目的 評價不同劑量寶兒康散對于小兒急性水樣便腹瀉?。ㄆ⑻摑窭ёC）的疾病療效、縮短病程作用和中醫(yī)證候改善作用，同時觀察臨床應用的安全性。方法 采用隨機、雙盲雙模擬、陽性藥平行對照、多中心臨床試驗的方法，16家醫(yī)療機構納入受試者360例，按照1：1：1的比例隨機分配為高劑量組、低劑量組、陽性對照藥組（止瀉靈顆粒）。分別給予不同的試藥，療程為3 d。觀察疾病療效、止瀉時間、中醫(yī)證候療效、中醫(yī)單項癥狀，并對其安全性進行評價。結果 疾病療效總有效率，高劑量組為87.29%，低劑量組為76.67%，陽性對照組為66.67%，3組組間比較差異有統(tǒng)計學意義（P<0.05），高劑量組優(yōu)于低劑量組和陽性對照組。中位止瀉時間，高劑量組與低劑量均為3 d，陽性對照組未觀察到中位止瀉時間，3組組間比較差異有統(tǒng)計學意義（P<0.05），高劑量組與低劑量組均短于陽性對照組。中醫(yī)證候療效的總有效率，高劑量組為92.37%，低劑量組為86.67%，陽性對照組為77.50%，3組組間比較差異有統(tǒng)計學意義（P<0.05），且高劑量組優(yōu)于陽性對照組。中醫(yī)單項癥狀（大便稀溏、便次增多、肢體困倦、神疲、食欲不振和面色少華）總有效率，3組組間比較差異有統(tǒng)計學意義，高劑量組均優(yōu)于陽性對照組。試驗過程中，共發(fā)生5例不良事件，其中低劑量組發(fā)生不良事件2例，發(fā)生率1.67%；陽性對照藥組發(fā)生不良事件3例，發(fā)生率2.50%，研究者判斷所有不良事件均與試驗藥物無關。結論 加倍劑量寶兒康散治療小兒急性水樣便腹瀉（脾虛濕困證），療效優(yōu)于原劑量寶兒康散和止瀉靈顆粒，具有縮短腹瀉病程、改善中醫(yī)證候和中醫(yī)單項癥狀的作用，且安全性良好。

Objective To evaluate the efficacy and safety of two different doses of Baoerkang Powder in the treatment of acute watery diarrhea in children with the syndrome of dampness stagnancy due to spleen deficiency. Methods By the methods of randomized, double-blind, double-dummy, parallel, active-controlled, and multi-center clinical trail, a total of 168 patients were enrolled and randomly divided into 3 groups within the ratio of 1:1:1, including high dose group, low dose group and positive control group (Zhixie Ling Granules). The course of treatment was 3 d. The disease efficacy, anti-diarrheal time, traditional Chinese medicine syndrome efficacy, single symptom efficacy and the safety of the three different regimens were evaluated. Results The total effective rate of disease efficacy was 87.29% in the high dose group, 76.67% in the low dose group and 66.67% in the positive control group. There was statistical difference among the three groups (P<0.05), and the high dose group was superior to the other two groups. The median anti-diarrheal time was remarkably shortened to 3 d in both the high dose group and the low dose group which wasn't observed in the positive control group. The total effective rate of traditional Chinese medicine syndrome efficacy in the high dose group (92.37%) was superior to the positive control group (86.67%), which was 77.50% in the low dose group. The single symptom efficacy in the high dose group was also superior to the positive control group (P<0.05), such as thin stool even like water, increased defecation frequency, etc. During the study, there were 2 (1.67%) adverse event in the low dose group and 3 (2.50%) adverse event in the positive control group. The researchers concluded that all the adverse events were unrelated to the test drug. Conclusion The efficacy of Baoerkang Powder in high dose in the treatment of acute watery diarrhea in children with the syndrome of dampness stagnancy due to spleen deficiency was superior to the positive control group (Zhixie Ling Granules) and Baoerkang Powder in low dose (the dosage of instructions), and good safety.