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The present study conducted a systematic review and Meta-analysis on the efficacy and safety of Biyuan Tongqiao Granules in the treatment of chronic sinusitis. CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science were searched for randomized controlled trials(RCTs) of Biyuan Tongqiao Granules in the treatment of chronic sinusitis. The quality of the included RCTs was assessed according to the Cochrane risk-of-bias assessment tool and the final included trials underwent Meta-analysis with RevMan 5.4.1. Fifty-four RCTs were included, with a total sample size of 7 278 cases. The results of Meta-analysis showed that the clinical efficacy of Biyuan Tongqiao Granules alone or in combination in the experimental group in the treatment of chronic sinusitis was superior to that in the control group with conventional western medicine, Chinese medicinal preparations, or surgery only(RR=1.19, 95%CI[1.15, 1.24], P<0.000 01). The combined use of Biyuan Tongqiao Granules on the basis of the control group was superior to the control group in improving the main symptoms and signs of chronic sinusitis [RR_(nasal congestion)=1.33, 95%CI[1.21, 1.45], P<0.000 01, RR_(runny nose)=1.28, 95%CI[1.18, 1.40], P<0.000 01, RR_(turbinate congestion or swelling)=1.28, 95%CI[1.16, 1.41], P<0.000 01]. Biyuan Tongqiao Granules alone or in combination could effectively reduce the Snot-20 score, which was superior to the control group(MD=-2.94, 95%CI[-3.60,-2.28], P<0.000 01). Biyuan Tongqiao Granules alone and in combination could effectively reduce the VAS score, which was superior to the control group(MD_(total score)=-4.44, 95%CI[-6.05,-2.82], P<0.000 01; MD_(nasal congestion VAS score)=-0.99, 95%CI[-1.38,-0.60], P<0.000 01; MD_(runny nose VAS score)=-1.19, 95%CI[-1.62,-0.76], P<0.000 01; MD_(dysosmia VAS score)=-0.96, 95%CI[-1.26,-0.65], P<0.000 01; MD_(head and face pain VAS score)=-0.73, 95%CI[-0.98,-0.47], P<0.000 01). The combined use of Biyuan Tongqiao Granules could effectively reduce the sinus CT score and the Lund-Mackey score of the endoscopic mucosal morphology(MD_(sinus CT score)=-3.68, 95%CI[-5.47,-1.88], P<0.000 1, MD_(endoscopic mucosal morphology score)=-3.06, 95%CI[-5.53,-0.59], P=0.02). Compared with the control group with conventional western medicine, Chinese medicinal preparations, or surgery only, combined use of Biyuan Tongqiao Granules did not increase the occurrence of adverse reactions(RR=0.68, 95%CI[0.26, 1.77], P=0.43). As demonstrated by the existing evidence, Biyuan Tongqiao Granules can improve the clinical efficacy of chronic sinusitis, relieve the clinical symptoms and signs, and reduce the Snot-20 score, VAS score, and Lund-Mackey score, without inducing serious adverse reactions, indicating that Biyuan Tongqiao Granules alone or in combination are more effective and safe in the treatment of chronic sinusitis than conventional western medicine, Chinese medicinal preparations, or surgical treatment. Since the quality of the included trials was generally low, large-scale, high-quality, rigorous, multi-center, and blinded-designed RCTs that meet international standards should be adopted in the future to increase the strength and level of evidence.
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Medicamentos de Ervas Chinesas , Sinusite , Doença Crônica , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Rinorreia , Sinusite/induzido quimicamente , Sinusite/tratamento farmacológico , Resultado do TratamentoRESUMO
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.
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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
Background: Osteoporosis (OP) patients are usually asymptomatic until osteoporotic fractures occur, which makes early diagnosis and prevention difficult, and the associated fractures secondary to OP could be preventable with appropriate management. Therefore, early identification and relevant evidence-based management of OP could guide the prevention of subsequent fractures. This study will investigate the prevalence of OP and the incidence of osteoporotic fractures in Beijing community residents to further explore the related risk factors and put forward suggestions for people aged 45-80 years old. Methods: Over 2 years, this study will conduct an OP screening and a prospective follow-up in the Beijing community to investigate the incidence of osteoporotic fractures. The study will undertake bone mineral density detection, collect biological samples, and record information via questionnaires. Discussion: The study aims to investigate the potential risk factors for osteoporosis and explore syndromes from traditional Chinese medicine that are associated with this condition based on large samples from the Beijing community. Data on the incidence of osteoporotic fractures among community dwellers in Beijing over the two-years will be available on the Chinese clinical trial registry: ChiCTR-SOC-17013090.
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The coronavirus disease 2019 (COVID-19) epidemic has been almost controlled in China under a series of policies, including "early diagnosis and early treatment". This study aimed to explore the association between early treatment with Qingfei Paidu decoction (QFPDD) and favorable clinical outcomes. In this retrospective multicenter study, we included 782 patients (males, 56 %; median age 46) with confirmed COVID-19 from 54 hospitals in nine provinces of China, who were divided into four groups according to the treatment initiation time from the first date of onset of symptoms to the date of starting treatment with QFPDD. The primary outcome was time to recovery; days of viral shedding, duration of hospital stay, and course of the disease were also analyzed. Compared with treatment initiated after 3 weeks, early treatment with QFPDD after less than 1 week, 1-2 weeks, or 2-3 weeks had a higher likelihood of recovery, with adjusted hazard ratio (HR) (95 % confidence interval [CI]) of 3.81 (2.65-5.48), 2.63 (1.86-3.73), and 1.92 (1.34-2.75), respectively. The median course of the disease decreased from 34 days to 24 days, 21 days, and 18 days when treatment was administered early by a week (P < 0.0001). Treatment within a week was related to a decrease by 1-4 days in the median duration of hospital stay compared with late treatment (P<0.0001). In conclusion, early treatment with QFPDD may serve as an effective strategy in controlling the epidemic, as early treatment with QFPDD was associated with favorable outcomes, including faster recovery, shorter time to viral shedding, and a shorter duration of hospital stay. However, further multicenter, prospective studies with a larger sample size should be conducted to confirm the benefits of early treatment with QFPDD.
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Tratamento Farmacológico da COVID-19 , Medicamentos de Ervas Chinesas/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , China , Estudos de Coortes , Feminino , Seguimentos , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Tempo para o Tratamento , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: To investigate the relevance ratio of osteoporosis and bone mass of middle aged and elderly people in Beijing communities, in order to understand occurrence and development trend of abnormality of bone mass in high-risk population from community. METHODS: Based on the method of cross-sectional investigation, the information data of 1 540 middle-aged and elderly people from 10 communities were collected, including 415 males and 1 125 females, aged from 45 to 80 years old with the average of (63.02±7.15) years old; the height was (161.34±7.24) cm, the weight was (65.90±10.19) kg, body mass index was (25.29±3.32) kg /m2. Bone mineral density (BMD) of lumbar vertebrae (L1-L4) and both hips were measured by dual energy X ray absorptiometry (DEXA). The differences of bone mineral density and bone mass in different age groups were evaluated, and the relevance ratio of osteoporosis in different parts of the subjects was calculated. Elbow venous blood was collected on an empty stomach, and the gender differences of serum bone metabolic markers were detected and compared. RESULTS: The level of ß-CTX was(0.27±0.12) ng /ml, procollanen type 1 N-terminal propeptide(P1NP) was(51.03± 22.36) ng /ml, 25(OH) D3 was (16.68±6.24) ng /ml, serum calcium was(2.34±0.09) mmol / L, blood phosphorus was (1.43± 0.37) mmol / L, and blood magnesium was (0.94±0.07) mmol / L, alkaline phosphatase was (79.28±20.48) U/ L, parathyroid hormone was (3.09±1.60) pmol / L, osteocalcin was (13.29±6.65) ng /ml. Except for blood magnesium, the other indexes had significant differences between different sex groups(P<0.05). Results of T value of bone mineral density and level of bone mass showed that bone mineral density of lumbar vertebrae and both hips fluctuated and decreased with the increase of age, and there were significant differences in level of bone mass among different age groups in women(P<0.05), and except lumbar vertebrae in males, there were significant differences in other parts of bone mass among different age groups (P<0.05). The relevance ratio of lumbar osteoporosis, left hip osteoporosis, and right hip osteoporosis was 27.89%, 14.80% and 14.47%, respectively. CONCLUSION: There are obvious differences in relevance ratio of osteoporosis and low bone mass among different sites. It is suggested that the clinical diagnosis of osteoporosis should be combined with bone mineral density and bone metabolic markers. With the increasing prevalence of osteoporosis among middle aged and elderly people in Beijing community, continuous follow-up research based on community primary health care units could promote early examination, early diagnosis, and early treatment of middle aged and elderly people at high risk of osteoporosis in community.
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Densidade Óssea , Osteoporose , Absorciometria de Fóton , Idoso , Idoso de 80 Anos ou mais , Pequim/epidemiologia , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteoporose/epidemiologiaRESUMO
Lanqin Oral Liquid is a Chinese patent medicine which contains Isatidis Radix, Scutellariae Radix, Gardeniae Fructus, Phellodendri Chinensis Cordex and Sterculiae Lychophorae Semen. It is known for the pharmaceutical effect on the upper respiratory tract infection as it is beneficial for relieving the swelling of pharyngeal. In terms of Chinese medicine, it offers a clearing action on heat and toxic materials. According to the principle of Chinese medicine, different diseases can be treated by the same therapy as long as they have the same syndrome. Based on this unique diagnosis and treatment approach, Lanqin Oral Liquid was applicable to diseases with syndrome of excessive heat in lung and stomach. It was therefore commonly be used in the therapeutic approach towards hand, foot and mouth disease as well. However, no systematic evaluation had yet been done to verify this Chinese patent medicine on the efficacy and clinical safety for the disease. In order to achieve the manner of evidence-based medicine, this study had adopted a systematic review and Meta-analysis to evaluate the efficacy and safety of Lanqin Oral Liquid in the treatment of hand, foot and mouth disease. All related randomized controlled trials(RCT) were searched in the following data bases: CNKI, WanFang, VIP, SinoMed, Cochrane Library and PubMed. Based on the method provided by the Cochrane collaboration, the study assessed the quality of papers selected and RevMan 5.3 software was used to perform Meta-analysis. Totally 24 studies were included with 3 491 sample size, which 1 826 cases were treatment group and 1 665 cases were control group. From the results of Meta-analysis, the total effective rate of combination of Lanqin Oral Liquid and Western medicines shown better than Western medicine alone in the treatment for hand, foot and mouth di-sease, but mild adverse event were also found(RR=1.20,95%CI[1.16,1.23],P<0.000 01). Incidence of adverse reaction between experimental and control group was statistically insignificant(RR=1.16, 95%CI[0.79, 1.70], P=0.45). No conclusion was able to made in terms of the remission time of clinical symptoms, as the studies included were not qualified for Meta-analysis. As a matter of fact, the number of existing studies related to the Lanqin Oral Liquid were limited with poor quality as well. In other words, high quality studies were essential to further evaluate the efficacy and safety of Lanqin Oral Liquid.
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Medicamentos de Ervas Chinesas , Doença de Mão, Pé e Boca , Medicina Tradicional do Leste Asiático , Humanos , Medicamentos sem Prescrição , Projetos de PesquisaRESUMO
This study aimed to systematically evaluate the efficacy and safety of Breviscapine Injection in the treatment of diabetic nephropathy( DN). Eight electronic databases and Clinical Trials.gov were searched to collect randomized controlled trials on Breviscapine Injection in the treatment of DN. According to the Cochrane Handbook 5. 1,two independent reviewers screened out the literatures,extracted data and assessed the quality of the studies included. Rev Man5. 3 software was used for the data analysis. A total of 29 studies containing 37 trials were included,involving 2 097 patients,1 054 cases in test groups and 1 043 cases in control groups. The clinical studies included had a low overall quality. According to Meta-analysis: â Conventional therapy plus breviscapine injection was superior to conventional therapy in total efficiency rate,24 h UTP,SCR,BUN,UEAR,ALB and m ALB during DN stage â ¢( RRtotal effective rate=1. 60,95%CI [1. 32,1. 93],P<0. 000 01; SMD24 h UTP=-1. 21,95%CI[-1. 56,-0. 87],P<0. 000 01; MDSCR=-6. 33,95%CI[-9. 20,-3. 46],P<0. 000 1; MDBUN=-6. 6,95%CI[-1. 10,-0. 22],P = 0. 003; MDUEAR=-20. 30,95%CI [-28. 14,-12. 46],P<0. 000 01; MDALB= 0. 47,95%CI[0. 42,0. 52],P<0. 000 01; MDmALB=-10. 03,95%CI[-10. 62,-9. 46],P<0. 000 01). â¡Conventional therapy plus Breviscapine Injection was better than conventional therapy in total efficiency rate( only 1 study),24 h UTP,SCR and BUN during DN stage â £( RRtotal effective rate= 1. 57,95% CI[1. 10,2. 25],P = 0. 01; SMD24 h UTP=-0. 52,95% CI [-0. 71,-0. 33],P<0. 000 01; MDSCR=-35. 38,95%CI[-48. 57,-22. 19],P<0. 000 01; MDBUN=-1. 89,95%CI [-3. 01,-0. 77],P<0. 000 01). â¢Conventional therapy plus Breviscapine Injection was better than conventional therapy in SCR( MD =-26. 35,95% CI[-47. 45,-5. 24],P= 0. 01),but with no significant difference in 24 h UTP,BUN and ALB during DN stageâ ¤. â£It was impossible to obtain the specific judgment information on the adverse reactions of Breviscapine Injection in the treatment of the disease from the existing evidences. The current evidences suggest that the combination of Breviscapine Injection and conventional therapy had a certain curative effect in the treatment of DN,especially in stages â ¢ and â £. The safety of Breviscapine Injection needs to be further explored.Because the low quality of the study impacted the accuracy of the result,more rigorous,high-quality,multi-center,randomized doubleblind controlled trials are required to increase the support of the evidences in the future.
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Nefropatias Diabéticas , Quimioterapia Combinada , Flavonoides , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
To systematically review the effectiveness and safety of Kudiezi Injection in treating patients with acute cerebral infarction( ACI). Four Chinese databases( CNKI,VIP,Wan Fang,Sino Med),three English databases( Cochrane Library,EMbase,Medline)and Clinical Trail.gov were systematically and comprehensively retrieved. The retrieval time was from the establishment of each database to November 2017. Randomized controlled trials( RCTs) for the treatment of acute cerebral infarction with Kudiezi Injection were screened out according to pre-established inclusion criteria and exclusion criteria. The quality of the included studies was assessed using the Cochrane Risk Assessment Tool,and the included studies were put into descriptive analysis or Meta-analysis using the Rev Man 5. 3 software. A total of 932 articles were retrieved,and finally 14 studies were included. Except for 2 multi-arm trials,the total sample size was 1 244 in the experimental group and 638 in the control group. The overall quality of the included studies was not high. The results of Meta-analysis showed that Kudiezi + conventional therapy for acute cerebral infarction was superior to conventional therapy in total effective rate( RR = 0. 86,95% CI[0. 77,0. 96],P = 0. 006); Kudiezi + conventional therapy for acute cerebral infarction was superior to conventional therapy in serum inflammatory factors( MDhs-CRP=-3. 77,95% CI[-4. 17,-3. 37],P < 0. 000 01; MDIL-18=-16. 18,95% CI[-19. 26,-13. 11],P<0. 000 01); Kudiezi + conventional therapy was superior to conventional therapy in Barthel index( MD = 12. 52,95%CI[8. 93,16. 10],P<0. 000 01). Adverse reactions included in the study reports showed mild adverse reactions. Based on the results of this study,Kudiezi Injection combined with conventional therapy or other Western medicine had a certain curative effect on acute cerebral infarction,with no serious adverse reactions. However,due to the low quality of the included research methodology,the conclusions of this study were not recommended. In addition,in order to produce high-quality evidence for the clinical application of Kudiezi Injections,more randomized controlled trials with a large sample size,scientific design and strict implementation were required to study the effectiveness and safety of Kudiezi Injection in the treatment of cerebral infarction.
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Infarto Cerebral/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Injeções , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
To systematically evaluate the efficacy and safety of breviscapine injection in the treatment of unstable angina pectoris (UAP). Eight electronic databases and clinical trials registries were searched to collect randomized controlled trials on breviscapine injection in the treatment of UAP. According to the evaluation standards in Cochrane Handbook 5.1, two independent reviewers screened out the literature, extracted data and assessed the quality of the studies included. RevMan 5.3 software was used for Meta quantitative analysis and corresponding description analysis. A total of 36 studies involving 3 058 patients were included, 1 552 cases in the trial group, 1 506 cases in the control group, 1 846 males and 1 212 females. All the clinical studies showed a low quality. Meta-analysis results showed that the combination of breviscapine injection and conventional therapy was superior to conventional therapy in angina pectoris efficacy (RRangina pectoris efficacy=1.29, 95%CI[1.23,1.35],P<0.000 01ï¼RRECG1=1.25,95%CI[1.12,1.38],P<0.000 1ï¼RRECG2=1.38,95%CI[1.27,1.49],P<0.000 01); descriptive analysis of a single study showed that the efficacy of combination of breviscapine injection and conventional therapy was superior to that of conventional therapy alone. In respect of hemorheology, the combination of breviscapine injection and conventional therapy was better than conventional therapy in lowering LBV and EAI (MDLBV=-1.27,95%CI[-1.55,-0.99],P<0.000 01ï¼MDEAI=-0.38,95%CI[-0.60,-0.16],P=0.000 6), as well as in lowering WBV and HCT in the descriptive analysis of single study. In respect of blood lipid, the combination of breviscapine injection and conventional therapy was better than conventional therapy in lowering TC, TG and LDL-C (MDTC=-0.30,95%CI[-0.51,-0.10],P=0.003ï¼MDTG=-0.32,95%CI[-0.77,0.13],P=0.16ï¼MDLDL-C=-0.45,95%CI[-0.76,-0.14],P=0.004). In reducing the frequency of angina attacks, heart rate, high sensitive C-reactive protein and improving exercise tolerance, the combination of breviscapine injection and conventional therapy was also superior to the conventional therapy alone (MDFAP=-3.30,95%CI[-4.06,-2.54],P< 0.000 01ï¼MDHR=-9.38,95%CI[-12.78,-5.98],P=0.000 2ï¼MDhs-CRP=-0.56,95%CI[-0.85,-0.27],P=0.000 2ï¼MDET=0.88,95%CI[0.41,1.35],P=0.000 2). The main adverse reactions in the two groups included headache, dizziness, palpitations, nausea, abdominal distension, skin pruritus, flushes and allergic reactions in the study. The safety of breviscapine injection needs to be further studied and clarified because of the combination of drugs and the incomplete information reported in the original study. The current evidence suggested that the combination of breviscapine injection and conventional therapy had certain advantages in curative effect for the treatment of UAP. Due to the low quality of the study and its own shortcomings, it is necessary to design more rigorous, high-quality, multi-center randomized double-blind controlled trials to increase the strength of the evidence.
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Angina Pectoris/tratamento farmacológico , Angina Instável/tratamento farmacológico , Flavonoides/farmacologia , Feminino , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
To evaluate the effectiveness and safety of Kudiezi injection in the treatment of angina pectoris of coronary heart disease. Four Chinese databases (CNKI, VIP, WanFang, and SinoMed) and three English databases (Cochrane Library, Medline, and ClinicalTrail.gov) were systematically and comprehensively searched from the establishment of each database to March 2018. Randomized controlled trials (RCTs) on the treatment of angina pectoris of coronary heart disease with Kudiezi injection (KDZ) were screened according to the pre-established inclusion criteria and exclusion criteria. The quality of the included studies was evaluated by using the ROB tool developed by the Cochrane Collaboration, and RevMan 5.3 software was used for Meta-analysis. A total of 712 articles were retrieved and finally 38 studies were included. The total sample size was 3 812 cases, 1 945 in the experimental group and 1 867 in the control group. The overall quality of the included studies was generally low. The results of Meta-analysis showed that: KDZ combined with conventional or western medicine was superior to conventional or western medicine alone in the effectiveness and electrocardiogram efficacy of angina pectoris and unstable angina. The descriptive analysis showed that KDZ combined with conventional treatment group was superior to conventional treatment group in agina pectoris associated indicators of angina pectoris and unstable angina. Other outcome measures were easily affected by various factors (such as too large heterogeneity of outcome indicators) and could not be concluded. Adverse reactions included in the study report were all mild adverse reactions and did not affect treatment. Based on the results of this study, it can be seen that Kudiezi injection had a certain effect on the treatment of angina pectoris of coronary heart disease, especially with significant positive effect on the improvement of the curative effect for angina pectoris and the effect of electrocardiogram. No serious adverse reactions occurred. However, due to the limited number of studies included, the generally low quality of the included studies, and the existence of published biases, the quality of the evidence in this study was low, so that caution should be taken to apply this conclusion. The effectiveness and safety of Kudiezi injection in the treatment of angina pectoris of coronary heart disease remained to be confirmed in the future with a well-designed and rigorous multi-center randomized controlled trials with standardized report, large sample, and enough follow-up time.
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Angina Pectoris/tratamento farmacológico , Angina Instável/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Coração , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
To evaluate the methodological quality and reporting quality of randomized controlled trials(RCTs) published in China Journal of Chinese Materia Medica, we searched CNKI and China Journal of Chinese Materia webpage to collect RCTs since the establishment of the magazine. The Cochrane risk of bias assessment tool was used to evaluate the methodological quality of RCTs. The CONSORT 2010 list was adopted as reporting quality evaluating tool. Finally, 184 RCTs were included and evaluated methodologically, of which 97 RCTs were evaluated with reporting quality. For the methodological evaluating, 62 trials(33.70%) reported the random sequence generation; 9(4.89%) trials reported the allocation concealment; 25(13.59%) trials adopted the method of blinding; 30(16.30%) trials reported the number of patients withdrawing, dropping out and those lost to follow-up;2 trials ï¼1.09%ï¼ reported trial registration and none of the trial reported the trial protocol; only 8(4.35%) trials reported the sample size estimation in details. For reporting quality appraising, 3 reporting items of 25 items were evaluated with high-quality,including: abstract, participants qualified criteria, and statistical methods; 4 reporting items with medium-quality, including purpose, intervention, random sequence method, and data collection of sites and locations; 9 items with low-quality reporting items including title, backgrounds, random sequence types, allocation concealment, blindness, recruitment of subjects, baseline data, harms, and funding;the rest of items were of extremely low quality(the compliance rate of reporting item<10%). On the whole, the methodological and reporting quality of RCTs published in the magazine are generally low. Further improvement in both methodological and reporting quality for RCTs of traditional Chinese medicine are warranted. It is recommended that the international standards and procedures for RCT design should be strictly followed to conduct high-quality trials. At the same time, in order to improve the reporting quality of randomized controlled trials, CONSORT standards should be adopted in the preparation of research reports and submissions.
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Materia Medica , Publicações , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , China , Humanos , Medicina Tradicional ChinesaRESUMO
To systematically evaluate the effectiveness and safety of Kuhuang injection in treating viral hepatitis. Eight electronic databases and clinic trials were searched to collect randomized controlled trials for the effect of Kuhuang injection in the treatment of viral hepatitis. According to the Cochrane Handbook 5.1, two independent reviewers screened out the literatures, extracted data and assessed the quality of thestudies included. RevMan5.3 software was used for the data analysis. A total of 32 articles were included, involving 3 188 patients, including male 1 951 cases (61.2%), female 859 cases (26.9%), and 378 cases of unknown sex (11.9%). All the clinical studies showed a low quality. Due to the complication of diseases and difficulty in intervention measures, most trails were classified by the condition of diseases, and then a descriptive analysis was made. The results showed that the test group was better than the control group in total efficiency of treating severe icteric viral hepatitis, and the test group was advantageous over the control group in jaundice removal and liver function recovery rate in treating icteric hepatitis. In the Meta-analysis on the RCTs for icteric viral hepatitis, the total efficiency of Kuhuang injection + comprehensive treatment group was higher than that of the comprehensive treatment group ï¼RR=1.35, 95%CI=[1.10,1.66], P=0.61ï¼. In addition, when Kuhuang injection was dripped too fast, patients had such adverse reactionsas dizziness, palpitation, nausea, vomiting and skin rash, which could be relieved at a lower dripping speed.Based on the existing evidences, Kuhuang injection had a certain effect in treating viral hepatitis. Most clinic trails did not include viral hepatitis etiology, clinical classification and diversified intervention measures, which resulted in a high clinical heterogeneity and poor comparability between trails. Besides, most trials had a low methodological quality, which affected the authenticity of the results. Therefore, more high-quality, multi-center, large-sample, randomized double-blind controlled trialsarerequired to prove the evidences.
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Medicamentos de Ervas Chinesas/uso terapêutico , Hepatite Viral Humana/tratamento farmacológico , Humanos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
This study is aimed to identify and assess the methodological quality of community-acquired pneumonia (CAP) clinical practice guidelines (CPG) in China by using AGREE â ¡ tool. CNKI, SinoMed, Wanfang, and VIP Chinese databases from database establishment to March 2017 were searched by manual retrieval to collect all the clinical practice guidelines prepared by various associations or organizations, then AGREE â ¡tool was used to assess them. Data in each CPG were analyzed in terms of six domains, including scope and purpose, participants, rigor, clarity and readability, applicability and editorial independence. A total of 4 CPGs were included. The results showed that the scope and purpose scored 45.8%; the clarity of expression scored 44.75%; the participants scored 31.9%; the rigor scored 18.98%; the applicability scored 7%; and finally the editorial independence scored 1%. It is concluded that the quality of applicability and the editorial independence should attained paid more attention in future development or updating of the guidelines. In addition to strengthening the compliance with international general principles, we should also pay attention to the characteristics of traditional Chinese medicine treatment, especially the related evidences as complementary and alternative treatment for western intervention measures.
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Infecções Comunitárias Adquiridas/terapia , Pneumonia/terapia , Guias de Prática Clínica como Assunto , China , Infecções Comunitárias Adquiridas/diagnóstico , Humanos , Medicina Tradicional Chinesa , Pneumonia/diagnósticoRESUMO
To analyze the regularity in combined medication with Xiyanping injection (Xiyanping for short) in the real world by as- sociation rules. Totally 5 822 patients using Xiyanping injection was collected from the 18 Class III Grade I hospitals nationwide to study the combined medication information of the patient with lung infection and make the analysis by using association rules and Apriori. According to the results, major drugs combined with Xiyanping in treatment of lung infection included compound amino acid, inosine, coenzyme A, cytidine triphosphate, vitamin C. Common drugs combined with Xiyanping can be divided into 5 categories: nutrition support therapy (vitamin C, compound amino acid) , coenzymes (coenzyme A, cytidine triphosphate, inosine), expectorants and antiasthmatics (ambroxol, salbutamol, doxofylline), hormones (dexamethasone, budesonide), antibiotics (mainly cefminox). The main combined medicines mostly conformed to the regularity for drugs treating lung infection. In addition, there were two most common medical combination models: the model for Xiyanping combined a single medicine is Xiyanping + nutrition support therapy, while the model for Xiyanping combined two or more than two medicines is Xiyanping + nutrition support therapy + coenzyme. Pharmacologically, Xiyanping is mostly combined with western medicines with similar pharmacological effects to substitute or supplement the antibiotic effect in treating lung infection. However, further studies shall be conducted for the safety and rationality of the combined medication based on clinical practices, in order to provide reference for clinical medication.
Assuntos
Quimioterapia Combinada , Medicamentos de Ervas Chinesas/administração & dosagem , Pneumopatias/tratamento farmacológico , Adulto , Antibacterianos/administração & dosagem , Ácido Ascórbico/administração & dosagem , Cefamicinas/administração & dosagem , Feminino , Sistemas de Informação Hospitalar , Humanos , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
OBJECTIVE: To estimate treatment effects of Shuxuetong injection on abnormal changes on ALT index, that is, to explore whether the Shuxuetong injection harms liver function in clinical settings and to provide clinical guidance for its safe application. METHOD: Clinical information of traditional Chinese medicine (TCM) injections is gathered from hospital information system (HIS) of eighteen general hospitals. This is a retrospective cohort study, using abnormal changes in ALT index as an outcome. A large number of confounding biases are taken into account through the generalized boosted models (GBM) and multiple logistic regression model (MLRM) to estimate the treatment effects of Shuxuetong injections on abnormal changes in ALT index and to explore possible influencing factors. RESULT: The advantages and process of application of GBM has been demonstrated with examples which eliminate the biases from most confounding variables between groups. This serves to modify the estimation of treatment effects of Shuxuetong injection on ALT index making the results more reliable. CONCLUSION: Based on large scale clinical observational data from HIS database, significant effects of Shuxuetong injection on abnormal changes in ALT have not been found.
Assuntos
Alanina Transaminase/metabolismo , Medicamentos de Ervas Chinesas/administração & dosagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Tratamento Farmacológico , Medicamentos de Ervas Chinesas/efeitos adversos , Feminino , Sistemas de Informação Hospitalar/estatística & dados numéricos , Humanos , Fígado/efeitos dos fármacos , Fígado/enzimologia , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Pragmáticos como Assunto , Pontuação de Propensão , Estudos Retrospectivos , Adulto JovemRESUMO
OBJECTIVE: To estimate real world treatment effects of parenterally administered Shuxuetong on abnormal changes in blood urea nitrogen (BUN) index, inorder to to explore whether parenterally administered Shuxuetong affects kidney function and to provide clinical guidance for its safe application. METHOD: Analyze hospital information system (HIS) data and laboratory information management system (LIS) data from 18 nationawide general hospitals in China. A retrospective cohort study with two cohorts of patients, assessing abnormal changes of BUN index as an outcome, confounding factors are balanced through use of generalized boosted models (GBM) and multiple logistic regression based on adjusted propensity score to estimate treatment effects of parenterally administered Shuxuetong on abnormal changes of BUN index and to explore possible influencing factors. RESULT: Logistic regression based on adjusted propensity score results showed that there was a statistically significant difference (P < 0.05), in abnormal BUN in rates between the two groups. However, the GBM propensity score method showed that abnormal BUN rates were not statistically significantly different between the two groups. CONCLUSIONS: Based on large sample clinical observational data from HIS and LIS database, significant effects of parenterally administered Shuxuetong on abnormal changes of BUN have not been found. The generalized boosted models (GBM) method is more suitable for retrospective non-randomized observational data. These results should be confirmed through largescale prospective randomized controlled trials.
Assuntos
Medicamentos de Ervas Chinesas/efeitos adversos , Sistemas de Informação Hospitalar/estatística & dados numéricos , Ureia/sangue , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Nitrogênio da Ureia Sanguínea , China , Medicamentos de Ervas Chinesas/administração & dosagem , Feminino , Humanos , Infusões Parenterais , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Pragmáticos como Assunto , Estudos Retrospectivos , Adulto JovemRESUMO
OBJECTIVE: Hospital information system data of cerebral infaction patients who received parenterally administered Shuxuetong was analyzed. This provided frequency data regarding patients' conditions and related information in order to provide a clinical reference guide. METHOD: In this study, HIS data from 18 hospitals was analyzed. Patients receiving parenterally administered Shuxuetong for the treatment of cerebral infarction were included. Information on age, gender, costsand route of administration were collated. RESULT: The average age of patients was 66 years old. Days of hospitalization ranged from 15 to 28 days. The majority of patients were classified as having phlegm and blood stasis syndrome, which is inaccordance with the indications for this drug. The most commonly used drugs used in combination with parenterally administered Shuxuetong were: aspirin, insulin and heparin. CONCLUSION: Patients with cerebral infarction crowd using parenterally administered Shuxuetong were a mostly elderly population, with an average age of 66. Although generally use was in accordance with indications, dosage, and route of administration, there were however some discrepancies. Therefore, doctors need to pay close attention to guidelines and closely observe patients when using parenterally administered Shuxuetong and to consider both the clinical benefits and risks.
Assuntos
Infarto Cerebral/tratamento farmacológico , Medicamentos de Ervas Chinesas/administração & dosagem , Sistemas de Informação Hospitalar/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Aspirina/uso terapêutico , Criança , Quimioterapia Combinada , Feminino , Heparina/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde , Ensaios Clínicos Pragmáticos como Assunto , Adulto JovemRESUMO
OBJECTIVE: In order to find out the condition of patients who used the Shuxuetong injection and provide reference and guidance for clinical practice, we analyzed the data of related indicators in patients in the HIS based of the frequency analysis methods. METHOD: In this study, we selected the hospitalized patient information in 20 hospital information systems (HIS). Reference to the integrated data warehouse build mode, including some information such as age, gender, cost categories of patients, route of administration etc. RESULT: The average age of patients are 59-years-old , 56-years-old age and 71-years-old age are the two high peaks during the age distribution. Patients covered by health insurance accounted for 75.8%; Intravenous infusion in patients accounted for 95.76%; Patient are also diagnosed as cardiovascular and cerebrovascular diseases, such as hypertension, cerebral infarction, coronary heart diseas, combined with other medicines such as aspirin, insulin, heparin etc. CONCLUSION: Crowd using Shuxuetong injection mostly in the elderly population, most patients covered by health insurance, the route of administration conforms instructions basically, please attention the benefits and risks of the patients in the clinical practice.
Assuntos
Tratamento Farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Avaliação de Resultados em Cuidados de Saúde , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Pré-Escolar , Ensaios Clínicos como Assunto , Medicamentos de Ervas Chinesas/administração & dosagem , Feminino , Sistemas de Informação Hospitalar , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
The adverse reactions caused by the traditional Chinese medicine has become increasingly aroused great attention. Traditional Chinese medicine injection may produce insoluble particles in the process of production, preparation and infusion, which is one of the reasons caused some adverse drug reactions such as phlebitis, allergic reactions, so it is essential that how to control Chinese medicine injection of insoluble drug particles enter human clinical safety. The author retrieve a large number of paper, from the infusion of particles, analysis traditional Chinese medicine injection and insoluble particles in the liquid compatibility increased occurrence and cause, comparative advantages and disadvantages of the ordinary infusion and precision infusion, which found that using sophisticated filters infusion of traditional Chinese medicine injection control of traditional Chinese medicine injection of insoluble particles enter the blood vessels, thereby reducing the occurrence of adverse drug reactions part of the traditional Chinese medicine injection, is the best, most effective, most secure way of infusion.