Evidence map›Paper›PMID 32733255›Full record

ArticleFrontiers in pharmacology2020

Tolerability, Safety, Pharmacokinetics and Drug Interaction of Cefotaxime Sodium-Tazobactam Sodium Injection (6:1) Following Single and Multiple Intravenous Doses in Chinese Healthy Subjects.

Ning Chen, Lu-Ning Sun, Wen-Hui Hu, Yi-Ya Wang, Li-Jun Xie, Juan Cheng, Hong-Wen Zhang, Yun Liu, Yong-Qing Wang, Li Ding

Abstract read
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Article in Frontiers in pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

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0cells of the map it votes in
2citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

10 authors.

Ning ChenResearch Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Lu-Ning SunResearch Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Wen-Hui HuDepartment of Bioanalysis, Nanjing Clinical Tech. Laboratories Inc., Nanjing, China.
Yi-Ya WangDepartment of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, China.
Li-Jun XieResearch Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Juan ChengResearch Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Hong-Wen ZhangResearch Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yun LiuResearch Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yong-Qing WangResearch Division of Clinical Pharmacology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Li DingDepartment of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the tolerability, safety, pharmacokinetics and drug interaction of cefotaxime sodium-tazobactam sodium injection (6:1) in Chinese healthy subjects. The results of the safety and pharmacokinetic studies supported further clinical trials.

methodA randomized, single-blind, ascending dose, placebo-controlled, single-center study was conducted. Sixty healthy subjects (38 males, 22 females) participated in this study. For the single-dose part, 0.47, 1.17, 2.34, 3.51, and 4.68 g of cefotaxime sodium-tazobactam sodium injection (6:1) was administered. For the multiple-dose part, the subjects were administered 2.34 and 3.51 g cefotaxime sodium-tazobactam sodium injection (6:1) three times a day for 7 consecutive days. For the drug interaction part, the subjects received 2.0 g cefotaxime sodium and 0.34 g tazobactam sodium alone and in combination.

resultsMost adverse events and adverse drug reactions were mild. Moderate rash was considered a serious adverse event because of prolongation of hospitalization. The main pharmacokinetic parameters of cefotaxime and tazobactam had no significance difference between the 1.17, 2.34, and 3.51 g dose cohorts and between genders. There was no difference in trough concentrations on days 6, 7, and 8. The R

conclusionsCefotaxime sodium-tazobactam sodium injection (6:1) was well-tolerated at doses of 0.47 to 4.68 g. The pharmacokinetics of cefotaxime and tazobactam were reported as linear over a dose range of 1.17-3.51 g. Cefotaxime was partially excreted

Indexed as

cefotaximedrug interactionpharmacokineticssafetytazobactam

Identifiers

PMID32733255
PMCPMC7360824

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