A practical guide to the sublingual immunotherapy tablet adverse event profile: implications for clinical practice

Objectives: Treatment with allergy immunotherapy improves allergic rhinoconjunctivitis, but can also improve comorbidities associated with allergic rhinitis such as asthma. Sublingual immunotherapy (SLIT)-tablets are a convenient and efficacious method of allergy immunotherapy. They are self-administered after the first tablet has been provided under medical supervision. Therapy may elicit local reactions or, rarely, systemic allergic reactions. The objective of this report is to inform healthcare practitioners about the safety and tolerability profile of SLIT-tablets and use this information to provide practical guidance that may inform patients regarding potential adverse reactions and how to manage them.

Methods: Pooled analyses of safety data from completed randomized, multicenter, double-blind, placebo-controlled phase 2 and phase 3 US and EU trials of timothy grass, short ragweed, and SQ house dust mite SLIT-tablets were conducted to characterize safety and tolerability.

Results: SLIT-tablets are generally well tolerated. No life-threatening events, serious systemic allergic reactions, or events that compromised the airway have been reported. The most common treatment-related adverse events (AEs) are oral site reactions, most of which begin on day 1 of treatment, recur for less than 2 weeks, and resolve after approximately 30–60 minutes. Systemic allergic reactions have been managed with conventional pharmacotherapy. Reactions treated with epinephrine are uncommon, but have been reported. Treatment of AEs, treatment discontinuation considerations, and patient FAQs regarding SLIT-tablet safety/tolerability are discussed.

Conclusions: This report gives healthcare providers valuable information to educate patients regarding what to expect in terms of SLIT-tablet safety and tolerability. Practical guidance is also provided to ensure proper treatment of any adverse reactions.     

单硝酸异山梨酯缓释片联合治疗老年单纯收缩期性高血压病

目的探讨单硝酸异山梨酯缓释片联合治疗老年单纯收缩期性高血压病的疗效。方法将182例经血管紧张素转换酶抑制剂(ACEI)、钙离子阻滞剂、β-受体阻滞剂、利尿剂等合理剂量治疗4周后全天平均收缩压仍≥160mmHg、舒张压<95mmHg的患者分为两组,治疗组加用单硝酸异山梨酯缓释片40mg,每天1次,对照组加用α-受体阻滞剂或外周肾上腺能神经元阻滞剂。均实行24小时动态血压(24hABP)监测。结果治疗组全天收缩压平均值较对照组明显减小,总有效率治疗组87.9%,对照组35.2%(P<0.01)。结论单硝酸异山梨酯缓释片联合治疗老年单纯收缩期性高血压病是一种有效的方法。     

Budesonide Oral Suspension Improves Outcomes in Patients With Eosinophilic Esophagitis: Results From a Phase 3 Trial

Background & AimsEosinophilic esophagitis (EoE) is a chronic, immune-mediated disease for which there is currently no pharmacologic therapy approved by the U.S. Food and Drug Administration.MethodsIn this double-blind, placebo-controlled, phase 3 trial, patients 11–55 years of age with EoE and dysphagia were randomized 2:1 to receive budesonide oral suspension (BOS) 2.0 mg twice daily or placebo for 12 weeks at academic or community care practices. Co-primary endpoints were the proportion of stringent histologic responders (≤6 eosinophils/high-power field) or dysphagia symptom responders (≥30% reduction in Dysphagia Symptom Questionnaire [DSQ] score) over 12 weeks. Changes in DSQ score (key secondary endpoint) and EoE Endoscopic Reference Score (EREFS) (secondary endpoint) from baseline to week 12, and safety parameters were examined.ResultsOverall, 318 patients (BOS, n = 213; placebo, n = 105) were randomized and received ≥1 dose of study treatment. More BOS-treated than placebo-treated patients achieved a stringent histologic response (53.5% vs 1.0%; Δ53% [95% confidence interval (CI), 43.8%–59.5%]; P < .001) or symptom response (52.6% vs 39.1%; Δ13% [95% CI, 1.6%–24.3%]; P = .024) over 12 weeks. BOS-treated patients also had greater improvements in least-squares mean DSQ scores and EREFS over 12 weeks than placebo-treated patients: DSQ, –13.0 (SEM 1.2) vs –9.1 (SEM 1.5) (Δ–3.9 [95% CI, –7.1 to –0.8]; P = .015); EREFS, –4.0 (SEM 0.3) vs –2.2 (SEM 0.4) (Δ–1.8 [95% CI, –2.6 to –1.1]; P < .001). BOS was well tolerated; most adverse events were mild or moderate in severity.ConclusionsIn patients with EoE, BOS 2.0 mg twice daily was superior to placebo in improving histologic, symptomatic, and endoscopic outcomes over 12 weeks. BOS 2.0 mg twice daily was well tolerated. ClinicalTrials.gov number: NCT02605837.     

复方鳖甲软肝片治疗原发性胆汁性肝硬化的临床疗效评价

目的评价复方鳖甲软肝片治疗原发性胆汁性肝硬化(PBC)患者的临床疗效。方法按照随机双盲安慰剂对照设计方法,纳入上海中医药大学附属曙光医院2011年11月-2013年12月确诊的56例PBC患者,分为治疗组和对照组各28例。治疗组给予复方鳖甲软肝片(4片/次,3次/d,口服)联合熊去氧胆酸片(UDCA)(50 mg/片,10~15 mg·kg-1·d-1)治疗。对照组给予空白安慰剂(4片/次,3次/日,口服)联合UDCA 50 mg/片,10~15 mg·kg-1·d-1)治疗。两组患者均治疗12个月。观察治疗前后患者临床症状、PBC-40量表、肝功能(ALT、AST、ALP、GGT、TBil)、肝脏弹力硬度值的变化。组间计量资料比较采用t检验,计数资料比较采用χ2检验。结果治疗12个月后,治疗组患者肝功能ALT、AST、GGT、ALP、TBil均有显著下降,与治疗前相比差异有统计学意义(t值分别为3.2019、3.0953、3.0279,P值均<0.01;t值分别为2.4420、2.1621,P值均<0.05),对照组患者肝功能仅GGT显著下降,与治疗前相比差异有统计学意义(t=1.9981,P<0.05);治疗后两组患者肝功能比较,治疗组GGT、ALP较对照组显著下降,两组相比差异有统计学意义(t值分别为2.0061、2.3106,P值均<0.05)。治疗组患者脏弹力硬度值由治疗前(14.37±10.58)k Pa显著下降至(10.02±5.96)k Pa,差异有统计学意义(t=2.1134,P<0.05)。治疗组患者治疗后PBC-40量表皮肤瘙痒、社交和疲劳维度较治疗前显著下降,差异有统计学意义(t值分别为2.5158、2.1409、3.2441,P值均<0.05),两组患者治疗后在疲劳和社交维度差异有统计学意义(t值分别为3.1491、2.6287,P值均<0.05)。结论复方鳖甲软肝片可显著改善PBC患者肝功能,降低患者肝脏弹力硬度值,显著改善患者PBC-40皮肤瘙痒和疲劳等临床症状,在临床上具有一定推广应用价值。     

复方夏天无片治疗老年骨质疏松性桡骨远端骨折的疗效观察

复方夏天无片具有祛风逐湿、舒筋通络、行血止痛等功效,临床广泛应用于风湿性关节炎、腰椎间盘突出症、骨关节炎等的治疗,但未见对骨折治疗的有关报道。该文观察复方夏天无片治疗老年骨质疏松性桡骨远端骨折的疗效,通过选取2011年1月—2014年6月在我院就诊骨质疏松性桡骨远端骨折患者180例,随机数字表法将患者分为观察组和对照组,每组各90例。对照组予以手法复位,石膏外固定后,予以钙尔奇D,观察组在对照组的基础上加复方夏天无片治疗。观察2组治疗后的疗效,腕关节功能和并发症发生率。结果显示观察组的优良率为95.56%,明显高于对照组的77.78%,差异有统计学意义(χ²=4.712,P<0.05)。观察组的并发症发生率明显低于对照组(P<0.05)。结果说明复方夏天无片能够提高老年骨质疏松性桡骨远端骨折的疗效,减少并发症的发生率, 减轻患者的痛苦,对提高生命质量具有重要作用。     

穿心莲总内酯亲水凝胶骨架片的制备及体外释药机制研究

该实验研究了穿心莲总内酯骨架片的处方工艺及其体外释药行为。通过单因素试验,以不同型号及用量的羟丙甲基纤维素(HPMC)为主要考察因素,以3种内酯成分累积释放度为评价指标,优选出最佳处方,所制缓释片无突释现象,缓释周期14 h。采用零级、一级、Higuchi及Peppas方程判断穿心莲3种内酯类成分的释药机制,结果表明总内酯释放行为符合Higuchi模型,释放机制为骨架溶蚀机制。该法制备的穿心莲总内酯骨架片制备工艺简单易行,具有良好的释放性能。     

中药内服配合灌肠治疗慢性前列腺炎40例

目的:观察中药内服配合保留灌肠治疗慢性前列腺炎的临床疗效。方法:将80例慢性前列腺炎患者随机分为治疗组和对照组各40例,对照组单纯以西医治疗,治疗组在对照组的基础上加用中药内服配合保留灌肠治疗。结果:对照组有效率为82.5%,治疗组有效率为92.5%,两组有效率比较,差异有显著性(P0.05)。结论:中药内服配合灌肠治疗慢性前列腺炎疗效显著,无不良反应发生。     

不同剂量盐酸坦洛新缓释片治疗早泄的临床疗效

目的 探讨不同剂量盐酸坦洛新缓释片治疗早泄的临床疗效. 方法 2010年9月至2011年1月收治的早泄患者80例,随机数字表法均分为0.2和0.4 mg盐酸坦洛新缓释片组,观察临床疗效和治疗前后患者CIPE-5评分的变化,并进行组内和组间比较. 结果 两组各脱落2例,原因均为服药后出现头晕、眩晕、体位性低血压.0.2和0.4 mg组患者治疗前阴道内射精潜伏期分别为(0.98±0.47)、(0.89±0.47)min,治疗后分别为(4.40±1.86)、(6.40±5.10) min,差异有统计学意义(P＜0.01).在夫妻性生活满意度、性生活焦虑减轻程度及延迟射精困难减轻程度方面,0.4 mg组均优于0.2 mg组. 结论 大剂量、长周期盐酸坦洛新缓释片治疗早泄可延长射精潜伏期,提高夫妻性生活满意度.     

六味五灵片联合替比夫定治疗活动性慢性乙型肝炎肝硬化临床疗效观察

目的观察六味五灵片联合替比夫定治疗活动性慢性乙型肝炎（CHB）肝硬化的临床疗效。方法将72例HBV DNA、HBeAg阳性的CHB肝硬化患者随机分为治疗组和对照组,两组均为36例。治疗组给予六味五灵片联合替比夫定治疗,对照组单用替比夫定治疗,疗程均为24周。治疗前后分别检测患者肝功能、慢性HBV标志物、HBV DNA低于检测下限的比率。结果治疗组血清ALT、AST下降明显,与对照组比较,差异有统计学意义（P〈0.05）,治疗组HBeAg低于检测下限的比率及HBeAg/抗-HBe血清转换率均高于对照组,治疗组总有效率高于对照组,差异有统计学意义（P〈0.05）。结论六味五灵片联合替比夫定治疗活动性CHB肝硬化疗效显著,不良反应发生率小,疗效优于单一用药组,是治疗活动性CHB肝硬化的有效方法。     

f2因子法评价头孢呋辛酯片溶出曲线相似性

目的：评价自制制剂与原研药的溶出行为相似性。方法基于药典中的溶出度测定方法,分别考察自制制剂与原研药品在纯水,0．1、0．05 mol/L 盐酸,pH4．5、pH6．8的介质,以及在25、50、75 r/min 转速时的溶出行为,并用 f2因子法比较溶出曲线。结果当转速为50 r/min 在5种介质中,f2因子分别为57．65,79．17,73．56,66．83和62．33;介质为0．1 mol/L 的盐酸,转速为25 r/min 和75 r/min 时,f2值分别为65．35、78．48。结论自制制剂与原研药各条件下的溶出曲线相似。