八珍益母草胶囊联合欣妈富隆治疗药物流产后阴道出血临床观察

目的探讨八珍益母草胶囊+欣妈富隆治疗药物流产后阴道出血效果。方法选择2018年6月—2020年7月收治的64例药物流产后阴道出血患者为研究对象,以随机数字表法分为对照组(32例)和研究组(32例)。2组均行清宫术治疗,对照组采用欣妈富隆治疗,研究组在对照组的基础上采用八珍益母草胶囊治疗,2组均治疗3周。观察2组治疗前后阴道出血程度,比较2组临床疗效、子宫纵径、子宫内膜厚度、子宫横径及治疗期间不良反应发生率。结果治疗前,2组阴道出血程度分级差异无统计学意义(P> 0.05),治疗后,2组阴道出血程度分级差异有统计学意义(P <0.05);2组疗效等级差异有统计学意义(P <0.05),且研究组总有效率比对照组高(93.75%VS 71.88%,P <0.05);研究组子宫纵径、子宫横径均比对照组短(P <0.05),且研究组子宫内膜厚度比对照组厚(P <0.05);2组治疗期间不良反应发生率相近(P> 0.05)。结论八珍益母草胶囊+欣妈富隆治疗药物流产后气虚血瘀证阴道出血患者,疗效显著,可促进患者子宫内膜修复,降低阴道出血等级,且安全可靠。     

Impact of fillers on dissolution kinetic of fenofibrate dry foams

Abstract

Dry foam technology reveals the opportunity to improve the dissolution behavior of poorly soluble drugs tending to agglomeration due to micronization. In this study, the impact of fillers on the manufacturability, the properties of dry foams and granules as well as the dissolution kinetics of dry foam tablets was investigated using fenofibrate as a model compound. Different maltodextrins and dried glucose syrups, a maltodextrin–phosphatidylcholine complex, isomalt and a 1:1 mixture of mannitol/glucose syrup were used as filler. Within the group of maltodextrins and glucose syrups, the influences of dextrose equivalent (DE), particle morphology and botanical source of starch were investigated. Comparable macroscopic foam structures were obtained with maltodextrins and glucose syrups whereas different foam morphologies were obtained for the other fillers tested. Regarding the maltodextrins and glucose syrups, different physicochemical and particle properties had a minor impact on granule characteristics and tablet dissolution. Using the maltodextrin–phosphatidylcholine complex resulted in a low specific surface area of the granules and a slow tablet dissolution caused by a slow disintegration. In contrast, a high specific surface area and a fast release were obtained with isomalt and glucose syrup/mannitol mixture indicating that high soluble low molecular weight fillers enable the development of fast dissolving dry foam tablets.     

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.     

曲安奈德配合金纳多治疗单侧急性低频下降型感音神经性聋

目的探讨耳后注射曲安奈德配合金纳多银杏叶提取物片治疗单侧急性低频下降型感音神经性聋(ALHL)临床疗效。方法选取2014-05—2016-09开封市祥符区中医院收治的78例单侧ALHL患者,通过随机数字表法分为研究组与对照组各39例。对照组采用舒血宁注射液+地塞米松注射液治疗,研究组采用曲安奈德+金纳多银杏叶提取物片治疗,2组均持续治疗10d。疗程结束后对比2组临床疗效、不良反应发生率,分析治疗前后血清免疫功能指标(IgM、IgG、CD3~+、CD4~+)水平变化。结果研究组总有效率为94.87%(37/39),高于对照组的74.36%(29/39),差异有统计学意义(P0.05);治疗前2组IgM、IgG、CD3~+、CD4~+水平比较差异无统计学意义(P0.05),治疗后研究组IgM、IgG、CD3~+、CD4~+水平高于对照组,差异有统计学意义(P0.05);研究组不良反应发生率7.69%(3/39),与对照组10.26%(4/39)比较,差异无统计学意义(P0.05)。结论耳后注射曲安奈德配合金纳多银杏叶提取物片治疗单侧ALHL效果显著,可有效提高患者听力水平,且对改善其免疫功能具有重要作用,安全性较高,值得推广。     

来得时联合拜唐平治疗初发Ⅱ型糖尿病疗效观察

目的观察来得时联合拜唐平治疗初发Ⅱ型糖尿病的临床疗效，并作安全性评价。方法将符合初发Ⅱ型糖尿病纳入标准病例90例，按入院顺序随机分为治疗组45例与对照组45例，对照组予以诺和灵30R治疗，治疗组给予来得时联合拜唐平治疗，比较两组的疗效，以及两组治疗前后各项实验室指标的变化情况。结果治疗组总有效率明显优于对照组（P〈O．05），且治疗组在降低空服血糖、餐后2小时血糖及糖化血红蛋白水平方面均明显优于对照组（P〈0．05或P〈0．01）。治疗组低血糖发生率明显低于对照组，差异有统计学意义（P〈0．05）。结论来得时联合拜唐平治疗初发Ⅱ型糖尿病疗效确切，安全有效，低血糖发生率低，值得临床推广应用。     

Prediction of oral disintegration time of fast disintegrating tablets using texture analyzer and computational optimization

One of the promising approaches to predict in vivo disintegration time of orally disintegrating tablets (ODT) is the use of texture analyzer instrument. Once the method is able to provide good in vitro in vivo correlation (IVIVC) in the case of different tablets, it might be able to predict the oral disintegration time of similar products. However, there are many tablet parameters that influence the in vivo and the in vitro disintegration time of ODT products. Therefore, the measured in vitro and in vivo disintegration times can occasionally differ, even if they coincide in most cases of the investigated products and the in vivo disintegration times may also change if the aimed patient group is suffering from a special illness. If the method is no longer able to provide good IVIVC, then the modification of a single instrumental parameter may not be successful and the in vitro method must be re-set in a complex manner in order to provide satisfactory results. In the present experiment, an optimization process was developed based on texture analysis measurements using five different tablets in order to predict their in vivo disintegration times, and the optimized texture analysis method was evaluated using independent tablets.     

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。     

应用解剖型补片行开放TEP腹股沟疝修补术效果研究

目的 通过应用解剖型补片行开放TEP腹股沟疝修补术与应用双层补片行无张力疝修补法进行比较,探讨解剖型补片行开放TEP手术的临床效果.方法 回顾性分析我院2010年1月至2011年9月收治的腹股沟斜疝患者109例,随机分为实验组(开放TEP组)和对照组(双层补片组).分析二组患者的手术时间、术后发生疼痛、神经感觉异常、阴囊肿胀、尿潴留、复发等情况以及恢复正常活动的时间等指标.结果 实验组的各项指标均优于对照组,差异有统计学意义(P<0.05).结论 应用解剖型补片的开放TEP手术具有手术操作简单、操作时间短、创口小、损伤小的优点,更符合人体生理解剖特点,尤其在双侧腹股沟疝修补手术的应用中更具有优势,值得临床推广.     

阑尾消炎片联合抗生素治疗急、慢性阑尾炎96例临床体会

目的观察阑尾消炎片联合抗生素治疗急性阑尾炎的效果。方法采取阑尾消炎片口服,同时给予抗生素静点。结果本文报道96例,以用药一周为疗效统计依据。痊愈64例(66.66%),有效13例(13.54%),无效19例(19.79%),治愈率66.66%。结论口服阑尾消炎片联合抗生素口服或静点治疗阑尾炎效果很好,此种治疗方法可以免除一些不必要的手术,减少患者痛苦及经济上负担。     

盐酸昂丹思琼的两种不同剂型的临床应用研究

目的观察盐酸昂丹司琼口腔崩解片与注射液两种剂型的临床应用情况。方法选取拟行TACE治疗的肝癌患者38例,按随机原则分为A组和B组,各19例。A组在TACE围手术期使用盐酸昂丹司琼口腔崩解片,B组在TACE围手术期使用盐酸昂丹司琼注射液。观察两组术后恶心、呕吐的发生率及输液量的差异。结果 A组的恶心、呕吐的发生率及输液量均显著低于B组。结论盐酸昂丹司琼的两种剂型均可有效地预防和治疗肝癌TACE后的恶心、呕吐,口腔崩解片较注射液更有效、更安全、更便捷。