Han Mengyu, Liu Ziqiang, Nong Luqi, Zi Yingxin, Meng Huan, Deng Yu, Wang Zhi-Jun, Jin Ming
Beijing University of Chinese Medicine.
Department of Ophthalmology, China-Japan Friendship Hospital, Beijing, China.
Medicine (Baltimore). 2020 May;99(19):e20086. doi: 10.1097/MD.0000000000020086.
Vitreous hemorrhage (VH) is a common ophthalmic disease with a high rate of blindness, which will seriously affect the quality of life of patients and bring great burden to patients' families and society. The treatment for VH contains medical therapy, lasers, and surgery. At present, there is no recognized western medicine with definite curative effect and little side effect for the treatment of VH. In most cases, PRP is not available to treat VH; intravitreal injection or surgical treatment is adopted as the primary therapy. However, in the long-term treatment, the effect of the above-mentioned treatment is not satisfactory, so many patients choose oral Chinese medicines, which has been widely used in China to treat VH. Numerous clinical trials have demonstrated that Chinese medicines can promote the absorption of VH and improve the visual function of patients. The purpose of this review is to evaluate the efficacy and safety of Chinese medicines in the treatment of VH and inform a decision aid for the clinical encounter between patients and clinicians. Besides, it is beneficial to establish a future research agenda.
The systematic review will include all of the randomized controlled trials on the efficacy and safety of Chinese medicines for VH. Nine electronic databases, namely PubMed, Web of Science, EMBASE, the Cochrane Library, Google Scholar, China National Knowledge Infrastructure (CNKI), Wanfang Database, China Science and Technology Journal database (VIP), and CBM, will be searched normatively on the basis of the rule of each database from the inception to August 31, 2019. We will also search registers of clinical trials, potential gray literature, and conference abstracts. There are no limits on language and publication status. The literature screening, data extraction, and quality assessment will be conducted by 2 reviewers independently. The reporting quality and risk of bias will be assessed by other 2 researchers. Standard of curative effect and total treatment efficacy rate were assessed as the primary outcome. The secondary outcomes will include the curative effect of single symptom and sign, the improvement rate of single auxiliary examination, withdrawal and reduction of western medicines in a course of treatment, maintenance of western medicines after the course of treatment, laboratory efficacy indexes. Meta-analysis will be performed using RevMan5.3 software provided by the Cochrane Collaboration.
This study will provide a comprehensive review based on current evidence of Chinese medicines treatment for VH in several aspects, including standard of curative effect, total treatment efficacy rate, the curative effect of single symptom and sign, the improvement rate of single auxiliary examination, withdrawal and reduction of western medicines in a course of treatment, laboratory efficacy indexes, total treatment efficacy, and safety, among others.
The conclusion of this study will provide evidence to determine whether Chinese medicines are an effective and safe intervention for patients with VH.
It is not necessary to obtain ethical approval for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences and will be shared on social media platforms.
PROSPERO CRD42020152321.
玻璃体积血（VH）是一种常见的致盲性眼病，会严重影响患者的生活质量，给患者家庭和社会带来沉重负担。VH的治疗方法包括药物治疗、激光治疗和手术治疗。目前，尚无公认的治疗VH疗效确切且副作用小的西药。多数情况下，光凝治疗不适用于VH，主要采用玻璃体腔内注射或手术治疗。然而，在长期治疗中，上述治疗效果并不理想，因此许多患者选择口服中药，中药在中国已广泛用于治疗VH。众多临床试验表明，中药可促进VH吸收，改善患者视功能。本综述旨在评估中药治疗VH的疗效和安全性，为患者与临床医生的临床诊疗提供决策依据。此外，有助于确立未来的研究议程。
本系统评价将纳入所有关于中药治疗VH疗效和安全性的随机对照试验。将依据各数据库检索规则，对9个电子数据库进行规范检索，检索时间范围为各数据库建库至2019年8月31日，这9个数据库分别为PubMed、Web of Science、EMBASE、Cochrane图书馆、谷歌学术、中国知网（CNKI）、万方数据库、中国科技期刊数据库（维普）和中国生物医学文献数据库（CBM）。我们还将检索临床试验注册库、潜在的灰色文献和会议摘要。对语言和发表状态不设限制。由2名评价员独立进行文献筛选、数据提取和质量评估。由另外2名研究人员评估报告质量和偏倚风险。将疗效标准和总治疗有效率作为主要结局指标。次要结局指标将包括单个症状和体征的疗效、单项辅助检查的改善率、一个疗程内西药的撤减情况、疗程结束后西药的维持情况、实验室疗效指标。将使用Cochrane协作网提供的RevMan5.3软件进行Meta分析。
本研究将基于现有证据，从多个方面对中药治疗VH进行全面综述，包括疗效标准、总治疗有效率、单个症状和体征的疗效、单项辅助检查的改善率、一个疗程内西药的撤减情况、实验室疗效指标、总治疗疗效和安全性等。
本研究结论将为判定中药对VH患者是否为有效且安全的干预措施提供证据。
本研究无需获得伦理批准。本系统评价将发表在同行评议期刊上，在会议上报告，并在社交媒体平台上分享。
PROSPERO CRD42020152
