Different therapy for different types of ulcerative colitis in China

AIM: To study the different therapy for different types of ulcerative colitis (UC) in China. METHODS: Among 102 UC patients, 42 chronic relapse type UC patients were randomly divided into olsalazine sodium treatment group (n=21) and SASP group (n=21). Clinical effects and safety were observed in the 2 groups. Forty-two first episode type UC patients were randomly divided into Heartleaf houttuynia herb treatment group (n=21) and SASP group (n=21). Clinical effects were observed in the 2 groups while ultrastructure of colonic mucosa, ICAM-1 and the pressure of distant colon were studied in Heartleaf houttuynia herb group. Eighteen patients (8 males, 10 females) with refractory UC and unresponsive to high-dose prednisolone and sulfasalazine therapy more than one month were treated with Kangshuanling (7200 U/d). Prednisolone was gradually stopped and sulfasalazine was maintained. Stool frequency, rectal bleeding, colonoscopy, general well-being, histology were observed and CD62p, CD63, CD54, Pgp-170 (flow cytometry), TXA2 (RIA), blood platelet aggregation rate and thrombosis length in vitro were assessed. RESULTS: In the 42 chronic relapse type UC patients, the overall clinical effects of olsalazine sodium group (complete remission in 16, improvement in 4, inefficiency in 1) were better than those of SASP group (complete remission in 10, improvement in 4, inefficiency in 7, P<0.05). Symptomatic remission of olsalazine sodium group (complete remission in 15, partial remission in 5, inefficiency in 1) was better than that of SASP group (complete remission in 10, partial remission in 5, inefficiency in 6, P<0.05). The colonoscopic remission of olsalazine sodium group(complete remission in 11, partial remission in 9, inefficiency in 1) was better than that of SASP group (complete remission in 7, partial remission in 8, inefficiency in 6, P<0.05). The histologic remission of olsalazine sodium group (complete remission in 13, partial remission in 7, inefficiency in in 1) was better than that of SASP group (complete remission in 6, partial remission in 10, inefficiency in 5, P<0.05). The side effects of gastrointestinal tract in olsalazine sodium group were less than those of SASP group except for frequency of watery diarrhea. No other side effects were observed in olsalazine sodium group while ALT increase, WBC decrease and skin eruption were observed in SASP group. Two patients relapsed in olsalazine sodium group while 8 cases relapsed in SASP group during the flow-up period (from six months to one year). In the 42 first episode type UC patients, the clinical effect of Heartleaf houttuynia herb group (complete remission in 20, 95.2%; improvement in 1, 4.8%) was better than that of SASP group (complete remission in 15, 72.4%, improvement in 5, 23.8%; inefficiency in 1, 3.8%, P<0.01). The time of stool frequency recovering to normal (5.6+/-3.3 d), and blood stool disappearance (6.7+/-3.8 d) and abdominal pain disappearance (6.1+/-3.5 d) in Heartleaf houttuynia herb group was all shorter than that in SASP group (9.5+/-4.9 d, 11.7+/-6.1 d, 10.6+/-5.3 d, P<0.01). Heartleaf houttuynia herb could inhibit the epithelial cell apoptosis of colonic mucous membrane and the expression of ICAM-1 (45.8+/-5.7% vs 30.7+/-4.1%, P<0.05). Compared with normal persons, the mean promotive speed of contraction wave stepped up (4.6+/-1.6 cm/min vs 3.2+/-1.8 cm/min, P<0.05) and the mean amplitude of the wave decreased (14.2+/-9.3 kPa vs 18.4+/-8.0 kPa, P<0.05) in active UC patients. After treatment with Heartleaf houttuynia herb, these 2 indexes improved significantly (17.3+/-8.3 kPa, 3.7+/-1.7 cm/min, P<0.05). In normal persons, the postprandial pressure of sigmoid (2.9 +/-0.9 kPa) was higher than that of descending colon (2.0+/-0.7 kPa) and splenic flexure (1.7+/-0.6 kPa), while the colonic pressure (1.5+/-0.5 kPa, 1.4+/-0.6 kPa, 1.3+/-0.6 kPa) decreased significantly (P<0.05) in active UC patients. After treatment with Heartleaf houttuynia herb, the colonic pressure (2.6+/-0.8 kPa, 1.8+/-0.6 kPa, 1.6+/-0.5 kPa) recovered to normal. The pain threshold Heartleaf houttuynia herb, the colonic pressure (2.6+/-0.8 kPa, 1.8+/-0.6 kPa, 1.6+/-0.5 kPa) recovered to normal. The pain threshold of distant colon (67.3+/-18.9 mL) in active UC patients decreased significantly compared with that of normal persons (216.2+/-40.8 mL, P<0.05) and recovered to normal after treatment with Heartleaf houttuynia herb(187.4+/-27.2 mL, P<0.05). In the 18 refractory UC patients with platelet activation, after more than 4 wk of combined Kangshuanling and sulfasalazine therapy, 16 patients achieved clinical remission, with a highly significant statistical difference (P<0.01) between pre-and post-treatment mean scores for all disease parameters: stool frequency (8.2/d vs 1.6/d), rectal bleeding (score 2.7 vs 0.3), colonoscopy (score 2.6 vs 1.1), histology (score 12.0 vs 5.0), general well being (score 4.0 vs 0.6) and CD62p (8.0+/-3.1% vs 4.1+/-1.8%), CD63 (6.3+/-2.1% vs 3.2+/-1.6%), TXA2 (548+/-85 ng/L vs 390+/-67 ng/L), platelet aggregation rate (43.2+/-10.7% vs 34.8+/-8.1%), thrombosis length in vitro (2.3+/-0.6 cm vs 1.8+/-0.3 cm), CD54 in blood (26.9+/-6.9% vs 14.4+/-5.1%), CD54 in tissues (51.1+/-6.2% vs 23.1+/-4.1%), Pgp-170 in blood (18.9+/-3.9% vs 10.4+/-2.7%), Pgp-170 in tissues (16.5+/-3.2% vs 10.2+/-2.3%, P<0.01 or 0.05). CONCLUSION: Based on the characteristics of UC cases in China, different therapy should be given to different types of UC with expected satisfactory results.     

腐殖酸钠保留灌肠治疗轻中度溃疡性结肠炎

目的:观察腐殖酸钠(SHA)保留灌肠治疗活动期的轻中度溃疡性结肠炎(UC)的疗效和副作用。方法:采用与柳氮磺胺吡啶(SASP)对照方法进行分析,以活动指数进行临床分级来评价疗效。结果:SASP缓解率为92.86%,SHA达93.75％,两者无显著差异。结论:SHA治疗活动期的轻中度UC有较高的疗效,且价谦,无明显副作用。     

Delayed-release oral mesalamine 4.8 g/day (800 mg tablets) compared to 2.4 g/day (400 mg tablets) for the treatment of mildly to moderately active ulcerative colitis: The ASCEND I trial.

BACKGROUND: Delayed-release oral mesalamine 2.4 g/day to 4.8 g/day has been shown to be effective in treating mildly to moderately active ulcerative colitis (UC), but it is unknown whether an initial dose of 4.8 g/day is more effective than 2.4 g/day in patients with mildly to moderately active UC and in the subgroup with moderate disease. PATIENTS AND METHODS: A six-week, multicentre, randomized, double-blind, controlled trial assessing the safety and clinical efficacy of a new dose (ASCEND I) of medication randomly assigned 301 adults with mildly to moderately active UC to delayed-release oral mesalamine 2.4 g/day (400 mg tablet [n=154]) or 4.8 g/day (800 mg tablet [n=147]). The primary efficacy end point was overall improvement (ie, treatment success), defined as complete remission or response to therapy from baseline to week 6. Primary safety end points were adverse events and laboratory evaluations. Data were also analyzed separately for the prespecified subgroup of patients with moderate UC at baseline. RESULTS: Treatment success was not statistically different between the treatment groups at week 6; 51% of the group (77 of 150) who received delayed-release oral mesalamine 2.4 g/day and 56% of the group (76 of 136) who received 4.8 g/day reached the efficacy end point (P=0.441). Among the moderate disease subgroup, however, the higher initial dose was more effective; 57% of patients (53 of 93) given delayed-release oral mesalamine 2.4 g/day and 72% of patients (55 of 76) given 4.8 g/day achieved treatment success (P=0.0384). Both regimens were well tolerated. CONCLUSIONS: Delayed-release oral mesalamine is an effective and well-tolerated initial therapy in patients with mildly to moderately active UC, and a 4.8 g/day dose may enhance treatment success rates in patients with moderate disease compared with mesalamine 2.4 g/day.     

奥沙拉嗪治疗溃疡性结肠炎疗效观察

目的 观察国产奥沙拉嗪钠胶囊治疗轻、中度活动期溃疡性结肠炎的治疗效果，比较国产奥沙拉嗪钠胶囊与水杨酸偶氮磺胺吡啶(SASP)对轻、中度溃疡性结肠炎(活动期)的疗效和不良反应。方法 采用随机双盲方法验证56例轻中度溃疡性结肠炎(活动期)的疗效和不良反应，疗程为8周。结果 国产奥沙拉嗪钠胶囊的总有效率为85％，观察组患者在临床完全缓解率、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，分别达75％、35％、48％，其疗效与对照组相比无明显差异。结论 国产奥沙拉嗪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，继续用药或合并使用抗腹泻药后，腹泻即消失。     

Effects of sulfasalazine on biopsy mucosal pathologies and histological grading of patients with active ulcerative colitis

AIM: To investigate the mechanisms of sulfasalazine (SASP) in the treatment of ulcerative colitis (UC). METHODS: Changes of pathological signs and histological grading of 106 patients with active UC were observed before and after the treatment with SASP, 1 g, thrice daily for 6 wk. RESULTS: The effect of SASP on the vasculitis in lamina propria was 48.2% and 17.4% in the mild active UC (P<0.001) and 68% and 26.7% in the moderate active UC (P<0.001) before and after treatment. Fibroid necrosis of vessel wall was found in one case of mild UC and two cases of moderate UC before treatment and was not found after treatment. No thrombosis was found in mild UC before and after treatment, while thrombosis was found in one case of moderate UC before treatment. The effect on mucosal glandular abnormality was 30.4% and 13.0% in mild UC (P<0.05), and 42% and 40% in moderate UC (P>0.05) before and after treatment. The rate of eosinophil infiltration was 98.2% and 80.4% in mild UC (P<0.01), and 100% and 91.1% in moderate UC (P<0.05) before and after treatment. The effect on crypt abscess was 21.4% and 4.4% in mild UC (P<0.05), and 48% and 13.3% in moderate UC (P<0.001) before and after treatment. The effect on mucosal pathohistological grading was 2.00+/-0.84 and 0.91+/-0.46 in mild UC (P<0.001), and 2.49+/-0.84 and 1.31+/-0.75 in moderate UC (P<0.001) before and after treatment. CONCLUSION: SASP can improve small vessel lesions and crypt abscesses and reduce neutrophilic and eosinophilic leukocyte infiltration in inflammatory mucosa of UC.     

Effect of ecabet sodium enema on mildly to moderately active ulcerative proctosigmoiditis: an open-label study

OBJECTIVES: Ecabet sodium (ES), a nonabsorbable antigastric ulcer agent, has been shown to adhere to the region of an ulcer. It topically enhances gastric mucosal defensive factors such as the endogenous prostaglandins, capsaicin-sensitive sensory nerves, nitric oxide, and mucin. All of these mucosal defensive factors play an important role in maintaining the mucosal integrity of the colon and rectum. Therefore, we investigated the effect of ES in patients with mildly to moderately active ulcerative proctosigmoiditis. METHODS: In an open-label study, seven patients with mildly to moderately active ulcerative colitis (UC) who had an inflamed mucosa in the rectum and/or sigmoid and were resistant to 4-wk topical and systemic standard treatment were treated with an ES enema b.i.d. for 14 days. The enema consisted of ES (1 g) and tepid water (20 or 50 ml). These patients were assessed by the Clinical Activity Index, colonoscopically, and histologically before and after the ES therapy. The ES therapy was started after obtaining informed consent from the patients. RESULTS: Six of the seven patients responded to therapy and achieved clinical, endoscopic, and histological remissions. One patient was withdrawn because of increased stool frequency. All six patients who completed the study showed a significant change in the mean Clinical Activity Index score from 5.3+/-1.4 (mean +/- SD) to 0.5+/-0.8 (p < 0.05), in the colonoscopic score from 3.0+/-0.9 to 0.8+/-0.4 (p < 0.05), and in the histological score from 2.7+/-0.5 to 0.5+/-0.6 (p < 0.05), and achieved remission at the end of the study. There were no side effects attributable to the ES therapy. Five of the six patients are still in clinical remission after a median follow-up period of 5 months. CONCLUSIONS: The ES enemas proved to be a safe and potentially useful adjuvant therapy currently available for treating patients with mildly to moderately active ulcerative proctosigmoiditis. A controlled study is necessary to confirm our results.     

健脾解毒化瘀方对大鼠实验性溃疡性结肠炎细胞因子的影响

[目的]探讨以益气健脾、清热解毒、活血化瘀为原则组成方剂对溃疡性结肠炎(UC)大鼠细胞因子的影响,探讨其治疗UC的机制.[方法]除15只大鼠作为正常组外,其他大鼠采用TNBS复制UC模型后随机分成模型组、对照组、柳氮磺胺吡啶(SASP)组、中药组,肉眼及镜下观察各组大鼠的组织学损伤,并检测血清中细胞因子的含量.[结果]中药组、SASP组在减轻肉眼及镜下的组织学损伤方面和改善细胞因子方面较模型组、对照组均具有明显效果(P＜0.05);中药组较SASP组疗效更明显(P＜0.05).[结论]以益气健脾、清热解毒、活血化瘀为原则组成方剂对UC治疗有效,其机制可能是提高抗炎因子的含量,降低炎症因子的含量,维持细胞因子之间的平衡,进而调节免疫炎症反应.     

三种灌肠剂治疗左半结肠溃疡性结肠炎疗效观察

研究氢化可的松,对氨基水杨酸,水杨酸偶氮磺胺吡啶三种灌肠剂治疗左半结肠溃疡性结肠炎（ＵＣ）的疗效和安全性。方法用随机双盲对照方法对６２例ＵＣ病人分组治疗,以安慰剂为对照,疗程４周,观察临床症状,结肠镜和组织学炎症及疾病活动指数（ＤＡＩ）的改善情况。结果三种灌肠剂和对照组治疗后症状改善率分别为７５％、６８．７％、６８．７％和２１．４％（Ｐ〈０．０５）;结肠镜下炎症改善率下７５％、６８％、６１．５％和     

新加白头翁汤治疗活动期溃疡性结肠炎的临床疗效评价

目的:观察新加白头翁汤联合西药对比单用西药治疗溃疡性结肠炎(UC)的临床疗效.方法:采用前瞻性队列研究.纳入活动期UC患者50例,对照组24例,试验组26例.试验组予新加白头翁汤联合西药治疗,对照组单用西药治疗,观察临床疗效.结果:与对照组比较,试验组临床缓解率69.2％高于对照组37.5％(P＜0.05);临床有效率...     

脑干听觉诱发电位诊断新生儿高胆红素血症的临床应用价值

目的 探讨应用脑干听觉诱发电位(BAEP)诊断新生儿高胆红素血症的临床价值.方法 选择2017-08～2019-08阳春市妇幼保健院收治的98例高胆红素血症新生儿作为观察组,另选择同期98名健康新生儿作为对照组.两组均施行BAEP检测,并比较检测结果.结果 观察组有71例(72.45％)发生BAEP异常,对照组有6例(...     

Effect of mucosal healing (Mayo 0) on clinical relapse in patients with ulcerative colitis in clinical remission

Objective: The aim of this study was to identify the effect of mucosal healing (MH) on clinical relapse in patients with ulcerative colitis (UC) who are in clinical remission, with special reference to Mayo endoscopic subscore 0.

Methods: Between November 2005 and December 2013, medical records from a total of 215 patients with UC who underwent colonoscopic examination at the time of clinical remission were retrospectively reviewed. Endoscopic MH was defined as a ‘0 point’ of Mayo endoscopic subscore (Mayo 0). Patients were categorized into two groups according to Mayo endoscopic subscore and then analyzed.

Results: The baseline characteristics of both groups (MH vs. no-MH), including age at diagnosis, gender, and initial clinical and colonoscopic findings, were not significantly different. The median follow-up duration was 80 (12–118) months. Factors predictive of longer clinical remission duration were age ≥30 years at diagnosis (≥30 years vs. <30 years; hazard ratio [HR] 3.16, 95% CI 1.88–5.30, p?p?=?0.015), and presence of MH at clinical remission (HR 1.95, 95% CI 1.15–3.32, p?=?0.014). With a Cox regression model, patients with MH at clinical remission were more likely to have longer duration of clinical remission than patients without MH.

Conclusion: The achievement of MH, Mayo 0 in particular, in patients with UC who are in clinical remission is important in predicting a favorable disease course prognosis.     

血清铜锌离子变化对双相障碍发作的影响

目的探讨血清铜锌离子变化对双相障碍发作的影响。 方法回顾性分析2013年8月至2015年2月在暨南大学附属第一医院精神科接受诊治的64例双相障碍患者和30例健康志愿者的临床资料。其中男43例,女51例;平均年龄（28±10）岁。研究对象均签署知情同意书,符合医学伦理学规定。根据所处的心境状态将研究对象分为3组：双相障碍抑郁期组32例、双相障碍缓解期组32例和正常对照组30例。早晨空腹抽取静脉血检测研究对象的铜离子、锌离子和铜蓝蛋白浓度。3组研究对象临床和实验室数据的比较采用单因素方差分析,两两比较采用LSD-t检验;性别比较采用χ²检验。 结果双相障碍抑郁期组研究对象的铜离子浓度、铜蓝蛋白浓度和铜/锌比值均低于正常对照组（LSD-t_铜离子=–2.32,LSD-t_铜蓝蛋白=–0.11,LSD-t_{铜/锌比值}=–0.74,P值均<0.05）,而锌离子浓度高于正常对照组（LSD-t=3.28,P<0.05）。双相障碍缓解期组研究对象的铜离子浓度、铜蓝蛋白浓度和铜/锌比值高于双相障碍抑郁期组（LSD-t_铜离子=–3.94,LSD-t_铜蓝蛋白=–0.05,LSD-t_{铜/锌比值}=–0.79,P值均<0.05）,而锌离子浓度低于双相障碍抑郁期组（LSD-t=2.51,P<0.05）。双相障碍缓解期组研究对象的铜蓝蛋白浓度低于正常对照组（LSD-t=–0.06,P<0.05）,而铜离子浓度、锌离子浓度和铜/锌比值与正常对照组比较差异无统计学意义（P>0.05）。 结论双相障碍抑郁期和缓解期组患者均存在微量元素铜、锌浓度的异常。铜、锌离子浓度的改变可能成为双相障碍微量元素监测的特征性表现之一,其变化机制仍在探索中。     

Clinical course of distal ulcerative colitis in relation to appendiceal orifice inflammation status

BACKGROUND: Although appendiceal orifice inflammation (AOI) is frequently observed as a skip lesion of ulcerative colitis (UC), its clinical significance is not clearly understood. We aimed to evaluate whether AOI is associated with the clinical course of UC. METHODS: Ninety-four patients with newly diagnosed distal UC were prospectively enrolled at the Asan Medical Center between March 1996 and October 2002. Clinical features and colonoscopic findings during the follow-up period were analyzed in relation to initial AOI status. RESULTS: Forty-eight patients were found to be initially AOI-positive and 46 to be initially AOI-negative. We found no difference in the baseline demographics and clinical characteristics between these two groups. The median follow-up periods for AOI-positive and AOI-negative groups were 45 and 41 months, respectively. Clinical remission was achieved in all patients of each group. The cumulative risk of relapse at 1, 3, and 5 years after remission was 31.2%, 59.8%, and 69.2%, respectively, in the AOI-positive group and 17.4%, 46.5%, and 67.2%, respectively, in the AOI-negative group (P = 0.124). The cumulative risk of proximal disease extension at 1, 3, and 5 years after diagnosis was 17.9%, 24.9%, and 44.5%, respectively, in the AOI-positive group and 9.8%, 21.5%, and 43.9%, respectively, in the AOI-negative group (P = 0.522). Proctocolectomy was performed in no patients in the AOI-positive group and in 1 patient in the AOI-negative group. No mortalities were observed in either group. CONCLUSIONS: In patients with distal UC, AOI may have no prognostic implications in terms of remission, relapse, or proximal disease extension.     

118例溃疡性结肠炎临床、内镜与直肠动力分析

目的了解溃疡性结肠炎(UC)的临床、内镜和直肠动力特点。方法分析1982年2002年我院确诊118倒UC的临床、内镜、直肠动力特点。结果①UC症状以腹泻、粘液、粘液血便、腹痛为主,肠外表现少见;病程通常较短;病变范围以左半结肠为主;IgG、IgM升高;②肠镜下充血水肿最多见,其次是糜烂、溃疡;③腹压增加时肛门内外括约肌净增压降低(P<0.05),直肠最低敏感量、最大耐受性、最大顺应性明显降低(P<0.01);④大多数患者以柳氮磺胺吡啶治疗有效。结论了解UC的临床、内镜和直肠动力特点,有助于理解UC的发病规律、病理生理和更有效地治疗该病。     

Clinical and colonoscopic investigation of skipped periappendiceal lesions in ulcerative colitis

BACKGROUND: Ulcerative colitis (UC) is typically a continuous and diffuse inflammation extending proximally from the rectum. However, skipped lesion in the appendiceal region has been reported recently. Although appendectomy has been shown to reduce the risk of UC, the clinical significance of skipped periappendiceal lesion remains unclear. The present study examined the relationship between the continuous distal lesion of UC and the skipped periappendiceal lesion by observing colonoscopic changes in both lesions. METHODS: Among 279 patients with UC who underwent total colonoscopy from January 1994 to December 2000, 54 patients (19.4%) had skipped periappendiceal lesions. Serial colonoscopic examinations were performed in 35 of the 54 patients to determine the activities in the distal UC lesion and skipped periappendiceal lesion during the course of disease. RESULTS: Patients with skipped periappendiceal lesions were younger and had a longer history of UC than those without them, but no differences in sex ratio and treatment modality were observed between the two groups. In 28 of 35 patients (80%), the activity in the distal lesion correlated well with that in the skipped periappendiceal lesion. Both lesions were improved in 17 patients, unchanged in 5 patients and worsened in 6 patients. Linear regression analysis showed a significant correlation between the changes in colonoscopic activity index in the two lesions. CONCLUSION: A close association is found between disease activity in the skipped periappendiceal lesion and that in the distal lesion of UC.     

Ulcerative colitis and irritable bowel syndrome: relationships with quality of life

OBJECTIVES: Quality of life is reduced in inflammatory bowel disease. Irritable bowel syndrome (IBS)-like symptoms seem to be common in inflammatory bowel disease patients during the remission phase. We aimed to (i) assess the prevalence of IBS-like symptoms in ulcerative colitis (UC) patients during the remission phase and (ii) evaluate the impact of IBS symptoms on health-related quality of life (HRQOL) of UC patients in remission compared with the HRQOL of those in the active phase. METHODS: Ninety-five patients with UC (45 patients in the active phase and 50 in remission for at least 12 months) and 100 selected controls (recruited from among those who visited the orthopedic minor trauma outpatient clinic during 2004-2005) completed questionnaires to evaluate IBS-like symptoms according to ROME II criteria: the influence of these symptoms on the HRQOL of UC patients in remission was compared with that on the HRQOL of those in the active phase. Chi square and nonparametric tests were used. RESULTS: The prevalence of IBS-like symptoms in UC patients in remission and controls were 46 and 13%, respectively (P<0.001). HRQOL seemed to be significantly reduced in both active UC patients and UC patients in remission with IBS, compared with UC patients in remission without IBS and with controls (P<0.001). In active UC patients, the mean scores for most elements (as measured by SF36) were considerably lower than for UC patients in remission (P<0.05). CONCLUSION: The prevalence of IBS-like symptoms in UC patients in remission is about three times higher than in controls, and these patients have impaired HRQOL comparable with that of UC patients in the active phase.     

Efficacy and Safety of Adsorptive Granulocyte and Monocyte Apheresis in Elderly and Pregnant Patients With Ulcerative Colitis

In patients with active ulcerative colitis (UC), adsorptive granulocyte/monocyte apheresis (GMA) is expected to promote remission. We conducted a retrospective cohort study to evaluate the efficacy and safety of GMA in patients with active UC. Twenty‐one UC patients including five pregnant or lactating mothers and four elderly patients (aged >60 years) received up to 10 GMA sessions. UC severity was evaluated at baseline and after GMA therapy according to Lichtiger's Clinical Activity Index (CAI). We defined clinical remission as CAI ≤4. Overall, the median CAI score after GMA therapy had decreased from 9 to 4 (P < 0.001). The clinical remission rate was 62%, but in the elderly and pregnant or lactating mothers, the remission rates were 100% and 60%, respectively. No severe adverse effects were seen in this study. Our results may support GMA as an effective and safe treatment for active UC patients, including elderly patients and pregnant cases.     

6-mercaptopurine or methotrexate added to prednisone induces and maintains remission in steroid-dependent inflammatory bowel disease

BACKGROUND: As treatment of steroid-dependent patients with inflammatory bowel disease (IBD) is controversial, we analysed the efficacy and tolerance of 6-mercaptopurine (6-MP) and methotrexate (MTX) added to prednisone in increasing and maintaining the disease remission rate. METHODS: Seventy-two steroid-dependent IBD patients, 34 with ulcerative colitis (UC) and 38 with Crohn's disease (CD), receiving treatment with prednisone were randomly assigned in a 2:2:1 ratio to additionally receive, orally, over a period of 30 weeks 1.5 mg/kg/day of 6-MP (group A) or 15 mg/week of MTX (group B), or 3 g/day of 5-aminosalicylic acid (5-ASA) (group C). All patients who achieved remission were included in a maintaining remission study for 76 weeks. Remission was defined after stopping prednisone as a CD activity index of <150 and normal serum orosomucoid concentration for CD patients and a Mayo Clinic score <7 for UC patients. RESULTS: With regard to achieved remission, a significantly higher (P< 0.05) rate existed for UC patients in group A (78.6%) than in group C (25%), with no statistical differences in group B (58.3%) versus C. For CD patients, the rates were significantly higher (P< 0.001 and 0.01, respectively) in groups A (93.7%) and B (80%) versus C (14%). With regard to maintaining remission, UC patients in group A (63.6%) presented significantly higher rates (P < 0.0015 and P < 0.001, respectively) versus 14.3% in group B and none in group C. For CD patients, statistical differences (P < 0.001) existed when comparing rates in groups A (53.3%) and B (66.6%) versus none in group C. Noticeable side effects appeared in 13.3% of patients from group A and 11.5% from group B. CONCLUSIONS: These results suggest that 6-MP or MTX added to prednisone could be effective in steroid sparing, as well as in achieving and maintaining remission in steroid-dependent IBD patients. MTX was less effective in maintaining remission in UC patients.