CAJ | 학술논문

目的通过大样本的前瞻性多中心随机对照试验，评价茵栀黄口服液对足月新生儿高间接胆红素血症的治疗效果及安全性。方法 2010年3月至9月期间16家医院收治的胆红素水平达到美国儿科学会指南的时龄-胆红素水平曲线第40百分位的足月儿，随机分为单纯光疗组(409例)、苯巴比妥联合光疗组（373例）和茵栀黄口服液联合光疗组（395例）。入组后立即开始药物治疗，并持续5d,一旦胆红素水平达到光疗水平则加用光疗。分别记录各组患儿的一般资料，比较治疗前、治疗72 h和治疗完成后的血清胆红素水平及胆红素水平的下降率，以及不同干预对光疗率的影响。比较各组不良反应的发生率。结果符合人选标准患儿共计1177例，男性707例(60.1％),汉族1119例(95.1％)。治疗前血清总胆红素平均为(282.0±70.9)μmol/L，最高为626 μmol/L。其中血清总胆红素水平在342 μmol/L～427μmol/L((20 mg/dl～25 mg/dl)的重度高胆红素血症186例，占15.8％；＞427 μmol/L(25 mg/dl)的极重度高胆红素血症30例，占2.5％。3组间治疗72 h的胆红素水平下降率差异没有统计学意义（F=2.89，P=0.056）。治疗完成后茵栀黄口服液组的胆红素水平下降率明显超过其他2组（F=5.55，P=0.004）。茵栀黄口服液组未接受光疗的比例显著高于苯巴比妥组和单纯光疗组(x2=47.38,P=0.000)。30例极重度高胆红素血症患儿，经过光疗或光疗联合药物治疗，虽未经换血，但均未出现神经系统症状。茵栀黄口服液联合光疗组有25.1％的患儿每天大便次数超过5次，该比例显著高于其他两组；皮疹的发生率高于苯巴比妥组，但是和单纯光疗组并没有显著差异。结论因黄疸入院的足月儿约18％是重度或极重度高胆红素血症。茵栀黄口服液联合光疗对于足月儿高间接胆红素血症具有较好的疗效，尽早服用茵栀黄口服液可以抑制胆红素水平进一步上升，使部分患儿避免光疗。应用茵栀黄口服液除大便次数增加和皮疹以外，未观察到其他严重不良反应。目的通過大樣本的前瞻性多中心隨機對照試驗，評價茵梔黃口服液對足月新生兒高間接膽紅素血癥的治療效果及安全性。方法 2010年3月至9月期間16傢醫院收治的膽紅素水平達到美國兒科學會指南的時齡-膽紅素水平麯線第40百分位的足月兒，隨機分為單純光療組(409例)、苯巴比妥聯閤光療組（373例）和茵梔黃口服液聯閤光療組（395例）。入組後立即開始藥物治療，併持續5d,一旦膽紅素水平達到光療水平則加用光療。分彆記錄各組患兒的一般資料，比較治療前、治療72 h和治療完成後的血清膽紅素水平及膽紅素水平的下降率，以及不同榦預對光療率的影響。比較各組不良反應的髮生率。結果符閤人選標準患兒共計1177例，男性707例(60.1％),漢族1119例(95.1％)。治療前血清總膽紅素平均為(282.0±70.9)μmol/L，最高為626 μmol/L。其中血清總膽紅素水平在342 μmol/L～427μmol/L((20 mg/dl～25 mg/dl)的重度高膽紅素血癥186例，佔15.8％；＞427 μmol/L(25 mg/dl)的極重度高膽紅素血癥30例，佔2.5％。3組間治療72 h的膽紅素水平下降率差異沒有統計學意義（F=2.89，P=0.056）。治療完成後茵梔黃口服液組的膽紅素水平下降率明顯超過其他2組（F=5.55，P=0.004）。茵梔黃口服液組未接受光療的比例顯著高于苯巴比妥組和單純光療組(x2=47.38,P=0.000)。30例極重度高膽紅素血癥患兒，經過光療或光療聯閤藥物治療，雖未經換血，但均未齣現神經繫統癥狀。茵梔黃口服液聯閤光療組有25.1％的患兒每天大便次數超過5次，該比例顯著高于其他兩組；皮疹的髮生率高于苯巴比妥組，但是和單純光療組併沒有顯著差異。結論因黃疸入院的足月兒約18％是重度或極重度高膽紅素血癥。茵梔黃口服液聯閤光療對于足月兒高間接膽紅素血癥具有較好的療效，儘早服用茵梔黃口服液可以抑製膽紅素水平進一步上升，使部分患兒避免光療。應用茵梔黃口服液除大便次數增加和皮疹以外，未觀察到其他嚴重不良反應。
목적 통과대양본적전첨성다중심수궤대조시험，평개인치황구복액대족월신생인고간접담홍소혈증적치료효과급안전성。방법 2010년3월지9월기간16가의원수치적담홍소수평체도미국인과학회지남적시령-담홍소수평곡선제40백분위적족월인，수궤분위단순광료조(409례)、분파비타연합광료조（373례）화인치황구복액연합광료조（395례）。입조후립즉개시약물치료，병지속5d,일단담홍소수평체도광료수평칙가용광료。분별기록각조환인적일반자료，비교치료전、치료72 h화치료완성후적혈청담홍소수평급담홍소수평적하강솔，이급불동간예대광료솔적영향。비교각조불량반응적발생솔。결과 부합인선표준환인공계1177례，남성707례(60.1％),한족1119례(95.1％)。치료전혈청총담홍소평균위(282.0±70.9)μmol/L，최고위626 μmol/L。기중혈청총담홍소수평재342 μmol/L～427μmol/L((20 mg/dl～25 mg/dl)적중도고담홍소혈증186례，점15.8％；＞427 μmol/L(25 mg/dl)적겁중도고담홍소혈증30례，점2.5％。3조간치료72 h적담홍소수평하강솔차이몰유통계학의의（F=2.89，P=0.056）。치료완성후인치황구복액조적담홍소수평하강솔명현초과기타2조（F=5.55，P=0.004）。인치황구복액조미접수광료적비례현저고우분파비타조화단순광료조(x2=47.38,P=0.000)。30례겁중도고담홍소혈증환인，경과광료혹광료연합약물치료，수미경환혈，단균미출현신경계통증상。인치황구복액연합광료조유25.1％적환인매천대편차수초과5차，해비례현저고우기타량조；피진적발생솔고우분파비타조，단시화단순광료조병몰유현저차이。결론인황달입원적족월인약18％시중도혹겁중도고담홍소혈증。인치황구복액연합광료대우족월인고간접담홍소혈증구유교호적료효，진조복용인치황구복액가이억제담홍소수평진일보상승，사부분환인피면광료。응용인치황구복액제대편차수증가화피진이외，미관찰도기타엄중불량반응。
Objective Alarge-scale prospective multicenter randomized controlled tial was conducted to evaluate the efficacy and safety of Yinzhihuang oral solution for the treatment of neonatal indirect hyperbilirubinemia in term newborn infants. Yinzhihuang oral solution is a herbal extract with the main components of Herba Artemisiae Scopariae, Scutellaria, Lonicera Japonica and Gardenia jasminoides. Methods A total of 16 hospitals participated in this study. From March to September 2010, the term infants whose bilirubin level ≥ 40 th percentile for age in hours were enrolled, except for those who received exchange transfusion or had signs of bilirubin encephalopathy. All the 1177 cases were divided randomly into three groups: phototherapy group (409 cases ), phenobarbital combined with phototherapy group (373 cases) and Yinzhihuang oral liquid combined with phototherapy group (395 cases). Phenobarbital and Yinzhihuang oral liquid was started once the infants participated the study, and persisted for 5 days. Phototherapy was added as soon as the bilirubin level reached the lowest threshold ( the threshold for infants at higher risk). The demographic data of infants in each group were recorded, the serum bilirubin level before treatment, after treatment for 72 hours and after the treatment completion were checked. The reduction rate of serum bilirubin and the phototherapy rate in different groups were compared. The adverse events were assessed as well. Results Of the total of 1177 cases, 707 (60. 1％ ) were male, 1119 cases (95. 1％ ) were of Han ethnicity. The average total bilirubin level before treatment was ( 282. 0 ± 70. 9) μmol/L and the highest level was 626 μmol/L The severe hyperbilirubinemia (total bilirubin level at 342 μmoL/L to 427 μmol/L) accounted for 15.8％ (186 cases), and the extremely severe hyperbilirubinemia (total bilirubin ＞427 μmol / L) accounted for 2. 5％ (30 cases). After treatment for 72 hours, the reduction of bilirubin was not significantly different among three groups ( F =2. 89, P =0. 056). After completion of treatment, the reduction rate of bilirubin in Yinzhihuang group was higher than that of the other two groups (F =5.55, P =0. 004). The rate of infants who did not receive phototherapy in Yinzhihuang group was higher than that in phenobarbital group (x2 =47. 38, P=0. 000). In Yinzhihuang group, more infants had bowel movements more than five times a day. The incidence of rashes was higher than that in phenobarbital group (P =0. 019), but no significant difference was found as compared with that in phototherapy group (P =0. 339). Conclusions About 18％ of the term infants who were admitted for jaundice had severe or extremely severe hyperbilirubinemia. Yinzhihuang oral solution combined with phototherapy is effective in bilirubin reduction. Early treatment with Yinzhihuang oral solution may inhibit further increase in bilirubin levels, reduce the phototherapy requirement.