RESUMO
This article focused on the significant public health issue of comorbidities in the elderly population and highlighted the important role of traditional Chinese medicine(TCM) in the prevention and treatment of comorbidities in the elderly. It suggested that TCM should fully utilize its advantages in holistic perspective, syndrome differentiation and treatment, and preventive medicine in the process of preventing and treating comorbidities in the elderly. At the same time, in response to the significant shift in the disease spectrum of the elderly, the increasingly innovative concepts in diagnosis and treatment, the growing demand for proactive health by the el-derly population, and the current emphasis on patient-centered evaluation standards, it is necessary to further conduct basic theoretical and experimental research on comorbidities in the elderly using TCM, emphasize clinical research on comorbidities in the elderly, explore appropriate efficacy evaluation systems, improve TCM prevention and treatment strategies and comprehensive intervention programs for comorbidities in the elderly, and leverage the unique role of TCM in the rehabilitation of elderly comorbidity patients. By analyzing the potential of TCM in the field of comorbidities in the elderly, this article is expected to provide new insights for future clinical practice and scientific research.
Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Idoso , Humanos , Saúde Pública , Comorbidade , Medicamentos de Ervas Chinesas/uso terapêuticoRESUMO
S-RNase plays vital roles in the process of self-incompatibility (SI) in Rutaceae plants. Data have shown that the rejection phenomenon during self-pollination is due to the degradation of pollen tube RNA by S-RNase. The cytoskeleton microfilaments of pollen tubes are destroyed, and other components cannot extend downwards from the stigma and, ultimately, cannot reach the ovary to complete fertilisation. In this study, four S-RNase gene sequences were identified from the 'XiangShui' lemon genome and ubiquitome. Sequence analysis revealed that the conserved RNase T2 domains within S-RNases in 'XiangShui' lemon are the same as those within other species. Expression pattern analysis revealed that S3-RNase and S4-RNase are specifically expressed in the pistils, and spatiotemporal expression analysis showed that the S3-RNase expression levels in the stigmas, styles and ovaries were significantly higher after self-pollination than after cross-pollination. Subcellular localisation analysis showed that the S1-RNase, S2-RNase, S3-RNase and S4-RNase were found to be expressed in the nucleus according to laser confocal microscopy. In addition, yeast two-hybrid (Y2H) assays showed that S3-RNase interacted with F-box, Bifunctional fucokinase/fucose pyrophosphorylase (FKGP), aspartic proteinase A1, RRP46, pectinesterase/pectinesterase inhibitor 51 (PME51), phospholipid:diacylglycerol acyltransferase 1 (PDAT1), gibberellin receptor GID1B, GDT1-like protein 4, putative invertase inhibitor, tRNA ligase, PAP15, PAE8, TIM14-2, PGIP1 and p24beta2. Moreover, S3-RNase interacted with TOPP4. Therefore, S3-RNase may play an important role in the SI of 'XiangShui' lemon.
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Ácido Aspártico Proteases , Citrus , Autoincompatibilidade em Angiospermas , Citrus/metabolismo , Diacilglicerol O-Aciltransferase , Endorribonucleases , Fucose , Giberelinas , Fosfolipídeos , Proteínas de Plantas/genética , Proteínas de Plantas/metabolismo , Pólen/genética , RNA , RNA Ligase (ATP) , Ribonucleases/genética , Ribonucleases/metabolismo , Autoincompatibilidade em Angiospermas/genética , beta-FrutofuranosidaseRESUMO
The editorial group of the clinical practice guideline for postmenopausal osteoporosis(PMOP) with traditional Chinese medicine(TCM)(hereinafter referred to as "guideline") is composed of experts specialized in TCM orthopedics, TCM gynecology, clinical epidemiology, etc. The guideline was formulated through registration, collection and selection of clinical issues/outcome indicators, evidence retrieval and screening, preparation of systematic reviews, evaluation of evidence quality, formation of recommendations, drafting, and peer review. The syndromes and treatment of PMOP are elaborated in detail. Specifically, Liuwei Dihuang Pills and Zuogui Pills are recommended for PMOP with Yin deficiency in the liver and kidney, Qing'e Pills for PMOP with kidney deficiency and blood stasis, Yougui Pills and Jingui Shenqi Pills for PMOP with Yang deficiency in the spleen and kidney, and Er'xian Decoction for PMOP with Yin and Yang deficiency in the kidney. In addition, Duhuo Jisheng Decoction can be used to relieve pain. The commonly used Chinese patent medicines include Xianling Gubao Capsules, Qianggu Capsules, Jintiange Capsules, Gushukang Capsules, Hugu Capsules, Jinwu Gutong Capsules, and Guyuling Capsules. Acupuncture and moxibustion are also effective approaches for PMOP. The rehabilitation and daily management were carried out by exercise therapies such as Baduanjin(eight-section brocade), Wuqinxi(five-animal exercises), and Taijiquan(Tai Chi), Chinese medicine diet, health education, and fall prevention. The promotion and application of this guideline will facilitate the implementation of TCM prevention and treatment of PMOP, ensure the quality of life of PMOP patients, provide effective and safe TCM treatment measures for PMOP, and reduce the risk of fracture complications.
Assuntos
Medicamentos de Ervas Chinesas , Osteoporose Pós-Menopausa , Animais , Medicamentos de Ervas Chinesas/uso terapêutico , Feminino , Humanos , Medicina Tradicional Chinesa , Osteoporose Pós-Menopausa/tratamento farmacológico , Qualidade de Vida , Revisões Sistemáticas como Assunto , Deficiência da Energia YinRESUMO
This study evaluated the outcome indicators of the randomized controlled trials(RCTs) of traditional Chinese medicine(TCM) in the treatment of postmenopausal osteoporosis(PMOP) to provide a reference for the related research. Four Chinese databa-ses(CNKI, VIP, Wanfang and CBM) and three English databases(Cochrane Library, EMbase and PubMed) were searched syste-matically to screen RCTs of TCM in the treatment of PMOP according to the pre-set criteria, and the quality of the included trials was evaluated by the Cochrane risk-of-bias tool. A total of 29 627 articles were initially retrieved, and finally, 43 articles were included, including 34 in Chinese and 9 in English. As revealed by the results, the outcome indicators of 43 RCTs were mainly divided into six categories, with biochemical indicators accounting for 54.59%, bone mineral density(BMD) for 26.57%, quality of life for 6.28%, fracture for 1.94%, safety for 5.31%(including adverse reactions or events) and others for 5.31%. Biochemical indicators showed the maximum occurrence, followed by BMD. Many problems were found in the selection of outcome indicators of the TCM RCTs in the treatment of PMOP, such as the confusion of primary and secondary outcome indicators, the lack of endpoint criteria and vital clinical outcome indicators substituted by intermediate indicators, inconsistent evaluation standard of syndrome curative efficacy and neglected blinding in the measurement of subjective outcome indicators. The problems also included importance given to the efficacy indicators instead of the adverse outcome indicators, unnormalized indicator name, large quantitative range of the indicators, unconventional application of TCM efficacy criteria, seldom used confidence interval, relative effect indicator and absolute effect indicator.
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Medicamentos de Ervas Chinesas , Osteoporose Pós-Menopausa , Densidade Óssea , Medicamentos de Ervas Chinesas/uso terapêutico , Feminino , Humanos , Medicina Tradicional Chinesa , Osteoporose Pós-Menopausa/tratamento farmacológico , Qualidade de Vida , Resultado do TratamentoRESUMO
From January 1, 2004 to July 21, 2016 a total of 2 796 cases of adverse drug reaction/adverse event(ADR/AE) after the use of Xianling Gubao Capsules/Tablets were reported by National Adverse Drug Reaction Monitoring Center. The following results were obtained by analyzing the reports of 2 796 cases of adverse drug reactions/adverse drug events after the use of Xianling Gubao Capsules/Tablets. A total of 75 patients, accounting for 2.68% of the total ADR/AE time, had severe ADR/AE events. Among them, 30 patients were aged 65 and above, accounting for 40.00% of the total number of severe ADR/AE patients. All the patients with ADR/AE were aged 45-64 years, which totaled 1 346 cases and took up 48.14% of the total patients with ADR/AE. All of ADR/AE cases and severe ADR/AE cases were orally given Xianling Gubao Capsules/Tablets. Females accounted for 52.50% and 76.00%, respectively, and the proportion of females was significantly higher than that of males. Among patients with a medical history of ADR/AE, severe ADR/AE was higher than the average, accounting for about 1.33%. The proportion of cases orally given 1-3 tablets of Xianling Gubao Capsules/Tablets in all ADR/AE cases and severe ADR/AE cases was 95.32% and 96.00%, which conformed to the usage in the package insert. All ADR/AE cases and severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets twice daily occupied the highest proportions, or 77.00% and 61.00%, respectively. The proportion of severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets was slightly higher than that of all ADR/AE cases in the medication frequency, which didn't conform to the usage in the package insert. All the symptoms of ADR/AE orally given Xianling Gubao Capsules showed many manifestations, and the top 10 symptoms were nausea, rash, itching, stomach dysfunction, vomiting, abdominal pain, dizziness, diarrhea, anaphylaxis, and reflux heartburn. The symptoms of severe ADR/AE after oral administration of Xianling Gubao Capsules were varied, and the top 10 symptoms were abnormal liver function, rash, suffocation, itching, dizziness, vomiting, anaphylaxis, abdominal pain, weakness, and convulsions. Abnormal liver function accounted for 44.12%. All of ADR/AE cases occurred within 2 days after oral administration of Xianling Gubao Capsules/Tablets, accounting for 54.26%. Severe ADR/AE occurred within 2 days after the use of Xianling Gubao Capsules/Tablets, accounting for 25.34%. The proportion of ADR/AE cases occurring within 15 days after oral administration of Xianling Gubao Capsules/Tablets increased again(57.33%). The overall trend contained two peaks.
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Anafilaxia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Administração Oral , Idoso , Cápsulas , Tontura , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
To evaluate the clinical efficacy and safety of Shentong Zhuyu Decoction in the treatment of lumbar disc herniation, in order to provide evidence for its clinical application. PubMed, Cochrane Library, EMbase, CNKI, WanFang, VIP, CBM and Clinical Trials.gov databases were sysmatically retrieved. Two researchers independently searched, screened and extracted data. Randomized controlled trials in line with the inclusion criteria were included in the study. The article quality was assessed with the bias risk tool in the Cochrane Handbook. Meta-analysis was performed using RevMan 5.3. A total of 604 articles were obtained from the retrieval, and 824 patients in 9 studies were finally selected through screening. The course of treatment was about 1 month, and all of the studies were completed in China. Meta-analysis showed that the efficacy of Shentong Zhuyu Decoction in the treatment of lumbar disc herniation was better than that of the control group(RR=1.19, 95%CI[1.12, 1.26], P<0.000 01), including the comparison with Yaotongning Capsules(RR=1.10, 95%CI[1.02, 1.19], P=0.01) and diclofenac sodium tablets(RR=1.26, 95%CI[1.11, 1.44], P=0.000 4). In VAS pain score, Shentong Zhuyu Decoction had also obvious advantages(MD=-3.70, 95%CI[-6.31,-1.09], P=0.005). In addition, the number of adverse events in the Shentong Zhuyu Decoction group was lower than that in the control group. Shentong Zhuyu Decoction can effectively alleviate discomfort symptoms of patients with LDH. It has an obvious clinical efficacy and less adverse reactions. However, restricted by the quality of the included literatures, prospective, multi-center, large-sample-size randomized controlled trials are still needed to further improve the clinical evidence of the effect of Shentong Zhuyu Decoction in the treatment of LDH.
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Medicamentos de Ervas Chinesas/uso terapêutico , Deslocamento do Disco Intervertebral/tratamento farmacológico , China , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
To evaluate the effectiveness and safety of Xiyanping Injection in the treatment of acute bronchitis in children. The research systematically retrieved four Chinese databases( namely CNKI,VIP,Wan Fang,Sino Med) and four English databases( namely EMbase,Cochrane Library,Medline,Clinical Trail.gov). The retrieval time ranged from the commencement of each database to April2019. According to pre-set inclusion criteria and exclusion criteria,randomized controlled trials( RCTs) of Xiyanping Injection in the treatment of acute bronchitis in children were screened out. The quality assessment of the included studies was performed using the " Cochrane Bias Risk Assessment" tool,and the Meta-quantitatively analysis on the included studies was performed using Rev Man 5.3 software. A total of 648 articles were retrieved,and 10 studies were finally included. Except for one multi-arm test,the total sample size was 1 260,including 630 cases in the test group and 630 cases in the control group. The overall quality of the included study was not high. The results of Meta-analysis showed that in terms of antipyretic time,Xiyanping Injection combined with routine therapy was superior to routine therapy in the shortening of fever time in children with acute bronchitis( MD =-0.94,95%CI[-1.18,-0.70],P<0.000 01); in the overall efficacy,Xiyanping Injection combined with routine therapy was superior to routine therapy( RR = 1. 34,95% CI[1.26,1.42],P<0.000 01) and Yanhuning Injection + routine therapy( RR = 1.28,95%CI[1.19,1.38],P<0.000 01); descriptive analysis showed that Xiyanping Injection was excellent in the overall efficacy in treating acute bronchitis in children. The differences between the two groups were statistically significant( P< 0.000 1). The adverse reactions included in the study were mild adverse reactions,with no impact on treatment. Based on the results of this study,Xiyanping Injection combined with routine therapy or other Western medicine had a certain effect on acute bronchitis in children,especially in improving the overall efficacy of acute bronchitis in children. No serious adverse reactions were observed. And in the time of fever,cough and cough disappearance time,lung voice loss time,Xiyanping Injection + routine therapy or Western medicine therapy was better than routine therapy or Western medicine therapy. However,the small size of included studies,the low quality of the included studies,and the existence of publication bias and the low quality of the evidence had impacts on the reliability of the conclusion. Therefore,more large-sample,multi-center,well-designed,rigorous randomized controlled trials with best case reports are required to further verify the efficacy and safety.
Assuntos
Bronquite/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Doença Aguda , Criança , Humanos , Injeções , Masculino , Reprodutibilidade dos TestesRESUMO
To systematically review the efficacy and safety of Huoxiang Zhengqi Pills combined with Western medicine in the treatment of acute gastroenteritis. Four Chinese databases( CNKI,VIP,Wan Fang,Sino Med) and three English databases( Cochrane Library,Medline,EMbase) were systematically and comprehensively searched from the database establishment to April 2019 to collect the randomized controlled trials( RCTs) about the treatment of acute gastroenteritis with Huoxiang Zhengqi Pills combined with Western medicine. Two investigators independently performed literature screening,data extraction and bias risk assessment. Rev Man 5. 3 software was used for data analysis. A total of 316 articles were retrieved and finally 44 studies were included in this study,involving 4153 patients. The overall quality of the included studies was generally low. Meta-analysis results showed that in the total clinical effective rate,Huoxiang Zhengqi Pills combined with conventional treatment or norfloxacin tablets was superior to conventional treatment or norfloxacin tablets alone. In terms of the time for improving clinical symptoms,Huoxiang Zhengqi Pills combined with conventional treatment or norfloxacin tablets could better relieve fever than conventional treatment or norfloxacin tablets alone. In terms of incidence of adverse reactions,there was no statistical difference between Huoxiang Zhengqi Pills combined with conventional treatment and conventional treatment alone. Other outcome measures were affected by various factors( such as inclusion of only 1 study or excessive heterogeneity among studies) and could not be concluded. Due to the limitations of the quality and quantity of included studies,this conclusion still needs to be verified by more high quality researches.
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Medicamentos de Ervas Chinesas/uso terapêutico , Gastroenterite/tratamento farmacológico , Humanos , Norfloxacino/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
To evaluate the efficacy and safety of Lianhua Qingwen Capsules in the treatment of viral influenza in order to guide clinical medication. Randomized controlled trials(RCTs) regarding Lianhua Qingwen Capsules for treatment of viral influenza were searched in the CNKI, WanFang, VIP, SinoMed and PubMed. The quality of papers selected based on the inclusion criteria were assessed according to the Cochrane collaboration method and Meta-analysis was performed by using RevMan 5.3 software. A total of 8 articles were included, with a total sample size of 955 cases, including 478 cases in the treatment group, and 477 cases in the control group. In terms of the therapeutic effect, Lianhua Qingwen Capsules group was superior to the control group, with a total effective rate RR=1.20, 95%CI [1.09,1.32], P=0.70; recovery rate of body temperature RR=1.13, 95%CI [1.02,1.24], P=0.001; rate of symptom improvement RR=1.18, 95%CI [1.12,1.24], P=0.16. In terms of adverse reactions, the control group was superior to Lianhua Qingwen Capsules, with the incidence of adverse reactions RR=1.54, 95%CI [0.73,3.24], P=0.93. Lianhua Qingwen Capsules has a better therapeutic effect on viral influenza, but the incidence of adverse reactions is high, and its safety must be taken seriously. Given the small number of documents included and the low quality, the efficacy and safety of Lianhua Qingwen Capsules shall be confirmed by more high-quality clinical studies.
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Medicamentos de Ervas Chinesas/uso terapêutico , Influenza Humana/tratamento farmacológico , Cápsulas , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
To analyze the clinical characteristics of Maixuekang Capsules combined with traditional Chinese medicines in the treatment of patients with nephrotic syndrome,and provide references for improving rationality of clinical drug use. Based on the database of hospital information system(HIS) in 15 hospitals in China,the electrical medical records of the patients diagnosed as nephrotic syndrome and treated with Maixuekang Capsules were collected. Their diagnostic information and characteristics of combined traditional Chinese medicines were analyzed by using association rules. The results showed that 1 588 patients of nephrotic syndrome who used Maixuekang Capsules were often complicated with hypertension(863 cases,accounting for 7. 54%),anemia(551 cases,accounting for 4. 81%),and coronary heart disease(349 cases,accounting for 3. 05%). Maixuekang Capsules were mainly combined with Tabellae Rhei et Natrii Bicarbonatis,Baining Capsules,tanshinone,Ganmao Qingre Granule,Shuxuening Injection in treating nephrotic syndrome. The results indicated that in the real world,Maixuekang Capsules was mainly used in combination with traditional Chinese medicines such as blood-activating and stasis-removing agents,pathogens eliminating and supporting healthy Qi agents,digestants,anti-bacterial and anti-inflammatory agents,wind-dispersing and antipyretic agents for patients with nephropathy. By the pharmacological effect,it was suitable for nephropathy patients based on combined diagnosis. The association rules of combination were specific,and can provide reference for subsequent studies and rational clinical medication of traditional Chinese medicines.
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Medicamentos de Ervas Chinesas/uso terapêutico , Síndrome Nefrótica/tratamento farmacológico , Anemia/complicações , Cápsulas , China , Doença das Coronárias/complicações , Humanos , Hipertensão/complicações , Medicina Tradicional ChinesaRESUMO
To systemically evaluate the efficacy and safety of Jintiange Capsules in the treatment of postmenopausal osteoporosis(PMOP).Seven literature databases were retrieved systematically,and two reviewers independently searched and screened studies,extracted data,and included all the randomized controlled trials on Jintiange Capsules in the treatment of PMOP.Interventions included comparison of Jintiange Capsules with placebo and routine treatment,and the studies on Jintiange Capsules combined with routine treatment versus conventional treatment were also included.The evaluation indicators of the study included at least one of the followings:fracture,quality of life,daily living ability,clinical symptoms,death,adverse events/adverse reactions,bone density,and bone metabolism indexes.The original study quality evaluation was conducted by following the Cochrane Handbook standard and statistical analysis was performed by using Rev Man 5.2.A total of 7 randomized controlled trials were included and the study quality was low.Meta-analysis showed that as compared with conventional treatment alone,Jintiange Capsules combined with conventional treatment showed more obvious effects in pain relief(MD=-0.98,95% CI[-1.55,-0.41],P=0.000 8),increasing blood calcium levels(MD=0.05,95% CI[0.02,0.09],P=0.003) and lowering serum alkaline phosphatase levels(MD=-12.92,95% CI[-24.09,-1.75],P=0.02).In addition,the Chinese patent medicine alone or in combination with conventional treatment was relatively safe.In conclusion,Jintiange Capsules has a certain effect in treating PMOP,but the quality of evidence is low.It is necessary to conduct well designed randomized controlled trials and select recognized evaluation indicators,especially the end outcomes in order to further improve the clinical evidence.
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Antineoplásicos , Densidade Óssea , Fraturas Ósseas , Osteoporose Pós-Menopausa , Feminino , Humanos , Masculino , Antineoplásicos/uso terapêutico , Cálcio/sangue , Cápsulas , Fraturas Ósseas/prevenção & controle , Osteoporose Pós-Menopausa/tratamento farmacológico , Qualidade de VidaRESUMO
Drynariae Rhizoma has great significance in the clinical practice of osteoporosis treatment. Based on the perspective of integrative pharmacology, the study explored the mechanism of action of Drynariae Rhizoma in the treatment of osteoporosis. Six active components in Drynariae Rhizoma were obtained, mainly including glycosides and sterols. Taking the median of 2 times of "node connectivity" as the card value, the core node of the Chinese medicine target disease gene interaction network was selected. Based on this, three topological structural eigenvalues, such as "node connectivity" "node tightness" and "node connectivity" were calculated, thereby screening out four core targets of Drynariae Rhizoma treatment for osteoporosis, including thyroid parathyroid hormone 1 receptor (PTH1R), parathyroid hormone 2 receptor (PTH2R), calcitonin receptor gene (CALCR), and SPTBN1 gene (SPTBN1). Based on the gene ontology database GO and KEGG pathway database, the molecular function, intracellular localization, and biological reactions and pathways of proteins encoded by drug target genes were determined. Combined with enrichment calculation, it is predicted that osteoporosis may play a role in biosynthetic processes, such as circulatory system, nervous system, energy metabolism, prolactin signal pathway, GnRH signaling pathway, neurotrophic factor signaling pathway and other pathway. The conclusion of this study is certain with the existing research results, and the new target and new pathway could also be used as a theoretical basis for the further verification of osteoporosis.
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Medicamentos de Ervas Chinesas/farmacologia , Osteoporose/tratamento farmacológico , Polypodiaceae/química , Humanos , Receptor Tipo 1 de Hormônio Paratireóideo/metabolismo , Receptor Tipo 2 de Hormônio Paratireóideo/metabolismo , Receptores da Calcitonina/metabolismo , Rizoma/química , Espectrina/metabolismoRESUMO
To evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of osteoporosis (OP). Eight Chinese and English databases were retrieved (from establishment to February 2017), and clinical trials were screened according to the preset inclusion criteria and exclusion criteria. Then risk assessment tools were used for quality evaluation of the studies, and data extraction and analysis were conducted by using RevMan 5.3 software for Meta-analysis. A total of 1 895 articles were retrieved, and finally 54 studies were included. The total sample number was 5 030, including 2 543 cases in experimental group and 2 487 cases in control group. As compared with CT (routine therapy) intervention, Xianling Gubao capsules showed higher SOP efficiency and improved bone mineral density in patients with OP [MD=0.08, 95%CI (0.06, 0.10)]. As compared with control group, Xianling Gubao capsule+CT showed higher efficiency in PMOP and SOP, increased bone mineral density in OP patients [MD=0.04, 95%CI (0.03, 0.05)], POP patients [MD=0.08, 95%CI (0.05, 0.10)], and SOP patients [MD=0.06, 95%CI (0.05, 0.07)], relieved osteoporotic pain in OP patients [MD=-0.93,95%CI(-1.16, -0.70), increased alkaline phosphatase level in OP patients [MD=7.53, 95%CI (5.91, 9.14), blood calcium in OP patients [MD=0.03, 95%CI (0.01, 0.06)], and osteocalcin level in OP patients [MD=4.09, 95%CI (3.20, 4.98)], and increased serum phosphorus level in SOP patients [MD=0.03, 95%CI (0.00, 0.05)]. The main adverse reactions reported were liver injury and gastrointestinal symptoms. Xianling Gubao capsule alone or combined use with other medicines had better efficacy than western medicine alone in the treatment of osteoporosis. However, because of potential bias in the included studies, more high-quality randomized controlled trials would be needed to improve the level of evidence.
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Medicamentos de Ervas Chinesas/uso terapêutico , Osteoporose/tratamento farmacológico , Fosfatase Alcalina/sangue , Densidade Óssea , Humanos , Osteocalcina/sangue , Fósforo/sangue , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
To systemically evaluate the safety of Xianling Gubao capsule after launching. Computer retrieval of Medline, EMbase, the Web of Science, Clinical Trials. gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM was conducted to collect information on all the research types of Xianling Gubao capsule. The literature was screened according to inclusion and exclusion criteria, and the quality of the studies was assessed according to the internationally accepted quality evaluation standards for data extraction and analysis. A total of 156 papers were included in this study, including 117 randomized control trials, 11 quasi-randomized control trials, 10 non-randomized control trials, 11 case report series, and 7 individual case reports; a total of 167 studies were analyzed. Xianling Gubao capsules were used in 7 496 patients, with an accumulative 377 cases of adverse reactions (ADR) and 4 cases of severe adverse reactions, including 1 death, 1 cerebrovascular accident, 1 case of skin allergy reaction, and 1 case of gastrointestinal discomfort; gastrointestinal system damage was most common in mild ADRs. In this study, we found that the overall safety of Xianling Gubao capsule was acceptable, but it lacked the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study, so the further studies on the safety of drug use should be conducted. Meanwhile, the application scope of Xianling Gubao capsules was beyond the manual, in urgent needs of the relevant departments to formulate norms and provide better guidance for clinical medication.
Assuntos
Medicamentos de Ervas Chinesas/efeitos adversos , Cápsulas , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
A randomized, double-blind, active parallel controlled trial will be conducted to include patients with acute upper respiratory infection and wind-warmth lung heat disease (heat in lung-wei pattern). Patients with serious bacterial infection (white blood cell count>1.2×1010, neutrophil>80%) will be excluded.so as to further identify Jinye Baidu Granule indications of Wind-warmth lung heat disease (heat in lung-wei pattern).According to the subjects of symptoms of fever and sore throats,Patients will be divided into three blocksï¼ fever, swelling and sore throat, combined fever and swelling and sore throat. Subjects in three blocks will be divided into treatment group and control group with stratified blocked randomization. The treatment group will be treated with Jinye Baidu Granule, and the control group will be treated with Fufang Shuanghua granule. Primary outcome measure of patients with fever will be body temperature recovery time. Primary outcome measure of patients with swelling and sore throat will be throat symptom score. Primary outcome measures of patients combined with fever and swelling and sore throat will be body temperature recovery time and throat symptom score. Before and after all of the patients in the group were collected blood and urine routine, liver and renal function, electrocardiogram (ECG) data as the safety index while observing it adverse events. A total of 623 patients were included. Compared with control group,sore throat symptoms of patients with sore throat and pharyngeal symptoms total score have significantly different. so Jinny Baidu granule have a significant advantage in the treatment of sore throat. All of the experiments showed that the safety of the drug was good. Nausea, vomiting, stomach pain, diarrhea, digestive tract symptoms may occur only occasionally. We should pay attention to the changes when using in patients with spleen deficiency cold to avoid adverse reaction.
Assuntos
Medicamentos de Ervas Chinesas/uso terapêutico , Febre/tratamento farmacológico , Faringite/tratamento farmacológico , Infecções Respiratórias/tratamento farmacológico , Método Duplo-Cego , HumanosRESUMO
This systematic review aims to evaluate the drug safety of sofren injection in clinical studies. Seven databases were retrieved, and the articles were extracted by 2 researchers according to inclusion and exclusion criteria. Then the quality of all studies and extracted information was evaluated. Sixty three articles were finally included in our study, including 58 randomized controlled trials, 3 non randomized controlled trials, and 2 case reports. All studies included 5 872 patients. Intervention group had a total of 23 cases of adverse drug reaction(ADR), accounting for 0.39% of the total number of patients. ADRs mainly included headache(6 cases), palpitations(4 cases) and dizziness(4 cases). ADRs mainly occurred in the nervous system, cardiovascular system, digestive system and so on. Serious adverse events about sofren injection have not been found in the study, but it is still needed to be cautious in clinical applications. As the current systematic review is based on the previous studies, it is necessary to strengthen the safety monitoring in a long period, and regulate its clinical use as well.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Medicamentos de Ervas Chinesas/uso terapêutico , Tontura , Medicamentos de Ervas Chinesas/efeitos adversos , Cefaleia , Humanos , Injeções , Ensaios Clínicos Controlados não Aleatórios como Assunto , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
This is a study based on hospital intensive monitoring to explore medication use of Diemailing Kudiezi injection(one Chinese herbal medicine injection) in real word in the patients with cerebral infarction. The active monitoring model was adopted and hospital intensive monitoring on safety of 7 189 cases of patients with cerebral infarction was conducted to obtain the drug use information of Diemailing injection. The results were analyzed by using statistical description and association rule method. The statistical description and association rule analysis were conducted based on patients' basic demographic characteristics, use of Diemailing injection and combined use of drugs. Sixty-two percent(4 437/7 189) of the patients were from traditional Chinese medicine hospitals as compared with 39%(2 752/7 189) from western medicine hospitals; 84%(6 003/7 189) of the patients were from tertiary hospitals as compared with 16%(1 186/7 189) from second-class hospitals. The hospitals were mostly located in north China. Drug related indicators such as a single dripping speed, stash time after allocating transfusion, duration of injection, and injecting room temperature were not noted in instruction manual. It was also found that there were off label use in the practice, for instance, non-intravenous infusion, >14 d treatment course, use of non-designated solvent, and a single dose>40 mL or<10 mL. Analysis of association rules showed that only Edaravone among the most frequent combined drugs was listed in the current guideline in China, and the other three most frequent combined drugs deproteinized calf blood extractive injection, Cinepazide Maleate injection and Alprostadil injection were used with little evidence. Diemailingï¼Aspirinï¼Alprostadil was the most common combined use in our study, but the recommended clopidogrelï¼Aspirin was not found in this study. The drug use situation of Diemailing injection in the real world was obtained by data analysis on large size samples, providing basic reference information for clinicians and researchers. However, efficacy was not concerned in this study, so efficacy-related information could not be explained.
Assuntos
Infarto Cerebral/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , China , Revisão de Uso de Medicamentos , Humanos , Injeções , Medicina Tradicional ChinesaRESUMO
Statement of the REporting of studies conducted using routinely collected data (RECORD) and evaluating checklist of good research for comparative effectiveness (GRACE) were translated and introduced in this paper. The two evaluation tools would help researchers of Chinese medicine to conduct real world study in future. RECORD statement focus on unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues. Researchers of comparative effectiveness research could refer to GRACE checklist. It was believed that researchers of Chinese medicines who were keen on real world studies would be benefited from the two tools.