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阿托伐他汀仿制药与原研药的有效性和安全性系统评价
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| 篇名： | 阿托伐他汀仿制药与原研药的有效性和安全性系统评价 |
| TITLE： | Effectiveness and safety of generic and original drugs of atorvastatin ：a systematic review |
| 摘要： | 目的 系统评价阿托伐他汀仿制药与原研药的有效性和安全性，为临床用药选择提供最新的循证参考。方法计算机检索PubMed、CochraneLibrary、Embase、中国知网、维普网、万方数据库，收集阿托伐他汀仿制药与原研药的干预性研究和观察性研究，检索时限均为数据库建库起至2021年4月。对符合纳入标准的研究进行资料提取后，采用Cochrane风险偏倚评估工具5.1.0对干预性研究进行质量评价，采用纽卡斯尔-渥太华量表（NOS）对观察性研究进行质量评价；运用RevMan5.4统计软件进行Meta分析，同时进行描述性分析。结果共纳入24项研究，其中21项为随机对照试验（RCT）、3项为回顾性队列研究（RCS），合计20001例患者。RCT的Meta分析结果显示，仿制药降低低密度脂蛋白胆固醇（LDL-C）程度[MD＝－0.05，95％CI（－0.12，0.02），P＝0.16]、升高高密度脂蛋白胆固醇（HDL-C）程度[MD＝－0.00，95％CI（－0.02，0.01），P＝0.52]与原研药比较差异无统计学意义，降低总胆固醇（TC）程度[MD＝－0.11，95％CI（－0.17，－0.06），P＜0.0001]、降低三酰甘油（TG）程度[MD＝－0.05，95％CI（－0.09，－0.01），P＝0.02]小于原研药，差异有统计学意义；两组总不良反应发生率[OR＝1.08，95％CI（0.85，1.37），P＝0.55]和其他不良反应发生率（P＞0.05）方面的差异无统计学意义。亚组分析结果显示，北京嘉林药业生产的仿制药（简称“嘉林仿制药”）降低TC、TG的程度小于原研药，差异有统计学意义，其他指标及其他厂家仿制药组各指标与原研药组比较差异均无统计学意义；与原研药相比，嘉林仿制药20mg/d组降低TC、TG的程度小于原研药，随访12、24周时降低TC的程度和随访24周时降低TG的程度小于原研药，差异有统计学意义，其余指标差异均无统计学意义。RCS的定性描述结果表明，对于死亡/急性冠状动脉综合征老年患者，仿制药与原研药在心血管事件或严重副作用方面的差异无统计学意义；对于由原研药转换为仿制药的成年患者，仿制药代替原研药的效果不会降低，但升高HDL-C的程度小于原研药。结论在有效性方面，阿托伐他汀仿制药可代替原研药，长期应用时应关注其对HDL-C、TC、TG的影响程度；在安全性方面，仿制药与原研药相似。 |
| ABSTRACT： | OBJECTIVE To systema tically evaluate the effectiveness and safety of gen eric and original drugs of atorvastatin ， and to provide the latest evidence-based reference for drug selection in clinic. METHODS Retrieved from PubMed ，Cochrane Library，Embase，CNKI，VIP and Wanfang database ，intervention trials and observational studies about generic and original drugs of atorvastatin were collected during the inception to Apr. 2021. After data extraction of literatures met inclusion criteria ，the Cochrane risk bias evaluation tool 5.1.0 was used to evaluate the quality of intervention trials ；Newcastle-Ottawa Scale （NOS）was used to evaluate the quality of observational studies. RevMan 5.4 software was used to conduct meta-analysis ，and descrptive analysis was performed at the same time. RESULTS A total of 24 studies were included ，involving 21 randomized controlled trials （RCTs）and 3 retrospective cohort studies （RCSs），with 20 001 patients involved. Meta-analysis results of RCT showed there was no statistically significant difference between the two groups in reducing low-density lipoprotein cholesterol （LDL-C）levels [MD ＝ － 0.05，95％ CI（－ 0.12，0.02），P＝0.16] and increasing Δ 基金项目：国家重点研发计划项目（No.2017YFC0910004）；山 东省重点研发计划项目（No.2020RKB14165） high-density lipoprotein cholesterol （HDL-C）levels [MD ＝ ＊硕士研究生 。研究方向：临床药学。E-mail：1677032023@qq. － 0.00，95％ CI（－ 0.02，0.01），P＝0.52]；the degree of com reducing total cholesterol （TC）level [MD ＝－0.11，95％CI # 通信作者：主任药师，硕士生导师。研究方向：临床药学、药事 （ － 0.17，－ 0.06），P＜0.000 1] and triglyceride （TG） 管理。电话：0351-89268349。E-mail：13791120711@126.com level [MD ＝－0.05，95％CI（－0.09， －0.01），P＝0.02] in ·358· China Pharmacy 2022Vol. 33 No. 3 中国药房 2022年第33卷第3期 generic drug group was lower than orig inal drug group ，with statistical significance difference. There was no statistical significance difference in total incidence of adverse drug reaction （ADR）[OR＝1.08，95％ CI（0.85，1.37），P＝0.55] and the incidence of other ADR（P＞0.05）. The results of subgroup analysis showed that the reductions of TC and TG of generic drugs produced by Beijing Jialin Pharmaceutical Enterprise （hereinafter refer to Jialin generic drugs ）were less than those of the original drug ，and the difference was statistically significant ；compared with original drugs ，there was no significant difference in other indexes or all indexes of the generic drugs from other manufacturers. Compared with original drugs ，the reductions of TC and TG in 20 mg/d group of Jialin generic drugs were less than original drug group ；the degree of TC reduction at 12 and 24 weeks of follow-up and TG reduction at 24 weeks of follow-up were less than those of the original drugs ，the difference was statistically significant ；there was no significant difference in other indexes. The qualitative description of RCS showed that for elderly patients with death/acute coronary syndrome ，there was no statistical difference between the two groups in terms of cardiovascular events or serious side effects. For the adult patients who switched from original drugs to generic drugs ，the effect of generic drugs instead of original drugs would not be reduced ，but the increase of HDL-C was less than that of original drug. CONCLUSIONS In terms of effectiveness，generic drugs of atorvastatin can replace original drugs and caution should be taken on the levels of HDL-C ，TC and TG for long time use ；in terms of safety ，generic drugs are similar to the original drugs. |
| 期刊： | 2022年第33卷第03期 |
| 作者： | 吕淑贤，梁笑笑，杨蕊，李晓，李妍，韩毅，黄欣 |
| AUTHORS： | LYU Shuxian ，LIANG Xiaoxiao ，YANG Rui，LI Xiao，LI Yan，Han Yi，HUANG Xin |
| 关键字： | 阿托伐他汀；仿制药；原研药；有效性；安全性；系统评价 |
| KEYWORDS： | atorvastatin；generic drugs ；original drugs ；effectiveness；safety；systematic review |
| 阅读数： | 395 次 |
| 本月下载数： | 19 次 |
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