1.Evaluation of the efficacy and safety of Xiao′er Huangjin Zhike Granules in the treatment of acute bronchitis-caused cough (syndrome of phlegm-heat obstructing the lung) in children
Jun LIU ; Mengqing WANG ; Xiuhong JIN ; Yongxue CHI ; Chunying MA ; Xiaohui LIU ; Yiqun TENG ; Meiyun XIN ; Fei SUN ; Ming LIU ; Ling LU ; Xinping PENG ; Yongxia GUO ; Rong YU ; Quanjing CHEN ; Bin WANG ; Tong SHEN ; Lan LI ; Pingping LIU ; Xiong LI ; Ming LI ; Guilan WANG ; Baoping XU
Chinese Journal of Applied Clinical Pediatrics 2024;39(10):774-779
Objective:To evaluate the efficacy and safety of Xiao′er Huangjin Zhike Granules in the treatment of cough caused by acute bronchitis in children, which is defined in TCM terms as a syndrome of phlegm-heat obstructing the lung.Methods:This was a block-randomized, double-blind, placebo-controlled, multicenter clinical trial.From January 2022 to September 2023, 359 children aged 3 to 7 years old diagnosed as acute bronchitis (lung-obstructing phlegm-heat syndrome) were enrolled from 21 participating hospitals and randomly assigned to the experimental group and placebo group in a 3︰1 ratio, and respectively treated with Xiao′er Huangjin Zhike Granules and its matching placebo.Cough resolution/general resolution rate after 7 days of treatment was used as the primary efficacy outcome for both groups.Results:(1)On the seventh day of treatment, the rate of cough disappearance/basically disappearance in the experimental group and placebo group were 73.95% and 57.61% retrospectively, which had statistically significance ( P=0.001).(2)After 7 days of treatment, the median duration of cough disappearance/basic disappearance were 5 days and 6 days in the two groups , with a statistically significant difference ( P=0.006).The area under the curve of cough symptom severity time was 7.20 ± 3.79 in the experimental group and 8.20±4.42 in the placebo group.The difference between the two groups was statistically significant ( P=0.039).(3) After 7 days of treatment, the difference between TCM syndrome score and baseline was -16.0 (-20.0, -15.0) points in the experimental group and -15.0 (-18.0, -12.0) points in the placebo group, with significant difference between the two groups ( P=0.004).In the experimental group, the clinical control rate, the markedly effective rate, the effective rate and the ineffective rate were 49.04%, 28.35%, 16.48% and 6.13% severally; and in the placebo group, the clinical control rate, the markedly effective rate, the effective rate and the ineffective rate were 38.04%, 26.09%, 29.35%, and 6.52% separately, which had statistically significant ( P=0.014).(4) There was no significant difference in the incidence of adverse events or adverse reactions during the trial between both groups.Moreover, while adverse reactions in the form of vomiting and diarrhea were occasionally reported, no serious drug-related adverse event or adverse reaction was reported.(5)The tested drug provided good treatment compliance, showing no statistically significant difference from the placebo in terms of compliance rate. Conclusions:Based on the above findings, it can be concluded that Xiao′er Huangjin Zhike Granules provides good safety, efficacy, and treatment compliance in the treatment of cough caused by acute bronchitis, and lung-obstructing phlegm-heat syndrome, in children.
2.Recent advances in microneedles-mediated transdermal delivery of protein and peptide drugs.
Ting LIU ; Minglong CHEN ; Jintao FU ; Ying SUN ; Chao LU ; Guilan QUAN ; Xin PAN ; Chuanbin WU
Acta Pharmaceutica Sinica B 2021;11(8):2326-2343
Proteins and peptides have become a significant therapeutic modality for various diseases because of their high potency and specificity. However, the inherent properties of these drugs, such as large molecular weight, poor stability, and conformational flexibility, make them difficult to be formulated and delivered. Injection is the primary route for clinical administration of protein and peptide drugs, which usually leads to poor patient's compliance. As a portable, minimally invasive device, microneedles (MNs) can overcome the skin barrier and generate reversible microchannels for effective macromolecule permeation. In this review, we highlighted the recent advances in MNs-mediated transdermal delivery of protein and peptide drugs. Emphasis was given to the latest development in representative MNs design and fabrication. We also summarize the current application status of MNs-mediated transdermal protein and peptide delivery, especially in the field of infectious disease, diabetes, cancer, and other disease therapy. Finally, the current status of clinical translation and a perspective on future development are also provided.
3.Membrane-disruptive peptides/peptidomimetics-based therapeutics: Promising systems to combat bacteria and cancer in the drug-resistant era.
Liming LIN ; Jiaying CHI ; Yilang YAN ; Rui LUO ; Xiaoqian FENG ; Yuwei ZHENG ; Dongyi XIAN ; Xin LI ; Guilan QUAN ; Daojun LIU ; Chuanbin WU ; Chao LU ; Xin PAN
Acta Pharmaceutica Sinica B 2021;11(9):2609-2644
Membrane-disruptive peptides/peptidomimetics (MDPs) are antimicrobials or anticarcinogens that present a general killing mechanism through the physical disruption of cell membranes, in contrast to conventional chemotherapeutic drugs, which act on precise targets such as DNA or specific enzymes. Owing to their rapid action, broad-spectrum activity, and mechanisms of action that potentially hinder the development of resistance, MDPs have been increasingly considered as future therapeutics in the drug-resistant era. Recently, growing experimental evidence has demonstrated that MDPs can also be utilized as adjuvants to enhance the therapeutic effects of other agents. In this review, we evaluate the literature around the broad-spectrum antimicrobial properties and anticancer activity of MDPs, and summarize the current development and mechanisms of MDPs alone or in combination with other agents. Notably, this review highlights recent advances in the design of various MDP-based drug delivery systems that can improve the therapeutic effect of MDPs, minimize side effects, and promote the co-delivery of multiple chemotherapeutics, for more efficient antimicrobial and anticancer therapy.
4.Tailored core‒shell dual metal-organic frameworks as a versatile nanomotor for effective synergistic antitumor therapy.
Biyuan WU ; Jintao FU ; Yixian ZHOU ; Sulan LUO ; Yiting ZHAO ; Guilan QUAN ; Xin PAN ; Chuanbin WU
Acta Pharmaceutica Sinica B 2020;10(11):2198-2211
Malignant tumor has become an urgent threat to global public healthcare. Because of the heterogeneity of tumor, single therapy presents great limitations while synergistic therapy is arousing much attention, which shows desperate need of intelligent carrier for co-delivery. A core‒shell dual metal-organic frameworks (MOFs) system was delicately designed in this study, which not only possessed the unique properties of both materials, but also provided two individual specific functional zones for co-drug delivery. Photosensitizer indocyanine green (ICG) and chemotherapeutic agent doxorubicin (DOX) were stepwisely encapsulated into the nanopores of MIL-88 core and ZIF-8 shell to construct a synergistic photothermal/photodynamic/chemotherapy nanoplatform. Except for efficient drug delivery, the MIL-88 could be functioned as a nanomotor to convert the excessive hydrogen peroxide at tumor microenvironment into adequate oxygen for photodynamic therapy. The DOX release from MIL-88-ICG@ZIF-8-DOX nanoparticles was triggered at tumor acidic microenvironment and further accelerated by near-infrared (NIR) light irradiation. The
5.A homogenous nanoporous pulmonary drug delivery system based on metal-organic frameworks with fine aerosolization performance and good compatibility.
Yixian ZHOU ; Boyi NIU ; Biyuan WU ; Sulan LUO ; Jintao FU ; Yiting ZHAO ; Guilan QUAN ; Xin PAN ; Chuanbin WU
Acta Pharmaceutica Sinica B 2020;10(12):2404-2416
Pulmonary drug delivery has attracted increasing attention in biomedicine, and porous particles can effectively enhance the aerosolization performance and bioavailability of drugs. However, the existing methods for preparing porous particles using porogens have several drawbacks, such as the inhomogeneous and uncontrollable pores, drug leakage, and high risk of fragmentation. In this study, a series of cyclodextrin-based metal-organic framework (CD-MOF) particles containing homogenous nanopores were delicately engineered without porogens. Compared with commercial inhalation carrier, CD-MOF showed excellent aerosolization performance because of the homogenous nanoporous structure. The great biocompatibility of CD-MOF in pulmonary delivery was also confirmed by a series of experiments, including cytotoxicity assay, hemolysis ratio test, lung function evaluation,
7.Knowledge,attitude and practice on early screening for breast cancer of female first-degree relatives of breast cancer Patients
Xin ZHAO ; Hongyan MENG ; Guilan SUN ; Yuzhen WANG
Chinese Journal of Modern Nursing 2019;25(20):2581-2585
ObjectiveTo investigate the status of early screening for breast cancer among female first-degree relatives of breast cancer patients. MethodsBy convenience sampling, the female first-degree relatives of the patients with breast cancer admitted in Department of Breast and Thyroid Disease from 2 hospitals in Suzhou from January to August of 2018 were selected and investigated using questionnaires (n=180). By cross-sectional study method, their knowledge, attitude and practice(KAP) about the early screening of breast cancer were assessed. Univariate analysis, correlation analysis and Logistic multivariate regression analysis were conducted to analyze the influencing factors on the participating behaviors of the first-degree relatives of breast cancer pativents in the early screening for breast cancer. Results6.7% participants reported doing breast self-examination once a month and 22.8% reported getting image examination of breasts once a year. The results of multivariate logistic regression indicated that age, educational background, employment status and attitude towards early screening were the influencing factors of the early screening practice for breast cancer. ConclusionsThe screening rate among female first-degree relatives of breast cancer patients is very low. In future studies, effective intervention should be carried out for the female first-degree relatives of breast cancer patients, focusing on the elderly and poorly educated population, in order to promote their breast cancer early screening practice.
8.Synergistic immunoreaction of acupuncture-like dissolving microneedles containing thymopentin at acupoints in immune-suppressed rats.
Qian ZHANG ; Chuncao XU ; Shiqi LIN ; Huanbin ZHOU ; Gangtao YAO ; Hu LIU ; Lili WANG ; Xin PAN ; Guilan QUAN ; Chuanbin WU
Acta Pharmaceutica Sinica B 2018;8(3):449-457
Dissolving microneedles carried drug molecules can effectively penetrate the stratum corneum of skin to improve the transdermal drug delivery. The traditional Chinese medicine acupuncture is based on the needle stimulation at a specific location (acupoint) to generate and transmit biochemical and physiological signals which alter the pathophysiological state of patients. However, the pain associated with conventional acupuncture needles and the requirement of highly trained professionals limit the development of acupuncture in non-Asian countries. The purpose of this study is to investigate whether the dissolving microneedles can be utilized as a self-administered painless replacement for acupuncture and locally released drug molecules can achieve expected therapeutic outcomes. Immunosuppressive rats were treated with acupuncture at Zusanli (ST36) acupoint using microneedles containing thymopentin. The immune functions and psychological mood of the immunosuppressed animals were examined. The proliferation of splenocytes was examined by CCK-8 assay. CD4 and CD8 expression patterns in spleen cells were detected by flow cytometry. The current study showed that use of either microneedles containing thymopentin or conventional acupuncture both resulted in immune cell proliferation, which was confirmed by flow cytometry. Furthermore, either conventional acupuncture or microneedles were able to effectively mitigate the anxiety caused by immune-suppression when applied on the ST36.
9.Mesoporous silica nanoparticles for drug and gene delivery.
Yixian ZHOU ; Guilan QUAN ; Qiaoli WU ; Xiaoxu ZHANG ; Boyi NIU ; Biyuan WU ; Ying HUANG ; Xin PAN ; Chuanbin WU
Acta Pharmaceutica Sinica B 2018;8(2):165-177
Mesoporous silica nanoparticles (MSNs) are attracting increasing interest for potential biomedical applications. With tailored mesoporous structure, huge surface area and pore volume, selective surface functionality, as well as morphology control, MSNs exhibit high loading capacity for therapeutic agents and controlled release properties if modified with stimuli-responsive groups, polymers or proteins. In this review article, the applications of MSNs in pharmaceutics to improve drug bioavailability, reduce drug toxicity, and deliver with cellular targetability are summarized. Particularly, the exciting progress in the development of MSNs-based effective delivery systems for poorly soluble drugs, anticancer agents, and therapeutic genes are highlighted.
10.Preparation and release behaviour of mesoporous silica/ethylcellulose sustained-release mini-matrix.
Qiaoli WU ; Guilan QUAN ; Yu HONG ; Linna WU ; Youmei ZENG ; Ge LI ; Xin PAN ; Chuanbin WU
Acta Pharmaceutica Sinica 2015;50(4):492-9
Hot-melt extrusion was applied to prepare mesoporous silica/ethylcellulose mini-matrix for sustained release, and fenofibrate was used as a model drug, ethylcellulose and xanthan gum were chosen as sustained-release agent and releasing moderator, respectively. This novel matrix obtained the controlled release ability by combining mesoporous silica drug delivery system and hot-melt extrusion technology. And mesoporous silica particle (SBA-15) was chosen as drug carrier to increase the dissolution rate of fenofibrate in this martix. Scanning electron microscope, transmission electron microscope, small angle X-ray powder diffraction and N2 adsorption-desorption were introduced to determine the particle morphology, particle size and pore structure of the synthesized SBA-15. The results showed that SBA-15 had a very high Brunauer-Emmett-Teller specific surface area, a narrow pore size distribution, large pore volume and a ordered two-dimensional hexagonal structure of p6mm symmetry. Differential scanning calorimetry and X-ray powder diffraction results demonstrated that fenofibrate dispersed in an amorphous state inside the pores of the mesoporous silica which contributed to the improvement in the dissolution rate. The drug release of mini-matrices was influenced by ethylcellulose viscosity grades and xanthan gum concentration, which increased with the increasing of xanthan gum concentration and decreasing of ethylcellulose viscosity. Mini-matrix containing 22% xanthan gum exhibited a good sustained release performance, and the drug release behavior followed the first-order kinetics.


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