Syhakhang Lamphone, Lundborg Cecilia Stålsby, Lindgren Björn, Tomson Göran
Food and Drug Department, Ministry of Health, Vientiane, Lao PDR, and Division of International Health (IHCAR), Department of Public Health Sciences, Karolinska Institutet, 171 76 Stockholm, Sweden.
Pharm World Sci. 2004 Dec;26(6):333-8. doi: 10.1007/s11096-004-0558-3.
To present a repeated test of the quality of ampicillin, tetracycline, chloroquine and ASA from private pharmacies in Laos in 1997 and 1999, and to discuss the quality in relation to the National Drug Policy Programme.
A total of 115 of 214 licensed private pharmacies were selected in Savannakhet province, a pilot province in the Lao National Drug Policy Programme. The four drugs, if available, were collected at each pharmacy. Thirty tablets of each drug were taken from a selected container. In 1997, 366 samples were analysed and three hundred in 1999. Identity, assay (content of active component) and measurement of weight variation tests were performed. Drug quality was compared mainly according to the standards of the British and United States' pharmacopoeias.
The percentage of substandard drugs decreased significantly from 46% to 22% between 1997 and 1999 (P< 0.001). Substandard ampicillin and tetracycline were reduced significantly from 67% to 9% and from 38% to 12%, respectively (P < 0.001). In total, 3% vs 1% contained no active ingredient, 12% vs 4% had too little or too much active ingredient, and 35% vs 14% had weight variation outside pharmacopoeial limits.
Drug quality was improved. However, the prevalence of substandard drugs was still unacceptably high, which may result in adverse clinical effect or treatment failure for individual patients.
对1997年和1999年老挝私营药店的氨苄西林、四环素、氯喹和阿司匹林质量进行重复检测，并结合国家药品政策计划讨论其质量情况。
在老挝国家药品政策计划的试点省份沙湾拿吉省，从214家有执照的私营药店中总共选取了115家。若有这四种药品，每家药店都进行收集。从选定的容器中每种药品取30片。1997年分析了366个样本，1999年分析了300个样本。进行了鉴别、含量测定（活性成分含量）和重量差异检测。主要根据英国和美国药典标准比较药品质量。
1997年至1999年不合格药品的百分比从46%显著降至22%（P<0.001）。不合格的氨苄西林和四环素分别从67%显著降至9%和从38%显著降至12%（P<0.001）。总体而言，不含活性成分的药品比例分别为3%和1%，活性成分含量过少或过多的药品比例分别为12%和4%，重量差异超出药典规定范围的药品比例分别为35%和14%。
药品质量有所提高。然而，不合格药品的流行率仍然高得令人无法接受，这可能导致个别患者出现临床不良反应或治疗失败。
