实炎方治疗轻中度大肠湿热型溃疡性结肠炎的临床观察

目的观察实炎方治疗轻中度大肠湿热型溃疡性结肠炎的临床疗效。方法将60例大肠湿热型溃疡性结肠炎患者随机分为治疗组和对照组,每组30例。治疗组予以中药实炎方口服,对照组予以美沙拉嗪肠溶片口服;两组疗程均为3个月,观察临床疗效,比较主要症状量化积分、修正的Baron评分及血清中白介素-1β(IL-1β)、白介素-10(IL-10)水平的变化情况。结果 (1)治疗组、对照组总有效率分别为93.33%、86.67%;组间临床疗效比较,治疗组明显优于对照组(P0.05)。(2)治疗前后组内比较,两组主要症状量化积分均下降,差异有统计学意义(P0.05);组间积分下降差值比较,治疗组明显高于对照组(P0.05)。(3)治疗前后组内比较,两组修正的Baron评分均下降(P0.05);组间评分下降差值比较,治疗组明显高于对照组(P0.05)。(4)治疗前后组内比较,两组IL-1β水平均明显降低,IL-10水平均明显升高(P0.05);组间治疗后比较,治疗组IL-1β水平明显低于对照组,IL-10水平明显高于对照组(P0.05)。结论相比美沙拉嗪,实炎方能更好地改善溃疡性结肠炎患者的主要临床症状及结肠黏膜病变,降低血清IL-1β水平,提高血清IL-10水平。     

A clinical trial on absorption and N-acetylation of oral and rectal mesalazine

BACKGROUND: Mesalazine (5-ASA) is a standard treatment for ulcerative colitis. Extent of absorption and N-acetylation determine systemic exposure to 5-ASA, and are thereby relevant for the safety of the treatment. The aim of the study was to compare absorption and N-acetylation of 5-ASA following rectal or oral drug administration. Healthy subjects were compared to patients with ulcerative colitis to evaluate the impact of chronic inflammation of colorectal mucosa on disposition of 5-ASA. MATERIALS AND METHODS: First, 12 healthy adults were randomized to receive 2 g of 5-ASA by each of four different formulations: oral delayed release granules, 30 mL enema, 60 mL rectal foam, and 120 mL rectal foam. Second, 12 patients with active ulcerative colitis received 60 mL rectal foam. Pharmacokinetic analysis was performed by determination of 5-ASA and its acetylated, pharmacologically inactive metabolite (Ac-5-ASA) in plasma and urine. RESULTS: First, systemic exposure to 5-ASA was markedly lower after rectal drug administration as compared to oral dosing (P < 0.001; e.g. median relative bioavailability of 60 mL rectal foam: 36%). Second, N-acetylation of rectal 5-ASA was lower in patients than in healthy subjects [area under the curve (AUC) ratio Ac-5-ASA/5-ASA: 1.6 +/- 0.5 vs. 2.3 +/- 0.4, mean +/- SD, P < 0.01]. High peak plasma concentrations of 5-ASA were correlated with high microscopic disease activity (r = 0.67, P < 0.05). CONCLUSIONS: Rectal delivery of 5-ASA results in low systemic drug exposure with potentially reduced toxicity in comparison with oral drug administration. Chronic inflammation of colorectal mucosa might be a relevant source of variability in pharmacokinetics of 5-ASA.     

清热利湿解毒方治疗湿热蕴结型溃疡性结肠炎实验研究

目的:观察清热利湿解毒方对湿热蕴结溃疡性结肠炎(Ulcerative Colitis,UC)模型大鼠肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)、白细胞介素-8(interleukin-8,IL-8)的影响和其对UC的治疗效果并分析其作用机制。方法:采用TNBS/乙醇+高脂高糖辛辣饮食建立湿热蕴结型UC大鼠模型。将48只大鼠随机分为对照组,模型组,中药组,西药组,每组12只,造模成功后,各治疗组给予相应药物干预治疗,通过证候学指标(DAI评分),结肠黏膜损伤指数(CMDI评分),酶联免疫法测定血清TNF-α、IL-8含量。结果:清热利湿解毒方能明显改善UC大鼠一般情况,促进结肠损伤黏膜的修复,中药组与模型组对比较,能够明显降低DAI评分,CMDI评分,血清中TNF-α、IL-8含量(P0.01)。中药组与西药组对比,DAI评分,CMDI评分,血清中TNF-α、IL-8含量均无明显差异(P0.05)。结论:清热利湿解毒方能明显改善UC大鼠结肠形态、降低黏膜损伤指数、降低血清TNF-α、IL-8含量,与美沙拉嗪具有等效性。清热利湿解毒方能够减轻或消除多种因素对结肠黏膜的损伤,从始动环节干预溃疡性结肠炎的发生发展,从而起到防治溃疡性结肠炎的作用。     

加味芍药汤联合美沙拉秦治疗湿热下注型溃疡性结肠炎临床研究

[目的]探讨加味芍药汤联合美沙拉秦治疗湿热下注型溃疡性结肠炎（UC）的临床疗效。[方法]选取2020年11月—2022年1月就诊于河北省中医院的UC患者64例作为研究对象,并通过随机数字表法将研究对象随机分成观察组32例和对照组32例。观察组给予加味芍药汤联合美沙拉秦肠溶片（莎尔福）口服治疗,对照组给予美沙拉秦肠溶片口服治疗,两组患者均需要进行为期8周的治疗,对比两组治疗前后的中医证候积分（TCMPS）评分、血清炎症因子水平、肠镜检查评分各项指标的变化及临床疗效、不良反应。[结果]两组患者治疗后的血清C反应蛋白（CRP）、白介素（IL）-13、肿瘤坏死因子（TNF）-α含量均较治疗前降低,且观察组的下降程度相比对照组明显,差异具有统计学意义（P<0.05）;两组TCMPS评分、肠镜检查评分均较治疗前降低,且观察组治疗后的评分比对照组下降程度明显,差异具有统计学意义（P<0.05）;观察组的总有效率以及治疗效果均优于对照组,差异具有统计学意义（P<0.05）。[结论]对UC患者来说,采用加味芍药汤联合美沙拉秦治疗可以获得较好的疗效,不仅能够帮助UC患者大幅度缓解临床症状...     

美沙拉嗪治疗轻中度溃疡性结肠炎患者的肠黏膜愈合率分析

目的:研究不同蒙特利尔分型及Mayo内镜评分的轻中度溃疡性结肠炎患者接受美沙拉嗪为主的治疗方案后的肠黏膜愈合情况以及影响愈合情况的相关因素。方法:收集229例轻中度溃疡性结肠炎且接受美沙拉嗪治疗的患者资料并进行回顾性研究,分析比较不同患者之间肠黏膜愈合率的差异。结果:接受美沙拉嗪治疗后达到黏膜愈合的患者占29.7%(68/161),黏膜愈合率在不同性别患者之间的差异有统计学意义(P<0.05)。不同蒙特利尔分型及Mayo内镜评分的患者之间的黏膜愈合率存在显著性差异(P<0.05)。结论:临床实践中接受美沙拉嗪治疗的轻中度溃疡性结肠炎患者,达到理想的黏膜愈合目标还存在一定差异。患者的性别、肠黏膜的炎症程度与炎症累及的范围对美沙拉嗪疗效的影响具有一定的相关性。     

龙血竭散联合美沙拉嗪缓释片灌肠治疗溃疡性结肠炎

目的：观察美沙拉嗪缓释片联合龙血竭散灌肠对溃疡性结肠炎（UC）的疗效。方法收集70例 UC患者,随机分为观察组和对照组,各35例,2组均给予相应调节酸碱失衡、水电解质紊乱及改善营养状况等治疗。对照组以美沙拉嗪缓释片1.0 g 口服,4次/ d,观察组在对照组基础上给予龙血竭散1.0 g 溶于生理盐水150 mL 进行灌肠,肠道保留1 h,1次/ d,均连续治疗4周。观察治疗前后 IL-8、IL-10、TNF-α、红细胞压积、纤维蛋白原、全血黏度水平,并进行疗效评价。结果治疗后 IL-8、TNF-α明显降低,IL-10明显升高,且观察组优于对照组（P ﹤0.05）;治疗后红细胞压积、纤维蛋白原、全血黏度水平观察组降低程度优于对照组（P ﹤0.05）;观察组总有效率91.4℅,对照组71.4℅（P ﹤0.05）。结论美沙拉嗪口服联合龙血竭散灌肠可以明显减轻 UC患者炎性反应,改善血液高凝状态,提高治疗效果,改善患者生活质量。     

中药保留灌肠联合美沙拉嗪治疗溃疡性结肠炎临床分析

目的探讨中药保留灌肠联合美沙拉嗪治疗溃疡性结肠炎的临床疗效。方法选取收治的溃疡性结肠炎患者64例,随机分为对照组和治疗组,各32例,对照组给予美沙拉嗪治疗,治疗组在对照组的基础上应用中药保留灌肠进行治疗。比较治疗前后患者中医症状积分变化情况,对比2组患者临床疗效。结果治疗组患者中医症状积分降低较对照组更为明显,结果具有显著差异(P<0.05);治疗组临床总有效率为93.75%,对照组临床总有效率为81.25%,治疗组的临床疗效优于对照组(P<0.05)。结论中药保留灌肠联合美沙拉嗪可以改善溃疡性结肠炎患者受损部位微循环,修复结肠黏膜,有较好的的治疗效果,值得临床推广应用。     

Film coated tablets (ColoPulse technology) for targeted delivery in the lower intestinal tract: Influence of the core composition on release characteristics

The design of a film coating technology which allows a tablet to deliver the drug in the ileocolonic segment would offer new treatment possibilities. The objective is to develop a platform technology that is suitable for a broad range of drug compounds. We developed a coated tablet with a delayed, pulsatile release profile based on a pH-sensitive coating technology (ColoPulse). The production process was validated, and the effect of core composition on the in vitro release and water uptake investigated. The release profile of the standard tablet core composition, based on the use of cellulose as a filler, was independent of the coat thickness in a range of 9.0–13.2?mg/cm². The release profile of a coated tablet was strongly influenced when cellulose was partly replaced by the model substance glucose (loss of sigmoidal release), citric acid (stabilization), sodium bicarbonate (destabilization) or sodium benzoate (destabilization). The film coating takes up water when below the pH-threshold. However, this did not cause early disintegration of the coating. The ColoPulse technology is successfully applied on tablets. The in vitro release characteristics of the coated tablets are influenced by the composition of the core.     

美沙拉嗪肠溶片治疗肠易激综合征的临床疗效

目的探讨美沙拉嗪肠溶片(惠迪)治疗肠易激综合征(IBS)患者的临床疗效。方法选取2010年2月-2012年6月至上海市第八人民医院就诊的52例不同亚型的IBS患者进行自身对照试验,均予惠迪口服,500mg,4次/d,治疗1个月(30d)。监测治疗前后的腹痛强度、腹胀、大便情况。结果 (1)所有亚型的IBS患者在治疗后疼痛得分均降低[腹泻型由(7.3±0.4)降至(2.2±0.8),便秘型由(6.4±0.7)降至(1.1±0.2),混合型由(8.1±0.6)降至(2.7±0.5),不定型由(8.9±0.5)降至(3.6±0.8)],疼痛强度明显降低。(2)大便的各种异常症状发病率均明显降低,(腹泻型由100.0%降至6.3%,便秘型由100.0%降至38.1%,混合型由100%降至20.0%,不定型由100.0%降至40.0%)。(3)腹部不适的症状也得到减轻。发病率明显降低(腹泻型由68.8%降至18.8%,便秘型由95.2%降至19.0%,混合型由90.0%降至30.0%,不定型由80.0%降至40.0%)。结论惠迪能有效缓解IBS患者的多种症状,明显的减低患者的疼痛强度,显著改善腹部不适和大便异常。     

花生四烯酸代谢物在湿热型溃疡性结肠炎大鼠的表达与调节

目的:探讨花生四烯酸(AA)代谢物在湿热型溃疡性结肠炎(UC)大鼠发病的作用以及黄芩汤的调节。方法:采用高脂高糖饲料结合人工气候箱法造成大鼠湿热,使用三硝基苯磺酸灌肠造成湿热型UC模型;将造模大鼠分为模型组(n=12)、黄芩汤治疗组(n=13)及美沙拉嗪组(n=12)。治疗两周后用ELISA法检测大鼠前列腺素E2(PGE2)、血小板活化因子(PAF)、白三烯B4(LTB4)及环氧合酶-2(COX-2)含量;检测甘油三酯(TG)及总胆固醇(CH)含量并计算粪便脂肪球数量从而反映湿热程度;对结肠进行肉眼组织学评分从而评价UC的严重程度;将AA代谢物与以上湿热型UC指标进行相关性分析。结果:与空白组(n=12)比较,造模组血清及结肠PGE2、PAF、LTB4及COX-2含量明显升高(P<0.05);治疗后黄芩汤组的PGE2及LTB4均显著低于美沙拉嗪组(P<0.05),但PAF及COX-2无组间差异。湿热指标方面,治疗后黄芩汤组血脂及粪便脂肪球数量均显著低于美沙拉嗪组(P<0.05);UC方面,黄芩汤及美沙拉嗪组的组织学评分无统计学差异。相关性分析显示组织评分与AA代谢物、血脂及粪便脂肪球均呈显著正相关性(r>0.930,P<0.01)。结论:AA代谢物在湿热型UC大鼠血清及结肠明显升高,且与反映湿热的血脂及粪便脂肪球、与反映UC程度的组织学评分均呈正相关性;黄芩汤对代谢物PGE2、LTB4及对湿热指标的调节作用优于美沙拉嗪。