利用鎝 99m 閃爍造影評估乳酸菌膠囊對胃排空功能之臨床試驗   全文下載

Evaluation of Multi-strain Lactobacillus Capsule on Gastric Emptying Function by Tc-99m Scintigraphy in a Crossover Placebo-Controlled Clinical Trial

目前在胃輕癱症的藥物治療上，因可選擇的藥品少且具有高副作用，故有相當的限制性。益生菌同時具有促蠕動及抗生素的屬性，而可成為優良的替代治療。本研究以安慰劑交叉控制的臨床試驗，報導複合三種乳酸菌之膠囊製劑在胃排空功能上的效應。研究中招募15位健康受試者，分組為20-40歲組七位及41-60歲組八位。各分組中所有的參與者都分別給予益生菌膠囊及安慰劑膠囊，早晚飯後每天兩次給予三週，接下來三週兩組交換治療。胃排空速率以核子醫學鎝-99m造影在實驗中的第零、第三及第六週分別測定。胃排空及半排空時間以簡單線性擬合的方式來計算，同一受試者之時間-活性曲線及半排空時間均計算建構以資比較。研究結果在20-40組之受試前、安慰劑及乳酸菌膠囊給予時段的胃半排空時間分別為73.0 ± 16.0分鐘， 85.7 ± 10.5分鐘，及87.8 ± 10.0分鐘。在41-60組分別為79.1 ± 23.9分鐘，70.9 ± 33.1分鐘，及 68.4 ± 15.2分鐘。研究發現乳酸菌囊膠對於41-60歲組達顯著（p = 0.013），而在20-40歲組未達顯著；兩組給予安慰劑時無明顯的差異。本研究指出，以乳酸菌做為治療胃排空異常的處方測試相當安全，初步反應的結果在健康中老年受試者上可以加速胃排空的速率，而在未來大型臨床試驗中能成為病態性胃輕癱症的治療處方，尤其是糖尿病胃輕癱症。

Current pharmacological therapy for gastroparesis is limited by a few optional agents with high side effect profiles. Probiotics, which exert both prokinetic and antibiotic properties, can be a good alternative. This study investigates the effects of capsules containing three species of Lactobacillus on gastric emptying function by using a crossover placebo-controlled clinical trial. The 15 healthy participants recruited were divided into two groups, with one group of 7 persons aged between 20-40 and another group of 8 persons aged between 41-60. All the participants in each group were provided with placebo capsules and probiotic capsules, respectively, to be taken twice a day after meals for 3 weeks with crossover in the following 3 weeks. Tc-99m scintigraphy was performed at the beginning of weeks 0, 3 and 6 to determine the gastric emptying rate. All time-activity curves were constructed and the half time of gastric emptying (GEt1/2) was calculated for the same subject for comparison. The GEt1/2 of the baseline, placebo and Lactobacillus regimen periods for the 20-40 age group were 73.0 ± 16.0, 85.7 ± 10.5, and 87.8 ± 10.0 min, respectively, while those for the 41-60 age group were 79.1 ± 23.9, 70.9 ± 33.1, and 68.4 ± 15.2 min, respectively. Comparison of the two groups showed a positive effect of probiotics capsules on the 41 to 60-year-old participants (p = 0.013) but not on the 20 to 40-year-old participants. There was no significant statistical difference between the two groups in the period of treatment with placebo. This early stage trial indicated that the multi-strain Lactobacillus capsule is safe and the results provided some evidence that it accelerated gastric emptying in healthy adults above 40 years of age and may become a therapeutic approach in future trials for pathological gastric emptying delay, by implication, especially in diabetic gastroparesis.