Identification of Gastrodiae Rhizoma chromatographic peaks identification by liner calibration with two reference substances assisted / 药学学报

This study aimed to establish a method for positioning six chromatographic peaks occurred in HPLC profile of Gastrodiae Rhizoma. The "liner calibration with two reference substances" (LCTRS) method was used to calculate the retention time so as to assist in positioning of chromatographic peaks in terms of the prediction accuracy of retention time and the coincidence rate of chromatographic column. A total of 24 C18 chromatographic columns from different brands and types available were used to determine the retention times of six components in Gastrodiae Rhizoma, then the average retention time of each component was obtained as standard retention time (SRT). Parishin E (peak 3) and Parishin A (peak 6) were simultaneously taken as reference substance to forecast the retention time of the other four components by using the LCTRS method. Four different C18 columns were employed to verify the method. Meanwhile, for the purpose of comparison, the relative retention time (RRT) method was applied to forecast the retention time, by using Parishin E as the single reference substance. The comparison between LCTRS and RRT methods indicated that the former was more accurate in predicting the retention time and more applicable in utilization of chromatographic columns. This study demonstrated that the LCTRS method shows the superior performance in positioning of chromatographic peak, and therefore has a good prospect of application.

Changes of serum 25 hydroxyvitamin D 3 expression in diabetic patients and its correlation with macrovascular complications / 中国医师进修杂志

Objective:To analyze the changes of serum 25-hydroxyvitamin D 3[25-(OH)D 3] expression in diabetic patients and its correlation with macrovascular complications. Methods:Two hundreddiabetic patients admitted to Cangzhou Central Hospital from February 2018 to November 2019 were divided into macrovascular complications group (87 cases) and without macrovascular complicationsgroup (113 cases). According to the degree of 25-(OH)D 3 deficiency, 32 cases were divided into 25-(OH)D 3 normal group, 94 cases were mild deficiency group and 74 cases were moderate and severe deficiency group. At the same time, 168 outpatients were selected as control group. The levels of serum 25-(OH)D 3 were compared between diabetic group and control group, macrovascular complications group and without macrovascular complications group, and the correlation between the level of serum 25-(OH)D 3 and carotid intima-media thickness (IMT) was analyzed. Results:The level of serum 25-(OH)D 3 in diabetic group was lower than that in control group: (24.79 ± 3.02) μg/L vs. (39.18 ± 4.38) μg/L, the difference was statistically significant ( P<0.05). The level ofserum 25-(OH)D 3 in diabetic patients with macrovascular complications group was lower than that in without macrovascular complications group: (21.08 ± 2.64) μg/L vs. (27.65 ± 3.31) μg/L; while the IMT was higher than that without macrovascular complications group: (1.29 ± 0.13) mm vs. (0.93 ± 0.10) mm, the differences were statistically significant ( P<0.05). The incidence of macrovascular complications in 25-(OH)D 3 moderate and severe deficiency group was higher than that in 25-(OH)D 3 mild deficiency group and 25-(OH)D 3 normal group: 60.81%(45/74) vs. 40.43%(38/94), 12.50%(4/32), the difference was statistically significant ( χ2 = 21.896, P<0.05). The level of serum 25-(OH)D 3 in patients with diabetic macrovascular complications was negatively correlated with IMT ( r = -0.513, P<0.05). Conclusions:The level of serum 25-(OH)D 3 in diabetic patients is decreased, and the change of its concentration is related to the occurrence of macrovascular complications.

The intestinal micro-ecology influences the clinical efficacy of immune checkpoint inhibitors in cancer patients / 中华检验医学杂志

Immune checkpoint inhibitors (ICIs) targeting CTLA-4 and PD-1 /PD-L1 are increasingly used to treat several types of cancer.Although several agents have been approved,only 10％ to 30％ of patients have benefited from them.Some studies have shown that intestinal micro-ecology can affect the outcome of ICIs through immune regulation in cancer patients.This literature review s summarized the regulation and predictive functions of intestinal micro-ecology on ICIs treatment,and introduced possible mechanisms of intestinal micro-ecology that affacted the efficacy of immunotherapy.In addition,some approaches for detecting gut microbiome were also summarized.Gut microbiota highlighted in this review may serve as novel biomarkers to predict clinical outcomes in cancer patients.

Clinical analysis of 51 female children with condyloma acuminatum / 中华皮肤科杂志

Objective To analyze clinical features and treatment outcomes of female children with condyloma acuminatum.Methods Female outpatients with condyloma acuminatum aged less than 12 years were enrolled into this study.Through a questionnaire survey,medical histories were collected,and a physical examination was performed in these patients.Polymerase chain reaction (PCR) was conducted to determine the genotypes of human papillomavirus (HPV).Descriptive statistical methods were used to identify high risk factors for condyloma acuminatum,manifestations of skin lesions,and results of HPV test.The number of sessions of laser therapy and photodynamic therapy was also recorded.Results A total of 51 female children aged under 12 years with a diagnosis of condyloma acuminatum were enrolled into this study.Their median age and course of disease (M [P25-P75]) were 3 (2-5) years and 6 (4-8) months respectively.Of the 51 patients,29 (56.9％) lived in the small towns or suburb of a city,and 16 (31.4％) lived in the rural areas.Only 2 children's parents had a definite HPV infection history.Twelve children (23.6％) usually wore open-seat pants,24 (47％) often took a bath in public bath houses,and only 1 child had a definite history of sexual assault.Among these patients,39 (76.5％) mainly had perianal skin lesions,and all cauliflower-like lesions occurred on the perianal area.A total of 35 patients underwent the HPV test in the exfoliated cells.The positive rate of HPV was 71.4％,and all the HPV-positive patients were infected by low-risk HPV types (HPV6/11).During the treatment,5 patients were lost to follow-up.In the remaining 46 patients,the median number of sessions of laser therapy and photodynamic therapy was 2 (1-4) and 3 (3-4) respectively.The median course of treatment was 4 (2-6) months.After the treatment,all the remaining 46 patients were cured with a recovery rate of 90.2％ (46/51).Conclusions In these female children with condyloma acuminatum,the source of infection may maninly come from the environment,and skin lesions mostly occur on the perianal area.The prognosis is good after laser and photodynamic therapy.

Simultaneous Determination of Five Components in Ermiao Pills by UHPLC with Dual-Wavelength / 中国药学杂志

OBJECTIVE: To develop an ultra-high performance liquid chromatography(UHPLC) method for simultaneous determination of berberine hydrochloride, phellodendrine hydrochloride, palmatine hydrochloride, magnoflorine, and rhizoma atractylodis in Ermiao pills. METHODS: The UHPLC analyses were performed on a Waters BEH C18 column (2.1 mm×100 mm, 1.7 μm)eluted with acetonitrile and 0.1% phosphoric acid(each 100 mL containing 0.1 g sodium dodecyl sulfate). The flow rate was 0.3 mL·min-1, the detection wavelength was set at 280 and 340 nm, and the column temperature was set at 30℃. RESULTS: The calibration curves of the five compositions had good linear relationship in the ranges of the tested concentrations. The precision, stability and repeatability complied with the requirements of methodology. The recoveries were between 96.8%-99.3% respectively. The RSDs were below 2.8%. CONCLUSION: The developed method is simple, sensitive, rapid and accurate. This work provides helpful information for the comprehensive quality evaluation of Ermiao pills.

A randomized clinical study on optimum proposal of integration of disease and syndrome to treat viral myocarditis / 中国结合医学杂志

<p><b>OBJECTIVE</b>To determine the optimum treatment for viral myocarditis (VMC).</p><p><b>METHODS</b>A total of 126 VMC patients were randomly divided into the control group (42 cases) that was treated with conventional Western medicine, and the intervention group (84 cases) that was treated with a combination of Chinese medicine (CM) and Western medicine intervention termed optimum proposal of integration of disease and syndrome (OPIDS). Before and after 4 weeks of treatment, the integral of CM syndrome, self-rating depression and anxiety scales (SDS and SAS, respectively), echocardiograms (ECGs), heart rate variability and left ventricular systolic function were observed.</p><p><b>RESULTS</b>Compared with the control group, the intervention group showed significant reductions on the SDS and SAS (P <0.05); improvement of premature ventricular beats, atrioventricular blocks, ST-segment abnormalities, and significant T wave changes (P <0.05); greater reductions in standard deviation of NN intervals (SDNN), standard deviation for per 5 min averages NN intervals (SDANN), and root-mean-square of successive difference of NN intervals (rMSSD) (P <0.05); and increases in cardiac output, stroke volume, and ejection fraction, the last of which was statistically significant (P <0.05). Overall, the treatment efficacy rate was significantly better P<0.05) in the intervention group (75.61%) compared with the control group (69.70%).</p><p><b>CONCLUSION</b>OPIDS is quite effective in treating VMC and improves symptoms such as anxiety and depression, left ventricular systolic dysfunction, premature ventricular contraction, and cardiac autonomic nervous system dysfunction. [</p><p><b>REGISTRATION</b>Chinese clinical trial center (No. ChiCTR-TRC-00000298)].</p>

Item selection analysis based on quality of life scale in patients with viral myocarditis / 中国医学科学院学报

<p><b>OBJECTIVE</b>To further select the items based on the pre-test version of quality of life scale in patients with viral myocarditis.</p><p><b>METHODS</b>Totally 100 patients with viral myocarditis were enrolled in this study. Methodologies including frequency distribution, discrete trend, t-test, Cronbach's α coefficient, correlation coefficient and factor analysis were applied to select items from different perspectives.</p><p><b>RESULTS</b>A total of 17 items were selected by frequency distribution method from the perspective of central tendency, 15 items were selected by discrete trend method from the perspective of sensitivity, 16 items were selected by t-test method from the perspective of sensitivity and discrimination, 16 items were selected by Cronbach's α coefficient method from the perspective of internal consistency, 12 items were selected by correlation coefficient method from the perspective of representation and independence, and 18 items were selected by factor analysis method from the perspective of representation.</p><p><b>CONCLUSION</b>Item selection of quality of life scale in patients with viral myocarditis was successfully conducted based on the clinical epidemiological data using a variety of statistical methods.</p>

Modeling and simulation activities to design sampling scheme for population pharmacokinetic study on amlodipine / 药学学报

Reasonable sampling scheme is the important basis for establishing reliable population pharmacokinetic model. It is an effective method for estimation of population pharmacokinetic parameters with sparse data to perform population pharmacokinetic analysis using the nonlinear mixed-effects models. We designed the sampling scheme for amlodipine based on D-optimal sampling strategy and Bayesian estimation method. First, optimized sample scenarios were designed using WinPOPT software according to the aim, dosage regimen and visit schedule of the clinical study protocol, and the amlodipine population model reported by Rohatagi et al. Second, we created a NONMEM-formatted dataset (n = 400) for each sample scenario via Monte Carlo simulation. Third, the estimation of amlodipine pharmacokinetic parameters (clearance (CL/F), volume (V/F) and Ka) was based on the simulation results. All modeling and simulation exercises were conducted with NONMEM version 7.2. Finally, the accuracy and precision of the estimated parameters were evaluated using the mean prediction error (MPE) and the mean absolute error (MAPE), respectively. Among the 6 schemes, schemes 6 and 3 have good accuracy and precision. MPE is 0.1% for scheme 6 and -0.6% for scheme 3, respectively. MAPE is 0.7% for both schemes. There is no significant difference in MPE and MAPE of volume among them. Therefore, we select scheme 3 as the final sample scenario because it has good accuracy and precision and less sample points. This research aims to provide scientific and effective sampling scheme for population pharmacokinetic (PK) study of amlodipine in patients with renal impairment and hypertension, provide a scientific method for an optimum design in clinical population PK/PD (pharmacodynamics) research.