摘要
目的探讨不同剂量复方藏茴香肠溶液体胶囊对功能性消化不良（FD）的疗效性和安全性。方法从全国7个中心纳入2011年7月至2013年11月符合罗马Ⅲ标准的FD患者228例，分为高剂量、低剂量和安慰剂组，每组各76例。受试者于基线期（1～2周）、治疗2周、治疗4周和停药后随访2周时接受4次访视，评价症状积分、生命质量和安全性。采用单因素方差分析、Wilcoxon秩和检验、卡方检验进行比较。结果最终纳入198例符合方案者进行疗效评价，高剂量组67例，低剂量组66例，安慰剂组65例。228例受试者均纳入安全性评估。治疗2周、治疗4周和停药后随访2周时，高剂量组、低剂量组症状总积分均低于安慰剂组[治疗2周：14．57±6．12，13．68±6．57比18．92±9．54，F=9．051，P〈0．01。治疗4周：7．39±5．73，7．18±5．43比15．42±10．35，F=25．750，P〈0．01。停药后随访2周：2．50（1．00，7．00），3．00（1．00，6．00）比14．。（8．00，19．00），Z=57．904，P〈0．01]，餐后不适综合征和上腹痛综合征亚组症状总积分亦低于安慰剂组（F=5．761、10．998、30．159、4．571、14．758、27．162，P均〈0．05），高剂量组和低剂量组症状总积分及各亚组症状总积分比较，差异无统计学意义（P均〉0．05）。治疗2周、治疗4周和停药后随访2周时，低剂量组和高剂量组对餐后饱胀不适（F：5．139、14．309、19．111）、早饱（F=5．480、13．709、26．287）和上腹痛（F=1．169、9．224、24．142）、上腹部烧灼感（F一0．156、4．225、15．770）的疗效均优于安慰剂组（P均〈0．05），而高剂量组和低剂量组比较，差异均无统计学意义（P均〉0．05）。与基线期比较，治疗4周高剂量组、低剂量组和安慰剂组生命质量差异均无统计学意义（P均〉0．05）。不良反应主要包括肝功能和血脂轻度异常，3组不良反应�
Objective To evaluate efficacy and safety of enteroplant in the treatment of patients with functional dyspepsia （FD）. Methods From July 2011 to November 2013, 228 patients met Rome 111 criteria were enrolled and divided into high dose, low dose and placebo groups. The assessment of symptoms score, life quality and safety of subjects was conducted at baseline period （one to two weeks）, week two of treatment, week four of treatmeat and week two of follow-up. Single factor analysis of variance, Wileoxon test and X2 test were used for comparing the differences among three groups. Results The efficacy evaluation was conducted in 198 patients conformed to the protocol, 67 patients in high dose group, 66 patients in low dose group, and 65 patients in placebo group. All the 228 patients received safety evaluation. At week two, four of treatment and week two of follow-up, the total symptom scores of high dose group, low dose group were lower than those of placebo group （week two of treatment 14. 574-6.12,13. 684-6.57 vs 18.92_--4-9.54,F=9. 051,P〈0.01~week four of treatment 7. 394-5.73,7.18-t-5.43 vs 15. 424-10.35,F=25. 750,P〈0.01） week two of follow-up was 2.50 （1.00,7.00）,3.00（1.00,6.00） vs 14.00（8.00,19.00）,Z=57. 904,P〈0.01）. The above scores as well as scores of postprandial discomfortable syndrome （postprandial fullness, early satiety） and upper abdominal pain syndrome （epigastric pain, epigastric buring） of high dose group and low dose group were all lower than those of placebo group （F^5. 761, 10. 998, 30. 159, 4. 571, 14. 758, 27. 162,all P〈0. 05）. However, there was no significant difference between low dose group and high dose group in the total symptom scores and subtype symptom scores （P〉0. 05）. At week two, four of treatment and week two of follow-up, the efficacy of postprandial fullness discomfort （F= 5. 139,14. 309,19. 111）, early satiation （F= 5. 480,13. 709,26. 287）, upper abdominal pain （F = 1. 169,9. 224,24. 142 ） and buring （F= 0.156 , 4
出处
《中华消化杂志》
CAS
CSCD
北大核心
2016年第5期319-324,共6页
Chinese Journal of Digestion
关键词
藏茴香
功能性消化不良
餐后不适综合征
上腹疼痛综合征
Enteroplant
Functional dyspepsia
Postprandial distress syndrome
Epigastric pain syndrome
