吸入沙美特罗替卡松联合特异性脱敏防治支气管哮喘的研究

目的观察吸入沙美特罗替卡松联合特异性脱敏防治支气管哮喘的疗效。方法常见变应原皮内试验,根据试验结果,行特异性脱敏,阶梯式吸入沙美特罗替卡松干粉剂,峰速仪监测PEFam值,疗程1年。结果临床控制率80% ,显效率88% ,总有效率100%。结论特异性脱敏联合吸入沙美特罗替卡松可有效的防治支气管哮喘。     

Formulation of a novel fixed dose combination of salmeterol xinafoate and mometasone furoate for inhaled drug delivery

Co-administration of an inhaled corticosteroid and long acting beta agonist for chronic obstructive pulmonary disease has reduced mortality compared to either drug alone. This combination reduces exacerbations, hospitalization, emergency department visits and health care costs. A novel fixed-dose combination of the long acting beta-2 agonist salmeterol xinafoate (SX) and the corticosteroid mometasone furoate (MF) were prepared in a composite particle formulation as brittle matrix powder (BMP) and investigated for suitability as an inhaled combination product. In this study, BMP fixed dose combinations of SX and MF with or without stabilizing excipients (lactose, mannitol, glycine and trehalose) were prepared and characterized with respect to their thermal properties, morphology, aerodynamic performance and physical stability. BMP combination formulations of SX and MF exhibited improved aerodynamic properties when delivered by dry powder inhalation as compared to the micronized blends of the same substances. Aerodynamic evaluation was carried out by next generation pharmaceutical impactor (NGI) with a marketed DPI device. Results demonstrated that co-deposition occurred when SX and MF were formulated together as composite particles in a BMP, while physical blends resulted in inconsistent deposition and dose uniformity. As a result of the bottom-up particle engineering approach, combination BMP formulations allow for dual API composite formulations to be dispersed as aerosolized particles. Aerosolized BMP combination formulations resulted in delivered dose uniformity and co-deposition of each API. Further, an excipient-free formulation, BMP SXMF, delivered approximately 50% of the loaded dose in the respirable range and demonstrated stability at ambient conditions for 6 months. Single dose 24-h pharmacokinetic studies in rats demonstrated that lung tissue deposition and blood circulation (AUC_0–24h) of two APIs were higher for the BMP combination group exhibiting a significantly higher lung concentration of drugs than for the crystalline physical blend. While high system drug levels are generally undesirable in lung targeted therapies, high blood levels in this rodent study could be indicative of increased pulmonary tissue exposure using BMP formulations.     

沙美特罗联合丙酸氟替卡松治疗儿童中度哮喘疗效观察

目的:观察用沙美特罗联合丙酸氟替卡松治疗儿童中度哮喘疗效。方法:选择我院2009年1月-2011年1月5～14岁符合中度哮喘诊断标准的患儿136例,随机分为沙美特罗联合丙酸氟替卡松治疗组68例与丙酸氟替卡松对照组68例,随访1年,观察无症状的时间、急诊就医次数及PEF(最大呼气流量)在治疗前后的变化。结果:治疗后治疗组无症状的时间、急诊就医次数及PEF的提高优于对照组,两组比较差异有显著统计学意义(P<0.01)。结论:沙美特罗联合丙酸氟替卡松治疗儿童中度哮喘疗效优于单独使用丙酸氟替卡松治疗。     

孟鲁司特联合沙美特罗替卡松治疗儿童支气管哮喘疗效分析

目的：分析孟鲁司特联合沙美特罗替卡松治疗儿童支气管哮喘的疗效。方法：以我院2012年4月～2015年4月收治的60例支气管哮喘患儿为研究对象,以随机双盲法将其分为两组,各30例,对照组采取单纯沙美特罗替卡松治疗,观察组在对照组基础上联合孟鲁司特治疗,比较两组临床疗效、临床症状缓解时间及治疗前后肺功能达标情况。结果：观察组总有效率、治疗3个月肺功能达标率分别为96.7%、73.3%,较对照组的80.0%、43.3%差异有统计学意义（P＜0.05）。两组喘息消失时间[（4.6±1.5）VS（5.8±1.3）]d、气促消失时间[（5.3±2.2）VS（6.5±2.3）]d、肺部啰音消失时间[（5.5±2.4）VS（7.8±2.3）]d比较差异有统计学意义（P＜0.05）。结论：孟鲁司特联合沙美特罗替卡松治疗儿童支气管哮喘疗效明确,能明显改善临床症状,促进肺功能恢复,值得临床推广。     

The functional impact of adding salmeterol and tiotropium in patients with stable COPD

The aim of this double-blind, double-dummy, crossover, randomised, pilot study was to explore the acute effects of adding salmeterol and tiotropium in patients with stable COPD. A total of 20 outpatients with stable COPD were enrolled. Single doses of 18-microg tiotropium, 50-microg salmeterol, and 18-microg tiotropium+ 50-microg salmeterol were given. Serial measurements of forced expiratory volume in 1 s (FEV1) were performed over 24h. The mean maximum increases in FEV1 from pre-dosing value on each of the dosing days were 0.165l (95% CI: 0.098-0.232) for tiotropium, 0.241 l (95% CI: 0.151-0.332) for salmeterol, and 0.290 l (95% CI: 0.228-0.353) for the combination and occurred 4 h after inhalation of tiotropium or salmeterol and 3 h after the combination. At 12h, the mean increases in FEV1 from pre-dosing value were 0.071 l (95% CI: 0.001-0.141; P = 0.047) for tiotropium, 0.069 l (95% CI: 0.018-0.120; P = 0.010) for salmeterol, and 0.108 l (95% CI: 0.047-0.170; P = 0.001) for the tiotropium + salmeterol combination. Only the difference between salmeterol and tiotropium + salmeterol was statistically significant (P = 0.009). At 24h, the mean FEV1 value was still higher than the mean pre-dosing value for tiotropium (0.042 l; 95% CI: -0.012-0.097; P=0.119) and the tiotropium+salmeterol combination (0.051 l; 95% CI: 0.01 5-0.087; P = 0.007), but not for salmeterol alone (-0.013 l; 95% CI: -0.041-0.014; P = 0.324). The FEV1 area under the curve (AUCs0-12h) were 1.657 l (95% CI: 1.152-2.162) for tiotropium, 2.068 (95l CI: 1.385-2.752) for salmeterol, and 2.541 l (95% CI: 1.954-3.129) for tiotropium + salmeterol. Only the difference between tiotropium and the tiotropium +salmeterol combination was statistically significant (P = 0.01). The FEV1 AUCs0-24h were 2.854 l (95% CI: 1.928-3.780) for tiotropium, 2.786 l (95% CI: 1.913-3.660) for salmeterol, and 3.640 l (95% CI: 2.674-4.605) for tiotropium + salmeterol. ALL differences between treatments were not statistically significant (P> 0.05). These results seem to indicate that the use of the tiotropium + salmeterol combination is more efficacious than the single agents alone, but the once-daily administration of the two drugs is inadvisable due to the broncholytic profile of salmeterol.     

珠贝定喘丸联合沙美特罗替卡松治疗儿童支气管哮喘的疗效观察

目的 探讨珠贝定喘丸联合沙美特罗替卡松治疗儿童支气管哮喘的临床效果。方法 选取2016年9月-2018年9月河南科技大学第一附属医院（开元院区）收治的支气管哮喘患儿116例,随机分为对照组（58例）和治疗组（58例）。对照组吸入沙美特罗替卡松气雾剂,1揿/次,1次/d;治疗组患儿在对照组的基础上口服珠贝定喘丸,3~4岁儿童1丸/次,5~6岁2丸/次,7~8岁3丸/次,9~10岁4丸/次,11~13岁5丸/次,3次/d。两组患儿连续治疗3个月。观察两组患者临床疗效,同时比较治疗前后两组患者症状和体征消失时间,肺功能指标一秒用力呼气容积（FEV₁）、用力肺活量（FVC）和FEV₁/FVC,及血气指标血氧分压（pO₂）和二氧化碳分压（pCO₂）。结果 治疗后,对照组和治疗组临床有效率分别为84.48%和96.55%,两组比较差异具有统计学意义（P<0.05）。治疗组患儿症状、体征消失时间均明显短于对照组（P<0.05）。治疗后,两组FEV₁、FVC、FEV₁/FVC均显著升高（P<0.05）,且治疗组明显高于对照组（P<0.05）。治疗后,两组患儿pO₂明显升高（P<0.05）,而pCO₂明显降低（P<0.05）;且治疗组患儿pO₂和pCO₂明显好于对照组（P<0.05）。结论 珠贝定喘丸联合沙美特罗替卡松治疗小儿支气管哮喘可显著提升疗效,有助于改善肺功能并缩短病程时间,且安全性较高。     

沙美特罗替卡松联合孟鲁斯特对哮喘患儿IL－4 INF－γIgE EOS 影响研究

目的：探讨沙美特罗替卡松联合孟鲁斯特治疗支气管哮喘患儿对临床疗效、免疫功能的影响。方法：选取我院自2011年1月至2013年12月收治的哮喘患儿102例,按治疗方法的不同分为试验组及对照组,各51例。对照组患儿给予沙美特罗替卡松粉吸入剂,试验组在此基础上给予口服孟鲁司特钠。观察患儿治疗前后临床疗效及免疫功能的情况。结果：试验组患儿治疗总有效率为96．1％,对照组患儿治疗后总有效率为82．4％,试验组患儿治疗后总有效率显著优于对照组,差异有统计学意义（P＜0．05）。两组患儿治疗前肺功能达标率,差异无统计学意义（P＞0．05）。试验组患儿治疗3个月及治疗后3个月肺功能达标率显著优于对照组患儿,差异有统计学意义（ P＜0．05）。两组患儿治疗前IL－4、INF－γ、IgE、EOS无显著差异,差异无统计学意义（ P＞0．05）。两组患儿治疗3个月及治疗后3个月肺功能IL－4、IgE及EOS水平均较治疗前明显降低,而INF－γ较治疗前明显升高（P＜0．05）,试验组患儿治疗3个月及治疗后3个月肺功能IL－4、IgE及EOS水平降低及INF－γ升高有显著差异,差异有统计学意义（ P＜0．05）。结论：应用沙美特罗替卡松联合孟鲁斯特治疗小儿哮喘具有明显疗效,安全性较好,依从性好,值得临床推广。     

肺力咳合剂联合沙美特罗替卡松治疗儿童支气管哮喘的临床研究

目的探究肺力咳合剂联合沙美特罗替卡松粉吸入剂治疗儿童支气管哮喘的临床疗效。方法选取2016年12月—2018年12月天津市儿童医院收治的142例支气管哮喘患儿为研究对象,将所有患儿随机分为对照组和治疗组,每组各71例。对照组患儿吸入沙美特罗替卡松粉吸入剂,1吸/次,1次/d;治疗组在对照组治疗的基础上口服肺力咳合剂,10 mL/次,3次/d。两组患儿持续治疗3个月。观察两组的临床疗效,比较两组的临床症状缓解时间、肺功能指标、血气指标、血清炎性因子水平。结果治疗后,对照组和治疗组的总有效率分别为84.51%、95.77%,两组比较差异有统计学意义(P0.05)。治疗后,治疗组患儿喘憋、咳嗽、肺部啰音消失时间显著短于对照组,两组比较差异有统计学意义(P0.05)。治疗后,两组患儿第一秒用力呼气容积(FEV1)、用力肺活量(FVC)和FEV1/FVC均显著升高,同组治疗前后比较差异有统计学意义(P0.05);且治疗组患儿肺功能指标明显高于对照组,两组比较差异有统计学意义(P0.05)。治疗后,两组患儿全血氧分压(pO_2)水平明显升高,二氧化碳分压(pCO_2)水平明显下降,同组治疗前后比较差异有统计学意义(P0.05);且治疗组患儿血气指标水平显著优于对照组,两组比较差异有统计学意义(P0.05)。治疗后,两组患儿肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)水平均显著降低,干扰素-γ(IFN-γ)水平显著升高,同组治疗前后比较差异有统计学意义(P0.05);并且治疗组患儿血清炎性因子水平明显优于对照组,两组比较差异有统计学意义(P0.05)。结论肺力咳合剂联合沙美特罗替卡松粉吸入剂治疗儿童支气管哮喘具有较好的临床疗效,可缩短临床症状缓解时间,改善肺部功能,降低血清炎性因子水平,具有一定的临床推广应用价值。     

平喘益气颗粒联合沙美特罗替卡松气雾剂治疗慢性阻塞性肺疾病稳定期的临床研究

目的探讨平喘益气颗粒联合沙美特罗替卡松气雾剂治疗慢性阻塞性肺疾病稳定期的临床疗效。方法选取2017年6月—2018年6月在天津市黄河医院治疗的94例慢性阻塞性肺疾病稳定期患者为研究对象,将患者按随机数表法分为对照组和治疗组,每组各47例。对照组吸入沙美特罗替卡松吸入气雾剂,2揿/次,2次/d。治疗组在对照组基础上口服平喘益气颗粒,2袋/次,3次/d。两组患者连续治疗3个月。观察两组的临床疗效,比较两组的肺功能指标、SGRQ评分、6 min步行距离、免疫功能、炎症因子。结果治疗后,对照组和治疗组的总有效率分别为76.60%、91.49%,两组比较差异有统计学意义(P0.05)。治疗后,两组第1秒用力呼气容积(FEV1)、用力肺活量(FVC)、FEV1/FVC均显著提高,同组治疗前后比较差异有统计学意义(P0.05);且治疗后治疗组FEV1、FVC、FEV1/FVC明显高于对照组,差异有统计学意义(P0.05)。治疗后,两组圣乔治呼吸问卷(SGRQ)评分显著降低,6 min步行距离显著增加,同组治疗前后比较差异有统计学意义(P0.05);且治疗后治疗组SGRQ评分低于对照组,6 min步行距离长于对照组,差异有统计学意义(P0.05)。治疗后,治疗组CD3~+、CD4~+、CD4~+/CD8~+明显高于治疗前,且治疗组CD3~+、CD4~+、CD4~+/CD8~+明显高于对照组,差异有统计学意义(P0.05)。治疗后,两组肿瘤坏死因子-α(TNF-α)、白细胞介素-8(IL-8)水平显著下降,同组治疗前后比较差异有统计学意义(P0.05);且治疗后治疗组炎症因子水平明显低于对照组,差异有统计学意义(P0.05)。结论平喘益气颗粒联合沙美特罗替卡松气雾剂治疗慢性阻塞性肺疾病稳定期具有较好的临床疗效,可改善患者临床症状及肺功能,调节免疫功能及相关炎症因子,提高生活质量,具有一定的临床推广应用价值。