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桂枝茯苓丸治疗慢性盆腔炎的方案:系统评价和荟萃分析方案。

Guizhi Fuling wan for chronic pelvic inflammatory disease protocol: A protocol for systematic review and meta analysis.

机构信息

College of Basic Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.

出版信息

Medicine (Baltimore). 2020 Dec 18;99(51):e23549. doi: 10.1097/MD.0000000000023549.

Abstract

BACKGROUND

Chronic pelvic inflammatory disease (CPID) is one of common diseases of department of gynaecology, point to female inside genital and circumferential organization to suffer from infection of all sorts of pathogenic bacteria and cause chronic inflammation sex disease, also cause one of main factors of infertile of female of childbearing age period. Due to its insidious onset, it is not easy to find out in the early stage. Therefore, it is difficult to obtain satisfactory curative effect by taking routine treatment with antibiotics. In recent years, TCM has made great strides in the treatment of chronic pelvic inflammation, a number of clinical studies have shown that Guizhi Fuling wan combined with antibiotics can significantly improve the clinical symptoms and enhance the therapeutic effect. Therefore, we intend to conduct a system review and meta-analysis to further clarify the effectiveness and safety of GZFLW for CPID.

METHODS

We will search each database from the built-in until September2020.The English literature mainly searches Cochrane Library, PubMed, EMBASE, and Web of Science, while the Chinese literature comes from CNKI, CBM, VIP, and Wangfang database. Simultaneously we will retrieval clinical registration tests and grey literatures. This study only screens the clinical randomized controlled trials (RCTs) about GZFLW for CPID to assess its efficacy and safety. The 2 researchers worked independently on literature selection, data extraction, and quality assessment. The dichotomous data is represented by relative risk (RR), and the continuous is expressed by mean difference (MD) or standard mean difference (SMD), eventually the data is synthesized using a fixed effect model (FEM) or a random effect model (REM) depending on whether or not heterogeneity exists. The clinical efficacy, pelvic effusion and mass were evaluated as the main outcomes. The serum interleukin-6 (IL-6), C-reactive protein (CRP), tumor necrosis factor (TNF)-α, erythrocyte sedimentation rate (ESR), erythrocyte specific volume was secondary outcomes. Finally, meta-analysis was conducted by RevMan software version 5.3.

RESULTS

This study will provide high-quality evidence for treatment of CPID with GZFLW in terms of effectiveness and safety.

CONCLUSION

This systematic review aims to provide new options for GZFLW treatment of CPID in terms of its efficacy and safety.

ETHICS AND DISSEMINATION

This study does not require ethical approval. We will disseminate our findings by publishing results in a peer-reviewed journal.

OSF REGISTRATION NUMBER

DOI 10.17605 / OSF.IO / R9NVT.

摘要

背景

慢性盆腔炎(CPID)是妇科常见病,是指女性内生殖器及其周围结缔组织、盆腔腹膜的慢性炎症。可引起不孕,是女性不孕的主要因素之一。由于其发病隐匿,早期不易发现。因此,采用常规抗生素治疗往往难以取得满意的疗效。近年来,中医药在慢性盆腔炎的治疗中取得了长足的进步,多项临床研究表明,桂枝茯苓丸联合抗生素可明显改善临床症状,增强治疗效果。因此,我们拟进行系统评价和荟萃分析,进一步阐明桂枝茯苓丸治疗 CPID 的有效性和安全性。

方法

我们将从自建数据库搜索至 2020 年 9 月。英文文献主要检索 Cochrane Library、PubMed、EMBASE 和 Web of Science,中文文献来源于中国知网、CBM、VIP 和万方数据库。同时检索临床注册试验和灰色文献。本研究仅筛选桂枝茯苓丸治疗 CPID 的临床随机对照试验(RCT),评估其疗效和安全性。两名研究人员独立进行文献选择、数据提取和质量评估。二分类数据采用相对危险度(RR)表示,连续性数据采用均数差(MD)或标准化均数差(SMD)表示,根据是否存在异质性,采用固定效应模型(FEM)或随机效应模型(REM)进行数据合成。临床疗效、盆腔积液和肿块为主要结局,血清白细胞介素-6(IL-6)、C 反应蛋白(CRP)、肿瘤坏死因子-α(TNF-α)、红细胞沉降率(ESR)、红细胞比容为次要结局。最终采用 RevMan 软件版本 5.3 进行荟萃分析。

结果

本研究将为桂枝茯苓丸治疗 CPID 的有效性和安全性提供高质量证据。

结论

本系统评价旨在为桂枝茯苓丸治疗 CPID 的有效性和安全性提供新的选择。

伦理与传播

本研究不需要伦理批准。我们将通过在同行评议期刊上发表研究结果来传播我们的发现。

OSF 注册号:DOI 10.17605/OSF.IO/R9NVT。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/88ad/7748215/8b8f2a12f7d9/medi-99-e23549-g001.jpg

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