Latest ArticlesSince the reform of the drug review and approval system, with the support of a series of policies and technology that encourages innovation, a large number of clinical trial application of new drugs for skin disease has been approved. In addition, innovative drugs, high-quality generic drugs, and biosimilar products have been accelerately approved, which meets the availability and accessibility of drugs to a certain extent. In order to guide innovation and scientific development of new drugs for skin disease, this article reviews the reform of drug review and approval system, the continuous improvement of the drug regulatory system, and the progress in development, evaluation and approval of new drugs for skin disease in China. We focus on the challenges, opportunities, and improvement measures faced in the development, evaluation, and regulation of drugs in this field. With multiple measures simultaneously taken, the goal is to meet the urgent clinical medication needs of patients with skin disease, so that effective and safe drugs can benefit patients as soon as possible.
Vitiligo is a kind of refractory depigmentation skin disease, which seriously affects the appearance and psychology of patients. At present, the pathogenesis of vitiligo includes heredity, oxidative stress, autoimmunity and environmental factors. The treatment includes systematic application of glucocorticoid, local application of glucocorticoid or calcineurin inhibitor, phototherapy and melanocyte transplantation. In this article, we reviewed the commonly used therapeutic drugs for vitiligo in the past and summarized the new progress of therapeutic drugs for the treatment of vitiligo. The emergence of new small-molecule targeted drugs, such as Janus kinase inhibitor baricitinib, has brought hope for vitiligo.
To explore the key technical elements of clinical trial design for the treatment of plaque psoriasis vulgaris.
By searching both relevant domestic and international literature, and combined with research and evaluation practices in China, scientific considerations on innovative drug clinical trial design for the treatment of psoriasis are summarized and proposed.
The overall design of clinical trials for the treatment of psoriasis vulgaris should be based on the characteristics of the disease's pathophysiology and drug action mechanisms, with a reasonable selection of control and population, as well as the design of trial duration, efficacy, and safety indicators. To comprehensively evaluate the effectiveness and safety of drugs, attention should be paid to the improvement of patients' quality of life, relapse or rebound after drug withdrawal, and long-term medication while evaluating the improvement of psoriasis symptoms and signs after drug treatment.
To establish the method of simultaneous determination of 12 major chemical components (such as berberine, magnolflorine and curcumin) in Tibetan medicine Ji-Ni De-Xie.
The separation was achieved on a WondaSil C18-WR column. High performance liquid chromatography-triple quadrupole mass spectrometry (HPLC-QqQ-MS) was used with the mobile phase 0.1% formic acid solution (A)-methanol (B) under gradient elution. The temperature of Electron Spray Ionization (ESI) was 300 ℃. The charged ions were scanned in positive and negative ion modes at the same time with multiple reaction monitoring. The contents of 12 components in 5 batches of samples were calculated according to the linear equation of 12 reference substances.
The 12 components of the Ji-Ni De-Xie have a good linear relationship within the detection range. The average contents of magnolflorine, jatrorrhizine, berberine, curcumin, demethoxycurcumin, gallic acid, chebulagic acid, ferulic acid 4-O-β-D-glucopyranoside, hydroxysafflor yellow A, rutin, ferulic acid, and ellagic acid are 3.18, 0.20, 1.71, 0.52, 0.22, 15.93, 7.56, 3.29, 0.07, 0.20, 1.47, 2.89 mg·g-1, respectively.
The established analytical method is highly selective with high sensitivity. providing reference for the quality control of the Tibetan medicine Ji-Ni De-Xie.
To explore the consideration on the key techniques of clinical trial design of drugs for the treatment of atopic dermatitis.
By summarizing the clinical research status of drugs for the treatment of atopic dermatitis, and investigating the progress of technical guidelines for the drugs in China and abroad in recent years, relevant technical considerations are proposed based on the China's experience in Drug R&D and the process of review.
The design of whole clinical trial of drugs treating atopic dermatitis should be based on the characteristics of the disease and investigational drug, the purpose of the study. Clinical trials for pediatric patients should be conducted as early as possible under the premise of prior research evidence and ensuring the safety of subjects. The appropriate study population should be selected, and a series of key elements, such as control drugs, efficacy and safety indicators, study period, etc., should be reasonably set up in the clinical trial design, in order to assist the scientific research and the development of the drugs. The positioning of the study population should be based on the drug action mechanism and drug effect intensity, and the patients with corresponding severity should be selected. The efficacy of the study should be comprehensively evaluated to assess the improvement of skin lesions, symptoms, quality of life, etc., and attention should be paid to the efficacy and safety of the study when used in pediatric patients as well as in long-term treatment.
During the past ten years, the research and development of new drugs for skin diseases have boomed. The new drugs including biologics and small molecules have rapidly developed and greatly improved the treatment of common inflammatory/immunological skin diseases. More than 200 clinical trials have been performed and many new drugs was approved in China, bringing the dermatological treatment to a new era. In this paper, recent progress was reviewed in new drug development on psoriasis, atopic dermatitis, alopecia areata and androgenetic alopecia in China.
Atopic dermatitis is a chronic inflammatory disease of skin that is commonly seen and easy to relapse. Treatments nowadays still have many drawbacks and adverse effects, thus cannot meet the needs of clinicians and patients. In recent years, our expanding knowledge of the complex pathomechanisms of atopic dermatitis has given rise to new interventions of targeted therapy, which will help clinicians better treat and manage the atopic dermatitis. This review summarizes the advances in new medications for pediatric atopic dermatitis.
Autoimmune skin diseases are a kind of diseases caused by the immune response to self-antigens, resulting in damages to skin with or without to other tissues and organs. The traditional immunosuppressants exert their curative effect, but accompanied by a wide range of adverse reactions. In-depth understanding of pathogenesis facilitated the development of various cytokine-based therapies or drugs targeting the signaling pathways, which has significantly improved the patient's condition. However, these therapies often require long-term maintenance treatment, and the targeting pathways of many autoimmune skin diseases are still not quite clear. Therefore, emerging therapeutic strategies and innovative drugs are still in need to balance the homeostasis of the immune system and induce the long-term remission of the disease, providing new hope for the treatment of autoimmune skin diseases. This review discusses the development of drugs treating autoimmune skin diseases according to different mechanisms of action and targets.
This study used "microneedles" as the keyword to search for relevant literature in CNKI and PubMed databases from 2017 to 2022. This article reviews the research progress of the carriers of microneedles based on structures, preparation methods, pharmacodynamics and clinical applications. A total of 1 040 valid kinds of literature were retrieved from the two databases. The structure of microneedles can be divided into solid microneedles, coated microneedles, dissolve microneedles, hydrogel microneedles, and hollow microneedles. The microneedles preparation methods involve microcasting, drawing lithography, and 3D printing methods. Some microneedle carrier pharmacodynamics studies include the treatment of skin, metabolic diseases, immune system diseases, and eye diseases. The microneedles' clinical application researches include vaccine, radiofrequency therapy and biological diagnosis. The main direction of future microneedle research is to develop a new transdermal microneedle drug delivery system, which is combined with the new pharmaceutical preparation technology. This study provides reference for further development of microneedle transdermal delivery formulations. The authors expect to provide a reference for the related research on microneedles.
Psoriasis is a chronic immune-mediated inflammatory skin disease. A growing understanding of the mechanism has led to the advent of biological agents that specifically target the cytokines which are involved in the pathogenesis. Because of the significant efficacy with high safety shown in the treatment of psoriasis, biologic agents have becoming more and more usual in clinical practice. Rapid progress in biotechnology allows the development of an increasing number of novel biologic agents, such as biologics targeting existing and promising inflammatory mediators, bispecific agents targeting multiple different antigens and agents including nanobodies and peptides. This review summarizes the current application of biologic agents in clinical practice, new drugs that are under study, potential targets and novel technology of biologics.
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