全性。

结论

本研究将为口服中药联合西医治疗PCM的临床应用提供可靠的循证依据。

伦理与传播

本研究旨在整理分析文献。本系统评价也不涉及危害参与者权益。无需伦理批准。研究结果可能发表在同行评议期刊上或在相关会议上传播。开放科学框架(OSF)注册号:doi 10.17605/OSF.IO/K9A78 。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4b3d/7598849/8484e5cd3aa5/medi-99-e22858-g002.jpg

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