Yu Weiwei, Zhou Dongqi, Zhang Li, Rumeng Chen, Zhang Peishuai, Sun Lisha, Gao Ziping
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China.
Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China.
Medicine (Baltimore). 2020 Aug 21;99(34):e20772. doi: 10.1097/MD.0000000000020772.
Type 1 diabetes mellitus (T1DM) is a chronic, immune-mediated disease characterized by the destruction of insulin producing cells and persistent hyperglycemia. At present, the drugs for type 1 diabetes mellitus can reduce blood glucose rapidly and effectively, but there are risks of hypoglycemia, large fluctuation of blood glucose, and chronic complications. Related research found that compared with continuous hyperglycemia, blood glucose fluctuations are more harmful to the chronic complications of diabetes. Blood glucose variation is closely related to the occurrence and development of chronic complications of diabetes. Sancai powder (SC) is made on the basis of 3 ancient Chinese medicine formulas, which has the effect of lowering blood glucose. There have been reports on the clinical study of SC in the treatment of diabetic patients, but there is no systematic evaluation of SC in the treatment of type 1 diabetes, so it is necessary to summarize and evaluate the existing evidence.
This study will be conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols. We will search 3 English databases and 4 Chinese databases. Two methodologically trained researchers will read titles, abstracts, and full texts, and independently select eligible literature based on inclusion and exclusion criteria. After assessing the risk of bias and extracting data, we will conduct a meta-analysis of the results, including: standard deviation of blood glucose level, coefficient of variation, mean blood glucose, postprandial blood glucose fluctuation, hypoglycemia index, glycated hemoglobin, overall impact rate, and adverse effects. The heterogeneity of the data will be tested by Cochrane x2 and I2. Based on reliable subgroup effect guidance, we established 3 hypotheses for subgroup analysis: disease status at baseline, duration of intervention, and type of concomitant medication. Sensitivity analysis will be carried out to assess the stability of the results. The publication bias assessment will then be performed by funnel plot analysis and Egger test. Finally, we will use the "grading, evaluation, development and evaluation of recommendations" system to assess the quality of evidence.
The results of this systematic review and meta-analysis will be published in a peer-reviewed journal.
In our study, the evidence of SC in the treatment of reducing blood sugar fluctuation in type 1 diabetes will be comprehensively summarized and carefully evaluated. It will provide more options for clinical treatment of the disease.
INPLASY202050052.
1型糖尿病（T1DM）是一种慢性免疫介导性疾病，其特征为胰岛素生成细胞被破坏以及持续性高血糖。目前，用于1型糖尿病的药物能快速有效地降低血糖，但存在低血糖、血糖大幅波动及慢性并发症的风险。相关研究发现，与持续性高血糖相比，血糖波动对糖尿病慢性并发症的危害更大。血糖变异性与糖尿病慢性并发症的发生和发展密切相关。三参散（SC）是在3个古代中药方剂基础上制成的，具有降血糖作用。已有关于SC治疗糖尿病患者的临床研究报道，但尚无对SC治疗1型糖尿病的系统评价，因此有必要对现有证据进行总结和评估。
本研究将按照系统评价和Meta分析方案的首选报告项目进行。我们将检索3个英文数据库和4个中文数据库。两名经过方法学培训的研究人员将阅读标题、摘要和全文，并根据纳入和排除标准独立选择符合条件的文献。在评估偏倚风险并提取数据后，我们将对结果进行Meta分析，包括：血糖水平标准差、变异系数、平均血糖、餐后血糖波动、低血糖指数、糖化血红蛋白、总体影响率及不良反应。数据的异质性将通过Cochrane χ²和I²进行检验。基于可靠的亚组效应指导，我们建立了3个亚组分析假设：基线疾病状态、干预持续时间及合并用药类型。将进行敏感性分析以评估结果的稳定性。然后通过漏斗图分析和Egger检验进行发表偏倚评估。最后，我们将使用“推荐分级、评价、制定与评估”系统来评估证据质量。
本系统评价和Meta分析的结果将发表在同行评审期刊上。
在我们的研究中，将全面总结并仔细评估SC治疗1型糖尿病降低血糖波动的证据。这将为该疾病的临床治疗提供更多选择。
INPLASY注册号：INPLASY202050052。
