CAJ | 학술논문

目的：探析马来酸曲美布汀缓释片的用药特点，并进一步总结治疗功能性消化不良（ FD）的安全性以及耐受性，为临床用药提供更加科学的方案与依据。方法将130例FD患者按照随机数字表格法以1∶1比例分成2组各65例，观察组口服马来酸曲美布汀缓释片1片／次，2次／d；对照组口服马来酸曲美布汀片2片／次，3次／d。观察评估2组治疗前及治疗2周后FD患者的症状，记录患者体温变化、呼吸、血压、脉搏，并行常规检查，包括尿常规、便隐血试验、肝功能与肾功能的检查，同时记录2组不良反应情况。并进行症状评分以及疗效评价。结果2组FD症状均有一定改善，2组症状积分评估均显示有所下降，但观察组FD症状积分下降更为明显，与对照组比较差异有统计学意义（P＜0．05）。观察组总有效率为82％，对照组为62％，观察组明显优于对照组（P＜0．05）。2组治疗后患者的体温、心率以及呼吸情况等指标未见明显变化，对照组中仅1例出现谷丙转氨酶升高现象，而余患者的心电图检查、肝肾功能等差异均无统计学意义。观察组不良反应发生率为0，对照组的不良反应发生率为2％，2组比较差异无统计学意义（ P＞0．05）。结论应用马来酸曲美布汀缓释片治疗功能性消化不良可以缓解其症状，近期疗效较为稳定，同时具有良好的安全性及耐受性，对临床用药有较好的指导意义，值得医院进一步推广应用。
목적：탐석마래산곡미포정완석편적용약특점，병진일보총결치료공능성소화불량（ FD）적안전성이급내수성，위림상용약제공경가과학적방안여의거。방법장130례FD환자안조수궤수자표격법이1∶1비례분성2조각65례，관찰조구복마래산곡미포정완석편1편／차，2차／d；대조조구복마래산곡미포정편2편／차，3차／d。관찰평고2조치료전급치료2주후FD환자적증상，기록환자체온변화、호흡、혈압、맥박，병행상규검사，포괄뇨상규、편은혈시험、간공능여신공능적검사，동시기록2조불량반응정황。병진행증상평분이급료효평개。결과2조FD증상균유일정개선，2조증상적분평고균현시유소하강，단관찰조FD증상적분하강경위명현，여대조조비교차이유통계학의의（P＜0．05）。관찰조총유효솔위82％，대조조위62％，관찰조명현우우대조조（P＜0．05）。2조치료후환자적체온、심솔이급호흡정황등지표미견명현변화，대조조중부1례출현곡병전안매승고현상，이여환자적심전도검사、간신공능등차이균무통계학의의。관찰조불량반응발생솔위0，대조조적불량반응발생솔위2％，2조비교차이무통계학의의（ P＞0．05）。결론응용마래산곡미포정완석편치료공능성소화불량가이완해기증상，근기료효교위은정，동시구유량호적안전성급내수성，대림상용약유교호적지도의의，치득의원진일보추엄응용。
Objective It is to approach the characteristics of medication in Trimebutine Maleate Sustained-Release Tab-lets, and further summarize the treatment of functional dyspepsia (FD) safety and tolerability, provide the scheme and the ba-sis for clinical use of more scientific.Methods 130 cases of functional dyspepsia patients according to the random number ta-ble method with a ratio of 1:1, were divided into two groups, the patients in observation group were treated with oral Trimebu-tine Maleate Sustained-Release Tablets, 1 tablets each time, twice a day;and in control group with oral Trimebutine Maleate Tablets, 2 tablets each time, Three times a day.Before treatment and after 2 weeks, the symptoms of the patients with FD were evaluated in two groups, and the body temperature, respiration, blood pressure patients, pulse recording, parallel routine examination, including urine, fecal occult blood, liver and renal function, and record the adverse reactions of two groups. And the symptom score and evaluation of curative effect were analyzed.Results The FD symptoms of two groups were some im-proved, symptom assessment were decreased, but FD symptom score in the observation group decreased more obviously, there was significant difference compared with the control group (P<0.05).The total effective rate of observation group was 82%, and 62%of control group, there was significant difference between the two groups (P<0.05).The body temperature, heart rate and breathing index did not change significantly after treatment in two groups, but only 1 case had elevated alanine amin-otransferase phenomenon in control group, while the rest of electrocardiogram, kidney function and so were no significant ab-normality.The incidence of adverse reaction was 0 in observation group, and 2% in control group, there was no significant difference (P>0.05).Conclusion The application of Trimebutine Maleate Sustained-Release Tablets in treatment of func-tional dyspepsia can alleviate the symptoms, has a recent curative effect of relatively stable, and has a good safety and tolera-bility, has good guidance for clinical treatment, worthy of further promotion for acute hospital.