1.Redefining counterfeit medicines and updating the legal framework to address falsified medicines: A qualitative policy review.
Imelda G. PENA ; Yolanda R. ROBLES ; Roderick L. SALENGA ; Monet M. LOQUIAS ; Francis R. CAPULE ; Bryan Paul I. BULATAO ; Jean Flor C. CASAUAY
Acta Medica Philippina 2025;59(14):118-131
BACKGROUND
The existence of counterfeit medicines has been a long-standing global public health concern. In the Philippines, Republic Act No. 8203 Section 3 provides a definition of counterfeit medicines, outlines prohibited acts, and states liabilities and penalties of concerned parties. The Philippine legal definiti on of counterfeit medicine needs to be aligned to what is widely accepted by the international community and to update its scope to prevent varied interpretations due to a mix in the categories of “counterfeit medicines.”
OBJECTIVEThis qualitative narrative policy review aims to generate evidence on counterfeit and falsified medicines from grey literature and recent publications in order to propose recommendations for updating the legal framework to address specifically “falsified” medical products.
METHODSAn online search was performed to identify relevant literature that discussed counterfeit medications. A review of narrative textual evidence from grey literature was conducted including extraction of data on the proliferation of fake, unregistered, and substandard medicines from published news articles and reports for the past six years. A review of published literature was also conducted to supplement findings from aforementioned reports and articles.
RESULTSLiterature search revealed that the presence of counterfeit medicines remains prevalent in the country despite the enactment of RA 8203. Counterfeited products include over-the-counter medicines, prescription medicines, and vaccines. The classification of counterfeit medicines in grey literature, including news articles and FDA advisories, are aligned with the WHO definitions.
CONCLUSIONThere is a clear need to update the regulatory framework on counterfeit medicines which would entail revisiting RA 8203 to amend the definition of counterfeit medicines and other related provisions in alignment with the WHO definitions.
Human ; Philippines ; Drugs ; Medicine ; Pharmaceutical Preparations
3.Elemene Antitumor Drugs Development Based on "Molecular Compatibility Theory" and Clinical Application: A Retrospective and Prospective Outlook.
Xiao-Ying JIANG ; Li-Ping SHI ; Jun-Long ZHU ; Ren-Ren BAI ; Tian XIE
Chinese journal of integrative medicine 2024;30(1):62-74
Elemene, derived from Curcuma wenyujin, one of the "8 famous genuine medicinal materials of Zhejiang province," exhibits remarkable antitumor activity. It has gained wide recognition in clinical practice for effectiveness on tumors. Dr. XIE Tian, introduced the innovative concept of "molecular compatibility theory" by combining Chinese medicine principles, specifically the "monarch, minister, assistant, and envoy" theory, with modern biomedical technology. This groundbreaking approach, along with a systematic analysis of Chinese medicine and modern biomedical knowledge, led to the development of elemene nanoliposome formulations. These novel formulations offer numerous advantages, including low toxicity, well-defined composition, synergistic effects on multiple targets, and excellent biocompatibility. Following the principles of the "molecular compatibility theory", further exploration of cancer treatment strategies and methods based on elemene was undertaken. This comprehensive review consolidates the current understanding of elemene's potential antitumor mechanisms, recent clinical investigations, advancements in drug delivery systems, and structural modifications. The ultimate goal of this review is to establish a solid theoretical foundation for researchers, empowering them to develop more effective antitumor drugs based on the principles of "molecular compatibility theory".
Humans
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Retrospective Studies
;
Antineoplastic Agents/therapeutic use*
;
Neoplasms/drug therapy*
;
Drugs, Chinese Herbal/therapeutic use*
;
Sesquiterpenes/therapeutic use*
4.Protective Effects of Danmu Extract Syrup on Acute Lung Injury Induced by Lipopolysaccharide in Mice through Endothelial Barrier Repair.
Han XU ; Si-Cong XU ; Li-Yan LI ; Yu-Huang WU ; Yin-Feng TAN ; Long CHEN ; Pei LIU ; Chang-Fu LIANG ; Xiao-Ning HE ; Yong-Hui LI
Chinese journal of integrative medicine 2024;30(3):243-250
OBJECTIVE:
To investigate the effects of Danmu Extract Syrup (DMS) on lipopolysaccharide (LPS)-induced acute lung injury (ALI) in mice and explore the mechanism.
METHODS:
Seventy-two male Balb/C mice were randomly divided into 6 groups according to a random number table (n=12), including control (normal saline), LPS (5 mg/kg), LPS+DMS 2.5 mL/kg, LPS+DMS 5 mL/kg, LPS+DMS 10 mL/kg, and LPS+Dexamethasone (DXM, 5 mg/kg) groups. After pretreatment with DMS and DXM, the ALI mice model was induced by LPS, and the bronchoalveolar lavage fluid (BALF) were collected to determine protein concentration, cell counts and inflammatory cytokines. The lung tissues of mice were stained with hematoxylin-eosin, and the wet/dry weight ratio (W/D) of lung tissue was calculated. The levels of tumor necrosis factor-α (TNF-α), interleukin (IL)-6 and IL-1 β in BALF of mice were detected by enzyme linked immunosorbent assay. The expression levels of Claudin-5, vascular endothelial (VE)-cadherin, vascular endothelial growth factor (VEGF), phospho-protein kinase B (p-Akt) and Akt were detected by Western blot analysis.
RESULTS:
DMS pre-treatment significantly ameliorated lung histopathological changes. Compared with the LPS group, the W/D ratio and protein contents in BALF were obviously reduced after DMS pretreatment (P<0.05 or P<0.01). The number of cells in BALF and myeloperoxidase (MPO) activity decreased significantly after DMS pretreatment (P<0.05 or P<0.01). DMS pre-treatment decreased the levels of TNF-α, IL-6 and IL-1 β (P<0.01). Meanwhile, DMS activated the phosphoinositide 3-kinase/protein kinase B (PI3K/Akt) pathway and reversed the expressions of Claudin-5, VE-cadherin and VEGF (P<0.01).
CONCLUSIONS
DMS attenuated LPS-induced ALI in mice through repairing endothelial barrier. It might be a potential therapeutic drug for LPS-induced lung injury.
Mice
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Male
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Animals
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Proto-Oncogene Proteins c-akt/metabolism*
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Lipopolysaccharides
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Phosphatidylinositol 3-Kinases/metabolism*
;
Interleukin-1beta/metabolism*
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Vascular Endothelial Growth Factor A/metabolism*
;
Tumor Necrosis Factor-alpha/metabolism*
;
Claudin-5/metabolism*
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Acute Lung Injury/chemically induced*
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Lung/pathology*
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Interleukin-6/metabolism*
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Drugs, Chinese Herbal
5.Si-Wu-Tang attenuates liver fibrosis via regulating lncRNA H19-dependent pathways involving cytoskeleton remodeling and ECM deposition.
Jiaorong QU ; Xiaoyong XUE ; Zhixing WANG ; Zhi MA ; Kexin JIA ; Fanghong LI ; Yinhao ZHANG ; Ruiyu WU ; Fei ZHOU ; Piwen ZHAO ; Xiaojiaoyang LI
Chinese Journal of Natural Medicines (English Ed.) 2024;22(1):31-46
Liver fibrosis is a dynamic wound-healing response characterized by the agglutination of the extracellular matrix (ECM). Si-Wu-Tang (SWT), a traditional Chinese medicine (TCM) formula, is known for treating gynecological diseases and liver fibrosis. Our previous studies demonstrated that long non-coding RNA H19 (H19) was markedly upregulated in fibrotic livers while its deficiency markedly reversed fibrogenesis. However, the mechanisms by which SWT influences H19 remain unclear. Thus, we established a bile duct ligation (BDL)-induced liver fibrosis model to evaluate the hepatoprotective effects of SWT on various cells in the liver. Our results showed that SWT markedly improved ECM deposition and bile duct reactions in the liver. Notably, SWT relieved liver fibrosis by regulating the transcription of genes involved in the cytoskeleton remodeling, primarily in hepatic stellate cells (HSCs), and influencing cytoskeleton-related angiogenesis and hepatocellular injury. This modulation collectively led to reduced ECM deposition. Through extensive bioinformatics analyses, we determined that H19 acted as a miRNA sponge and mainly inhibited miR-200, miR-211, and let7b, thereby regulating the above cellular regulatory pathways. Meanwhile, SWT reversed H19-related miRNAs and signaling pathways, diminishing ECM deposition and liver fibrosis. However, these protective effects of SWT were diminished with the overexpression of H19 in vivo. In conclusion, our study elucidates the underlying mechanisms of SWT from the perspective of H19-related signal networks and proposes a potential SWT-based therapeutic strategy for the treatment of liver fibrosis.
Humans
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RNA, Long Noncoding/genetics*
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Liver Cirrhosis/genetics*
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Liver/metabolism*
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Hepatic Stellate Cells/pathology*
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MicroRNAs/metabolism*
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Extracellular Matrix/metabolism*
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Drugs, Chinese Herbal
6.Polysaccharides from Chinese herbal medicine: a review on the hepatoprotective and molecular mechanism.
Jifeng LI ; Haolin GUO ; Ying DONG ; Shuo YUAN ; Xiaotong WEI ; Yuxin ZHANG ; Lu DONG ; Fei WANG ; Ting BAI ; Yong YANG
Chinese Journal of Natural Medicines (English Ed.) 2024;22(1):4-14
Polysaccharides, predominantly extracted from traditional Chinese medicinal herbs such as Lycium barbarum, Angelica sinensis, Astragalus membranaceus, Dendrobium officinale, Ganoderma lucidum, and Poria cocos, represent principal bioactive constituents extensively utilized in Chinese medicine. These compounds have demonstrated significant anti-inflammatory capabilities, especially anti-liver injury activities, while exhibiting minimal adverse effects. This review summarized recent studies to elucidate the hepatoprotective efficacy and underlying molecular mechanisms of these herbal polysaccharides. It underscored the role of these polysaccharides in regulating hepatic function, enhancing immunological responses, and improving antioxidant capacities, thus contributing to the attenuation of hepatocyte apoptosis and liver protection. Analyses of molecular pathways in these studies revealed the intricate and indispensable functions of traditional Chinese herbal polysaccharides in liver injury management. Therefore, this review provides a thorough examination of the hepatoprotective attributes and molecular mechanisms of these medicinal polysaccharides, thereby offering valuable insights for the advancement of polysaccharide-based therapeutic research and their potential clinical applications in liver disease treatment.
Humans
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Drugs, Chinese Herbal/pharmacology*
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Liver Diseases/drug therapy*
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Antioxidants
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Polysaccharides/therapeutic use*
;
Medicine, Chinese Traditional
7.Professor ZHUANG Li-xing's experience of mind-regulation acupuncture for psychosomatic disorders.
Yu-Ting WANG ; Jun YU ; Li-Xing ZHUANG
Chinese Acupuncture & Moxibustion 2023;43(4):401-404
Professor ZHUANG Li-xing's diagnosis and treatment method and manipulation key points of mind-regulation acupuncture for psychosomatic disorders are summarized. Professor ZHUANG proposes that psychosomatic disorders can be subdivided into "mind-body disorder" and "body-mind disorder". The former requires treatment aimed at regulating the mind. The main acupoints are Sishenzhen, Shenting (GV 24), Yintang (GV 24+), Shenmen (HT 7) and Sanyinjiao (SP 6). The additional acupoints are Suliao (GV 25), Shuigou (GV 26), Shenmai (BL 62), Zhaohai (KI 6), Hegu (LI 4) and Taichong (LR 3), etc. The latter requires treatment aimed at improving the original diseases, supplemented by regulating the mind (row acupuncture on the governor vessel). Acupoint selection is based on the theories of brain-mind, and the emphasis is placed on the governor vessel; in the meanwhile, regulating zangfu and qi-blood should be valued. After the arrival of qi, the Daoqi Tongjing method (the specific technique for directing qi and preserving essence) is applied, combined with auricular point sticking and fire needling at affected part to enhance the curative effect.
Humans
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Psychophysiologic Disorders/therapy*
;
Acupuncture Therapy
;
Acupuncture Points
;
Drugs, Chinese Herbal
;
Ethnicity
8.Application of "Sancai principle" for needle-knife treatment of bi syndrome of neck region.
Xin ZHANG ; Wen-Long YANG ; Fang-Ming LIU
Chinese Acupuncture & Moxibustion 2023;43(6):697-700
Under the guidance of the "Sancai principle", based on the understanding of the etiology and pathogenesis of the imbalance of muscles and bones in bi syndrome of neck region, holistic treatment should be used. The needle-knife release therapy is applied at corresponding acupoints in the three parts i.e. head, neck and back including Tiancai points (Naohu [GV 17] and Naokong [GB 19]), Rencai points (neck Jiaji [EX-B 2]), and Dicai points (Dazhui [GV 14], Quyuan [SI 13] and Tianzong [SI 11]). According to the layers of the lesion's meridians and muscles, the needle-knife is inserted into skin, muscle and bone to relax the tendons and treat bone disorders, and restore the normal mechanical balance of neck.
Needles
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Drugs, Chinese Herbal
;
Muscles
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Tendons
10.Chinese expert consensus on intra-arterial drug and combined drug administration for primary hepatocellular carcinoma.
Chinese Journal of Internal Medicine 2023;62(7):785-801
Transarterial interventional therapy is one of the most widely used treatment methods in patients with primary hepatocellular carcinoma. With the progress in interventional technology and the use of new drugs, transarterial interventional therapy has achieved favorable results in the treatment of primary hepatocellular carcinoma and has become the first choice non-surgical treatment for advanced liver cancer. However, at present, there are great differences in the drugs used in transarterial interventional treatment and the combined application of other drugs among centers, and there is no uniform consensus or guideline. Based on the latest research data and clinical practice experience, as well as the characteristics of Chinese patients, the Specialist Group of Interventional Drugs, Interventionalists Branch of the Chinese Medical Doctor Association was organized to formulate the Chinese expert consensus on intra-arterial drug and combined drug administration for primary hepatocellular carcinoma. The purpose of this consensus is to explore the efficacy and safety of drugs and drug combinations related to intra-arterial interventional therapy, the use of drugs in special populations, the management of adverse reactions, and adjuvant drugs to provide a reference for clinical practice.
Humans
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Carcinoma, Hepatocellular/pathology*
;
Consensus
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East Asian People
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Liver Neoplasms/pathology*
;
Pharmaceutical Preparations
;
Infusions, Intra-Arterial/methods*
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Antineoplastic Agents/therapeutic use*
;
Drug Therapy, Combination/methods*


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