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低剂量锌治疗儿童腹泻的效果不逊于标准剂量

本期文章:《新英格兰医学杂志》:Vol.383 No.13

世界卫生组织青少年健康与老龄化部Jonathon Simon团队研究了低剂量锌治疗儿童腹泻的疗效。2020年9月24日,该研究发表在《新英格兰医学杂志》上。

世界卫生组织建议急性腹泻儿童每天服用20mg锌,持续10到14天。在以前的试验中,该剂量可减少腹泻但增加了呕吐。

研究组在印度和坦桑尼亚招募了4500名6至59个月大、患有急性腹泻的儿童,将其随机分配,分别接受5mg、10mg或20mg硫酸锌治疗14天。三个主要结局是腹泻持续时间超过5天、大便次数、以及服用锌后30分钟内的呕吐发生率。

20mg组中腹泻超过5天的儿童占6.5%,10mg组中为7.7%,5mg组中为7.2%。20mg和10mg组间的差异为1.2个百分点,而20mg和5mg组间的差异为0.7个百分点,均低于4个百分点的非劣效性边缘。

20mg组的腹泻大便平均10.7次,10mg组为10.9次,5mg组为10.8次。20mg和10mg组间的差异为0.3次大便,20mg和5mg组间的差异为0.1次大便,均低于2次大便的非劣效性边缘。

20mg、10mg和5mg组的患者在服药后30分钟内呕吐的发生率分别为19.3%、15.6%和13.7%。10mg组的风险显著低于20mg组,5mg组的风险亦显著低于20mg组。给药30分钟后,较低剂量组呕吐较少。

总之,低剂量锌治疗儿童腹泻的效果不逊于标准的20mg剂量,且呕吐较少。

附:英文原文

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.

Issue&Volume: 2020-09-23

Abstract:

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

DOI: 10.1056/NEJMoa1915905

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1915905

期刊信息

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
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