口服中成药联合他汀类药物治疗血脂异常的网状Meta分析

目的基于网状Meta分析方法,比较不同调脂类口服中成药联合他汀类药物(statines,TT)治疗血脂异常的临床疗效与安全性。方法计算机检索国内中国知网、万方、维普、中国生物医学文献数据库及国外PubMed、Embase、Cochrane Library等数据库,检索时间为建库至2020年7月,由NoteExpress文献管理系统对检索到的文献进行自动查重,查重后由2名研究者独立进行文献筛选和资料提取,并采用Cochrane协作网研发的偏倚风险评估工具进行文献质量的评价,最后采用Stata16和GeMTC14.3进行网状Meta分析。结果最终纳入42项研究,涉及血脂康胶囊(Xuezhikang Capsule,XZK)、蒲参胶囊(Pushen Capsule,PS)、荷丹片(Hedan Tablet,HD)、丹田降脂丸(Dantian Jiangzhi Pills,DTJZ)、脂必妥胶囊(Zhibituo Capsule,ZBTUO)、脂必泰胶囊(Zhibitai Capsule,ZBTAI)、松龄血脉康胶囊(Songling Xuemaikang Capsule,SLXMK)7种调脂类口服中成药,3718例样本量。网状Meta分析显示,在降低总胆固醇(totalcholesterol,TC)方面,疗效排序为ZBTUO+TT(72.1%)>DTJZ+TT(68.4%)>HD+TT(68.1%)>ZBTAI+TT(66.9%)>XZK+TT(51.0%)>SLXMK+TT(45.1%)>PS+TT(26.4%)>TT(1.9%);在降低三酰甘油(triglyceride,TG)方面,疗效排序为HD+TT(98.6%)>SLXMK+TT(70.7%)>PS+TT(63.1%)>ZBTAI+TT(52.4%)>ZBTUO+TT(49.5%)>XZK+TT(34.5%)>DTJZ+TT(27.4%)>TT(1.9%);在降低低密度脂蛋白胆固醇(low-density lipoprotein cholesterol,LDL-C)方面,疗效排序为HD+TT(89.8%)>ZBTUO+TT(76.4%)>ZBTAI+TT(65.6%)>XZK+TT(54.3%)>DTJZ+TT(46.1%)>PS+TT(33.2%)>SLXMK+TT(24.3%)>TT(10.4%);在升高高密度脂蛋白胆固醇(high-density lipoproteincholesterol,HDL-C)方面,疗效排序为HD+TT(82.8%)>PS+TT(76.8%)>ZBTUO+TT(61.4%)>DTJZ+TT(48.3%)>XZK+TT(43.9%)>SLXMK+TT(39.5%)>ZBTAI+TT(36.5%)>TT(10.8%);定性分析显示口服中成药联合他汀类药物治疗血脂异常不良反应发生率较低。结论口服中成药联合他汀类药物调脂疗效优于单用他汀类药物,在降低TC方面,ZBTUO联合他汀疗效最优,在降低TG、LDL-C和升高HDL-C方面,HD联合他汀疗效最优,且口服中成药联合他汀类药物治疗血脂异常安全性较好。但纳入文献整体质量偏低,因此尚需大样本、高质量随机对照试验进一步验证调脂类口服中成药治疗血脂异常的疗效和安全性。

Oral Chinese patent medicine combined with statins in treatment of dyslipidemia:A network Meta-analysis

Objective To compare the clinical efficacy and safety of different lipid-regulating oral Chinese patent medicines combined with statins(TT) in the treatment of dyslipidemia by network Meta-analysis. Methods The literatures were searched from databases such as National Knowledge Infrastructure Databases(CNKI), Wanfang Database, VIP Database for Chinese Technical Periodicals(VIP), Chinese Biomedical Literature Database(Sino Med), Pub Med, Embase, Cochrane Library by computer from the establishment of the database to July 2020. Firstly, NoteExpress literature management system was used to check the retrieved literatures and exclude duplicate literatures. And data extraction and quality assessment were performed according to the Cochrane standards. Stata16 and GeMTC14.3 were then used for network Meta-analysis. Results Forty-two studies were included, involving seven kinds of lipid-regulating oral Chinese patent medicines: Xuezhikang Capsules(血脂康胶囊, XZK), Pushen Capsules(蒲参胶囊, PS), Hedan Tablets(荷丹片, HD), Dantian Jiangzhi Pills(丹田降脂丸, DTJZ), Zhibituo Capsules(脂必妥胶囊, ZBTUO), Zhibitai Capsules(脂必泰胶囊, ZBTAI), Songling Xuemaikang Capsules(松龄血脉康胶囊, SLXMK), with a sample size of 3718 cases. The results of network Meta-analysis showed that in terms of reducing TC levels, the order of efficacy was ZBTUO + TT(72.1%) > DTJZ + TT(68.4%) > HD + TT(68.1%) > ZBTAI + TT(66.9%) > XZK + TT(51.0%) > SLXMK + TT(45.1%) > PS + TT(26.4%) > TT(1.9%);In terms of reducing TG levels, the order of efficacy was HD + TT(98.6%) > SLXMK + TT(70.7%) > PS + TT(63.1%) > ZBTAI + TT(52.4%) > ZBTUO + TT(49.5%) > XZK + TT(34.5%) > DTJZ + TT(27.4%) > TT(1.9%);In terms of reducing LDL-C levels, the order of efficacy was HD + TT(89.8%) > ZBTUO + TT(76.4%) > ZBTAI + TT(65.6%) > XZK + TT(54.3%) > DTJZ + TT(46.1%) > PS + TT(33.2%) > SLXMK + TT(24.3%) > TT(10.4%);In terms of increasing HDL-C levels, the order of efficacy was HD + TT(82.8%) > PS + TT(76.8%) > ZBTUO + TT(61.4%) > DTJZ + TT(48.3%) > XZK + TT(43.9%) > SLXMK + TT(39.5%) > ZBTAI + TT(36.5%) > TT(10.8%). Qualitative analysis showed that the incidence of adverse reactions of oral Chinese patent medicines combined with statins in the treatment of dyslipidemia was low. Conclusion In conclusion, the lipid-regulating effect of oral Chinese patent medicines combined with statins was better than that of statins alone. In terms of reducing TC level, ZBTUO + TT had the best effect, in terms of reducing TG and LDL-C levels and increasing HDL-C levels, HD + TT had the best effect, and oral Chinese patent medicine combined with statins were safe for the treatment of dyslipidemia. However, because the overall quality of the literatures included in this study was low, large samples and high-quality randomized controlled trials were still needed to further verify the efficacy and safety of lipid-lowering oral Chinese patent medicines in the treatment of dyslipidemia.