沈阳市某二级甲等医院妇产科围手术期抗菌药物不良事件的调查分析

doi:10.3877/cma.j.issn.1673-5250.2013.05.012

中华妇幼临床医学杂志(电子版) ›› 2013, Vol. 09 ›› Issue (05) : 624 -627. doi: 10.3877/cma.j.issn.1673-5250.2013.05.012

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沈阳市某二级甲等医院妇产科围手术期抗菌药物不良事件的调查分析

孙云萍¹, 潘雯², 宫建³^,^*^,^*(

), 顾敏华⁴, 黄晓艳⁵, 朴哲⁶, 吕丽娜⁷, 徐文明⁸, 冒小鸥⁴, 孙永发⁹, 陈建峰¹⁰

^1. 110011，沈阳市妇婴医院
^2. 辽宁省疾病预防控制中心
^3. 沈阳药科大学生命科学与生物制药学院临床药学教研室
^4. 江苏省江阴市疾病预防控制中心
^5. 沈阳市精神卫生中心科教科
^6. 北京市石景山医院
^7. 天津市河东区疾病预防控制中心计免科
^8. 辽河油田疾病预防控制中心
^9. 卫生部卫生发展研究中心
^10. 江苏省南通市卫生监督所

收稿日期:2013-04-30 修回日期:2013-09-01 出版日期:2013-10-01
通信作者: 宫建

A Cross-Section Study of Adverse Drug Event of Antibacterials Drugs for Patients With Preoperative Gynecological and Obstetric Surgery From a Second-Grade Class-A Hospital

Yun-ping SUN¹, Wen PAN², Jian GONG³(), Min-hua GU⁴, Xiao-yan HUANG⁵, Zhe PIAO⁶, Li-na LYU⁷, Wen-ming XU⁸, Xiao-ou MAO⁴, Yong-fa SUN⁹, Jian-feng CHEN¹⁰

^1. Shenyang Women's and Children's Hospital, Shenyang 110011, Liaoning Province, China

Received:2013-04-30 Revised:2013-09-01 Published:2013-10-01
Corresponding author: Jian GONG
About author:
(Corresponding author: GONG Jian, Email: fanxing1230@163.com)

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引用本文：

孙云萍, 潘雯, 宫建, 顾敏华, 黄晓艳, 朴哲, 吕丽娜, 徐文明, 冒小鸥, 孙永发, 陈建峰. 沈阳市某二级甲等医院妇产科围手术期抗菌药物不良事件的调查分析[J]. 中华妇幼临床医学杂志(电子版), 2013, 09(05): 624-627.

Yun-ping SUN, Wen PAN, Jian GONG, Min-hua GU, Xiao-yan HUANG, Zhe PIAO, Li-na LYU, Wen-ming XU, Xiao-ou MAO, Yong-fa SUN, Jian-feng CHEN. A Cross-Section Study of Adverse Drug Event of Antibacterials Drugs for Patients With Preoperative Gynecological and Obstetric Surgery From a Second-Grade Class-A Hospital[J]. Chinese Journal of Obstetrics & Gynecology and Pediatrics(Electronic Edition), 2013, 09(05): 624-627.

目的

探讨沈阳市某二级甲等医院妇产科围手术期患者使用抗菌药物的不良事件，以促进妇产科围手术期患者抗菌药物的合理应用。

方法

采用分层随机抽样法，选取2010年6月至2011年6月于沈阳市某二级甲等医院妇产科手术期患者300例的临床病历资料为研究对象，提取其中抗菌药物的使用信息，分析抗菌药物不良事件的发生情况(本研究遵循的程序得到参与单位的医学伦理委员会批准，并与研究对象签署临床研究知情同意书)。

结果

300例妇产科围手术期患者中，103例出现抗菌药物不良事件，发生率为34.33%。以头孢菌素类药物(53.32%，201/377)发生抗菌药物不良反应为主，不良反应的类型以消化道反应(28.12%，106/377)多见，Ⅰ类，Ⅱ类手术切口的抗菌药物合理应用较不合理应用的不良事件发生率明显低。

结论

促进沈阳市某二级甲等医院妇产科围手术期患者抗菌药物的合理使用可明显降低抗菌不良事件的发生率。

关键词: 妇产科, 抗菌药物, 合理用药, 不良事件

Objective

To study the adverse drug event of antibacterial drugs for patients with preoperative gynecological and obstetrical surgery in a second-grade class-A hospital.

Methods

A random sampling study was conducted on the use of antibacterial drugs in patients with preoperative gynecological and obstetrical surgery between June 2010 and June 2011. Their clinical data were retrospectively analyzed in the aspects of usage and adverse drug event of antibacterial drugs. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Shenyang Women's and Children's Hospital. Informed consent was obtained from all participates.

Results

Out of 300 patients with preoperative gynecological and obstetrical surgery, 103 (34.33%) had adverse drug event report. The cases that caused by cephalosporins were accounted for the most (53.32%, 201/377), and damage to the digest system (28.12%, 106/377) was the commonest type. Adverse event rate of rational use of antibacterial drugs was significantly lower than that of the irrational use of antibacterial.

Conclusions

Rational use of antibacterial for gynecologic and obstetric patients with surgical operation could significantly reduce the incidence of adverse drug event in this second-grade class-A hospital in Shenyang.

Key words: gynecology and obstetrics, antibacterial, rational use of drug, adverse drug event

表1 妇产科围手术期抗菌药物导致不良事件分布情况

Table 1 Distribution of adverse drug event of antibacterial drugs

抗菌药物类别	例次	发生率(%)	构成比(%)	相关药物
头孢菌素类	201	62.62	53.32	头孢西丁、头孢呋辛、头孢噻肟、头孢替安、头孢米诺、头孢替唑、头孢地嗪、头孢曲松
硝基咪唑类	88	51.76	23.34	甲硝唑、奥硝唑、替硝唑
庆大霉素类	40	45.45	10.61	依替米星、庆大霉素
青霉素类	33	47.83	8.75	呋布西林、美洛西林
大环内酯类	15	71.43	3.98	阿奇霉素

表1 妇产科围手术期抗菌药物导致不良事件分布情况

Table 1 Distribution of adverse drug event of antibacterial drugs

抗菌药物类别	例次	发生率(%)	构成比(%)	相关药物
头孢菌素类	201	62.62	53.32	头孢西丁、头孢呋辛、头孢噻肟、头孢替安、头孢米诺、头孢替唑、头孢地嗪、头孢曲松
硝基咪唑类	88	51.76	23.34	甲硝唑、奥硝唑、替硝唑
庆大霉素类	40	45.45	10.61	依替米星、庆大霉素
青霉素类	33	47.83	8.75	呋布西林、美洛西林
大环内酯类	15	71.43	3.98	阿奇霉素

表2 妇产科围手术期抗菌药物不良事件的临床表现[n(%)]

Table 2 Clinical manifestation of adverse drug event of antibacterial drugs[n(%)]

累及系统	不良反应率	临床表现
消化系统	106 (28.12)	恶心、呕吐、腹泻、食欲不振
神经系统	95 (25.20)	困倦、头痛、眩晕、乏力、四肢麻木
皮肤反应	84 (22.28)	瘙痒、皮疹、荨麻疹
血液系统	34(9.02)	红红细胞、血小板、血红蛋白减少，嗜酸性粒细胞增多
肾功能	30(7.96)	谷丙转氨酶、谷草转氨酶升高
肝功能	28(7.42)	尿量、排尿次数减少，一过性血尿素氮增高
总计	377(100.00)	?

表2 妇产科围手术期抗菌药物不良事件的临床表现[n(%)]

Table 2 Clinical manifestation of adverse drug event of antibacterial drugs[n(%)]

累及系统	不良反应率	临床表现
消化系统	106 (28.12)	恶心、呕吐、腹泻、食欲不振
神经系统	95 (25.20)	困倦、头痛、眩晕、乏力、四肢麻木
皮肤反应	84 (22.28)	瘙痒、皮疹、荨麻疹
血液系统	34(9.02)	红红细胞、血小板、血红蛋白减少，嗜酸性粒细胞增多
肾功能	30(7.96)	谷丙转氨酶、谷草转氨酶升高
肝功能	28(7.42)	尿量、排尿次数减少，一过性血尿素氮增高
总计	377(100.00)	?

表3 Ⅰ，Ⅱ类手术切口患者抗菌药物应用时间是否合理导致抗菌药物不良事件发生率比较[n(%)]

Table 3 Comparison of rates of adverse drug events of rational usage of antibacterial drugs[n(%)]

抗菌药物应用是否合理	Ⅰ类切口		Ⅱ类切口
抗菌药物应用是否合理	n	发生率	n	发生率
合理	22	7(31.82)	226	48(21.24)
不合理	13	9(69.23)	39	28(71.79)
χ²	?	1.63	?	18.31
P	?	0.20	?	<0.01

表3 Ⅰ，Ⅱ类手术切口患者抗菌药物应用时间是否合理导致抗菌药物不良事件发生率比较[n(%)]

Table 3 Comparison of rates of adverse drug events of rational usage of antibacterial drugs[n(%)]

抗菌药物应用是否合理	Ⅰ类切口		Ⅱ类切口
抗菌药物应用是否合理	n	发生率	n	发生率
合理	22	7(31.82)	226	48(21.24)
不合理	13	9(69.23)	39	28(71.79)
χ²	?	1.63	?	18.31
P	?	0.20	?	<0.01

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