1.Efficacy and safety of Omalizumab for the treatment of pediatric allergic asthma: a retrospective multicenter real-world study in China
Li XIANG ; Baoping XU ; Huijie HUANG ; Mian WEI ; Dehui CHEN ; Yingying ZHAI ; Yingju ZHANG ; Dan LIANG ; Chunhui HE ; Wei HOU ; Yang ZHANG ; Zhimin CHEN ; Jingling LIU ; Changshan LIU ; Xueyan WANG ; Shan HUA ; Ning ZHANG ; Ming LI ; Quan ZHANG ; Leping YE ; Wei DING ; Wei ZHOU ; Ling LIU ; Ling WANG ; Yingyu QUAN ; Yanping CHEN ; Yanni MENG ; Qiusheng GE ; Qi ZHANG ; Jie CHEN ; Guilan WANG ; Dongming HUANG ; Yong YIN ; Mingyu TANG ; Kunling SHEN
Chinese Journal of Applied Clinical Pediatrics 2023;38(1):64-71
Objective:To assess the clinical effectiveness and safety of Omalizumab for treating pediatric allergic asthma in real world in China.Methods:The clinical data of children aged 6 to 11 years with allergic asthma who received Omalizumab treatment in 17 hospitals in China between July 6, 2018 and September 30, 2020 were retrospectively analyzed.Such information as the demographic characteristics, allergic history, family history, total immunoglobulin E (IgE) levels, specific IgE levels, skin prick test, exhaled nitric oxide (FeNO) levels, eosinophil (EOS) counts, and comorbidities at baseline were collected.Descriptive analysis of the Omalizumab treatment mode was made, and the difference in the first dose, injection frequency and course of treatment between the Omalizumab treatment mode and the mode recommended in the instruction was investigated.Global Evaluation of Treatment Effectiveness (GETE) analysis was made after Omalizumab treatment.The moderate-to-severe asthma exacerbation rate, inhaled corticosteroid (ICS) dose, lung functions were compared before and after Omalizumab treatment.Changes in the Childhood Asthma Control Test (C-ACT) and Pediatric Asthma Quality of Life Questionnaire (PAQLQ) results from baseline to 4, 8, 12, 16, 24, and 52 weeks after Omalizumab treatment were studied.The commodity improvement was assessed.The adverse event (AE) and serious adverse event (SAE) were analyzed for the evaluation of Omalizumab treatment safety.The difference in the annual rate of moderate-to-severe asthma exacerbation and ICS reduction was investigated by using t test.The significance level was set to 0.05.Other parameters were all subject to descriptive analysis.A total of 200 allergic asthma patients were enrolled, including 75.5% ( n=151) males and 24.5% ( n=49) females.The patients aged (8.20±1.81) years. Results:The median total IgE level of the 200 patients was 513.5 (24.4-11 600.0) IU/mL.Their median treatment time with Omalizumab was 112 (1-666) days.Their first dose of Omalizumab was 300 (150-600) mg.Of the 200 cases, 114 cases (57.0%) followed the first Omalizumab dosage recommended in the instruction.After 4-6 months of Omalizumab treatment, 88.5% of the patients enrolled ( n=117) responded to Omalizumab.After 4 weeks of treatment with Omalizumab, asthma was well-controlled, with an increased C-ACT score [from (22.70±3.70) points to (18.90±3.74) points at baseline]. Four-six months after Omalizumab administration, the annual rate of moderate-to-severe asthma exacerbation had a reduction of (2.00±5.68) per patient year( t=4.702 5, P<0.001), the median ICS daily dose was lowered [0 (0-240) μg vs. 160 (50-4 000) μg at baseline] ( P<0.001), the PAQLQ score was improved [(154.90±8.57) points vs. (122.80±27.15) points at baseline], and the forced expiratory volume in one second % predicted (FEV 1%pred) was increased [(92.80±10.50)% vs. (89.70±18.17)% at baseline]. In patients with available evaluations for comorbidities, including allergic rhinitis, atopic dermatitis or eczema, urticaria, allergic conjunctivitis and sinusitis, 92.8%-100.0% showed improved symptoms.A total of 124 AE were reported in 58 (29.0%) of the 200 patients, and the annual incidence was 0(0-15.1) per patient year.In 53 patients who suffered AE, 44 patients (83.0%) and 9 patients (17.0%) reported mild and moderate AE, respectively.No severe AE were observed in patients.The annual incidence of SAE was 0(0-1.9) per patient year.Most common drug-related AE were abdominal pain (2 patients, 1.0%) and fever (2 patients, 1.0%). No patient withdrew Omalizumab due to AE. Conclusions:Omalizumab shows good effectiveness and safety for the treatment of asthma in children.It can reduce the moderate-to-severe asthma exacerbation rate, reduce the ICS dose, improve asthma control levels, and improve lung functions and quality of life of patients.
2.Effects of Different Penetration Enhancers on in vitro Transdermal Permeation of Flavaspidic Acid BB Cream
Yuting LIANG ; Xiaoyun LIU ; Jingling PAN ; Xiaoshi WU ; Xiaotong HUANG ; Chunping TANG ; Zhibin SHEN
China Pharmacy 2020;31(5):590-594
OBJECTIVE:To study the effects of different penetration enhancers on in vitro transdermal permeation of Flavaspidic acid BB cream. METHODS :Flavaspidic acid BB cream was prepared ,containing 11 kinds of different penetration enhancers as 1% azone,2% azone,3% azone,4% azone,1% menthol,1% propylene glycol ,1% oleic acid ,1% azone+1% menthol,1% azone+1% propanediol,1% azone+1% oleic acid or 1% menthol+1% propanediol. Modified Franz diffusion cell was adopted using abdominal skin of isolated male rat as transdermal barrier. The content of flavaspidic acid BB was determined by UPLC. The accumulative transdermal amount (Q24 h)and percutaneous permeability (Jss)within 24 h were calculated ;and compared with Flavaspidic acid BB cream without transdermal enhancer ,the enhancement ratio (ER)was calculated. RESULTS : Q24 h of Flavaspidic acid BB cream with above 11 kinds of transdermal enhancers were (82.96±7.15),(80.17±0.66),(78.22± 1.87),(73.53±1.24),(35.65±2.23),(34.02±1.73),(42.68±2.66),(33.94±1.37),(34.16±1.54),(46.78±1.21),(43.66±1.69) μg/cm2,respectively. Jss value were (5.26±0.10),(4.69±0.12),(4.45±0.45),(4.00±0.06),(3.74±0.33),(3.23±0.18), (3.73±0.53),(3.14±0.47),(3.54±0.11),(3.98±0.34),(4.34±0.14)μg(/ cm2·h),respectively. ER were 2.055,1.831,1.738, 1.564,1.462,1.263,1.456,1.227,1.385,1.557,1.698,respectively. CONCLUSIONS :All of the above transdermal absorption enhancers can enhance the percutaneous absorption of Flavaspidic acid BB cream ,among which ,1% azone is the best.
3.Research Progress in New Dosage Forms of Anti-tumor Drugs for Pulmonary Administration
Chunqing LU ; Yiping ZHENG ; Ya'nan GAO ; Jingling TANG
China Pharmacist 2018;21(3):493-496
Lung cancer is one of the most common malignancies. Anti-tumor drugs with intravenous administration have systemic adverse effects as well as limited efficacy. Drugs can concentrate in lungs after pulmonary administration,which limits the distribution in the other organs and reduces the side effects of anti-tumor drugs. The paper focused on the recent progress in the studies on new dos-age forms of anti-tumor drugs for pulmonary administration for the therapy of lung cancer,so as to provide reference for the development of anti-tumor drugs for pulmonary administration.
4.Research Progress in New Dosage Forms of Nevirapine
Xiaona LIU ; Lili CHE ; Yanming WANG ; Hongmei LIU ; Jingling TANG
China Pharmacist 2017;20(1):148-150
Nevirapine ( NVP) is the first-generation non-nucleoside reverse transcriptase inhibitor, which is a front-line drug for the treatment of AIDS and the prevention of mother-to-child transmission of HIV-1. NVP is with poor solubility and low bioavailability. With the development of new dosage forms, such as solid dispersion, self-emulsifying, microparticles, micelles, sustained-release tab-lets and floating microspheres, the bioavailability of NVP can be increased and the adverse reactions can be decreased. Research pro-gress in the new dosage forms of NVP at home and abroad was reviewed through searching literatures in order to provide basis for the development of new dosage forms of NVP.
5.Research Advance in the Drug Absorption Model of Vaginal Administration
Lili CHE ; Bo YANG ; Yanming WANG ; Xiaona LIU ; Hongmei LIU ; Jingling TANG
China Pharmacist 2017;20(3):537-540
Vaginal delivery system has a unique therapeutic advantage. In recent years, the rapid development of dosage forms shows a good prospect of development. The related literatures at home and abroad in recent years were analyzed and summarized. The research progress in the drug absorption model of various vaginal administrations was reviewed. The review provided reference for the research of new drug preparations and drug absorption mechanisms of vaginal administration.
6.Research Progress in the Influencing Factors in Particles Uptaking of Alveolar Macrophages
Yanming WANG ; Qingqing ZHAO ; Lili CHE ; Hongmei LIU ; Xiaona LIU ; Jinfeng JIAO ; Jingling TANG
China Pharmacist 2017;20(1):151-153,197
Pulmonary drug delivery has become a research focus in recent years, while the action between particles and pulmonary macrophages after particles transportation to lung tissue was paid little attention. Therapeutic efficacy can be enhanced by regulating the particles uptake action of pulmonary macrophages according to different diseases. Referring to a lot of articles, the relationship between common diseases and macrophages was reviewed and the influencing factors in the particles uptake of alveolar macrophages were sum-marized. The review laid foundation for the development of preparations and clinical application of pulmonary drug delivery systems.
7.Research Progress in Absorption Evaluation Methods for Pulmonary Delivery
Liying SHI ; Jingling TANG ; Yanan GAO ; Qingli MENG ; Lijun WU
China Pharmacist 2016;19(2):341-343
Objective:To review the drug absorption evaluation methods for pulmonary delivery. Methods: The drug absorption cell models, in vitro pulmonary membrane model and in vivo animal model were systematically summarized, and the advantages and disadvantages of those models and applications were reviewed by referring to the databases in CNKI and Pubmed. Results:The appro-priate animal model and method for the study of pulmonary absorption should be chosen according to the experimental purpose and char-acteristics of drugs. Conclusion:The review provides the thoughts and theoretical basis for the research and development of pulmonary delivery.
8.Research Progress in Bioavailability Improvement Methods for Curcumin
Qingli MENG ; Jinglin ZHAO ; Liying SHI ; Hongmei LIU ; Jingling TANG
China Pharmacist 2016;19(3):571-573
Curcumin is the main active component in turmeric, which possesses many pharmacologic effects, including anti-in-flammatory, antioxidant, anti-tumor, anti-atherosclerosis, liver and kidney protection and so on. However, due to its poor bioavail-ability, its clinical application is limited. Therefore, the methods for improving the bioavailability of curcumin were reviewed by refer-ring to a large number of literatures. The bioavailability of curcumin can be improved by different administration routes and various dos-age forms. The review provides theoretical basis and research ideas for the development of new drugs.
9.Application of Microemulsions on Transdermal Delivery Systems
Yuting ZHUANG ; Hongyu JI ; Jingling TANG ; Yuting MAO ; Hongmei LIU ; Dongyou ZHENG ; Linhua WU
China Pharmacist 2015;(1):130-132
Objective:To review the application of microemulsions as vehicles in transdermal delivery systems. Methods:Based on the recently published papers, the research on the application of microemulsions was classified and summarized. Results: Microe-mulsions is extensively applied as drug vehicles due to the ability of solubilization, drug permeation enhancement and efficacy improve-ment. Conclusion:Microemulsions as promising vehicles for transdermal delivery show a good application prospect.
10.Study Progress in Eye Irritation Test in vivo for Ophthalmic Preparations
Jiayu XIN ; Hongyu JI ; Jingling TANG ; Meng BU ; Hongmei LIU ; Linhua WU
China Pharmacist 2015;(4):644-646
Various new ophthalmic formulations have been prepared to enhance ocular bioavailability,while lots of irritant sub-stances are applied,including surfactants,polymers and other cationic materials. Therefore,safety of the preparations has been paid more and more attention besides the efficacy. Since in vitro experiments lack of associated enzymes and integral reaction of organiza-tion,the reasonability and correlation of the results extrapolated to the animal experiments still need to be further proved. The in vivo common eye irritation methods( winking,histopathological slices,Draize score and confocal microscopy test etc)were reviewed,eval-uated and analyzed in the paper.

Result Analysis
Print
Save
E-mail