Comparison of efficacy and safety of national centralized volume-based procurement and original cefdinir oral normal-release preparations
10.3760/cma.j.cn114015-20221101-01015
- VernacularTitle:集中带量采购中选与原研头孢地尼口服常释制剂疗效和安全性比较
- Author:
Zhizhou WANG
1
;
Xianzhe DONG
;
Ke WANG
;
Yingnan FENG
;
Qiao LUO
;
Xiaolin YUE
;
Lan ZHANG
Author Information
1. 首都医科大学宣武医院药学部，北京 100053
- Publication Type:Journal Article
- Keywords:
Cefdinir;
Drugs, generic;
Real world study;
Treatment outcome;
Safety;
Volume-based procurement
- From:
Adverse Drug Reactions Journal
2023;25(3):152-158
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the clinical efficacy and safety of cefdinir dispersible tablets selected in the national centralized volume-based procurement (VBP) and the original drug cefdinir capsules.Methods:Clinical data of single-use cefdinir in outpatient of Xuanwu Hospital, Capital Medical University between January 1, 2020 and December 31, 2021 were collected through the hospital information system. The clinical data included gender, age, type of medical insurance, type of infection, application of cefdinir, whether to combine other antibacterial drugs, laboratory test results such as blood routine, C-reactive protein, liver and kidney function before and after cefdinir treatment, and adverse reaction report of cefdinir. After propensity score matching (PSM) of the age, sex, type of medical insurance, type of infection and whether to combine with other antibacterial drugs in the cefdinir dispersible tablets group selected in the VBP (VBP group) and the original cefdinir group (original group), the clinical application in patients in the 2 groups was compared to indirectly evaluate the efficacy of the 2 drugs. The white blood cell count, neutrophils percentage, and C-reactive protein levels before and after the use of cefdinir was compared to evaluate the efficacy. Adverse drug reaction report of cefdinir and liver and kidney function before and after the use of cefdinir were compared to evaluate the safety.Results:A total of 9 514 patients treated with cefdinir were entered, including 7 037 patients in the VBP group and 2 477 patients in the original group. After PSM, each group comprised 1 268 patients, the differences in gender, age, type of infection, and combination with other antibacterial drugs were not statistically significant (all P>0.05). The daily dose, course, and use density of cefdinir in the VBP group were lower than those in the original group[(0.30±0.04) g vs. (0.35±0.12) g, P<0.001; 8(4, 8) d vs. 10(8, 10) d, P<0.001; (3.96±1.70) g vs. (5.22±2.03) g, P<0.001]. The white blood cell count, neutrophils percentage, and C-reactive protein levels after the cefdinir application in patients in the VBP group were lower than those before the use of the cefdinir [11.2(8.7, 13.8)×10 9vs. 7.2(5.5, 9.9)×10 9, P<0.001; 80(74, 87)% vs. 66(56, 73)%, P<0.001; 23(10, 64) mg/L vs. 13(6, 44) mg/L, P=0.032]. No adverse drug reactions related to cefdinir were reported in the 2 groups. The differences in alanine aminotransferase, aspartate aminotransferase, blood creatinine, and urea nitrogen levels in patients between the 2 groups before and after use of cefdinir were not statistically significant (all P>0.05). The difference in aspartate aminotransferase before and after use of the cefdinir in the original group was statistically significant [21(18, 23) U/L vs. 23(20, 29) U/L, P=0.040], and the differences in alanine aminotransferase, blood creatinine, and urea nitrogen levels were not statistically significant (all P>0.05). The detection values of liver and kidney function in the 2 groups before and after use of the cefdinir were within the reference range. Conclusion:No significant differences were found in the clinical efficacy and safety between the VBP cefdinir dispersible tablets and the original cefdinir capsules.
