血脂康胶囊治疗高脂血症有效性和安全性的系统评价

Xuezhikang Capsule for Hyperlipidemia: A Systematic Review

目的系统评价血脂康胶囊(简称血脂康)治疗高脂血症的有效性和安全性。方法电子检索MEDLINE、EMBASE、Cochrane图书馆临床对照试验注册库、Cochrane协作网内分泌代谢组资料库、中国生物医学文献数据库、中国医院知识仓库,手工检索已发表与未发表的相关文献(检索至2005年12月)。纳入治疗组服用血脂康,对照组服用他汀类等调脂药治疗高脂血症的随机或半随机对照试验。采用CochraneReviewer’sHandbook4.2.2中的方法进行文献质量评价和资料分析。结果共纳入11个研究,1073例原发性高血脂症患者。纳入研究质量均为B或C级。①血脂康降低TC的作用与他汀类[WMD0.06,95%CI(-0.09,0.20),RR1.02,95%CI(0.93,1.12)]、贝特类药物[WMD0.05,95%CI(-0.22,0.31)]及丙丁酚[WMD0.42,95%CI(-0.01,0.85)]相似,并优于烟酸肌醇酯[WMD0.96,95%CI(0.73,1.18)]。②血脂康降低TG作用与他汀类药物[WMD0.02,95%CI(-0.10,0.14),RR1.17,95%CI(0.92,1.49)]、烟酸肌醇酯[WMD0.28,95%CI(-0.17,0.73)]相似、丙丁酚[WMD0.71,95%CI(0.22,1.20)],但弱于贝特类[WMD-0.81,95%CI(-1.40,-0.23)]。③血脂康升高HDL-C作用与他汀类药物相似[WMD-0.03,95%CI(-0.10,0.04),RR1.03,95%CI(0.80,1.33)],优于烟酸肌醇酯[WMD0.15,95%CI(0.01,0.29)],与贝特类[WMD0.03,95%CI(-0.08,0.15)]、丙丁酚[WMD0.04,95%CI(-0.16,0.24)]相似。④血脂康降低LDL-C作用与他汀类药物比较,差异无统计学意义[WMD-0.23,95%CI(-0.61,0.15),RR1.15,95%CI(0.75,1.77)]。血脂康降低LDL-C作用与贝特类[WMD0.19,95%CI(-0.12,0.50)]、丙丁酚相似[WMD0.35,95%CI(-0.03,0.73)],优于烟酸肌醇酯[WMD0.53,95%CI(0.16,0.90)]。⑤不良反应:短期服用血脂康的不良反应主要为胃肠道反应,较少有肝功能异常改变和肌痛。结论血脂康能降低高脂血症患者的TC、TG和LDL-C水平,升高HDL-C水平,其作用与他汀类药物相似,短期服用血脂康未发现有明显的不良反应。本系统评价纳入研究质量和数量有限,上述结论尚需更多高质量、大样本、长期随访的随机对照试验予以验证。

Objective To assess the efficacy and safety of Xuezhikang capsule （XZK） for hyperlipidemia. Methods MEDIINE, EMBASE, Cochrane Central Register of Controlled Trials（CCTR）, Cochrane Metabolic and Endocrine Disorders Group data bank, and Chinese Biomedical Database（CBM）, China Hospital Knowledge Database（CHKD） were searched, and the published/unpublished information was handsearched （updated to Dec., 2005） to identify randomized controlled trials （RCTs） or quasi-RCT of XZK versus statins or other lipid lowering drugs in treating hyperlipidemia patients. The quality evaluation, data extraction and analysis were conducted by the method recommended in Cochrane Reviewer＇s Handbook 4.2.2. Data were analyzed using Review Manager （Version 4.2）. Results Eleven trials （conducted in China） were identified, including 1 073 patients with hyperlipidemia met the inclusion criteria. All the included RCTs were graded as B or C. ① The effect of XZK in reducing TC： There were no significant differences between XZK and statins （ WMD 0.06, 95%CI-0.09 to 0.20 and RRI.02, 95%CI 0.93 to 1.12）, XZK and fibrates （WMD 0.05, 95%CI -0.22 to 0.31） and XZK and probucol（WMD 0.42, 95%C1 -0.01 to 0.85）. XZK was superior to hexanicit （WMD 0.96, 95%CI 0.73 to 1.18）. ② The effect of XZK in reducing TG： XZK had the same effect as statins （WMD 0.02, 95%CI -0.10 to 0.14 and RR 1.17, 95%CI 0.92 to 1.49） and hexanicit （WMD 0.28, 95%CI -0.17 to 0.73 ）.Meanwhile, XZK was superior to probucol （WMD 0.71, 95%CI 0.22 to 1.20）, but it was not as good as fibrates （WMD -0.81, 95%CI - 1.40 to -0.23）. ③The effect of XZK in increasing HDL-C ： XZK had the same effect as that of statins （WMD -0.03, 95%CI -0.10 to 0.04 and RR 1.03, 95% CI 0.80 to 1.33）. The effect of XZK was better than that of hexanicit （WMD 0.15, 95%CI 0.01 to 0.29）. XZK had the same effect offibrates （WMD 0.03, 95%CI -0.08 to 0.15） and probucol （WMD 0.04, 95%CI -0.16 to 0.24）.④ The effect of XZK in reducing LDL-C. The effects of XZK and statins were the same （WMD -0.23, 95%CI -0.61 to 0.15 and RR 1.15, 95%CI 0.75 to 1.77）. The effect of XZK was better than that of hexanicit （WMD 0.53, 95%CI 0.16 to 0.90）. Meanwhile, XZK had the same effect as those of fibrates （WMD 0.19, 95%CI -0.12 to 0.50） and probucol （WMD 0.35, 95%CI -0.03 to 0.73）. ⑤The adverse reactions of XZK were mainly the gastrointestinal tract reaction, while liver function abnormality and myalgia were scarcely found. Conclusion Xuezhikang capsule have the same effects as those of statins in reducing the levels of TC, TG, LDL-C and raising HDL-C in patients with hyperlipidemia. No obvious adverse reactions are found during the short-term treatment. But further confirmation with clinical randomized controlled trials of high quality, large sample and long-term follow-up is needed.