Kharkiv National Medical University, Kharkiv, Ukraine.
Vinnytsya National Medical University named after M. I. Pirogov, Vinnytsya, Ukraine.
Sci Rep. 2020 Apr 14;10(1):6344. doi: 10.1038/s41598-020-62386-0.
The acute diarrhea is a wide-spread disease. The prescription of enterosorbents is appropriate as a primary measure for the treatment of the acute diarrhea for effective prevention of the fluid and electrolyte loss, as well as method for symptom relief of the attack of the disease. Aim of the study - the antidiarrheal efficacy and safety study of high-dispersion silicon dioxide enterosorbent in tablet dosage form in patients with acute diarrhea. This was randomized, double-blind, placebo-controlled, 4-center study. Acute diarrhea was defined as three and more episodes of watery stool per day either during 48 hours or less before study entry in the patients having normal stool recently. It has been postulated that symptoms and signs of acute diarrhea have to be caused by direct infection of the gastrointestinal tract and did not associated with moderate-to-severe systemic states. 144 patients with established acute diarrhea were randomized into treatment group (enterosorbent "Carbowhite", n = 120) or placebo group. Date collection including severity diarrhea, systemic symptoms was performed at baseline and daily during 7 days. Stool examination and serological assay were performed at baseline. The primary end points were declared as time to complete recovery from acute diarrhea. It has been found that the use of the siliceous enterosorbent ("Carbowhite") allowed to reduce (p < 0.001) the treatment period averagely for 0.9 days (95% confidence interval 0.5-1.2 days) in comparison with placebo. Data of safety monitoring has revealed that both patient groups had negative stool culture, while initiation of antibiotic treatment was run more frequently in placebo group (8.3%) compared to investigational product group (4.1%, P = 0.044). The siliceous enterosorbent "Carbowhite" was well tolerated and reduced the recovery time of the acute episode of the diarrhea in the clinically significant form.
急性腹泻是一种广泛存在的疾病。作为急性腹泻治疗的主要措施，肠吸附剂的处方是合适的，可有效预防液体和电解质流失，并缓解疾病发作时的症状。本研究的目的是研究高分散二氧化硅肠吸附剂片剂在急性腹泻患者中的止泻疗效和安全性。这是一项随机、双盲、安慰剂对照的 4 中心研究。急性腹泻的定义为每天有 3 次或 3 次以上水样便，或在研究入组前 48 小时内有 4 次或 4 次以下水样便，且最近大便正常。据推测，急性腹泻的症状和体征必须是由胃肠道直接感染引起的，而与中度至重度全身状态无关。144 例确诊为急性腹泻的患者被随机分为治疗组（肠吸附剂“Carbowhite”，n=120）或安慰剂组。在基线和第 7 天每天收集包括腹泻严重程度、全身症状在内的数据。在基线时进行粪便检查和血清学检测。主要终点是从急性腹泻完全恢复的时间。研究发现，与安慰剂相比，使用硅质肠吸附剂（“Carbowhite”）可平均减少（p<0.001）治疗期 0.9 天（95%置信区间 0.5-1.2 天）。安全性监测数据显示，两组患者的粪便培养均为阴性，而安慰剂组开始抗生素治疗的频率高于研究产品组（8.3%比 4.1%，P=0.044）。硅质肠吸附剂“Carbowhite”耐受性良好，可显著缩短急性腹泻发作的恢复时间。
