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Objective To investigate the efficacy of the therapy of soothing liver and strengthening spleen(shortened as Shugan Jianpi therapy)in the treatment of active thyroid-associated ophthalmopathy(TAO)complicated with dry eye,and to provide a reference basis for clinical treatment.Methods A total of 108 patients with active TAO complicated with dry eye of liver depression and qi stagnation type were randomly divided into observation group and control group,54 patients in each group.Both groups were given conventional treatment for intervention of Graves'disease,and additionally the control group was given hormone shock therapy by intravenous injection of Methylprednisolone Sodium Succinate,and the observation group was treated with Chinese medicine prescription for soothing liver and strengthening spleen orally and intravenous injection of Methylprednisolone Sodium Succinate.The treatment period lasted for 12 weeks,and then the patients were followed up till to the 6th month.The changes of clinical activity score(CAS),proptosis,ocular surface disease index(OSDI),corneal fluorescein staining(FL),Schirmer I test(SIT)and tear film break-up time(BUT)in the two groups were observed before and after the treatment.After treatment,the clinical efficacy of the two groups was evaluated.Results(1)After 6 months of treatment,the total effective rate in the observation group was 94.44%(51/54)and that in the control group was 74.07%(40/54),and the intergroup comparison(tested by chi-square test)showed that the efficacy of the observation group was significantly superior to that of the control group(P＜0.05).(2)After treatment,the CAS,OSDI score and proptosis of the patients in the two groups were all lower than those before treatment(P＜0.01),and the reduction in the observation group was significantly superior to that in the control group(P＜0.01).(3)After treatment,the indicators of tear secretion function such as SIT,FL score and BUT of patients in the two groups were improved compared with those before treatment(P＜0.01),and the improvement in the observation group was significantly superior to that in the control group,the differences being all statistically significant(P＜0.01).Conclusion Shugan Jianpi therapy exerts certain clinical efficacy in treating patients with active TAO complicated with dry eye of liver depression and qi stagnation type,which can effectively relieve the proptosis,prolong the tear film break-up time,promote the secretion of tears and the repair of corneal epithelium,improve the visual function,and enhance the quality of life of the patients.
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The comprehensive diagnosis and treatment of advanced breast cancer has entered the era of"accurate classification and precise stratification",and is moving towards the road of personalized precision medicine.In 2023,significant breakthroughs have been achieved in the research on different molecular classifications of advanced breast cancer,influencing clinical guidelines and transforming clinical practice.The primary focus of research for hormone receptor positive advanced breast cancer lies in selecting appropriate treatments for patients who have failed cyclin-dependent kinase 4 and 6(CDK4/6)inhibitors.Advanced breast cancer with low human epidermal growth factor receptor 2(HER2)expression has emerged as a promising treatment direction,with T-DXd being an important therapeutic option.With the release of results from the PHILA study,a new era has begun for first-line treatment of HER2-positive advanced breast cancer.Simultaneously,T-DXd has become the preferred choice in clinical practice following tyrosine kinase inhibitor failure.Research related to immune and targeted therapy for advanced triple-negative breast cancer(TNBC)is also progressing rapidly,yielding positive outcomes in studies such as TORCHILIGHT and BEGONIA.Additionally,ongoing clinical studies on precision treatment based on the"Fudan classification"for TNBC are expected to revolutionize current treatment approaches.This paper summarized major advancements in clinical research on advanced breast cancer in 2023 according to various molecular classifications,aiming to provide improved reference and guidance for clinical management.
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Tralokinumab is a selective interleukin-13 inhibitor developed by LEO Pharma in Denmark. It was granted approval by the US Food and Drug Administration on December 27, 2021, for the treatment of patients aged 18 years or older with moderate to severe atopic dermatitis whose disease is refractory to or cannot be fully controlled by local prescription therapy. This article presents a comprehensive review of the recent research progress in the treatment of moderate to severe atopic dermatitis with tralokinumab.
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AIM:To perform a multidimensional analysis of the clinical study characteristics of endo-metriosis based on the ClinicalTrials.gov,providing comprehensive and objective information for re-searchers,clinicians,and clinical pharmacists.METHODS:A thorough investigation was conduct-ed on clinical trials related to endometriosis,regis-tered on the ClinicalTrials.gov from its inception to October 20,2023.Relevant trial data were extract-ed and statistically analyzed using bibliometrics and comparative research methods.RESULTS:A to-tal of 667 endometriosis clinical studies were regis-tered globally,showing an annual increase.The United States(127 trials),France(70 trials),and Ita-ly(57 trials)had the highest number of registered trials.Interventional studies were predominant(416 trials,62.4%),followed by observational stud-ies(251 trials,37.6%).Within interventional stud-ies,drug therapy was the primary intervention(223 trials,53.6%).Despite endometriosis being a female condition,male subjects were also consid-ered,with 6 trials specifically requiring male partici-pants and 37 trials not restricting gender.Compa-nies/corporations were the main funding sources,while public and governmental organizations pro-vided relatively less funding.CONCLUSION:Clinical trial research on endometriosis is in a phase of growth,with drug therapy being the main treat-ment approach.However,there is a relative lack of investment and attention from public funds and governmental organizations.
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The central nervous system (CNS) is home to neuronal and glial cells. Traditionally, glia was disregarded as just the structural support across the brain and spinal cord, in striking contrast to neurons, always considered critical players in CNS functioning. In modern times this outdated dogma is continuously repelled by new evidence unravelling the importance of glia in neuronal maintenance and function. Therefore, glia replacement has been considered a potentially powerful therapeutic strategy. Glial progenitors are at the center of this hope, as they are the source of new glial cells. Indeed, sophisticated experimental therapies and exciting clinical trials shed light on the utility of exogenous glia in disease treatment. Therefore, this review article will elaborate on glial-restricted progenitor cells (GRPs), their origin and characteristics, available sources, and adaptation to current therapeutic approaches aimed at various CNS diseases, with particular attention paid to myelin-related disorders with a focus on recent progress and emerging concepts. The landscape of GRP clinical applications is also comprehensively presented, and future perspectives on promising, GRP-based therapeutic strategies for brain and spinal cord diseases are described in detail.
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ObjectiveTo evaluate the efficacy and safety of Qingyusan capsules in the long-term treatment of mild to moderate active ulcerative colitis （UC） with the syndrome of large intestine dampness-heat. MethodA randomized， controlled design was adopted， and 88 patients with mild to moderate UC and syndrome of large intestine dampness-heat were randomized into a Qingyusan （Qingyusan capsules， 0.8 g·d-1） group and a control （mesalazine， 0.4 g·d-1） group， with 44 patients in each group. Three and one patients dropped out in the control and Qingyusan groups， respectively， during the 32 weeks of treatment. The clinical remission rate， mucosal healing rate， and modified Mayo score， TCM symptom score， and short inflammatory bowel disease questionnaire （SIBDQ） score before and after treatment were compared between the two groups. The colonoscopic and pathological changes were observed， and the clinical safety was compared between the two groups. ResultAfter treatment， the clinical remission rate and mucosal healing rate in the Qingyusan group were 72.1% （31/43） and 74.4% （32/43）， respectively， which were higher than those ［26.8% （11/41） and 41.5% （17/41）， respectively］ in the control group （χ2=17.200， χ2=10.843， respectively， both P<0.01）. The treatment in both groups decreased the modified Mayo score， partial Mayo score， and TCM symptom score （P<0.05）， and the decreases in the Qingyusan group were higher than those in the control group （P<0.01）. After treatment， the SIBDQ scores in both groups increased （P<0.05）， and the increase was more pronounced in the Qingyusan group than in the control group （P<0.01）. There was no difference in the incidence of adverse events between the two groups. ConclusionThe clinical efficacy of Qingyusan capsules is remarkable in the long-term treatment of UC with the syndrome of large intestine dampness-heat. Particularly， Qingyusan capsules demonstrates advantages in inducing and maintaining clinical remission， promoting mucosal healing， alleviating TCM symptoms， and enhancing the survival quality of patients， with high safety.
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Osteoarthritis (OA) is a chronic degenerative joint disease and the most common type of arthritis. It involves almost any joint and can lead to chronic pain and disability. In the late 19th century, Roentgen discovered X-rays, and then began to use radiotherapy to treat tumors. In the 1980s, Luckey thought that low-level radiation (LDRT) might be beneficial to biology, and it was gradually applied to the treatment of some diseases. This paper introduces the epidemiology, risk factors, clinical manifestations and treatment methods of OA, points out that the cartilage injury and the important effect of synovial inflammation in the pathogenesis of OA, namely when the homeostasis of articular cartilage are destroyed, synthetic metabolism and catabolism imbalances, cartilage cells damaged their breakdown products consumed by synovial cells. Synovial cells and synovial macrophages secrete proinflammatory cytokines, metalloproteinases and proteolytic enzymes, leading to cartilage matrix degradation and chondrocyte damage, which aggravates synovial inflammation and cartilage damage, forming a vicious cycle. The possible mechanism and clinical research progress of LDRT in alleviating OA are discussed. LDRT can regulate inflammatory response, inhibit the production of pro-inflammatory cytokines, and promote the production of anti-inflammatory cytokines, thereby achieving anti-inflammatory effect. Studies have shown that after irradiation, the expression of inducible nitric oxide synthase (iNOS) was decreased, the release of reactive oxygen species (ROS) and the production of superoxide were inhibited, the anti-inflammatory phenotype of macrophages was differentiated from M1 to M2, the inflammatory CD8+ T cells were transformed into CD4+ T cells, and the number of dendritic cells (DC) was significantly reduced. LDRT inhibit the production of proinflammatory factors in leukocytes, reduce their recruitment and adhesion, and down-regulate the expression levels of cell adhesion molecules such as selectin, intercellular adhesion molecule (ICAM) and vascular endothelial cell adhesion molecule (VCAM). LDRT can regulate endothelial cells, stimulate endothelial cells to produce a large amount of TGF-β1, reduce the adhesion of endothelial cells to peripheral blood mononuclear cells (PBMC), and contribute to the anti-inflammatory effect of LDRT. It also exerted anti-inflammatory effects by regulating mitochondrial growth differentiation factor 15 (GDF15). After low-level radiation, the MMP-13 (matrix metalloproteinases-13) and the ADAMTS5 (recombinant a disintegrin and metalloproteinase with thrombospondin-5) decreased, the Col2a1 (collagen type 2) increased in chondrocytes. In the existing clinical studies, most patients can achieve relief of joint pain and recovery of joint mobility after irradiation, and the patients have good feedback on the efficacy. The adverse reactions (acute reactions and carcinogenic risks) caused by LDRT in the treatment of OA are also discussed. During the treatment of OA, a few patients have symptoms such as redness, dryness or itching at the joint skin, and the symptoms are mild and do not require further treatment. Patients are thus able to tolerate more frequent and longer doses of radiotherapy. In general, LDRT itself has the advantages of non-invasive, less adverse reactions, and shows the effect of pain relief and movement improvement in the treatment of OA. Therefore, LDRT has a broad application prospect in the treatment of OA.
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Informed consent is one of the key elements to protect the rights and welfare of the patients or research subjects. With the development of electronic information technology, the diversity and convenience brought by the electronization makes the electronic informed consent (E-Consent) come into being. European and American countries have begun to apply E-Consent in the field of clinical trials, established a relatively perfect E-Consent platform and software system, and initially formed the guiding principles and recommendations of E-Consent. However, the implementation of E-Consent is still less in China, and there is no targeted legal basis and guidelines for ethical review. Therefore, this paper explored the implementation potential of E-Consent domestically by analyzing the application scenarios, advantages and disadvantages, and feasibility of E-Consent, and tried to establish the practical ethic review points of E-Consent based on the basic principles of ethical principles, to ensure that clinical trials have an appropriate E-Consent process.
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This paper took a hospital in Anhui province as an example, aimed at the problems existing in the protection of human subjects’ rights and interests in China, and put forward relevant suggestions from the ethical perspective. The suggestions included shaping the international vision, playing the core role of ethics committee, strengthening the construction of legal and regulatory protection mechanism, setting up the human research protection committee and actively promoting the construction of subject protection system. These measures will effectively promote the construction and improvement of the rights and interests protection system of human subjects in China.
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Fundamento los intentos de suicidio en edades pediátricas son un problema actual con tendencia creciente a nivel mundial. Este grupo es muy vulnerable a la acción de factores internos y externos que alteran su integridad. En Cuba, a pesar de los logros obtenidos en ese sentido, también se considera como un problema de salud mental. Objetivo caracterizar desde el punto de vista clínico y epidemiológico a pacientes pediátricos con intento suicida. Métodos se realizó un estudio descriptivo, retrospectivo y de corte transversal, en el Hospital Pediátrico Provincial Octavio Concepción y de la Pedraja, de la provincia de Holguín, en el periodo enero/2020-diciembre/2021. Se trabajó con la totalidad del universo, conformado por 397 pacientes atendidos en la institución hospitalaria por intento suicida en el periodo de estudio. Las variables estudiadas fueron: edad, sexo, procedencia y método utilizado. Se empleó la estadística descriptiva. Resultados predominaron los pacientes con edades entre 16 y 18 años (48,4 %), del sexo femenino (74,6 %) y de procedencia urbana (70,3 %). El 92,2 % utilizó como método de suicidio la ingestión de psicofármacos. Conclusiones las variables estudiadas se comportan de forma similar a lo descrito en otras poblaciones y contextos, en los cuales también predominaron las adolescentes de procedencia urbana que ingirieron psicofármacos.
Background suicide attempts in pediatric ages are a current problem with a growing trend worldwide. This group is very vulnerable to the action of internal and external factors that alter their integrity. In Cuba, despite the achievements in this regard, it is also considered a mental health problem. Objective to characterize, from the clinical and epidemiological point of view, pediatric patients with suicide attempts. Methods a descriptive, retrospective and cross-sectional study was carried out at the Octavio Concepción y de la Pedraja Provincial Pediatric Hospital, in the Holguín province, from January/2020 to December/2021. The entire universe was analyzed made up of 397 patients, treated at the hospital for suicide attempts during the studied period. The variables were: age, sex, origin and method used. Descriptive statistics were used. Results patients aged between 16 and 18 years old (48.4%), female (74.6%) and urban origin (70.3%) predominated. 92.2% used the ingestion of psychotropic drugs as a method of suicide. Conclusions the studied variables behave in a similar way to that described in other populations and contexts, in which adolescents from urban origin who ingested psychoactive drugs also predominated.
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The aim of this study was to observed the anesthetic efficacy of the alveolar nerve block on nine patients that CBCT diagnosed unilateral retromolar canal on a double-blind, split-mouth approach. The assessments of patient response to thermal (pulp vitality test) and pressure (compression of soft tissue) stimuli were carried out before and 5 minutes after the inferior alveolar nerve block procedure, using both visual analog scale (VAS) and Mc Gill pain questionnaires (McG). The mean percentage of patient response decreased after alveolar nerve block, according to both VAS and McG, and was statistically similar among hemi mandibles with and without retromolar canal (Wilcoxon>0.05); however, those without retromolar canal presented greater reduction in patient response in 6 out of 9 cases. Therefore, the retromolar canal is not a determinant factor of inferior alveolar nerve block failure.
El objetivo de este estudio fue observar la eficacia anestésica del bloqueo del nervio alveolar en nueve pacientes que CBCT diagnosticó canal retromolar unilateral en un abordaje de boca dividida doble ciego. Las evaluaciones de la respuesta del paciente a los estímulos térmicos (prueba de vitalidad pulpar) y de presión (compresión de los tejidos blandos) se realizaron antes y 5 minutos después del procedimiento de bloqueo del nervio alveolar inferior, utilizando tanto la escala analógica visual (VAS) como los cuestionarios de dolor de Mc Gill ( McG). El porcentaje medio de respuesta de los pacientes disminuyó tras el bloqueo del nervio alveolar, según EVA y McG, y fue estadísticamente similar entre hemimandíbulas con y sin canal retromolar (Wilcoxon>0,05); sin embargo, aquellos sin canal retromolar presentaron mayor reducción en la respuesta del paciente en 6 de 9 casos. Por lo tanto, el canal retromolar no es un factor determinante del fracaso del bloqueo del nervio alveolar inferior.
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Humans , Cone-Beam Computed Tomography , Mandibular Canal/drug effects , Anesthesia , BrazilABSTRACT
Background: Anxiety is a widespread disorder that approximately 18% of the population experience at some stage in their lives. Pain is a common stimulus that induces anxiety in both animals and human beings. Combination of drugs with good anti-anxiety and analgesic effect can be used for the treatment of chronic pain induced anxiety, post-operative, and procedure-related pain-induced anxiety. Aims and Objectives: The study was conducted to evaluate the anxiolytic activity of combination of gabapentin with tramadol, pregabalin with tramadol compared to standard fluoxetine, in elevated plus maze (EPM) and light-dark arena (LDA) models of anxiety in Wistar albino rats. Materials and Methods: Twenty-four male or female albino Wistar rats from Central Animal House, MRMC, Kalaburagi, were utilized. Fluoxetine 10 mg/kg, gabapentin 30 mg/kg, tramadol 30 mg/kg, and pregabalin 30 mg/kg were used. Eddy’s hot plate method used for inducing anxiety. EPM and LDA models were used to study the effect of drugs in reducing the pain and anxiety. Results: The present study showed that the exposure to hot plate induces pain, creates anxiety, and reduces locomotor and explorative activity among the rats when exposed to hot plate. There was reduction in anxiety after drug administration, in fluoxetine and gabapentin with tramadol groups with >75% increase in entry into the light chamber or open arm at least once or more during the time period of 5 min when compared to hot plate post-exposure readings. Whereas in pregabalin and tramadol group, it was observed that 25% increase in entry of rats into open arm at least once during the time period of 5 min and 25% decrease in entry of rats into light chamber as compared to those rats after exposure to hot plate. Conclusion: Our study has demonstrated that tramadol, pregabalin, and gabapentin have got analgesic as well as anti-anxiety effects in rats when given in combination. All these experimental data, together with the previous experimental studies and the results reported in this work, suggest that combination of these drugs could be more effective in treating anxiety-related disorders such as chronic pain, pain-induced anxiety, post-operative, and procedure-related pain-induced anxiety with minimal side effects. Further dose ranging studies and models might be necessary to better understand the effects of these drugs in combination.
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Abstract Placebo use in clinical trials, whenever a proven effective treatment exists, is one of the most debated topics in contemporary research ethics. This article addresses the ethical framework for placebo use in clinical trials assessing vaccine efficacy in pregnant women. Vaccine trial participants are healthy at the outset and some must be infected during the study to demonstrate the product's efficacy, meaning that placebo-treated participants are under risk of serious and irreversible harm. If effective vaccines exist, such risk precludes placebo use. This interdiction should be extended to any clinical trial of vaccine efficacy in pregnant women, because a demonstration of clinical efficacy in nonpregnant individuals and comparable immunogenic responses in pregnant women are predictors of efficacy in pregnancy as well. Moreover, product effectiveness in real-world use scenarios can be ascertained by observational studies conducted after its inclusion in vaccination campaigns.
Resumen El uso de placebo en ensayos clínicos es uno de los principales temas debatidos sobre la ética en investigación contemporánea cuando existe un tratamiento eficaz probado. Este artículo aborda la ética en el uso de placebo en ensayos clínicos sobre la eficacia de vacuna en mujeres embarazadas. Las participantes en los ensayos de vacunas estaban sanas al inicio del estudio, y algunas fueron vacunadas durante el estudio para demostrar la eficacia del producto. Las participantes tratadas con placebo corren el riesgo de sufrir daños graves e irreversibles. Si existen vacunas efectivas, este riesgo impide el uso de placebo. Este impedimento debe extenderse a cualquier ensayo clínico de eficacia de vacuna en embarazadas, pues la eficacia clínica demostrada en mujeres no embarazadas y las respuestas inmunogénicas comparables con las embarazadas son predictores de eficacia en el embarazo. Además, la efectividad del producto se constata en estudios observacionales realizados tras las campañas de vacunación.
Resumo O uso de placebo em ensaios clínicos, quando um tratamento comprovadamente eficaz existe, é um dos principais tópicos debatidos na ética em pesquisa contemporânea. Este artigo aborda o quadro ético para o uso de placebo em ensaios clínicos que avaliam a eficácia de vacina em gestantes. Participantes em ensaios de vacina são saudáveis no início e alguns devem ser inoculados durante o estudo para demonstrar a eficácia do produto. Ou seja, participantes tratados com placebo estão sob risco de danos graves e irreversíveis. Se existirem vacinas eficazes, esse risco impede o uso de placebo. Essa interdição deve ser estendida a qualquer ensaio clínico de eficácia de vacina em gestantes, pois a demonstração de eficácia clínica em não gestantes e as respostas imunogênicas comparáveis em gestantes também são preditoras de eficácia na gravidez. Ademais, a eficácia do produto em cenários reais de uso pode ser verificada por estudos observacionais realizados após sua inclusão em campanhas de vacinação.
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Bioethics , Influenza, Human , Therapeutic Equipoise , COVID-19ABSTRACT
Objective:To summarize the characteristics of the participants (P), interventions (I), control measures (C), outcomes (O) and study design (S) of the clinical study of chronic back pain (CBP) in recent years; To further systematically organize the outcomes of the clinical study of CBP and their corresponding measurement tools.Methods:Clinical studies of CBP were retrieved from various databases including CNKI, Wanfang Database, VIP, SinoMed, Cochrane Library, Pubmed, Embase, Web of Science, etc. The search period was from January 1, 2015 to December 31, 2019. The retrieved literature was extracted and analyzed.The retrieved literatures will be extracted and analyzed. The retrieved literature was subjected to data extraction and analysis, and the quality of outcome indicators was evaluated according to 6 items. The Newcastle-Ottawa Scale ( NOS ) was used to evaluate the quality of cohort studies and case-control studies. Analyze the relationship between outcome indicators and interventions.Results:A total of 3 028 articles were finally included after examination and screening. The top 7 diagnoses of CBP were low back pain, lumbar disc protrusion, lumbar vertebral stenosis, lumbar vertebral slip, lumbar disc degression, non-specific chronic low back pain and post-operative pain syndrome. The top 7 intervention measures in clinical studies of CBP were surgery, acupuncture, physiotherapy, Tuina, exercise therapy, Western medicine painkillers and oral Chinese patent medicines. A total of 47 outcomes and 348 outcome measurement tools were reported in the literature included.Conclusion:In the clinical study of CBP in the recent years, there are problems such as incomplete and low quality of reporting, a wide variety of outcome measurement tools and lack of uniform reporting standards. The characteristics of patients determine the common characteristics of outcomes selection and it is also necessary to consider the specific outcomes related to interventions.
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Objective To analyze the clinical characteristics,treatment regimens and influencing factors of prognosis of patients with mantle cell lymphoma(MCL).Methods The clinical data of 41 patients with MCL was collected.These patients were initially diagnosed and treated in the Fifth Medical Center of Chinese PLA General Hospital between August 2004 and December 2019.The clinical features,therapeutic efficacy and prognosis-related factors were clarified.Results The median duration of follow-up was 68(1-165)months.The 3-year progression free survival(PFS)and overall survival(OS)were 37.29%and 62.75%respectively.Based on univariate analysis,B symptoms,Eastern Cooperative Oncology Group(ECOG)scores,the mantle cell lymphoma international prognostic index(MIPI),relapse and refractory state and the therapeutic effect were statistically significant for progression free survival.B symptoms,R-chemotherapy and therapeutic effect were statistically significant for overall survival.In multivariate analysis,B symptoms and the MIPI were statistically significant for progression free survival.B symptoms,R-chemotherapy and therapeutic effect were statistically significant for overall survival.There were statistically significant differences in 3-year OS between patients with different MIPI and MIPI-C scores.Conclusion Mantle cell lymphoma mostly occurs in elder males,and is more likely to be detected in late the stage.B symptoms,R-chemotherapy and therapeutic effect are independent prognostic factors for patients with MCL.The MIPI and MIPI-C scores have clinical guidance significance for patient survival.
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In recent years, with the development of ophthalmic therapeutic drugs, the vitreous body, as a channel for the treatment of ophthalmic diseases, especially fundus diseases, has opened up a new therapeutic approach for various choroidal neovascular diseases, macular edema, uveitis and other diseases associated with fundus diseases, which is represented by wet age-related macular degeneration (wAMD). The drugs administered through the vitreous body mainly include ocular anti-vascular endothelial growth factor (VEGF) injections, microplasmin and hormones. For this kind of ophthalmic products, there are no clear technical guidelines and norms for non-clinical research at home and abroad. This article combines review practices and cases of marketed products to sort out the research progress and considerations on non-clinical studies of ophthalmic drugs dosing through the ocular vitreous body, in order to provide references for the research and evaluation of such drugs.
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ObjectiveTo investigate the clinical efficacy and safety of Qihuang Jianpi Zishen granules in the treatment of cardiac involvement in systemic lupus erythematosus （SLE）. MethodA total of 62 SLE patients with cardiac involvement treated in the Department of Rheumatology and Immunology， the First Affiliated Hospital of Anhui University of Chinese Medicine from June 2021 to December 2022 were randomized into control and observation groups （n=31）. The control group was treated with methylprednisolone tablets and hydroxychloroquine sulfate tablets， and the observation group with Qihuang Jianpi Zishen granules on the basis of the therapy in the control group. After 12 weeks of treatment， the two groups were compared in terms of the therapeutic effect， cardiac function indicators ［left atrial end-diastolic diameter （LADd）， left ventricular end-diastolic diameter （LVDd）， left ventricular posterior wall thickness （LVPWTd）， peak blood flow velocity in early diastolic period （peak E）， peak blood flow velocity in late diastolic period （peak A）， E/A ratio， stroke volume （SV）， left ventricular ejection fraction （LVEF）， left ventricular short axis shortening rate （LVFS）， and B-type natriuretic peptide （BNP）］， vascular damage indicators ［nitric oxide （NO）， endothelin-1 （ET-1）， vascular endothelial growth factor （VEGF）， and homocysteine （Hcy）］， inflammation indicators ［erythrocyte sedimentation rate （ESR） and hypersensitive C-reactive protein （Hs-CRP）］， anti-double-stranded DNA （dsDNA） antibodies， disease activity index （SLEDAI） score， mitigation of symptoms and signs， and occurrence of adverse reactions. ResultThe total response rate in the observation group was 87.09%， which was higher than that （67.74%） in the control group （P<0.01）， and the incidence of adverse reactions had no significant difference between the two groups. After treatment， the control group showed lowered LVDd， LVPWTd， BNP， ET-1， VEGF， and Hcy （P<0.05） and increased E peak， E/A ratio， SV， LVEF， and LVFS （P<0.05）. In the observation group， LADd， LVDd， LVPWTd， peak A， BNP， NO， ET-1， VEGF， and Hcy decreased （P<0.05）， while peak E， E/A ratio， SV， LVEF and LVFS increased （P<0.05） after treatment. The treatment in both groups decreased the scores of palpitation， chest tightness， dyspnea， and edema （P<0.05）， reduced ESR， Hs-CRP， ds-DNA， and SLEDAI （P<0.05）. After treatment， the observation group had lower LADd， LVDd， LVPWTd， peak A， BNP， and scores of palpation， chest tightness， dyspnea， and edema （P<0.05） and higher peak E， E/A ratio， SV， LVEF， and LVFS （P<0.05） than the control group. In addition， the observation group had lower NO， ET-1， VEGF， Hcy， ESR， Hs-CRP， ds-DNA， and SLEDAI than the control group （P<0.05）. ConclusionQihuang Jianpi Zishen granules combined with hydroxychloroquine sulfate and methylprednisolone can improve multiple indicators and mitigate the symptoms and signs of SLE patients with cardiac involvement， demonstrating a clinical application value.
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Chronic obstructive pulmonary disease （COPD） is a chronic heterogeneous airway disease characterized by persistent and progressive airflow restriction， which can be divided into stable COPD and acute exacerbations of COPD （AECOPD）. Its morbidity and mortality remain high， posing a serious threat to human health. Traditional Chinese Medicine （TCM） believes that COPD belongs to the categories of "cough"， "dyspnea syndrome"， "lung distension"， etc. And its basic pathogenesis is intermingled phlegm and stasis with deficiency in origin and excess in superficiality. Qianjin Weijingtang， derived from the Records of Proved Prescriptions， Ancient and Modern （古今录验方）， consists of Phragmitis Caulis， Persicae Semen， Coicis Semen， and Benincasae Semen， with remarkable functions in clearing the lung， resolving phlegm and eliminating blood stasis， and has definite clinical efficacy in treating COPD and its syndromes. At present， in clinical studies， Qianjin Weijingtang has been used to treat COPD with modifications. It can be used alone or in combination with other prescriptions/western medicines to treat stable COPD， AECOPD， COPD complications， and other TCM syndromes of COPD such as phlegm-heat-stagnation obstructing the lung syndrome. It can significantly improve clinical symptoms， lung function， and blood gas indexes， and inhibit inflammatory response. Animal experiments mainly explored the mechanism of COPD from the level of pathological changes. Specifically， the underlying mechanism may be related to regulating T helper 17 （Th17）/regulatory T cells （Treg） balance， up-regulating single immunoglobulin IL-1-related receptor （SIGIRR） for resisting inflammation， up-regulating hyperplasia suppressor gene （HSG） and inhibiting Wnt signaling pathway activation to inhibit airway remodeling. It was found that there were many problems， such as low quality of clinical research， failure in sharing research standards， and the lack of mechanism research. This article systematically reviewed clinical studies of Qianjin Weijingtang in the treatment of COPD and its mechanism based on animal experiments in recent years， and put forward thoughts and suggestions according to the existing problems to provide references for the clinical application and further research on Qianjin Weijingtang.
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Clinical research reports serve as the presentation of scientific research findings and directly reflect the quality of the research. This article describes the writing of different types of clinical research reports， such as observational studies and randomized controlled trial studies， with a particular focus on randomized controlled trials. Each scientific research design has its reporting focus， and the writing of scientific research papers has uniform requirements and a specific writing format. Mastering the proper format of drafting research reports is of practical value and significant importance for conduction high-quality clinical research.
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Objective: To investigate the safety and efficacy of troxatabine in advanced or relapsed malignant tumors resistant to standard therapy in China. Methods: This is a phase Ⅰ prospective study. During dose escalation, patients in Cancer Hospital, Chinese Academy of Medical Sciences received a single-dose intravenous infusion of troxacitabine. The planned dosing groups were 1.8, 3.6, 4.8, 6.4 and 8.0 mg/m(2) on days 1 and 8 every 3 weeks. The data of all patients were collected for safety analyses. Safety and tolerability were evaluated by monitoring adverse events. Results: Nineteen patients were enrolled from April 2018 to May 2019. The major adverse events were fatigue (89.5%, 17/19), leukopenia (84.2%, 16/19) and neutropenia (78.9%, 15/19). The dose limiting toxicity was neutropenia. The maximum tolerated dose was 6.4 mg/m(2). The best effect was stable disease (43.8%). The half-life of elimination phase from 15.91 hours to 76.63 hours in each dose group. Conclusions: The toxicity of troxacitabine is well tolerant. We recommend that the dose for Phase Ⅱ clinical trial should be 6.4 mg/m(2).