左奥硝唑治疗厌氧菌感染的系统评价
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摘要
目的:系统评价左奥硝唑治疗厌氧菌感染的临床疗效及安全性,为临床合理用药提供参考。方法:计算机检索PubMed、Medline(viaOvidSP)、Cochrane Library、CNKI、WanFang Data、VIP数据库,搜集有关左奥硝唑治疗厌氧菌感染的随机对照试验(RCTs),检索时限均为建库至2018年10月1日,由两名研究人员独立交叉筛选文献,并进行质量评估和数据提取,采用RevMan 5.3软件进行Meta分析。结果:纳入16个RCTs,共计1 557例研究对象,其中左奥硝唑治疗厌氧菌感染的试验组779例,奥硝唑治疗厌氧菌感染的对照组778例。Meta分析结果显示:试验组的临床治愈率明显优于对照组,差异有统计学意义[OR=2.28,95%CI(1.60,3.25),P<0.000 01];但腹部感染两组临床治愈率差异无统计学意义[OR=1.73,95%CI(0.76,3.96),P<0.19]。两组在细菌清除上效果相当,差异无统计学意义(P>0.05)。试验组在消化系统不良反应、过敏反应以及白细胞减少等方面的发生率略低于对照组,但差异均无统计学意义(P>0.05);但在神经系统不良反应方面,试验组与对照组相比发生率较低,差异有统计学意义(P<0.05)。在假设其他治疗方案一致的情况下,试验组的成本及成本-效果比显著高于对照组,在一定程度上增加了患者的医疗负担。结论:基于目前的临床研究,左奥硝唑治疗厌氧菌感染可提高临床治愈率,减少神经系统不良反应的发生,但鉴于临床发生的药品不良反应均为轻中度,无需针对治疗处理,停药后即可缓解或消失,且奥硝唑的成本-效果比远低于左奥硝唑,因此,临床医生综合评估患者病情后仍可考虑选用奥硝唑治疗厌氧菌感染。而对于合并消化系统、神经系统、免疫系统、恶性肿瘤等基础疾病,以及药品不良反应不耐受的患者,则可优选左奥硝唑。
Objective:The purpose of this study was to systematic review the clinical efficacy and safety of levonidazole in the treatment of anaerobic infections by meta-analysis, and to provide reference for clinical rational drug use. Methods:CNKI, VIP, WanFang Data, PubMed, Medline(viaOvidSP), Cochrane Library were electronically searched to collect randomized controlled trials(RCTs) of anaerobic infection treated by levonidazole from their inception to October 1, 2018. Two reviewers independently screened literatures, extracted data and assessed risk of bias of included studies. Then RevMan 5.3 software was used for Meta-analysis. Results:A total of 1 557 patients were enrolled in 16 RCTs, among which 779 patients in the experimental group with levonidazole for anaerobic infection, and 778 patients in the control group with ornidazole. The results of Meta-analysis showed that the clinical total cure rate of the experimental group was significantly better than that of the control group(92.9% vs. 85.2%), and the difference was statistically significant(OR=2.28, 95%CI 1.60 to 3.25, P<0.000 01); However, there was no significant difference in the clinical cure rate of abdominal anaerobic infection between the two groups(OR=1.73, 95%CI 0.76 to 3.96, P=0.19). The effect of the two groups on bacterial clearance was comparable, and the difference was not statistically significant(P>0.05). The incidence of digestive system, allergic reaction and leukopenia in the experimental group was slightly lower than that in the control group, but the difference was not statistically significant(P>0.05). However, the neurotoxicity of the experimental group was significantly lower than that of the control group, and the difference was statistically significant(P<0.05). Assuming that the other treatment options are the same, the cost-effectiveness ratio of the experimental group was significantly higher than that of the control group, which increases the medical burden of the patient. Conclusion:Based on current clinical studies, levonidazole in the treatment of anaerobic infections can improve the clinical cure rate and reduce the incidence of adverse reactions in the nervous system. However, the clinical adverse reactions are almost mild or moderate, no need for treatment, and can be relieved or disappeared after stop. Moreover, the cost-effectiveness of ornidazole is much lower than that of levonidazole. Therefore, after comprehensively evaluating the patient's condition, Ornidazole can still be considered for the treatment of anaerobic infection. And then levonidazole can be preferred for patients with basic diseases such as digestive system, nervous system, immune system, malignant tumor, and adverse reaction intolerance.
Objective:The purpose of this study was to systematic review the clinical efficacy and safety of levonidazole in the treatment of anaerobic infections by meta-analysis, and to provide reference for clinical rational drug use. Methods:CNKI, VIP, WanFang Data, PubMed, Medline(viaOvidSP), Cochrane Library were electronically searched to collect randomized controlled trials(RCTs) of anaerobic infection treated by levonidazole from their inception to October 1, 2018. Two reviewers independently screened literatures, extracted data and assessed risk of bias of included studies. Then RevMan 5.3 software was used for Meta-analysis. Results:A total of 1 557 patients were enrolled in 16 RCTs, among which 779 patients in the experimental group with levonidazole for anaerobic infection, and 778 patients in the control group with ornidazole. The results of Meta-analysis showed that the clinical total cure rate of the experimental group was significantly better than that of the control group(92.9% vs. 85.2%), and the difference was statistically significant(OR=2.28, 95%CI 1.60 to 3.25, P<0.000 01); However, there was no significant difference in the clinical cure rate of abdominal anaerobic infection between the two groups(OR=1.73, 95%CI 0.76 to 3.96, P=0.19). The effect of the two groups on bacterial clearance was comparable, and the difference was not statistically significant(P>0.05). The incidence of digestive system, allergic reaction and leukopenia in the experimental group was slightly lower than that in the control group, but the difference was not statistically significant(P>0.05). However, the neurotoxicity of the experimental group was significantly lower than that of the control group, and the difference was statistically significant(P<0.05). Assuming that the other treatment options are the same, the cost-effectiveness ratio of the experimental group was significantly higher than that of the control group, which increases the medical burden of the patient. Conclusion:Based on current clinical studies, levonidazole in the treatment of anaerobic infections can improve the clinical cure rate and reduce the incidence of adverse reactions in the nervous system. However, the clinical adverse reactions are almost mild or moderate, no need for treatment, and can be relieved or disappeared after stop. Moreover, the cost-effectiveness of ornidazole is much lower than that of levonidazole. Therefore, after comprehensively evaluating the patient's condition, Ornidazole can still be considered for the treatment of anaerobic infection. And then levonidazole can be preferred for patients with basic diseases such as digestive system, nervous system, immune system, malignant tumor, and adverse reaction intolerance.
引文
1 Brook I. Spectrum and treatment of anaerobic infections[J].J Infect Chemother,2016,22(1):1-13
2 Brook I. Antimicrobials therapy of anaerobic infections[J].J Chemother,2016,28(3):143-150
3 Wei TT,Sun JH,Han LW,et al. Effects of the ornidazole enantiomers on the central nervous system:Involvement of the GABAA receptor[J]. Chem Biol Interact,2015,242:163-169
4 Miyamoto Y,Kalisiak J,Korthals K,et al. Expanded therapeutic potential in activity space of next-generation 5-nitroimidazole antimicrobials with broad structural diversity[J].Proc Natl Acad Sci USA,2013,110(43):17564-17569
5 龚翔.一类新药左奥硝唑及左奥硝唑氯化钠注射液上市[N].中国医药报,2009-09-19(1)
6 谷鸿秋,王杨,李卫. Cochrane偏倚风险评估工具在随机对照研究Meta分析中的应用[J].中国循环杂志,2014,29(2):147-148
7 刘妤.左奥硝唑氯化钠注射液治疗厌氧菌性盆腔感染的疗效[J].医学信息,2013,26(4):515
8 刘翠珍,周鹏羽.左奥硝唑氯化钠注射液治疗口腔厌氧菌感染的临床研究[J].家庭医药,2017,37(6):80
9 周芳.左奥硝唑氯化钠注射液治疗厌氧菌性盆腔感染的临床疗效观察[J].山西医药杂志,2015,44(20):2422-2424
10 尹林,陈建钢,张汉东,等.左奥硝唑氯化钠注射液治疗口腔厌氧菌感染的临床研究[J].安徽医药,2015,19(11):2179-2182
11 方雪峰.口腔厌氧感染患者应用不同药物治疗效果比较分析[J].山西医药杂志,2015,44(7):743-745
12 李宇生,黄东.左奥硝唑氯化钠注射液和奥硝唑氯化钠注射液治疗厌氧菌性盆腔感染的效果对比[J].包头医学院学报,2018,34(6):44-45
13 林琳,姜晓峰.左奥硝唑氯化钠注射液治疗细菌性肝脓肿的临床疗效观察[J].中国医学装备,2018,15(2):84-86
14 沈国满.左奥硝唑治疗腹部厌氧菌感染的临床疗效评价[J].中国医学工程,2012,20(10):96
15 秦向斐.左奥硝唑氯化钠注射液治疗厌氧菌性盆腔感染的临床效果分析[J].北方药学,2018,15(7):69
16 秦蓉,孔世杰.口腔厌氧感染患者应用不同药物治疗效果比较分析[J].中国保健营养,2017,27(32):313
17赵旭鹏,郭大伟,李震,等.左奥硝唑氯化钠注射液治疗胆囊结石合并胆总管结石术后患者的临床效果[J].中国医药,2018,13(1):85-87
18 邹东娜,许珂,侯宁,等.左奥硝唑治疗腹部厌氧菌感染临床观察[J].中国医院用药评价与分析,2015,15(4):460-463
19 郝玉凤,王茜,袁晓洁,等.左奥硝唑、奥硝唑、替硝唑治疗盆腔炎临床对比研究[J].中国性科学,2012,21(8):38-39
20 陈穗,张汉东,王阅春,等.左奥硝唑-氯化钠注射液治疗口腔厌氧菌感染的疗效[J].江苏医药,2011,37(6):714-715
21 颉瑞君.评价左奥硝唑氯化钠注射液在口腔厌氧菌感染治疗中的安全性及疗效[J].健康必读,2017,(31):16-17,25
22马玲,张元珍,郑漪霖,等.左奥硝唑氯化钠注射液治疗厌氧菌性盆腔感染的多中心临床研究[J].中华妇产科杂志,2010,45(10):754-756
23 孙继红,王志强,顾兴丽,等.左旋和右旋奥硝唑对小鼠中枢神经系统毒副作用的比较研究[J].中国药科大学学报,2008,39(4):343-347
24 陈珂,孙继红,王志强,等.奥硝唑对映体对小鼠中枢抑制作用研究[J].中国药科大学学报,2012,43(3):271-274
25 魏婷婷,孙继红,韩璐薇,等.奥硝唑对映体对小鼠中枢抑制作用的机制探究[J].药学与临床研究,2015,23(1):9-12
2 Brook I. Antimicrobials therapy of anaerobic infections[J].J Chemother,2016,28(3):143-150
3 Wei TT,Sun JH,Han LW,et al. Effects of the ornidazole enantiomers on the central nervous system:Involvement of the GABAA receptor[J]. Chem Biol Interact,2015,242:163-169
4 Miyamoto Y,Kalisiak J,Korthals K,et al. Expanded therapeutic potential in activity space of next-generation 5-nitroimidazole antimicrobials with broad structural diversity[J].Proc Natl Acad Sci USA,2013,110(43):17564-17569
5 龚翔.一类新药左奥硝唑及左奥硝唑氯化钠注射液上市[N].中国医药报,2009-09-19(1)
6 谷鸿秋,王杨,李卫. Cochrane偏倚风险评估工具在随机对照研究Meta分析中的应用[J].中国循环杂志,2014,29(2):147-148
7 刘妤.左奥硝唑氯化钠注射液治疗厌氧菌性盆腔感染的疗效[J].医学信息,2013,26(4):515
8 刘翠珍,周鹏羽.左奥硝唑氯化钠注射液治疗口腔厌氧菌感染的临床研究[J].家庭医药,2017,37(6):80
9 周芳.左奥硝唑氯化钠注射液治疗厌氧菌性盆腔感染的临床疗效观察[J].山西医药杂志,2015,44(20):2422-2424
10 尹林,陈建钢,张汉东,等.左奥硝唑氯化钠注射液治疗口腔厌氧菌感染的临床研究[J].安徽医药,2015,19(11):2179-2182
11 方雪峰.口腔厌氧感染患者应用不同药物治疗效果比较分析[J].山西医药杂志,2015,44(7):743-745
12 李宇生,黄东.左奥硝唑氯化钠注射液和奥硝唑氯化钠注射液治疗厌氧菌性盆腔感染的效果对比[J].包头医学院学报,2018,34(6):44-45
13 林琳,姜晓峰.左奥硝唑氯化钠注射液治疗细菌性肝脓肿的临床疗效观察[J].中国医学装备,2018,15(2):84-86
14 沈国满.左奥硝唑治疗腹部厌氧菌感染的临床疗效评价[J].中国医学工程,2012,20(10):96
15 秦向斐.左奥硝唑氯化钠注射液治疗厌氧菌性盆腔感染的临床效果分析[J].北方药学,2018,15(7):69
16 秦蓉,孔世杰.口腔厌氧感染患者应用不同药物治疗效果比较分析[J].中国保健营养,2017,27(32):313
17赵旭鹏,郭大伟,李震,等.左奥硝唑氯化钠注射液治疗胆囊结石合并胆总管结石术后患者的临床效果[J].中国医药,2018,13(1):85-87
18 邹东娜,许珂,侯宁,等.左奥硝唑治疗腹部厌氧菌感染临床观察[J].中国医院用药评价与分析,2015,15(4):460-463
19 郝玉凤,王茜,袁晓洁,等.左奥硝唑、奥硝唑、替硝唑治疗盆腔炎临床对比研究[J].中国性科学,2012,21(8):38-39
20 陈穗,张汉东,王阅春,等.左奥硝唑-氯化钠注射液治疗口腔厌氧菌感染的疗效[J].江苏医药,2011,37(6):714-715
21 颉瑞君.评价左奥硝唑氯化钠注射液在口腔厌氧菌感染治疗中的安全性及疗效[J].健康必读,2017,(31):16-17,25
22马玲,张元珍,郑漪霖,等.左奥硝唑氯化钠注射液治疗厌氧菌性盆腔感染的多中心临床研究[J].中华妇产科杂志,2010,45(10):754-756
23 孙继红,王志强,顾兴丽,等.左旋和右旋奥硝唑对小鼠中枢神经系统毒副作用的比较研究[J].中国药科大学学报,2008,39(4):343-347
24 陈珂,孙继红,王志强,等.奥硝唑对映体对小鼠中枢抑制作用研究[J].中国药科大学学报,2012,43(3):271-274
25 魏婷婷,孙继红,韩璐薇,等.奥硝唑对映体对小鼠中枢抑制作用的机制探究[J].药学与临床研究,2015,23(1):9-12