今日药学

2018, v.28(10) 678-684

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氨溴索注射剂吸入与静注有效性安全性的系统评价
Efficacy and Safety of Ambroxol Injection by Inhalation Versus Intravenous Administration:A Systematic Review

林璐;吴伟英;刘晓琦;曾英彤;劳海燕;杨敏;
LIN Lu;WU Weiying;LIU Xiaoqi;ZENG Yingtong;LAO Haiyan;YANG Min;Department of Pharmacy,Guangdong General Hospital ( Guangdong Academy of Medical Sciences );Guangdong Pharmaceutical University;Guangdong Provincial Cardiovascular Research Institute;

摘要(Abstract):

目的系统评价盐酸氨溴索注射剂雾化吸入与静脉注射的有效性和安全性。方法采用Cochrane系统评价方法,检索中英文电子数据库,由两名评价者独立评价并交叉核对纳入研究的质量,把最终纳入的研究采用Rev Man5.2软件进行Meta分析。结果 Meta分析共纳入25个随机对照试验,包括2 392例患者,其中吸入组1 195例,静注组1 197例。有效性方面,在PPCs预防组、成人呼吸系统感染组和老年COPD组,吸入组的临床总有效率均大于静注组,差异有统计学意义[OR=2.33,95%CI=(1.23,4.42),P=0.009; OR=3.06,95%CI=(1.71,5.46),P=0.000 2; OR=4.98,95%CI=(1.98,12.45),P=0.000 7];而在儿童肺炎组,两组的差异无统计学意义[OR=1.44,95%CI=(0.88,2.37),P=0.14];在早产儿NRDS预防组,静注组的NRDS发生率小于吸入组,差异有统计学意义[OR=2.38,95%CI=(1.13,5.02),P=0.02]。安全性方面,吸入组的不良反应发生率小于静注组,差异有统计学意义[OR=0.33,95%CI=(0.15,0.72),P=0.000 5]。结论雾化吸入氨溴索注射剂在预防PPCs和治疗成人肺部疾病是安全有效的,甚至优于静脉注射给药,但在儿童患者的使用上有待商榷。尚需设计良好的随机对照试验加以评价,并确定雾化吸入的合理剂量和疗程。
OBJECTIVE To systematically review the efficacy and safety of ambroxol injection by inhalation versus intravenous administration. METHODS Followed the Cochrane Collaboration methodology and searched relevant electronic databases. The quality of the included studies was evaluated independently by two reviewers,RevMan5.2 was used to perform the meta-analysis. RESULTS A total of 2 392 patients from 25 RCTs were included,of which the inhalation group contained 1 195 cases,injection group 1 197 cases.The total effective rate of inhalation was higher than intravenous injection of ambroxol hydrochloride in the PPCs prevention group,adult respiratory infections group and elder COPD group,with significant difference [OR = 2. 33,95% CI =( 1. 23,4. 42),P = 0. 009; OR =3.06,95%CI =(1.71,5. 46),P = 0. 000 2; OR = 4. 98,95% CI =( 1. 98,12. 45),P = 0. 000 7]. However,no significant difference was observed in the subgroup of childhood pneumonia [OR = 1.44,95%CI =(0.88,2.37),P = 0.14]. But in the NRDS prevention group,the incidence of NRDS of intravenous injection was lower than inhalation of ambroxol hydrochloride,with significant difference [OR = 2.38,95%CI =(1.13,5.02),P = 0.02]. The incidence of adverse reactions in the inhalation group was less than that of intravenous injection group,with significant difference [OR = 0. 33,95% CI =( 0. 15,0. 72),P = 0. 000 5]. CONCLUSION Compared with intravenous administration,inhalation of ambroxol hydrochloride is safe and effective in the prevention of PPCs and treatment of adult lung disease,but still remains questionable for children patients. More well-designed randomized controlled trials are needed to confirm the results,and to establish a reasonable dose and course for inhalation of ambroxol injection.

关键词(KeyWords): 氨溴索;雾化吸入;静脉注射;系统评价
ambroxol;inhalation;injection;systematic review

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基金项目(Foundation): 广州市科技计划项目(201509010012)

作者(Author): 林璐;吴伟英;刘晓琦;曾英彤;劳海燕;杨敏;
LIN Lu;WU Weiying;LIU Xiaoqi;ZENG Yingtong;LAO Haiyan;YANG Min;Department of Pharmacy,Guangdong General Hospital ( Guangdong Academy of Medical Sciences );Guangdong Pharmaceutical University;Guangdong Provincial Cardiovascular Research Institute;

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