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3种集采与非集采注射用头孢菌素有效性和安全性的多中心研究
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| 篇名： | 3种集采与非集采注射用头孢菌素有效性和安全性的多中心研究 |
| TITLE： | Multicenter study on the efficacy and safety of 3 kinds of Cephalosporin for injection from centralized procurement or non-centralized procurement |
| 摘要： | 目的 比较国家组织药品集中采购（简称“集采”）与非集采注射用头孢唑林钠、注射用头孢呋辛钠和注射用头孢他啶治疗细菌性感染患者的有效性和安全性。方法回顾性收集昆明市19家医疗机构2020年1月至2022年9月使用过3种集采或非集采注射用头孢菌素治疗细菌性感染的住院患者的病例数据，采用倾向性评分匹配平衡组间基线差异后，分别比较3种集采与非集采注射用头孢菌素的有效性和安全性差异。结果平衡组间基线差异后，注射用头孢唑林钠集采组与非集采组各394例，注射用头孢呋辛钠集采组与非集采组各472例，注射用头孢他啶集采组504例、非集采组590例。有效性方面，注射用头孢唑林钠和注射用头孢呋辛钠集采组与非集采组的临床有效率、72h有效率、细菌清除率及体温、白细胞计数、中性粒细胞计数、中性粒细胞百分比、C反应蛋白、降钙素原恢复率比较，差异均无统计学意义（P＞0.05）；注射用头孢他啶集采组C反应蛋白恢复至正常参考范围的患者比例显著高于非集采组（46.9%vs.27.9%，P＜0.05），但其余有效性指标差异均无统计学意义（P＞0.05）。安全性方面，3种注射用头孢菌素集采组患者的药品不良反应发生率与非集采组比较，差异均无统计学意义（P＞0.05）；注射用头孢唑林钠集采组患者血小板计数降低的发生率显著高于非集采组（20.7%vs.7.1%，P＜0.05），注射用头孢他啶集采组患者嗜酸性粒细胞升高的发生率显著高于非集采组（5.3%vs.1.9%，P＜0.05）。此外，3种注射用头孢菌素其余实验室相关指标异常率的组间差异均无统计学意义（P＞0.05）。结论3种集采注射用头孢菌素的有效性不劣于非集采品种，安全性与非集采品种相当。 |
| ABSTRACT： | OBJECTIVE To compare the efficacy and safety of Cefazolin sodium for injection， Cefuroxime sodium for injection， and Ceftazidime for injection from nationally organized centralized drug procurement （hereinafter referred to as “centralized procurement”） and non-centralized procurement in patients with bacterial infection. METHODS The case data of hospitalized patients who had used 3 kinds of Cephalosporins for injection from centralized procurement or non-centralized procurement in the treatment of bacterial infections were retrospectively collected from 19 medical institutions in Kunming from January 2020 to September 2022. After balancing the baseline differences between the groups with the propensity score matching method， the effectiveness and safety differences of 3 kinds of Cephalosporins for injection from centralized procurement or non- centralized procurement were compared respectively. RESULTS After balancing the baseline differences among the groups， 394 cases in each group of Cefazolin sodium for injection from centralized procurement or non-centralized procurement， 472 cases in each group of Cefuroxime sodium for injection from centralized procurement or non-centralized procurement， 504 cases in group of Ceftazidime for injection from centralized procurement and 590 cases in group of non-centralized procurement were included in the analysis. In terms of effectiveness， there were no significant differences in clinical response rate， 72 h response rate， bacterial clearance rate， and the recovery rate of body temperature， white blood cell count， neutrophil count， neutrophil percentage， C-reactive protein， procalcitonin recovery between the centralized procurement group and non-centralized procurement group of Cefazolin sodium for injection and Cefuroxime sodium for injection （P＞0.05）. The proportion of patients in centralized procurement group of Ceftazidime for injection with C-reactive protein restored to normal reference range was significantly higher than that in non-centralized procurement group （46.9% vs. 27.9%， P＜0.05）， but there were no statistically significant differences in other effectiveness indicators among groups （P＞0.05）. In terms of safety， there was no statistical difference in the incidence of adverse drug reactions between centralized procurement group and non-centralized procurement group of 3 kinds of Cephalosporins for injection （P＞0.05）； the incidence of platelet count reduction in centralized procurement group of Cefazolin sodium for injection was significantly higher than non-centralized procurement group （20.7% vs. 7.1%， P＜0.05）， the incidence of eosinophilia elevation in centralized procurement group of Ceftazidime for injection was significantly higher than non-centralized procurement group （5.3% vs. 1.9%， P＜0.05）. In addition， there was no statistically significant difference in the abnormal rates of other laboratory indicators among the three types of injection Cephalosporins （P＞ 0.05）. CONCLUSIONS The efficacy of 3 kinds of Cephalosporin for injection from centralized procurement is not inferior to non- centralized procurement varieties， and the safety is equivalent to that of non-centralized procurement varieties. |
| 期刊： | 2024年第35卷第07期 |
| 作者： | 刘璐；宋沧桑；李兴德；邓雨琴；毛盼盼；张函舒；董艳珍；程瑶瑶 |
| AUTHORS： | LIU Lu， SONG Cangsang，LI Xingde，DENG Yuqin，MAO Panpan，ZHANG Hanshu，DONG Yanzhen，CHENG Yaoyao |
| 关键字： | 注射用头孢唑林钠；注射用头孢呋辛钠；注射用头孢他啶；药品集中采购；头孢菌素 |
| KEYWORDS： | Cefazolin sodium for injection； Cefuroxime sodium for injection； Ceftazidime for injection； centralized drug |
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