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Background: Significant challenges are associated with the pharmacological management of dyslipidemia, an important risk factor for cardiovascular disease. Limited reliable evidence exists regarding the efficacy of red yeast rice (RYR)-containing commercial Chinese polyherbal preparation (CCPP), despite their widespread use in China. Purpose: We aimed to investigate the efficacy of RYR-containing CCPPs combined with statins in treating dyslipidemia. Methods: Eight databases were searched for relevant randomized controlled trials (RCTs) from database inception date to November 2023. Outcome measures, including low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglyceride (TG), clinical efficacy, and adverse reactions, were assessed. The Cochrane Handbook for Systematic Reviews of Interventions was used for quality evaluation, and the meta-analysis was conducted using RevMan 5.3 and Stata 15.1. Results: Thirty-three studies involving 4,098 participants were included. The combination of RYR-containing CCPP, such as Xuezhikang (XZK), Zhibitai (ZBTAI), or Zhibituo (ZBTUO) with statins had a significant effect on the increase in clinical efficacy [RR:1.16, 95%CI (1.13, 1.19), p < 0.00001]. In addition, they also improved blood lipid profile parameters by increasing HDL-C levels [MD:0.21, 95%CI(0.17, 0.25), p < 0.00001], and decreasing TC [MD: 0.60, 95%CI(-0.76, -0.45), p < 0.00001], TG [MD: 0.33, 95%CI(-0.39, -0.26), p < 0.00001] and LDL-C levels [MD: 0.45, 95%CI(-0.54, -0.36), p < 0.00001]. No significant adverse reactions was observed in the RYR-containing CCPPs. Notably, ZBTAI and XZK significantly reduced the incidence of gastrointestinal disturbances and muscular adverse reactions. However, subgroup analyses suggested that the type of CCPPs, dose, and treatment duration might affect the efficacy of RYR-containing CCPPs. Conclusion: RYR-containing CCPPs combined with statins appears to improve lipid profiles and clinical efficacy in patients with dyslipidemia. However, due to the poor quality of the included studies, and some studied showing negative findings was unpublished. The results should be interpreted with caution until further confirmation by well-designed RCTs. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=487402, identifier CRD42023487402.
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Objective:To observe the effect of Zhibitai capsule combined with pitavastatin on blood lipid levels in pa-tients with coronary heart disease(CHD).Methods:A total of 180 CHD patients who were treated in our hospital from Mar 2018 to Feb 2021 were selected.According to random number table method,they were divided into pita-vastatin group(n=90)and combined treatment group(n=90,received Zhibitai capsule combined with pitavasta-tin),and both groups were treated for eight weeks.Clinical therapeutic effect,levels of blood lipids and inflamma-tory factors before and after treatment,and incidence of adverse reactions were observed and compared between two groups.Results:Total effective rate of combined treatment group was significantly higher than that of pitavas-tatin group(94.44％vs.80.00％,P=0.001).Compared with pitavastatin group after treatment,there were signif-icant reductions in serum levels of total cholesterol(TC)[(4.39±0.71)mmol/L vs.(2.86±0.56)mmol/L],tri-glyceride(TG)[(2.28±0.43)mmol/L vs.(1.46±0.39)mmol/L],low density lipoprotein cholesterol(LDL-C)[(2.93±0.50)mmol/L vs.(1.84±0.52)mmol/L],lipoprotein(a)[(124.57±11.37)mmol/L vs.(85.83± 11.96)mmol/L],interleukin-6(IL-6)[(21.28±3.64)pg/mlvs.(12.39±2.08)pg/ml],high mobility group box-1 protein B1(HMGB1)[(3.84±0.98)μg/L vs.(1.28±0.79)μg/L],tumor necrosis factor-α(TNF-α)[(4.06±0.62)ng/ml vs.(2.39±0.48)ng/ml],and significant rise in level of high density lipoprotein cholesterol(HDL-C)[(1.89±0.26)mmol/L vs.(2.63±0.31)mmol/L]in combined treatment group,P=0.001 all.There was no significant difference in incidence rate of adverse reactions between two groups,P=0.600.Conclu-sion:Zhibitai capsule combined with pitavastatin can effectively regulate blood lipids,reduce the levels of inflamma-tory factors in patients with coronary heart disease,which is safe and effective.
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Objective:To investigate the efficacy of Zhibitai capsules combined with low-dose atorvastatin in the treatment of cervical arteriosclerosis and its effects on high-sensitivity C-reactive protein and regulatory T cells in the peripheral blood. Methods:A total of 104 patients with carotid arteriosclerosis admitted to Fenyang Hospital from January 2021 to April 2022 were retrospectively included in this study. They were divided into a control group ( n = 52) and an observation group ( n = 52) according to different treatment methods. The control group was orally given atorvastatin calcium tablets 20 mg once a day. The observation group was orally given atorvastatin calcium tablets 10 mg once a day, and Zhibitai capsules 0.24 g, one capsule in the morning and one capsule in the evening. After 8 weeks of treatment, changes in total cholesterol, triacylglycerol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, high-sensitivity C-reactive protein, and regulatory T cell proportion in the peripheral blood were evaluated. Results:After treatment, high-density lipoprotein cholesterol level and regulatory T cell proportion in the observation group were (1.53 ± 0.29) mmol/L and (5.52 ± 1.38)%, respectively, which were significantly higher than (1.19 ± 0.21) mmol/L and (4.48 ± 0.86)% respectively in the control group ( t = 6.84, 4.61, both P < 0.05). Total cholesterol, triacylglycerol, low-density lipoprotein cholesterol, and high-sensitivity C-reactive protein levels in the observation group were (2.88 ± 0.27) mmol/L, (1.21 ± 0.15) mmol/L, (2.01 ± 0.19) mmol/L, (2.58 ± 0.43) mg/L, respectively, which were significantly lower than (3.68 ± 0.41) mmol/L, (1.33 ± 0.19) mmol/L, (2.69 ± 0.31) mmol/L, (3.70 ± 0.25) mg/L, respectively in the control group ( t = 11.75, 3.57, 12.31, 17.23, all P < 0.05). There was no significant difference in carotid plaque size pre-treatment between the two groups, but the plaque size decreased after treatment compared with before treatment. The efficacy of Zhibitai capsules combined with low-dose atorvastatin in the treatment of cervical arteriosclerosis in the observation group was superior to that in the control group ( P < 0.05). Conclusion:Oral administration of Zhibitai capsules combined with low-dose atorvastatin for the treatment of cervical arteriosclerosis is safe and has few adverse reactions. The combined therapy can decrease serum high-sensitivity C-reactive protein levels, increase the proportion of regulatory T cells in the peripheral blood, help stabilize plaques, and reduce plaque size.
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Objective:To investigate the effects of Zhibitai capsule combined with pitavastatin calcium tablets on blood lipids, blood glucose, and glycated hemoglobin in patients with coronary heart disease complicated by diabetes mellitus. Methods:A total of 100 patients with coronary heart disease and diabetes mellitus who received treatment in The Third Affiliated Hospital of Jinzhou Medical University from January 2017 to June 2020 were included in this study. They were divided into a control group ( n = 50) and an observation group ( n = 50) according to different treatment methods. Both groups were given conventional treatment such as pitavastatin calcium tablets. The control group was given pitavastatin calcium tablets based on conventional treatment. The observation group was given Zhibitai capsule combined with pitavastatin calcium tablets based on conventional treatment. After 6 months of treatment, serum levels of triacylglycerol, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, fasting plasma glucose, and glycated hemoglobin were compared between the two groups. Results:After treatment, serum levels of triacylglycerol, total cholesterol, low-density lipoprotein cholesterol, fasting plasma glucose, glycated hemoglobin in the observation group were (4.26 ± 0.67) mmol/L, (1.85 ± 0.38) mmol/L, (3.16 ± 0.27) mmol/L, (8.29 ± 1.07) mmol/L, and (8.20 ± 0.77)%, respectively, and they were (4.50 ± 0.39) mmol/L, (1.99 ± 0.19) mmol/L, (3.28 ± 0.27) mmol/L, (8.80 ± 0.66) mmol/L, (8.54 ± 0.74)%, respectively in the control group. After treatment, these indices in each group were decreased compared with those before treatment (control group: t = 19.56, 14.60, 10.66, 8.60, 10.18; observation group: t = 15.04, 14.68, 11.36, 12.36, 12.89, all P < 0.05). After treatment, these indices in the observation group were significantly lower than those in the control group ( t = -2.12, -2.23, 2.26, -2.84, -2.44, all P < 0.05). After treatment, the level of high-density lipoprotein cholesterol in the observation and control groups was (1.16 ± 0.18) mmol/L and (1.09 ± 0.13) mmol/L, respectively. After treatment, the level of high-density lipoprotein cholesterol in each group was increased compared with that before treatment (control group: t = -11.10, observation group: t = -11.07, P < 0.05). After treatment, the level of high-density lipoprotein cholesterol in the observation group was significantly higher than that in the control group ( t = 2.11, P < 0.05). Conclusion:Zhibitai capsule combined with pitavastatin calcium tablets can greatly improve the level of blood lipids and blood glucose in patients with coronary heart disease complicated by diabetes mellitus.
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Objective: To evaluate the efficacy and safety of Zhibitai (ZBT) in the treatment of patients with hyperlipidemia (HLP). Methods: A search of 8 electronic databases was conducted to find randomized controlled trials (RCTs), to evaluate the efficacy and safety of ZBT for the treatment of HLP. The risk of bias in randomized controlled trials was assessed by using the Cochrane Collaboration Risk of Bias tool for randomized controlled trials 2.0 (RoB 2.0). The primary outcomes were the levels of triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). The total effective rate served as the secondary outcome. The incidence of adverse events was considered the safety outcome. Review Manager 5.4 was used to conduct meta-analyses. Data were pooled by random-effects or fixed-effects model to obtain the mean difference (MD), risk ratio (RR), odds ratio (OR), and 95% confidence interval (CI). Results: There were 28 eligible RCTs with a total of 2,952 participants. Overall, we verified that ZBT plus conventional therapy (CT) was superior to CT for the treatment of HLP [TC: MD = -0.50, 95% CI (-0.80, -0.19); TG: MD = -0.38, 95% CI (-0.49, -0.27); LDL-C: MD = -0.50, 95% CI (-0.69, -0.31); HDL-C: MD = 0.17, 95% CI (0.11, 0.24); total effective rate: OR = 4.26, 95% CI (2.28, 7.95)]. There were no significant differences in the primary outcomes between ZBT alone vs. CT (p > 0.05). For safety, the ZBT group (with CT or alone) outperformed the CT group [ZBT alone: RR = 0.51, 95% CI (0.32, 0.81); ZBT plus CT: RR = 0.51, 95% CI (0.30, 0.89)]. For each outcome, the subgroups and the sensitivity analysis matched the overall results. Conclusion: ZBT may be safe and beneficial to HLP patients, especially for serum lipid management. ZBT can be used along with CT for the treatment of HLP. However, it is necessary to conduct more rigorous RCTs to confirm these findings. Systematic Review Registration: [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42022316251].
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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.
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Doença das Coronárias , Medicamentos de Ervas Chinesas , Inibidores de Hidroximetilglutaril-CoA Redutases , Cápsulas , China , Humanos , LipídeosRESUMO
Objective:To observe the clinical efficacy of Zhibitai capsule in the treatment of dyslipidemia with phlegm-stasis binding pattern, in order to evaluate its effectiveness and safety. Method:Totally 82 patients of dyslipidemia with phlegm-stasis binding pattern were selected from the outpatient department of internal medicine in Hospital of Xidian University from July 2018 to July 2019. According to the random number table method, they were divided into control group and observation group, with41 cases in each group. Control group was treated with aAtorvastatin calcium, and observation group was treated with Zhibitai capsules. The changes in blood lipid index, liver function and renal function were measured before and after 8-week treatment in two groups, the efficacy on traditional Chinese medicine (TCM) syndromes and clinical symptom scores before and after treatment were compared between two groups, and the adverse reactions, such as liver pain and muscle pain, were recorded among patients. Result:The changes of blood lipids were compared after 8 weeks of treatment, total cholesterol (TC), triglyceride (TG), and low-density lipoprotein cholesterol (LDL-C) were all lower than before, while high-density lipoprotein cholesterol (HDL-C) was increased (P<0.05), the total effective rate in control group was 90.24% (37/41), which was 92.68% (38/41) in observation group, with no significant difference between two groups, in the TCM syndrome scores of two groups before and after treatment, four common TCM syndromes, namely scores dizziness, chest tightness, head heavy as if swathed and chest fullness, were decreased (P<0.05). In terms of the efficacy of two groups of TCM syndromes, the total effective rate in control group was 87.80% (36/41), which was 92.68% (38/41) in observation group, with no statistically significant difference between two groups. Control group had 3 cases of increased transaminase, but none of them beyond 2 times of the normal upper limit, and observation group had 1 case of mild abdominal distension and nausea, which did not affect continued medication. No muscle pain or liver pain occurred in two groups. Conclusion:Zhibitai capsule is effective in treating dyslipidemia, which is comparable to atorvastatin calcium in treating dyslipidemia, with the safety and reliability.
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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.
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Humanos , Cápsulas , China , Doença das Coronárias , Medicamentos de Ervas Chinesas , Inibidores de Hidroximetilglutaril-CoA Redutases , LipídeosRESUMO
Objective To study the effect of Zhibitai capsule on blood lipids,blood glucose and omentin in hyperlipidemic rats. Methods Thirty SPF male rats were randomly divided into control group,model group and Zhibitai group. The control group was fed with common diet,while the rest rats were fed with high - fat diet. After the model was successfully established,the Zhibitai group was orally administered 8mg/ kg Zhibitai capsule powder twice daily,the rats in the control group and the model group were given the same amount of normal saline respectively. After 4 weeks,the serum levels of total cholesterol (TC),triglyceride (TG),high density lipoprotein (HDL - C),low density lipoprotein (LDL - C),blood glucose and omentin were evaluated. Results Compared with the model group, the serum levels of TC[(3. 97 ± 0. 62) mmol/ L vs. (6. 33 ± 1. 10) mmol/ L,t = 5. 910,P < 0. 01],TG[(1. 51 ± 0. 47)mmol/ L vs. (2. 18 ± 0. 64)mmol/ L,t = 2. 472,P < 0. 05]and LDL - C[(0. 30 ± 0. 04)mmol/ L vs. (0. 48 ± 0. 16)mmol/ L,t = 3. 451,P < 0. 01)] of the Zhibitai group were significantly decreased,the HDL - C level was significantly increased[(1. 35 ± 0. 28) mmol/ L vs. (1. 06 ± 0. 31) mmol/ L,t = 2. 195,P < 0. 05],blood glucose decreased significantly[(5. 04 ±0. 82)mmol/ L vs. (6. 43 ± 1. 10)mmol/ L,t = 3. 204,P < 0. 01],and the concentration of omentin was significantly increased[(68. 59 ± 24. 82) ng/ L vs. (46. 86 ± 20. 12) ng/ L,t = 2. 151,P < 0. 05]. Conclusion Zhibitai capsule can effectively reduce the serum levels of TC,TG and LDL - C of hyperlipidemic rats and increase the content of HDL - C,effectively reduce blood sugar,and can increase the content of omentin.
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Objective To study the effect of atorvastatin combined with Zhibitai in the treatment of coronary heart disease with hyperlipidemia and its influence on the level of high-sensitivity C-reactive protein ( hsCRP). Methods A total of 136 patients with coronary heart disease and hyperlipidemia admitted to the Third People 's Hospital of Jingdezhen from September 2016 to September 1818 were randomly divided into control group and combi-nation group using stochastic comprehensive balance method , with 68 cases in each group.The control group was treated with atorvastatin and the combination group was treated with lipidine plus atorvastatin .The patient's treatment effect,including the blood lipid compliance rate and the occurrence of adverse reactions during the treatment were observed,as well as the patient's pre-and post-treatment triglyceride ( TG),12h serum total cholesterol ( TC), high-density lipoprotein-cholesterol ( HDL-C), low density lipoprotein-cholesterol ( LDL-C) and high-sensitivity C-reactive protein(hsCRP)and other indicators were measured.Results (1)The blood lipid compliance rate(89.86%) in the combined group was higher than that in the control group (59.70%),the difference was statis-tically significant(χ2 ＝14.915,P＝0.000).(2)The incidence of adverse reactions in the combined group (1.45%) was lower than that in the control group (17.91%), the difference was statistically significant ( χ2 ＝8.836, P ＝ 0.003).(3)The results showed that the TC,TG,LDL-C,hsCRP and other indicators of the combined group were lower than those of the control group and before treatment ,while the HDL-C index of the combined groupwas higher than that of the control group and before treatment ,the differences were statistically significant ( t＝20.800,4.903, 11.657,4.346,6.262,P＝0.000,0.000,0.000,0.000,0.000).Conclusion Zhibitai combined with atorvastatin in the treatment of coronary heart disease patients with hyperlipidemia has remarkable effect .It can accurately control TC,TG,LDL-C,HDL-C and hsCRP,improve blood lipid control rate.
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Objective To study the effect of Zhibitai capsule on blood lipids,blood glucose and omentin in hyperlipidemic rats.Methods Thirty SPF male rats were randomly divided into control group, model group and Zhibitai group.The control group was fed with common diet,while the rest rats were fed with high－fat diet.After the model was successfully established,the Zhibitai group was orally administered 8mg/kg Zhibitai capsule powder twice daily,the rats in the control group and the model group were given the same amount of normal saline respectively. After 4 weeks,the serum levels of total cholesterol (TC),triglyceride (TG),high density lipoprotein (HDL－C),low density lipoprotein (LDL－C),blood glucose and omentin were evaluated.Results Compared with the model group, the serum levels of TC[(3.97 ± 0.62) mmol/L vs.(6.33 ± 1.10) mmol/L,t =5.910,P <0.01],TG[(1.51 ± 0.47)mmol/L vs.(2.18 ± 0.64)mmol/L,t=2.472,P<0.05]and LDL－C[(0.30 ± 0.04)mmol/L vs.(0.48 ± 0.16) mmol/L, t =3.451, P <0.01)] of the Zhibitai group were significantly decreased,the HDL －C level was significantly increased[(1.35 ± 0.28) mmol/L vs.(1.06 ± 0.31) mmol/L,t =2.195,P <0.05],blood glucose decreased significantly[(5.04 ± 0.82)mmol/L vs.(6.43 ± 1.10)mmol/L,t=3.204,P<0.01],and the concentration of omentin was significantly increased[(68.59 ± 24.82) ng/L vs.(46.86 ± 20.12) ng/L,t =2.151,P <0.05]. Conclusion Zhibitai capsule can effectively reduce the serum levels of TC,TG and LDL－C of hyperlipidemic rats and increase the content of HDL－C,effectively reduce blood sugar,and can increase the content of omentin.
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Objective@#To study the effect of atorvastatin combined with Zhibitai in the treatment of coronary heart disease with hyperlipidemia and its influence on the level of high-sensitivity C-reactive protein(hsCRP).@*Methods@#A total of 136 patients with coronary heart disease and hyperlipidemia admitted to the Third People's Hospital of Jingdezhen from September 2016 to September 1818 were randomly divided into control group and combination group using stochastic comprehensive balance method, with 68 cases in each group.The control group was treated with atorvastatin and the combination group was treated with lipidine plus atorvastatin. The patient's treatment effect, including the blood lipid compliance rate and the occurrence of adverse reactions during the treatment were observed, as well as the patient's pre-and post-treatment triglyceride(TG), 12h serum total cholesterol(TC), high-density lipoprotein-cholesterol(HDL-C), low density lipoprotein-cholesterol(LDL-C)and high-sensitivity C-reactive protein(hsCRP)and other indicators were measured.@*Results@#(1)The blood lipid compliance rate(89.86%) in the combined group was higher than that in the control group(59.70%), the difference was statistically significant(χ2=14.915, P=0.000). (2)The incidence of adverse reactions in the combined group(1.45%) was lower than that in the control group(17.91%), the difference was statistically significant(χ2=8.836, P=0.003). (3)The results showed that the TC, TG, LDL-C, hsCRP and other indicators of the combined group were lower than those of the control group and before treatment, while the HDL-C index of the combined groupwas higher than that of the control group and before treatment, the differences were statistically significant(t=20.800, 4.903, 11.657, 4.346, 6.262, P=0.000, 0.000, 0.000, 0.000, 0.000).@*Conclusion@#Zhibitai combined with atorvastatin in the treatment of coronary heart disease patients with hyperlipidemia has remarkable effect.It can accurately control TC, TG, LDL-C, HDL-C and hsCRP, improve blood lipid control rate.
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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 P < 0.05) in both groups but had no significant differences between the two groups (P > 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 (P < 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 (P < 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 (P < 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.
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The components of Zhibitai capsules are based on classic Chinese traditional medicinal formula, including natural statin, statin homologue, triterpenes and flavonoids. Zhibitai capsules is effective on dyslipidemia by inhibiting cholesterol synthesis and absorption. Several randomized clinical trials in Chinese patients have shown that Zhibitai capsules could reduce low density lipoprotein cholesterol (LDL-C) by 18%-34% and triglycerin (TG) by 30%.Zhibitai capsules had less side effects compared to statins, which interpreted a synergistic effect with Zhibitai capsules. Although no evidence has been proved to use Zhibitai capsules as prophylaxis of cardiovascular diseases, Zhibitai capsules is still an alternative choice of both primary and secondary prophylaxis of cardiovascular diseases.
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Povo Asiático , Cápsulas , Doenças Cardiovasculares/prevenção & controle , LDL-Colesterol/efeitos dos fármacos , Medicamentos de Ervas Chinesas/uso terapêutico , Dislipidemias/tratamento farmacológico , Consenso , Medicamentos de Ervas Chinesas/farmacologia , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases , Prevenção SecundáriaRESUMO
Objective To explore the effect of Zhibitai capsule in the treatment of elderly coronary artery disease patients with normal lipid,and to investigate its influence on prognosis.Methods 90 elderly coronary artery disease patients with normal lipid were randomly divided into the control group (n =30),the treatment group 1 (n =30) and the treatment group 2 (n =30).The control group received routine treatment,once a day for 2 months.The treatment group 1 received the Xuezhikang capsule,once a day for 2 months.The treatment group 2 received the Zhibitai capsule,once a day for 2 months.The expression of inflammatory factors,the level of blood fat,the maintenance rate of sinus rhythm and the incidence rate of embolism before and after treatment were compared among the three groups.Results After treatment,the levels of hs-CRP,IL-6,TNF-α,TC,TG,LDL-C of the three groups were significantly lower than those before treatment(P ＜ 0.05),and the level of HDL-C was significantly higher than before treatment (P ＜ 0.05).The levels of hs-CRP,IL-6,TNF-α,TC,TG,LDL-C in the treatment group 2 were significantly lower and the level of HDL-C was significantly higher than the other two goups (P ＜ 0.05).Moreover,the differences between the control group and the treatment group 1 were not statistically significant.The maintenance rate of sinus rhythm of the treatment group 2 was significantly higher and the incidence rate of embolism was significantly lower than the treatment group 1.Conclusion For elderly coronary artery disease patients with normal lipid,the Zhibitai capsule has ideal effect in controlling inflammation,which can delay the progress of atherosclerosis,decrease the major cardiovascular events and better than the Xuezhikang capsule.
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Objective To observe the influence of Zhibitai capsule combined with atorvastatin calcium tablet on blood lipid and inflammatory factors in elder patients with dyslipidemia. Methods Sixty-four elder patients with dyslipidemia were randomly divided into control group and treatment group, with 32 cases in each group. Patients of the control group were treated with atorvastatin calcium tablet (10 mg, qd, bedtime administration), while patients in the treatment group were given Zhibitai capsule (240 mg, bid) for 6 weeks. Serum levels of TC, TG, HDL-C, LDL-C, tumor necrosis factor-alpha ( TNF-α) and interleukin-6 (IL-6) were measured before and after treatment. Results After treatment, compared with the control group, TC [(5. 18±0. 57) mmol·L-1 vs. (5. 73±0. 65)mmol·L-1], TG [(1. 52±0. 43) mmol·L-1 vs. (1. 86±0. 48) mmol·L-1], LDL-C [(3. 36±0. 48) mmol·L-1 vs. (3. 85±0. 53)mmol·L-1], TNF-α[(5. 37±2. 21) ng·L-1 vs. (7. 63±2. 59) ng·L-1] and IL-6 [(12.27±2.75) ng·L-1 vs. (15. 63±2. 92) ng·L-1] were significantly decreased (P<0. 01 for all); however, HDL-C [(1. 26±0. 25) mmol·L-1 vs. (1. 13±0. 23) mmol·L-1] was significantly increased in the patients of treatment group (P<0. 05). Conclusion Zhibitai capsule combined with atorvastatin calcium tablet may not only regulate blood lipid level, but also decrease serum tumor necrosis factor-alpha and interleukin-6 so as to inhibit inflammation reaction in elder patients with dyslipidemia.
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Objective To analyze the lipid levels in liver damage.Methods 82 patients with liver damage were divided into the study group(41 patients)and control group(41 patients),the control group patients were given treatment of atorvastatin,while the study group patients were given treatment of Zhibitai,the lipid metabolism of the two groups were compared.Results In the study group,levels of TC (5.16 ±0.8)mmol/L,TG(1.90 ±0.08)mmol/L,LDL(2.03 ±0.11)mmol/L were significantly lower than before treatment TC(5.82 ±1.26)mmol/L (t =4.38, P <0.05),TG(2.16 ±0.85)mmol/L (t =6.37,P <0.05),LDL(3.67 ±0.09)mmol/L (t =6.42).The HDL level (1.39 ±0.26)mmol/L was significantly increased (0.86 ±0.21)mmol/L (t =7.52,P <0.05)after 4 weeks treat-ment(P <0.05).The incidence of adverse events in the study group (7.3%)was significantly lower than the control group (17.1%)(P <0.05).Conclusion Zhibitai is safe and effective with use value in the treatment of liver dys-function.
