摘要
目的 评价国产乌司他丁 (尿抑制素 ,Ulinastatin)治疗急性胰腺炎病人的疗效和不良反应 ,及该药对急性出血坏死型胰腺炎的临床疗效。方法 采用多中心随机对照研究 ,按是否出血坏死型随机分为试验组和对照组 ,并分别接受乌司他丁和甲磺酸加贝酯或奥曲肽治疗 ,并进行随访。临床症状及体征按无、轻、中、重度不同分为 4级 ,实验室指标包括血淀粉酶、肝功能、血常规、血糖、血钙、肾功能、血pH及氧饱和度等。按痊愈、显效、有效和无效四级评定疗效。记录治疗中出现的全部不良事件。结果 自 2 0 0 0年 4月～ 7月共有 94例急性胰腺炎患者进入本研究。其中男 5 0例 ,女 44例 ;轻型 6 8例 ,重型 2 6例。根据入选和排除标准以及研究设计 ,共有 7例剔除。最终共有 87例患者进入研究和分析。结果显示 ,乌司他丁用于治疗急性水肿型胰腺炎 ,总有效率达 10 0 .0 % ,痊愈率达 83.3% ,略高于对照组加贝酯 (71.4% ) ,但差异无显著性 (P >0 .0 5 )。腹痛、上腹胀等症状均能在 3～ 5d内基本缓解或消失。乌司他丁用于治疗急性出血坏死型胰腺炎 ,总有效率与奥曲肽相似 (78.6 %比 81.9% ,P =0 .840 )。治疗出血坏死型胰腺炎出现的并发症主要为假性囊肿。仅 1例丙氨酸转氨酶轻度升高 ,未发现过敏、皮疹。
Objective To assess the effectiveness of ulinastatin in the treatment of patients with acute edematic pancreatitis(AEP) and acute hemorragic and necrotic pancreatitis(AHNP). Methods Multi center randomized clinical trial was performed. Patients were randomly alloccated into the treatment group(with ulinastatin) and control group(with cabexate or sandostatin) which were stratified by AHNP or AEP. Clinical symptoms and signs were scored as none,mild,moderate and severe. Laboratory tests were included as serum amylase,liver function,blood RT,FBG,Ca 2+ , renal function, blood pH and SaO 2. Clinical results were assessed as cured,significant effective, effective and non effective. All the side effects were recorded during the whole process. Results From April 2000 to July 2000,totally 94 acute pancreatitis patients were enrolled (male 50,female 40). Among them,68 cases were mild,26 cases were severe. The study showed that total effectiveness of ulinastatin in treating acute pancreatitis was 100%,while the cured rate was 83.3%,a little bit higher than control group with cabexate(71.4%),but no statistical significance existed. Clinical symptoms such as abdominal pain,fullness almost disappeared within 3～5 days. Total effectiveness of ulinastatin in treating AHNP was similar as that of sandostatin(78.6% vs 81.9%, P =0.840). The main complication after treating AHNP was pancreatic pseudocyst. Only one case showed increase of ALT. No side effects of hypersensitivity,skin rash,WBC decrease were noted. Safety had been proved by monitoring of liver and renal function,eletrolytes and blood RT. Conclusions Ulinastatin showed effectiveness in treating AEP and AHNP with fewer side effects.
出处
《中华消化杂志》
CAS
CSCD
北大核心
2001年第5期293-296,共4页
Chinese Journal of Digestion
