Title: Lower-Dose Zinc for Childhood Diarrhea — A Randomized, Multicenter Trial
Author: Usha Dhingra, M.A., M.C.A.,, Rodrick Kisenge, M.D., Ph.D., M.Med.,, Christopher R. Sudfeld, Sc.D.,, Pratibha Dhingra, Ph.D.,, Sarah Somji, M.P.H.,, Arup Dutta, M.B.A.,, Mohamed Bakari, M.Sc.,, Saikat Deb, Ph.D.,, Prabhabati Devi, Ph.D.,, Enju Liu, M.B., B.S., Ph.D.,, Aishwarya Chauhan, Ph.D.,, Jitendra Kumar, Ph.D.,, Om P. Semwal, M.B., B.S., D.C.H.,, Said Aboud, M.D., M.Med., Ph.D.,, Rajiv Bahl, M.B., B.S., M.D., Ph.D.,, Per Ashorn, M.D., Ph.D.,, Jonathon Simon, D.Sc., M.P.H,, Christopher P. Duggan, M.D., M.P.H.,, Sunil Sazawal, M.B., B.S., M.P.H., Ph.D.,, and Karim Manji, M.B., B.S., M.Med., M.P.H.
The World Health Organization recommends 20 mg of zinc per day for 10 to 14 days for children with acute diarrhea; in previous trials, this dosage decreased diarrhea but increased vomiting.
We randomly assigned 4500 children in India and Tanzania who were 6 to 59 months of age and had acute diarrhea to receive 5 mg, 10 mg, or 20 mg of zinc sulfate for 14 days. The three primary outcomes were a diarrhea duration of more than 5 days and the number of stools (assessed in a noninferiority analysis) and the occurrence of vomiting (assessed in a superiority analysis) within 30 minutes after zinc administration.
The percentage of children with diarrhea for more than 5 days was 6.5% in the 20-mg group, 7.7% in the 10-mg group, and 7.2% in the 5-mg group. The difference between the 20-mg and 10-mg groups was 1.2 percentage points (upper boundary of the 98.75% confidence interval [CI], 3.3), and that between the 20-mg and 5-mg groups was 0.7 percentage points (upper boundary of the 98.75% CI, 2.8), both of which were below the noninferiority margin of 4 percentage points. The mean number of diarrheal stools was 10.7 in the 20-mg group, 10.9 in the 10-mg group, and 10.8 in 5-mg group. The difference between the 20-mg and 10-mg groups was 0.3 stools (upper boundary of the 98.75% CI, 1.0), and that between the 20-mg and 5-mg groups was 0.1 stools (upper boundary of the 98.75% CI, 0.8), both of which were below the noninferiority margin (2 stools). Vomiting within 30 minutes after administration occurred in 19.3%, 15.6%, and 13.7% of the patients in the 20-mg, 10-mg, and 5-mg groups, respectively; the risk was significantly lower in the 10-mg group than in the 20-mg group (relative risk, 0.81; 97.5% CI, 0.67 to 0.96) and in the 5-mg group than in the 20-mg group (relative risk, 0.71; 97.5% CI, 0.59 to 0.86). Lower doses were also associated with less vomiting beyond 30 minutes after administration.
Lower doses of zinc had noninferior efficacy for the treatment of diarrhea in children and were associated with less vomiting than the standard 20-mg dose.
The New England Journal of Medicine：《新英格兰医学杂志》，创刊于1812年。隶属于美国麻省医学协会，最新IF：70.67