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In this study, an overview of systematic reviews/Meta-analysis(SR/MA) of Chinese herbal injections for sepsis was performed to provide references for clinical practice and promote the quality improvement of clinical evidence. Eight Chinese and English databases such as CNKI, Medline, and EMbase were electronically searched for SR/MA of Chinese herbal injections for sepsis from database inception to June 2022. AMSTAR 2, PRISMA 2020, and GRADE system, combined with Recommendations for Clinical Evidence Grading on Traditional Chinese Medicine Based on Evidence Body, were applied to evaluate the methodological quality, reporting quality, and evidence quality of the included articles. Twenty-seven articles of SR/MA were included, containing four Chinese herbal injections(Xuebijing Injection, Shenfu Injection, Shenmai Injection, and Shengmai Injection). AMSTAR 2 checklist showed that the methodological quality of the SR/MA ranged from moderate to very low. Item 2(prior study design) was the critical item with poor scores, and the non-critical items with poor scores were items 3(explain the selection of the study designs), items 10(report on the sources of funding), and items 16(conflicts of interest stated). In terms of PRISMA 2020, items in eight topics with complete reporting of missing>50%, including search strategy, certainty assessment, results of syntheses, certainty of evidence, registration and protocol, support, competing interests, availability of data, code and other materials. The included SR/MA involved 30 outcome indicators. Evidence quality of mortality, APACHE Ⅱ, and safety, the top three outcome indicators, was evaluated, and all of them were graded as the medium level. The lack of random allocation sequence, allocation concealment mechanism, blinding, and trial sample size was the main reason for the reduction of the evidence level. The available evidence shows that Chinese herbal injections can serve as an effective and safe adjunctive treatment for sepsis, which can reduce mortality, inhibit inflammation, improve coagulation function, and regulate immune function, tissue perfusion, and oxygenation in patients with sepsis. However, the quality of SR/MA was suboptimal, and more high-quality SR/MA is needed to provide evidence to support the efficacy and safety of Chinese herbal injections in the treatment of sepsis.
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Humanos , Inyecciones , Medicina Tradicional China , Proyectos de Investigación , Sepsis/tratamiento farmacológicoRESUMEN
The present study collected, collated, analyzed, and evaluated randomized controlled trial(RCT) of Chinese patent medicine published in Chinese and English journals in 2020, and summarized clinical evidence of Chinese patent medicine in stages, providing references for follow-up clinical research and evidence transformation and application. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, and EMbase were searched for RCTs of Chinese patent medicine published in 2020, and their research characteristics and methodological quality were analyzed and evaluated. A total of 1 285 research papers on Chinese patent medicine(1 257 in Chinese/28 in English) were included, involving 146 054 patients and 639 Chinese patent medicines, including 526 oral drugs, 68 injections, and 45 external drugs. A total of 412 diseases in 23 types were involved, which were dominated by circulatory system diseases and respiratory system diseases, specifically, cerebral infarction and angina pectoris. The sample size ranged from 20 cases to 2 673 cases, and 57.67% of RCTs had samples sizes less than 100. Single-center trials were the main ones, and multi-center trials only accounted for 4.75%(n=61). In terms of methodological quality, 52.91% of the RCTs had unclear descriptions or incorrect application of randomization methods, and the implementation of allocation concealment and blinding methods has not been paid much attention. In conclusion, compared with the conditions in 2019, the number of RCTs published in 2020 has decreased, and the research interest in respiratory diseases has increased, while the quality control in the process of research design and implementation has not been improved. Therefore, it is necessary to strengthen the methodological training of researchers and promote the output of high-quality research evidence.
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Humanos , China , Medicamentos Herbarios Chinos/uso terapéutico , Medicina Tradicional China , Medicamentos sin Prescripción , Control de CalidadRESUMEN
The present study systematically collected, analyzed, and evaluated randomized controlled trial(RCT) of Chinese patent medicine in the treatment of heart failure to provide references for follow-up clinical research design, guideline update, and policy formulation, and promote the improvement of clinical evidence quality. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, VIP, Wanfang, SinoMed, PubMed, and Web of Science were searched for RCTs of Chinese patent medicine in the treatment of heart failure from database inception to December 31, 2020. The di-sease type, publication time, sample size, intervention/control setting, course of treatment, evaluation indexes, and methodological quality were analyzed and evaluated. A total of 1 631 RCTs were included, including 1 622 in Chinese and 9 in English. It was first published in 1995, with the largest number of publications in 2016. There were only 56 RCTs(3.43%) with a sample size≥200. Seventy-eight types of Chinese patent medicines were involved, including 49 types of oral drugs and 29 types of injections. There were 34 intervention/control protocols, which were dominated by Chinese patent medicine+conventional treatment vs conventional treatment, accounting for 28.51%(n=465). About 94.0% of RCTs reported the course of treatment, mainly 14-56 days. The evaluation indexes were mainly physical and chemical tests and symptoms/signs, and left ventricular ejection fraction(LVEF) was the most frequently used measurement index. In enumeration indexes, clinical efficacy(response rate) was used the most frequently. Methodologically, 92.0% of the research subjects were rated as high risk of blindness. There were only 13 RCTs(0.80%) reporting registered information. It is necessary to further standardize the design, implementation, and quality control of clinical studies in order to improve the quality of evidence and avoid research waste.
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Humanos , China , Medicamentos Herbarios Chinos/uso terapéutico , Insuficiencia Cardíaca/tratamiento farmacológico , Medicina Tradicional China , Medicamentos sin Prescripción/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Volumen Sistólico , Función Ventricular IzquierdaRESUMEN
To systematically collect and analyze clinical randomized controlled trial(RCT) of Chinese patent medicine treatment for stroke in 2020, in order to provide basic information for clinical decision-making and related research. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, EMbase were searched for RCTs of Chinese patent medicine for stroke in 2020. The publication, sample size, intervention and control measures, course of treatment, outcome indicators, methodological quality and other contents were statistically analyzed.A total of 68 RCTs studies on Chinese patent medicine for stroke were included in 2020, of which 29(42.60%) were RCTs with sample size>100 cases. A total of 41 kinds of proprietary Chinese medicines were involved, including 23 kinds of oral proprietary Chinese medicines and 18 kinds of injections. A total of 18 intervention/control cases were included in RCTs, and 19 cases(Chinese patent medicine+Western medicine vs Western medicine) were applied in RCTs, accounting for 27.90%. The duration of treatment was reported in 91.18% of the studies, and the intervention duration was 8-14 days in 50.00% of the studies. Evaluation indexes were widely used, among which physical and chemical testing indexes(49.36%) were the most widely used. According to the methodological quality evaluation, the overall methodological quality of the study is not high, especially the implementation of the allocation hidden, blind method is not accurate, and the registration, ethics and other links are often missing. In conclusion, 2020 implementation of proprietary Chinese medicine in the treatment of stroke research methodology problems is outstanding, the similar function scale large range of optional, no specification selection criteria, reliability and practicability of the impact study, need to further standardize the proprietary Chinese medicine in the treatment of stroke study design, implementation and quality control, and highlight the value of proprietary Chinese medicine in the treatment of stroke and improve the quality of the evidence.
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Humanos , China , Ensayos Clínicos como Asunto , Medicamentos Herbarios Chinos/uso terapéutico , Medicina Tradicional China , Medicamentos sin Prescripción/uso terapéutico , Reproducibilidad de los Resultados , Accidente Cerebrovascular/tratamiento farmacológicoRESUMEN
<p><b>OBJECTIVE</b>To observe early rehabilitation of two different acupuncture programs for hemiplegia due to stroke.</p><p><b>METHODS</b>Seventy cases of early hemiplegia due to stroke were randomly divided into a treatment group and a control group. The treatment group were treated by acupuncture at acupoints of both the healthy and affected sides, twice each day, respectively, and the control group by acupuncture at the affected side, once daily. Their therapeutic effects were evaluated by the brief Fugl-Meyer movement scale and the modified Barthel indexes.</p><p><b>RESULTS</b>The patients with over grade IV for FMA accounted for 68.6% and the good rate for ADL was 74.3% in the treatment group, and 31.4% and 42.8% in the control group, respectively, the therapeutic effect of the treatment group being better than that of the control group (P<0.01 or P<0.05).</p><p><b>CONCLUSION</b>The acupuncture program in which acupoints at both the healthy and affected sides are applied alternately is more beneficial to recovery of motor function and activity daily living (ADL) of the patient with hemiplegia due to stroke.</p>
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Humanos , Actividades Cotidianas , Puntos de Acupuntura , Terapia por Acupuntura , Hemiplejía , Terapéutica , Accidente Cerebrovascular , TerapéuticaRESUMEN
<p><b>OBJECTIVE</b>To study the effects of toxicity of ammonium perchlorate (AP) on thyroid of rats.</p><p><b>METHODS</b>Eighty-eight Wistar rats were treated orally with different dosages of AP. Three treated groups received 129, 257, 514 mg.kg(-1).d(-1) of AP respectively and one control group drunk water for 13 weeks. Another 3 groups received 1.2, 46.5, 465.0 mg.kg(-1).d(-1) of AP respectively and one control group drunk water for 36 weeks. The behavior and change of body weight in rats were observed. The levels of thyroid hormones in serum were measured and the pathological changes of thyroid tissue were observed as well.</p><p><b>RESULTS</b>There were no differences in behavior and change of body weight between different AP exposure time. When the rats were treated with AP 514 mg for 13 weeks, free triiodothyronine (FT3, 2.48 pmol/L), free thyroxin (FT4, 13.33 pmol/L) were lower than those in control group (3.24, 20.92 pmol/L respectively, P<0.05). Thyroid-stimulating hormone (TSH, 0.375 mIU/L), thyroglobulin (TG, 3.37 microg/L) were higher than those in control group (0.29 mIU/L, 2.00 microg/L respectively, P<0.05). When the rats were treated with AP 465 mg for 36 weeks, FT3 (2.65 pmol/L) was lower than that in control group (4.97 pmol/L, P<0.01). FT4 in 46.5, 465 mg groups (10.63, 2.17 pmol/L respectively) were lower than that in control group (15.74 pmol/L, P<0.05, P<0.01). TSH in 465 mg group (0.34 mIU/L) was higher than that in control group (0.14 mIU/L, P<0.05). Histopathologic examination showed that follicle proliferation, no colloid in follicle, gore, follicular diminishing or atresia were found in 46.5, 465 mg groups with a dose-effect relationship.</p><p><b>CONCLUSIONS</b>The toxic effects of AP on the growth of rats were not found, but those on the thyroid of rats were found significantly. Thyroid is the target organ of AP. It is considered that none effect dose of AP for rat thyroid may be 1.2 mg.kg(-1).d(-1), its threshold dose may be 46.5 mg.kg(-1).d(-1).</p>