Systemic effects of two nasally administered glucocorticosteroids

Two topical corticosteroids, budesonide (BUD) and beclomethasone dipropionate (BDP), both administered as suspensions in water, were investigated in healthy volunteers regarding influence on cortisol in plasma and urine (U-cortisol) after nasal application. In the first study, single doses of 200, 400, and 800 μg of BDP and BUD were given at 10:00 pm. In the second study, 100, 200, and 400 μg were given mornings and evenings for 4 days. In the single-dose study, none of the drugs or doses showed any significant influence on cortisol in plasma. However, U-cortisol decreased significantly after BUD 400 and 800 μg. In the multidose study, U-cortisol values were significantly reduced after all doses of BUD and the highest dose of BDP. The compounds tested showed different ability to cause measurable systemic effects after nasal application. The clinical implication is that the prescriber, when choosing a compound, should take the application site into consideration and should also be encouraged to find the lowest effective dose.     

Pulmonary tuberculosis in patients treated with inhaled beclomethasone

Inhaled beclomethasone dipropionate (BDP) has been used with few side effects in the treatment of bronchial asthma for 2 decades. Until now the manifestation of tuberculosis (TB) in patients on inhaled BDP has not been reported. Eight patients with allergic asthma, of a total of 548 asthmatics (1.46%) seen over a 2-year period, developed active TB following the use of inhaled BDP. All were sputum-positive for acid-fast bacilli (AFB) on smear and/or culture, all responded well to a combination of anti-TB drugs, and none showed evidence of immunological or pituitary-adrenal suppression. Two patients agreed to a repeat administration of BDP; both developed TB again within 2 weeks and are again on anti-TB treatment.     

Efficacy response of inhaled beclomethasone dipropionate in asthma is proportional to dose and is improved by formulation with a new propellant

BACKGROUND: This study tested the hypothesis that there would be improved asthma control with increasing doses of beclomethasone dipropionate (BDP) formulated in hydrofluoroalkane-134a (HFA-BDP) and the standard chlorofluorocarbon propellants (CFC-BDP). Because HFA-BDP has improved lung deposition compared with CFC-BDP, this study also tested the hypothesis that HFA-BDP would provide more effective control of asthma than CFC-BDP. METHODS: In this multicenter, randomized, parallel-group blinded study, asthmatic subjects who had deterioration in asthma control after discontinuation of inhaled corticosteroids were randomized to receive one of 6 possible treatments: 100 microg/d, 400 microg/d, or 800 microg/d of HFA-BDP or 100 microg/d, 400 microg/d, or 800 microg/d of CFC-BDP for 6 weeks. Changes in spirometry, daytime asthma symptom and nighttime asthma-related sleep disturbance scores, morning and evening peak expiratory flows, and daily use of inhaled beta-agonist for symptom control on diary cards were assessed over 6 weeks of treatment. RESULTS: Three hundred twenty-three patients were randomized to the 6 treatment groups, which had similar demographics and baseline lung function. There were significantly larger changes from baseline at week 6 in FEV(1) percent predicted with increasing doses of both HFA-BDP and CFC-BDP. The FEV(1) percent predicted dose-response curve for HFA-BDP was shifted to the left compared with the dose-response curve for CFC-BDP. By using the Finney bioassay method, it was calculated that 2.6 times as much CFC-BDP would be required to achieve the same improvement in FEV(1) percent predicted as HFA-BDP (95% confidence interval, 1.1-11.6). All treatment groups except the 100 microg/d CFC-BDP group tolerated study drug well. Ten (17%) of 59 patients in this group reported an acute asthma episode, increased asthma symptoms (6 of the 8 reports of increased asthma symptoms were classified as severe), or both, and 8 patients withdrew from the study (3 for adverse events related to asthma). CONCLUSIONS: Increasing doses of inhaled corticosteroids lead to improved lung function and asthma control. Moreover, the reformulation of BDP in HFA enables effective asthma control at much lower doses than CFC-BDP.     

低剂量丙酸倍氯松吸入对轻度哮喘儿童气道高反应性的影响

为探讨低剂量丙酸倍氯松吸入对轻度哮喘儿童肺功能及气道高反应性的影响,将 ３０例轻度哮喘患儿（年龄 ５～ １４岁,男２１例,女 ９例）随机分为 ３组（每组 １０例）,分别吸入安慰剂,ＢＤＰ２００或４００μｇ／日,结果：患儿吸入２００或４００μｇ／日的ＢＤＰ后,哮喘症状明显改善, ＦＥＶＩ及 ＰＥＦ明显升高。且Ｌｏｇ［ＰＤ２０ＦＥＶ１（μｇ）］显著增加即 ＢＨＲ显著下降。其下降程度随吸药时间的延长而增加,而对照组的各项指标均无明显变化。２００μｇ组及４００μｇ组间有关临床症状改善,各项肺功能指标及 ＢＨＲ的变化,不存在显著差异（Ｐ均＜０．０５）。结论：吸入２００μｇ／日的ＢＤＰ即能有效地控制轻度儿童哮喘患者的临床症状,改善其肺功能并降低ＢＨＲ,将剂量增力。至４００μｇ／日并不能明显增力。疗效。建议临床上使用ＢＤＰ吸入疗法治疗轻度儿童哮喘时,宜采用２００μｇ／日为常规剂量。     

高效液相色谱法测定无极膏中丙酸倍氯米松的含量

建立高效液相色谱法测定无极膏中丙酸倍氯米松的含量.色谱柱为Hypersil ODS2(4.6×250mm),流动相为甲醇-水(64:36);流速为1.0ml·min-1;检测波长为240 nm;线性范围为2.0～18.0μg·ml-1(r=0.9998);高、中、低三种不同浓度的平均回收率为98.83%～101.2%;RSD为1.25%.本法简便、准确、可靠,可有效地控制无极膏的质量.     

皮损内注射治疗瘢痕疙瘩规律停药的临床研究

目的：探讨皮损内注射得宝松规律性停药对治疗瘢痕疙瘩临床效果的影响。方法：选择2007年1月-2014年12月期间到本院就诊的符合瘢痕疙瘩诊断的患者156例,采用随机数字表法将其分成A、B两组,A组为试验组共81例,B组为对照组共75例。A组在瘢痕疙瘩皮损内注射,采取逐渐减少浓度的方法规律停药;B组采用常规疗程停药方法。观察6个月,评估两组患者治疗效果及复发情况。结果：两组在治疗后1个月与治疗后6个月效果差异均无统计学意义（P>O.01）;治疗组复发率低于对照组,两组比较差异有统计学意义（P相似文献   

A comparison of the effects of oral prednisone and inhaled beclomethasone dipropionate on circulating leukocytes

Background: While the side effects of oral glucocorticoids are well recognised there is debate about the systemic effects of high doses of inhaled glucocorticoids such as beclomethasone dipropionate and how these compare with the effects of oral prednisone. Aim: To compare the effects of different doses of oral prednisone and inhaled beclomethasone dipropionate (BDP) on changes in circulating leukocytes. Methods: Changes in different subsets of circulating leukocytes were measured as an index of the systemic effects of inhaled BDP and oral prednisone. We compared the effects of inhaled placebo and 500 and 1000 μg of inhaled BDP with oral placebo and 2.5, 5 and 10 mg of prednisone in eight healthy volunteers. Leukocyte numbers were measured before and four hours after each dose of medicine. Results: Compared with inhaled placebo, 1000 (xg of inhaled BDP led to a significant increase in neutrophils as a percentage of the total white count (ρ<0.05) and a significant decrease in the total lymphocyte number (ρ<0.05) and in the number of CD4 lymphocytes (ρ<0.05). For 1000 μg BDP the increase in the % neutrophil count was 8.55% (95% CI 5.17 to 11.93) and the fall in lymphocyte numbers was -0.14X107L (95% CI 0.06 to -0.34) while 2.5mg prednisone led to an increase in the % neutrophil count of 9.31% (95% CI 5.82 to 12.80) and a fall in lymphocyte numbers of -0.07X 107L (95% CI 0.05 to -0.19). Conclusions: The systemic effects of 1000 μg inhaled BDP and 2.5 mg of prednisone are similar.     

Bronchial hyperresponsiveness in a patient with systemic mastocytosis

In order to investigate the possible involvement of airway mast cells in bronchial hyperresponsiveness (BHR), we examined whether a patient with systemic mastocytosis would demonstrate BHR against ultrasonically nebulized distilled water (UNDW) and histamine inhalation challenge. A 56-year-old man with systemic mastocytosis underwent both UNDW and histamine inhalation challenge. We also evaluated the effect of beclomethasone dipropionate inhalation (BDI) treatment on the histamine inhalation challenge. The results showed that UNDW inhalation caused no changes in forced expiratory volume in 1 s (FEV1) for this patient. The provocative dose causing a 20% fall (PC20) in FEV1 in the histamine inhalation challenge was 625 microg/mL. After BDI treatment for 8 weeks, the histamine PC20 was still 625 microg/mL. These data suggest that UNDW-induced bronchoconstriction may be independent of airway mast cells and that the mechanism of histamine-induced bronchoconstriction in systemic mastocytosis may be independent of airway inflammation, which is often present in asthmatics.