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This study aims to assess the safety and efficacy of Shumian Capsules in the treatment of insomnia. Randomized controlled trial(RCT) about Shumian Capsules for insomnia were retrieved from databases. RevMan 5.4 was used for statistical analysis. A total of 23 articles were included, involving 2 621 patients. Meta-analysis showed that Shumian Capsules had advantages in the treatment of insomnia(RR=1.07, 95%CI[1.03, 1.10], P=0.000 2) and insomnia with depression(RR=1.13, 95%CI[1.02, 1.25], P=0.02) in terms of total response rate. Shumian Capsules had advantages in the treatment of insomnia(MD=-0.75, 95%CI[-1.33,-0.17], P=0.01) and insomnia with depression(MD=-2.51, 95%CI[-2.96,-2.06], P<0.000 01) in terms of PSQI score. The incidence of adverse events in the Shumian Capsules(RR=0.33, 95%CI[0.24, 0.46], P<0.000 01) and Shumian Capsules + conventional western medicine(RR=0.71, 95%CI[0.54, 0.95], P=0.02) was lower than that in the conventional wes-tern medicine alone. In addition, Shumian Capsules had an advantage in treating insomnia complicated with depression in terms of HAMD score(P<0.000 1) and reducing the serum levels of 5-HT, TSH, T3, and T4 in insomnia patients(P<0.05). The quality of evidence was mostly medium or low. The studies demonstrate that Shumian Capsules is effective and safe for treating insomnia, which may be related to the mechanism of lowering the levels of 5-HT, TSH, T3, and T4 in the serum. In view of the quality of evidence, the application of Shumian Capsules should be considered after comprehensive evaluation in clinical practice.
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Medicamentos Herbarios Chinos , Trastornos del Inicio y del Mantenimiento del Sueño , Humanos , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Trastornos del Inicio y del Mantenimiento del Sueño/inducido químicamente , Medicamentos Herbarios Chinos/efectos adversos , Serotonina , Cápsulas , TirotropinaRESUMEN
Oxidative stress-induced enteric neuropathy is an important factor in slow transit constipation (STC). Cistanche deserticola crude polysaccharides (CDCP) are natural antioxidants with various biological activities. We prepared CDCP through water-extract and alcohol-precipitation methods. The structural characteristics of CDCP were analyzed by infrared spectroscopy and methylation analysis. The results showed that CDCP was primarily composed of (1 â 4)-linked glucans with minor amounts of pectic polysaccharides. Different doses of CDCP (100, 200, and 400 mg/kg) were administered to loperamide-induced STC mice to explore the therapeutic effects of CDCP. Compared with the untreated group, CDCP treatment significantly improved constipation symptoms, relevant gut-regulating peptides levels, colonic pathological damage, and colonic myenteric nerons injury. CDCP enhanced the antioxidant capacity by decreasing Malondialdehyde (MDA) content, increasing Superoxide Dismutase (SOD) activity and Reduced Glutathione (GSH) content. CDCP significantly reduced oxidative stress-induced injury by preserving mitochondrial function in the colonic myenteric plexus. Furthermore, the neuroprotective effects of CDCP might be associated with the Nrf2/Keap1 pathway. Thus, our findings first revealed the potential of CDCP to protect the colonic myenteric plexus against oxidative stress-induced damage in STC, establishing CDCP as promising candidates for natural medicine in the clinical management of STC.
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Cistanche , Fármacos Neuroprotectores , Ratones , Animales , Cistanche/química , Fármacos Neuroprotectores/farmacología , Proteína 1 Asociada A ECH Tipo Kelch/metabolismo , Factor 2 Relacionado con NF-E2/metabolismo , Estreñimiento/inducido químicamente , Estreñimiento/tratamiento farmacológico , Estreñimiento/metabolismo , Estrés Oxidativo , Antioxidantes/farmacología , Antioxidantes/metabolismo , Polisacáridos/farmacología , Polisacáridos/químicaRESUMEN
One new species of leaf katydids, Elimaea (Poaefoliana) kiukiangensis sp. nov. from the Himalaya-Hengduan Mountains region, is described, based on recently collected material. Illustrations of mounted specimens including male genitalia, and habitat images are provided. A distribution map is also provided. The types are deposited in Insect Collection of Institute of Zoology, Chinese Academy of Sciences, Beijing, China (IZCAS).
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Ortópteros , Masculino , Animales , China , Ecosistema , Academias e Institutos , Distribución AnimalRESUMEN
The genus Paraxantia was recorded to be distributed in south of China, previously including 11 species. After examining numerous specimens of Paraxantia, here, we first propose that the genus Paraxantia could be divided into three species groups, and describe two new species from Himalaya-Hengduan Mountains: P. angustipennis sp. nov. and P. nujiangensis sp. nov.. A key to the species group of Paraxantia, necessary illustrations and life images of Paraxantia species are presented. The distribution of Paraxantia in Himalaya-Hengduan Mountains is discussed and mapped.
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Ortópteros , Animales , Distribución AnimalRESUMEN
Previously 47 genera of the subfamily Phaneropterinae were recorded from China, not including the genus Himertula Uvarov, 1940. Here, Himertula Uvarov, 1940 is reported in China for the first time, adding a new species H. gyirongensis sp. nov., specimens of which were collected in Tibet, China. Illustrations and habitat images are provided. The distribution of Himertula species is also discussed and mapped. The types are deposited in Insect Collection of Institute of Zoology, Chinese Academy of Sciences, Beijing, China (IZCAS).
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Ortópteros , Animales , Distribución Animal , China , EcosistemaRESUMEN
Background: Diabetic Foot (DF) is one of the most common complications of diabetes, and it is characterized by high morbidity, disability, lethality and low cure rate. Traditional Chinese medicine treatment has certain characteristics and advantages in diabetic foot. Due to selective reporting bias and heterogeneity of research results, on the one hand, relevant clinical studies are of low quality and poor practicability, and on the other hand, similar studies cannot be included in meta-analysis to form high-quality evidence-based evidence and evaluate the value of studies. Therefore, the development of a core set of outcomes (COS-TCM-DF) for traditional Chinese medicine for the treatment of diabetic foot is an important way to address these issues. Methods: The COS-TCM-DF project will refer to the developed COS methodology and the steps are divided into four stages: (1) a scoping review and analysis of enrolled research protocols to collect and analyze all existing outcomes that have been used in trials on the prevention or treatment of diabetic foot with Chinese Medicine; (2) qualitative interviews with Diabetic foot patient and attendants to Collect additional outcomes related to them; (3) Gather opinionest and obtain initial consensus from key stakeholders, including patients, clinicians, researchers, and pharmaceutical company staff, through a Delphi survey; (4) a consensus meeting was held to develop the final COS-TCM-DF. Discussion: Currently, there is no COS on measuring or monitoring diabetic foot with TCM in trials or clinical practice. The COS-TCM-DF will be developed to advance the synthesis of evidence regarding the prevention and treatment of diabetic foot in TCM and to promote the standardized and consistent application of results in future studies in this field. Trial registration: Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, December 2019 https://www.comet-initiative.org/Studies/Details/1553.
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OBJECTIVE: To observe the clinical effect of moxibustion combined with plucking technique at Jiquan (HT 1) for preventing peripherally inserted central catheter (PICC)-related venous thrombosis in the upper limbs of malignant tumor patients. METHODS: A total of 80 malignant tumor patients undergoing PICC were randomized into an observation group and a control group, 40 cases in each one. In the control group, the routine care for PICC was exerted. In the observation group, besides the routine care, moxibustion combined with plucking technique at Jiquan (HT 1) was added. Mild moxibustion was exerted along the venous distribution of PICC (avoiding the entry site) for 10 to 15 min, and then, the circling moxibustion was applied to Quchi (LI 11), Xuehai (SP 10) and Tianfu (LU 3), 3 to 5 min at each acupoint. Finally, plucking technique was given at Jiquan (HT 1) for 5 to 10 min. This combined therapy was intervened since the 2nd day of PICC placement, once daily, 5 times a week, for 3 weeks totally. The incidence of the PICC-related venous thrombosis in the upper limbs was compared between the two groups on day 42 of placement. On day 2, 7, 14, 21, 28, 35 and 42 of PICC placement, the peak systolic velocity (PSV) and the end-diastolic velocity (EDV) of the subclavicular vein on the placement side were observed separately in the two groups. RESULTS: The incidence of the PICC-related venous thrombosis in the upper limbs in the observation group was lower than that in the control group (2.5% [1/40] vs 17.5% [7/40], P<0.05). From day 7 to 35 of PICC placement, PSV of the subclavicular vein on the placement side was higher than that on the day 2 of PICC placement in the observation group (P<0.05). On day 28 and 42 of PICC placement, PSV of the subclavicular vein on the placement side was lower than that on the day 2 of PICC placement in the control group (P<0.05). In the observation group, EDV of the subclavicular vein on the placement side was higher than that on the day 2 of PICC placement from day 7 to 28 of PICC placement (P<0.05). In the control group, EDV of the subclavicular vein on the placement side from day 28 to 42 of PICC placement was lower than that on the day 2 of PICC placement (P<0.05). From day 7 to 42 of PICC placement, PSV and EDV of the subclavicular vein on the placement side in the observation group were all higher than those in the control group (P<0.01, P<0.05). CONCLUSION: The combined treatment of moxibustion with plucking technique at Jiquan (HT 1) can effectively prevent PICC-related venous thrombosis in the upper limbs and improve venous blood flow velocity in malignant tumor patients.
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Cateterismo Venoso Central , Cateterismo Periférico , Moxibustión , Neoplasias , Trombosis de la Vena , Cateterismo Venoso Central/efectos adversos , Cateterismo Venoso Central/métodos , Cateterismo Periférico/efectos adversos , Humanos , Moxibustión/efectos adversos , Neoplasias/complicaciones , Extremidad Superior , Trombosis de la Vena/epidemiología , Trombosis de la Vena/etiologíaRESUMEN
The genus Paraxantia Liu Kang, 2009 hitherto included 8 species from China. Herein we describe two new species: P. rubripes sp. nov. from ES-Tibet and P. kaquewa sp. nov. from WN-Yunnan. A female of Paraxantia is described for the first time. The differences separating Paraxantia and Xantia are redefined. Illustrations and habitus images are provided. The distribution of Paraxantia species in China is discussed and mapped. The types are deposited in Insect Collection of Institute of Zoology, Chinese Academy of Sciences, Beijing, China (IZCAS).
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Ortópteros , Distribución Animal , Animales , China , FemeninoRESUMEN
The genus Paraxantia Liu Kang, 2009 previously included 10 species, which are endemic to south of China. Herein we describe one new species: P. hakka sp. nov. from Guangdong Province, China. Illustrations of male stridulatory files of most Paraxantia species are provided. The distribution of the new species is discussed and mapped. All types are deposited in Insect Collection of Institute of Zoology, Chinese Academy of Sciences, Beijing, China (IZCAS).
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Ortópteros , Distribución Animal , Animales , China , Insectos , MasculinoRESUMEN
Bush-crickets (or katydids) of the genus Mecopoda are relatively large insects well-known for their sounds for centuries. Bioacoustic studies in India and China revealed a surprisingly large diversity of sound patterns. We extend these studies into the tropics of South East Asia using integrative taxonomy, combining song analysis, morphology of sound producing organs and male genitalia as well as chromosomes, to get a better understanding of the phylogeny and evolution of this widespread group. Besides the closely related genus Eumecopoda, the genus Mecopoda contains some isolated species and a large group of species which we assign to the Mecopoda elongata group. Some species of this group have broad tegmina and stridulatory files with different tooth spacing patterns and produce continuous, often relatively complicated, trill-like songs. The species of another subgroup with narrower wings have all similar files. Their songs consist of echemes (groups of syllables) which differ in syllable number and syllable repetition rate and also in echeme repetition rate. Our results show that South East Asia harbours a large and certainly not yet fully explored number of Mecopoda species which are most easily and clearly identified by song. Based on the data, five new forms are described: Mecopoda mahindai Heller sp. nov., Mecopoda paucidens Ingrisch, Su Heller sp. nov., Mecopoda sismondoi Heller sp. nov., Mecopoda niponensis vietnamica Heller Korsunovskaya subsp. nov., Eumecopoda cyrtoscelis zhantievi Heller subsp. nov. In addition, some taxonomic changes are proposed: Eumecopoda Hebard, 1922 stat. rev., Paramecopoda Gorochov, 2020, syn. nov. of Eumecopoda Hebard, 1922, Mecopoda javana (Johansson, 1763) stat. nov. (neotype selected) with M. javana minahasa Gorochov, 2020 stat. nov., M. javana darevskyi Gorochov, 2020 stat. nov., M. javana buru Gorochov, 2020 stat. nov., Mecopoda macassariensis (Haan, 1843) stat. rev., Mecopoda ampla malayensis Gorochov, 2020 syn. nov., Mecopada ampla javaensis Gorochov, 2020 syn. nov., Mecopoda fallax aequatorialis Gorochov, 2020 syn. nov., the last three are all synonyms of Mecopoda himalaya Liu, 2020, Mecopoda yunnana Liu 2020, stat. nov.
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Ortópteros , Distribución Animal , Estructuras Animales , Animales , Cromosomas , Insectos , Masculino , Tamaño de los Órganos , Ortópteros/genéticaRESUMEN
To systematically review the efficacy and safety of Yangxin Dingji Capsules in the treatment of arrhythmia. PubMed, EMbase, Cochrane Library, CNKI, VIP, CBM and Wanfang databases were electronically retrieved to collect randomized controlled trial(RCT) on the efficacy of Yangxin Dingji Capsules in the treatment of arrhythmia from the time of database establishment to October 20 th, 2020. Two reviewers independently screened out the literatures, input the data, and evaluated the literature quality of the included studies. RevMan 5.3 software was used for Meta-analysis. A total of 127 studies were retrieved, and 15 articles were included after screening, involving 1 371 cases, with 685 cases in the treatment group and 686 cases in the control group. Yangxin Dingji Capsules combined with anti-arrhythmia western medicine was adopted for intervention in the treatment group, while the patients in the control group were treated with the anti-arrhythmia western medicine alone. Meta-analysis results showed that in arrhythmia patients, the combination of Yangxin Dingji Capsules and conventional western medicine significantly increased the clinical efficacy(RR=1.23, 95%CI[1.17, 1.30], P<0.000 01)and left ventricular ejection fraction(MD=4.31, 95%CI[3.10, 5.52], P<0.000 01), reduced heart rate(MD=-3.79, 95%CI[-7.42,-0.15], P=0.04), left ventricular end-diastolic diameter(MD=-7.06, 95%CI[-11.91,-2.21],P=0.004), left ventricular end-systolic diameter(MD=-4.78, 95%CI[-6.63,-2.93],P<0.000 01), N-terminal B-type natriuretic peptide precursor(MD=-200.51, 95%CI[-254.52,-146.51], P<0.000 01)and high-sensitivity C-reactive protein(MD=-1.74, 95%CI[-3.23,-0.24], P=0.02), all with statistically significant differences. Compared with the control group, Yangxin Dingji Capsules had fewer adverse reactions(RR=0.53, 95%CI[0.36, 0.79], P=0.002). The existing evidences showed that Yangxin Dingji Capsules had certain effect in the treatment of arrhythmia, with a safety. However, due to the limitation in sample size, outcome measures and quality of the included studies, more high-quality studies are required to verify the above conclusion.
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Medicamentos Herbarios Chinos , Bradicardia , Cápsulas , Humanos , Volumen Sistólico , Función Ventricular IzquierdaRESUMEN
To analyze the outcome indicators from the randomized controlled trials(RCTs) on traditional Chinese medicine(TCM) treatment for diabetic foot, and to lay a foundation for the establishment of the core index set of the clinical trials on TCM treatment of diabetic foot. Computer retrieval of RCTs on TCM treatment of diabetic foot was performed in CNKI, Wanfang, SinoMed, PubMed, Cochrane Library, EMbase and Web of Science databases. Literature screening and data extraction were conducted independently by two researchers in strict accordance with inclusion and exclusion criteria. Any difference was resolved through discussion. A total of 72 RCTs involving 5 791 patients were included and 204 indicators were used. The number of indicators used in a single study was 2-22, with an average of 3 indicators used for each RCT. The indicators with top 16 frequency were clinical total effective rate, ankle brachial index(ABI), ulcer area, TCM syndrome integral, fibrinogen(FIB), fasting blood glucose(FBG), plasma viscosity(PV), c-reactive protein(CRP), saccharification blood of eggs(HbAlc), 2 h postprandial blood glucose(2 hPG), wound healing time, triglyce-rides(TC), TCM efficacy for syndromes, total cholesterol(TG), percutaneous oxygen partial pressure(TCPO2) and TCM symptom scores. The difference in selection of RCT indicators was large among TCM treatment methods for diabetic foot, and the combination of outcome indicators was arbitrary. The description on indexes was not standardized. Some non-laboratory examination indicators, some indicators not recommended in guidelines or not recognized in clinical practice, and some self-made indicators were not explained in detail. There was a lack of standardized evaluation criteria for indicators. The indicators had large time-point difference in measurement, and the time points were not distinguished in the measurement for diabetic foot patients with different degrees of severity. In addition, the patients with long course of treatment weren't timely measured. The characteristics of TCM or significant endpoint indicators were insufficient. It was urgent to establish the core index set of TCM in treating diabetic foot.
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Diabetes Mellitus , Pie Diabético , Medicamentos Herbarios Chinos , Glucemia , Pie Diabético/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Humanos , Medicina Tradicional China , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
The genus Theopropus Saussure, 1898 is distributed with five species in SE Asia, three of which were recorded in South China: T. elegans (Westwood), T. cattulus (Westwood) and T. sinecus Yang. After examining numerous specimens of Theopropus, we attempt to resolve some taxonomic confusion about Theopropus occurring in China. Those Chinese specimens that were inaccurately identified as T. cattulus represent a new subspecies of T. sinecus Yang: T. s. qiongae Wu & Liu, ssp. nov.. A new species, T. xishiae Wu & Liu, sp. nov., is described from the rainforests of the southern slopes of the Himalayas. The records of T. elegans in China are also clarified. Biological characteristics of the species and subspecies, necessary illustrations, and ecological images are provided. The distribution of the known Chinese Theopropus species is discussed and mapped.
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To systematically evaluate the clinical efficacy and safety of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in the treatment of hypertensive left ventricular hypertrophy. China National Knowledge Infrastructure(CNKI), Wanfang, VIP, PubMed, EMbase, Cochrane Library, Ovid and Web of Science databases were searched by computer to retrieve the randomized controlled trials(RCTs) of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in the treatment of hypertensive left ventricular hypertrophy from the establishment of databases to July 2020. After two researchers performed data retrieval, data extraction, and risk assessment of bias, they used RevMan 5.3 software for Meta-analysis. A total of 10 RCTs were included, with a total of 979 patients. Meta-analysis results showed that in terms of interventricular septal thickness(MD=-0.70, 95%CI[-1.15,-0.24], P=0.003), left ventricular posterior wall thickness(MD=-0.81, 95%CI[-1.41,-0.21], P=0.008), left ventricular mass index(MD=-8.75, 95%CI[-17.40,-0.10], P=0.05), systolic blood pressure(MD=-8.97, 95%CI[-13.46,-4.48], P<0.000 1), diastolic blood pressure(MD=-5.87, 95%CI[-8.39,-3.34], P<0.000 01) and left ventricular end-diastolic diameter(MD=-1.73, 95%CI[-2.38,-1.08], P<0.000 01), Compound Danshen Dripping Pills combined with conventional antihypertensive drugs was superior to conventional antihypertensive drugs. In terms of left ventricular ejection fraction(MD=0.41, 95%CI[-0.74, 1.55], P=0.49), there was no statistical difference in treatment between the two groups. Because of the small amount of literatures included in the safety aspect, it is impossible to give an accurate conclusion. The GRADE score showed that the level of evidence was low and extremely low. The results show that the Compound Danshen Dripping Pills combined with conventional antihypertensive drugs may effectively improve the clinical efficacy for hypertensive ventricular hypertrophy, and the safety needs to be further explored. Due to the low quality of the included literatures, more high-quality RCTs are needed for verification.
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Antihipertensivos , Medicamentos Herbarios Chinos , Antihipertensivos/efectos adversos , Canfanos , China , Medicamentos Herbarios Chinos/efectos adversos , Humanos , Hipertrofia Ventricular Izquierda/tratamiento farmacológico , Panax notoginseng , Salvia miltiorrhiza , Volumen Sistólico , Resultado del Tratamiento , Función Ventricular IzquierdaRESUMEN
Metasurfaces with orthogonal nano-slit pairs arranged on spirals are proposed to generate vector beams (VBs) of Bell-like states and slanted polarizations. The design of the metasurfaces is based on the theoretically derived parameter condition for manipulation of the two vector vortex modes, which is satisfied by matching the three parameters of rotation order m, the spiral order n, and incident polarization helicity σ. The linear polarization states of the VBs are controlled by the initial orientation angle φ0 of slit pairs. VBs of satisfying quality are experimentally obtained, with the analytical and simulated results validated.
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The Eurypalpae genus group includes two genera, Ceratopompa Karsch and Zulpha Walker, which are distributed from southeastern Asia to northern Oceania southwards, and to southern China northwards. Each genus has been recorded as monotypic, including two mysterious taxa: C. festiva Karsch and Z. perlaria (Westwood). In this study, we redescribe the known species with broadened distributional ranges, and describe 2 new species: Zulpha ruohua sp. nov. and Zulpha fenghuang sp. nov., with relevant illustrations. The geographic fistribution of the genus group is discussed and mapped. The types are deposited in Insect Collection of Institute of Zoology, Chinese Academy of Sciences, Beijing, China (IZCAS).
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Ortópteros , Distribución Animal , AnimalesRESUMEN
OBJECTIVES: By performing an overview of systematic reviews and meta-analyses of the efficacy and safety of oral Chinese patent medicine combined with conventional therapy in the treatment of heart failure, to evaluate the reliability and applicability of the conclusions of the current studies and provide evidence for clinical decision-making. METHODS: Systematic reviews and meta-analyses of oral Chinese patent medicine combined with conventional therapy treating heart failure were searched based on standardized search strategy in six electronic databases including PubMed, Embase, Cochrane Library (No. 2 of 2020), China National Knowledge Infrastructure (CNKI), Wanfang Database (Wanfang), and Chinese Scientific Journal Database (VIP) from inception to February 2020. The literature was independently screened and extracted by two researchers. The methodological quality of the included literature was evaluated using the AMSTAR-2 (A Measurement Tool to Assess Systematic Review 2). If necessary, we would summarize the original research data and further perform data synthesis using RevMan software (version 5.3), and the evidence quality of the included literature was graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. RESULTS: A total of 38 systematic reviews and meta-analyses were included, involving 11 kinds of oral Chinese patent medicines, including Qili Qiangxin Capsules (11/38), Qishen Yiqi Dropping Pills (9/38), Shexiang Baoxin Pills (4/38), Wenxin Keli (2/38), Tongxinluo Capsules (2/38), Compound Danshen Dripping Pills (2/38), Zhenyuan Capsules (3/38), Buyi Qiangxin Tablets (2/38), Yangxinshi Tablets (1/38), Xuezhikang (1/38), and Yixinshu Capsules (1/38). The methodological quality of all literature was rated as critically low. The grading of the quality of evidence was 43 moderate, 101 low, and 40 very low. The main reason for the degradation of evidence quality was the risk of bias. In the evaluation of efficacy, there was no statistically significant difference between the two groups in terms of mortality, which is a piece of low-quality evidence. Qili Qiangxin Capsules or Qishen Yiqi Dripping Pills combined with conventional therapy can significantly reduce the hospitalization rate of patients with chronic heart failure, and the quality of the evidence is moderate. The overall efficacy of oral Chinese patent medicine combined with conventional therapy in improving the clinical symptoms, quality of life, exercise endurance, laboratory tests, physical examination, and other indicators of patients with heart failure is confirmed. In the evaluation of safety, there was no significant difference between the two groups. CONCLUSIONS: Oral Chinese patent medicine combined with conventional therapy has good clinical efficacy and safety in the treatment of heart failure. However, due to its low level of methodological quality and evidence quality, the current evidence-based conclusions need to be further verified.
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OBJECTIVES: To systematically evaluate the efficacy and safety of sinomenine preparation (SP) for treating ankylosing spondylitis (AS). METHODS: Clinical randomized controlled trials (RCTs) of SP for treating AS were systematically identified in six electronic databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and Wanfang Databases from the inception up to 31 October 2019. Cochrane's risk of bias tool was used to assess the methodological quality and Review Manager 5.3 software was used to analyze data. RESULTS: A total of 12 RCTs involving 835 patients were finally included. According to interventions, RCTs were divided into two types. The intervention in 10 RCTs was SP combined with conventional pharmacotherapy (CPT) versus CPT and that in 2 RCTs was SP alone versus CPT. The results of the meta-analysis showed that, compared with CPT alone, SP combined with oral CPT has better improvement in BASDAI (WMD = -1.84, 95% CI [-3.31, -0.37], P=0.01), morning stiffness time (WMD = -13.46, 95% CI [-16.12, -10.79], P < 0.00001), the Schober test (WMD = 1.26, 95% CI [0.72, 1.80], P < 0.00001), the occipital wall test (WMD = -0.55, 95% CI [-0.96, -0.14], P=0.009), the finger-to-ground distance (WMD = -3.28, 95% CI [-5.64, -0.93], P=0.006), 15 m walking time (WMD = -8.81, 95% CI [-13.42, -4.20], P=0.0002), the C-reactive protein (CRP) (WMD = -1.84, 95% CI [-3.24, -0.45], P=0.01), and the total effective rate (RR = 1.10, 95% CI [1.01, 1.20], P=0.03). Besides, it also showed that oral SP alone may be more effective in improving morning stiffness time (WMD = -31.89, 95% CI [-34.91, -28.87], P < 0.00001) compared with CPT alone. However, this study cannot provide evidence that loading the injectable SP based on CPT can significantly increase the efficacy due to the insufficient number of studies included. In terms of adverse events, there was no statistically significant difference between the experimental group and the control group. CONCLUSIONS: This study shows that oral SP may be effective and safe in the treatment of AS. Due to the low methodological quality of the included RCTs and the limitations of the meta-analysis, it is still necessary to carry out more multicenter, large-sample, and high-quality RCTs to further verify the conclusions. The review protocol was registered on PROSPERO (CRD42018099170), and the review was constructed following the PRISMA guidelines (Annex 1).
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To analyze the registered clinical trial protocols of traditional Chinese medicine(TCM) for the prevention and treatment of coronavirus disease 2019(COVID-19), in order to provide information for improving the quality of research design. The website of the Chinese Clinical Trial Registry(www.chictr.org.cn) and the American Clinical Trial Registry(clinicaltrials.gov) were searched to collect protocols of TCM for COVID-19. Documents were screened following the inclusion criteria, and data were extracted in regard to registration date, study objective, type of design, sponsor, patient, sample size, intervention, and evaluation index. Descriptive analysis was conducted. A total of 49 clinical trial protocols of TCM for COVID-19 were included. Primary sponsors were mainly hospitals or universities in places like Hubei, Beijing, Zhejiang and other regions. The implementation units are mainly in Hubei, Guangdong, Zhejiang, Henan and other regional hospitals. The types of study design were mainly experimental studies(40), including 30 randomized parallel controlled trials, 7 non-randomized controlled trials, 2 single arm trials and 1 consecutively recruited trial; besides, there were also 6 observational studies, 2 health service studies and 1 preventive study. The sample size reached a total of 30 562 cases, with a maximum of 20 000 for a single study and a minimum of 30. The 49 trials subjects included healthy people(3), isolation and observation cases(1), suspected cases(10),confirmed COVID-19 patients(31) and COVID-19 recovery patients(4). Of the 31 trials planned to include confirmed COVID-19 patients, 16 protocols no definite disease classification, 3 with a clear exclusion of severe subjects, 4 with common subjects, 2 with light, common or severe subjects, 1 with light and common subjects, 1 with common or severe subjects, 3 with severe subjects, and 1 with severe or critical subjects. The experimental interventions included Chinese patent medicine(Lianhua Qingwen Capsules/Granules, Huoxiang Zhengqi Dropping Pills/Oral Liquid, Babao Dan, Gubiao Jiedu Ling, Jinhao Jiere Granules, Compound Yu-xingcao Mixture, Jinye Baidu Granules, Shufeng Jiedu Capsuless, Shuanghuanglian Oral Liquid, Tanreqing Injection, Xuebijing Injection, Reduning Injection, Xiyanping Injection), Chinese medicinal decoction and taichi. The primary evaluation outcomes mainly included antipyretic time, clinical symptom relief, novel coronavirus nucleic acid turning to negative, conversion rate of severe cases and chest CT. There was a quick response of clinical research on the prevention and treatment of COVID-19 with TCM, with the current registered protocols covers the whole process of disease prevention, treatment and rehabilitation. However, issues need to be concerned, including unclear definition of patient's condition, unclear research objectives, unclear intervention process and inappropriate outcomes, etc. In addition, researchers should consider the actual difficulties and workload of doctors in epidemic response environment, and make effort to optimize the process and improve the operability of research protocols under the principle of medical ethics.
Asunto(s)
Protocolos de Ensayos Clínicos como Asunto , Infecciones por Coronavirus/tratamiento farmacológico , Medicamentos Herbarios Chinos/uso terapéutico , Neumonía Viral/tratamiento farmacológico , Betacoronavirus , COVID-19 , China , Humanos , Medicina Tradicional China , Pandemias , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , SARS-CoV-2 , Tratamiento Farmacológico de COVID-19RESUMEN
To investigate the regularity of prescription and clinical syndromes by analyzing the diagnosis and treatment protocols of traditional Chinese medicine(TCM) for coronavirus disease 2019(COVID-19), so as to provide references for syndrome differentiation and relevant researches. The diagnosis and treatment protocols of COVID-19 published by national and regional health authorities were searched, and information was extracted in regard to disease stages, type of syndromes, and prescriptions, etc. Frequency statistics and relative analysis were used to analyze the rule of syndrome differentiation and prescription with TCM, and further discussion on the pathogenesis and progress of the disease. A total of 26 diagnosis and treatment protocols of TCM for COVID-19 were retrieved after screening(including 1 national scheme and 25 regional ones), among which 16 contained aspects of both prevention and treatment, 7 only involved treatment contents and 3 were prevention schemes. The courses of COVID-19 can be divided into early stage, middle stage, severe stage and recovery stage. The pathogeny of COVID-19 in TCM is damp-toxin, with the core pathogenesis of damp-toxin retention in lung and Qi repression. Its pathological features can be summarized as "damp, toxin, obstruction, deficiency". The location of the disease is lung, always involving spleen and stomach, and may further affect heart and kidney in severe cases. The major treatments for each course are Fanghua Shizuo, Xuanfei Touxie(early stage); Qingre Jiedu, Xuanxie Feire(middle stage); Kaibi Gutuo, Huiyang Jiuni(severe stage); Qingjie Yure, Yiqi Yangyin(recovery stage). There were many diagnosis and treatment protocols for COVID-19 have been published, which generally followed the national edition, through with certain personalities in different regional protocols. There were common features with respect to the disease stage, syndrome differentiation, therapeutic principles and methods, as well as prescriptions; the treatment were generally carried out against the core pathogenesis and progress of the disease. Along with the deepening recognition of COVID-19, the diagnosis and treatment protocols are still need further concretization and standardization. We hope researchers and decision-makers can pay more attention to the treatment of Huayu Tongluo in severe and recovery period.