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1.
Lasers Med Sci ; 39(1): 29, 2024 Jan 13.
Article in English | MEDLINE | ID: mdl-38216803

ABSTRACT

To investigate the efficacy of laser acupuncture and photobiomodulation therapy in alleviating symptoms among patients diagnosed with Bell's palsy with duration of greater than 8 weeks. The randomized controlled trial has been performed from May 2021 to April 2023. Patients were eligible who had Bell's palsy with duration of greater than 8 weeks on out-patient Department of Otorhinolaryngology in Beijing Tongren Hospital. The laser acupuncture group received class IV laser treatment for 3 times per weeks, a total of 72 times. The control group received the same treatment procedure except the laser parameter. The primary outcome measures comprised House-Brackmann facial nerve grading system and electroneurography. Secondary outcome measures comprised Sunnybrook facial grading system, electromyography, and the blink reflex. A total of 84 participants were included (42 control group, 42 laser acupuncture group). After treatment, House-Brackmann facial nerve grading system (OR, 0.11; 95% CI, 0.04-0.30; P < 0.001), and the pathologic numbers of electroneuronography were statistically different between the laser acupuncture group and control group, including orbicularis oculi (OR,0.08; 95% CI, 0.02-0.21; P < 0.001), Frontalis muscle (OR,0.14; 95% CI, 0.05-0.39; P < 0.001), Orbicularis oris (OR,0.13; 95% CI, 0.04-0.36; P < 0.001), Ala nasi muscle (OR,0.06; 95% CI, 0.02-0.18; P < 0.001). In secondary outcomes, Sunnybrook facial grading system, has significant difference between the two groups (20.26; 95% CI, 14.69 to 25.83; P < 0.01). Latency by ENoG, include orbicularis oculi (-0.61; 95% CI, -0.43 to -0.09; P < 0.001), frontalis muscle (-0.12; 95% CI, -0.21 to -0.03; P < 0.01), orbicularis oris (-0.28; 95% CI, -0.41 to -0.16; P < 0.001), and ala nasi muscle (-0.26; 95% CI, -0.38 to -0.16; P < 0.001). All amplitudes of MUAPs and durations by electromyography (EMG) showed statistically significant differences compared with the control group after treatment. For the frontalis muscle, the amplitude of MUAPs was -64.23 (95% CI, -80.89 to -47.56; P < 0.001) and duration was -1.18 (95% CI, -1.49 to -0.87; P < 0.001). For orbicularis oris, amplitude of MUAPs was -29.82 (95% CI, -55.03 to -4.62; P = 0.02) and duration was -0.57 (95% CI, -0.94 to -0.20; P < 0.001). For depressor angulli oris, amplitude of MUAPs was -47.06 (95% CI, -62.15 to -31.97; P < 0.001) and duration was -2.21 (95% CI, -2.69 to -1.72; P < 0.001). Blink reflex, including R1 (OR, 0.03; 95% CI, 0.01-0.16; P < .001), R2 (OR, 0.04; 95% CI, 0.004-0.29; P < .001), and R2 latency differences (OR, 0.15; 95% CI, 0.05-0.51; P < .001), have significant difference between the two groups, respectively. The findings suggest that laser acupuncture relieve symptoms for patients with Bell's palsy with a duration of greater than 8 weeks.Trial registration: ClinicalTrials.gov Identifier: NCT05846217.


Subject(s)
Acupuncture Therapy , Bell Palsy , Low-Level Light Therapy , Humans , Bell Palsy/radiotherapy , Facial Nerve , Acupuncture Therapy/methods , Electromyography/methods
2.
Molecules ; 28(17)2023 Aug 28.
Article in English | MEDLINE | ID: mdl-37687125

ABSTRACT

CAG is a burdensome and progressive disease. Numerous studies have shown the effectiveness of RUT in digestive system diseases. The therapeutic effects of RUT on MNNG-induced CAG and the potential mechanisms were probed. MNNG administration was employed to establish a CAG model. The HE and ELISA methods were applied to detect the treatment effects. WB, qRT-PCR, immunohistochemistry, TUNEL, and GES-1 cell flow cytometry approaches were employed to probe the mechanisms. The CAG model was successfully established. The ELISA and HE staining data showed that the RUT treatment effects on CAG rats were reflected by the amelioration of histological damage. The qRT-PCR and WB analyses indicated that the protective effect of RUT is related to the upregulation of the SHH pathway and downregulation of the downstream of apoptosis to improve gastric cellular survival. Our data suggest that RUT induces a gastroprotective effect by upregulating the SHH signaling pathway and stimulating anti-apoptosis downstream.


Subject(s)
Gastritis, Atrophic , Hedgehog Proteins , Mice , Rats , Animals , Gastritis, Atrophic/chemically induced , Gastritis, Atrophic/drug therapy , Methylnitronitrosoguanidine , Quinazolines , Nitrosoguanidines , Signal Transduction
3.
Photobiomodul Photomed Laser Surg ; 41(9): 490-500, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37738368

ABSTRACT

Objective: To determine whether photobiomodulation therapy (PBMT) by class IV Multiwave Locked System laser treatment as an adjunctive therapy could relieve symptoms in patients with Bell's palsy with a duration of greater than 8 weeks. Materials and methods: This nonrandomized controlled trial was conducted from January 2020 to December 2022. Patients were eligible if they had Bell's palsy with a duration of greater than 8 weeks at the out-patient department of otorhinolaryngology in Beijing Tongren Hospital. The control group consisted of patients recruited between January 1, 2020, and December 31, 2020. The PBMT group consisted of patients recruited between January 1, 2021, and December 31, 2022. In this study, the PBM used has a wavelength of 808 and 905 nm, 1.2 W power (808 nm is 1 W, 905 nm is 200 mW), continuous mode emission (808 nm) and pulsed mode emission (905 nm), 8.35 J/cm2 dosimetry, administered 3 times per week, 72 times of total treatment. The primary outcome measures included the House-Brackmann facial nerve grading system, the Sunnybrook facial grading system, and the Facial Clinimetric Evaluation Scale (FaCE). Secondary outcome measures comprised electroneurography, electromyography, and the blink reflex. Results: A total of 54 participants were included (27 in the control group and 27 in the photobiomodulation group). After 6 months, the House-Brackmann grading system [risk difference, -0.59, confidence interval (95% CI), -0.81 to -0.38, relative risk, 0.27, 95% CI, 0.13-0.56, p < 0.001], Sunnybrook facial grading system (21.14, 95% CI, 11.71-30.58; p < 0.001), and FaCE (-0.20, 95% CI, 0.41-0.02; p = 0.07) had significant difference between the two groups. Latency of ala nasi muscle (10.92, 95% CI, 5.58-16.27; p < 0.001) was not statistically significant after treatment compared with the control group; however, most of the electrophysiological examinations have significant difference between the two groups, respectively. Conclusions: The results of this study suggest that PBMT may relieve symptoms for patients with Bell's palsy with a duration of greater than 8 weeks. Trial Registration: ClinicalTrials.gov Identifier: NCT05585333.


Subject(s)
Bell Palsy , Facial Paralysis , Low-Level Light Therapy , Humans , Bell Palsy/radiotherapy , Phototherapy , Pain Management
4.
Chin Med ; 18(1): 102, 2023 Aug 17.
Article in English | MEDLINE | ID: mdl-37592331

ABSTRACT

ETHNOPHARMACOLOGICAL RELEVANCE: Psoralea corylifolia Linn. (BGZ) is a commonly used traditional Chinese medicine (TCM) for the treatment of kidney-yang deficiency syndrome (Yangsyn) with good curative effect and security. However, BGZ was also reported to induce liver injury in recent years. According to TCM theory, taking BGZ may induce a series of adverse reactions in patients with kidney-yin deficiency syndrome (Yinsyn), which suggests that BGZ-induced liver damage may be related to its unreasonable clinical use. AIM OF THE STUDY: Liver injury caused by TCM is a rare but potentially serious adverse drug reaction, and the identification of predisposed individuals for drug-induced liver injury (DILI) remains challenging. The study aimed to investigate the differential responses to BGZ in Yangsyn and Yinsyn rat models and identify the corresponding characteristic biomarkers. MATERIALS AND METHODS: The corresponding animal models of Yangsyn and Yinsyn were induced by hydrocortisone and thyroxine + reserpine respectively. Body weight, organ index, serum biochemistry, and Hematoxylin and Eosin (HE) staining were used to evaluate the liver toxicity effect of BGZ on rats with Yangsyn and Yinsyn. Transcriptomics and metabonomics were used to screen the representative biomarkers (including metabolites and differentially expressed genes (DEGs)) changed by BGZ in Yangsyn and Yinsyn rats, respectively. RESULTS: The level changes of liver organ index, alanine aminotransferase (ALT), and aspartate aminotransferase (AST), suggested that BGZ has liver-protective and liver-damaging effects on Yangsyn and Yinsyn rats, respectively, and the results also were confirmed by the pathological changes of liver tissue. The results showed that 102 DEGs and 27 metabolites were significantly regulated related to BGZ's protective effect on Yangsyn, which is mainly associated with the glycerophospholipid metabolism, arachidonic acid metabolism, pantothenate, and coenzyme A (CoA) biosynthesis pathways. While 28 DEGs and 31 metabolites, related to the pathway of pantothenate and CoA biosynthesis, were significantly regulated for the BGZ-induced liver injury in Yinsyn. Furthermore, 4 DEGs (aldehyde dehydrogenase 1 family member B1 (Aldh1b1), solute carrier family 25 member 25 (Slc25a25), Pim-3 proto-oncogene, serine/threonine kinase (Pim3), out at first homolog (Oaf)) and 4 metabolites (phosphatidate, phosphatidylcholine, N-Acetylleucine, biliverdin) in the Yangsyn group and 1 DEG [galectin 5 (Lgals5)] and 1 metabolite (5-amino-1-(5-phospho-D-ribosyl)imidazole-4-carboxylate) in Yinsyn group were significantly correlated to the ALT and AST levels of BGZ treated and untreated groups (receiver operating characteristic (ROC) ≥ 0.9). CONCLUSIONS: Yinsyn and Yangsyn are the predisposed syndromes for BGZ to exert liver damage and liver protection respectively, which are mainly related to the regulation of amino acid metabolism, lipid metabolism, energy metabolism, and metabolism of cofactors and vitamins. The results further suggest that attention should be paid to the selection of predisposed populations when using drugs related to the regulation of energy metabolism, and the Yinsyn/Yangsyn animal models based on the theory of TCM syndromes may be a feasible method for identifying the susceptible population to receive TCM.

5.
Ying Yong Sheng Tai Xue Bao ; 34(5): 1225-1234, 2023 May.
Article in English | MEDLINE | ID: mdl-37236939

ABSTRACT

Ectomycorrhizal (EM) fungi play an important role in forest ecosystems. However, little is known about the mechanisms driving diversity and community composition of soil EM fungi in urban forest parks which are intensively affected by anthropogenic activities. In this study, we investigated the EM fungal community using Illumina high-throughput sequencing with soil samples collected from three typical forest parks, including Olympic Park, Laodong Park, and Aerding Botanical Garden of Baotou City. The results showed that soil EM fungi richness index followed a pattern of Laodong Park (146.43±25.17) > Aerding Botanical Garden (102.71±15.31) > Olympic Park (68.86±6.83). Russula, Geopora, Inocybe, Tomentella, Hebeloma, Sebacina, Amanita, Rhizopogon, Amphinema, and Lactarius were the dominant genera in the three parks. EM fungal community composition was significantly different among the three parks. Results of linear discriminant analysis effect size (LEfSe) indicated that all parks had biomarker EM fungi that exhibiting significantly different abundance. The normalized stochasticity ratio (NST) and the inferring community assembly mechanisms by phylogenetic-bin-based null model analysis (iCAMP) showed that both stochastic and deterministic processes determined soil EM fungal communities in the three urban parks, with a dominant role of the stochastic process. Drift and dispersal limitation in the stochastic process and homogeneous selection in the deterministic process were the dominant ecological processes of soil EM fungal community assembly in the three urban parks.


Subject(s)
Agaricales , Basidiomycota , Mycorrhizae , Ecosystem , Soil , Parks, Recreational , Phylogeny , Fungi/genetics , Soil Microbiology
6.
ACS Omega ; 7(39): 35159-35169, 2022 Oct 04.
Article in English | MEDLINE | ID: mdl-36211039

ABSTRACT

Driven by a high-speed rotating electric field (E-field), molecular motors with polar groups may perform a unidirectional, repetitive, and GHz frequency rotation and thus offer potential applications as nanostirrers. To drive the unidirectional rotation of molecular motors, it is crucial to consider factors of internal charge flow, thermal noise, molecular flexibility, and so forth before selecting an appropriate frequency of a rotating E-field. Herein, we studied two surface-mounted dipolar rotors of a "caltrop-like" molecule and a "sandwich" molecule by using quantum-mechanical computations in combination with torque analyses. We find that the rotational trend as indicated by the magnitude and the direction of torque vectors can sensitively change with the lag angle (α) between the dipolar arm and the E-field. The atomic charges timely flow within the molecule as the E-field rotates, so the lag angle α must be kept in particular intervals to maintain the rotor's unidirectional rotation. The thermal effect can substantially slow down the rotation of the dipolar rotor in the E-field. The flexible dipolar arm shows a more rigid geometry in the E-field with higher rotation speed. Our work would be useful for designing E-driven molecular rotors and for guiding their practical applications in future.

7.
Zhongguo Zhong Yao Za Zhi ; 47(8): 1989-1994, 2022 Apr.
Article in Chinese | MEDLINE | ID: mdl-35531713

ABSTRACT

Toxicity-attenuating compatibility is an effective measure to ensure the safety of Chinese medicine. Involving the origin, processing method, compatibility mode, and dosage, it faces multiple challenges, such as the uncertainty of toxic substances, toxicity latency, indefinite safe dose, complex toxicity-efficacy relationship, and individual difference. As a result, research on clinical safety of Chinese medicine is limited by the consistency at "molecular-cellular-organ-overall" levels, unclear interaction of multiple medicinals and multiple substances, the "toxicity-efficacy-compatibility-syndrome" correlation, and the "dosage-time-toxicity-efficacy" conversion law. Therefore, following the principle of "starting from the clinical practice, verifying via the theoretical basis, and finally applying in clinical practice", we verified the toxicity at "molecular-cellular-organ-overall" levels, revealed the interaction of multiple medicinals and substances, collected evidence at multiple levels, clarified the "dosage-time-toxicity-efficacy" relationship, and tested the consistency between basic and clinical biomarkers. On this basis, we studied the toxicity-alleviating and efficacy-enhancing(preserving) compatibility characteristics, the fate of one medicinal and multiple medicinals in vivo, the molecular mechanism of toxicity, the "dosage-time-toxicity-efficacy" conversion law, and the clinical characteristics of toxic traditional Chinese medicine based on disease and syndrome. The three mechanisms of toxicity-attenuating compatibility reflect the seven-reaction theory in Chinese medicine compatibility. Finally, the strategies for safe use of Chinese medicine were proposed.


Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Drugs, Chinese Herbal/toxicity , Research Design
8.
Zhongguo Zhong Yao Za Zhi ; 46(22): 5987-5991, 2021 Nov.
Article in Chinese | MEDLINE | ID: mdl-34951190

ABSTRACT

Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.


Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Drugs, Chinese Herbal/adverse effects , Humans , Prescriptions , Reproducibility of Results , Research
9.
Gene ; 805: 145907, 2021 Dec 30.
Article in English | MEDLINE | ID: mdl-34411648

ABSTRACT

The gene polymorphisms of ABCB1, EPHX1, and SCN1A were found to influence carbamazepine (CBZ) metabolism and resistance in epilepsy patients, but the relevance remains controversial. To reveal the relationships among the gene polymorphisms of ABCB1, EPHX1, SCN1A and the metabolism and resistance of CBZ, the databases of PubMed, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure, Chinese Science and Technique Journals, China Biology medicine disc and Wan Fang were retrieved for suitable studies up to April 2021. 18 studies containing 3293 epilepsy patients were included. The result revealed the gene polymorphism of ABCB1 c.3435C > T is significantly associated with altered concentration-dose ratios of CBZ (CDRCBZ) (CC vs. CT, OR = 0.25 (95% CI: 0.08-0.42), P = 0.004), and EPHX c.416A > G gene polymorphism may also significantly adjusted the concentration-dose ratios of carbamazepine-10, 11-trans dihydrodiol (CDRCBZD) (AA vs. GG, OR = 0.48 (95% CI: 0.01-0.96), P = 0.045; AG vs. GG, OR = 0.68 (95% CI: 0.16-1.20), P = 0.010, respectively) and the ratio of CBZD:carbamazepine-10,11-epoxide (CBZE) (CDRCBZD:CDRCBZE) (AG vs GG, OR = 0.83 (95% CI: 0.31-1.36), P = 0.002). Furthermore, ABCB1 c.3435C > T polymorphism was also observed to be significantly influenced CBZ resistance (CC vs TT, OR = 1.78 (95% CI: 1.17-2.72), P = 0.008; CT vs TT, OR = 1.60 (95% CI: 1.12-2.30), P = 0.01; CC + CT vs TT, OR = 1.61 (95% CI: 1.15-2.26), P = 0.006, respectively). Therefore, CBZ metabolism and resistance in patients with epilepsy may be adjusted by the gene polymorphisms of ABCB1 c.3435C > T and EPHX1 c.416A > G which provides the further scientific basis for clinical individualized therapy of epilepsy. However, larger sample size studies are still needed to provide further conclusive evidence.


Subject(s)
Carbamazepine/metabolism , Epoxide Hydrolases/genetics , ATP Binding Cassette Transporter, Subfamily B/genetics , ATP Binding Cassette Transporter, Subfamily B/metabolism , ATP Binding Cassette Transporter, Subfamily B, Member 1/genetics , ATP Binding Cassette Transporter, Subfamily B, Member 1/metabolism , Adult , Anticonvulsants/pharmacology , Carbamazepine/blood , Carbamazepine/pharmacology , China , Databases, Genetic , Drug Resistant Epilepsy/genetics , Drug Resistant Epilepsy/metabolism , Epilepsy/genetics , Epilepsy/metabolism , Epoxide Hydrolases/metabolism , Female , Genotype , Humans , Male , NAV1.1 Voltage-Gated Sodium Channel/genetics , NAV1.1 Voltage-Gated Sodium Channel/metabolism , Polymorphism, Single Nucleotide/genetics
10.
Phytomedicine ; 91: 153619, 2021 Oct.
Article in English | MEDLINE | ID: mdl-34320422

ABSTRACT

BACKGROUNDS: Dehydroevodiamine (DHE) is a quinazoline alkaloid isolated from a Chinese herbal medicine, named Euodiae Fructus (Wu-Zhu-Yu in Chinese). This study aimed to investigate the therapeutic effects and potential mechanism of DHE on N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)-induced chronic atrophic gastritis (CAG) based on integrated approaches. METHODS: Therapeutic effects of DHE on serum biochemical indices and histopathology of gastric tissue in MNNG-induced CAG rats were analyzed. MNNG-induced GES-1 human gastric epithelial cell injury model was established. Cell viability and proliferation was quantified by a cell counting kit-8 assay. Cell morphology and mitochondrial membrane potential (MMP) were detected by a high content screening (HCS) assay. Cell migration and invasion were detected by a Transwell chamber. Moreover, UHPLC-Q-TOF/MS was performed to investigate the potential metabolites and signaling pathway affecting the protective effects of DHE on MNNG-induced cell migration and invasion of GES-1. Furthermore, in view of the key role of angiogenesis in the transformation of inflammation and cancer, this study explored relative mRNA and protein expression levels of HIF-1α-mediated VEGF pathway in vivo and in vitro by RT-PCR and Western Blotting, respectively. RESULTS: The results showed that the therapeutic effects of DHE on CAG rats were presented in down-regulation serum biochemical indices and alleviating histological damage of gastric tissue. Besides, DHE has an effect on increasing cell proliferation of GES-1 cells, ameliorating MNNG-induced gastric epithelial cell damage and mitochondrial dysfunction. In addition, DHE could inhibit MNNG induced migration and invasion of GES-1 cells. Cell metabolomics analyses showed that the protective effect of DHE on GES-1 cells is mainly associated with the regulation of inflammation metabolites and energy metabolism related pathways. It was found that DHE has a regulating effect on tumor angiogenesis and can inhibit the relative gene and protein expression of HIF-1α-mediated VEGF signaling pathway. CONCLUSIONS: The present work highlighted the role of DHE ameliorated gastric injury in MNNG-induced CAG rats in vivo and GES-1 cell migration in vitro by inhibiting HIF-1α/VEGF angiogenesis pathway. These results suggest that DHE may be the effective components of Euodiae Fructus, which provides a new agent for the treatment of CAG.


Subject(s)
Alkaloids/therapeutic use , Gastritis, Atrophic , Animals , Cell Proliferation , Cells, Cultured , Epithelial Cells/drug effects , Gastritis, Atrophic/chemically induced , Gastritis, Atrophic/drug therapy , Humans , Methylnitronitrosoguanidine , Rats
11.
Zhongguo Zhong Yao Za Zhi ; 46(7): 1681-1685, 2021 Apr.
Article in Chinese | MEDLINE | ID: mdl-33982468

ABSTRACT

Collecting and summarizing human use experience(HUE) data, forming high-quality data and evidences that can be used for evaluation are the key links of HUE research on traditional Chinese medicine(TCM). The collection, collation and summary of human experience data were discussed in this paper. It is pointed out that the collection of HUE should be focus on the source of prescription of new traditional Chinese medicines, and be summarized based on dialectical thinking, experience in medication, characte-ristics of prescription and clinical application. The collected contents include prescription, process, clinical location and applicable population, efficacy data and safety data, etc. The methods include interview, clinical data summary and data mining. When the data formed based on HUE information is used as drug registration information, it is necessary to ensure that the data source is legal and compliant, and the ownership of intellectual property is clear.Data sources should meet the requirements of medical ethics. To avoid conflict of interest, data analysis should be conducted by an independent third party. It is necessary to develop the quality control measures of HUE data to ensure the data traceability, integrity, consistency and accuracy, and avoid data bias.The data of HUE should include the key data such as accurate clinical location and applicable population, recognized clinical efficacy and safety.After the formation of HUE, the statistical analysis plan of empirical data of human use should be formulated. Through strict data processing, statistical analysis and clinical interpretation, HUE can be produced for evaluation.


Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Data Collection , Humans , Prescriptions , Quality Control
12.
Zhongguo Zhong Yao Za Zhi ; 46(7): 1696-1700, 2021 Apr.
Article in Chinese | MEDLINE | ID: mdl-33982471

ABSTRACT

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.


Subject(s)
Biomedical Research , Drugs, Chinese Herbal , Pharmaceutical Preparations , Clinical Trials as Topic , Consensus , Ethical Review , Humans , Medicine, Chinese Traditional , Multicenter Studies as Topic
13.
Zhongguo Zhong Yao Za Zhi ; 46(7): 1701-1705, 2021 Apr.
Article in Chinese | MEDLINE | ID: mdl-33982472

ABSTRACT

Since "the implementation of good clinical practice"(GCP), especially after 2015, the overall quality of new drug cli-nical trials in China has made significant progress, but compared with developed countries, there are still some obvious quality problems in clinical trials in China. Clinical trials of new drugs of traditional Chinese medicine are an important part of clinical trials of new drugs in China. In addition to some common problems in all clinical trials, there are also some special quality problems. In terms of security data, such as the collection of human safety data is not standardized, the management and judgment of unexpected serious adverse reactions(SUSAR) were not professional and timely, the relationship between adverse events and trial drug was not fully judged by investigator, In terms of effective data, such as primary efficacy outcome of the scale cannot be traced, TCM syndrome data cannot meet the requirements of "source data" in the revised GCP and the quality of traditional Chinese medicine placebo is not high, in terms of overall quality system construction, the sponsors and research institutions have not established a quality assurance system that conforms to the characteristics of new drug research of traditional Chinese medicine, etc. The quality of clinical trials of new drugs of traditional Chinese medicine is based on the current GCP and ICH-GCP in China, we should also consider the characteristics of clinical trials of new traditional Chinese medicine drugs, and formulate targeted quality control measures according to the characteristics of these new drugs of traditional Chinese medicine, to improve the overall quality of clinical trials of new drugs of traditional Chinese medicine in China, which has important strategic significance for promoting the research and development of new drugs of traditional Chinese medicine in China.


Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , China , Clinical Trials as Topic , Consensus , Drugs, Chinese Herbal/therapeutic use , Humans , Quality Control
14.
Front Microbiol ; 12: 646821, 2021.
Article in English | MEDLINE | ID: mdl-33796093

ABSTRACT

Ectomycorrhizal (EM) fungi play vital roles in ensuring host plants' health, plant diversity, and the functionality of the ecosystem. However, EM fungal diversity, community composition, and underlying assembly processes in Inner Mongolia, China, where forests are typically semiarid and cold-temperate zones, attract less attention. In this study, we investigated EM fungal communities from 63 root samples of five common pine plants in Inner Mongolia across 1,900 km using Illumina Miseq sequencing of the fungal internal transcribed spacer 2 region. We evaluated the impact of host plant phylogeny, soil, climatic, and spatial variables on EM fungal diversity and community turnover. Deterministic vs. stochastic processes for EM fungal community assembly were quantified using ß-nearest taxon index scores. In total, we identified 288 EM fungal operational taxonomic units (OTUs) belonging to 31 lineages, of which the most abundant lineages were Tomentella-Thelephora, Wilcoxina, Tricholoma, and Suillus-Rhizopogon. Variations in EM fungal OTU richness and community composition were significantly predicted by host phylogeny, soil (total nitrogen, phosphorus, nitrogen-phosphorus ratio, and magnesium), climate, and spatial distance, with the host plant being the most important factor. ß-nearest taxon index demonstrated that both deterministic and stochastic processes jointly determined the community assembly of EM fungi, with the predominance of stochastic processes. At the Saihanwula site selected for preference analysis, all plant species (100%) presented significant preferences for EM fungi, 54% of abundant EM fungal OTUs showed significant preferences for host plants, and 26% of pairs of plant species and abundant fungal OTUs exhibited remarkably strong preferences. Overall, we inferred that the high diversity and distinctive community composition of EM fungi associated with natural pine species in Inner Mongolia and the stochastic processes prevailed in determining the community assembly of EM fungi. Our study shed light on the diversity and community assembly of EM fungi associated with common pine species in semiarid and cold temperate forests in Inner Mongolia, China, for the first time and provided a better understanding of the ecological processes underlying the community assembly of mutualistic fungi.

15.
Mitochondrial DNA B Resour ; 6(2): 483-484, 2021 Feb 09.
Article in English | MEDLINE | ID: mdl-33628897

ABSTRACT

Ephedra monosperma is an important medicinal plant of Ephedra (Ephedraceae). The complete chloroplast genome of E. monosperma was assembled from Illumina pair-end sequence reads. The whole chloroplast (cp) genome is 109,548 bp in length and presents a quadripartite structure consisting of two copies of inverted repeat (IR) regions (20,398) separated by a large single copy (LSC) region (60,674 bp) and a small single copy (SSC) region (8078 bp). The cp genome of E. monosperma encodes a total of 118 genes, including 73 protein-coding genes, 37 tRNA genes and 8 rRNA genes. The overall GC content of E. monosperma cp genome is 36.6%. A maximum likelihood (ML) phylogenetic analysis revealed that E. monosperma was close to Ephedra equisetina. The ML tree also showed Ephedraceae appeared more closely related to Gnetaceae than to the other families in Gymnospermae.

16.
J Hazard Mater ; 399: 123090, 2020 Nov 15.
Article in English | MEDLINE | ID: mdl-32526426

ABSTRACT

Strategies to maximize the reuse of electronic and industrial wastes have scientific, economic, social and environmental implications. We herein propose a strategy of "treating waste with waste" using LiCoO2 cathode powders from spent lithium ion batteries to eliminate industrial pollutants led by sulfur (S) (IV) in waste water. By radical scavenging experiments and electron spin resonance (ESR) analysis, we identified singlet 1O2 as the dominant species while SO4- and OH as the secondary species for decontamination during the oxidization process mediated by LiCoO2 powders. The intrinsic mechanism of S(IV) conversion was revealed to be two-step hydrogen migrations from HSO3- to O2 occurring on LiCoO2 surface by density functional theory (DFT) calculations. The surface of LiCoO2 powders plays a key role in anchoring sulfur species and forming surface complex as an excellent medium, which is found to be stable and reusable by material characterizations and the recycling experiment. Free Co(II) ions in solvents have no catalysis effect on the conversion of pollutants. Our work offers a particularly vivid example for rational reuse of electronic wastes to eliminate industrial pollutants, and may raise economic benefits in environmental practice due to two aims achieved in once action.

18.
J Pharm Pharmacol ; 72(2): 279-293, 2020 Feb.
Article in English | MEDLINE | ID: mdl-31743450

ABSTRACT

OBJECTIVES: This study was aimed to explore the mechanism of Aconiti Lateralis Radix Praeparata (ALRP) and Zingiberis Rhizoma (ZR) on doxorubicin (DOX)-induced chronic heart failure (CHF) in rats by integrated approaches. METHODS: Effects of ALRP and ZR on cardiac function, serum biochemical indicators and histopathology in rats were analysed. Moreover, UHPLC-Q-TOF/MS was performed to identify the potential metabolites affecting the pathological process of CHF. Metabolomics and network pharmacology analyses were conducted to illustrate the possible pathways and network in CHF treatment. The predicted gene expression levels in heart tissue were verified and assessed by RT-PCR. KEY FINDINGS: ALRP-ZR demonstrated remarkable promotion of hemodynamic indices and alleviated histological damage of heart tissue. Metabolomics analyses showed that the therapeutic effect of ALRP and ZR is mainly associated with the regulation of eight metabolites and ten pathways, which may be responsible for the therapeutic efficacy of ALRP-ZR. Moreover, the results of RT-PCR showed that ALRP-ZR could substantially increase the expression level of energy metabolism-related genes, including PPARδ, PPARγ, Lpl, Scd, Fasn and Pla2g2e. CONCLUSIONS: The results highlighted the role of ALRP-ZR in the treatment of CHF by influencing the metabolites related to energy metabolism pathway via metabolomics and network pharmacology analyses.


Subject(s)
Aconitum/chemistry , Heart Failure/drug therapy , Plant Extracts/pharmacology , Zingiber officinale/chemistry , Animals , Doxorubicin/toxicity , Energy Metabolism/drug effects , Gene Expression Regulation , Heart Failure/chemically induced , Heart Failure/genetics , Male , Metabolomics , Rats , Rats, Sprague-Dawley , Reverse Transcriptase Polymerase Chain Reaction , Rhizome
19.
Med Sci Monit ; 25: 8213-8220, 2019 Nov 01.
Article in English | MEDLINE | ID: mdl-31675354

ABSTRACT

BACKGROUND The aim of this study was to identify the nosocomial infection (NI) risk factors in neonatal Intensive Care Units (NICU). MATERIAL AND METHODS Databases (PubMed, Embase, Cochrane, VANFUN, CNKI, and VTTMS) were searched using index words to find relevant studies published before November 2018. Meta-analyses of relative risk (RR) were performed for the identification of risk factors. RESULTS Data from 22 cohort studies (2270 infants with and 21 605 infants without NI) were included in the meta-analysis. Infant weight of <2500 g (RR: 3.44, 95% CI: 2.31-5.11), gestational age of <37 weeks (RR: 3.85, 95% CI: 1.87-7.92), mechanical ventilation use (RR: 3.16, 95% CI: 2.21-4.50), venipuncture (RR: 3.01, 95% CI: 1.20-7.57), the incidence of asphyxia (RR: 1.68, 95% CI: 1.04-2.71), and feeding intolerance (RR: 2.12, 95% CI: 1.60-2.81) were identified as the risk factors for the incidence of NI. There was no significant publication bias. CONCLUSIONS This study shows that <2500 g infant body weight, gestational age of <37 weeks, mechanical ventilation utility, venipuncture, asphyxia incidence, and feeding intolerance are the risk factors for NI nosocomial infection in infants in NICU. Appropriate preventive measures and targeted interventions are needed.


Subject(s)
Cross Infection/epidemiology , Cross Infection/etiology , Asphyxia , Birth Weight , China/epidemiology , Female , Gestational Age , Humans , Incidence , Infant , Infant, Newborn , Intensive Care Units, Neonatal/trends , Male , Respiration, Artificial/adverse effects , Risk Factors
20.
Plant Physiol Biochem ; 139: 672-680, 2019 Jun.
Article in English | MEDLINE | ID: mdl-31054469

ABSTRACT

Cell wall components and structure impact the physical and mechanical properties of plants, thereby affecting wood applications. Lignin is the most abundant biopolymer after cellulose in the wood cell wall and can be modified by certain lignin biosynthesis enzymes. 4-Coumarate: coenzyme A ligase(4CL) is an important lignin biosynthesis enzyme. To demonstrate the impact of the regulation of Pto4CL1 from poplar on wood properties, we analyzed the composition and anatomy of 5-year-old Pto4CL1-modified poplar cell walls, assessing the density, strength, volume shrinkage, and impact toughness of the transgenic trees. These results showed that the up-regulation of Pto4CL1 increased the lignin content to 46.65% from 33.11% in the control plants, while hydrophilic polysaccharides such as cellulose, hemi-cellulose, and pectin decreased. In contrast, the down-regulation of Pto4CL1 resulted in a reduction in lignin content to 27.39%, and the content of cellulose and hemi-cellulose showed compensatory variation. Raman spectroscopy showed that the change in lignin in the transgenic events was embodied in the deposition and concentration of lignin in the secondary cell wall. Moreover, the increased lignin content caused significantly increased wood strength and slightly increased wood density. In contrast, a reduction in lignin content resulted in a significant decrease in wood strength and a slight decrease in wood density. However, the Pto4CL1-modified trees had similar stiffness to the control group. We also found a significant decrease in volume shrinkage and increase in impact toughness in the low-lignin events. These results indicate that Pto4CL1 regulation alters the chemical composition of plant cell walls and these changes affect the physical and mechanical properties of the wood.


Subject(s)
Cell Wall/metabolism , Populus/metabolism , Wood/metabolism , Lignin/metabolism , Plant Proteins/genetics , Plant Proteins/metabolism , Plants, Genetically Modified , Populus/genetics , Spectrum Analysis, Raman
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