Therapeutic Mechanism of Huangqi Guizhi Wuwutang on Rheumatoid Arthritis / 中国实验方剂学杂志

ObjectiveTo reveal the mechanism of action of Huangqi Guizhi Wuwutang in the treatment of rheumatoid arthritis by pharmacological research based on its clinical application. MethodThe collagen-induced arthritis （CIA） rat model was established by injecting bovine type Ⅱ collagen and Freund's adjuvant at the tail， and was treated with different concentrations of Huangqi Guizhi Wuwutang. The rats were randomly divided into blank group， model group， methotrexate （0.9 mg·kg-1） group， and Huangqi Guizhi Wuwutang low- and high-dose （5.13， 20.52 g·kg-1·d-1） groups， with continuous intragastric administration for 4 weeks. The degree of joint swelling， weight， degree of foot swelling and arthritis index score were determined and the pathological changes of ankle joints were detected by hematoxylin and eosin （HE） staining to observe the therapeutic effect of Huangqi Guizhi Wuwutang on rheumatoid arthritis. In addition， enzyme-linked immunosorbent assay （ELISA） and Western blot were used to measure the expression of interleukin 1β （IL-1β）， interleukin 6 （IL-6）， interleukin 10 （IL-10） and tumor necrosis factor-α （TNF-α） in serum and the expression of nuclear factor kappa-B （NF-κB） pathway related proteins in synovial tissue， respectively to clarify the molecular mechanism of Huangqi Guizhi Wuwutang in the treatment of rheumatoid arthritis. ResultCompared with the conditions in blank group， the body weight and IL-10 level were decreased （P<0.01）， and the degree of foot swelling and arthritis index score， the levels of IL-1β， IL-6 and TNF-α， and the expression of NF-κB pathway related proteins were increased （P<0.01，） in the model group， with impaired morphology and function of the ankle joint. Additionally， compared with the model group， Huangqi Guizhi Wuwutang low- and high-dose groups had increased body weight of rats and IL-10 level （P<0.01）， and reduced degree of foot swelling and arthritis index score （P<0.05， P<0.01）， levels of IL-1β， IL-6 and TNF-α （P<0.01） and expression of NF-κB pathway related proteins （P<0.05， P<0.01）， with improved function and morphology of the ankle joint. ConclusionHuangqi Guizhi Wuwutang can significantly alleviate joint inflammatory injury by down-regulating NF-κB pathway and reducing the inflammatory response in CIA rats.

Association between obesity with the diversity and genus of gut microbiota in school-aged children / 中华流行病学杂志

Objective: To analyze the diversity differences of gut microbiota between school-aged obese children and normal-weight children and identify the characteristic flora in obese children to provide some evidence for the subsequent study of the following study-related mechanisms and the prevention and treatment of obesity in school-aged children. Methods: This study was based on a cohort established in a primary school in Jiading district, Shanghai, 2016. Sixty-three children, including 43 boys and 20 girls, who were obese during the three years from 2016 to 2018, were enrolled in the obesity group. Among children who were average weight for three years, a total of 63 were selected as the control group, with matching with the obese ones in a 1 to 1 way according to age, sex and class. The primary characteristics, diet status, breastfeeding, and other information of children were collected by questionnaire. Fecal samples of participants in both groups were collected, and 16S rDNA sequencing was performed. Operable taxon units clustering according to 97% similarity and species annotation were based on the quality-optimized sequences. The difference in the diversity and genius of gut microbiota among children in the obesity and control groups were analyzed. The α diversity indices, including Ace, Chao1, Shannon, and Simpson index, were calculated. The β diversity was presented based on unweighted Unifrac distance and weighted Unifrac space by principal coordinate analysis. The differences in β diversity between the two groups were compared by similarity analysis (ANOSIM).The differences in genus distribution between the two groups were selected by STAMP software. The association of obesity with the α diversity and genus with significant differences were analyzed by the generalized linear model (GLM). Results: The Ace and Chao1 index in the obesity group was significantly lower than those in the control group (The P values were 0.026 and 0.039, respectively). There was no significant difference in Shannon and Simpson index between the two groups (The P values were 0.879 and 0.922, respectively). The results of ANOSIM showed differences in gut microbiota between the two groups (R>0), but the group contribution was not significant (unweighted Unifrac distance: R=0.006, P=0.223; weighted Unifrac distance: R=0.010, P=0.134). Among the obese group, the relative abundance of Prevotella and Sarcina was highest in the endemic genus. The STAMP results showed that the relative lots of 15 genera were significantly different between the two groups (P<0.05). The results of GLM showed that, compared with the control group, the obesity group had a lower level of the relative abundance in Akkermansia muciniphila, while a higher level in Coprococcus_3, Ruminococcus, Agathobacter and Collinsella. After stratification by sex, the Chao1 index was also lower in the obese boys than that in the normal-weight boys. However, the obese girls only had a higher level in Coprococcus_3 than the ordinary weight girls. Conclusions: Compared with children with average weight, obese children had lower α diversity of gut microbiota and lower relative abundance of dominant probiotics but had a higher relative lot of genus associated with metabolic disorders, inflammation promotion, and metabolism rate reduction.

Clinical trials and evaluation of Chinese patent medicine for stroke / 中国中药杂志

To systematically collect and analyze clinical randomized controlled trial(RCT) of Chinese patent medicine treatment for stroke in 2020, in order to provide basic information for clinical decision-making and related research. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, EMbase were searched for RCTs of Chinese patent medicine for stroke in 2020. The publication, sample size, intervention and control measures, course of treatment, outcome indicators, methodological quality and other contents were statistically analyzed.A total of 68 RCTs studies on Chinese patent medicine for stroke were included in 2020, of which 29(42.60%) were RCTs with sample size>100 cases. A total of 41 kinds of proprietary Chinese medicines were involved, including 23 kinds of oral proprietary Chinese medicines and 18 kinds of injections. A total of 18 intervention/control cases were included in RCTs, and 19 cases(Chinese patent medicine+Western medicine vs Western medicine) were applied in RCTs, accounting for 27.90%. The duration of treatment was reported in 91.18% of the studies, and the intervention duration was 8-14 days in 50.00% of the studies. Evaluation indexes were widely used, among which physical and chemical testing indexes(49.36%) were the most widely used. According to the methodological quality evaluation, the overall methodological quality of the study is not high, especially the implementation of the allocation hidden, blind method is not accurate, and the registration, ethics and other links are often missing. In conclusion, 2020 implementation of proprietary Chinese medicine in the treatment of stroke research methodology problems is outstanding, the similar function scale large range of optional, no specification selection criteria, reliability and practicability of the impact study, need to further standardize the proprietary Chinese medicine in the treatment of stroke study design, implementation and quality control, and highlight the value of proprietary Chinese medicine in the treatment of stroke and improve the quality of the evidence.

Clinical trials and evaluation of Chinese patent medicine for heart failure / 中国中药杂志

The present study systematically collected, analyzed, and evaluated randomized controlled trial(RCT) of Chinese patent medicine in the treatment of heart failure to provide references for follow-up clinical research design, guideline update, and policy formulation, and promote the improvement of clinical evidence quality. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, VIP, Wanfang, SinoMed, PubMed, and Web of Science were searched for RCTs of Chinese patent medicine in the treatment of heart failure from database inception to December 31, 2020. The di-sease type, publication time, sample size, intervention/control setting, course of treatment, evaluation indexes, and methodological quality were analyzed and evaluated. A total of 1 631 RCTs were included, including 1 622 in Chinese and 9 in English. It was first published in 1995, with the largest number of publications in 2016. There were only 56 RCTs(3.43%) with a sample size≥200. Seventy-eight types of Chinese patent medicines were involved, including 49 types of oral drugs and 29 types of injections. There were 34 intervention/control protocols, which were dominated by Chinese patent medicine+conventional treatment vs conventional treatment, accounting for 28.51%(n=465). About 94.0% of RCTs reported the course of treatment, mainly 14-56 days. The evaluation indexes were mainly physical and chemical tests and symptoms/signs, and left ventricular ejection fraction(LVEF) was the most frequently used measurement index. In enumeration indexes, clinical efficacy(response rate) was used the most frequently. Methodologically, 92.0% of the research subjects were rated as high risk of blindness. There were only 13 RCTs(0.80%) reporting registered information. It is necessary to further standardize the design, implementation, and quality control of clinical studies in order to improve the quality of evidence and avoid research waste.

Clinical evidence analysis report of Chinese patent medicine in 2020 / 中国中药杂志

The present study collected, collated, analyzed, and evaluated randomized controlled trial(RCT) of Chinese patent medicine published in Chinese and English journals in 2020, and summarized clinical evidence of Chinese patent medicine in stages, providing references for follow-up clinical research and evidence transformation and application. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, and EMbase were searched for RCTs of Chinese patent medicine published in 2020, and their research characteristics and methodological quality were analyzed and evaluated. A total of 1 285 research papers on Chinese patent medicine(1 257 in Chinese/28 in English) were included, involving 146 054 patients and 639 Chinese patent medicines, including 526 oral drugs, 68 injections, and 45 external drugs. A total of 412 diseases in 23 types were involved, which were dominated by circulatory system diseases and respiratory system diseases, specifically, cerebral infarction and angina pectoris. The sample size ranged from 20 cases to 2 673 cases, and 57.67% of RCTs had samples sizes less than 100. Single-center trials were the main ones, and multi-center trials only accounted for 4.75%(n=61). In terms of methodological quality, 52.91% of the RCTs had unclear descriptions or incorrect application of randomization methods, and the implementation of allocation concealment and blinding methods has not been paid much attention. In conclusion, compared with the conditions in 2019, the number of RCTs published in 2020 has decreased, and the research interest in respiratory diseases has increased, while the quality control in the process of research design and implementation has not been improved. Therefore, it is necessary to strengthen the methodological training of researchers and promote the output of high-quality research evidence.

Association of diet and physical activity with myopia among middle school students in Jiading District, Shanghai / 上海预防医学

Objective To explore the association between daily diet and physical activity with myopia in middle school students in Shanghai, so as to provide evidence for the prevention of myopia. Methods A stratified cluster random sampling of 795 students from two middle schools and one high school in Jiading District of Shanghai was selected. Data was extracted from 2017 adolescent health related behaviors surveillance in Shanghai. Results The reported rate of myopia among middle and high school students was determined to be 57.2%. The proportion of middle school students reporting no drinking soda, no eating desserts and no eating fried foods during the past week were 45.2%, 16.4% and 31.1%, respectively. The proportion of reporting eating fresh fruit, eating vegetables, drinking a cup of milk or yogurt among middle school students every day were 45.8%, 73.2% and 40.7%, respectively. The proportion of physical activity over 60 minutes and moderate intensity exercise over 30 minutes every day were 25.6% and 15.4%, respectively. The proportion of no drinking soda, no eating fried foods, eating fresh fruit every day, eating vegetables every day, and physical activity over 60 minutes during the past week in the non-myopia group were significantly higher than those in the myopia group(P < 0.01). Middle school students eating fresh fruit every day and physical activity over 60 minutes every day were determined to be protective factors for myopia(P < 0.01). Conclusion The proportions of Middle and high school students in Shanghai reporting healthy diet and physical activity are relatively low. Healthy diet and sufficient physical activity may be protective against myopia.

Clinical efficacy of Bushen Huoxue Culuan Formula in treatment of infertility caused by diminished ovarian reserve due to kidney deficiency and blood stasis / 中国中药杂志

To study the clinical efficacy and safety of Bushen Huoxue Culuan Formula in treating infertility caused by diminished ovarian reserve(DOR) with kidney deficiency and blood stasis. A total of 100 DOR patients treated at Xiyuan Hospital, Acupuncture Hospital and Clinic of China Academy of Chinese Medical Sciences from 2017 to 2020 in line with the inclusion criteria were selected and randomly divided into experimental group and control group at the ratio of 1∶1. The experimental group was treated with Bushen Huoxue Culuan Formular, while the control group was treated with Climen and Clomiphene for 3 menstrual cycles. The ovulation rate, pregnancy rate, pregnancy success rate, serum hormone levels, and traditional Chinese medicine(TCM) symptom scores were observed in the 2 groups. The total effective rate was 92.00% in the experimental group and 72.00% in the control group, with a statistical difference between the two groups(P<0.01); the experimental group was superior to the control group in reducing FSH level, increasing AMH level, improving TCM symptoms, increasing pregnancy rate and pregnancy success rate, with a significant difference(P<0.05). There was no abnormal safety indicator and adverse reaction. Bushen Huoxue Culuan Formular is effective in treating infertility caused by DOR due to kidney deficiency and blood stasis, with a safety and reliability.

Distribution of bacteria infected by metagenomic sequencing technology in maxillofacial space / 华西口腔医学杂志

OBJECTIVES@#This study aimed to compare and analyze the consistency and difference between metageno-mic next-generation sequencing (mNGS) and conventional bacterial culture in the detection of pathogenic microorganisms in maxillofacial space infection, as well as to provide a new detection method for the early clinical identification of pathogenic bacteria in maxillofacial space infection.@*METHODS@#The clinical data of 16 patients with oral and maxillofacial space infections in the First Affiliated Hospital of Zhengzhou University from March 2020 to June 2020 were collected. mNGS and conventional bacterial culture methods were used to detect pus. We then analyzed and compared the test results of the two methods, including the test cycle, positive detection rate, anaerobic bacteria, facultative anaerobes and aerobic bacteria detection rates, distribution of pathogenic bacteria, relative species abundance, and resistance genes.@*RESULTS@#The average inspection period of mNGS was (18.81±3.73) h, and the average inspection period of bacterial culture was (83.25±11.64) h, the former was shorter than the latter (@*CONCLUSIONS@#Compared with conventional bacterial culture, mNGS has the characteristics of short test time, high sensitivity, and high accuracy. Thus, it is a new detection method for the early identification of pathogenic bacteria in maxillofacial space infection and is beneficial to the early clinical diagnosis and treatment of the disease.

The research progress on the structure pharmaceutics and dosage form structures of traditional Chinese medicines / 药学学报

Traditional Chinese medicine (TCM) preparations have made tremendous progresses in modernization, whereas there exist relatively few researches pertaining to preparation structures. As demonstrated by the theory and practice of structure pharmaceutics, the structure properties of dosage forms have significant influences on the quality and efficacy of drugs, which might offer reference for the research and development of TCM dosage forms. With the application of synchrotron radiation X-ray micro-computed tomography (SR-μCT) and other novel technologies in recent years, researches in structure pharmaceutics have made huge advancement, which provide reference and methodology basis for the study of TCM preparations. The article generalized and summarized the recent progresses and methods in the structure researches of pharmaceutics and TCM preparations, and further explored the significance of the researches of structure of TCM preparations. It is expected to provide the basis for the dosage form design, production process improvement, and quality evaluation of TCM and promote the modernization of TCM preparations.

Serum Insulin-Like Growth Factor Binding Protein 7 as a Potential Biomarker in the Diagnosis and Prognosis of Esophagogastric Junction Adenocarcinoma

Background/Aims@#Esophagogastric junction adenocarci-noma (EJA) is a malignant tumor associated with high mor-bidity and has attracted increasing attention due to a rising incidence and low survival rate. Pathological biopsy is the gold standard for diagnosis, but noninvasive and effective tests are lacking, resulting in diagnoses at advanced stages.This study explored the diagnostic value of insulin-like growth factor binding protein 7 (IGFBP7) in EJA. @*Methods@#A total of 120 EJA patients and 88 normal controls were recruited, and their serum levels of IGFBP7 were measured by enzymelinked immunosorbent assay. Receiver operating character-istic (ROC) curve analysis was used to assess the diagnostic value, and Pearson chi-square analysis was used to evaluate the correlation between IGFBP7 and clinical parameters. Ka-plan-Meier survival analysis was carried out to assess the ef-fect of IGFBP7 on overall survival (OS). @*Results@#The levels of IGFBP7 were higher in both early- and late-stage EJA patients than in normal controls (p<0.001). The area under the ROC curve for EJA patients was 0.794 (95% confidence interval [CI], 0.733 to 0.854), with a cutoff value of 2.716 ng/mL, a sensitivity of 63.3% (95% CI, 54.0% to 71.8%) and a specific-ity of 90.9% (95% CI, 82.4% to 95.7%). For the diagnosis of early-stage EJA, the same cutoff value and specificity were obtained, but the sensitivity of IGFBP7 was 54.3% (95% CI, 36.9% to 70.8%). Patients with low IGFBP7 protein expres-sion had lower OS than those with high expression (p=0.034).The multivariate analysis showed that IGFBP7 is an inde-pendent prognostic factor for EJA (p=0.011). @*Conclusions@#Serum IGFBP7 acts as a potential diagnostic and prognostic marker for EJA.

Effect of Acupuncture and Biofeedback on Fecal Incontinence after Anus Preservation Operation for Rectal Cancer / 中国康复理论与实践

Objective:To investigate the effect of acupuncture and biofeedback on the recovery of fecal incontinence after anus preservation operation for rectal cancer. Methods:From January 1st, 2016 to June 30th, a total of 226 patients with rectal cancer after anus preservation operation were selected. Finally, 120 patients with fecal incontinence were randomly divided into control group (n = 40), acupuncture group (n = 40) and observation group (n = 40). All the groups accepted levator ani movement. In addition, the acupuncture group received acupuncture, and the observation group received acupuncture and biofeedback, for three months. Cleveland Clinic Florida Faecal Incontinence Scores (CCF-FIS), anorectal pressure, pelvic floor surface electromyography and quality of life were measured before treatment, and one month, two months and three months after treatment. Results:There was no significant difference in CCF-FIS, anorectal pressure, pelvic floor surface electromyography and quality of life among three groups before treatment (F < 2.943, P > 0.05). After treatment, all the above indexes improved (F > 5.235, P < 0.01), and were better in the acupuncture group and observation group than in the control group (P < 0.05), especially in the observation group (P < 0.05) at each time point. The curative effect of the observation group was related to the location of the tumor (χ2 > 4.405, P < 0.05) one month after treatment, and it was related to whether pelvic autonomic nerve preservation was performed during the operation (χ2 > 4.706, P < 0.05) and whether radiotherapy was added after the operation (χ2 > 5.013, P < 0.05) at each time point after treatment. At three months follow-up, the recurrence rate was lower in the observation group (8.6%) than in the acupuncture group (35.7%) and in the control group (35.0%) (χ2 > 5.976, P < 0.05). No complication occurred in all groups. Conclusion:Acupuncture and biofeedback can improve the symptoms of defecation incontinence and promote the recovery of anal function after anus preservation operation for rectal cancer.

Progress in Research on Effect of Processing on Chemical Constituents and Pharmacological Effect of Notoginseng Radix et Rhizoma / 中国实验方剂学杂志

Notoginseng Radix et Rhizoma, one of precious and important traditional Chinese medicinal herb, has the functions of dispersing blood stasis and stopping bleeding, detaching swelling and alleviating pain, and invigorating Qi and blood. It is a traditional Chinese medicine for promoting blood circulation and removing blood stasis. After processing, the efficacy of Notoginseng Radix et Rhizoma was obviously different, the raw products mainly dispersed blood stasis and hemostasis, while the main effect of processed products was to replenish blood and Qi. In recent years, more attention has been paid to Notoginseng Radix et Rhizoma research, mainly focusing on the chemical constituent, pharmacological action and clinical application of the raw products. Although the research on processed Notoginseng Radix et Rhizoma has been increasing in these years, the mechanism of processing and the changes of bioactive constituents before and after processing are still unclear. This paper systematically summarized the modern processing methods of Notoginseng Radix et Rhizoma and compared the changes in chemical constituent and pharmacological action before and after processing through literature search. It is proposed that modern technologies should be put forward to study the correlation between the chemical constituent transformation and enriching blood as the breakthrough point, in order to explain the processing mechanism of Notoginseng Radix et Rhizoma, improve the quality evaluation system of this decoction pieces, and provide guarantee for the safety and effectiveness of its clinical medication.

Meta-analysis on the association of leptin receptor Q223R polymorphism with the susceptibility to systemic lupus erythematosus / 中国基层医药

Objective:The association between leptin receptor (LEPR) Q223R (Gln>Arg) gene polymorphism and systemic lupus erythematosus (SLE) remains controversial.In this study, a meta-analysis was used to comprehensively evaluate the association between LEPR Q223R gene polymorphism and SLE susceptibility.Methods:Case control studies on the relationship between LEPR Q223R gene polymorphism and SLE susceptibility were comprehensively searched by Medline (PubMed), Web of Science, CNKI, Wanfang digital journal full-text database, etc., and the search time was up to April 2020.The data of A/G allele frequency and AA/AG/GG genotype in SLE patients and healthy controls were extracted, the odds ratio ( OR) value and 95% confidence interval ( CI) were used as the combined effect-size indicators to analyze the correlation between allele, genotype and SLE risk.The heterogeneity among studies was analyzed quantitatively, and the publication bias was evaluated by Begg and Egger’s test. Results:A total of 7 case-control studies from 4 studies were retrieved.A total of 9 052 patients with SLE and 8 146 healthy controls were included in the meta-analysis.The results showed that there was no significant association between LEPR Q223R A/G gene polymorphism and SLE susceptibility, and the OR of A allele in LEPR Q223R gene locus associated with SLE risk was 1.03(95% CI: 0.92-1.14). The dominant (AA+ AG vs GG) and recessive (AA vs AG+ GG) models both suggested that LEPR Q223R A/G gene polymorphism was not associated with SLE, and the combined OR (95% CI) was 0.88(0.15-5.37) and 1.13(0.37-3.49), respectively.The results also showed that the distribution of LEPR Q223R genotype was different among different populations, and the inter-study heterogeneity was large. Conclusion:The existing evidence is insufficient to indicate that there is an association between LEPR Q223R A/G gene polymorphism and SLE susceptibility, which needs to be confirmed by further studies.

Simultaneous determination of 13 bioactive components in Jiawei Zuojin Pill by HPLC-MS/MS / 中草药

Objective: To develop and validate an high performance liquid chromatography coupled with electrospray tandem mass spectrometry (HPLC-ESI-MS/MS) method for simultaneously qualitative and quantitative determination of 13 major bioactive components (ferulic acid, costunolide, baicalin, paeoniflorin, tetrahydropalmatine, rutecarpine, berberine, palmatine, evodiamine, naringin, hesperidin, saikosaponin a, and saikosaponin d) in Jiawei Zuojin Pills (JZP). Methods: The chromatographic separation was performed on a Thermo Syncronis C18 column (100 mm × 4.6 mm, 3.0 μm) with a gradient elution of methanol and 0.02 mol/L ammonium acetate in water at a flow rate of 0.35 mL/min, and the injection volume was 10 μL. The 13 major bioactive components were detected using an electrospray ionization source in ESI+ and ESI- ionization mode, quantified by multiple reaction monitor (MRM) scanning at the same time. Results: The linear ranges of ferulic acid, costunolide, baicalin, paeoniflorin, tetrahydropalmatine, rutecarpine, berberine, palmatine, evodiamine, naringin, hesperidin, saikosaponin a and saikosaponin d were 2-80 μg/mL (r = 0.999 2), 0.5-20.0 μg/mL (r = 0.999 1), 3.5-140.0 μg/mL (r = 0.999 8), 1-40 μg/mL (r = 0.999 2), 0.3-12.0 μg/mL (r = 0.999 1), 1-40 μg/mL (r = 0.999 2), 3-120 μg/mL (r = 0.999 7), 2.5-100.0 μg/mL (r = 0.999 5), 0.5-20.0 μg/mL (r = 0.999 3), 0.5-20.0 μg/mL (r = 0.999 1), 1-40 μg/mL (r = 0.999 1), 0.3-12.0 μg/mL (r = 0.999 2), 0.3-12.0 μg/mL (r = 0.999 2), and the average recoveries were 99.5% (RSD = 4.11%), 98.9% (RSD = 4.88%), 100.2% (RSD = 1.08%), 99.2% (RSD = 3.23%), 99.5% (RSD = 4.13%), 99.7% (RSD = 3.23%), 98.6% (RSD = 2.78%), 99.9% (RSD = 3.12%), 101.3% (RSD = 4.53%), 98.7% (RSD = 3.43%), 99.8% (RSD = 3.58%), 97.9% (RSD = 5.22%), and 101.3% (RSD = 5.13%), respectively. The contents of 12 batches of the 13 major bioactive components were 0.324-0.383, 0.051-0.072, 3.225-3.466, 0.154-0.198, 0.015-0.062, 0.144-0.199, 2.145-2.982, 0.441-0.953, 0.032-0.099, 0.062-0.089, 0.111-0.178, 0.012-0.065, 0.011-0.069 mg/g, respectively. Conclusion: The developed method is simple, specific, and sensitive, and it can be applied for the determination of 13 major bioactive components and the quality control of JZP.

In situ characterization of structural change and internal particle distributions of soft capsules based on synchrotron radiation X-ray micro computed tomography / 药学学报

It is difficult to directly observe the structural transformation inside of soft capsules if their shells are opaque. This study was designed to noninvasively in situ measure the structural characteristics of the soft capsules and internal particle distributions to reveal the intrinsic quality of the soft capsules and develop a new technique for reverse engineering and the physical stability evaluation of the soft capsules. In this research, the CT projection images of soft capsules, namely, propolis soft capsules, were collected via synchrotron radiation X-ray micro computed tomography (SR-μCT). After three-dimensional reconstruction, the structural differences of the soft capsules under long-term test and accelerated test for 6 months were quantitatively analyzed by calculating the three-dimensional structure parameters such as volume, number and distribution of the particles inside and the thickness for the wall of the capsules. There were only a small number of particles evenly distributed in the soft capsules stored under common storage condition without layering. On the other hand, the shell wall of the soft capsule turned thinner locally at the occlusal portion and the particles with strong X-ray absorption were densely distributed at the edge of the capsule wall after the accelerated test. This study revealed that the structural parameters of soft capsules obtained by SR-μCT could be used to evaluate the influence of storage environment on the physical stability of soft capsules. The technology provides a new method for quality control and evaluation for the soft capsules.

Research on the fingerprint and three active components assay in Shenshuaining granules by HPLC / 药学实践杂志

Objective To establish the fingerprint spectrum and assay three active components (hesperidin, salvianolic acid B and chrysophanol) in Shenshuaining granule by HPLC method. Methods The chromatographic separation was achieved on SunFireTM C18 column with acetonitrile-0.1% formic acid aqueous solution as mobile phase. Gradient elution program was applied with flow rate of 1.0 ml/min, detection wavelength at 254 nm and the column temperature at 25 ℃. The fingerprint spectrum was established and three active components in Shenshuaining granule were assayed. Results There were 22 common peaks on the fingerprints after analyzing chromatograms from 10 batches of Shenshuaining granules. Good fingerprint similarities (≥0.9) between different batches and the control chromatogram were found. This method has great repeatability, stability and precision, which meets all the assay requirements. Conclusion A simple and reliable HPLC method was developed, which is suitable for the fingerprint establishment of Shenshuaining granules. It provides a method for the quality control of Shenshuaining granules.

Predictive value of apolipoprotein B in the risk of progression to renal replacement therapy in diabetic kidney diseases patients / 中华肾脏病杂志

Objective To analyze the predictive value of apolipoprotein B (ApoB) in the risk of progression to renal replacement therapy (RRT) in diabetic kidney disease (DKD) patients with chronic kidney disease (CKD) stage 3-5. Methods The data of DKD patients with CKD stage 3-5 who were hospitalized and followed up with detailed clinical data from January 2011 to November 2014 in the Third Affiliated Hospital of Sun Yat-sen University were retrospectively collected. Estimated glomerular filtration rate (eGFR) was calculated according to the CKD-EPI formula. After 2 years of follow-up, the patients were divided into RRT group and non-RRT group according to whether they had entered renal replacement therapy. Cox regression analysis was used to analyze the influencing factors of DKD progression to RRT. The predicted value of ApoB in the risk of progression to renal replacement therapy (RRT) of DKD patients within 2 years of follow-up was analyzed by plotting the receiver operating characteristic curve (ROC). By establishing multiple Cox models, the effect of ApoB elevation on the progression of DKD patients to RRT was analyzed after adjusting for the influencing factors gradually. Results A total of 258 cases were included in this study, including 156 males and 102 females. They were (66.13±11.88) years old (27-91 years old). CKD 3-5 patients were 181 cases, 50 cases and 27 cases respectively. There were 165 cases in the non-RRT group and 93 cases in the RRT group. There were statistically significant difference in hemoglobin, hematocrit, blood phosphorus, ApoB, serum creatinine, urea nitrogen, serum cystatin C, eGFR and in the proportion of using angiotensin converting enzyme inhibitor, diuretic, β blockers between the two groups (all P＜0.05). Multivariate Cox regression analysis showed that ApoB was an independent predictor of progression to RRT in patients with DKD within 2 years (HR=2.203, 95% CI 1.352-3.589, P=0.002). The area under the ROC curve of ApoB for DKD progression to RRT within 2 years of follow-up was 0.641 (C-index=0.749, P＜0.01). After adjusting for confounding factors, Cox regression analysis showed that for every 1 mmol/L increase in ApoB, the risk of RRT increased by 1.038 times in DKD patients with CKD stage 3-5 (HR=2.038, 95% CI 1.312-3.168, P=0.002). Conclusions ApoB is an independent predictor of progression to RRT with CKD stage 3-5 diabetic kidney disease (DKD). For every 1 mmol/L increase in ApoB, the risk of progression to RRT in patients with CKD 3-5 DKD increases by 1.038 times.

Effect of serum uric acid level on prognosis in maintenance hemodialysis patients / 中华肾脏病杂志

Objective@#To analyze the relationship between serum uric acid (SUA) level and clinical indicators in maintenance hemodialysis (MHD) patients, and explore its influence on all-cause mortality and cardiovascular mortality.@*Methods@#This study was a retrospective cohort study. Patients who received MHD from the blood purification center of the Third Affiliated Hospital of Sun Yat-sen University from January 1, 2011 to December 30, 2015 were enrolled in the queue. They were divided into 3 groups according to the first and third quantile of the SUA level quartiles, and the baseline data of clinical and laboratory examinations were compared. The correlation between SUA level and clinical indicators was analyzed by Pearson correlation coefficient. Kaplan-Meier method and Cox proportional hazard regression model were used to examine the association between SUA and all-cause mortality and cardiovascular mortality in MHD patients.@*Results@#A total of 201 patients were enrolled in the study. The age of the patients was (56.9±16.7) years and the baseline SUA level was (531.1±137.9) μmol/L. Patients were divided into 3 groups with the first quantile (442 μmol/L) and the third quantile (620 μmol/L) of the SUA quartiles as the boundary points: group 1 (SUA<442 μmol/L, n=52), group 2 (SUA 442-620 μmol/L, n=101) and group 3 (SUA>620 μmol/L, n=48). The results showed that the patients in group 1 were older and had more proportion of patients with diabetes mellitus and cardiovascular diseases than those in group 3 (all P<0.05). Compared to group 3, the serum albumin, serum phosphorus and serum creatinine were lower in group 1, while the hypersensitive C-reactive protein was higher (all P<0.05). Pearson correlation analysis showed that SUA level was positively correlated with albumin (r=0.135, P=0.047), blood phosphorus (r=0.269, P<0.001) and serum creatinine (r=0.333, P<0.001), and negatively correlated with hypersensitive C-reactive protein (r=-0.216, P=0.002). After a median follow-up of 49.8 months, 66(32.8%) all-cause deaths and 32(15.9%) cardiovascular deaths were recorded. Kaplan-Meier method showed that with the decrease of SUA, all-cause mortality (Log-rank χ2=18.27, P<0.001) and cardiovascular mortality (Log-rank χ2=15.04, P=0.001) increased. After adjusting for age, gender, comorbidity and other factors using the Cox proportional hazards model, the all-cause mortality and cardiovascular mortality decreased by 20.1% (HR=0.799, 95% CI 0.651-0.980, P=0.031) and 29.6% (HR=0.704, 95% CI 0.524-0.946, P=0.020) for each 100 μmol/L increase in baseline SUA. Compared to group 1, all-cause mortality (HR=0.332, 95%CI 0.142-0.774, P=0.011) and cardiovascular mortality (HR=0.140, 95%CI 0.030-0.657, P=0.013) were lower in the group 3.@*Conclusion@#Low SUA level increases the risk of all-cause mortality and cardiovascular mortality in MHD patients.

Effect of serum uric acid level on prognosis in maintenance hemodialysis patients / 中华肾脏病杂志

Objective To analyze the relationship between serum uric acid (SUA) level and clinical indicators in maintenance hemodialysis (MHD) patients, and explore its influence on all-cause mortality and cardiovascular mortality. Methods This study was a retrospective cohort study. Patients who received MHD from the blood purification center of the Third Affiliated Hospital of SunYat-sen University from January 1, 2011 to December 30, 2015 were enrolled in the queue. They were divided into 3 groups according to the first and third quantile of the SUA level quartiles, and the baseline data of clinical and laboratory examinations were compared. The correlation between SUA level and clinical indicators was analyzed by Pearson correlation coefficient. Kaplan-Meier method and Cox proportional hazard regression model were used to examine the association between SUA and all-cause mortality and cardiovascular mortality in MHD patients. Results A total of 201 patients were enrolled in the study. The age of the patients was (56.9 ± 16.7) years and the baseline SUA level was (531.1±137.9)μmol/L. Patients were divided into 3 groups with the first quantile (442μmol/L) and the third quantile (620 μmol/L) of the SUA quartiles as the boundary points: group 1 (SUA<442 μmol/L, n=52), group 2 (SUA 442-620 μmol/L, n=101) and group 3 (SUA>620 μmol/L, n=48). The results showed that the patients in group 1 were older and had more proportion of patients with diabetes mellitus and cardiovascular diseases than those in group 3 (all P<0.05). Compared to group 3, the serum albumin, serum phosphorus and serum creatinine were lower in group 1, while the hypersensitive C-reactive protein was higher (all P<0.05). Pearson correlation analysis showed that SUA level was positively correlated with albumin (r=0.135, P=0.047), blood phosphorus (r=0.269, P<0.001) and serum creatinine (r=0.333, P<0.001), and negatively correlated with hypersensitive C-reactive protein (r=-0.216, P=0.002). After a median follow-up of 49.8 months, 66(32.8％) all-cause deaths and 32 (15.9％) cardiovascular deaths were recorded. Kaplan-Meier method showed that with the decrease of SUA, all-cause mortality (Log-rank χ2=18.27, P<0.001) and cardiovascular mortality (Log-rank χ2=15.04, P=0.001) increased. After adjusting for age, gender, comorbidity and other factors using the Cox proportional hazards model, the all-cause mortality and cardiovascular mortality decreased by 20.1％(HR=0.799, 95％CI 0.651-0.980, P=0.031) and 29.6％(HR=0.704, 95％CI 0.524-0.946, P=0.020) for each 100μmol/L increase in baseline SUA. Compared to group 1, all-cause mortality (HR=0.332, 95％CI 0.142-0.774, P=0.011) and cardiovascular mortality (HR=0.140, 95％CI 0.030-0.657, P=0.013) were lower in the group 3. Conclusion Low SUA level increases the risk of all-cause mortality and cardiovascular mortality in MHD patients.