乳梨醇对亚临床性肝性脑病的疗效观察──随机双盲临床试验

Lactitol in treatment of subclinical hepatic encephalopathy ──A double-blind placebo- controlled randotaised trial

目的：评估乳梨醇（Ｌａｃｔｉｔｏｌ）治疗亚临床性肝性脑病的疗效和安全性。方法：３１例亚临床性肝性脑病病人随机分为两组，治疗组１６例，对照组１５例。双盲法分别给予４０％乳梨醇溶液０．５５－１．７５ｍｌ·ｋｇ￣（－１）·ｄ￣（－１），平均１．０５ｍｌ·ｋｇ￣（－１）·ｄ￣（－１）１日３次，以获得每天１－２次软便，及安慰剂５％葡萄糖１０ｍｌ，１日３次，均连续服用２周。服药前后分别行数字连按试验（ＮＣＴ）、数字符号试验（ＤＳ），体表感觉诱发电位（ＳＳＥＰ）及血氨检查，并随访有无临床肝性脑病发生。结果：乳梨醇能有效降低血氨，改善ＮＣＴ、ＤＳ，缩短ＳＳＥＰ的Ｎ２、Ｐ２、Ｎ３、Ｐ３潜伏期。Ｎ１－Ｐ３、Ｎ１－Ｎ３峰间潜伏期，且副反应小。结论：乳梨醇是一种安全，有效的亚临床性肝性脑病的治疗药物。

Objectives: To evaluate the efficacy and safety of lactitol in the treatment of subclinical hepatic encepbalopathy. Methods: Thirty one cases of cirrhotic patients with subclinical hepatic encephalopathy were randomly allocated into two groups. Sixteen cases received an average of 1.05ml·kg(-)·d￣(-1) (range 0.55- 1.75ml·kg(-1)·(-1)) of lactitol orally tds for two weeks to achieve one to two semiformed stools/day. Fifteen cases were given placebo (5% GW) 10ml orally tds as control also for a period of two weeks, Assessment of response included two psychometric tests: number connection test (NCT) and digit symbol (DS), somatosensory evoked potentials (SSEP), blood ammonia and clinical evaluation of mental status. Results: After a two-week treatment with lactitol, the blood ammonia, the latency of N2, P2, N3, P3 and inter- peak latency of N1-P2, N1-N3 of SSEP were significantly decreased while the NCT, DS were significantly improved (P< 0.01). The differences of the above parameters found in the control group were not significant statistically, Adverse effects of lactitol such as meteorism, nausea , diarrhea were mild, transient and did not affect the treatment. Conclusion: Lactitol is a safe and effective drug in the treatment of subclinical hepatic encephalopathy, the optimum dosage and the regimen should be individualized.