国产奥沙拉秦钠胶囊治疗溃疡性结肠炎149例

目的 验斑点国产奥沙拉秦钠胶囊治疗轻、中度溃疡性结肠炎（活动期）的治疗效果，比较国产奥沙拉秦钠胶囊与水杨酸柳氮磺胺吡啶（SASP）对轻、中度溃疡性结肠炎（活动期）的疗效和不良反应。方法 采用多中心随机双盲对照验证107例轻、中度溃疡性结肠炎（活动期）的疗效和不良反应。同时，治疗42例作为开放组，疗程为8周。结果 国产奥沙拉秦钠胶囊的总有效率达84.6%，双盲组中，其临床完全缓解率、内镜完全缓解率和组织学完全缓解率在治疗8周后均比治疗前明显改善，分别各自达75.00%，34.62%，55.77%，其疗效与开放组和对照组SASP均类同。国产奥沙拉秦钠胶囊不良反应主要为腹泻。结论 国产奥沙拉秦钠胶囊治疗活动期轻、中度溃疡性结肠炎有效，其结果与SASP相当，主要不良反应为腹泻，宜与控制腹泻药物合用。     

奥沙拉秦钠胶囊联合硫糖铝片治疗46例溃疡性结肠炎的临床疗效观察

目的：以药物联合应用治疗溃疡性结肠炎的基础理论为指导,研究奥沙拉秦钠胶囊联合硫糖铝片治疗溃疡性结肠炎的临床疗效,为选择安全及有效的治疗溃疡性结肠炎的药物及方法提供科学依据。方法：将46例经本院检查确诊为溃疡性结肠炎的患者分为实验组和对照组,每组23例,实验组以奥沙拉秦钠胶囊联合硫糖铝片进行治疗,对照组以奥沙拉秦钠胶囊进行治疗,记录患者治疗前后的临床症状变化,分析药物的疗效,并对试验结果进行统计学分析。结果：实验组与对照组治疗效果差异有统计学意义（P〈0.05）,不良反应发生率差异无统计学意义（P〉0.05）。结论：奥沙拉秦钠胶囊联合硫糖铝片治疗溃疡性结肠炎的疗效确切,使以往单一口服药物效果不明显的溃疡性结肠炎患者临床症状明显改善。     

3种药物治疗轻中度溃疡性结肠炎的成本-效果比较

目的比较柳氮磺吡啶、美沙拉嗪和奥沙拉秦钠治疗轻、中度溃疡性结肠炎的成本 效果。方法将62例门诊轻、中度溃疡性结肠炎患者随机分为3组，A组21例给予柳氮磺吡啶片餐后口服，每次1.0 g，qid；B组22例给予美沙拉嗪缓释颗粒剂餐中口服，每次1.0 g，qid；C组19例给予奥沙拉秦钠胶囊餐中口服，每次1.0 g，tid。疗程均为4周。并运用药物经济学原理进行成本 效果分析。结果柳氮磺吡啶、美沙拉嗪和奥沙拉秦钠治疗轻、中度溃疡性结肠炎的成本－效果比(C/E)分别为17.47，28.14和21.20；美沙拉嗪和奥沙拉秦钠的增量成本－效果比(ΔC/ΔE)分别为48.96和27.77。结论奥沙拉秦钠是溃疡性结肠炎的较佳治疗药物。     

美沙拉嗪颗粒联合培菲康胶囊治疗溃疡性结肠炎的临床观察

目的观察联合应用美沙拉嗪颗粒和培菲康胶囊治疗轻、中度溃疡性结肠炎的临床疗效。方法选择66例轻、中度结肠炎患者，随机分为治疗组34例，对照组32例。治疗组口服美沙拉嗪颗粒1g，4次／d，同时加服培菲康胶囊2粒，3次／d，对照组口服美沙拉嗪颗粒1g，4次／d，疗程8周。分别统计2组完全缓解、有效、无效病例数以及有效率。结果治疗组完全缓解26例（76．47％），有效8例（23．53％），无效0例。对照组治愈16例（50．00％），有效16例（50．00％），两组分别进行样本均数比较的χ^2检验，治疗组和对照组相比，差异有统计学意义（P〈0．05）。结论联合应用美沙拉嗪颗粒和培菲康胶囊比单独应美沙拉嗪颗粒治疗轻中度溃疡性结炎具有更好的临床疗效，能更好地改善患者的临床症状。     

双歧三联活菌联合美沙拉嗪治疗轻中度溃疡性结肠炎疗效分析

目的观察双歧三联活菌联合美沙拉嗪治疗轻、中度溃疡性结肠炎的临床疗效。方法将符合诊断标准的86例轻、中度溃疡性结肠炎患者分为两组,联合用药组46例给予双歧三联活菌胶囊和美沙拉嗪治疗,对照组40例单独给予美沙拉嗪治疗,观察两组治疗后疗效。结果两组治疗后联合用药组临床疗效显著优于对照组,临床症状、DAI及内镜下评分变化较对照组更为显著（P〈0．05）。结论双歧三联活菌联合美沙拉嗪治疗轻、中度溃疡性结肠炎疗效优于单独应用美沙拉嗪,且患者耐受性好,不良反应少,值得推广应用。     

奥沙拉嗪治疗溃疡性结肠炎的缶床疗效探讨

目的探讨奥沙拉嗪用于治疗溃疡性结肠炎的临床临床疗效。方法2011年1月～2013年10月期间收治溃疡性结肠炎患者220例,随机分为观察组（121例）和对照组（99例）,观察组应用奥沙拉嗪进行治疗,对照组应用柳氮磺胺吡啶进行治疗,对比分析两组的临床疗效。结果观察组的临床治疗总有效率为96．7％,显著高于对照组的80.8％,差异有统计学意义（x^2=12．663,P〈0．05）;观察组的不良反应率为3．姒,显著低于对照组的18．2％,差异有统计学意义（x^2=11．569,P〈0．05）。结论奥沙拉嗪用于治疗溃疡性结肠炎疗效显著优于柳氮磺胺吡啶,且不良反应较少,值得在临床中推广应用。     

微生态制剂联合美沙拉嗪治疗20例溃疡性结肠炎的临床观察

目的:观察微生态制剂(培菲康)联合美沙拉嗪缓释颗粒治疗溃疡性结肠炎患者的临床疗效。方法:选择肠镜确诊的活动期溃疡性结肠炎(轻、中度)的住院患者38例,随机分为治疗组20例和对照组18例,治疗组采用美沙拉嗪联合培菲康治疗;对照组采用美沙拉嗪治疗,观察两组患者治疗8周后的疗效。结果:治疗组完全缓解14例,有效6例,100%有效;对照组完全缓解7例,有效7例,总有效率77.8%。结论:美沙拉嗪联合培菲康治疗溃疡性结肠炎疗效更好。     

国产奥沙拉嗪治疗溃疡性结肠炎的临床观察

目的观察国产奥沙拉嗪钠胶囊治疗活动期中、轻度溃疡性结肠炎的疗效及不良反应。方法以2004年6月至2008年12月在阳新县人民医院UC患者72为观察对象,随机分为观察组和对照组各36例,对照组给予奥沙拉嗪口服,1g,3次／d。对照组给予柳氮磺胺吡啶片口服,初剂量为2～3g／d,分3—4次口服,渐增至4～6g／d。疗程8周。在治疗前和治疗8周末进行内镜检查和组织学评价,以评估UC病变改善情况。用药期间记录症状变化及药物不良反应。结果治疗8周末,观察组总有效率86．1％,对照组总有效率77．8％,两组无统计学意义（P〉0．05）。内镜检查和组织学检查均比治疗前明显减轻,但两组比较差异无统计学意义（P〉0．05）。观察组与对照组不良反应发生率分别为8．3％,19．4％,差异有统计学意义（P〈0．05）。结论奥沙拉嗪钠胶囊治疗溃疡性结肠炎与柳氮磺胺吡啶片疗效相似,不良反应轻。     

美沙拉嗪联合双歧三联活菌治疗溃疡性结肠炎的疗效观察

目的:评价美沙拉嗪联合双歧三联活菌治疗溃疗性结肠炎(UC)的临床疗效。方法:选择66例轻、中度UC患者,随机分为2组:治疗组33例,口服美沙拉嗪肠溶胶囊联合双歧三联活菌胶囊;对照组33例,口服美沙拉嗪肠溶胶囊。分别统计2组总有效率、完全缓解、有效及无效病例数。结果:2组总有效率均为93.94%,但治疗组的72.73%完全缓解率明显优于对照组的51.52%(P<0.05),且未见明显不良反应。结论:在治疗轻、中度UC中,美沙拉嗪联合双歧三联活菌临床疗效优于单用美沙拉嗪,完全缓解率高。     

三种氨基水杨酸制剂治疗溃疡性结肠炎的安全性和有效性研究

目的观察美沙拉嗪、奥沙拉嗪和柳氮磺吡啶治疗溃疡性结肠炎的临床疗效和不良反应。方法选择120例轻中度溃疡性结肠炎患者,随机分为美沙拉嗪组（n=40）、奥沙拉嗪组（n=39）和柳氮磺吡啶组（n=41）,分别接受上述三种药物治疗。美沙拉嗪组和奥沙拉嗪组患者口服药物剂量均为每次1．0g,每日3次;而柳氮磺吡啶组患者服用剂量为每次1．0g,每日4次。治疗12周后观察治疗疗效和不良反应发生情况。结果美沙拉嗪组、奥沙拉嗪组和柳氮磺吡啶组临床有效率分别为30．0％、28．2％和51．2％,总有效率分别为75．0％、76．9％和92．7％。柳氮磺吡啶组疗效优于美沙拉嗪组、奥沙拉嗪组（P〈0．05）。结论与美沙拉嗪、奥沙拉嗪相比,柳氮磺吡啶治疗溃疡性结肠炎有效性更高,但不良反应发生率稍高。     

Olsalazine versus mesalazine in the treatment of mild to moderate ulcerative colitis

Aim:

To compare the efficacy and tolerability of olsalazine sodium with enteric-coated mesalazine in inducing endoscopic remission in patients with mild to moderate active ulcerative colitis.

Patients and methods:

Patients with mild to moderate active ulcerative colitis were randomized to receive either olsalazine sodium, 3 g/day (n = 88), or mesalazine, 3 g/day (n = 80), for up to 12 weeks.

Results:

Of the patients treated with olsalazine sodium, 52.2% achieved endoscopic remission, compared with 48.8% of patients treated with mesalazine. This difference was not significant (P = 0.67). There was a non-significant trend for patients with left-sided colitis or a more severe endoscopic grade to achieve remission if they were treated with olsalazine sodium than if they were treated with mesalazine. Both treatments were comparable with respect to clinical activity index and an investigator’s global assessment. Seventy patients reported one or more adverse events; adverse events were seen in 45% of olsalazine sodium-treated patients and in 36% of mesalazine-treated patients. Eleven patients treated with olsalazine sodium and nine patients treated with mesalazine withdrew from the study because of adverse events. One patient treated with olsalazine sodium compared with two treated with mesalazine stopped treatment because of diarrhoea. Serious adverse events occurred in three patients treated with olsalazine sodium and in four treated with mesalazine.

Conclusion:

Therapeutic effectiveness and tolerance to the treatment did not differ between olsalazine sodium, 3 g/day, and mesalazine, 3 g/day, in inducing endoscopic remission in patients with mild to moderate active ulcerative colitis within 12 weeks of treatment.

     

Olsalazine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in inflammatory bowel disease.

Olsalazine (sodium azodisalicylate; azodisal sodium) is an anti-inflammatory agent designed to deliver its active moiety, mesalazine (5-aminosalicylic acid; mesalamine), to the colon while avoiding the adverse effects associated with the use of a sulfapyridine carrier. As a prodrug, olsalazine is an effective oral treatment for both active ulcerative colitis and for maintenance of disease remission and may possibly be of benefit in patients with Crohn's colitis. Findings from both short and long term noncomparative and comparative studies demonstrate that olsalazine 1 to 3g daily in divided doses improves clinical signs and symptoms of colitis in approximately 60 to 80% of patients with acute ulcerative colitis of mild to moderate severity. This improvement rate was similar to that obtained with sulfasalazine. Lower doses of olsalazine, usually 1g daily in divided doses, also maintained remission in patients with chronic ulcerative colitis. While olsalazine effectively delivers mesalazine to the colon, the prodrug itself increases net luminal water secretion and accelerates gastrointestinal transit of a meal. The resulting diarrhoea (occurring in approximately 17% of patients and resulting in withdrawal from therapy in 6% of patients) is distinguishable from that associated with inflammatory bowel disease by the high water content and the absence of blood. Olsalazine-induced diarrhoea usually occurred soon after initiation of olsalazine therapy or dosage increase, was more frequent with higher doses and was usually transient. Dosage reduction, increases in frequency of dosing and concomitant administration with food reduced the severity in many patients with persistent olsalazine-induced diarrhoea. With the exception of diarrhoea, olsalazine was generally well tolerated. Fewer than 14% of patients allergic to or intolerant of sulfasalazine had similar reactions to olsalazine. Olsalazine appears to be a suitable therapy for the treatment of first attacks as well as acute exacerbation of mild to moderate acute ulcerative colitis, and for the maintenance of remission in patients with chronic ulcerative colitis.     

奥沙拉嗪与柳氮磺吡啶治疗溃疡性结肠炎的临床对比研究

目的比较奥沙拉嗪和柳氮磺吡啶(SPAP)治疗溃疡性结肠炎(UC)的有效性及安全性。方法将来74例UC患者,随机分为观察组和对照组各37例,治疗组应用奥沙拉嗪,对照组使用SPAP治疗,观察两组疗效和不良反应。结果治疗组患者的总有效率显著高于对照组,差异有统计学意义(P<0.05);治疗组不良反应发生率为5.41%,低于观察组的27.03%,差异有统计学意义(P<0.05)。结论奥沙拉嗪是治疗UC安全、有效的药物,不良反应少,值得临床推广。     

柳氮磺吡啶加中药与单用柳氮磺吡啶在溃疡性结肠炎中的疗效比较

目的 :比较柳氮磺吡啶 (SASP)单用和加中药对溃疡性结肠炎 (UC)的疗效及不良反应。方法 :63例UC病人 ,随机分为治疗组 3 1例 ,给予SASP0 .5g,po,qid,另加中药治疗 ;对照组 3 2例给予SASP 0 .5g,po,qid。疗程均为 4wk ,比较 2组在临床症状、肠镜下、组织学方面的变化。结果 :2组在临床症状、肠镜下表现、组织学进步方面 (总有效率分别为 97%和 75 % ,90 %和 5 9% ,81 %和41 % ) ,经Ridit分析差异均有显著和非常显著意义(P <0 .0 5 ,P <0 .0 1 ,P <0 .0 1 )。结论 :SASP配合中药治疗UC疗效满意 ,不良反应小 ,较单用柳氮磺吡啶好     

经结肠治疗机联合柳氮磺胺吡啶治疗溃疡性结肠炎临床观察

目的:评价经结肠治疗机联合柳氮磺胺吡啶(SASP)治疗溃疡性结肠炎(UC)的疗效。方法:轻、中度溃疡性结肠炎共82例,随机分为经结肠治疗机加SASP治疗组(n=44)和SASP加中药灌肠对照组(n=38),评价治疗前后总的疗效、主要症状、肠镜的改变。结果:治疗组总有效率为90.91%,明显高于对照组(68.42%);腹痛、腹泻、黏液血便主要症状变化、肠镜对照两组间有统计学意义(P<0.05)。结论:经结肠治疗机联合SASP治疗UC比SASP加中药灌肠治疗效果好。     

巴柳氮治疗轻、中度溃疡性结肠炎24例

目的：观察巴柳氮胶囊治疗轻、中度溃疡性结肠炎(UC)的临床疗效和安全性。方法：采用随机、双盲、双模拟及阳性药物平行对照方案,将46例UC病人随机分为巴柳氮胶囊试验组(24例,6.75 g·d~(-1))和柳氮磺吡啶(SASP)对照组(22例,3 g·d~(-1)),疗程均为8 wk。对2组病人治疗前后的临床症状、肠镜检查及不良反应情况进行比较。结果：试验组总有效率为96%,明显高于对照组45%(P＜0.01)。试验组不良反应发生率低于对照组(4%比36%,P＜0.05)。结论：巴柳氮胶囊治疗轻、中度急性发作性溃疡性结肠炎是安全、有效的,适用于SASP耐受性差的UC病人。     

Mesalazine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in chronic inflammatory bowel disease

Mesalazine (5-aminosalicylic acid; mesalamine), the active moiety of sulphasalazine (salazosulfapyridine), is available in specially formulated oral and rectal forms for the treatment of active ulcerative colitis of mild to moderate severity and for maintenance therapy during disease remission. Tablets or capsules coated with acrylic-based resin and tablets containing microgranules coated with ethylcellulose deliver mesalazine to the distal small intestine and colon, thus avoiding the need for the carrier, sulphapyridine, which is responsible for many of the adverse effects associated with sulphasalazine. Since mesalazine is released in the small intestine from some coated preparations in contrast to sulphasalazine, these oral formulations have therapeutic potential in Crohn's disease. A limited number of therapeutic trials suggest that orally administered mesalazine 1.5 to 2.4g daily is of similar efficacy to sulphasalazine 2 to 3g daily in patients with mild to moderate ulcerative colitis. The efficacy of mesalazine enemas has been more widely investigated, a dose of 1 to 4g once daily being consistently more effective than placebo and apparently similar to enemas of prednisone 25mg or oral sulphasalazine 3g. Initial results suggest that mesalazine 4g enemas may be more effective than those containing hydrocortisone 100mg. Mesalazine and sulphasalazine in approximately equivalent oral dosages are similarly effective in maintaining remission in ulcerative colitis. Orally administered coated mesalazine is generally well tolerated by about 85% of patients allergic to or intolerant of sulphasalazine, the remainder experiencing similar reactions to both drugs. Adverse effects of mesalazine enemas are confined to local irritation and effects resulting from enema-tip insertion. Thus, orally administered coated mesalazine is a suitable alternative to sulphasalazine in the treatment of patients with mild to moderate active distal ulcerative colitis and for maintaining remission particularly in patients allergic to or intolerant of sulphasalazine. In patients who find enema therapy acceptable, mesalazine enemas are effective and well tolerated.     

Comparative pharmacokinetics of sulphasalazine and sulphapyridine after rectal and oral administration to patients with ulcerative colitis

Summary Rectal administration of sulphasalazine to patients with ulcerative colitis has recently been shown to have similar therapeutic activity but fewer side effects than oral treatment. The present study is a comparison of the pharmacokinetics of sulphasalazine (SASP) and its metabolite sulphapyridine (SP) after rectal and oral administration of SASP to 6 patients with ulcerative colitis. The areas under the concentration-time curves (AUC) and the maximum concentrations (C_max) of SASP and SP were significantly lower after rectal than oral administration of SASP (p<0.05). These findings support the view that the lower frequency of side effects after rectal administration of SASP may result from the lower plasma levels of SASP and SP.     

Sulphasalazine treatment and the colorectal mucosa-associated flora in ulcerative colitis

Aim: To study the influence of sulphasalazine treatment on the mucosa-associated bacterial flora of rectal biopsy tissue specimens in patients with ulcerative colitis.
Patients: Twenty-four patients had newly diagnosed active ulcerative colitis; 20 patients had acute relapse of ulcerative colitis (10 not taking maintenance sulphasalazine); (40 patients had quiescent ulcerative colitis; 21 not taking maintenance sulphasalazine). The influence of 3 weeks of sulphasalazine treatment on the mucosa-associated flora was studied in the patients presenting with active disease.
Results: Comparison of patients according to sulphasalazine usage revealed few differences in the mucosal flora. In patients with quiescent ulcerative colitis, Escherichia coli was found at lower counts in patients taking maintenance sulphasalazine; however, this effect was not evident in patients with active disease. Inconsistent changes in other facultatives were seen between the two active disease groups, particularly for a miscellaneous group of unidentified Gram-positive rods. Three patients, all receiving sulphasalazine, were colonized with Clostridium difficile, but this did not appear to influence their disease.
Conclusion: Sulphasalazine treatment in ulcerative colitis causes only minor disturbance to the populations of bacteria colonizing the colorectal mucosa.     

Comparative efficacy of coated, oral 5-aminosalicylic acid (Claversal) and sulphasalazine for maintaining remission of ulcerative colitis. International Study Group

The safety and efficacy of Claversal (coated, oral 5-aminosalicylic acid (5-ASA) 0.75 g/day) and sulphasalazine 1.5-2.0 g/day were compared for the maintenance treatment of ulcerative colitis in a 1-year double-blind trial. Three hundred and thirty-four patients, whose disease was controlled on a stable dose of sulphasalazine (1.5-2.0 g/day) for a 1-month pre-trial, entered the study. On entry, patients were assigned in a random manner to continue sulphasalazine or to switch to coated 5-ASA. One hundred and thirty-one patients in the coated 5-ASA group and 142 on sulphasalazine were analysed for efficacy. No significant difference was observed between treatments with respect to the cumulative rate of relapse. Over the 12 months, 30 (28%) of the coated 5-ASA patients versus 29 (23%) of those treated with sulphasalazine had an exacerbation of their disease (log rank test P = 0.7011). The incidence of drug-related adverse events and subsequent withdrawals was similar. The high incidence of side-effects usually associated with sulphasalazine was not observed, probably due to the fact that this population was tolerant of sulphasalazine pre-trial. Of the 37 patients who reported adverse events with previous sulphasalazine therapy, however, only two (8%) of the 24 experienced those events when randomized to coated 5-ASA while five (38%) of the 13 who continued on sulphasalazine reported those same events. Coated 5-ASA is a safe, effective therapy for maintaining ulcerative colitis in remission.