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Antimicrobial Original Research Paper

Efficacy and safety of generic cefoperazone/sulbactam versus branded cefoperazone/sulbactam in the treatment of bacterial infections: a systematic review and meta-analysis

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Received 28 Nov 2023, Accepted 12 Apr 2024, Published online: 21 Apr 2024

References

  • Ku YH, Yu WL. Cefoperazone/sulbactam: new composites against multiresistant gram negative bacteria? Infect Genet Evol. 2021;88:104707. doi: 10.1016/j.meegid.2021.104707.
  • Wang RR, Jiang SP. Research progress in the clinical application of cefoperazone/sulbactam. Chin J Clin Ration Drug Use. 2017;10(12):177–180.
  • Qin Y, Zhang J, Wu L, et al. Comparison of the treatment efficacy between tigecycline plus high-dose cefoperazone-sulbactam and tigecycline monotherapy against ventilator-associated pneumonia caused by extensively drug-resistant Acinetobacter baumannii. Int J Clin Pharmacol Ther. 2018;56(3):120–129. doi: 10.5414/CP203102.
  • Lai CC, Chen CC, Lu YC, et al. In vitro activity of cefoperazone and cefoperazone-sulbactam against carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa. Infect Drug Resist. 2019;12:25–29. doi: 10.2147/IDR.S181201.
  • Tehrani KHME, Martin NI. β-Lactam/β-lactamase inhibitor combinations: an update. Medchemcomm. 2018;9(9):1439–1456. doi: 10.1039/c8md00342d.
  • Principe L, Di BS, Conti J, et al. Acinetobacter baumannii resistance to sulbactam/durlobactam: a systematic review. Antibiot. 2022;11:1793.
  • Chang P-C, Chen C-C, Lu YC, et al. The impact of inoculum size on the activity of cefoperazone-sulbactam against multidrug resistant organisms. J Microbiol Immunol Infect. 2018;51(2):207–213. doi: 10.1016/j.jmii.2017.08.026.
  • Su J, Guo Q, Li Y, et al. Comparison of empirical therapy with cefoperazone/sulbactam or a carbapenem for bloodstream infections due to ESBL-producing Enterobacteriaceae. J Antimicrob Chemother. 2018;73(11):3176–3180. doi: 10.1093/jac/dky323.
  • Lin S-Y, Lu P-L, Wu T-S, et al. Correlation between cefoperazone/sulbactam MIC values and clinical outcomes of Escherichia coli bacteremia. Infect Dis Ther. 2022;11(5):1853–1867. doi: 10.1007/s40121-022-00672-2.
  • Lan SH, Chang SP, Lai CC, et al. Efficacy and safety of cefoperazone-sulbactam in empiric therapy for febrile neutropenia: a systemic review and meta-analysis. Medicine. 2020;99(8):e19321. doi: 10.1097/MD.0000000000019321.
  • Sheu MJ, Chen CC, Lu YC, et al. In vitro antimicrobial activity of various cefoperazone/sulbactam products. Antibiot. 2020;9:77.
  • Sader HS, Carvalhaes CG, Streit JM, et al. Antimicrobial activity of cefoperazone-sulbactam tested against Gram-negative organisms from Europe, Asia-Pacific, and Latin America. Int J Infect Dis. 2020;91:32–37. doi: 10.1016/j.ijid.2019.11.006.
  • Chen R, Ma DY, Cai XP, et al. Quality evaluation of domestic cefoperazone/sulbactam sodium for injection. Chin J Antibiot. 2022;47:55–65.
  • Darrow JJ, Avorn J, Kesselheim AS. FDA approval and regulation of pharmaceuticals, 1983–2018. JAMA. 2020;323(2):164–176. doi: 10.1001/jama.2019.20288.
  • Charoo NA. Converging generic drug product development: bioequivalence design and reference product selection. Clin Pharmacokinet. 2020;59(11):1335–1355. doi: 10.1007/s40262-020-00912-z.
  • Gupta R, Shah ND, Ross JS. Generic drugs in the United States: policies to address pricing and competition. Clin Pharmacol Ther. 2019;105(2):329–337. doi: 10.1002/cpt.1314.
  • Yang ZZ, Yang Y, Chen HJ, et al. Clinical efficacy and economic study of three kinds of cefoperazone-sulbactam in treating Acinetobacter baumannii pulmonary infection. Chin J Hosp Pharm. 2017;37:2285–2288.
  • He ZG, Zhai XB, Bao SW, et al. Comparison of the efficacy of domestic and imported cefoperazone/sulbactam in treating lower respiratory tract infection. Chin Pharm. 2010;21:157–158.
  • Koomanachai P, Tongsai S, Thamlikitkul V. Effectiveness and safety of generic formulation of cefoperazone/sulbactam (Bacticep®) in treatment of infections at Siriraj Hospital. J Med Assoc Thai. 2016;99:8–14.
  • Araya I, Fasce G, Núñez E, et al. A non-inferiority pilot study comparing the clinical efficacy and safety of generic wide-spectrum antibiotic use in septic oncology patients. Drug Res. 2015;65(12):635–639. doi: 10.1055/s-0034-1396884.
  • Lu SJ, Li X, Guo LJ, et al. Clinical observation of cefoperazone/sulbactam combined with minocycline on lower respiratory tract infection caused by PDR-Ab. Chin Pharm. 2011;22:3004–3006.
  • Tang YC, Zhang KX, Rao X, et al. One hundred twenty-eight lower respiratory tract and urinary tract infection cases were treated with Haishubi and sulperazon for injection. Chin J New Drugs. 1997;6:74–76.
  • Hu J, Wu HH, Lu YH, et al. Comparison of efficacy of two kinds of cefoperazone sodium/sulbactam sodium on elderly pulmonary infection. J Chin Physician. 2005;7(06):854.
  • Liu A. Cost-effectiveness analysis of imported and domestic cefoperazone/sulbactam sodium in treating lower respiratory tract infection. Chin Pharm. 2006;17(07):510–511.
  • Dang DS, Gong XX, Fan R. Clinical efficacy of a domestic cefoperazone sodium sulbactam and a joint venture formulation in the treatment of stroke-associated pneumonia and clinical observation of the difference in antibiotic-associated diarrhea. Chinese Hospital Association pharmaceutical management committee. Proceedings of the Ninth Clinical Pharmacist Forum. Department of Pharmacy, General Hospital of Shenyang Military Region; 2013. p. 757–760.
  • Jing Y, Qiu P, Wang GL, et al. Cost-effect analysis of imported and domestic sulbactam cefoperazone treatment of acute bile duct infection. Strait Pharm J. 2015;27:254–256.
  • Wang YP, Huang C. Comparison of the clinical efficacy of two cefoperazone-sulbactam ratios in HAP. Women’s Health Res. 2016;6(15):17–18.
  • Mao GM, Wan LL. Efficacy of generic and originator cefoperazone combinations against ESBL-producing enterobacteriaceae. Chin J Pharm Economics. 2022;17:58–62.
  • Qu J, Huang Y, Lv X. Crisis of antimicrobial resistance in China: now and the future. Front Microbiol. 2019;10:2240. doi: 10.3389/fmicb.2019.02240.
  • Yang F, Zhao Q, Wang L, et al. Diminished susceptibility to cefoperazone/sulbactam and piperacillin/tazobactam in Enterobacteriaceae due to narrow-spectrum β-lactamases as well as omp mutation. Pol J Microbiol. 2022;71(2):251–256. doi: 10.33073/pjm-2022-023.
  • Chazin H, Woo J, Han J, et al. FDA's generic drug program: decreasing time to approval and number of review cycles. Ther Innov Regul Sci. 2020;54(4):758–763. doi: 10.1007/s43441-019-00016-2.
  • Luke MC, Kozak D. Regulating generic ophthalmologic drug bioequivalence-envisioning accessibility for patients. J Ocul Pharmacol Ther. 2021;37(3):157–161. doi: 10.1089/jop.2020.0041.
  • Wu S, Wu G, Wu H. A comparison of coagulation function in patients receiving aspirin and cefoperazone-sulbactam with and without vitamin K: a retrospective, observational study. Clin Ther. 2021;43(12):e335–e345. doi: 10.1016/j.clinthera.2021.10.005.
  • Wang W, Liu Y, Yu C, et al. Cefoperazone-sulbactam and risk of coagulation disorders or bleeding: a retrospective cohort study. Expert Opin Drug Saf. 2020;19(3):339–347. doi: 10.1080/14740338.2020.1713090.
  • Kesselheim AS, Avorn J, Sarpatwari A. The high cost of prescription drugs in the United States: origins and prospects for reform. JAMA. 2016;316(8):858–871. doi: 10.1001/jama.2016.11237.
  • Kharasch ED, Neiner A, Kraus K, et al. Bioequivalence and therapeutic equivalence of generic and brand bupropion in adults with major depression: a randomized clinical trial. Clin Pharmacol Ther. 2019;105(5):1164–1174. doi: 10.1002/cpt.1309.
  • Tattevin P, Crémieux AC, Rabaud C, et al. Efficacy and quality of antibacterial generic products approved for human use: a systematic review. Clin Infect Dis. 2014;58(4):458–469. doi: 10.1093/cid/cit769.
  • Mishuk AU, Fasina I, Qian J. Impact of U.S. federal and state generic drug policies on drug use, spending, and patient outcomes: a systematic review. Res Social Adm Pharm. 2020;16(6):736–745. doi: 10.1016/j.sapharm.2019.08.031.
  • Babar ZUD, Kan SW, Scahill S. Interventions promoting the acceptance and uptake of generic medicines: a narrative review of the literature. Health Pol. 2014;117(3):285–296. doi: 10.1016/j.healthpol.2014.06.004.

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