Sublingual immunotherapy tablets as a disease-modifying add-on treatment option to pharmacotherapy for allergic rhinitis and asthma

Allergic rhinitis (AR) with or without conjunctivitis (AR/C) is associated with a significant health and economic burden, and is often accompanied by asthma. Pharmacotherapies are the mainstay treatment options for AR and asthma, but guidelines also recommend allergy immunotherapy (AIT). Unlike pharmacotherapies, AIT has the ability to modify the underlying immunologic mechanisms of AR and asthma with the potential for long-term benefits after treatment is discontinued. Immunotherapy may also prevent progression of AR/C to asthma. Sublingual immunotherapy (SLIT)-tablets are a self-administered alternative to subcutaneous immunotherapy that provide the benefits of AIT without the cost and inconvenience of frequent office visits or the discomfort of injections. SLIT-tablets are also an option that can be utilized by primary care clinicians. Pharmacotherapies are generally effective in mild disease although a number of patients remain uncontrolled. SLIT-tablets have proven efficacy for AR in adults, children, and poly-sensitized allergic patients. Indirect comparisons indicate that SLIT-tablets have superior or comparable efficacy compared with traditional pharmacotherapies for seasonal AR, and superior efficacy for perennial AR. House dust mite (HDM) SLIT-tablets have also demonstrated clinically relevant benefits for asthma, with significant observed reductions in daily inhaled corticosteroid use, risk of asthma exacerbations, and asthma symptoms. SLIT-tablets are well tolerated, with minimal risk of systemic allergic reactions. The most common treatment-related adverse events are oral site reactions such as oral pruritus and throat irritation. Based on the favorable efficacy and safety profile, as well as the convenience of at-home oral administration and disease-modifying effects, SLIT-tablets should be considered as an alternative or add-on treatment to pharmacotherapy for AR/C, and as an add-on treatment for HDM allergic asthma.     

Influence of formulation composition and processing on the content uniformity of low-dose tablets manufactured at kilogram scale

The purpose of this study was to investigate the impact of processing, API loading, and formulation composition on the content uniformity of low-dose tablets made using direct compression (DC) and roller compaction (RC) methods at 1?kg scale. Blends of 1:1 microcrystalline cellulose/lactose or 1:1 microcrystalline cellulose/dicalcium phosphate anhydrous with active pharmaceutical ingredient (API) at loadings of 0.2, 1 and 5% were processed either by DC or RC. A statistical analysis showed that DC produced comparable content uniformity results to RC. Microcrystalline cellulose/lactose formulations had improved average potency compared to microcrystalline cellulose/dicalcium phosphate anhydrous formulations for both DC and RC. The impact of segregation in the DC blends and adhesion to equipment surfaces was assessed to aid in understanding potency trends. DC may be as suitable as RC for low-dose regime (e.g. <?1?mg) when manufacturing clinical supplies at small scale provided the API has a suitable particle size and potency loss to equipment is negligible.     

中西结合治疗84例盆腔炎疗效分析

盆腔炎主要是由于阴道内菌群内源性病原体以及来自外界外源性病原体引发。该病是中老年女性的常见病、多发病。该病反复缠绵，单一治疗久治难愈。发作期疼痛难隐，病情险恶。近年来我院采用中西结合用药，取得满意的临床效果。抗生素的恰当使用有利于尽快杀死致病菌。中药内服外用有利于健脾益气，清热解毒。诸药合力，起到＂消炎止痛、清热除湿，解毒祛邪＂显著效果。     

中药方剂抗肺纤维化方治疗肺纤维化患者的临床研究

〔摘 要〕 目的：研究中药方剂抗肺纤维化方治疗肺纤维化（PF）患者的疗效。方法：选取福建中医药大学附属 第二人民医院 2020 年 3 月至 2021 年 10 月期间收治的 70 例 PF 患者，采用随机数字表法分为对照组与观察组，各 35 例。对照组患者采用常规西药治疗，观察组患者在常规西药治疗基础上采用中药方剂抗肺纤维化方治疗。比较两 组患者的临床疗效、治疗前及治疗 3 个月后中医证候积分、肺功能指标、肺纤维化指标、圣乔治呼吸疾病问卷（SGRQ）、 高分辨计算机断层扫描（HRCT）评分。结果：观察组患者治疗总有效率为 88.67 %，高于对照组的 62.86 %，差异具 有统计学意义（P ＜ 0.05）。治疗后观察组患者的乏力、呼吸气短、自汗、咳嗽评分均低于对照组，差异具有统计学 意义（P ＜ 0.05）。治疗后观察组患者的第 1 秒用力呼气容积（FEV1）、用力肺活量（FVC）、最大呼气流量（PEF） 均高于对照组，差异具有统计学意义（P ＜ 0.05）。治疗后观察组患者的透明质酸（HA）、层粘连蛋白（LN）、 Ⅲ型胶原（Ⅲ –Col）均低于对照组，差异具有统计学意义（P ＜ 0.05）。治疗后观察组患者的 SGRQ、HRCT 评分均 低于对照组，差异具有统计学意义（P ＜ 0.05）。结论：采用中药方剂抗肺纤维化方与常规西药联合治疗 PF 患者， 能进一步改善患者临床症状，降低肺纤维化程度，增强肺功能，提高临床疗效。     

Effect of different polymers and their combinations on the release of metoclopramide HCl from sustained-release hydrophilic matrix tablets

Metoclopramide HCl (MTC) is commonly used for the management of gastrointestinal disorders. It has a short biological half-life and is usually administered four times daily to maintain effective concentrations throughout the day. The aim of this study is to develop sustained-release hydrophilic matrix tablet formulations of drug to achieve reproducible and predictable release rates, extended duration of activity, decreased toxicity, reduction of required dose, optimized therapy, and improved patient compliance. Hydroxypropylmethyl cellulose (HPMC), carboxymethylcellulose sodium (NaCMC), chitosan and Carbopol 981 were incorporated in the matrix system separately or in combinations as release controlling factor by direct compression technique. Compatibility among the formulation components was assessed by DSC and FTIR analysis. MTC release from matrix was evaluated by using the US Pharmacopeia dissolution apparatus II. All formulations met the criteria of pharmacopeial requirements. Dissolution studies show that polymer type and concentration are important parameters on drug release. Chitosan, carbopol and NaCMC formulations exhibited pH-dependent drug release profile whereas HPMC did not. All the formulations containing 1:1 ratio of HPMC and chitosan exhibited desired drug release showing that all active substance releases progressively in a period of whole dissolution time and therefore it can be regarded as worthy of consideration for the manufacture of sustained-release MTC product.     

贝尼地平治疗原发性高血压的疗效观察

目的探讨贝尼地平治疗原发性高血压的临床疗效。方法选择本院2011年3月至2012年3月前来我院门诊就诊的原发性高血压病患者60例,将60例患者随机分为服用贝尼地平片的治疗组（A组,n=30）和仅服用硝苯地平的对照组（B组,n=30）,治疗随访时间为10周。治疗期间分别记录治疗期间的收缩压、舒张压以及不良反应,结果一个疗程后30例贝尼地平治疗组14例显效,15例有效,1例无效,总有效率96.2%。结论贝尼地平组在降压效果方面明显优于硝苯地平,并且不良反应少,值得临床推广。     

吉法酯片联合抗Hp三联疗法治疗十二指肠溃疡合并Hp感染的临床观察

目的：观察吉法酯片联合抗幽门螺旋杆菌( Helicobacter pylori, Hp)三联疗法治疗十二指肠溃疡合并Hp感染的临床疗效。方法选取诊断为十二指肠溃疡且存在Hp感染的患者92例,将其随机分为两组,对照组45例,联合用药组47例。两组均口服进行给药,对照组服用兰索拉唑15 mg+克拉霉素0.5 g+阿莫西林0.1 g,早晚各1次;联合用药组在对照组基础上加用吉法酯片50 mg早晚各1次。两组患者均治疗两个疗程(7天/疗程),对比并观察两组的疗效差异、 Hp的转阴率及不良反应的发生情况。结果联合用药组的总有效率为100%,对照组的总有效率为82.23%;联合用药组的Hp转阴率为93.62%,对照组的Hp转阴率为77.78%;将两组治愈结果和Hp转阴率分别进行比较,差异均具有显著性( P<0.05);两组不良反应发生率均较低,且无显著性差异(P>0.05)。结论吉法酯片联合抗Hp三联疗法治疗十二指肠溃疡合并Hp感染的临床疗效显著,同时提高了Hp的转阴率,该治疗方案值得临床上进行推广。     

疏肝化痰消癖散与乳块消片治疗肝郁气滞型乳腺增生症的疗效对比

目的：比较疏肝化痰消癖散[1]与乳块消片[2]治疗肝郁气滞型乳腺增生症的疗效。方法随机选取该院2012年9月—2014年10月收治的肝郁气滞型乳腺增生症[3]患者80例为研究对象,随机分为治疗组和对照组两组,治疗组采用疏肝化痰消癖散进行治疗,对照组采用乳块消片进行治疗。观察两组患者的病情好转情况,统计治愈率和总有效率。结果经过统计分析后,治疗组采用疏肝化痰消癖散进行治疗的总有效率为80%,对照组采用乳块消片进行治疗的总有效率为70%,治疗组总体有效率高于治疗组的10.0%。两组之间的差异有统计学意义(P＜0.05)。两组患者在治疗期间都没有发生严重不良反应,主要是轻微的消化道反应,患者可以忍受。结论治疗组的治愈率、总有效率均明显高于对照组(P＜0.05)。因此,疏肝化痰消癖散治疗乳腺增生的临床疗效明显,同时病情不易复发,不良反应小,适用于乳腺增生患者的临床治疗。     

厄贝沙坦氢氯噻嗪片在原发性高血压治疗中的应用效果评价

目的探讨原发性高血压患者使用厄贝沙坦氢氯噻嗪片的临床疗效。方法随机选取该院收治的140例原发性高血压患者,将其随机分为A、B两组,每组70例患者,A组使用厄贝沙坦片进行治疗,B组则使用厄贝沙坦氢氯噻嗪片治疗,对比两组相关指标。结果 A组使用厄贝沙坦片进行治疗后收缩压为（140.3±11.7）,B组则使用厄贝沙坦氢氯噻嗪片治疗后收缩压为（129.4±12.3）;A组使用厄贝沙坦片进行治疗后舒张压为（86.2±7.7）,B组则使用厄贝沙坦氢氯噻嗪片治疗后舒张压为（81.1±5.3）。 A组使用厄贝沙坦片进行治疗的有效率为82.86%,B组使用厄贝沙坦氢氯噻嗪片治疗有效率为91.43%。结论原发性高血压患者使用厄贝沙坦氢氯噻嗪片进行治疗具有很好的治疗效果,不良反应较少,安全性高,值得广泛临床推广。