近日，巴基斯坦阿迦汗大学Fyezah Jehan团队比较了阿莫西林与安慰剂治疗非严重肺炎的疗效。该研究于2020年7月2日发表在《新英格兰医学杂志》上。

世界卫生组织（WHO）建议对患有呼吸急促性肺炎的患者口服阿莫西林，但试验数据表明，在这种情况下，不使用阿莫西林疗效似乎也不逊色。

研究组在巴基斯坦卡拉奇的低收入社区的初级卫生保健中心进行了一项涉及儿童的双盲，随机，安慰剂对照、非劣效性试验。2014年11月9日至2017年11月30日，研究组招募了4002名2-59个月的儿童，符合WHO的非严重肺炎伴呼吸急促标准，将其随机分组，其中2003名患儿接受阿莫西林混悬液治疗，1999名接受安慰剂治疗，均为期3天。预先确定的非劣效性界限为1.75个百分点。

在按方案分析中，安慰剂组的治疗失败率为4.9%，阿莫西林组为2.6%，组间差异为2.3个百分点。意向治疗分析的结果相似。发烧和喘息的存在预示着治疗失败。为预防一次治疗失败所需治疗的人数为44例。每组中各有一名患儿（<0.1%）死亡。安慰剂组中有40名儿童（2.2%）复发，阿莫西林组有58名（3.1%）。

结果表明，在5岁以下的非严重肺炎患儿中，安慰剂组的治疗失败率显著高于阿莫西林组，不符合非劣效性标准。

附：英文原文

Title: Randomized Trial of Amoxicillin for Pneumonia in Pakistan

Author: Fyezah Jehan, M.B., B.S.,, Imran Nisar, M.B., B.S.,, Salima Kerai, M.Sc.,, Benazir Balouch, M.B., B.S., M.B.A.,, Nick Brown, M.Sc.,, Najeeb Rahman, B.Sc.,, Arjumand Rizvi, M.Sc.,, Yasir Shafiq, M.Sc.,, and Anita K.M. Zaidi, M.B., B.S.

Issue&Volume: 2020-07-01

Abstract: BACKGROUND

The World Health Organization (WHO) recommends oral amoxicillin for patients who have pneumonia with tachypnea, yet trial data indicate that not using amoxicillin to treat this condition may be noninferior to using amoxicillin.

METHODS

We conducted a double-blind, randomized, placebo-controlled noninferiority trial involving children at primary health care centers in low-income communities in Karachi, Pakistan. Children who were 2 to 59 months of age and who met WHO criteria for nonsevere pneumonia with tachypnea were randomly assigned to a 3-day course of a suspension of amoxicillin (the active control) of 50 mg per milliliter or matched volume of placebo (the test regimen), according to WHO weight bands (500 mg every 12 hours for a weight of 4 to <10 kg, 1000 mg every 12 hours for a weight of 10 to <14 kg, or 1500 mg every 12 hours for a weight of 14 to <20 kg). The primary outcome was treatment failure during the 3-day course of amoxicillin or placebo. The prespecified noninferiority margin was 1.75 percentage points.

RESULTS

From November 9, 2014, through November 30, 2017, a total of 4002 children underwent randomization (1999 in the placebo group and 2003 in the amoxicillin group). In the per-protocol analysis, the incidence of treatment failure was 4.9% among placebo recipients (95 of 1927 children) and 2.6% among amoxicillin recipients (51 of 1929 children) (between-group difference, 2.3 percentage points; 95% confidence interval [CI], 0.9 to 3.7). Results were similar in the intention-to-treat analysis. The presence of fever and wheeze predicted treatment failure. The number needed to treat to prevent one treatment failure was 44 (95% CI, 31 to 80). One patient (<0.1%) in each group died. Relapse occurred in 40 children (2.2%) in the placebo group and in 58 children (3.1%) in the amoxicillin group.

CONCLUSIONS

Among children younger than 5 years of age with nonsevere pneumonia, the frequency of treatment failure was higher in the placebo group than in the amoxicillin group, a difference that did not meet the noninferiority margin for placebo.

DOI: 10.1056/NEJMoa1911998

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1911998