Price M, Schwartz R, Hoyt H
Invest Urol. 1978 Jul;16(1):13-4.
Inulin was not available for clinical testing in the United States between February 1973 and July 1975 because the raw material received in the United States differed from previously manufactured lots in molecular weight, glucose content, optical rotation, melting point, and water solubility. The comparability of the "new" and "old" inulin preparations was assessed in 12 adult male spinal cord injury patients, seven with normal renal function and five with compromised function. The "new" inulin proved to be as accurate and safe an agent for the determination of glomerular filtration rate as the previously available material in both groups of patients, and was made available for general clinical use in the United States in July 1975.
1973年2月至1975年7月期间,菊粉在美国无法用于临床试验,因为美国收到的原材料在分子量、葡萄糖含量、旋光度、熔点和水溶性方面与之前生产的批次不同。在12名成年男性脊髓损伤患者中评估了“新”菊粉制剂和“旧”菊粉制剂的可比性,其中7名肾功能正常,5名肾功能受损。结果证明,在两组患者中,“新”菊粉作为测定肾小球滤过率的试剂与之前可用的材料一样准确和安全,并于1975年7月在美国投入一般临床使用。