Short-term clinical efficacy observation of lesion removal, bone graft fusion, and external brace treatment for late-stage wrist tuberculosis / 中国骨伤

OBJECTIVE@#To observe the clinical efficacy of lesion removal, bone grafting, fusion, and external fixation in the treatment of late-stage wrist tuberculosis.@*METHODS@#From October 2015 to May 2019, 25 patients with late-stage wrist tuberculosis were treated using lesion removal, bone grafting, fusion, and external fixation. Among these patients, there were 14 males and 11 females, aged from 40 to 74 years old, with an average age of (60.72±8.45) years old. The duration of the disease ranged from 5 to 24 months, with an average of (11.52±7.61) months. There were 11 cases of left wrist tuberculosis and 14 cases of right wrist tuberculosis, with 5 cases accompanied by sinus formation. Postoperative regular anti-tuberculosis treatment was continued. Visual analogue score (VAS), inflammatory indicators, Gartland-Werley wrist function score, and upper limb function score were observed before and after treatment.@*RESULTS@#All 25 patients were followed up for ranging from 12 to 36 months with an average of (19.7±6.3) months. At the latest follow-up, all wounds were healed satisfactorily, and there was no recurrence of tuberculosis or infection. VAS at one week before operation and three months after operation were (5.16±1.14) score and (1.68±0.80) score respectively. One week before operation and three months after operation, erythrocyte sedimentation rate (ESR) was (44.20±20.56) mm·h-1 and (14.44±1.14) mm·h-1, and C-reactive protein (CRP) was (12.37±7.95) mg·L-1 and (4.3±3.37) mg·L-1. The differences in all three data sets were statistically significant (P<0.01). According to Gartland-Werley wrist function scoring, the scores at one week before operation and one year after operation were (21.32±3.44) and (14.96±1.37) respectively, showed a statistically significant difference (P<0.01). According to the upper limb function score (disabilities of the arm, shoulder, and hand, DASH), the score was (70.52±7.95) at one week before operation and(28.84±2.30) at one year after operation. The difference was statistically significant (P<0.01). At the latest follow-up, no patient had a recurrence of tuberculosis.@*CONCLUSION@#The short-term clinical efficacy of treating wrist tuberculosis with lesion removal, bone grafting, fusion, and external fixation is satisfactory.

Epidemiological Survey of Hemoglobinopathies Based on Next-Generation Sequencing Platform in Hunan Province, China / 生物医学与环境科学（英文）

OBJECTIVE@#This study was aimed at investigating the carrier rate of, and molecular variation in, α- and β-globin gene mutations in Hunan Province.@*METHODS@#We recruited 25,946 individuals attending premarital screening from 42 districts and counties in all 14 cities of Hunan Province. Hematological screening was performed, and molecular parameters were assessed.@*RESULTS@#The overall carrier rate of thalassemia was 7.1%, including 4.83% for α-thalassemia, 2.15% for β-thalassemia, and 0.12% for both α- and β-thalassemia. The highest carrier rate of thalassemia was in Yongzhou (14.57%). The most abundant genotype of α-thalassemia and β-thalassemia was -α 3.7/αα (50.23%) and β IVS-II-654/β N (28.23%), respectively. Four α-globin mutations [CD108 (ACC>AAC), CAP +29 (G>C), Hb Agrinio and Hb Cervantes] and six β-globin mutations [CAP +8 (C>T), IVS-II-848 (C>T), -56 (G>C), beta nt-77 (G>C), codon 20/21 (-TGGA) and Hb Knossos] had not previously been identified in China. Furthermore, this study provides the first report of the carrier rates of abnormal hemoglobin variants and α-globin triplication in Hunan Province, which were 0.49% and 1.99%, respectively.@*CONCLUSION@#Our study demonstrates the high complexity and diversity of thalassemia gene mutations in the Hunan population. The results should facilitate genetic counselling and the prevention of severe thalassemia in this region.

Inhibitory effect of three strains of biocontrol microbes on pathogens causing rhizome rot of Polygonatum cyrtonema / 中国中药杂志

Rhizome rot is one of the main disease in the cultivation of Polygonatum cyrtonema, and it is also a global disease which seriously occurs on the perennial medicinal plants such as Panax notoginseng and P. ginseng. There is no effective control method at present. To identify the effects of three biocontrol microbes(Penicillium oxalicum QZ8, Trichoderma asperellum QZ2, and Brevibacillus amyloliquefaciens WK1) on the pathogens causing rhizome rot of P. cyrtonema, this study verified six suspected pathogens for their pathogenicity on P. cyrtonema. The result showed that Fusarium sp. HJ4, Colletotrichum sp. HJ4-1, and Phomopsis sp. HJ15 were the pathogens of rhizome rot of P. cyrtonema, and it was found for the first time that Phomopsis sp. could cause rhizome rot P. cyrtonema. Furthermore, the inhibitory effects of biocontrol microbes and their secondary metabolites on three pathogens were determined by confrontation culture. The results showed that the three tested biocontrol microbes significantly inhibited the growth of three pathogens. Moreover, the secondary metabolites of T. asperellum QZ2 and B. amyloliquefaciens WK1 showed significant inhibition against the three pathogens(P<0.05), and the effect of B. amyloliquefaciens WK1 sterile filtrate was significantly higher than that of high tempe-rature sterilized filtrate(P<0.05). B. amyloliquefaciens WK1 produced antibacterial metabolites to inhibit the growth of pathogens, and the growth inhibition rate of its sterile filtrate against three pathogens ranged from 87.84% to 93.14%. T. asperellum QZ2 inhibited the growth of pathogens through competition and antagonism, and P. oxalicum QZ8 exerted the inhibitory effect through competition. The research provides new ideas for the prevention and treatment of rhizome rot of P. cyrtonema and provides a basis for the di-sease control in other crops.

Pharmacokinetics of antibody-drug conjugates and their research progress in the treatment of gastrointestinal malignancies / 药学学报

The morbidity and mortality of gastrointestinal malignancies are the highest in the world. For patients with poor response to conventional chemotherapy, new treatment methods are urgently needed. In recent years, under the background of precision medicine, antibody-drug conjugates (ADCs) with high tumor specificity and potent toxicity have become a hot research spot in the field of biomedicine. However, due to the complex structure and mechanism of ADCs, its pharmacokinetic research is facing great challenges which are the biggest resistance to the development of ADCs at present. In this case, it is of great significance to understand the pharmacokinetic properties of ADCs and make use of it to improve the efficacy of ADCs in the treatment of gastrointestinal malignancies. Based on the basic composition and mechanism of ADCs, this review summarizes the pharmacokinetic properties of ADCs, discusses its recent advances in the treatment of gastrointestinal malignancies, in order to provide more references for follow-up research on ADCs.

Blood Group Distribution Characteristics of COVID-19 Patients in Xinjiang / 中国实验血液学杂志

OBJECTIVE@#To analyze and summarize ABO and Rh(D) blood group distribution and related indicators of COVID-19 patients, and understand the relationship between blood group and disease course of COVID-19 patients in Xinjiang.@*METHODS@#A total of 831 patients with confirmed or asymptomatic COVID-19 infection treated in People's Hospital of Xinjiang Uygur Autonomous Region from July 2020 to August 2020 were enrolled as study group, and 2 778 healthy people in a third Grade A hospital in the region during the same period were selected as control group. ABO and Rh(D) blood group antigens were identified, and relevant medical data were collected for statistical analysis.@*RESULTS@#The proportion of O-type population and Rh(D) positive population in the study group was 24.79% and 96.27%, which were lower than those in the normal control group (29.73% and 97.73%) (P<0.05). The proportion of AB type and Rh(D) negative population was 14.20% and 3.73%, which was higher than that in control group (10.62% and 2.27%) (P<0.05). The proportion of female patients in Type O group was lower than that in control group. The proportion of female patients in AB group was higher than that in control group (P<0.01), while the proportion of type O patients in the age group less than or equal to 45 years old and greater than 60 years old was lower. Different blood groups of Uygur population showed their own characteristics in different sex, but there was no statistical significance due to the limited sample (P>0.05). Moreover, the course of disease and clinical diagnosis of COVID-19 patients were different among different blood groups (P<0.05).@*CONCLUSION@#This study found that the blood type distribution of COVID-19 patients in Xinjiang has its own characteristics, and the blood type is related to the course and clinical diagnosis of COVID-19. In the future, the data can be widely included in people from different ethnic groups and different regions to improve relevant studies.

Knockdown of NSUN2 Inhibits Melanoma Cells Proliferation by Regulating Cyclin Expression / 中国生物化学与分子生物学报

In order to investigate functions of NOP2/Sun RNA methyltransferase 2 (Nsun2) in melanoma cells, shRNA lentiviral vectors were constructed to target Nsun2 in mouse melanoma B16 cells. After treated B16 cells with recombinant virus, the mRNA and protein levels of NSUN2 in the interference group were significantly reduced, and the knock down efficiency reached 80%. EdU staining assay showed significant inhibition of DNA synthesis in Nsun2 knock-down B16 cells. RNA-seq was used to systematically analyze the gene expression of the Nsun2 knock-down and the control cells. A total of 1062 differentially expressed genes (DEGs) were screened, of which 678 were up-regulated and 384 were down-regulated. DEGs were mainly enriched in chromosome, centromere region, and protein binding GO terms. KEGG analysis showed that DEGs were significantly enriched in cell cycle, DNA replication, cell senescence and other pathways. RT-qPCR and RNA-seq data demonstrated that Cdk2, Ccnal, Cdc25b and other genes related to enhance cell division were significantly down-regulated, while Gadd45g and Gadd45a and other genes arresting cell growth were significantly up-regulated. Collectively, this study indicated that NSUN2 affects melanoma cell proliferation by regulating cell cycle and DNA replication, and provided fundamental data for exploring the molecular mechanism of melanoma genesis and development.

Recent advances in drug development targeting bile acids transporters and related disease / 药学学报

Bile acids (BAs) are a major component of bile salt, which plays a vital role in the metabolism of lipids in humans. Ninety-five percent of bile acids are recycled by the enterohepatic circulation (EHC), and therefore EHC is essential for bile acid homeostasis. There are four transporters that mediate the transmembrane transport of bile acids, each of which plays an important role in the enterohepatic circulation. Gene defects in bile acid transporters can lead to disorders of the enterohepatic circulation, ultimately leading to clinical phenotypes such as metabolic diseases and even death. Bile transporter expression is altered in patients with various metabolic disease states, suggesting that disruption of bile acid transporters may be a pivotal pathological mechanism for the development of metabolism diseases. Thus, many drugs targeting bile acid transporters are being developed. We provide a concise overview of the progress of bile acid transporters research, discuss the relationship between different bile acid transporters and disease development, and summarize the current progress in drug development targeting bile acid transporters.

Effect of Mankuining Decoction on Expression of Inflammatory Factors and Intestinal Flora in Mice with Ulcerative Colitis / 中国实验方剂学杂志

ObjectiveTo investigate the therapeutic effect and the possible mechanism of Mankuining decoction on dextran sulfate sodium （DSS）-induced ulcerative colitis （UC） in mice. MethodA total of 90 male SPF C57BL/6 mice were randomly classified into normal group， model group， mesalazine group （0.266 g·kg-1）， and high-， and medium-， low-dose （20， 10， 5 g·kg-1） Mankuining decoction groups， with 15 rats in each group. Mice， except the normal group， drank 3% DSS solution for 7 days to induce UC， and administration （ig） started on the day of modeling. The model group and the normal group were given equivalent amount of 0.9% normal saline once a day for 7 days. The general conditions of mice were recorded every day and the disease activity index （DAI） was calculated. On the 8th day， mice were killed by cervical dislocation. All the colons and feces were collected. The length of colon was recorded， and the histopathological changes of colon were observed based on hematoxylin-eosin （HE） staining. The content of inflammatory factors in colon was detected by enzyme-linked immunosorbent assay （ELISA）， and the changes of intestinal flora in mouse feces were determined based on 16SrRNA sequencing. ResultCompared with the normal group， the model group had severe colon damage， reduction in colon length （P<0.01）， increase in DAI （P<0.01）， decrease in interleukin-10 （IL-10） and transforming growth factor-β1 （TGF-β1） in colon（P<0.01）， rise of interleukin-1β （IL-1β）， interleukin-6 （IL-6）， interleukin-17α （IL-17α）， and tumor necrosis factor-α （TNF-α） in colon （P<0.05， P<0.01）， and decrease in abundance and diversity of intestinal flora. Compared with the model group， mesalazine and high-， medium-， low-dose Mankuining decoction alleviated the colon injury， recovered the length of colon （P<0.01）， decreased DAI （P<0.01）， increased IL-10 and TGF-β1 in colon （P<0.01）， and decreased IL-1β， IL-6， IL-17α， and TNF-α in colon （P<0.01）. Moreover， they raised the abundance and diversity of intestinal flora compared with the model group， as manifested by the increase in the abundance of Firmicutes， Akkermansia， Dubosiella， and Blautia and the decrease in the abundance of Bacteroidetes， Muribaculaceae， Clostridia_UCG-014， and Alistipes. ConclusionMankuining decoction has definite effect in treating UC mice， and the effect is positively correlated with the concentration. In addition， different concentration has different influence on the structure of flora. The mechanism is the likelihood that it alleviates the disorder of intestinal flora to restore intestinal immune balance and further promote the recovery of colonic mucosa.

Quality evaluation of Polygonatum cyrtonema based on HPLC fingerprint and multi-component quantitative analysis / 中国中药杂志

The medicinal and edible Polygonatum cyrtonema is one of the original species of Polygonati Rhizoma. In this study,HPLC fingerprints for 25 batches of P. cyrtonema from 6 provinces were established. A total of 14 common peaks were identified and the similarities of the fingerprints were in the range of 0. 939-0. 999. In additon, the partial least squares-discriminant analysis(PLSDA) demonstrated that the samples had low discriminability except for JX-1 and most components of them had no significant correlation with environmental factors such as longitude, latitude, and altitude. Thus, chemical composition specificity of P. cyrtonema in natural distribution areas had no obvious regularity and their variation might be induced by the local environment. This conclusion explained the lack of records about Dao-di area of Polygonati Rhizoma. However, JX-1 boasted significantly higher content of 5-hydroxymethylfurfural(HMF) and 4',5,7-trihydroxy-6,8-dimethylhomoisoflavone( HIF), thick and long inflorescence and rhizome, and extremely high yield. Therefore, excellent variety of P. cyrtonema might have great potential to improve the quality and yield of Polygonati Rhizoma. Moreover, three components of HMF, polygonalline A(PA), and HIF were identified in the fingerprint. Among them, HMF has the activities of blood rheology improvement, antioxidation, and anti-myocardial ischemia and PA is an indolizine alkaloid with potential anti-inflammatory activity. HIF, the characteristic homoisoflavone in Polygonatum, has the pharmacological activities of regulating blood glucose and anti-tumor. A quantitative analysis method can provide a theoretical basis for the improvement of the quality evaluation of Polygonati Rhizoma.

Comparable prognosis in different neonatal histidine-tryptophan-ketoglutarate dosage management / 中华医学杂志(英文版)

BACKGROUND@#Histidine-tryptophan-ketoglutarate (HTK) is a solution commonly used for organ transplantation. However, there is no certified fixed regimen for on-pump heart surgery in neonates. We aimed to retrospectively evaluate the outcomes related to different HTK dosages and to analyze the safety of high-dosage perfusion.@*METHODS@#A total of 146 neonates who underwent on-pump heart surgery with single-shot HTK perfusion were divided into two groups according to HTK dosages: a standard-dose (SD) group (n = 63, 40 mL/kg 60 mL/kg). Propensity score matching (PSM) was performed to control confounding bias.@*RESULTS@#The SD group had a higher weight (3.7 ± 0.4 vs. 3.4 ± 0.4 kg, P  0.05). The incidences of post-operative complications were not significantly different between the two groups. There were no significant differences in ventilation time, intensive care unit stay, and post-operative hospital stay (P > 0.05). Follow-up echocardiography outcomes at 1 month, 3 to 6 months, and 1 year showed that left ventricular ejection fraction and end-diastolic dimension were comparable between the two groups.@*CONCLUSIONS@#In neonatal on-pump cardiac surgery patients, single-shot HD (>60 mL/kg) HTK perfusion had a comparable heart protection effect and short-term post-operative prognosis as standard dosage perfusion of 40 to 60 mL/kg. Thus, this study provides supporting evidence of the safety of HD HTK perfusion.

The effects of borneol on the pharmacokinetics and brain distribution of tanshinone IIA, salvianolic acid B and ginsenoside Rg / 中国天然药物

Fufang Danshen preparation (FDP) is consisted of Salviae Miltiorrhizar Radix et Rhizoma (Danshen), Notoginseng Radix et Rhizoma (Sanqi) and Borneolum Syntheticum (borneol). FDP is usually used to treat myocardial ischemia hypoxia, cerebral ischemia and alzheimer's disease, etc. In the treatment of cerebrovascular diseases, borneol is usually used to promote the absorption and distribution of the bioactive components to proper organs, especially to the brain. The purpose of this study is investigating the effects of borneol on the pharmacokinetics and brain distribution of tanshinone IIA (TS IIA), salvianolic acid B (SAB) and ginsenoside Rg1 in FDP. Male healthy Sprague-Dawley (SD) rats were given Danshen extracts, Sanqi extracts (Panax notoginsengsaponins) or simultaneously administered Danshenextracts, Sanqi extracts and borneol. Plasma and brain samples were collected at different points in time. The concentration of TS IIA, SAB and Rg1 was determined by UPLC-MS/MS method. The main pharmacokinetics parameters of plasma and brain tissue were calculated by using Phoenix WinNolin 6.1 software. In comparison with Danshen and Sanqi alone, there were significant differences in pharmacokinetic parameters of TS IIA, SAB and Rg1, and the brain distribution of SAB and TS IIA when Danshen, Sanqi and borneol were administrated together. Borneol statistically significant shortened t

The protective effect of Medicoscab Tincture on deep partial thickness burn rats and its mechanism / 中国药理学通报

Aim To investigate the effect of Medi- coscab Tincture could increase the healing rate of burn coscab Tincture on the wound repair of deep partial thickness burn in rats and its possible mechanism. Methods SD100 rats were used to make a rat model of deep partial thickness burn. The rats were randomly divided into five groups; normal, model control, positive control, Medicoscab Tincture high-dose, and Medicoscab Tincture low-dose. The dosing group was changed daily for 14 consecutive days. The healing rate and water content of wound were measured at 3 d, 7 d and 14 d after burn. The activities of superoxide dismutase (SOD) and catalase (CAT) and the content of malondialdehyde ( MDA) were determined by bio-chemical analysis. Serum levels of tumor necrosis fac- tor-a (TNF-a), interleukin-1 (3 (IL-1(3) and interleu- kin-6 (IL-6) in rats were determined. Results Medi- wound and decrease the water content of burn wound tissue in rats ( P < 0. 05 ). The activity of SOD significantly increased, the content of MDA decreased (P < 0. 05), and the contents of TNF-a, IL-1 (3 and IL-6 in serum of burned rats decreased ( P < 0. 05, P < 0.01). Conclusions Medicoscab Tincture can improve the wound healing rate, reduce the wound water content, increase SOD activity, reduce the content of MDA in the wound, and reduce the serum levels of inflammatory factors TNF-a, IL-1 (3 and IL-6. Therefore, Medicoscab Tincture has a protective effect on deep partial thickness burn in rats.

Forensic Analysis of 43 Medical Disputes Caused by Death after Cardiac Surgery / 法医学杂志

Objective To explore the causes and characteristics of medical disputes caused by death after cardiac surgery and to analyze the pathological changes after cardiac surgery and the key points of forensic anatomy, thus to provide pathological evidence for clinical diagnosis and treatment of cardiac surgery and judicial appraisal as well as reference for the prevention of medical disputes in such cases. Methods Forensic pathological cases of medical disputes caused by death after cardiac surgery which were accepted by the Center for Medicolegal Expertise of Sun Yat-Sen University from 2013 to 2018 were analyzed retrospectively from aspects such as causes of death, pathological diagnosis, surgery condition, medical misconduct, and so on. Results The causes of death after cardiac surgery of 43 patients were abnormal operation, low cardiac output syndrome, postoperative infection, postoperative thrombosis, and other diseases. Among the 43 cases, there were 18 cases without medical fault while 25 cases had medical fault. Conclusion The medical disputes caused by death after cardiac surgery are closely related to the operative technique and postoperative complications. The causes of medical faults include defects in diagnosis and treatment technique, as well as unfulfillment of duty of care.

Normocalcemic with elevated post-operative parathormone in primary hyperpara-thyroidism: 9 case reports and literature review / 北京大学学报(医学版)

OBJECTIVE@#To summarize and analyze the clinical characteristics of primary hyperpara-thyroidism (PHPT) with normocalcemic parathormone elevation (NPE) after surgical treatment, so as to improve the therapeutic ability and standardized post-operative follow-up of PHPT patients.@*METHODS@#Nine patients who were diagnosed with PHPT in the Department of Endocrinology of China-Japan Friendship Hospital from August 2017 to November 2019 were selected as the subjects. They all developed NPE within 6 months after surgical treatment. The clinical features and outcomes were collected and analyzed retrospectively, in addition, the related literature was reviewed.@*RESULTS@#Clinical features: among the 9 patients, 6 were middle-aged and elderly females and 3 were male. The main clinical manifestations were bone pain, kidney stones, nausea and fatigue except for one case of asymptomatic PHPT. Pre-operative examination showed high serum calcium [(3.33±0.48) mmol/L], low serum phosphorus [0.76 (0.74, 0.78) mmol/L], high 24-hour urinary calcium [8.1(7.8, 12.0) mmol/24 h], obviously elevated intact PTH [(546.1±257.7) ng/L], vitamin D deficiency [25-hydroxyvitamin D3 (21.0±5.7) nmol/L]. Serum levels of bone alkaline phosphatase [7 patients 41.3(38.6, 68.4) μg/L, 2 patients >90 μg/L] and N-terminal midcourse osteocalcin (>71.4 μg/L) were significantly elevated. The estimated glomerular filtration rate decreased in 2 patients. Imaging examination: 7 patients had osteoporosis. Renal calculi were found in 3 patients by renal ultrasound. Imaging examination of parathyroid glands found definite lesions in all the patients, including 2 cases of multiple lesions and 7 cases of single lesions.@*TREATMENT AND OUTCOME@#two patients underwent parathyroidectomy, while other patients were treated with microwave thermal ablation. PTH increased 1 month after therapy [(255.0±101.4) ng/L], and no recurrent lesions were found by parathyroid ultrasound. After combined treatment with cal-cium and vitamin D for six months, PTH decreased significantly and the level of serum calcium remained normal at anytime during the follow-up period.@*CONCLUSION@#The occurrence of postoperative NPE may be related to the higher pre-operative PTH, vitamin D deficiency and lower creatinine clearance. However, NPE may not predict recurrent hyperthyroidism or incomplete parathyroidectomy. Adequate calcium and vitamin D supplementation after surgery seems to be beneficial for patients with NPE. Post-operative follow-up of PHPT patients should be standardized to prevent and treat post-operative NPE.

Effects of different storage conditions on edible quality and antioxidant activity of Polygonatum cyrtonema flowers / 中国中药杂志

The flower of Polygonatum cyrtonema has good edible and medicinal values. In this study, four samples of P. cyrtonema flowers from different regions were selected as test materials. The contents, composition and antioxidant activities of lipid-soluble pigments and alcohol-soluble components were determined under different light and temperature conditions, which help to reveal the discoloration reason and the composition variation patterns during storage. The results showed that light and temperature had different effects on the lipid-soluble pigments and alcohol-soluble components in the dried flowers during storage. After storage for 4 weeks, the contents of total chlorophyll, carotenoids, phenols and saponins in the samples exposed to light respectively decreased by 62.62%, 66.4%, 68.7% and 43.4% compared with those in the dark. The decreases in the contents of chlorophyll a, chlorophyll b, lutein, β-carotene and zeaxanthin were 64.64%, 56.74%, 59.2%, 77.7% and 45.4%, respectively. The contents of pigments and components in the samples stored at-20 ℃ were significantly higher than those at room temperature and 4 ℃, indicating that low temperature was conductive to the stability of lipid-soluble pigments and alcohol-soluble components. The samples stored at low temperature and in the dark had the strongest free radical scavenging activity. The results suggest that P. cyrtonema dried flowers should be stored in low temperature environment without light, which can slow down the degradation of internal components. The study provides a theoretical basis for the production, processing and storage of P. cyrtonema flowers.

Application of objective performance criteria in post-marketing evaluation schemes of traditional Chinese medicine / 中国中药杂志

Traditional Chinese medicines(TCMs) have certain limitations in the clinical research design in their post-marketing evaluation, so that randomized controlled programs cannot be strictly implemented in some studies, while the objective performance criteria is a reasonable external controlled research method that has been gradually recognized at home and abroad in recent years in addition to randomized controlled trial(RCT) method. It is more mature in medical devices, surgery and other research fields, but there is no relevant report in the field of post-marketing evaluation of Chinese patent medicines. In this paper, the application prospect of the objective performance criteria and the problems were discussed in the field of post-marketing evaluation of TCM. The characteristics of as TCM are more consistent with the scope of the objective performance criteria, the application of the objective performance criteria in post-marketing evaluation of Chinese patent medicines, especially in single arm research, can break through the limitations of existing conventional clinical research methods, and improve the level of evidence, with good feasibility and advantages. However, in the application process, we should pay attention to the key issues such as the selection of index, research population, follow-up period and the reference selection, to ensure the quality of research. This research group has carried out some exploration and practice in the field of post-marketing evaluation of TCM injections by using single arm combined with the objective performance criteria, hoping to establish the key technology in this field, and provide certain research and design reference for the secondary development of Chinese patent medicines.

Investigation on reproductive characteristics of Polygonatum cyrtonema / 中国中药杂志

The study is aimed to investigate the reproductive biology characteristics of Polygonatum cyrtonema, especially including phenology, flower bud differentiation, flowering timing, floral traits, pollen vigor and stigma receptivity. The results showed that P. cyrtonema forms inflorescence before the leaves spread. In the wild, P. cyrtonema is mainly pollinated by insects such as bumblebees, with a seed setting rate of 65.12%. The seed setting rate of indoor single plant isolation or self-pollination enclosed by parchment paper bag is 0, indicating that it is self-incompatible. In Lin'an city, seedlings begin to emerge from mid-March to early April(the temperature is higher than 7.5 ℃), buds begin to emerge from the end of March to mid-April, and then undergo the full bloom stage from mid-to-late April, and the final flowering stage from the end of April to mid-May. The whole flowering period lasts 36 to 45 days. There are obvious differences in the phenology of different provenances. The flowers come into bloom from the base to the top along the aboveground main axis, which usually contain 4-22 inflorescences with(2-) 4-10(-21) flowers per inflorescence. The flowering pe-riod for a single plant is 26-38 days. The single flower lasts about 20-25 days from budding to opening and withers 2 days after pollination, and then the ovary will gradually expand. If unpollinated, it will continue to bloom for 3-5 days and then wither. Flower development period is significantly related to pollen vigor and stigma remittance. The pollen viability is the highest when the flower is fully opened with anthers gathering on the stigma, and the receptivity is the strongest when the stigma protrudes out of the perianth and secretes mucus. The fruits and seeds ripen in October, and proper shading can ensure the smooth development and maturity of the seeds. This study provides a basis for the hybrid breeding and seed production of P. cyrtonema.

Structural Differences in Series Scores of Hamilton Anxiety Scale in Parkinson's Disease Patients / 中国康复理论与实践

Objective:To explore the structural differences in series scores of Hamilton Anxiety Scale (HAMA) in Parkinson's disease patients with anxiety. Methods:From January, 2016 to December, 2017, 180 inpatients with Parkinson's disease in Center for Neurodegenerative Disease, Beijing Tiantan Hospital were reviewed. Their age, gender, course of disease were recorded, and were assessed with HAMA, Hamilton Depression Scale (HAMD), unified Parkinson's Disease Rating Scale III (UPDRSIII)，Hoehn-Yahr stage and Mini-Mental State Examination (MMSE). They were divided into non-anxiety group, possible anxiety group, anxiety group and very anxiety group according to the scores of HAMA. The demographics, clinical data and series scores of HAMA were compared among these groups. The correlation between HAMA and HAMD were anlyzed. Results:The course of disease, UPDRSIII scores and the most improvement ratio by drug increased with the severities of anxiety (F > 4.951, P < 0.001), as well as the series scores of HAMA (F > 188.241, P < 0.001); however, the proportion of psychogenic anxiety score increased with the severities of anxiety. The scores of HAMA correlated with the scores of HAMD (r = 0.665, P < 0.05). Conclusion:The more serious the anxiety is, the more psychogenic are in Parkinson's disease patients.

Structural Differences of Depression for Patients with Parkinson's Disease Using Hamilton Depression Scale / 中国康复理论与实践

Objective:To explore the structural differences and the trend in series scores of Hamilton Depression Scale (HAMD) in patients with Parkinson's disease (PD). Methods:From June, 2017 to March, 2018, 168 PD patients from Beijing Tiantan Hospital were reviewed. Their genders, ages, courses of disease, Hamilton Depression Scale (HAMD) scores, unified Parkinson's disease rating scale III (UPDRS III) scores，Hoehn-Yahr stage and Mini-Mental State Examination (MMSE) scores, the most improvement ratios by PD drug and other clinical data were collected. The patients were divided into non-depression group (n = 61), mild depression group (n = 68) and moderate depression group (n = 39) according to the HAMD scores. The series scores of HAMD among the groups were compared. Results:The factor scores all increased with depression exacerbating (F > 10.546, P < 0.001), except day and night change in the mild depression group, while the proportion of anxiety/somatization score decreased, and the proportion of cognitive disorder and retardant scores increased. Conclusion:The depression structure changes in PD patients with depression exacerbating, which means decrease of anxiety/somatization and increase of cognitive disorder and retardant.

Efficacy and safety of early initiation of sacubitril-valsartan therapy in patients with acute decompensated heart failure / 中华心血管病杂志

Objective: To assess the efficacy and safety of the initiation of sacubitril-valsartan （ARNI） therapy, as compared with ACEI therapy, after hemodynamic stabilization among patients hospitalized for acute decompensated heart failure （ADHF）. Methods: A total of 199 hospitalized patients for ADHF in our department from January 2017 to June 2019 were included in this retrospective analysis. According to the medication early after hemodynamic stabilization, patients were divided into ARNI group (n=92) and ACEI group (n=107). Among the included patients, 61 patients with newly diagnosed heart failure at the time of admission were also divided into ARNI group (n=30) and ACEI group (n=31) according to the applied medication. Clinical baseline data and follow-up results of enrolled patients were collected through the electronic medical records at admission, outpatient and telephone follow-up. The primary effectiveness observation index was left ventricular ejection fraction (LVEF) and left ventricular end diastolic dimension (LVEDD) measured by echocardiography; the secondary observation index was death from any causes and hospitalization for heart failure. Safety outcomes were the incidences of symptomatic hypotension, worsening renal function, hyperkalemia, and angioedema. Results: The clinical baseline characteristics were similar between ARNI group and ACEI group（all P>0.05）. The duration of follow up was (15.2±6.5) months in all patients enrolled, (12.3±5.0) months in ARNI group, and (18.2±6.5) months in ACEI group. At the end of follow-up, prevalence of an absolute LVEF increase of more than 5% was 48.9% (45/92) in ANRI group and 25.2% (27/107) in ACEI group (P=0.001). Percent of LVEF increase to more than 50% was 17.4% (16/92) in ANRI group and 3.7% (4/107) in ACEI group (P=0.001). Percent of patients with more than 10 mm LVEDD reduction was 14.1% (13/92) in ANRI group and 3.7% (4/107) in ACEI group (P=0.009). All-cause mortality rate was 5.7% (5/88) in ARNI group and 15.3% (13/85) in ACEI group (P=0.038). Rate of re-hospitalization due to heart failure was 50% (46/92) in ARNI group and 71% (76/107) in ACEI group（P=0.002）.The rates of symptomatic hypotension, worsening renal function, hyperkalemia, and angioedema were similar between ARNI group and ACEI group (all P>0.05). In patients with first diagnosed heart failure，percent of LVEF increase to more than 50% was 30% (9/30) in ANRI group and 6.5% (2/31) in ACEI group (P=0.017). Percent of more than 10 mm LVEDD reduction was 26.7%(8/30) in ANRI group and 3.2%(1/31) in ACEI group (P=0.012). Percent of an absolute LVEF increase of more than 5% was 53.3% (16/30) in ANRI group and 51.6% (16/31) in ACEI group (P=0.893). Re-hospitalization due to heart failure was 23.3% (7/30） in ARNI group and 73.3% (11/31) in ACEI group（P<0.01）. Rate of all-cause death tended to be lower in patients receiving ARNI (3.4% (1/29)) as compared to patients receiving ACEI (13.0% (3/23), P=0.197）. Conclusions: Among patients with heart failure with reduced ejection fraction hospitalized for ADHF, the initiation of ARNI therapy after hemodynamic stabilization is associated with a more significant improvement of cardiac remodeling and pump function than ACEI therapy and satisfactory safety. In ADHF patients with first diagnosed heart failure, initiation of ARNI therapy after hemodynamic stabilization can more effectively improve cardiac remodeling and pump function than treatment with ACEI.