With the reform of drug evaluation and approval in advance,a series of new initiatives have be launched,including improving the drug registration classification,revision of GCP and carrying out clinical trial data verification,strengthening clinical trial data management etc.Clinical trials of traditional Chinese medicines are facing new opportunities and challenges.The development of new traditional Chinese medicines should meet the clinical needs and clearly answer the clinical problems.The effectiveness of traditional Chinese medicines can be measured,and the key is to grasp scientific and reasonable research methods.Clinical trials of traditional Chinese medicines should pay attention to the research logic of clinical trials,and pay more attention to the quality of clinical trial data.The efficacy of traditional Chinese medicines is indeed based on clinical data.Viewed from its tendency,new Traditional Chinese Medicines are based on compound prescription.Therefore,researchers should effectively improve the overall research quality of the clincal trials on the new medicines of traditional Chinese medical compounds.

The study on the active ingredients of single Chinese crude drugs has the various values,and it is an indispensable process of the modernization of Chinese materia medica.Ephedrine extraction opened a prelude of the active ingredients commonly used Chinese materia medica in China,and the found of indirubin and arsenic trioxide for the treatment of leukemia and artemisinin for the treatment of malaria were the proud achievements.Although the research of active ingredients on Chinese materia medica has brought some success in the development of new drugs,the reality can not be too optimistic.It needs get rid of a purely analytic perspective,needs to carry out the activity screen sufficiently,needs to adhere to the main body of complex prescription in the development of new drugs of Chinese materia medica,and needs to grasp the "precise" and "ambiguous" organically.

Objective To investigate the effects of health education model on the efficacy and toxicity of chemotherapy in patients with gastrointestinal cancer. Methods Random digit table was used to divide 108 patients with gastrointestinal cancer divided into control group and observation group , 54 cases in each group: the former was treated with routine nursing care and the latter with education model based on health awareness theory. The two groups compared in terms of efficacy and toxicity of chemotherapy. Results The effective rate in the observation group was significantly higher than that of the control group (P<0.05). The hematologic toxicity, gastrointestinal toxicity, skin toxicity, heart, lung and kidney toxicity in the observation group during chemotherapy were significantly lower than those of the control group (P<0.05). Conclusion The health education model on the efficacy and toxicity of chemotherapy in patients with gastrointestinal cancer can improve the effect and reduce the occurrence.

AIM: To establish a population pharmacokinetics (PPK) model of vancomycin in patients with hematological diseases who developed neutropenia. METHODS: Patients from department of hematology with neutropenia in our hospital were taken into oue study.The patients (n=77) were performed trough and peak serum concentration of vancomycin, and their clinical data and medication information were collected. The Nonlinear mixed effect modeling approach (NONMEM) was used to establish the PPK model of those patients and model assessment and validation was carried out. Goodneess of fit plots and visual predictive check plus Bootstrap approach were used to assess validate our model. RESULTS: The model was a two compartment model, the final formulas were: clearance rate CL=6.84×(BW/70)

There is a rare case of an elderly diabetic with diabetic foot infection at Hainan General Hospital in September 2021, which was diagnosed as Corynebacterium diphtheriae infection incidentally on routine culture with conventional methods and molecular biological approaches, to aid in diagnosis in clinical practice. Owing to smear staining, Albert staining and VITEK 2 system, automated identification systems viz matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) confirmed combing with 16S ribosomal RNA (16S rRNA) gene has been used for the taxonomic classification of bacteria. Otherwise, toxin gene tox was done for diphtheria toxin synthesis. The isolate was Gram-stain-positive, rod-like arrangement with irregular thickness, with characteristic metachromatic granules, ferment most sugars and homology of 16S rRNA analyses with C. diphtheriae NCTC11397^T (MW682323.1) was greater than a 100% possibility, toxin gene tox was negative. The findings lay the foundation to clinical identify and trace of non-toxigenic C. diphtheriae. Moreover, this work provides insights into the non-toxigenic C.diphtheriae that contribute to recognized risk of non-toxigenic C.diphtheriae infections.
Aged ; Corynebacterium/genetics* ; Corynebacterium diphtheriae/genetics* ; Diabetes Mellitus ; Diabetic Foot ; Diphtheria/microbiology* ; Humans ; RNA, Ribosomal, 16S/genetics*

Objective　To investigate the correlation between serum Adropin protein expression and the severity and prognosis of patients with hypertensive intracerebral hemorrhage.Methods　Patients with hypertensive intracerebral hemorrhage who were treated in our hospital from January 2016 to January 2018 were enrolled.One hundred patients were enrolled in the study group.One hundred healthy subjects were included as control group.Serum Adropin protein levels were measured and analyzed.The relationship between the levels of Adropin protein and the disease condition and prognosis in patients with hypertensive intracerebral hemorrhage.Results　The study group finally included in 97 cases.The control group finally included in 99 cases.The expression levels of Adropin protein in the study group were lower than that in the control group (P<0.05).The expression levels of Adropin protein were significantly different in patients with different severity of disease (P<0.05).The expression levels of Adropin protein in patients with hypertensive intracerebral hemorrhage with different prognosis were statistically significant (P<0.05).Univariate analysis showed that age,severity of disease,amount of bleeding,and whether it broke into the ventricle were the prognostic factors of hypertensive cerebral hemorrhage (P<0.05).Multivariate logistic regression analysis showed that Adropin protein,age,severity of disease,and whether bleeding broke into the ventricle were independent factors affecting the prognosis of patients with hypertensive intracerebral hemorrhage (P<0.05).Conclusion　Serum Adropin protein is associated with the severity and prognosis of patients with hypertensive intracerebral hemorrhage.Serum Adropin protein is an independent factor affecting the prognosis of patients with hypertensive intracerebral hemorrhage.

Objective To explore the clinical features of critical cases of coronavirus disease 2019 (COVID-19). Methods The clinical data of nine patients who were diagnosed with critical COVID-19 in Hainan General Hospital from January 21, 2020 to February 6, 2020 were retrospectively analyzed. RT-PCR testing for 2019 novel coronavirus (2019-nCoV) was performed with multi-sites synchronize specimens including pharyngeal swab, blood, excrement, and urine. The serum levels of leucocyte, C-reactive protein, procalcitonin and lactic acid between the improved group (five cases) and the deteriorated group (four cases) were compared. The t test was used for comparison of normally distributed continuous data between groups. Results There were eight males (88.9%) and 1 female enrolled. The patients aged 28-77 years old, with an age of (52.9±18.0) years. By March 4, 2020, all five cases in improved group were cured and discharged, three cases in deteriorated group died and 1case remained in critical condition. All multi-sites specimens of patients in improved group turned negative in 2-4 weeks of illness onset, while those of cases in deteriorated group showed sustained viral nucleic acid positive (up to 48th day of illness onset). The white blood cell counts ((13.52±8.24)×10 9 /L vs (10.49±4.46) ×10 9 /L), C-reactive protein ((139.71±87.46) mg/L vs (78.60±55.40) mg/L) and procalcitonin ((2.32±4.03) ng/mL vs (0.28±0.58) ng/mL) , lactic acid ((3.70±4.14) mmol/L vs (2.33±0.53) mmol/L) in deteriorated group were all significantly higher than those in improved group ( t =2.908, 5.009, 4.391 and 2.942, respectively, all P <0.01). A rapid rise of serum IL-6 level up to 8 500 pg/mL was observed in one patient three days prior to death. Conclusion Among the patients with critical COVID-19, serum levels of inflammatory cytokines of the death cases are higher than those of improved and discharged cases.

Diabetic foot wound repair is a challenging issue in clinical practice. Due to the influence of multiple factors including the damage and regeneration failure of local tissue, the impaired pathways of wound repairing through blood vessels and nerve nutrition, and disorders of a variety of cellular factors, traditional treatment methods are often difficult to achieve good therapeutic effects. Stem cells are a type of cells with potentials of multidirectional differentiation, which also possess functions such as regulating immunity and paracrine to facilitate the comprehensive wound repair, so they have promising application prospect at present for the treatment of diabetic foot wounds. Because the relevant parameters of stem cell treatment are in the exploratory phase, there were no standardized data. This paper reviews the application of stem cells in the research of diabetic foot wound treatment over the past 6 years, analyzing and summarizing the contents in focused aspects including the types and sources of stem cells, effects of donor age and gender on stem cells, mode of administration, transplantation survival rate and safety, which may provide a reference for further application of stem cells in the clinical treatment of diabetic foot wound.
Cell Differentiation ; Diabetes Mellitus ; Diabetic Foot/therapy* ; Humans ; Stem Cell Transplantation ; Wound Healing/physiology*

Organ transplantation is the most effective treatment for various types of end-stage diseases. To resolve the problem of donor shortage in organ transplantation, the possibility of xenotransplantation has been gradually explored by surgeons. Pig is one of the common donor sources for xenotransplantation. As a bridge between two species, the viruses carried by pig organs may be transmitted between species and cause the risk of zoonosis. Porcine endogenous retrovirus (PERV) is integrated into the genome, which is a category of retrovirus featuring cross-species transmission. In this article, the influencing factors of transmission characteristics of PERV, the transmission risk of PERV and its recombinant virus, and the detection and transmission risk assessment of PERV in xenotransplantation test were reviewed, aiming to provide reference for alleviating severe shortage of donor organs and driving the advancement of xenotransplantation technologies.

OBJECTIVE To provide reference for the adjustment of antibiotic treatment regimens， identification of adverse reactions， and individualized pharmaceutical care for melioidosis sepsis （MS）. METHODS Clinical pharmacists participated in the intensive and eradicating therapeutic processes for an MS patient by using blood concentration and gene detection. Based on the literature， antibiotic treatment regimens of MS were adjusted by determining the blood concentrations of β-lactam and trimethoprim/ sulfamethoxazole （TMP/SMZ） and calculating PK/PD parameters. The causes of adverse drug reactions were analyzed and addressed by detecting drug-related gene polymorphisms through high-throughput sequencing. RESULTS Clinical pharmacists used blood concentration and genetic testing methods to propose adjustments to imipenem-cilastatin sodium dosage and analyze the causes of various adverse drug reactions. PK/PD targets were calculated by measuring the blood concentrations of β-lactam and TMP/SMZ. Clinical pharmacists explained to clinical doctors the compliance status of patients with melioidosis in sepsis and non- sepsis stages through reviewing guidelines and literature； the results of blood concentration and genetic test were used to analyze the correlation of neurotoxicity of MS patients with B14） IMP cmin， and it was found that nephrotoxicity was not related to the cmax of TMP/SMZ， but to the patient’s water intake. After whole-process antibiotic treatment， the patient’s condition improved and was discharged， and the adverse reactions were effectively treated. CONCLUSIONS Clinical pharmacists use blood concentration and genetic tests to assist clinicians in formulating MS treatment regimens， and provide whole-course pharmaceutical care for a MS patient. This method has improved the safety and effectiveness of clinical drug therapy.