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一项关于乙酰氧肟酸治疗和预防脊髓损伤患者感染性尿路结石的随机试验。

A randomized trial of acetohydroxamic acid for the treatment and prevention of infection-induced urinary stones in spinal cord injury patients.

作者信息

Griffith D P, Khonsari F, Skurnick J H, James K E

机构信息

Veterans Administration Medical Center, Houston, Texas.

出版信息

J Urol. 1988 Aug;140(2):318-24. doi: 10.1016/s0022-5347(17)41592-8.

DOI:10.1016/s0022-5347(17)41592-8
PMID:3294442
Abstract

Acetohydroxamic acid is known to inhibit bacterial urease activity, thus, reducing urinary ammonia levels. A double-blind placebo-controlled clinical trial of acetohydroxamic acid was conducted at 12 Veterans Administration spinal cord injury units. A total of 210 male spinal cord injury patients with chronic urea-splitting urinary infection was enrolled for a scheduled followup of 2 years. The study data support the usefulness of acetohydroxamic acid in reducing urinary ammonia. At every followup visit the acetohydroxamic acid patients with stones had decreases in ammonia of 30 to 48 mg. per dh., while the placebo patients had increases in ammonia. Acetohydroxamic acid also retarded stone growth. Patients with stones treated with acetohydroxamic acid exhibited significantly longer intervals from randomization to first stone growth than patients treated with placebo (p less than 0.005, medians 15 versus 9 months). Acetohydroxamic acid reduced significantly the proportion of patients with stone growth at 12 months (33 versus 60 per cent, p equals 0.017). This decrease was diminished at 24 months (42 versus 60 per cent, p equals 0.260). Patient attrition was 31 per cent in the placebo group and 62 per cent in the acetohydroxamic acid group, the latter attrition being primarily owing to patient request because of mild symptoms. Of the acetohydroxamic acid and placebo patients 62 and 29 per cent, respectively, reported drug side effects but all were reversible and no unanticipated or life-threatening reactions occurred.

摘要

已知乙酰氧肟酸可抑制细菌脲酶活性,从而降低尿氨水平。在12个退伍军人管理局脊髓损伤病房进行了一项关于乙酰氧肟酸的双盲安慰剂对照临床试验。共有210名患有慢性尿素分解性尿路感染的男性脊髓损伤患者入选,计划进行2年的随访。研究数据支持乙酰氧肟酸在降低尿氨方面的有效性。在每次随访时,服用乙酰氧肟酸且有结石的患者氨水平每分升降低30至48毫克,而服用安慰剂的患者氨水平则升高。乙酰氧肟酸还延缓了结石生长。与服用安慰剂的患者相比,服用乙酰氧肟酸治疗结石的患者从随机分组到首次结石生长的间隔时间显著更长(p小于0.005,中位数分别为15个月和9个月)。乙酰氧肟酸显著降低了12个月时结石生长患者的比例(33%对60%,p等于0.017)。在24个月时这种降低有所减少(42%对60%,p等于0.260)。安慰剂组的患者流失率为31%,乙酰氧肟酸组为62%,后者的流失主要是由于患者因轻微症状提出要求。在服用乙酰氧肟酸和安慰剂的患者中,分别有62%和29%报告有药物副作用,但所有副作用均可逆转,且未发生意外或危及生命的反应。

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