心脑致宝平胶囊治疗高脂血症（痰瘀阻遏证）临床研究
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摘要
目的：
对心脑致宝平胶囊治疗高脂血症的临床有效性及其临床用药安全性做出评价,推荐临床使用方法。
方法：
1.对照药物选用安慰剂,采用分层区组随机、双盲单模拟、安慰剂平行对照的临床试验方法。将符合条件的36例患者分为治疗组18例(试验组病人每次口服心脑致宝平胶囊4粒,3次／日)；对照组18例(对照组病人每次口服安慰剂胶囊4粒,3次/日)。8周临床观察。两组患者的性别、年龄、病程及病情等方面比较,差异无显著性意义(P>0.05),具有可比性。
2.观察治疗前后中医症状和体征,计算症候积分。根据积分法判定中医症状疗效,并做统计学处理比较其疗效。
3.观察治疗前后血脂改变情况。
4.观察实验室检查血、尿、大便常规、心电图、肝功能(ALT、AST)、肾功能(BUN、Cr)、血脂(TC、TG、LDL-C、HDL-C)、CK检查等安全性指标,以检测心脑致宝平胶囊是否有毒副作用。
5.统计分析：将采用SPSS10.0统计分析软件进行计算。计量资料以X±S表示,采用t检验分析；计数资料采用X2检验,等级资料采用Ridit分析。
结果：
1.两组患者治疗前后中医症候积分比较(见表)：两组治疗后的中医症候积分均明显低于治疗前,统计学有显著差异(P<0.05)；两组治疗前后的中医症侯积分各自组间比较,治疗前两组无显著性差异(P>0.05),治疗后治疗组显著低于对照组,有显著性差异(P<0.05)。表明两组患者在治疗前后中医症候积分都有明显减低。但治疗组比对照组降低明显。
2.两组患者治疗前后中医症候改善比较(见表2)：治疗组总有效率88.90%,对照组总有效率50%,明显高于对照组,有显著性差异(P<0.05)。
3.两组患者治疗前后血脂改善比较(见表3)：治疗组组内比较,治疗后血脂四项与治疗前比较有显著性差异(P<0.05),与对照组治疗后比较有显著性差异(P<0.05)；对照组组内比较治疗前后比较无统计学意义。说明治疗组治疗后改善血脂,尤其能显著降低TC、TG、LDL-C。
4.两组患者安全性指标在治疗前后均没有出现异常情况,说明该药无毒副作用及不良反应。
结论：
心脑致宝平胶囊可以缓解患者头重、胸闷、肢麻沉重、恶心欲呕、口干不欲饮形体肥胖、心悸、眩晕、乏力等中医症状,改善和调节血脂代谢,显著减低TC、TG、LDL-C.但对HDL-C作用不明显,无明显的毒副作用和不良反应。推荐临床使用心脑致宝平胶囊治疗高脂血症(痰瘀阻遏证)。
Objective:
Xinnao Zhibaoping Capsules in treatment of hyperlipidemia clinical study effectiveness and clinical drug safety assessed. Recommend the clinical use.
Methods:
1.Control drug use placebo, stratified block randomized, double-blind, single-simulation, placebo-controlled clinical trial method,36 eligible patients were divided into treatment group,18 patients (test group of patients for each oral Xinnao Zhibaoping Capsules 4 capsules,3 times/day) and the control group,18 patients (control group patients in each placebo capsules 4 capsules,3 times/day).8 weeks clinical observation. Two groups of patients with sex, age, course of disease and illness, etc., the difference was not statistically significant (P<0.05), comparable.
2.Observation of TCM symptoms and signs before and after treatment to calculate symptom points. Under the integral method to determine efficacy of traditional Chinese medicine symptoms. And do statistical analysis to compare its efficacy.
3.Observed before and after treatment of blood lipid changes. Observation of laboratory tests of blood, urine, stool routine, electrocardiogram, liver function (ALT, AST), renal function (BUN, Cr), blood lipids, CK examination, electrocardiogram and other safety indicators, to detect Xinnao Zhibaoping Capsules whether the toxic side effects.
4.Statistical analysis:Statistical analysis software will be used SAS10.0calculated. Measurement information to S that the use of t test analysis; count data using X2 test, grade Ridit analysis of data used.
Results:
1.The two groups before and after treatment in patients with symptoms of integral medicine comparison (see Table 1):two points after treatment of Chinese medicine symptoms were significantly lower than before treatment, statistically significant differences (P<0.05); the two groups before and after treatment in Chinese medicine symptoms integration of their respective groups were compared before treatment was no significant difference between the two groups (P>0.05), treatment group after treatment was significantly lower than the control group, there is a significant difference (P<0.05). shows that the two groups before and after the traditional Chinese medicine in the treatment of patients with symptoms of points are markedly reduced. But the treatment group was significantly lower than in the control group.
2.Two groups before and after treatment in patients with symptoms of traditional Chinese medicine to improve the comparison (see table 2):the treatment group, the total efficiency of 88.90% do statistical analysis to compare its efficacy.
3.Observed before and after treatment of blood lipid changes. Observation of laboratory tests of blood, urine, stool routine, electrocardiogram, liver function (ALT, AST), renal function (BUN, Cr), blood lipids, CK examination, electrocardiogram and other safety indicators, to detect heart and brain caused by Bao-Ping Capsules whether the toxic side effects.
4.Statistical analysis:Statistical analysis software will be used SAS10. Ocalculated. Measurement information to S that the use of t test analysis; count data using X2 test, grade Ridit analysis of data used.
Results:
1.The two groups before and after treatment in patients with symptoms of integral medicine comparison (see Table 1):two points after treatment of Chinese medicine symptoms were significantly lower than before treatment, statistically significant differences (P<0.05); the two groups before and after treatment in Chinese medicine symptoms integration of their respective groups were compared before treatment was no significant difference between the two groups (P>0.05), treatment group after treatment was significantly lower than the control group, there is a significant difference (P<0.05). shows that the two groups before and after the traditional Chinese medicine in the treatment of patients with symptoms of points are markedly reduced. But the treatment group was significantly lower than in the control group.
2.Two groups before and after treatment in patients with symptoms of traditional Chinese medicine to improve the comparison (see table 2):the treatment group, the total efficiency of 88.90% in the control group, the total efficiency of 50%. Significantly higher than that, there is a significant difference (P<0.05).
3.Lipids to improve the two groups were compared before and after treatment (Table 3):the treatment group compared to 4 after treatment blood lipid (TC, TG, LDL-C, HDL-C) compared with before treatment there was significant difference (P<0.05), compared with the control group after treatment there was significant difference (P<0.05); control group, comparison group before and after treatment showed no statistical significance. Note After treatment, improvement of blood lipids, in particular, can significantly reduce TC, TG, LDL-C.
4. Two groups of patient safety indicators before and after treatment has been no unusual circumstances, the drug shows toxic side effects and adverse reactions.
Conclusions:
Xinnao Zhibaoping Capsules Chinese medicine can ease the symptoms, improve and regulate lipid metabolism, significantly reduced TC, TG, LDL-C. And a slight increase in the role of HDL-C, no obvious toxic side effects and adverse reactions. Recommend clinical use of Xinnao Zhibaoping Capsules in treatment of hyperlipidemia (phlegm and blood stasis deter card).
对心脑致宝平胶囊治疗高脂血症的临床有效性及其临床用药安全性做出评价,推荐临床使用方法。
方法：
1.对照药物选用安慰剂,采用分层区组随机、双盲单模拟、安慰剂平行对照的临床试验方法。将符合条件的36例患者分为治疗组18例(试验组病人每次口服心脑致宝平胶囊4粒,3次／日)；对照组18例(对照组病人每次口服安慰剂胶囊4粒,3次/日)。8周临床观察。两组患者的性别、年龄、病程及病情等方面比较,差异无显著性意义(P>0.05),具有可比性。
2.观察治疗前后中医症状和体征,计算症候积分。根据积分法判定中医症状疗效,并做统计学处理比较其疗效。
3.观察治疗前后血脂改变情况。
4.观察实验室检查血、尿、大便常规、心电图、肝功能(ALT、AST)、肾功能(BUN、Cr)、血脂(TC、TG、LDL-C、HDL-C)、CK检查等安全性指标,以检测心脑致宝平胶囊是否有毒副作用。
5.统计分析：将采用SPSS10.0统计分析软件进行计算。计量资料以X±S表示,采用t检验分析；计数资料采用X2检验,等级资料采用Ridit分析。
结果：
1.两组患者治疗前后中医症候积分比较(见表)：两组治疗后的中医症候积分均明显低于治疗前,统计学有显著差异(P<0.05)；两组治疗前后的中医症侯积分各自组间比较,治疗前两组无显著性差异(P>0.05),治疗后治疗组显著低于对照组,有显著性差异(P<0.05)。表明两组患者在治疗前后中医症候积分都有明显减低。但治疗组比对照组降低明显。
2.两组患者治疗前后中医症候改善比较(见表2)：治疗组总有效率88.90%,对照组总有效率50%,明显高于对照组,有显著性差异(P<0.05)。
3.两组患者治疗前后血脂改善比较(见表3)：治疗组组内比较,治疗后血脂四项与治疗前比较有显著性差异(P<0.05),与对照组治疗后比较有显著性差异(P<0.05)；对照组组内比较治疗前后比较无统计学意义。说明治疗组治疗后改善血脂,尤其能显著降低TC、TG、LDL-C。
4.两组患者安全性指标在治疗前后均没有出现异常情况,说明该药无毒副作用及不良反应。
结论：
心脑致宝平胶囊可以缓解患者头重、胸闷、肢麻沉重、恶心欲呕、口干不欲饮形体肥胖、心悸、眩晕、乏力等中医症状,改善和调节血脂代谢,显著减低TC、TG、LDL-C.但对HDL-C作用不明显,无明显的毒副作用和不良反应。推荐临床使用心脑致宝平胶囊治疗高脂血症(痰瘀阻遏证)。
Objective:
Xinnao Zhibaoping Capsules in treatment of hyperlipidemia clinical study effectiveness and clinical drug safety assessed. Recommend the clinical use.
Methods:
1.Control drug use placebo, stratified block randomized, double-blind, single-simulation, placebo-controlled clinical trial method,36 eligible patients were divided into treatment group,18 patients (test group of patients for each oral Xinnao Zhibaoping Capsules 4 capsules,3 times/day) and the control group,18 patients (control group patients in each placebo capsules 4 capsules,3 times/day).8 weeks clinical observation. Two groups of patients with sex, age, course of disease and illness, etc., the difference was not statistically significant (P<0.05), comparable.
2.Observation of TCM symptoms and signs before and after treatment to calculate symptom points. Under the integral method to determine efficacy of traditional Chinese medicine symptoms. And do statistical analysis to compare its efficacy.
3.Observed before and after treatment of blood lipid changes. Observation of laboratory tests of blood, urine, stool routine, electrocardiogram, liver function (ALT, AST), renal function (BUN, Cr), blood lipids, CK examination, electrocardiogram and other safety indicators, to detect Xinnao Zhibaoping Capsules whether the toxic side effects.
4.Statistical analysis:Statistical analysis software will be used SAS10.0calculated. Measurement information to S that the use of t test analysis; count data using X2 test, grade Ridit analysis of data used.
Results:
1.The two groups before and after treatment in patients with symptoms of integral medicine comparison (see Table 1):two points after treatment of Chinese medicine symptoms were significantly lower than before treatment, statistically significant differences (P<0.05); the two groups before and after treatment in Chinese medicine symptoms integration of their respective groups were compared before treatment was no significant difference between the two groups (P>0.05), treatment group after treatment was significantly lower than the control group, there is a significant difference (P<0.05). shows that the two groups before and after the traditional Chinese medicine in the treatment of patients with symptoms of points are markedly reduced. But the treatment group was significantly lower than in the control group.
2.Two groups before and after treatment in patients with symptoms of traditional Chinese medicine to improve the comparison (see table 2):the treatment group, the total efficiency of 88.90% do statistical analysis to compare its efficacy.
3.Observed before and after treatment of blood lipid changes. Observation of laboratory tests of blood, urine, stool routine, electrocardiogram, liver function (ALT, AST), renal function (BUN, Cr), blood lipids, CK examination, electrocardiogram and other safety indicators, to detect heart and brain caused by Bao-Ping Capsules whether the toxic side effects.
4.Statistical analysis:Statistical analysis software will be used SAS10. Ocalculated. Measurement information to S that the use of t test analysis; count data using X2 test, grade Ridit analysis of data used.
Results:
1.The two groups before and after treatment in patients with symptoms of integral medicine comparison (see Table 1):two points after treatment of Chinese medicine symptoms were significantly lower than before treatment, statistically significant differences (P<0.05); the two groups before and after treatment in Chinese medicine symptoms integration of their respective groups were compared before treatment was no significant difference between the two groups (P>0.05), treatment group after treatment was significantly lower than the control group, there is a significant difference (P<0.05). shows that the two groups before and after the traditional Chinese medicine in the treatment of patients with symptoms of points are markedly reduced. But the treatment group was significantly lower than in the control group.
2.Two groups before and after treatment in patients with symptoms of traditional Chinese medicine to improve the comparison (see table 2):the treatment group, the total efficiency of 88.90% in the control group, the total efficiency of 50%. Significantly higher than that, there is a significant difference (P<0.05).
3.Lipids to improve the two groups were compared before and after treatment (Table 3):the treatment group compared to 4 after treatment blood lipid (TC, TG, LDL-C, HDL-C) compared with before treatment there was significant difference (P<0.05), compared with the control group after treatment there was significant difference (P<0.05); control group, comparison group before and after treatment showed no statistical significance. Note After treatment, improvement of blood lipids, in particular, can significantly reduce TC, TG, LDL-C.
4. Two groups of patient safety indicators before and after treatment has been no unusual circumstances, the drug shows toxic side effects and adverse reactions.
Conclusions:
Xinnao Zhibaoping Capsules Chinese medicine can ease the symptoms, improve and regulate lipid metabolism, significantly reduced TC, TG, LDL-C. And a slight increase in the role of HDL-C, no obvious toxic side effects and adverse reactions. Recommend clinical use of Xinnao Zhibaoping Capsules in treatment of hyperlipidemia (phlegm and blood stasis deter card).
引文
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