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1.
Article in Chinese | WPRIM | ID: wpr-879194

ABSTRACT

The aim of the research was to evaluate the efficacy and safety associated with Shexiang Tongxin Dropping Pills combined with conventional therapy for patients with coronary heart disease(CHD). We searched 8 electronic databases up to November 2020, including PubMed, Cochrane Library, EMbase, Web of Science, CNKI, Wanfang, VIP and SinoMed. Eligible studies were clinical trials of Shexiang Tongxin Dropping Pills combined with conventional therapy used in the treatment of coronary heart disease(CHD). The Meta-analysis was performed using STATA 15 software. A total of 21 RCTs(n=2 186) were shortlisted for the Meta-analysis. The results of efficacy evaluation showed that the total effective rate of Shexiang Tongxin Dropping Pills combined with conventional therapy was higher than that of conventional therapy of coronary heart disease(RR=1.20, 95%CI[1.15, 1.26], Z=8.63, P<0.001). Furthermore, Shexiang Tongxin Dripping Pills combined with conventional therapy had better effect on electrocardiogram efficacy(RR=1.24, 95%CI[1.16, 1.34], Z=5.98, P<0.001) and the number of angina attacks(SMD=-2.30, 95%CI[-3.47,-1.14], Z=3.88, P<0.001), the duration of angina attack(SMD=-2.31, 95%CI[-3.07,-1.55], Z=5.97, P<0.001), with lower levels of LDL-C(SMD=-0.73, 95%CI[-1.32,-0.14], Z=2.42, P=0.016), TC(SMD=-1.16, 95%CI[-1.35,-0.96], Z=11.56, P<0.001) and TG(SMD=-0.87, 95%CI[-1.06,-0.68], Z=8.97, P<0.001), and higher levels of HDL-C(SMD=0.87, 95%CI[0.02, 1.71], Z=2.00, P=0.045). The results of safety evaluation showed that the incidence of adverse reactions of Shexiang Tongxin Dropping Pills combined with conventional therapy was lower than that of conventional therapy of coronary heart disease(RR=0.45, 95%CI[0.22, 0.91], Z=2.23, P=0.026). There were significant differences in the above outcome indexes between the two groups. After the Harbord method test, the total effective rate outcome index has publication bias, but the sensitivity analysis of the cut-and-fill method suggested that the result was stable. In general, limited by the quantity and quality of included literature, more high-quality studies are needed to further verify the conclusions of this study.


Subject(s)
Angina Pectoris , Coronary Disease/drug therapy , Drugs, Chinese Herbal/adverse effects , Electrocardiography , Humans
2.
Article in Chinese | WPRIM | ID: wpr-879193

ABSTRACT

To systemically evaluate the efficacy and safety of Gingko Ketone Ester Dropping Pills in treating angina pectoris and co-ronary heart disease. CNKI, Wanfang, SinoMed, PubMed, Cochrane Library and EMbase databases were retrieved on computer, and the randomized clinical trial(RCT) on Gingko Ketone Ester Dropping Pills in treating angina pectoris and coronary heart disease, which were published from the database establishment to December 31, 2019, were comprehensively collected. Literature screening, data extraction and quality evaluation were conducted independently by two researchers according to inclusion and exclusion criteria. Literature methodology quality evaluation was conducted with use of the Cochrane Handbook 5.3.0(bias risk assessment tool). Meta-analysis was performed with RevMan 5.3.0 software. A total of 10 RCTs were included. The results of the Meta-analysis showed that as compared with conventional Western medicine alone, the application of Gingko Ketone Ester Dropping Pills combined with conventional Western medicine treatment further improved the total effective rate and electrocardiogram effect(RR=1.43,95%CI[1.20,1.71],P<0.000 1). There were statistically significant differences in the number of angina attacks, the duration of angina and the amount of nitroglycerin used. In terms of safety indicators, four studies reported adverse reactions in the experimental group, including facial flu-shing, tachycardia, dizziness, dyspnea, nausea and other symptoms. Based on the existing findings, in the treatment of angina pectoris and coronary heart disease, Gingko Ketone Ester Dropping Pills combined with conventional Western medicine can improve the clinical total effective rate, electrocardiogram effect, number of angina attacks, duration of angina and the amount of nitroglycerin used. However, in the included studies, due to some methodological quality problems which would impact the reliability of literature results more high-quality randomized controlled trials are still needed for further verification.


Subject(s)
Angina Pectoris/drug therapy , Coronary Disease/drug therapy , Drugs, Chinese Herbal/adverse effects , Esters , Ginkgo biloba , Humans , Ketones/adverse effects , Randomized Controlled Trials as Topic , Reproducibility of Results
3.
Article in Chinese | WPRIM | ID: wpr-879163

ABSTRACT

To systematically evaluate the clinical efficacy and safety of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in the treatment of hypertensive left ventricular hypertrophy. China National Knowledge Infrastructure(CNKI), Wanfang, VIP, PubMed, EMbase, Cochrane Library, Ovid and Web of Science databases were searched by computer to retrieve the randomized controlled trials(RCTs) of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in the treatment of hypertensive left ventricular hypertrophy from the establishment of databases to July 2020. After two researchers performed data retrieval, data extraction, and risk assessment of bias, they used RevMan 5.3 software for Meta-analysis. A total of 10 RCTs were included, with a total of 979 patients. Meta-analysis results showed that in terms of interventricular septal thickness(MD=-0.70, 95%CI[-1.15,-0.24], P=0.003), left ventricular posterior wall thickness(MD=-0.81, 95%CI[-1.41,-0.21], P=0.008), left ventricular mass index(MD=-8.75, 95%CI[-17.40,-0.10], P=0.05), systolic blood pressure(MD=-8.97, 95%CI[-13.46,-4.48], P<0.000 1), diastolic blood pressure(MD=-5.87, 95%CI[-8.39,-3.34], P<0.000 01) and left ventricular end-diastolic diameter(MD=-1.73, 95%CI[-2.38,-1.08], P<0.000 01), Compound Danshen Dripping Pills combined with conventional antihypertensive drugs was superior to conventional antihypertensive drugs. In terms of left ventricular ejection fraction(MD=0.41, 95%CI[-0.74, 1.55], P=0.49), there was no statistical difference in treatment between the two groups. Because of the small amount of literatures included in the safety aspect, it is impossible to give an accurate conclusion. The GRADE score showed that the level of evidence was low and extremely low. The results show that the Compound Danshen Dripping Pills combined with conventional antihypertensive drugs may effectively improve the clinical efficacy for hypertensive ventricular hypertrophy, and the safety needs to be further explored. Due to the low quality of the included literatures, more high-quality RCTs are needed for verification.


Subject(s)
Antihypertensive Agents/adverse effects , China , Drugs, Chinese Herbal/adverse effects , Humans , Hypertrophy, Left Ventricular/drug therapy , Stroke Volume , Treatment Outcome , Ventricular Function, Left
4.
Article in Chinese | WPRIM | ID: wpr-879084

ABSTRACT

Since the safety re-evaluation of traditional Chinese medicine(TCM) injections began in 2009, some TCM injection companies and research institutes have done a lot of work. And with the increase of drug development and drug production technology levels in China, the safety of some TCM injections has been greatly improved. There are safety risks in TCM injections, which are mainly reflected in unclear basis of medicinal materials, simple production process, poor controllability of quality standards, nonstan-dard drug instructions and irrational medication in the use process. This paper describes the research progress of the above-mentioned aspects of TCM injections. In addition, the author team found that adverse reactions of TCM injections are mainly pseudo-allergic reactions. Therefore, a lot of work has been done in detection of pseudo-allergic reactions, mechanism research and risk control. This part of the work is also described in this article.


Subject(s)
China , Drugs, Chinese Herbal/adverse effects , Humans , Hypersensitivity/etiology , Injections , Medicine, Chinese Traditional/adverse effects
5.
Article in Chinese | WPRIM | ID: wpr-879058

ABSTRACT

To systematically evaluate the efficacy and safety of Yangxue Qingnao Granules combined with conventional Western medicine in the treatment of essential hypertension and its accompanying symptoms. PubMed, EMbase, Cochrane Library, VIP, CNKI, Wanfang, and China biomedical database(CBD) were searched to screen out from the establishment of the database to April 2020 about the clinical randomized controlled trials of Yangxue Qingnao Granules combined with conventional Western medicine in the treatment of essential hypertension and accompanying symptoms. The articles were selected according to the inclusion and exclusion criteria. RevMan 5.3 software was used for Meta-analysis. TSA 0.9.5.10 Beta software was used for sequential analysis, and GRADE 3.6 was used for evidence quality evaluation. A total of 4 532 patients were included in 34 randomized controlled trials. Meta-analysis results showed that: Yangxue Qingnao Granules combined with conventional anti-hypertensive agents reduced systolic blood pressure(MD=-10.56, 95%CI[-13.63,-7.50], P<0.000 01) and diastolic blood pressure(MD=-8.21, 95%CI[-10.84,-5.59], P<0.000 01), improved total effective rate(RR=1.21, 95%CI[1.14, 1.29], P<0.000 01), improved patients dizziness(RR=1.29, 95%CI[1.21, 1.37], P<0.000 01), insomnia(RR=1.66, 95%CI[1.44, 1.91], P<0.000 01), headache(RR=1.32, 95%CI[1.21, 1.43], P<0.000 01), chest distress(RR=1.26, 95%CI[1.12, 1.42], P=0.000 1), memory loss(RR=1.24, 95%CI[1.10, 1.40], P=0.000 4), palpitation(RR=1.28, 95%CI[1.17, 1.41], P<0.000 01), and improved traditional Chinese medicine symptom scores(MD=-4.24, 95%CI[-5.25,-3.23], P<0.000 01) and headache symptom improvement scores(MD=-2.02, 95%CI[-2.51,-1.53], P<0.000 01) as compared with Western medicine group alone. Subgroup analysis results showed that Yang-xue Qingnao Granules combined with ACEI drug had more obvious effects in lowering systolic blood pressure and diastolic blood pressure. There was no statistically significant difference in the incidence of adverse reactions, and no abnormal liver and kidney function was observed in each study. Trial sequential analysis showed that the total effective rate was cumulative across the traditional and TSA thresholds, further confirming its clinical efficacy. The evidence level was mostly low or extremely low in GRADE evaluation. The clinical application of Yangxue Qingnao Granules combined with conventional Western medicine in the treatment of essential hypertension and its accompanying symptoms is clear and safe, so it is recommended for clinical application.


Subject(s)
Antihypertensive Agents/adverse effects , China , Drugs, Chinese Herbal/adverse effects , Essential Hypertension , Humans , Medicine, Chinese Traditional , Randomized Controlled Trials as Topic
6.
Article in Chinese | WPRIM | ID: wpr-879056

ABSTRACT

To systemically evaluate the effect of Qishen Yiqi Dripping Pills combined with Western medicine on adverse cardiovascular events and quality of life after percutaneous coronary intervention(PCI). A total of 7 Chinese and English databases including CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library and Web of Science were searched by computer to collect the randomized controlled trials(RCTs) on Qishen Yiqi Dripping Pills combined with Western medicine in the treatment of patients with coronary heart disease after PCI with the retrieval time from the database establishment to April 1, 2020. Two researchers independently conducted li-terature screening, data extraction and bias risk assessment. Then, Meta-analysis was performed by using RevMan 5.3 software. A total of 31 RCTs were included, involving 3 537 patients. The results of Meta-analysis showed that in terms of major adverse cardiovascular events(MACE) after PCI, the combination of Qishen Yiqi Dripping Pills could significantly reduce the recurrence of angina pectoris, incidence of arrhythmia, heart failure and re-revascularization, and the effect was better than that of Western medicine treatment alone. However, there was no significant difference between the two groups in the improvement of non-fatal myocardial infarction, cardiac death, stent restenosis, stroke and other adverse cardiovascular events. In terms of improving left ventricular ejection fraction(LVEF), 6 min walking test(6 MWT), high-sensitivity C-reactive protein(hs-CRP) and Seattle angina pectoris scale(SAQ), the combination of Qishen Yiqi Dripping Pills and Western medicine treatment had obvious advantages over Western medicine treatment alone in increasing LVEF, 6 MWT and SAQ, and reducing the level of hs-CRP, with statistically significant differences. There were few adverse reactions in both groups, and there was no significant difference between the two groups. The main manifestations were gastrointestinal reactions, rash, gingiva and other small bleeding, and no serious adverse reactions occurred. The above reactions could disappear after drug withdrawal or symptomatic treatment. The application of Qishen Yiqi Dripping Pills combined with Western medicine in the treatment of patients after PCI could reduce the occurrence of MACE, improve the clinical efficacy, quality of life and prognosis in a safe and reliable manner. However, due to the quantity and quality limitations of included studies, more standardized, rigo-rous and high-quality clinical studies are still needed to further verify the above conclusions.


Subject(s)
Drugs, Chinese Herbal/adverse effects , Humans , Medicine , Percutaneous Coronary Intervention/adverse effects , Quality of Life , Stroke Volume , Ventricular Function, Left
7.
Article in Chinese | WPRIM | ID: wpr-879031

ABSTRACT

It is the core of the development for Chinese patent medicine enterprises to cultivate large varieties of Chinese patent medicine, and the selection of potential "seed" products is the prerequisite for the cultivation strategy. By constructing the evaluation model from multiple dimensions of value and risk, we can conduct specialized evaluation of Chinese patent medicines to effectively, professionally and objectively select the "seed" products with large variety cultivation potential. In this paper, the establishment of a multidimensional evaluation system would be discussed from the aspects of drug naming and prescription composition, safety risk and supply guarantee of raw materials and medicinal materials, competition situation, access to policy catalogue, scientific and technological support, clinical evidence and recognition, systematical and standardized collection of information on product instructions, quality standards, policy catalogue, scientific and technological literature, market competition and clinical application of Chinese patent medicines. Through the objective evaluation index and the range of objective index, the multi-dimensional evaluation model on values and risks of Chinese patent medicine products was discussed. Based on this model, a batch of Chinese patent medicine products can be quickly and comprehensively analyzed, and quantitative comparison can be formed among different types and fields of products. According to the evaluation results of the model and the comprehensive evaluation of experts, high-quality "seed" products can be selec-ted, laying a solid foundation for the next step of large variety cultivation. With use of this model, we can further clarify the external competitive advantages and internal priority levels of each product, and provide support for enterprises to optimize product structure and improve product strategic layout.


Subject(s)
China , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese Traditional , Nonprescription Drugs/adverse effects , Quality Control
8.
Article in Chinese | WPRIM | ID: wpr-879030

ABSTRACT

In order to systematically evaluate the safety of Sanfu acupoint herbal patching, CNKI, SinoMed, VIP, Wanfang, PubMed, Medline, EMbase, and Cochrane Library were searched in accordance with PICOS principles, with a time limit from database establishment to December 2019. Meta-analysis was used for a single-group rate analysis and a weighted combination of these two groups on rates of adverse reactions. A total of 9 articles meeting the inclusion criteria were included in the analysis, involving 2 119 patients. The single-group rate Meta-analysis showed that the adverse reactions incidence was 9% in the treatment group(OR=0.10,95%CI[0.06, 0.19], P<0.000 01), and 9% in the control group(OR=0.10, 95%CI[0.07, 0.13], P<0.000 01). In combined statistics of all samples OR=1.81, 95%CI[1.04, 3.15], P=0.04, the incidence of adverse reactions in the treatment group was slightly higher than that of the control group. In the subgroup analysis, the incidence of adverse reactions in terms of both single-group rate and weighed rate in the treatment group was higher than that in the control group in the asthma subgroup, rhinitis subgroup, ≥18 years old subgroup, and application time 2 h subgroup, with statistically significant differences(P<0.05). The results of the Meta-analysis and systematic review suggested that the incidence of adverse reactions in clinical use of the Sanfu acupoints herbal patching was relatively low. The main types of adverse reactions were skin ulcers, blisters and other skin symptoms. The symptoms were relatively mild, which could be relieved by drug withdrawal or symptomatic treatment. It shows that the safety of the Sanfu acupoint herbal patching was relatively high, and the occurrence of adverse reactions was related to the original disease and age, mainly in asthma and rhinitis or patients over 40 years old. Affected by clinical heterogeneity, the conclusions of the application time subgroup need to be further improved.


Subject(s)
Acupuncture Points , Adolescent , Adult , Asthma , Databases, Factual , Drugs, Chinese Herbal/adverse effects , Humans , Incidence , Randomized Controlled Trials as Topic
9.
Article in Chinese | WPRIM | ID: wpr-879028

ABSTRACT

To systematically evaluate the efficacy and safety of Ningxinbao Capsules in treatment of arrhythmia by Meta-analysis. Randomized controlled trial(RCT) or quasi-randomized control trial(Quasi-RCT) on Ningxinbao Capsules treating arrhythmia were obtained by computer-based retrieval in CNKI, Wanfang, VIP, SinoMed, PubMed, Web of Science, Cochrane Library and EMbase as well as manual retrieval, with time limit from database establishment to April 7, 2020. According to the inclusion and exclusion criteria of trials, all RCTs were screened and evaluated. Then the effective data were collected and RevMan 5.3 Meta-analysis software was used for analysis. Thirteen trials were included, involving 1 379 patients in total. Ningxinbao Capsules combined with anti-arrhythmia Western medicine were adopted as the intervention, and the patients in control group were treated with the anti-arrhythmia Western medicine alone. Meta-analysis results showed that as compared to control group, Ningxinbao Capsules combined with anti-arrhythmia Western medicine group was superior in clinical efficacy, dynamic electrocardiogram and average heart rate in patients with bradycardia, with indicated statistically significant differences. Ningxinbao Capsules had fewer adverse reactions and could relieve the toxic and side effects of anti-arrhythmia medicine possibly. The study showed that Ningxinbao Capsules played a role in treatment of arrhythmia and was relatively safe. However, due to the limited quality of the included studies, high-quality clinical trials are needed to verify the conclusions.


Subject(s)
Bradycardia , Capsules , Drugs, Chinese Herbal/adverse effects , Humans , Treatment Outcome
10.
Article in Chinese | WPRIM | ID: wpr-879003

ABSTRACT

Arecae Semen, as the first place among "Four South Medicines" in China, has great dual-use value of medicine and food. The research of Arecae Semen was mainly focused on the active ingredients and efficacy value, and its potential safety hazards were also concerned. Until now, there is still a lack of clear boundaries between medicine and food, resulting in its safety cannot be guaranteed. Therefore, it is of great significance to establish clear boundaries of medicine and food use and health risk assessment. In this paper, the differences of pretreatment and application methods of Arecae Semen were analyzed, and the research progress of Arecae Semen in chemical composition identification and toxicology research and safety evaluation were reviewed emphatically. Finally, the differences of quality control and safety evaluation of Arecae Semen in pharmacopoeias or standards were analyzed at home and abroad. It was expected to provide reference value for quality control, safety evaluation and international standardization research of Arecae Semen.


Subject(s)
Areca , China , Drugs, Chinese Herbal/adverse effects , Seeds , Semen
11.
Article in Chinese | WPRIM | ID: wpr-878965

ABSTRACT

To systematically evaluate the clinical efficacy and safety of Lianhua Qingwen in the treatment of adult pneumonia. The randomized controlled trial of Lianhua Qingwen combined with conventional Western medicine in the treatment of pneumonia were retrieved from PubMed, EMbase, Wanfang database, VIP database, and CNKI from the establishment of database to March 2020. Two researchers independently conducted literature screening and data extraction, and the third researcher was in charge of arbitration in case of any disagreement. Outcome indicators included total clinical effective rate, symptom improvement time, and incidence of adverse events. R 3.6.1 was used for Meta-analysis, and RevMan 5.3 was used for quality evaluation. Twenty-two studies were included, with a total of 2 007 patients, including 1 017 patients in the experimental group and 990 patients in the control group. The results showed that the total clinical effective rate of the experimental group was higher than that of the control group(RR=1.11, 95%CI[1.08, 1.15], P<0.001), and the antifebrile time(MD=-1.81, 95%CI[-2.42,-1.21], P<0.001), cough duration(MD=-2.32, 95%CI[-2.89,-1.76], P<0.001), rale duration(MD=-2.19, 95%CI[-2.74,-1.63], P<0.001), imaging recovery time(MD=-2.17, 95%CI[-2.76,-1.58], P<0.001) and post-treatment CRP(MD=-4.07, 95%CI[-6.39,-1.75], P<0.001] were all significantly lower than those of the control group. However, it did not proved that the experimental group was safer than the control group(RR=0.84, 95%CI[0.57, 1.24], P=0.382). The results confirmed that Lianhua Qingwen combined with conventional Western medicine in the treatment of pneumonia could improve the clinical treatment efficiency, shorten the time of fever, cough, rale disappearance and imaging recovery, improve CRP index and accelerate the recovery of pneumonia patients. However, the literatures included in this study had a low quality, and the conclusions still need to be further confirmed by more high-quality, multi-center, rigorously designed randomized controlled trial.


Subject(s)
Adult , Cough , Drugs, Chinese Herbal/adverse effects , Humans , Pneumonia/drug therapy , Treatment Outcome
12.
Article in Chinese | WPRIM | ID: wpr-878935

ABSTRACT

To evaluate the efficacy and safety of Compound Danshen Injection combined with Western medicine in the treatment of vascular dementia. Databases of Cochrane Library, PubMed, EMbase, CNKI, SinoMed, VIP, Wanfang Data were electronically retrieved for collecting randomized controlled trial(RCT)about vascular dementia treated with Western medicine alone or combined with Compound Danshen Injection from the year of database establishment to January 2020. Two researchers independently screened out li-teratures, extracted data, and evaluated the risk of bias for inclusion in the study. Meta-analysis was conducted using RevMan 5.3 software. A total of 5 RCTs were included, involving 588 patients, with 299 in treatment group and 289 in control group. Meta-analysis results showed that compared with Western medicine alone, Compound Danshen Injection combined with Western medicine was better in the effective rate(RR=1.23,95%CI[1.14,1.33],P<0.000 01), MMSE score(MD=3.54,95%CI[3.01,4.06],P<0.000 01), ADL score(MD=11.49,95%CI[8.05,14.93],P<0.000 01), the level of CRP(MD=-0.72,95%CI[-1.25,-0.20],P=0.007) and the level of IL-6(MD=-7.64,95%CI[-9.65,-5.63],P<0.000 01). Adverse reactions mainly included rash and skin prick, which did not affect the treatment effect. Based on the findings, the combination of Compound Danshen Injection in the treatment of vascular dementia could improve the effective rates, relieve the mental state damage and improve the daily living ability, with mild adverse reactions and a low incidence. However, due to the low quality of the included literatures, high-quality and large-scale randomized controlled trials are needed for further verification.


Subject(s)
Dementia, Vascular/drug therapy , Drugs, Chinese Herbal/adverse effects , Humans , Injections , Medicine , Salvia miltiorrhiza
13.
Article in Chinese | WPRIM | ID: wpr-878932

ABSTRACT

To systemically evaluate the efficacy and safety of sinomenine combined with methotrexate(SIN+MTX) in the treatment of rheumatoid arthritis(RA). Literature databases of Wanfang, CNKI, VIP, SinoMed, PubMed, Cochrane Library and Web of Science were retrieved comprehensively for relevant clinical trials. The literature retrieval time was from database establishment to February 4, 2020. The quality of literatures was assessed by the Cochrane Evaluation Handbook 5.1.0, and qualified literature was reviewed and analyzed by using the RevMan 5.3 statistical software. Twenty randomized controlled trials met the inclusion criteria, and were enrolled in the Meta-analysis. The results showed that SIN+MTX remarkably reduced DAS28(MD=-0.85, 95%CI[-1.03,-0.67], P<0.000 01), and improved total efficiency(P<0.000 01). SIN+MTX could inhibit swollen joint count(MD=-1.19, 95%CI[-1.75,-0.63], P<0.000 1), tender joint count(MD=-1.58, 95%CI[-2.89,-0.28], P=0.02) and reduce morning stiffness time(MD=-8.44, 95%CI[-11.82,-5.07], P<0.000 01) compared with control group. The results showed that SIN+MTX was equal to control group in grip strength(SMD=0.20,95%CI[-1.11,1.51],P=0.77). SIN+MTX remarkably alleviated the erythrocyte sedimentation rate(MD=-9.87, 95%CI[-14.52,-5.22], P<0.000 1), C-reactive protein(SMD=-0.30, 95%CI[-0.51,-0.09], P=0.005), and rheumatoid factor(MD=-11.23,95%CI[-13.81,-8.65],P<0.000 01). The frequency of adverse reactions were reduced compared with that in the control group(P<0.000 01). Current clinical studies demonstrate that the efficacy and safety of SIN+MTX in the treatment of RA were superior to control group. However, due to the low quality and quantity of the included studies, high-quality randomized controlled trials are necessary to support the clinical evidences.


Subject(s)
Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/drug therapy , Drugs, Chinese Herbal/adverse effects , Humans , Methotrexate/adverse effects , Morphinans
14.
Article in Chinese | WPRIM | ID: wpr-878898

ABSTRACT

This study aimed to comprehensively analyze and compare the differences of different clinical study types currently published in the safety evaluation of Xuebijing Injection. Six databases, namely the Cochrane Library, PubMed, EMbase, CNKI, VIP and Wanfang database, were electronically retrieved to collect all types of studies on the safety of Xuebijing Injection, including randomized controlled trials, case-controlled studies, cohort studies, systematic reviews, and centralized monitoring studies of clinical safety(hospital), in order to comprehensively and objectively evaluate the safety of Xuebijing Injection, and analyze the differences of different research results. A total of 211 literatures were included, involving a total of 46 384 patients treated with Xuebijing Injection, and 423 adverse reactions(ADRs) occurred. They included 191 randomized controlled trials, 3 cohort studies, 15 systematic reviews, and 2 centralized monitoring studies of clinical safety(hospital), and the incidence of adverse reactions was 2.54%(common), 2.31%(common), 0.95%(occasionally), and 0.50%(occasionally). More than half of the 423 cases of ADRs occurred in skin and adnexal system(151 cases) and gastrointestinal system(65 cases), including such manifestations as rash, skin itching, nausea and vomiting, diarrhea. The degree of ADRs was mild. Randomized controlled trials showed that the incidence of ADR was the highest when Xuebijing Injection was used for malignant tumor and multiple organ failure. And the systematic evaluation showed that the incidence of ADR was the highest when Xuebijing Injection was used for spontaneous peritonitis of liver cirrhosis. In conclusion, different study types could lead to significant differences in the results of drug safety evaluation. Sample size, study type, and quality control are the main factors for biased results. Due to large sample size and high-quality, centralized monitoring studies become the better clinical safety evaluation model of drugs at present, and full life cycle management could more objectively reflect drug safety and guide clinical rational drug use.


Subject(s)
Case-Control Studies , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drugs, Chinese Herbal/adverse effects , Humans , Injections
15.
Article in Chinese | WPRIM | ID: wpr-878896

ABSTRACT

To evaluate the efficacy and safety of Compound Glycyrrhizin Injection(CGI) in improving liver damage in chronic hepatitis B(CHB). PubMed, Web of Science, SinoMed, CNKI, Wanfang and VIP databases were retrieved from their inception to February 10, 2020. The randomized controlled trial(RCT) of CGI in the treatment of CHB was included. Data were independently extracted by two authors, and the methodological quality was evaluated using the Cochrane bias risk assessment tool by other two authors. Statistical analysis was performed using RevMan 5.3 software. A total of 18 two-armed RCTs were included, involving 1 915 participants. The methodological quality of all studies included was generally low. In the comparison between CGI and diammonium glycyrrhizinate, the results showed that CGI was superior to the control group in improving the overall clinical effectiveness, but there was no statistical difference between the two groups in increasing ALT normalization rate, reducing ALT and AST level. In the comparison between CGI and diammonium glycyrrhizinate+other general hepatoprotective drugs, the results showed that CGI was superior to the control group in reducing AST level, while there was no statistical difference between the two groups in reducing ALT level and increasing overall clinical effectiveness. In the comparison between CGI+other commonly used drugs(including energy mixture, glutathione, vitamins, potassium magnesium aspartate) and diammonium glycyrrhizinate+other commonly used drugs, the results showed that CGI combined with other commonly used drugs was better than the control group in reducing ALT and AST level and improving the clinical total effective rate, and there was no statistical difference between the two groups in increasing the rate of ALT normalization. In the comparison between CGI+other commonly used drugs and other commonly used drugs, the results showed that CGI combined with other commonly used drugs was superior to the control group in reducing ALT and AST level and improving the overall clinical effectiveness. In the comparison between CGI+vitamins and diammonium glycyrrhizinate+potassium magnesium aspartate+vitamins, the results showed no statistical difference between the two groups in reducing AST level. A small number of studies included reported that CGI caused mild adverse reactions when used alone or in combination with other drugs. Based on the results, CGI has a certain effect in improving CHB liver damage, but the evidence is not enough to prove that CGI would cause serious adverse events. In the future, more well-designed and strictly-enforced RCT with an adequate sample size are needed to further evaluate the effect CGI in alleviating CHB liver damage.


Subject(s)
Drugs, Chinese Herbal/adverse effects , Glycyrrhizic Acid , Hepatitis B, Chronic/drug therapy , Humans
16.
Article in Chinese | WPRIM | ID: wpr-878797

ABSTRACT

To evaluate the efficacy and safety of Yangxue Qingnao Granules alone or combined with calcium channel blocker in treatment of migraine. In this study, four Chinese databases(CNKI, VIP, WanFang, CBM), three English databases(Cochrane Library, EMbase, Medline) and clinical trials registration center(ClinicalTrials.gov) were retrieved. The retrieval time was from the establishment of each database to January 8, 2020. According to the set inclusion criteria and exclusion criteria,the randomized controlled trial(RCT) of Yangxue Qingnao Granules alone or combined with calcium channel blocker was selected. The "Cochrane bias risk assessment" tool was used to evaluate the quality of the included studies. RevMan 5.3 was used to conduct Meta-analysis of the included studies and grade system was used to evaluate the evidence quality of the outcome indicators. A total of 583 documents were retrieved and finally included in 23 studies, with a total sample size of 2 308 cases, 1 171 cases in the treatment group and 1 137 cases in the control group. The overall quality of the research included was not high. Meta-analysis showed that,(1)in terms of effective rate, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(RR=1.24, 95%CI[1.17, 1.32], P<0.000 01), and there was no significant difference between Yangxue Qingnao Granules and calcium channel blocker(RR=1.36, 95%CI[0.91, 2.03], P=0.14).(2)In terms of reducing headache frequency, when the unit of headache frequency was times per month, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-1.39, 95%CI[-1.83,-0.95], P<0.000 01), when the unit of headache frequency was times daily, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-2.08, 95%CI[-2.34,-1.82], P<0.000 01).(3)In terms of headache intensity, when headache intensity was scored by pain intensity, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-0.70, 95%CI[-0.81,-0.59], P<0.000 01), when headache intensity was scored by VAS score, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(MD=-1.59, 95%CI[-2.13,-1.06], P<0.000 01).(4)In terms of reducing headache duration, Yangxue Qingnao Granules combined with calcium channel blocker was better than calcium channel blocker(SMD=-3.13, 95%CI[-4.12,-2.15], P<0.000 01). GRADE system showed that the evidence level of the above outcome indicators was low and extremely low. Twelve cases of adverse reactions were reported, all of which were mild. The results showed that the combination of Yang-xue Qingnao Granules can improve the effective rate, reduce the headache frequency, the headache intensity and the headache duration, and had good safety and low incidence of adverse reactions compared with the single calcium channel blocker. However, there was no difference in the effective rate between Yangxue Qingnao Granules alone and calcium channel blocker. In view of the low quality of this study, which affects the reliability of the conclusion, it is necessary to use the conclusion of this study carefully, and more high-quality randomized controlled trials are needed to further verify in the future.


Subject(s)
Drugs, Chinese Herbal/adverse effects , Humans , Migraine Disorders/drug therapy , Reproducibility of Results
17.
Chinese Medical Journal ; (24): 185-192, 2020.
Article in English | WPRIM | ID: wpr-877954

ABSTRACT

BACKGROUND@#The Shexiang Baoxin Pill (MUSKARDIA) has been used for treating coronary artery disease (CAD) and angina for more than 30 years in China. Nevertheless, methodologically sound trials on the use of MUSKARDIA in CAD patients are scarce. The aim of the study is to determine the effects of MUSKARDIA as an add-on to optimal medical therapy (OMT) in patients with stable CAD.@*METHODS@#A total of 2674 participants with stable CAD from 97 hospitals in China were randomized 1:1 to a MUSKARDIA or placebo group for 24 months. Both groups received OMT according to local tertiary hospital protocols. The primary outcome was the occurrence of a major adverse cardiovascular event (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke. Secondary outcomes included all-cause mortality, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or heart failure, peripheral revascularization, angina stability and angina frequency.@*RESULTS@#In all, 99.7% of the patients were treated with aspirin and 93.0% with statin. After 2 years of treatment, the occurrence of MACEs was reduced by 26.9% in the MUSKARDIA group (MUSKARDIA: 1.9% vs. placebo: 2.6%; odds ratio = 0.80; 95% confidence interval: 0.45-1.07; P  = 0.2869). Angina frequency was significantly reduced in the MUSKARDIA group at 18 months (P = 0.0362). Other secondary endpoints were similar between the two groups. The rates of adverse events were also similar between the two groups (MUSKARDIA: 17.7% vs. placebo: 17.4%, P = 0.8785).@*CONCLUSIONS@#As an add-on to OMT, MUSKARDIA is safe and significantly reduces angina frequency in patients with stable CAD. Moreover, the use of MUSKARDIA is associated with a trend toward reduced MACEs in patients with stable CAD. The results suggest that MUSKARDIA can be used to manage patients with CAD.@*TRIAL REGISTRATION@#chictr.org.cn, No. ChiCTR-TRC-12003513.


Subject(s)
Angina Pectoris , China , Coronary Artery Disease/drug therapy , Double-Blind Method , Drugs, Chinese Herbal/adverse effects , Humans
18.
Braz. j. med. biol. res ; 50(10): e6363, 2017. tab
Article in English | LILACS | ID: biblio-888933

ABSTRACT

This study aimed to test the effects of xuezhikang, a cholestin extract that contains statin-like components, on arterial stiffness in patients with essential hypertension. One hundred hypertensive patients from the Chinese PLA General Hospital were randomly allocated to receive xuezhikang (1200 mg/day, orally) or placebo (same capsules containing only pharmaceutical excipients). Physical examination outcomes, lipid profile, high sensitivity C-reactive protein (hs-CRP) levels, matrix metalloproteinases-9 (MMP-9) levels, and arterial outcomes, including stiffness parameter (β), pressure-strain elasticity modulus (Ep), arterial compliance (AC), augmentation index (AI), and one-point pulse wave velocity (PWVβ) were obtained at baseline and after 6 months of the intervention. Xuezhikang significantly reduced β (8.4±3.1 vs 6.8±2.1, P=0.007), Ep (122.8±43.9 vs 100.7±33.2, P=0.009), PWVβ (6.7±1.2 vs 6.1±1.0, P=0.013), low-density lipoprotein cholesterol (3.4±0.6 vs 2.9±0.5, P=0.001), hs-CRP [2.1 (0.4-10.0) vs 1.4 (0.3-4.1), P=0.020], and MMP-9 (17.2±2.4 vs 12.7±3.8, P <0.001) compared to baseline. The placebo had no effect on these parameters. The changes of PWVβ in the xuezhikang group was significantly associated with the changes of hs-CRP and MMP-9 (r=0.144, P=0.043; r=0.278, P=0.030, respectively) but not with lipid profile changes. Our research showed xuezhikang can improve the parameters of arterial stiffness in hypertensive patients, and its effect was independent of lipid lowering.


Subject(s)
Humans , Male , Female , Middle Aged , Drugs, Chinese Herbal/therapeutic use , Essential Hypertension/drug therapy , Vascular Stiffness/drug effects , Drugs, Chinese Herbal/adverse effects , Essential Hypertension/blood , Essential Hypertension/physiopathology , Lipids/blood , Pulse Wave Analysis , Vascular Stiffness/physiology
19.
Gut and Liver ; : 27-36, 2016.
Article in English | WPRIM | ID: wpr-111621

ABSTRACT

Drug-induced liver injury (DILI) remains a significant clinical challenge and is the leading cause of acute liver failure in most countries. An aging population that uses more medications, a constant influx of newly developed drugs and a growing risk from unfamiliar herbal and dietary supplements will make DILI an increasing part of clinical practice. Currently, the most effective strategy for disease management is rapid identification, withholding the inciting agents, supportive care and having a firm understanding of the expected natural history. There are resources available to aid the clinician, including a new online "textbook" as well as causality assessment tools, but a heightened awareness of risk and the disease's varying phenotypes and good history-taking remain cornerstones to diagnosis. Looking ahead, growing registries of cases, pharmacoepidemiology studies and translational research into the mechanisms of injury may produce better diagnostic tools, markers for risk and disease, and prevention and therapeutics.


Subject(s)
Age Factors , Anti-Infective Agents/adverse effects , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Anticonvulsants/adverse effects , Biopsy , Dietary Supplements/adverse effects , Chemical and Drug Induced Liver Injury/diagnosis , Drugs, Chinese Herbal/adverse effects , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Incidence , Liver/pathology , Liver Function Tests , Risk Factors , Tumor Necrosis Factor-alpha/antagonists & inhibitors
20.
Gut and Liver ; : 525-533, 2015.
Article in English | WPRIM | ID: wpr-149096

ABSTRACT

BACKGROUND/AIMS: Drug-induced liver injury (DILI) is a frequent cause of pediatric liver disease; however, the data on DILI are remarkably limited. METHODS: All 69 children hospitalized with DILI between January 2009 and December 2011 were retrospectively studied. RESULTS: A total of 37.7% of the children had medical histories of respiratory infection. The clinical injury patterns were as follows: hepatocellular 89.9%, cholestatic 2.9%, and mixed 7.2%. Liver biopsies from 55 children most frequently demonstrated chronic (47.3%) and acute (27.3%) hepatitis. Hypersensitivity features, namely, fever (31.9%), rash (21.7%), and eosinophilia (1.4%), were found. Twenty-four children (34.8%) developed chronic DILI. Antibiotics (26.1%) were the most common Western medicines (WMs) causing DILI, and the major implicated herbs were Ephedra sinica and Polygonum multiflorum. Compared with WM, the children whose injuries were caused by Chinese herbal medicine (CHM) showed a higher level of total bilirubin (1.4 mg/dL vs 16.6 mg/dL, p=0.004) and a longer prothrombin time (11.8 seconds vs 17.3 seconds, p=0.012), but they exhibited less chronic DILI (2/15 vs 18/39, p=0.031). CONCLUSIONS: Most cases of DILI in children are caused by antibiotics or CHM used to treat respiratory infection and present with hepatocellular injury. Compared with WM, CHM is more likely to cause severe liver injury, but liver injury caused by CHM is curable.


Subject(s)
Anti-Bacterial Agents/adverse effects , Bilirubin/blood , Child , Child, Preschool , China , Chemical and Drug Induced Liver Injury/blood , Drugs, Chinese Herbal/adverse effects , Female , Humans , Liver/pathology , Male , Prothrombin Time , Respiratory Tract Infections/complications , Retrospective Studies
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