[Meta-analysis of Zhibitai Capsules combined with statin in reducing blood lipid levels in patients with coronary heart disease].
Li Mei-Huan,Li Ying,Chen Ming-Tai,Lin Hai-Dan,Wu Yan-Hui,Zhang Zhong
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica
To systematically review the efficacy and safety of Zhibitai Capsules combined with chemical drugs versus chemical drugs alone in regulating blood lipid of patients of coronary heart disease, so as to provide evidence-based reference for clinical treatment. In this study, PubMed, EMbase, Cochrane Library, China Knowledge Network Database(CNKI), Technology Journal Database(VIP) and WanFang Database(WanFang) were retrieved to find the randomized controlled trials(RCT) about therapeutic efficacy of Zhibitai Capsules combined with statins(experimental group)versus statins alone(control group)in the treatment of regulating blood lipid of patients with coronary heart disease. The retrieval time was restricted to be from the inception to October 2019. The data were extracted from the randomized controlled trials. Meta-analysis was conducted by RevMan 5.3 statistical software after quality evaluation by Cochrane 5.1.0 quality evaluation tool(blood lipid level, inflammation indicators, traditional Chinese medicine syndrome score and adverse reactions). A total of 11 RCT were included, involving 1 538 patients. The results of Meta-analysis showed that in terms of decrease of total cholesterol(MD=-0.15,95%CI[-0.25,-0.05],P=0.004), decrease of triglycerides improvement(MD=-0.16,95%CI[-0.23,-0.10],P<0.000 01), decrease of low-density lipoprotein(MD=-0.08,95%CI[-0.15,-0.01],P=0.03), and increase of high-density lipoprotein(MD=0.06,95%CI[0.03,0.10],P=0.000 2), experimental group was better than control group. At the same time, the incidence of adverse reactions were low in the experimental group(OR=0.40,95%CI[0.18,0.85],P=0.02). As a result, in treatment of coronary heart disease, the therapeutic efficacy of Zhibitai Capsules combined with statins is better than statins alone in lowering total cholesterol level, triglyceride level, low-density lipoprotein level, and increasing high-density lipoprotein level. Patients in the experimental group had a low incidence of adverse events, but the heterogeneity was slightly higher, and the result had a poor stability. However, due to the small sample size of studies included, some experimental designs were not perfect, which reduces the recommendation level and evidence intensity of this system evaluation. Therefore, high-quality multi-center, large-sample, randomized, double-blind randomized controlled trials are needed for providing more reliable basis.
Efficacy and safety of Zhibitai in combination with atorvastatin for lipid lowering in patients with coronary heart disease.
Xu Danyan,Hu Jiahui,Wu Qinghua,Du Zhiming,Xue Yusheng,Zhang Xu,Li Yi,Chen Yushan,Chen Xiaoping,Zhang Hong,Zhao Shuiping
Background:Zhibitai, a natural lipid-lowering Chinese medicine, is well tolerated in patients and has low incidence of adverse events. In this study, we evaluated the efficacy, safety, and side effects of Zhibitai in combination with low dose Atorvastatin compared to high dose Atorvastatin in patients with coronary heart disease or at high risk of coronary heart disease. Methods:This was a randomized, double-blind, multi-center clinical trial on 720 patients with coronary heart disease or at high risk of coronary heart disease. The patients were randomly assigned to a Zhibitai-Atorvastatin group (480 mg Zhibitai twice daily plus 10 mg atorvastatin once daily) or Monotherapy group (40 mg Atorvastatin once daily). Blood samples were obtained at baseline, week 4, and week 8 after a minimum 8-hour fast. Efficacy was evaluated in terms of the changes in the following parameters: lipoprotein profiles [total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C)]. Safety was assessed throughout the study by clinical laboratory tests including liver function [alanine transaminase, aspartate transaminase] and renal function [blood urea nitrogen], and creatine kinase; physical examination; and adverse events monitoring. Results:TC, TG, LDL-C levels were significantly decreased andHDL-C levels were significantly increased at week 4 and week 8 (all < 0.05) in both groups but had no significant differences between the two groups ( > 0.05). In subgroup analyses, Zhibitai-Atorvastatin Group produced significantly greater reduction in TG compared with Monotherapy Group at week 8 in patients with TG > 203.72mg/dL ( < 0.01). Among patients with LDL-C levels > 131.48 mg/dL, Zhibitai-Atorvastatin Group produced a greater reduction of LDL-C levels compared with the Monotherapy Group at week 4 ( < 0.05). The incidence of liver dysfunction, headache, or gastrointestinal intolerance was significantly lower in the Zhibitai-Atorvastatin Group compared with Monotherapy Group during the 8-week study peroid ( < 0.001). There were no significant differences in renal function, myopathy, and other adverse events between the groups. Conclusion:Overall the two groups have similar lipid regulation efficacy. Zhibitai plus low dose Atorvastatin is more efficacious in lowering TG in patients with TG > 203.72 mg/dL at week 8. There are fewer side effects in Zhibitai plus low dose Atorvastatin group. Long term follow up is required to evaluate cardiovascular outcomes.
Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins.
Baigent C,Keech A,Kearney P M,Blackwell L,Buck G,Pollicino C,Kirby A,Sourjina T,Peto R,Collins R,Simes R,
Lancet (London, England)
BACKGROUND:Results of previous randomised trials have shown that interventions that lower LDL cholesterol concentrations can significantly reduce the incidence of coronary heart disease (CHD) and other major vascular events in a wide range of individuals. But each separate trial has limited power to assess particular outcomes or particular categories of participant. METHODS:A prospective meta-analysis of data from 90,056 individuals in 14 randomised trials of statins was done. Weighted estimates were obtained of effects on different clinical outcomes per 1.0 mmol/L reduction in LDL cholesterol. FINDINGS:During a mean of 5 years, there were 8186 deaths, 14,348 individuals had major vascular events, and 5103 developed cancer. Mean LDL cholesterol differences at 1 year ranged from 0.35 mmol/L to 1.77 mmol/L (mean 1.09) in these trials. There was a 12% proportional reduction in all-cause mortality per mmol/L reduction in LDL cholesterol (rate ratio [RR] 0.88, 95% CI 0.84-0.91; p<0.0001). This reflected a 19% reduction in coronary mortality (0.81, 0.76-0.85; p<0.0001), and non-significant reductions in non-coronary vascular mortality (0.93, 0.83-1.03; p=0.2) and non-vascular mortality (0.95, 0.90-1.01; p=0.1). There were corresponding reductions in myocardial infarction or coronary death (0.77, 0.74-0.80; p<0.0001), in the need for coronary revascularisation (0.76, 0.73-0.80; p<0.0001), in fatal or non-fatal stroke (0.83, 0.78-0.88; p<0.0001), and, combining these, of 21% in any such major vascular event (0.79, 0.77-0.81; p<0.0001). The proportional reduction in major vascular events differed significantly (p<0.0001) according to the absolute reduction in LDL cholesterol achieved, but not otherwise. These benefits were significant within the first year, but were greater in subsequent years. Taking all years together, the overall reduction of about one fifth per mmol/L LDL cholesterol reduction translated into 48 (95% CI 39-57) fewer participants having major vascular events per 1000 among those with pre-existing CHD at baseline, compared with 25 (19-31) per 1000 among participants with no such history. There was no evidence that statins increased the incidence of cancer overall (1.00, 0.95-1.06; p=0.9) or at any particular site. INTERPRETATION:Statin therapy can safely reduce the 5-year incidence of major coronary events, coronary revascularisation, and stroke by about one fifth per mmol/L reduction in LDL cholesterol, largely irrespective of the initial lipid profile or other presenting characteristics. The absolute benefit relates chiefly to an individual's absolute risk of such events and to the absolute reduction in LDL cholesterol achieved. These findings reinforce the need to consider prolonged statin treatment with substantial LDL cholesterol reductions in all patients at high risk of any type of major vascular event.
Patterns of Stroke Between University Hospitals and Nonuniversity Hospitals in Mainland China: Prospective Multicenter Hospital-Based Registry Study.
Wang Deren,Liu Junfeng,Liu Ming,Lu Chuanzhen,Brainin Michael,Zhang Juying
BACKGROUND AND OBJECTIVE:In China, stroke has risen to the first commonest cause of death. Currently published data on stroke come mainly from university hospitals and less from community hospitals, especially lacking information on stroke focusing on the differences between university hospitals and nonuniversity hospitals. Therefore we aimed to investigate the patterns and differences of acute stroke between university hospitals and nonuniversity hospitals in China. METHODS:The survey was conducted in 281 hospitals in China: 62 in the west, 85 in the middle, and 134 in the eastern regions. The participating hospitals were sorted into university hospitals (n = 93) and nonuniversity hospitals (n = 118). We prospectively registered patients with acute stroke within 7 days of symptom onset between 1 April and 20 May 2006. The diagnosis of stroke was defined by World Health Organization criteria, and the pathologic types of stroke were determined by clinical and computed tomography/magnetic resonance imaging findings. The demographic data, pathologic types of stroke, and outcomes (death or disability) at discharge (or 30 days if not discharged) were collected. Disability was defined as modified Rankin Scale (mRs) score >2. Basic characteristics, pathologic types of stroke, and functional outcomes were compared between university hospitals and nonuniversity hospitals. RESULTS:We enrolled 5273 patients (3135 males; mean age, 65 ± 12 years), of which ischemic stroke accounted for 70.8% (3733), intracranial hemorrhage for 25.7% (1357), and subarachnoid hemorrhage for 3.5% (183). Most of the patients (3555, or 67.4%) were from nonuniversity hospitals, and 1718 patients (32.6%) came from university hospitals. There were no significant differences between university hospitals and nonuniversity hospitals in terms of age, sex, pathologic types of stroke, and history of stroke (all P > 0.05), except the less stroke severity (mRS) on admission (3.1 ± 1.4 vs. 3.2 ± 1.3; P = 0.005) in patients from nonuniversity hospitals. After adjustment for age, sex, and mRS on admission, only patients with intracranial hemorrhage from nonuniversity hospitals had significantly lower proportions of disability (40.8% vs. 47.1%; P = 0.005) and death/disability (49.9% vs. 57.1%; P = 0.008) at discharge than those from university hospitals. CONCLUSION:This survey comparing stroke patients treated in university and nonuniversity hospitals in China showed that both cohorts were largely comparable including most demographic features, such as age and gender, history of stroke, and stroke subtypes. It may be concluded that patient cohorts treated on stroke units in university and nonuniversity hospitals are similar and stroke units in both types of institutions are also comparable in terms of workload and most patient outcomes.
Prevalence, Incidence, and Mortality of Stroke in China: Results from a Nationwide Population-Based Survey of 480 687 Adults.
Wang Wenzhi,Jiang Bin,Sun Haixin,Ru Xiaojuan,Sun Dongling,Wang Linhong,Wang Limin,Jiang Yong,Li Yichong,Wang Yilong,Chen Zhenghong,Wu Shengping,Zhang Yazhuo,Wang David,Wang Yongjun,Feigin Valery L,
BACKGROUND:China bears the biggest stroke burden in the world. However, little is known about the current prevalence, incidence, and mortality of stroke at the national level, and the trend in the past 30 years. METHODS:In 2013, a nationally representative door-to-door survey was conducted in 155 urban and rural centers in 31 provinces in China, totaling 480 687 adults aged ≥20 years. All stroke survivors were considered as prevalent stroke cases at the prevalent time (August 31, 2013). First-ever strokes that occurred during 1 year preceding the survey point-prevalent time were considered as incident cases. According to computed tomography/MRI/autopsy findings, strokes were categorized into ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, and stroke of undetermined type. RESULTS:Of 480 687 participants, 7672 were diagnosed with a prevalent stroke (1596.0/100 000 people) and 1643 with incident strokes (345.1/100 000 person-years). The age-standardized prevalence, incidence, and mortality rates were 1114.8/100 000 people, 246.8 and 114.8/100 000 person-years, respectively. Pathological type of stroke was documented by computed tomography/MRI brain scanning in 90% of prevalent and 83% of incident stroke cases. Among incident and prevalent strokes, ischemic stroke constituted 69.6% and 77.8%, intracerebral hemorrhage 23.8% and 15.8%, subarachnoid hemorrhage 4.4% and 4.4%, and undetermined type 2.1% and 2.0%, respectively. Age-specific stroke prevalence in men aged ≥40 years was significantly greater than the prevalence in women (<0.001). The most prevalent risk factors among stroke survivors were hypertension (88%), smoking (48%), and alcohol use (44%). Stroke prevalence estimates in 2013 were statistically greater than those reported in China 3 decades ago, especially among rural residents (=0.017). The highest annual incidence and mortality of stroke was in Northeast (365 and 159/100 000 person-years), then Central areas (326 and 154/100 000 person-years), and the lowest incidence was in Southwest China (154/100 000 person-years), and the lowest mortality was in South China (65/100 000 person-years) (<0.002). CONCLUSIONS:Stroke burden in China has increased over the past 30 years, and remains particularly high in rural areas. There is a north-to-south gradient in stroke in China, with the greatest stroke burden observed in the northern and central regions.