Sanders S W, Tolman K G, Reitberg D P
Clinical Research, TheraTech, Inc., Salt Lake City, UT.
Clin Pharm. 1992 Jun;11(6):533-8.
The effect of a single dose or oral lactase on symptoms, breath hydrogen concentration, and glucose absorption in lactose-intolerant subjects challenged with lactose was studied. Volunteers underwent a lactose challenge test; those whose breath hydrogen concentrations increased 20 ppm or more and who met other criteria were admitted as subjects. After fasting, the subjects were given three chewable lactase tablets (total lactase dose, 9900 FCC units) or placebo tablets in a randomized, double-blind, crossover manner. The subjects also consumed 8 oz of whole milk in which 37.5 g of lactose powder was dissolved (total lactose content, 50 g). The washout period between lactose challenges was at least one week. Breath hydrogen and plasma glucose concentrations were measured before and at intervals after the challenges, and the subjects completed symptom-evaluation questionnaires every eight hours for four days. Twenty-four subjects completed the study. The maximum mean breath hydrogen concentration was significantly lower after lactase treatment than after placebo treatment. In 21 subjects, the area under the hydrogen concentration-time curve (AUC) was lower after lactase than after placebo; three subjects had hydrogen AUCs more than 300 ppm.hr lower. There were no significant differences in plasma glucose levels. Subjective ratings of the severity of abdominal cramping, belching, flatulence, and diarrhea were lower during the first eight hours after challenge in lactase-treated subjects; ratings for bloating were lower during the next eight hours. Single doses of a chewable lactase tablet reduced the concentration of expired hydrogen and symptoms of lactose intolerance after a lactose challenge.
研究了单剂量口服乳糖酶对乳糖不耐受受试者在乳糖激发试验后症状、呼出气氢气浓度及葡萄糖吸收的影响。志愿者接受乳糖激发试验;呼出气氢气浓度升高20 ppm或更多且符合其他标准者被纳入研究对象。禁食后,研究对象以随机、双盲、交叉方式服用三片可咀嚼乳糖酶片(乳糖酶总剂量为9900 FCC单位)或安慰剂片。研究对象还饮用了8盎司溶解有37.5克乳糖粉的全脂牛奶(乳糖总含量为50克)。两次乳糖激发试验之间的洗脱期至少为一周。在激发试验前及试验后每隔一段时间测量呼出气氢气和血浆葡萄糖浓度,研究对象在四天内每八小时完成一次症状评估问卷。24名研究对象完成了研究。乳糖酶治疗后最大平均呼出气氢气浓度显著低于安慰剂治疗后。21名研究对象中,乳糖酶治疗后氢气浓度-时间曲线下面积(AUC)低于安慰剂治疗后;三名研究对象的氢气AUC低300 ppm·小时以上。血浆葡萄糖水平无显著差异。在激发试验后的前八小时内,乳糖酶治疗组研究对象腹部绞痛、嗳气、肠胃胀气和腹泻严重程度的主观评分较低;在接下来的八小时内腹胀评分较低。单剂量可咀嚼乳糖酶片可降低乳糖激发试验后呼出气氢气浓度及乳糖不耐受症状。