The use of medicinal plants for the treatment of psoriasis: A systematic review and meta-analysis

Background: Psoriasis is a chronic inflammatory disease that presents as scaly patches on the skin that affects about 3% of the world's population. Adherence to treatment and discrimination against people are common problems, adversely impacts quality of life. Objectives: The aim of this study was to investigate the use of medicinal plants as therapeutic adjuvants in the treatment of plaque psoriasis through a systematic review and meta-analysis. Methods: A systematic review and meta-analysis of randomized controlled trials in patients with plaque psoriasis was carried out, comparing the efficacy of herbal treatments alone or in association with other therapies. The search was performed in the databases of The Cochrane Library, Lilacs, Medline via PubMed and Embase, only including studies published from 2016 to 2020.The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. A systematic review and meta-analysis of randomized controlled trials (RCT) in patients with plaque psoriasis was carried out, comparing the efficacy of herbal treatments alone or in association with other therapies. We comprehensively searched the MEDLINE, Embase, Lilacs and Cochrane Library databases, only including studies published from 2016 to 2020. The certainty of evidence was assessed using the GRADE approach. Results: Out of 2,268 articles evaluated, only seven RCT were eligible for final analysis. Five of these studies evidenced low risk of bias and a high level of evidence. Limitations: Few RCT of medicinal plants. Conclusion: This meta-analysis indicates that medicinal plants may be used as topical or oral products, either alone or combined with other forms of treatment. These products have the potential to greatly improve the quality of life of the patient

Research advances in nonalcoholic fatty liver disease in individuals with HIV infection / 临床肝胆病杂志

The prevalence rate of nonalcoholic fatty liver disease (NAFLD) tends to increase in the general population around the world, and the incidence rate of liver malignancies caused by NAFLD is also increasing continuously. Obesity is an independent risk factor for NAFLD. Among the individuals with HIV infection who have a normal body weight, 25% have NAFLD, and lean NAFLD is relatively common in individuals with HIV infection. With reference to related articles in China and globally, this article reviews the epidemiology, pathophysiology, histology, diagnosis, screening, intervention, treatment, and clinical management of NAFLD, in order to improve the awareness of NAFLD in individuals with HIV infection among the public, clinicians, and related institutions.

Yiyi Fuzi Baijiangsan in Treatment of Ulcerative Colitis： A Review / 中国实验方剂学杂志

Yiyi Fuzi Baijiangsan is scattered from the Essentials from the Golden Cabinet （《金匮要略》） for the treatment of intestinal carbuncles. The whole prescription is composed of Coicis Semen， Aconiti Lateralis Radix Praeparata， and Patrinia scabiosifolia， with the effect of invigorating spleen， warming Yang， clearing heat， removing dampness， and detoxification， which is a commonly used prescription for the clinical treatment of ulcerative colitis （UC）. UC is a chronic nonspecific inflammatory disease with lesions involving the colorectal mucosa， and the etiology is not yet very clear， which is mostly related to genetics， external and intestinal environment， immunity， infection， and other factors. Animal experiments and clinical studies have shown that Yiyi Fuzi Baijiangsan have the advantages of multi-target and multi-faceted treatment of UC. At present， the research mechanism of the treatment of UC is mainly focused on reducing intestinal inflammatory response， anti-colorectal cancer effect， alleviating oxidative stress， repairing the intestinal epithelial cell barrier， improving intestinal flora disorder， inhibiting apoptosis， maintaining intestinal immune balance， etc. Clinically， the combination of modified Yiyi Fuzi Baijiangsan and western medicine has a satisfactory effect， which can significantly improve the relevant clinical symptoms of patients with UC， delay the condition， and improve the quality of life of patients， with the advantages of high safety and small side effects. Its related research provides theoretical support and data support for the clinical prevention and treatment of UC and the follow-up exploration of the mechanism of Yiyi Fuzi Baijiangsan in the treatment of UC， and is also of great significance to the research on the treatment of UC with Chinese medicine. This paper reviewed the prevention and control mechanism of Yiyi Fuzi Baijiangsan in the treatment of UC.

Progress in clinical studies in cardiovascular surgery 2022 / 中国胸心血管外科临床杂志

@#In 2022, many excellent clinical studies emerged in the field of cardiovascular surgery. Selecting papers published in The New England Journal of Medicine and other top medicine and cardiology journals, this review focused on the research progress on 7 topics in the field of cardiovascular surgery: coronary artery surgery, vascular surgery, valvular surgery, structural heart disease, congenital heart disease, heart transplantation, perioperative management, and special population.

Huaiqihuang Granules in Treatment of Chronic Kidney Disease： A Review / 中国实验方剂学杂志

Chronic kidney disease is characterized by renal structural damage and dysfunction （for over three months） caused by various factors. In traditional Chinese medicine， chronic kidney disease can be classified as edema， ischuria， consumptive disease， and anuria and vomiting. The pathogenesis of chronic kidney disease is frequently attributed to the deficiency of lung， spleen and kidney， dampness combined with stasis， and accumulation of turbid toxin. Huaiqihuang granules are a Chinese patent medicine composed of Vanderbylia robiniophila， Lycii Fructus， and Polygonati Rhizoma， with diverse pharmacological effects such as improving immunity and protecting kidney function. It is widely used in the treatment of cancer， chronic kidney disease， and respiratory system diseases. The available studies have demonstrated that Huaiqihuang granules can intervene in the progression of chronic kidney disease via various ways， such as protecting glomerular podocytes， inhibiting the proliferation of glomerular mesangial cells， resisting renal interstitial fibrosis， alleviating renal inflammation and oxidative stress， and regulating renal cell apoptosis and the immune system function. The clinical application of Huaiqihuang granules is based on conventional treatment and has achieved remarkable effects in the treatment of children's nephrotic syndrome， diabetic nephropathy， nephritis of Schonlein-Henoch purpura， IgA nephropathy， and chronic renal failure. Scholars have achieved great progress in the research on the mechanism and the clinical application of Huaiqihuang granules in the treatment of chronic kidney disease. However， the detailed summary of the progress in recent years remains to be carried out. Therefore， this paper reviewed the available studies in this field， aiming to provide a reference for the comprehensive and extensive clinical application of Huaiqihuang granules in the treatment of chronic kidney disease.

Short-term effect of adhesive system on clinical performance of bulk fill composite: randomized clinical trial

Aim: Although bulk fill composites have been widely used as restorative material, there is no consensus regarding the best clinical protocol in terms of composite technique and adhesive system. Therefore, this clinical trial evaluated the clinical performance of bulk fill composites for class I restorations under different protocols. Methods: A randomized clinical trial including 155 class I restorations was conducted using different adhesive systems: conventional technique (phosphoric acid + conventional three-step adhesive system) (Group 1, 2 and 3); or self-etching adhesive system (Groups 4, 5 and 6). Control groups 1 and 4 were restored with conventional composite; groups 2 and 5 with low viscosity bulk fill and conventional composite as occlusal coverage; groups 3 and 6 with high viscosity bulk fill. The FDI criteria was used for clinical evaluation at baseline and after 6 months. Results: All groups showed good clinical performance. At baseline, the adhesive system did not affect postoperative hypersensitivity. After 6 months, group 5 showed a significant reduction in color and translucency; group 6 a reduction in terms of anatomical form and for postoperative sensitivity and an improvement in patient satisfaction (p<0.05). Considering the same restorative technique, the use of the self-etching adhesive system showed a significant decrease in color and translucency (p<0.05). Conclusion: All groups showed favorable clinical performance, and promising results were found for the conventional adhesive system and high viscosity bulk fill protocol

Research progress on sex-hormone-like effects of epimedium / 国际中医中药杂志

Epimedii folium is a commonly used Traditional Chinese Medicine (TCM) for warming the kidney and strengthening the yang qi. It has androgen-estrogen-like effect. It can not only directly act on sexual organs to regulate hormone levels, but also exert sex-hormone-like effect through hypothalamus-pituitary-gonadal axis. Its regulation of hormone levels is similar to that of plant hormones. At present, Epimedii folium is commonly used with other TCMs to treat diseases caused by sex-hormone deficiency, such as male spermatopenia, asthenospermia, benign prostatic hyperplasia, functional erectile dysfunction, female premature ovarian failure, perimenopausal syndrome, dysfunctional infertility during ovulation, hyperandrogenemia of PCOS patients, etc.

Clinical effect observation of Yangxue-Qingnao granule combined with ligustrazine injection in the treatment of wind-phlegm entering collaterals type of cerebral infarction / 国际中医中药杂志

Objective:To evaluate the clinical efficacy of Yangxue-Qingnao granule combined with ligustrazine injection in the treatment of wind-phlegm entering collaterals syndrome of cerebral infarction. Methods:A total of 96 patients with cerebral infarction and wind-phlegm entering collaterals syndrome to Suixi County Hospital of Traditional Chinese Medicine from January 2019 to December 2019 were selected and randomly divided into two groups by random number table method, with 48 in each group. The control group was given intravenous ligustrazine injection, and the observation group was given Yangxue-Qingnao granule on the basis of the treatment of the control group. Both groups were treated continuously for 2 weeks. TCM syndrome scores were performed before and after treatment, the National Institutes of Health Stroke Scale (NIHSS) was used to assess the degree of neurological impairment, and the Activity of Daily Living Scale (ADL) was evaluated. To evaluate the patient's quality of life, to detect the high-shear viscosity, low-shear viscosity and plasma viscosity of whole blood with an automatic hemorheology instrument. Results:The total effective rate of the observation group was 95.8% (46/48) and that of the control group was 70.8% (34/48). The difference between the two groups was statistically significant ( χ2=9.08, P<0.01). After treatment, the TCM syndrome score of the observation group was significantly lower than that of the control group ( t=3.51, P<0.01), the NIHSS score was significantly lower than that of the control group ( t=34.41, P<0.001), and the ADL score was significantly higher than that of the control group ( t=57.88, P<0.01). After treatment, the observation group's whole blood high shear viscosity [(5.04 ± 0.93)mPa?s vs. (5.64 ± 1.13)mPa?s, t=2.84], whole blood low shear viscosity [(11.32 ± 1.74)mPa?s vs. (13.39 ± 2.23)mPa?s, t=5.07] and plasma viscosity [(1.51 ± 0.33)mPa?s vs. (1.73 ± 0.47)mPa?s, t=2.65] of the observation group were significantly lower than those in the control group ( P<0.05 or P<0.01). Conclusion:Yangxue-Qingnao granule combined with ligustrazine injection can improve the neurological status and quality of life of patients with cerebral infarction syndrome of wind-phlegm entering the collaterals, and improve the clinical efficacy.

Medicamentos off-label e não licenciados no âmbito pediátrico: uma revisão descritiva dos últimos dez anos / Off-label and unlicensed drugs in the pediatric field: a descriptive review of the last ten years

A falta de medicamentos contendo bulas prevendo o tratamento de pacientes pediátricos representa um problema frequentemente observado em hospitais, principalmente nos setores de unidade de terapia intensiva (UTI) pediátrica e neonatais. Sabe-se que, para que um tratamento seja considerado seguro e eficaz, uma série de estudos clínicos são necessários, no entanto, relata-se um baixo número dessas pesquisas envolvendo crianças, principalmente devido a questões éticas que dificultam a condução das mesmas. Assim, poucos são os medicamentos que provam ser adequados para o tratamento desses pacientes, tornando necessário recorrer ao uso de medicamentos off-label e não licenciados. Os medicamentos são classificados como off-label quando seu uso se dá de maneira que difere de suas especificações aprovadas, por sua vez, produtos não licenciados são classificados desta forma por não possuírem aprovação para sua comercialização no país ou não possuírem comprovação de segurança e eficácia. O preparo de protocolos de estudo organizados, relato de informações aos pais e à criança de maneira clara e objetiva, aproximação entre pesquisadores e pais para o estabelecimento de uma relação de confiança e a condução das pesquisas em momentos de disponibilidade da família demonstram-se estratégias importantes para facilitar a realização dos ensaios clínicos.

The lack of medicines containing drug information leaflets considering the treatment of pediatric patients is a problem frequently observed in hospitals, especially in the pediatric and neonatal intensive care unit (ICU) sectors. It is known that, for a treatment to be considered safe and effective, a series of clinical studies are necessary; however, a low number of these studies involving children are reported, mainly due to ethical issues that make conducting them difficult. Thus, few drugs prove to be suitable for treating these patients, making it necessary to resort to using off-label and unlicensed drugs. Drugs are classified as off-label when their use differs from their approved specifications, in turn, unlicensed products are classified in this way due to not having approval for marketing in the country or do not have proof of safety and efficacy. Preparation of organized study protocols, reporting information to parents and the child in a clear and objective way, bringing researchers and parents closer to establish a relationship of trust and conducting research at moments when the family is available are important strategies to facilitate conducting clinical trials.

Barreras y facilitadores para la investigación en ciencias de la salud durante la crisis del COVID-19: una revisión de alcance / Health science research barriers and facilitators in the midst of the COVID-19 crisis: scoping review

RESUMEN Objetivo: La pandemia ocasionada por el Covid-19 ha significado un gran desafío para la investigación en salud por la necesidad de dar una respuesta oportuna y efectiva a esta situación de crisis. Es importante proveer una visión panorámica sobre las principales barreras y facilitadores encontrados en la conducción de estudios en ciencias de la salud durante la crisis del Covid-19, así como también de las iniciativas en investigación sugeridas por autoridades en salud de investigación a nivel global, regional o local. Materiales y métodos: Se desarrolló una revisión sistemática de alcance. Se hizo una búsqueda de la literatura en Medline, Cochrane library, Lilacs y Google Scholar. Se incluyeron estudios de investigación originales, artículos de revisión, de opinión y editoriales disponibles en texto completo, publicados entre enero de 2020 y mayo de 2021 en español, inglés o portugués. Se hizo selección de los documentos y extracción de los datos por dos autores de manera independiente. Las barreras y facilitadores identificados fueron descritos y organizados en cuatro categorías a partir de la literatura: socioculturales, administrativos, organizacionales y metodológicos. Asimismo, se incluyeron documentos y comunicados oficiales de autoridades en salud e investigación a nivel global, regional y local. Los resultados se presentan de manera narrativa y en tablas. Resultados: Se seleccionaron 26 documentos para el análisis y síntesis de la información. Las barreras mencionadas más frecuentemente en la literatura incluyen las dificultades en cuanto al acceso a los participantes, a los trámites asociados a los comités de ética; así como el riesgo biológico para los investigadores y la falta de coordinación inter e intrainstitucional. Por su parte, los facilitadores identificados incluyen la adopción de soluciones virtuales, el trabajo cooperativo entre los actores de la investigación y la flexibilidad en el proceso de obtención del consentimiento informado. Frente a las iniciativas difundidas por las autoridades en salud e investigación, se identificaron cuatro estrategias relacionadas con la priorización de preguntas de investigación, el fomento de la cooperación y la inclusión en la investigación, la lucha contra la infodemia y el fortalecimiento de la calidad metodológica de los estudios. Conclusiones: Para la investigación en el contexto de la pandemia representa un desafío continuar con la cooperación e interoperabilidad entre las instituciones, los países y las disciplinas, con el fin de facilitar los procesos investigativos en el futuro; del mismo modo, cobra importancia mantener la ciencia abierta y la financiación de estudios cooperativos cuando surjan otras prioridades. Asimismo, es evidente la necesidad de desarrollar y sostener mecanismos que gestionen la información de manera eficiente para la toma de decisiones. Se requiere evaluar de manera continua los efectos que ha dejado esta pandemia en la práctica de la investigación en ciencias de la salud para comprender de manera integral lo que debemos aprender como sociedad a partir de las crisis.

ABSTRACT Objective: The COVID-19 pandemic has imposed a great challenge on health research because of the pressing need to respond promptly and effectively to this crisis situation. It is important to offer a high level perspective of the main barriers and facilitators found when conducting health science studies during the COVID-19 crisis and to discuss the research initiatives suggested by global, regional or local health research authorities. Materials and methods: A systematic scoping review was carried out. A literature search was conducted in the Medline, Cochrane Library, Lilacs and Google Scholar databases. Original research studies, review and opinion articles and editorials available in full text published in Spanish, English or Portuguese between January 2020 and May 2021 were included. Two authors working independently selected the papers and collected the data. The barriers and facilitators identified were described and organized in four categories according to the literature: sociocultural, administrative, organizational and methodological. Official documents and communications from global, regional and local health and research authorities were also included. Results are presented in narrative and table form. Results: Overall, 26 documents were selected for data analysis and synthesis. The barriers most frequently mentioned in the literature include issues with access to participants, ethics committees paperwork, biological risk for the researchers, and lack of inter and intra-institutional coordination. On the other hand, the facilitators identified include the adoption of on-line solutions, cooperative work among research actors, and a more flexible informed consent process. Regarding the initiatives disseminated by health and research authorities, four strategies were identified: prioritization of research questions, cooperation and inclusion promotion, fight against infodemia, and strengthening of the methodological quality of the studies. Conclusions: Continued cooperation and interoperability among institutions, countries and disciplines to facilitate future research processes is a challenge in the context of the pandemic; similarly, it is now important to maintain open science and funding of cooperative studies when other priorities emerge. Likewise, there is an evident need to develop and sustain efficient information management systems to help with decision-making. Ongoing review of the effects of the pandemic on health research practice is needed in order to gain comprehensive insights of what we need to learn as a society from this crisis.

Evaluación nutricional de pacientes en edad pediátrica con drepanocitosis tratados con hidroxiurea / Nutritional Evaluation of Pediatric Patients with Sickle Cell Disease Treated with Hydroxyurea

RESUMEN Fundamento: estudios clínicos en pacientes con drepanocitosis han demostrado que el uso de hidroxiurea se asocia a una reducción de complicaciones agudas y crónicas, incluyendo las relacionadas con el estado nutricional de estos pacientes. Objetivo: evaluar el estado nutricional en pacientes con drepanocitosis tratados con hidroxiurea en el Hospital Pediátrico Universitario Paquito González Cueto de Cienfuegos. Métodos: se realiza un estudio descriptivo, analítico y prospectivo de la totalidad de los pacientes con drepanocitosis tratados con hidroxiurea, atendidos en el Servicio de Hematología del Hospital Pediátrico de Cienfuegos en el periodo de enero 2012 a diciembre 2018. Las variables del estudio fueron: edad, sexo, variante de hemoglobina, manifestaciones clínicas y evaluación nutricional, parámetros hematológicos, hospitalizaciones y requerimientos transfusionales. La información se obtuvo de los expedientes clínicos. Resultados: se estudiaron 15 pacientes, hubo predomino del sexo femenino (60 %) y los adolescentes representaron el 80 % de los pacientes en estudio. Presentaban la forma homocigota 10 pacientes (66,7 %); la variante Sβ talasemia y SC estuvo representada con 2 y 3 pacientes, respectivamente. No hubo diferencias significativas al comparar los valores hematológicos antes y después del tratamiento. Se observó una disminución en la frecuencia y gravedad de las crisis, en el número de hospitalizaciones y requerimientos transfusionales en la totalidad de los pacientes. La desnutrición estuvo presente en solo 4 pacientes del total. Conclusiones: el tratamiento con hidroxiurea para los pacientes en estudio resultó en mejoría clínica, reducción del número de ingresos y disminución de los requerimientos transfusionales, lo cual repercutió favorablemente en su estado nutricional.

ABSTARCT Background: clinical studies in patients with sickle cell disease have shown that the use of hydroxyurea is associated with a reduction in acute and chronic complications, including those related to the nutritional status of these patients. Objective: to evaluate the nutritional status in patients with sickle cell disease treated with hydroxyurea at the Paquito González Cueto University Pediatric Hospital in Cienfuegos. Methods: a descriptive, analytical and prospective study was carried out of all the patients with sickle cell disease treated with hydroxyurea, treated at the Hematology Service of the Pediatric Hospital of Cienfuegos in the period from January 2012 to December 2018. The study variables were: age, sex, hemoglobin variant, clinical manifestations and nutritional evaluation, hematological parameters, hospitalizations and transfusion requirements. The information was obtained from the clinical records. Results: 15 patients were studied, there was a predominance of females (60 %) and adolescents represented 80 % of the patients in the study. 10 patients (66.7 %) presented the homozygous form; the Sβ thalassemia and SC variant were represented with 2 and 3 patients, respectively. There were no significant differences when comparing hematological values ​​before and after treatment. A decrease was observed in the frequency and severity of the seizures, in the number of hospitalizations and transfusion requirements in all the patients. Malnutrition was present in only 4 patients out of the total. Conclusions: treatment with hydroxyurea for the study patients resulted in clinical improvement, reduction in the number of admissions and decrease in transfusion requirements, which favorably affected their nutritional status.

Problems and countermeasures in clinical studies on acupuncture and moxibustion in course of developing / 中国针灸

To explore the problems and countermeasures existing in acupuncture and moxibustion clinical studies, in the perspective of the key steps of

Research progress on the protective effect of exercise on retinal cells and functions / 国际眼科杂志(Guoji Yanke Zazhi)

@#Physical exercise is a low-cost, easy-to-implement therapeutic intervention. In recent years, it has been found that exercise has a protective effect on retinal diseases such as diabetic retinopathy, age-related macular degeneration and retinitis pigmentosa. The mechanism may be related to enhancing retinal defence against oxidative stress, reducing glutamate secretion and inhibiting retinal cell apoptosis through BDNF/TrkB pathway. This paper reviews the recent literature related to the protective effect of exercise on retina from animal experiments, clinical studies and mechanism investigation.

Current status of acute pancreatitis related clinical trial registrations in China / 中华胰腺病杂志

Objective:To analyze the registration status of acute pancreatitis-related clinical studies registered on the Chinese Clinical Trial Registry (ChiCTR) and USA ClinicalTrials.gov database.Methods:The ChiCTR and ClinicalTrials.gov database were searched to collect, sort and analyze the clinical studies related to acute pancreatitis registered from the establishment of the database to December 31, 2020. The clinical trials were manually grouped, and the features of clinical researches were compared based on different registered data (2007-2014 vs 2015-2020) and different financial sources (self-support, enterprise support or public support). Results:A total of 157 registered clinical studies related to acute pancreatitis have been included (ChiCTR n=99; ClinicalTrial.gov n=58). The top three areas with the greatest number of registered clinical studies were Sichuan (28.0%), Shanghai (14.6%) and Jiangsu (12.1%), totally accounting for 54.7%. There were 91 interventional studies, 41 observational studies and 25 other type studies. Masking was performed in 34 studies (21.6%). Randomized parallel controlling was performed in 84 studies (53.5%). 30 trials (19.1%) were at Ⅳ phase, and 7 trials (4.4%) were at Ⅱ or Ⅲ phase. 2007-2014 group tended to use randomized parallel controlled design (68.3% vs 45.4%, P=0.005) and randomization grouping (76.7% vs 47.4%, P=0.001). 2015-2020 group tended to use relatively large sample (72.6% vs 47.4%, P=0.002)and data management committee (53.6% vs 25.0%, P=0.001). The differences between the two groups were statistically significant. Of 92 trials from ChiCTR database, 48 were self-supported, 5 was supported by enterprise, and 38 was supported by the public. The percentage of self-support and public support was 86.9%. Conclusions:The number of acute pancreatitis-related clinical studies registered on ChiCTR was generally on the increase. Most registered studies were funded by public finances or by the researchers' institutions self. There was a lack of phaseⅡ or phase Ⅲ.

Agreements in clinical studies at German university clinics

The article aims to give an overview of the contractual situation in Germany, which arise in clinical studies. The goal of the authors is to show any potential sponsor of a clinical study, who is interested in cooperation with German partners such as universities or other study sites, what kind of agreements may be expected and to give a brief overview about necessary themes included within the contractual negotiations. The different contractual settings are considered from the perspective each different type of agreement. The authors have chosen amongst all possible types the ones which are the most common in a clinical study, such as CDA, MTA, grant agreement, clinical study agreement, CRO-service agreement etc. The authors show the complexity of the contractual setting of a clinical study and emphasize to pay close attention to the contractual settings. Even though the content of the agreement is mostly universal in nature, in some cases, Germany has some very special rules (e.g. regarding employees’ inventions), which any potential sponsor should keep in mind.

Pharmacology and Clinical Evaluation of Ensartinib Hydrochloride Capsule / 中国肺癌杂志

Lung cancer is one of the most common malignancies with the highest incidence rate and mortality rate worldwide, and non-small cell lung cancer (NSCLC) accounts for about 85%. Only 5% NSCLC patients are anaplastic lymphoma kinase (ALK) rearrangement positive NSCLC, but the prognosis of these patients is poor, and treatment is urgent. Ensartinib (X-396), a next-generation ALK tyrosine kinase inhibitor (ALK-TKI), has shown greater potency on inhibiting ALK activity and controlling brain metastases than crizotinib, which is indicated for the treatment of crizotinib-resistant, ALK-positive NSCLC patients. Several phase I to III clinical trials included both healthy volunteers and NSCLC patients have been conducted both in China and abroad. In this review, we briefly summarized the results of these trials, and preliminary efficacy, safety, pharmacology and pharmacokinetics/pharmacodynamics of ensartinib were discussed.

A comparative cross-sectional study of Chinese and American lung caner drug trial in 2019 / 中国胸心血管外科临床杂志

@#Objective    To compare the current status of clinical studies regarding lung cancer between China and the United States in 2019, and to indicate the weakness, trend and future development direction of clinical studies drug treatment in China. Methods    The data of lung cancer clinical studies from January 1st to November 30th, 2019 in China and the United States were retrieved and analyzed through Informa pharmaprojects database. Results    The United States was superior on the number of projects (128 vs. 156) and research institutions (743 vs. 2 250). Compared with the United State, there were more phase Ⅲ confirmatory researches (19.5% vs. 10.3%), bioequivalent drug researches (3.1% vs. 0%), and researches initiated by academic institutions (39.8% vs. 28.1%) in China. The United States exhibited advantages in phaseⅠ andⅠ/Ⅱstudies (25.8% vs. 60.3%), immunodrugs (49.2% vs. 60.3%), primary tested drug ratio (61.7% vs. 93.6%), targets abundance (32.9% vs. 69.6%), and chimeric antigen receptor-T (CAR-T, 0.7% vs. 7.1%). Conclusion    Compared with the United States, China should pay more attention to innovative drug investigations in early phase of clinical studies, especially novel immune agents, vaccines, and CAR-T.

Epigenetic therapies in patients with solid tumors: Focus on monotherapy with deoxyribonucleic acid methyltransferase inhibitors and histone deacetylase inhibitors

Epigenomics is the study of the gene expression changes due to epigenetic processes and not due to the deoxyribonucleic acid (DNA) base sequence alterations. The key mechanisms of epigenetic regulation include DNA methylation, histone modifications, and noncoding RNAs. Epigenetic alterations in cancer are predominantly linked with hypermethylation of promoters of the tumor suppressor genes, global DNA hypomethylation, and increased expression of histone deacetylases (HDAC). There is a growing need to investigate epigenetic patterns and to provide safe and effective, innovative therapeutic strategies for oncology patients, who did not improve on traditional anticancer regimens. The epi-drugs (e.g., DNA methyltransferase inhibitors, e.g., azacitidine and decitabine and HDAC inhibitors, e.g., vorinostat and romidepsin) have been approved for the clinical use. In this paper, we provide a brief overview of the mechanisms of action and targets for novel epi-drugs, focusing on their potential clinical applications in patients with solid tumors, resistant to standard oncology treatments

Immunoregulatory effects of Tripterygium wilfordii Hook F and its extracts in clinical practice / 医学前沿

Tripterygium wilfordii Hook F (TwHF) and its extracts have long been used for the treatment of rheumatoid arthritis, autoimmune diseases, and kidney disease due to their anti-inflammatory, immunoregulatory, and other pharmacological effects. However, the clinical immunoregulatory effects of TwHF and its extracts remain unclear, so we reviewed their effects for use in clinical practice. This review provides a comprehensive summary of the recent literature on the immunoregulatory effects of TwHF and its extracts in clinical studies. TwHF and its extracts affect the proliferation and activation of Tand B cells; ratio of Tcell subsets; inflammatory response of monocytes, macrophages, and immunoglobulins; and secretion of many cytokines. Together, these effects dictate immune function in a variety of diseases. TwHF and its extracts can be used alone or in combination with existing therapies against many immune disorders through immunomodulation.

Clinical study of Qixie-Huoxue-Tongluo decoction combined with ozagrel sodium injection in treatment of cerebral thrombosis / 国际中医中药杂志

Objective@#To study the clinical efficacy of Qixie-Huoxue-Tongluo decoction combined with ozagrel sodium injection in treatment of cerebral thrombosis.@*Methods@#According to the random number table method, 91 cerebral thrombosis patients who met the inclusion criteria were divided into the control group (45 cases) and the study group (46 cases). The control group was treated with ozagrel sodium injection on the basis of routine treatment, while the study group was treated with Qixie-Huoxue-Tongluo decoction on the basis of the control group. The two groups were treated for 7 days. The National Institute of Health Stroke Scale (NIHSS)was used to assess the degree of neurological impairment, the Activity of Daily Living (ADL) was used to assess the quality of life; and the levels of MDA, SOD, NO, neuron-specific enolase (NSE) and neuronal protein (S-100β)were detected by ELISA.The clinical efficacy was evaluated.@*Results@#The total effective rate was 93.5% (43/46) in the study group and 71.1% (32/45) in the control group, there was significant difference between the two groups (χ2=7.853, P=0.005). After treatment, the NIHSS score in the study group was significantly lower than that in the control group (16.1 ± 5.0 vs. 20.3 ± 5.3; t=3.889, P<0.01), and the ADL score in the study group (51.9 ± 9.3 vs. 45.3 ± 8.6, t=3.461) was significantly higher than that in the control group (P<0.01); the serum level of MDA (3.10 ± 0.48 mmol/L vs. 4.25 ± 0.76 mmol/L, t=11.427) and NO (41.14 ± 6.74 U/L vs. 62.20 ± 8.43 U/L, t=10.028) in the study group were significantly lower than those in the control group (P<0.01), the SOD (204.36 ± 21.29 vs. 163.39 ± 17.45, t=13.177) level in the study group was significantly higher than that of the control group (P<0.01); the serum NSE (4.85 ± 1.03 μg/L vs. 7.93 ± 1.14 μg/L, t=13.529) and S-100β protein (0.18 ± 0.03 μg/L vs. 1.02 ± 0.15 μg/L, t=37.232) levels in the study group were significantly lower than those in the control group (P<0.01).@*Conclusions@#Qixie-Huoxue-Tongluo decoction combined with ozagrel sodium injection can improve the degree of neurological impairment in patients with cerebral thrombosis, improve the quality of life clinical efficacy. And the mechanism may be related to inhibition of lipid peroxidation, anti-free radicals and so on.