Lao-Oxford-Mahosot Hospital-Wellcome Trust Research Unit (LOMWRU), Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR.
Public Health Unit, Faculty of Medicine, University of Alcalá, Alcalá de Henares, Spain.
J Antimicrob Chemother. 2022 May 29;77(6):1770-1778. doi: 10.1093/jac/dkab435.
In 2012, a stratified random survey, using mystery shoppers, was conducted to investigate the availability and quality of antibiotics sold to patients in the private sector in five southern provinces of the Lao People's Democratic Republic (Laos).
A total of 147 outlets were sampled in 10 districts. The active pharmaceutical ingredient (API) content measurements for 909 samples, including nine APIs (amoxicillin, ampicillin, ceftriaxone, ciprofloxacin, doxycycline, ofloxacin, sulfamethoxazole, tetracycline and trimethoprim), were determined using HPLC.
All the analysed samples contained the stated API and we found no evidence for falsification. All except one sample had all the units tested with %API values between 75% and 125% of the content stated on the label. However, we identified the presence of substandard antibiotics: 19.6% (201/1025) of samples had their units outside the 90%-110% content of the label claim and 18.3% (188/1025) of the samples had units outside the International Pharmacopoeia/United States Pharmacopoeia assay (percentage of label claim) specifications. Trimethoprim had a high number of samples [51.6% (64)] with units below the limit range, followed by ceftriaxone [42.9% (3)] and sulfamethoxazole [34.7% (43)]. Doxycycline, ofloxacin and ciprofloxacin had the highest number of samples with high API content: 43.7% (38), 14.7% (10) and 11.8% (2), respectively. Significant differences in %API were found between stated countries of manufacture and stated manufacturers.
With the global threat of antimicrobial resistance on patient outcomes, greater understanding of the role of poor-quality antibiotics is needed. Substandard antibiotics will have reduced therapeutic efficacy, impacting public health and control of bacterial infections.
2012 年，采用神秘顾客的分层随机调查，对老挝人民民主共和国（老挝）南部五个省份私营部门向患者出售的抗生素的供应和质量进行了调查。
在 10 个区抽取了 147 个网点。使用 HPLC 对 909 个样本（包括 9 种抗生素（阿莫西林、氨苄西林、头孢曲松、环丙沙星、强力霉素、氧氟沙星、磺胺甲恶唑、四环素和甲氧苄啶）的活性药物成分（API）含量进行了测量。
所有分析样本均含有规定的 API，且未发现伪造证据。除一个样本外，所有样本的所有单位均经过测试，其 API 值均在标签上规定值的 75%-125%之间。然而，我们发现存在不合格的抗生素：19.6%（201/1025）的样本单位超出标签声称的 90%-110%含量范围，18.3%（188/1025）的样本单位超出国际药典/美国药典测定值（标签声称值的百分比）规格。甲氧苄啶的样本数量较多[51.6%（64）]，单位低于下限，其次是头孢曲松[42.9%（3）]和磺胺甲恶唑[34.7%（43）]。强力霉素、氧氟沙星和环丙沙星的高 API 含量样本数量最多：分别为 43.7%（38）、14.7%（10）和 11.8%（2）。所报生产国和所报制造商之间的 API%差异有统计学意义。
鉴于全球抗生素耐药性对患者结局的威胁，需要进一步了解劣质抗生素的作用。劣质抗生素的治疗效果会降低，从而影响公共卫生和细菌感染的控制。
