3种方案治疗儿童流感样症状的成本效果分析

目的:评价磷酸奥司他韦颗粒以及联合百蕊颗粒和三臣散治疗儿童流感样症状的经济性。方法:采用前瞻性实际临床试验法将2017年12月-2018年2月门急诊收治的流感样症状患儿270例随机分成奥司他韦颗粒(A组)、磷酸奥司他韦颗粒联合百蕊颗粒(B组)和磷酸奥司他韦颗粒联合三臣散(C组)3组,收集效果和成本数据。从患儿家长角度出发,采用成本-效果法进行分析。结果:实际纳入奥司他韦颗粒82例、磷酸奥司他韦颗粒联合百蕊颗粒82例和磷酸奥司他韦颗粒联合三臣散80例。3组的总有效率分别是80.49%,96.34%,88.75%。差异有显著性(P=0.005<0.05),不良反应发生率分别是6.1%,7.32%,7.5%,差异无显著性(P=0.93>0.05)。3组平均医疗总成本分别是547.63,604.40,590.82元,发热缓解时间分别是2.93,1.99,2.24d,总成本和发热缓解时间均有显著性(P=0.000<0.05)。以总有效率为效果指标,C/E分别是680.37,327.36,665.71,增量成本效果比(ICER)以成本最小的A组为对照,B组358.17,C组522.88。结论:以总有效率为效果指标,磷酸奥司他韦颗粒联合百蕊颗粒在3组中疗效较好,C/E值和并发症较低,是较经济的方案。     

噻托溴铵粉雾剂联合沙美特罗替卡松粉吸入剂治疗慢性阻塞性肺疾病急性加重期伴呼吸衰竭的临床研究

目的观察噻托溴铵粉雾剂联合沙美特罗替卡松粉吸入剂治疗慢性阻塞性肺疾病(COPD)急性加重期伴呼吸衰竭的临床疗效及安全性。方法将76例COPD急性加重期伴呼吸衰竭患者随机分为对照组38例和试验组38例。对照组予以常规治疗配合呼吸机辅助通气治疗;试验组在对照组治疗的基础上,予以沙美特罗替卡松粉吸入剂每次1吸,bid,吸入治疗+噻托溴铵粉雾剂每次18μg,qd,吸入治疗。2组患者均治疗2周。比较2组患者的临床疗效、动脉血气指标、降钙素原和免疫功能,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为92.11%(35例/38例)和73.68%(28例/38例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的动脉血氧分压分别为(86.35±7.04)和(77.49±6.85)mm Hg,氧合指数分别为(310.89±29.87)和(281.34±27.53)mm Hg,降钙素原分别为(1.42±0.54)和(1.93±0.61)ng·m L^-1,肿瘤坏死因子-α分别为(275.49±48.62)和(310.05±54.73)ng·L^-1,白细胞介素-8分别为(312.62±75.64)和(389.75±78.76)pg·m L^-1,超敏C-反应蛋白分别为(4.73±2.45)和(8.34±2.53)mg·L^-1,差异均有统计学意义(均P<0.05)。2组患者治疗期间均未发生药物不良反应。结论噻托溴铵粉雾剂联合沙美特罗替卡松粉吸入剂治疗COPD急性加重期伴呼吸衰竭的临床疗效确切,其能显著降低患者的降钙素原水平,改善患者的血气指标和免疫功能,且安全性较好。     

Multi-walled carbon nanotube-induced inhalation toxicity: Recognizing nano bis-demethoxy curcumin analog as an ameliorating candidate

Human beings and ecosystems are being possibly exposed to CNTs, as there is a rise in global production rate of carbon nanotubes (CNTs). This may affect the health of humans and increases the environmental risk. We have already reported the pulmonary toxicity due to the inhalation of MWCNTs. We claim that a compound with anti-inflammatory and antioxidant activity may ameliorate the CNT-induced toxic effect. With this view, we have investigated the ameliorative effect of intravenously-administered nano bis-demethoxy curcumin analog (NBDMCA) against MWCNTs-induced inhalation toxicity by examining the lung histopathology for inflammatory cell dynamics, pulmonary remodeling and estimating the inflammatory biomarkers in the broncho-alveolar lavage fluid. We observed that NBDMCA could ameliorate the injury as evidenced by the decline in the levels of markers of inflammation, cell damage, and the histopathological changes induced by MWCNTs. We conclude that NBDMCA may be used to reduce the risk of MWCNTs-induced inhalation toxicity.     

基于粉雾剂的宫颈给药装置结构设计

目的为了克服传统宫颈给药方式存在的剂型缺陷,本文设计了一种基于粉雾剂的宫颈给药装置,并通过结构设计使该装置能够满足一般粉雾剂药物的给药作用,将粉雾剂药物送达人体病变位置。方法通过模拟现有吸入粉雾剂的装置结构,设计此宫颈给药装置,使粉雾剂均匀喷洒在人体宫颈内,以便于人体宫颈黏膜吸收粉雾剂药物。应用流体力学计算此装置所要求提供的压强参数,同时通过ANSYS软件定性分析该装置在规定参数下的可行性。结果装置在气流速度60L/min、出口压力1MPa状态下可以使粉雾剂达到很好的湍流状态,利于粉雾剂的分散。结论该装置能够满足一般粉雾剂的给药要求,对粉雾剂的分散效果明显。     

Low density,good flowability cyclodextrin-raffinose binary carrier for dry powder inhaler: anti-hygroscopicity and aerosolization performance enhancement

Background: The hygroscopicity of raffinose carrier for dry powder inhaler (DPI) was the main obstacle for its further application. Hygroscopicity-induced agglomeration would cause deterioration of aerosolization performance of raffinose, undermining the delivery efficiency.

Methods: Cyclodextrin-raffinose binary carriers (CRBCs) were produced by spray-drying so as to surmount the above issue. Physicochemical attributes and formation mechanism of CRBCs were explored in detail. The flow property of CRBCs was examined by FT4 Powder Rheometer. Hygroscopicity of CRBCs was elucidated by dynamic vapor sorption study. Aerosolization performance was evaluated by in vitro deposition profile and in vivo pharmacokinetic profile of CRBC based DPI formulations.

Results: The optimal formulation of CRBC (R₄) was proven to possess anti-hygroscopicity and aerosolization performance enhancement properties. Concisely, the moisture uptake of R₄ was c.a. 5% which was far lower than spray-dried raffinose (R₀, c.a. 65%). R₄ exhibited a high fine particle fraction value of 70.56 ± 0.61% and it was 3.75-fold against R₀. The pulmonary and plasmatic bioavailability of R₄ were significantly higher than R₀ (p < 0.05).

Conclusion: CRBC with anti-hygroscopicity and aerosolization performance enhancement properties was a promising approach for pulmonary drug delivery, which could provide new possibilities to the application of hygroscopic carriers for DPI.     

金水宝胶囊中发酵虫草菌粉多糖的指纹图谱研究

目的建立金水宝胶囊发酵虫草菌粉多糖的指纹图谱。方法沸水回流提取金水宝胶囊中的发酵虫草菌粉多糖,经酸水解和1-苯基-3-甲基-5-吡唑啉酮(PMP)衍生化后采用HPLC法分析,色谱条件为Phenomenex OOG-4252-EO C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.05 mol/L磷酸盐缓冲液梯度洗脱,体积流量1 m L/min,进样量20μL,检测波长250 nm,柱温30℃。结果对组成发酵虫草菌粉多糖的11种单糖成分进行鉴别,并建立了发酵虫草菌粉多糖指纹图谱。通过指纹图谱分析10批金水宝胶囊中各单糖成分,相似度均大于0.999,无显著性差异。结论建立的发酵虫草菌粉多糖指纹图谱操作简单,专属性强,重复性好,能够客观评价金水宝胶囊的质量。     

三七精准煮散饮片的研制——质量均一性分析

目的:饮片质量均一性是中药临床疗效稳定的基础,利用化学指纹图谱结合DNA分子鉴定技术考察三七精准煮散饮片与市售原饮片质量的均一性。方法:应用第二内转录间隔区(ITS2)序列DNA条形码对三七饮片进行分子鉴定;对比三七市售原饮片及精准煮散饮片的干膏收率;采用HPLC-DAD检测3批三七饮片混合粉碎前后的质量均一性和指纹图谱相似度。结果:三七煮散饮片出膏率显著高于原饮片出膏率;不同批次原饮片间指标成分三七皂苷R_1,人参皂苷Rg_1及Rb_1溶出量有明显的差异性,RSD分别为13.1%,32.7%及24.5%,混合制成煮散饮片后溶出量差异减小,RSD分别为3.6%,2.6%及3.5%;精准煮散饮片提取液中化学成分溶出量较原饮片高。混合粉碎后指纹图谱相似度提高,标定了共有峰14个,峰面积均有提高。结论:三七精准煮散饮片与市售原饮片基本属性相一致,但煮散饮片的浸出、有效成分溶出及质量均一性均有明显提高,提示煮散饮片可提高临床用药的精准性。     

根茎类药材丹参精准煮散饮片的质量评价

目的:对丹参精准煮散饮片进行质量评价,为临床用药安全有效提供保障。方法:应用第二内转录间隔区(ITS2)序列作为DNA条形码对丹参进行鉴定,采用化学指纹图谱表征药材化学组成,评价丹参原饮片及精准煮散饮片的相似度,测定指标成分丹酚酸B和迷迭香酸的含量,标定指纹图谱共有峰。采用标准汤剂煎煮法比较原饮片及精准煮散饮片的煎煮效率,对煮散体系进行综合评价。结果:ITS2序列对丹参药材可实现准确鉴定;原饮片及煮散饮片煎出成分基本无变化,指纹图谱相似度均很高,达到0.99以上,但是煮散饮片煎煮效率明显增高。按标准汤剂煎煮法,煮散饮片出膏率增加30%,迷迭香酸及丹酚酸B的煎出率均约1.7倍,其余化学成分的煎出率为原饮片的1.2~2.2倍;且精准煮散饮片差异明显小于原饮片批间差异。结论:丹参精准煮散饮片能提高原饮片的煎煮效率及均一性,具有较好的推广与应用价值。     

攻癌利水散外敷联合重组p53基因腺病毒治疗肺癌胸水30例

目的:观察攻癌利水散外敷联合重组p53基因腺病毒注射液胸腔灌注治疗对肺癌胸水的临床疗效。方法:将150例患者随机分为中药组、p53组、中药+p53组、顺铂组、空白组,每组30例。用药2疗程后观察临床疗效、毒副作用与生活质量的改变情况。结果:总有效率中药+p53组最高,与其他各组比较,差异均有统计学意义(P0.05)。白细胞下降及消化道反应情况顺铂组较明显,与其他各组比较,差异有统计学意义(P0.05);发热p53组较明显,与其他各组比较,差异有统计学意义(P0.05)。PKS评分治疗后中药+p53组升高最明显,与其他各组比较,差异有统计学意义(P0.05)。结论:攻癌利水散外敷联合重组p53基因腺病毒注射液胸腔灌注治疗肺癌胸水临床疗效显著,且不良反应小。     

加味参蛤散治疗缓解期慢性阻塞性肺疾病38例

目的:观察加味参蛤散治疗缓解期慢性阻塞性肺疾病(简称慢阻肺)患者的临床疗效。方法:将76例患者按就诊顺序均分为2组。2组均给予常规治疗,观察组同时服用加味参蛤散,1剂/d。2组均连续治疗1个月。结果:总有效率观察组为94.73%,对照组为86.84%。临床疗效观察组优于对照组,差异有统计学意义(P0.05)。最大呼气流速(PEF)、最大呼吸中期流量(MMEF)、第一秒用力呼气容积(FEV1)观察组均明显改善,治疗前后组内比较,差异有统计学意义(P0.05);治疗后与对照组比较,差异有统计学意义(P0.05)。治疗过程中2组均未见明显不良反应。结论:加味参蛤散能够较好地改善缓解期慢阻肺患者的肺通气功能,临床疗效显著。