Austin Peter David, Elia Marinos
Pharmacy Department, Southampton University Hospitals NHS Trust, Southampton, United Kingdom.
J Pharm Pharm Sci. 2009;12(2):233-42. doi: 10.18433/j3jp4b.
To review microbial contamination rates about preparation of individual and batch doses using aseptic techniques within pharmaceutical (controlled) and clinical (ward and theatre) environments.
Systematic review, involving amalgamation of data using a random effect model and metaanalysis.
A total of 19 studies from 17 reports (7277 doses), mostly single arm studies, were identified for analysis. The overall contamination rates for doses prepared in clinical environments were found to be 5.0% (95% CI; 1.8%, 13.1%, n = 8 studies) for individual doses and 2.0% (95% CI; 0.3%, 13.1%; n = 5) for doses prepared as part of a batch. Rates for doses prepared in pharmaceutical environments were found to be 1.9% (95% CI; 0.8%, 4.2%; n = 5) for individual doses and 0.0% (95% CI; 0.0%, 0.8%; n= 1) for doses prepared as part of a batch. The results indicate greater overall contamination rates of doses prepared in clinical than pharmaceutical environments, in those prepared individually than in batch preparation, and in those in which additions rather than no additions were made. Significant differences were only found between pharmaceutical and clinical environments for batch doses, and between batch and individual doses prepared in a pharmaceutical environment. The studies differed substantially in sample size, interventions and comparison conditions, especially in the clinical setting. The quality of the data was judged to be low.
Contamination rates in clinical and pharmaceutical environments were commonly found to be unacceptably high. Intuitive recommendations for reducing contamination rates by carrying out the procedures in a pharmaceutical environment using batch doses are supported by an evidence base that needs to be strengthened further.
回顾在制药（受控）和临床（病房及手术室）环境中采用无菌技术制备单剂量和批量剂量时的微生物污染率。
系统评价，采用随机效应模型合并数据并进行荟萃分析。
共纳入17篇报告中的19项研究（7277剂）进行分析，大多为单臂研究。临床环境中制备的单剂量总体污染率为5.0%（95%置信区间：1.8%，13.1%；n = 8项研究），批量制备剂量的污染率为2.0%（95%置信区间：0.3%，13.1%；n = 5）。制药环境中制备的单剂量污染率为1.9%（95%置信区间：0.8%，4.2%；n = 5），批量制备剂量的污染率为0.0%（95%置信区间：0.0%，0.8%；n = 1）。结果表明，临床环境中制备的剂量总体污染率高于制药环境，单剂量制备的污染率高于批量制备，添加辅料的高于未添加辅料的。仅在批量剂量方面，制药环境与临床环境之间存在显著差异；在制药环境中，批量制备与单剂量制备之间存在显著差异。这些研究在样本量、干预措施和对照条件方面差异很大，尤其是在临床环境中。数据质量被判定为低。
临床和制药环境中的污染率普遍高得令人无法接受。通过在制药环境中采用批量剂量进行操作来降低污染率的直观建议得到了证据支持，但该证据基础仍需进一步加强。
