目的 系統(tǒng)評(píng)估兒童功能性腹痛藥物臨床試驗(yàn)的設(shè)計(jì)要素，通過標(biāo)準(zhǔn)化試驗(yàn)設(shè)計(jì)，為不同試驗(yàn)結(jié)果的比較提供一定的可行性。方法 檢索PubMed、Cochrane以及EMBASE數(shù)據(jù)庫，納入兒童功能性腹痛的隨機(jī)對(duì)照臨床研究文獻(xiàn)，采用羅馬診斷標(biāo)準(zhǔn)，干預(yù)措施為藥物，語種為英文。結(jié)果 檢索出文獻(xiàn)561篇，最終納入14項(xiàng)研究，均以改善腹痛及其相關(guān)癥狀為主要試驗(yàn)?zāi)康?，其中改善腹?2項(xiàng)（85.71%）；均采用隨機(jī)、安慰劑對(duì)照、優(yōu)效性檢驗(yàn)，13項(xiàng)為雙盲，1項(xiàng)未提及，8項(xiàng)設(shè)計(jì)了樣本量估算，5項(xiàng)為多中心試驗(yàn)；診斷采用羅馬Ⅱ標(biāo)準(zhǔn)4項(xiàng)（28.57%），羅馬Ⅲ標(biāo)準(zhǔn)10項(xiàng)（71.43%）；干預(yù)措施依次為益生菌9項(xiàng)（64.29%）、抗抑郁藥2項(xiàng)（14.29%），以及抗過敏藥、解痙藥、促胃腸動(dòng)力藥各1項(xiàng)（各占7.14%）；6項(xiàng)設(shè)計(jì)了導(dǎo)入期，時(shí)長(zhǎng)為1~4周；療程為2周1項(xiàng)（7.14%），4周10項(xiàng)（71.43%），8周2項(xiàng)（14.29%），12周1項(xiàng)（7.14%）；10項(xiàng)設(shè)計(jì)了隨訪，時(shí)長(zhǎng)為4周~6個(gè)月；5項(xiàng)（35.71%）的主要有效性指標(biāo)為腹痛程度和據(jù)此定義的治療成功或應(yīng)答，4項(xiàng)（28.57%）為腹痛程度、頻率，3項(xiàng)（21.43%）為腹痛程度、頻率和持續(xù)時(shí)間，2項(xiàng)為基于量表的癥狀改善情況；腹痛評(píng)價(jià)，采用面部表情量表法（WBS或FPS）9項(xiàng)（64.29%），視覺模擬評(píng)分量表（VAS）或疼痛數(shù)字評(píng)分法（NRS-11）5項(xiàng)（35.71%），同時(shí)采用VAS和FPS1項(xiàng)（7.14%）。全部研究的主要安全性指標(biāo)均為不良事件的發(fā)生率。結(jié)論 納入研究的文獻(xiàn)信息完善、質(zhì)量較高，結(jié)果涵蓋了兒童功能性腹痛臨床研究設(shè)計(jì)的基本要素，具有一定的借鑒價(jià)值。

Objective To systematically evaluate the design points of clinical trials of children with functional abdominal pain, and to provide certain feasibility for comparison with different trail results through standardized trail design. Methods The PubMed, Cochrane and EMBASE databases were searched. Studies were included if it was a randomized controlled clinical study of children with functional abdominal pain. The Rome diagnostic criteria were used, the intervention was a drug and the language was English. Results A total of 561 articles were found and 14 were eventually included. All 14 studies were aimed at improving abdominal pain and related symptoms, including 12 (85.71%) cases of abdominal pain. All studies were randomized, placebo-controlled, and superiority trail. 13 items were double-blind, one item was not mentioned, eight items were designed for sample size estimation, and five items were multi-central trial; Roman Ⅱ standard was used for four (28.57%) items, Rome Ⅲ standard in 10 (71.43%) items; interventions followed by probiotics 9 (64.29%), antidepressants 2 (14.29%), and one item with antiallergic, antispasmodic and gastrointestinal motility drugs (7.14% each); six studies designed the introduction period, the duration was 1-4 weeks; the course of treatment was one (7.14%) item at 2 weeks, 10 (71.43%) item at 4 weeks, 2 (14.29%) items at 8 weeks and one (7.14%) item at 12 weeks; 10 studies designed follow-up with duration 4 weeks to 6 months; the main efficacy indicators of 5 (35.71%) items were the degree of abdominal pain and the treatment success or response based on it, 4 (28.57%) items were the degree and frequency of abdominal pain, 3 (21.43%) items were the degree, frequency and duration of abdominal pain, and 2 items were based on the improvement symptoms of the scale. In abdominal pain evaluation, 9 (64.29%) items were usd facial expression scale method (WBS or FPS), 5 (35.71%) items by visual analog scale score (VAS) or pain digital score method (NRS-11), and one (7.14%) item by using VAS and FPS 1. The main safety indicators for all studies were the incidence rate of adverse events. Conclusion The literature information included in the study is perfect and the quality is high. The results cover the basic elements of clinical research design of functional abdominal pain in children, and have certain reference value.