At present, the cause of traditional Chinese medicine(TCM) in China has entered a new period of high-quality development. How to strengthen the foundation for the TCM industry from the source is an important issue that deserves the attention of the authorities, industry, and academia. This study systematically analyzed the regulatory system of TCM raw materials and preparations. The study took the TCM industry chain and the product life cycle as a clue and focused on the dimensions of TCM resource protection and plant cultivation(farming), production and quality supervision of TCM raw materials and preparations, and their market access and distribution. It analyzed the current situation of the regulation of TCM raw materials and preparations under the regulatory system of drugs, discussed the main problems, and put forward corresponding suggestions. The results can provide an important reference value for the subsequent improvement of the regulatory system of drugs and the construction of a prominent regulatory system of drugs in accordance with TCM characteristics.
Drugs, Chinese Herbal/economics* ; Medicine, Chinese Traditional/standards* ; China ; Quality Control ; Humans ; Plants, Medicinal/chemistry*

Dry eye disease (DED) is a prevalent and intractable ocular disease induced by a variety of causes. Elevated sphingomyelin (SM) levels and pro-inflammatory cytokines were detected on the ocular surface of DED patients, particularly in the meibomian glands. Sphingomyelin synthase 2 (SMS2), one of the proteins involved in SM synthesis, would light a novel way of developing a DED therapy strategy. Herein, we report the design and optimization of a series of novel thiophene carboxamide derivatives to afford 14l with an improved highly potent inhibitory activity on SM synthesis (IC_{50, SMS2} = 28 nmol/L). Moreover, 14l exhibited a notable protective effect of anti-inflammation and anti-apoptosis on human corneal epithelial cells (HCEC) under TNF-α-hyperosmotic stress conditions in vitro, with an acceptable ocular specific distribution (corneas and meibomian glands) and pharmacokinetics (PK) profiles (t _{1/2, cornea} = 1.11 h; t _{1/2, meibomian glands} = 4.32 h) in rats. Furthermore, 14l alleviated the dry eye symptoms including corneal fluorescein staining scores and tear secretion in a dose-dependent manner in mice. Mechanically, 14l reduced the mRNA expression of Tnf-α, Il-1β and Mmp-9 in corneas, as well as the proportion of very long chain SM in meibomian glands. Our findings provide a new strategy for DED therapy based on selective SMS2 inhibitors.

Candidiasis has a high morbidity and mortality worldwide,and its main causative agent is Candi-da albicans.At present,the treatment effect of candidiasis is not ideal due to the shortcomings of antifungal drugs,such as toxicity,drug resistance,single route of administration,and high price.In order to overcome this situation,metal nanoparticles with antifungal activity and the potential to deliver antifungal drugs have been extensively studied.In this paper,the mechanism and application of gold,silver,copper and iron nanoparticles against Candida albicans are reviewed.Compared with traditional antifungal drugs,metal nanoparticles exert antifungal effects through a multi-target mechanism,which minimizes the emergence of antifungal resistance.Cytotoxicity limits the application of metal nanoparticles,but green synthesis can reduce the cytotoxicity of metal nanoparticles and improve antimicrobial properties.

Amyloidosis is a local or systemic disease caused by the deposition of misfolded proteins outside the cell,with rapid progression,and dire prognosis.Common types of cardiac amyloidosis are monoclonal immunoglobulin light chain amyloidosis(AL-CA)and transthyretin cardiac amyloidosis(ATTR-CA).Nuclear medicine examinations can be accurate,rapid,and non-invasive to help diagnose diseases and can effectively predict the prognosis of patients with CA.Technetium(99Tcm)-labeled bisphosphonate imaging has been included in the consensus of experts and has become the first-line imaging method for the diagnosis of ATTR-CA.123I-metaiodoenzylguanidine(MIBG)as a norepinephrine analogue can effectively assess cardiac sympathetic innervation in patients with CA.Aβ-amyloid imaging agents such as 11C-pittsburgh compound B and 18F-flubetaben are expected to be new techniques for diagnosing AL-CA and incorporating them into cardiac staging systems for AL-CA patients in the future.New imaging agents such as 18F-NaF has been widely used in the diagnosis,treatment response monitoring,and prognosis assessment of CA.Summarizing the research value of nuclide imaging in CA may provide new ideas for clinical realization of early detection of CA and accurate assessment of disease prognosis.

OBJEC TIVE To provide reference for clinical comprehensive evaluation of pediatric drugs in China. METHODS Taking pediatric anti-allergic drugs as an example ，the clinical comprehensive evaluation methods of pediatric drugs in medical institutions were explored from the aspects of theme selection ，evaluation content and dimension ，evaluation index ，evaluation method and evaluation result report. RESULTS & CONCLUSIONS During the clinical comprehensive evaluation of pediatric drugs，under the guidance of relevant national guidelines for clinical comprehensive evaluation ，the evaluation topics could be selected according to the three principles of importance ，relevance and evaluability ，and then an appropriate evaluation index system could be developed around the six dimensions of safety ， effectiveness， economy， suitability，accessibility and innovativeness；qualitative and quantitative data integration analysis of the drugs to be evaluated were performed. In the evaluation ， it is necessary to focus on children ’s clinical basic drug use practice and decision-making needs ，normatively，scientifically and reasonably define the core index set and standard data set required by different dimensions of evidence ，standardize the collection and use of real-world data ，and effectively combine other types of evidence to truly play its advantageous role in the clinical comprehensive evaluation of pediatric drugs in China.

Objective:To observe the protective effect of Huangqi Guizhi Wuwutang combined with Shengmaiyin on the heart function in patients with diabetic cardiomyopathy and explore its anti-myocardial fibrosis and anti-inflammatory effects. Method:The 96 patients were randomly divided into observation group （48 cases） and control group （48 cases）. Both groups were given comprehensive measures to control blood sugar， blood lipids， blood pressure and heart failure. Patients in control group took Tongmai Jiangtang capsule， 3 granules/time， 3 times/day. Patients in observation group took Huangqi Guizhi Wuwutang combined with modified Shengmaiyin， 1 dose/day. The treatment courses were three months in both groups. Left ventricular ejection fraction （LVEF）， early diastolic peak velocity E peak/late diastolic peak velocity A peak （E/A）， left ventricular end diastolic diameter （LVEDd） and cardiac output per stroke （SV） through echocardiography were recorded before and after therapy. Cardiac troponin-I （cTn I）， troponin T （cTn-T）， creatine kinase isoenzyme -MB （CK-MB）， lactate dehydrogenase （LDH）， transforming growth factor-β₁ （TGF-β₁） before and after treatment ， matrix metalloproteinase-2 （MMP-2）， insulin-like growth factor-1 （IGF-1）， interleukin-6 （IL-6）， IL-1， tumor necrosis factor-α （TNF-α）， N-terminal pro-B-type natriuretic peptide （NT-proBNP）， soluble ST2 （sST2） and galectin-3 （Gal-3） levels were detected. Symptom of cardiac insufficiency and traditional Chinese medicine （TCM） syndrome score were evaluated before and after treatment. Result:The LVEF and E/A data in observation group were higher than those in control group （P<0.01）. The levels of cTn-I， cTn-T， LDH and CK-MB in the observation group were lower than those in the control group （P<0.01）. After treatment， the levels of TGF-β₁， MMP-2， IGF-1， IL-6， IL-1， TNF-α， NT-proBNP， sST2 and Gal-3 in the observation group decreased and were lower than those in the control group （P<0.01）. The clinical efficacy of the observation group was better than that of the control group （Z=1.974，P<0.05）. Conclusion:On the basis of conventional intervention of western medicine， Huangqi Guizhi Wuwutang combined with modified Shengmaiyin has anti-inflammatory and anti-myocardial fibrosis effects， with inhibitory effect on myocardial remodeling， and can reduce myocardial tissue damage to improve ventricular diastolic function and protect heart function. With such high clinical efficacy， it is worthy of clinical use.

Objective: To evaluate the effect of transcutaneous electrical acupoint stimulation (TEAS) on the pregnancy outcomes of in vitro fertilization-embryo transfer (IVF-ET) based on the available clinical evidence. METHODS: We searched PubMed, MEDLINE, EMBASE, Cochrane Library, CNKI, VIP, CBM and Wanfang Database up to February 2021 for published randomized controlled trials (RCT) relevant to TEAS for the improvement of the pregnancy outcomes of IVF-ET. We performed literature screening, data extraction and quality evaluation according to the inclusion and exclusion criteria, followed by a meta-analysis with the RevMan 5.3 software. RESULTS: A total of 2 206 cases of IVF-ET from 9 RCTs were included, 1 018 in the TEAS group and 1 188 in the control. The clinical pregnancy rate was significantly higher in the TEAS than in the mock TEAS and non-TEAS control groups (RR = 1.85, 95% CI: 1.42－2.42, P < 0.001; RR = 1.23, 95% CI: 1.10－1.39, P = 0.0004), and so was it before and after oocyte retrieval (RR = 1.50, 95% CI: 1.03－2.17, P = 0.03; RR = 1.47, 95% CI: 1.12－1.92, P = 0.005). The TEAS group also showed dramatically improved embryo implantation rate (RR = 1.49, 95% CI: 1.24－1.79, P < 0.0001) and live birth rate (RR = 1.44, 95% CI: 1.04－1.98, P = 0.03) compared with the control. CONCLUSIONS As a safe and non-invasive treatment, TEAS can significantly improve the pregnancy outcomes of IVF-ET, with definite effectiveness. /.
Acupuncture Points ; Embryo Transfer ; Female ; Fertilization in Vitro ; Humans ; Pregnancy ; Pregnancy Outcome ; Randomized Controlled Trials as Topic

Objective:To explore the performance of the commonly used whole blood C-reactive protein (CRP) detection systems and give related recommendation on the performance requirements of detection systems.Methods:A total of 7 540 venous blood samples from 26 maternal, child and children′s hospitals were collected to conduct this multi-center study on the analytical performance of 5 commonly used whole blood CRP detection systems from March to April in 2019. The blank check, carryover, repeatability, intermediate precision, linearity, sample stability, influence of hematocrit/triglyceride/bilirubin, comparison with SIEMENS specific protein analyzer and trueness were evaluated. The 5 systems included BC-5390CRP autohematology analyzer, AstepPLUS specific protein analyzer, Ottoman-1000 Automated Specific Protein POCT Workstation, i-CHROMA Immunofluorometer equipment Reader and Orion QuikRead go detecting instrument. The 5 systems were labeled as a, b, c, d and e randomly.Results:Within the 5 systems, all values of blank check were less than 1.00 mg/L, the carryovers were lower than 1.00%. The repeatability of different ranges of CRP concentrations including 3.00-10.00, 10.00-30.00 and>30.00 mg/L were less than 10.00%, 6.00% and 5.00%, respectively, and the intermediate precision was less than 10.00%. The linearity correlation coefficients of the 5 systems were all above 0.975, while the slope was within 0.950-1.050. Whole blood samples were stable within 72 hours both at room temperature (18-25 ℃) and refrigerated temperature (2-8 ℃). The CRP results were rarely influenced by high triglyceride or bilirubin, except for the immmunoturbidimetric test based on microparticles coated with anti-human CRP F(ab) 2 fragments. When triglyceride was less than 15.46 mmol/L, the deviation of CRP was less than 10.00%. When bilirubin was less than 345.47 μmol/L, the deviation of CRP was less than 10.00%. CRP was more susceptible to Hct on the systems without Hct correction. The deviation of CRP between different Hct dilution concentration and 40% dilution concentration can reach as high as 67.48%. The correlation coefficients ( r) of 5 systems were all more than 0.975 in the range of 0-300.00 mg/L compared with Siemens specific protein analyzer. All systems passed the trueness verification using the samples with specified values of 12.89 and 30.60 mg/L. Conclusion:The performance of 5 systems can basically meet the clinical needs, but it is suggested that the whole blood CRP detection system without automatic Hct correction should be modified manually.

TORCH, which is considered as a series of pathogens, including the Toxoplasma gondii, Rubella virus, Cytomegalovirus or Herpes simplex virus, often infects the pregnant women to induce the the fetus or newborn infection by transplacental infection or exposure to contaminated genital tract secretions at delivery. Increasing evidence have been confirmed that the infection of TORCH may cause the miscarriage, premature birth, malformed fetus, stillbirth, intrauterine growth retardation, neonatal multiple organ dysfunction and other adverse pregnancy outcomes. For most TORCH-infections cases may lacking the effective treatments during pregnancy, and it is important to achieve the effacing monitoring of TORCH infections before and during pregnancy. The laboratory testing of TORCH has the great significance. However, the consensus opinions still need to improve the the standardization of TORCH testing process and the correct interpretation. Based on the characteristics of the TORCH detection method, this article gives a consensus opinion on the standardized detection and clinical application of TORCH from the laboratory perspective according to the characteristics and types of infection of different pathogens.

OBJECTIVE: To compare the registration accuracy of three-dimensional (3D) facial scans for the design of full-arch implant supported restoration by five methods and to explore the suitable registration method. METHODS: According to the criteria, ten patients with maxillary edentulous jaw or end-stage dentition requiring implant supported restorations were enrolled in this study. A special rim with individual feature marks reflected appropriate occlusal relationship and esthetic characteristics was made for each patient. Both 3D facial scan data of natural laughter and with opener traction to expose the teeth or occlusal rim of each patient were acquired by facial scan and input to the digital analysis software Geomagic Qualify 2012. The dataset was superimposed by five different methods: seven facial anatomical landmark points alignment, facial immobile area alignment (forehead and nasal area), facial anatomical landmark points and immobile area combining alignment, facial feature points alignment, facial and intraoral feature points alignment with the same local coordinate system. The three-dimensional deviation of the same selected area was calculated, the smaller the deviation, the higher the registration accuracy. The 3D deviation was compared among the three registration methods of facial anatomical landmark points, facial immobile area alignment and the combination of the above two methods. Friedman test was performed to analyze the difference among the three methods (α=0.05). The effect of the aid of the facial and intraoral feature points were evaluated. Paired t test were performed to analyze the difference (P<0.05). RESULTS: The average three-dimensional deviation of the selected area after alignment with the facial anatomical landmarks was (1.501 2±0.406 1) mm, significantly larger than that of the facial immobile area best-fit alignment [(0.629 1±0.150 6) mm] and the combination of the two methods[(0.629 1±0.150 6) mm] (P < 0.001). The aid of the facial feature points could significantly reduce the deviation (t=1.001 3, P < 0.001). There was no significant statistical difference in the remaining groups. CONCLUSION The forehead area of the 3D facial scan can be exposed as much as possible. The establishment of facial characteristic landmark points and the use of the invariant area alignment can improve the accuracy of registration. It should be clinically feasible to apply three-dimensional facial scan to the design of full-arch implant supported restoration with the registration of the immobile area on the face especially the forehead area.
Computer-Aided Design ; Humans ; Imaging, Three-Dimensional ; Jaw, Edentulous/diagnostic imaging* ; Maxilla/diagnostic imaging* ; Radionuclide Imaging