中华儿科杂志
中華兒科雜誌
중화인과잡지
Chinese Journal of Pediatrics
2012年
10期
732-736
,共5页
酪酸梭菌二联活菌散剂预防肺炎儿童抗生素相关性腹泻研究协作组
酪痠梭菌二聯活菌散劑預防肺炎兒童抗生素相關性腹瀉研究協作組
락산사균이련활균산제예방폐염인동항생소상관성복사연구협작조
有益菌种%儿童%抗生素相关性腹泻
有益菌種%兒童%抗生素相關性腹瀉
유익균충%인동%항생소상관성복사
Probiotics%Child%Antibiotic-Associated diarrhea
目的 评价酪酸梭菌二联活菌散剂预防肺炎住院儿童抗生素相关性腹泻(AAD)的疗效和安全性.方法 采用前瞻性、多中心、中心分层区组随机、空白对照的临床试验方法,纳入380例年龄3个月～3岁、因肺炎于2011年4-12月期间全国7家三级医院住院患儿.372例完成研究,其中对照组179例接受常规抗生素治疗,试验组193例在抗生素治疗基础上,加用酪酸梭菌二联活菌散剂(2袋/次,2次/d;日摄入活菌量5×109CFU/d,连续服用7d).每日观察记录大便次数,根据Bristol粪便评估量表评价粪便性状,统计腹泻发生率和药物相关不良反应.结果 两组患儿一般资料可比性好(P＞0.05),入组前及入组以后抗生素使用种类、途径、时间差异无统计学意义(P＞0.05).观察7d内试验组AAD发生率为7.8％ (13/193),对照组为16.8％ (30/179),两组差异有统计学意义,与对照组比较,试验组发生AAD的风险下降了53.6％(RR=0.419,95％ CI 0.217～0.808;P =0.008)；治疗组AAD发生时问分布较对照组存在显著差异(P=0.008)；观察期间未见药物相关不良反应.结论 酪酸梭菌二联活菌散剂可有效降低肺炎住院患儿发生AAD的风险,未发现其不良反应.
目的 評價酪痠梭菌二聯活菌散劑預防肺炎住院兒童抗生素相關性腹瀉(AAD)的療效和安全性.方法 採用前瞻性、多中心、中心分層區組隨機、空白對照的臨床試驗方法,納入380例年齡3箇月～3歲、因肺炎于2011年4-12月期間全國7傢三級醫院住院患兒.372例完成研究,其中對照組179例接受常規抗生素治療,試驗組193例在抗生素治療基礎上,加用酪痠梭菌二聯活菌散劑(2袋/次,2次/d;日攝入活菌量5×109CFU/d,連續服用7d).每日觀察記錄大便次數,根據Bristol糞便評估量錶評價糞便性狀,統計腹瀉髮生率和藥物相關不良反應.結果 兩組患兒一般資料可比性好(P＞0.05),入組前及入組以後抗生素使用種類、途徑、時間差異無統計學意義(P＞0.05).觀察7d內試驗組AAD髮生率為7.8％ (13/193),對照組為16.8％ (30/179),兩組差異有統計學意義,與對照組比較,試驗組髮生AAD的風險下降瞭53.6％(RR=0.419,95％ CI 0.217～0.808;P =0.008)；治療組AAD髮生時問分佈較對照組存在顯著差異(P=0.008)；觀察期間未見藥物相關不良反應.結論 酪痠梭菌二聯活菌散劑可有效降低肺炎住院患兒髮生AAD的風險,未髮現其不良反應.
목적 평개락산사균이련활균산제예방폐염주원인동항생소상관성복사(AAD)적료효화안전성.방법 채용전첨성、다중심、중심분층구조수궤、공백대조적림상시험방법,납입380례년령3개월～3세、인폐염우2011년4-12월기간전국7가삼급의원주원환인.372례완성연구,기중대조조179례접수상규항생소치료,시험조193례재항생소치료기출상,가용락산사균이련활균산제(2대/차,2차/d;일섭입활균량5×109CFU/d,련속복용7d).매일관찰기록대편차수,근거Bristol분편평고량표평개분편성상,통계복사발생솔화약물상관불량반응.결과 량조환인일반자료가비성호(P＞0.05),입조전급입조이후항생소사용충류、도경、시간차이무통계학의의(P＞0.05).관찰7d내시험조AAD발생솔위7.8％ (13/193),대조조위16.8％ (30/179),량조차이유통계학의의,여대조조비교,시험조발생AAD적풍험하강료53.6％(RR=0.419,95％ CI 0.217～0.808;P =0.008)；치료조AAD발생시문분포교대조조존재현저차이(P=0.008)；관찰기간미견약물상관불량반응.결론 락산사균이련활균산제가유효강저폐염주원환인발생AAD적풍험,미발현기불량반응.
Objective Many previous meta-analysis have shown that the probiotics can lower the incidence of antibiotic-associated diarrhea (AAD) in children.However,the function and efficacy of probiotics drugs showed obvious strains specificity and dose dependence.Currently,most of the reported meta-analysis regarding probiotics AAD prevention have adopted Saccharomyces,Lactobacilleae,Streptococcus and Bifidobacterium.This study aimed to evaluate the efficacy and safety of the live Clostridium butyricum and Bifidobacterium Powder to prevent AAD in hospitalized children with pneumonia.Method This study was a multicenter,randomized,controlled clinical trial; 380 hospitalized children with pneumonia aged from 3 months to 3 years were enrolled from April to Dec.2011.Totally 372 children completed the study,179 children in control group received antibiotics as routine treatment for pneumonia;193 children in treatment group received 5 × 109 colony-forming units of Clostridium butyricum and Bifidobacterium combined Powder daily for 7 days during the antibiotics treatment.The stool frequency and consistency (assessed according to the Bristol Excrement Assessment Scale) were observed for 7 consecutive days; the incidence of diarrhea and adverse drug reactions were recorded.Result Both treatment and control groups were similar in age distribution,sex,type of antibiotics,route of administration,and time of antibiotics used.During the 7 days period,the rate of AAD was 7.8％ (13/193) in treatment group and 16.8％ (30/179) in control group,there was significant differeuce; compared with the control group,the treatment with Clostridium butyricum and Bifidobacterium combined Powder can lead to 53.6％ reduction in AAD risk (RR =0.419,95 ％ CI 0.217-0.808;P =O.008).The severity of diarrhea was comparable in both study groups,as evidenced by similar stool frequency,dehydration,fever and vomiting.There was significant difference (P =0.008) in the AAD occurrence time distribution between the treatment group and control group.No drug related adverse reactions (ADRs) were found during the observation period.Conclusion The live Clostridium butyricum and Bifidobacterium combined Powder may effectively reduce the risk of AAD in hospitalized children with pneumonia,and no ADRs were found.
