摘要
目的系统评价黄连素治疗2型糖尿病的疗效和安全性。方法计算机检索Cochrane Library、PubMed(1966～2011.10)、EMbase(1974～2011.10)、CNKI(1994～2011.10)、VIP(1989～2011.10)和中国优秀硕士、博士学位毕业论文数据库(1979～2011),按照纳入排除标准选择文献、提取资料和进行质量评价后,采用RevMan5.0软件进行Meta分析。结果共纳入10个随机对照试验,合计647例2型糖尿病患者,试验地点均在中国大陆,试验人群为中国人。各纳入研究的方法学质量总体较差。试验组为单用黄连素或加用其他降糖西药(二甲双胍、格列吡嗪),对照组为安慰剂、生活方式干预或其他降糖西药(吡格列酮、罗格列酮、二甲双胍)。因纳入各研究两组药物的种类、剂量、患者病程、治疗疗程等方面均存在临床差异,故未进行合并分析,而分别报道了每个研究的结果。黄连素组与安慰剂组或生活方式干预组比较,有降低空腹血糖的趋势;但黄连素组与安慰剂组、生活方式干预组或降糖西药组比较,其降低餐后血糖、糖化血红蛋白、体重指数(BMI)及调节脂代谢方面的效果并不明确。此外,采用黄连素治疗,在治疗过程中并无低血糖发生,仅有少许患者出现胃肠道不良反应,但与安慰剂组或生活方式干预组相比无差异。结论黄连素可能可以降低2型糖尿病的空腹血糖,但并不优于二甲双胍、格列吡嗪、罗格列酮等药物;黄连素在降低餐后血糖、糖化血红蛋白、BMI和调脂方面的作用不确切;黄连素治疗2型糖尿病的不良反应少且轻,主要为消化道症状,无低血糖发生。目前黄连素治疗2型糖尿病临床研究的方法学和报告质量尚低,需要开展高质量的临床试验,以进一步证实黄连素治疗2型糖尿病的疗效。
Objective To systematically evaluate the effectiveness and safety of berberine in the treatment of type 2 diabetes. Methods The databases including The Cochrane Library, PubMed （1966 to October 2011）, Excerpta Medica Database （EMbase, 1974 to October 2011）, Chinese National Knowledge Infrastructure databases （CNKI, 1994 to October 2011）, the Chinese Scientific and Technical Journals database （VIP, 1989 to October 2011）, and China Doctor Dissertation Full-text Database （CDFD, 1979 to 2011） and China Master Dissertation Full-text Database （CMFD, 1979 to 2011） were searched. The randomized controlled trials （RCTs） on berberine in the treatment of type 2 diabetes were screened accord- ing to the inclusive and exclusive criteria. The data were extracted, the quality was assessed, and the systematic review was conducted by using Revman 5.0 software. Results Ten RCTs involving 647 Chinese patients with DM2 were included, and the quality of each study was generally low. The interventions in the treatment groups were berberine or combined with metformin or glipizide. The control groups included placebo, lifestyle intervention, pioglitazone, rosiglitazone or metformin. Because the experiment and control groups in each included trials were different in drug type and dose, dis- ease duration, and treatment regimens, only the results of all trials were reported rather than performing Meta-analysis. The berberine group was superior to the placebo and lifestyle intervention groups in lowering fasting blood glucose （FBG）, but it was not so obviously effective in lowering the postprandial blood glucose （PBG）, hemoglobin Alc and BMI and regulating lipid metabolism compared with the placebo, lifestyle intervention, and western hypoglycemic agents. In addition, the berberine treatment had no side effects of hypoglycemia although a few patients complained of gastrointes- tinal adverse reaction, and there was no significant difference when compared with the placebo and lifestyle intervention groups.
出处
《中国循证医学杂志》
CSCD
2012年第1期81-91,共11页
Chinese Journal of Evidence-based Medicine
