田口设计筛选硝苯地平喷雾干燥分散体的处方研究

目的 考察喷液处方对硝苯地平喷雾干燥分散体（spray dried dispersion,SDD）的表征和非漏槽条件下溶出度的影响。方法 采用minitab DOE（design of experiment）中的田口设计（Taguchi design）方法,以120 min以内的溶出度曲线下面积（AUC0~120 min）及120 min时的溶出浓度和最大浓度的比值（C₁₂₀/C_max）为评价指标,考察载体材料的种类和用量及喷雾溶液的固含量对硝苯地平SDD的药物存在状态和体外溶出度的影响。结果 硝苯地平与聚合物的比例对固体分散体中药物的存在状态和体外溶出度均有显著影响,固含量对结果影响较小。以共聚维酮为载体材料时,可以获得比醋酸羟丙甲基纤维素琥珀酸酯（HPMCAS）更高的最大溶出浓度（C_max）,但是HPMCAS的抑制药物重结晶的效果明显优于共聚维酮,其中药物-HPMCAS LG 1∶4时可以获得最大的C_max和AUC_{0~120 min}。结论 硝苯地平与HPMCAS LG按照1∶4的比例配成固含量10%的溶液进行喷雾干燥,可以制得溶出度显著改善的SDD。     

InVitro Evaluation of Optimal Inhalation Flow Patterns for Commercial Dry Powder Inhalers and Pressurized Metered Dose Inhalers With Human Inhalation Flow Pattern Simulator

This study aimed at developing a novel analytical method to identify optimal inhalation flow patterns for commercial dry powder inhalers (DPIs) and pressurized metered dose inhalers (pMDIs). As typical commercial DPI and pMDI, Pulmicort^® Turbuhaler^®, and Sultanol^® Inhaler were evaluated by an in vitro inhalation performance testing system with a flow pattern simulator. An 8-stage Andersen cascade impactor (ACI) or twin stage liquid impinger (TSLI) was applied to determine the inhalation performance. The peak flow rate (PFR) of the inhalation flow pattern was set from 15 to 80 L/min in reference to our previous study. From TSLI test results, a higher PFR improved the inhalation performance of the DPI, while the performance of the pMDI was less affected by the PFR. Conversely, from ACI test results, the pMDI performance decreased with a higher PFR, while the DPI followed a similar pattern as in the TSLI test results, because ACI is a finer aerodynamic classification apparatus than TSLI. These results suggested that our in vitro system using a human inhalation flow pattern simulator successfully detected different optimal inhalation patterns between DPI and pMDI. That is, the higher PFR is better for Pulmicort^® Turbuhaler^® (DPI). Conversely, lower PFR is desirable for Sultanol^® Inhaler (pMDI).     

Electrostimulating device in the management of xerostomia

INTRODUCTION: The present study was undertaken to evaluate the safety and effectiveness of a recently developed electrostimulating device mounted on an individualized intra-oral removable appliance. MATERIALS AND METHODS: The device, containing electrodes, a wetness sensor, an electronic circuit and a power source, was tested on patients with xerostomia in a crossover, randomized, sham-controlled, double-blinded, multicenter study. Electrical stimulation and also sham were delivered during 10 min to the oral mucosa, in the mandibular third molar region. Oral dryness was measured by the sensor. As the primary outcome, sensor dryness and xerostomia symptom changes as a result of device wearing were assessed, and compared between active and sham modes. In addition, side-effects were recorded. RESULTS: Electrostimulation resulted in a significant decrease in sensor dryness, leading to a beneficial effect on patients' subjective condition. No significant side-effects were observed.     

Safety and effectiveness of topical dry mouth products containing olive oil, betaine, and xylitol in reducing xerostomia for polypharmacy-induced dry mouth

Polypharmacy is a common cause of salivary hypofunction, producing symptoms of dry mouth or xerostomia, especially among older populations. As the number of older people continues to increase, polypharmacy-induced salivary hypofunction is becoming an increasing problem. Many over-the-counter products are available for relieving symptoms of dry mouth, but few have been tested in controlled clinical investigations. The purpose of this investigation was to evaluate the safety and efficacy of a group of topical dry mouth products (toothpaste, mouth rinse, mouth spray and gel) containing olive oil, betaine and xylitol. Forty adults were entered into this single-blinded, open-label, cross-over clinical study and 39 completed all the visits. Subjects were randomly assigned at baseline to using the novel topical dry mouth products daily for 1 week, or to maintain their normal dry mouth routine care. After 1 week, they were crossed over to the other dry mouth regimen. The results demonstrated that the use of the novel topical dry mouth products increased significantly unstimulated whole salivary flow rates, reduced complaints of xerostomia and improved xerostomia-associated quality of life. No clinically significant adverse events were observed. These data suggest that the daily use of topical dry mouth products containing olive oil, betaine and xylitol is safe and effective in relieving symptoms of dry mouth in a population with polypharmacy-induced xerostomia.     

中西医结合治疗围绝经期干眼疗效Meta分析

目的系统评价中西医结合治疗围绝经期干眼的临床疗效。方法计算机检索建库至2020年2月CNKI、万方、维普及PubMed等数据库,搜集相关中医药联合西医治疗围绝经期干眼的临床随机对照试验研究。由2名研究者独立筛选文献、提取资料并评价纳入研究的风险偏倚,运用RevMan 5.3软件对所纳入研究进行Meta分析。结果共纳入11项随机对照试验研究,合计622例受试者,其中治疗组312例,对照组310例。Meta分析结果表明,与单纯西医治疗相比,中西医结合治疗围绝经期干眼在总有效率(OR=4.90,95%CI[2.49,9.64],Z=4.60,P=0.000)、泪膜破裂时间(MD=1.46,95%CI[0.88,2.03],Z=4.97,P=0.000)、基础泪液分泌量(MD=1.64,95%CI[1.34,1.94],Z=10.74,P=0.000)、角膜荧光素钠染色(MD=-0.49,95%CI[-0.61,-0.38],Z=8.63,P=0.000)、主观症状积分(MD=-1.16,95%CI[-1.66,-0.67],Z=4.60,P=0.000)方面更优。结论检索得的证据表明,中西医结合治疗围绝经期干眼的临床疗效优于单纯西医治疗。     

雷火灸技术及其在干眼的临床进展

干眼是眼科临床的常见病、多发病之一,其治疗也成为眼科的一大难题。近年来,随着社会的发展,生活环境的改变,干眼发病率逐年上升且呈低龄化趋势,其临床治疗已成为眼科疾病研究的热点。目前,相比西医的人工泪液、自身血清、眼表损伤修复药物、手术及抗炎和免疫抑制剂等药物的对症治疗,中医非药物疗法雷火灸技术借助其温通作用在干眼治疗中有较好的应用,且取得较好的效果。本文通过对近年来雷火灸技术在干眼的临床应用及护理研究现状进行综述,以期为临床提供参考依据。     

陈皮压制饮片的煎煮质量评价

目的:评价陈皮压制饮片的煎煮质量。方法:采用传统煎煮法,以橙皮苷含量和干膏率为评价指标,考察陈皮压制饮片和普通饮片的煎煮溶出情况及二者在中药复方中的煎煮溶出情况。采用高效液相色谱法测定橙皮苷的含量;采用相似因子f2法比较二者溶出曲线的相似性。结果:在单味饮片和复方的煎煮中,压制饮片的干膏率和橙皮苷含量均高于普通饮片,但差异无统计学意义(P>0.05);f2相似因子比较结果f2=82,表明压制饮片和传统饮片溶出行为相似。结论:陈皮压制饮片不影响陈皮的煎煮溶出效果,且有效成分橙皮苷的含量较高,并具有易于运输、贮藏等优点,符合中药现代化的要求。     

自拟益气养阴散瘀方治疗干眼症的疗效及安全性分析

目的：探讨自拟益气养阴散瘀方对干眼症的临床疗效和安全性。

方法：将2009-01/2012-12我院眼科收治78例96眼干眼患者随机分为两组,对照组给予局部人工泪液,观察组增加中药益气养阴散瘀方治疗,比较两组泪液分泌量(Schirmer Ⅰ test,SⅠt)、泪膜破裂时间(BUT)、角膜荧光素染色(FL)及临床疗效。

结果：治疗后,两组SⅠt,BUT均高于治疗前,FL低于治疗前,差异有统计学意义(P<0.05),观察组SⅠt,BUT高于对照组,FL低于对照组,差异有统计学意义(P<0.05); 经治疗后观察组有效率为83%,对照组为71%,两组患者疗效差异有统计学意义(Ridit z=24.382,P=0.000),观察组疗效优于对照组。

结论：中药益气养阴散瘀方无明显毒副作用,能够改善干眼症临床症状,值得临床推广应用。     

飞秒激光制瓣LASIK术后不同性别泪膜的变化与分析

目的：观察飞秒激光制瓣LASIK术后不同性别泪膜的变化。

方法：收集2013-08/09于我院行飞秒激光制瓣LASIK术并随访3mo的患者120例240眼,将其按性别分为两组,A组：男55例110眼,B组：女65例130眼,观察两组术前、术后1wk; 1,2,3mo患者的干眼症状评分、泪膜破裂时间(break-up tear time,BUT)、泪液分泌试验(Schirmer Ⅰ test,SⅠt)、角膜荧光素染色(corneal fluorescence stain,FL)评分的变化。

结果：主观干眼症状评分：两组术后1wk; 1,2mo差异有统计学意义(P=0.000,0.023, 0.030),术后3mo差异无统计学意义(P=0.283)。 BUT：两组术后1wk; 1,2,3mo差异有统计学意义(P=0.000,0.017, 0.026, 0.032)。 SⅠt：两组术后1wk; 1,2mo差异有统计学意义(P=0.012,0.024, 0.018),术后3mo差异无统计学意义(P=0.206)。 FL评分：两组术后1wk; 1,2,3mo差异有统计学意义(P=0.022,0.015, 0.036, 0.041)。

结论：飞秒激光制瓣LASIK术后泪膜功能的影响男性小于女性。     

小牛血去蛋白提取物眼用凝胶治疗儿童干眼症的疗效

目的:评估小牛血去蛋白提取物眼用凝胶治疗儿童干眼症的效果。方法:干眼症儿童100例200眼被随机平均分为对照组和试验组,对照组用1g/L玻璃酸钠滴眼液4次/d,试验组用小牛血去蛋白提取物眼用凝胶4次/d;两组同时去除病因治疗。对比分析治疗前与治疗后30d的症状评分、SchirmerⅠ、泪膜破裂时间(BUT)、角膜荧光素染色评分。结果:各组治疗前后各项评分比较有统计学意义(P<0.05);两组治疗后各项评分比较有统计学意义(P<0.05)。结论:小牛血去蛋白提取物眼用凝胶能有效治疗儿童干眼症。