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Objective:To evaluate the clinical efficacy rate, vascular endothelial relaxation factor NO and safety of five different Chinese patent medicines combined with western medicine in the treatment of coronary microvascular disease (CMVD).Methods:Randomized controlled trials (RCTs) of Shexiang Baoxin Pills, Tongxinluo Capsules, Compound Danshen Dripping Pills, Yindan Xinnaotong Soft Capsules, and Xinkeshu Tablets combined with conventional western medicine therapy in the treatment of CMVD were retrieved from China National Knowledge Infrastructure (CNKI), China Academic Journal Database (Wanfang Data), Chinese Science and Technology Journal Database (Chongqing VIP), China Biomedical Literature Service System (SinoMed), PubMed, Cochrance Library and Embase databases from the establishment of the database to June 2022. The literature was imported and screened by EndNote software, and the risk quality of literature bias was evaluated by Revman 5.4 software. StataSE16 (64-bit) software was used for reticular meta analysis to compare the differences in clinical efficacy and drug safety of five proprietary Chinese medicines combined with western medicine.Results:A total of 24 RCT studies were included, 24 of which were double-arm studies, and five kinds of proprietary Chinese medicine combined with western medicine were compared. The results of reticular meta analysis: in terms of improving the clinical effective rate, the order of the five proprietary Chinese medicine combination groups was as follows: Yindan Xinnaotong Soft Capsules group > Shexiang Baoxin Pills group > Tongxinluo Capsules group > Xinkeshu Tablets group > Compound Danshen Dripping Pills group. In terms of regulating vasodilation factor NO, the order of the four proprietary Chinese medicine combination groups is as follows: Yindan Xinnaotong Soft Capsules group > Compound Danshen Dripping Pills group > Tongxinluo Capsules group > Shexiang Baoxin Pills group. In terms of safety, there were 3 reports of adverse reactions in the research literature of the five proprietary Chinese medicines.Conclusions:The clinical efficacy rate of five kinds of proprietary Chinese medicine combined with western medicine routine regimen is better than that of western medicine routine regimen alone, and the combination group of four kinds of proprietary Chinese medicine is superior to western medicine in regulating vasodilation factor NO, and Yindan Xinnaotong Soft Capsules group is superior in clinical efficacy rate and regulation of vasodilation factor NO. However, the quality and samples of this study are different, and the comparison of the curative effect of the combined group of proprietary Chinese medicine still needs a large sample and high-quality RCT study to demonstrate.
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Objective: To systematically evaluate the efficacy and safety of Xinkeshu combined with conventional western medicine in the treatment of unstable angina pectoris. Methods: The randomized controlled clinical trials of Xinkeshu combined with conventional western medicine for the treatment of unstable angina pectoris were searched from PubMed database, Viper database, CNKCN, Wanfang database and other databases from the establishment of the database to April 2020.The literatures were screened according to inclusion and exclusion criteria, and Rev Man5.3 software was used for Meta analysis. Results: A total of 1569 patients were included in 19 randomized controlled trials. Meta-analysis results showed that Xinkeshu combined with conventional western medicine reduced the frequency of angina attacks (SMD=-1.16, 95%CI [-1.75, -0.57], P=0.000 1), decreased the duration of angina (MD=-2.75, 95%CI [-3.77, -1.73], P < 0.000 01), reduced the dosage of nitroglycerin (MD=-0.67, 95%CI [-0.78, -0.56], P < 0.000 01), improved ECG efficacy (RR=1.26, 95%CI [1.18, 1.35], P < 0.000 01), angina pectoris efficacy (RR=1.26, 95%CI [1.20, 1.33], P < 0.000 01), decreased triglyceride (MD=-0.57, 95%CI [-1.02, -0.12], P=0.01), total cholesterol (MD=-0.78, 95%CI [-1.15, -0.41], P < 0.000 1), low-density lipoprotein cholesterol (MD=-0.58, 95%CI [-0.80, -0.36], P < 0.000 01), raised high-density lipoprotein cholesterol (MD=0.24, 95%CI [0.08, 0.40], P=0.004), decreased whole blood viscosity (MD=-1.32, 95%CI [-2.25, -0.39], P=0.005), and plasma viscosity (MD=-0.29, 95%CI [-0.38,-0.21], P < 0.000 01), fibrinogen (MD=-1.06, 95% CI [1.29, 0.83], P < 0.000 01), lower C-reactive protein (MD=-1.70, 95% CI [2.33, 1.06], P < 0.000 01), endothelin 1 (MD=-7.81, 95% CI [10.05, 5.57], P < 0.000 01), and homocysteine (MD=-2.35, 95% CI [2.63, 2.07], P < 0.000 01), improved the effect of nitric oxide (MD=8.74, 95%CI [7.00, 10.47], P < 0.000 01), which was better than that of the pure western medicine group, and subgroup analysis results showed that the treatment course was greater than or equal to three months with better treatment. There was no statistically significant difference in the incidence of adverse reactions (P=0.56), liver and kidney function were not abnormal in all the studies. Conclusion: Clinical application of Xinkeshu combined with conventional western medicine in the treatment of unstable angina pectoris is clear, which is recommended in clinical application.
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Objective: To explore the mechanism of the intervention of Xinkeshu Tablets (XKST) on atherosclerosis (AS) and provide reference for the secondary development and clinical application of XKST. Methods: The integrated pharmacology platform was used to predict the key targets and pathways of the intervention of XKST on AS and its molecular mechanism was also explored. Results: In the integrative analysis of heterogeneous network of “TCM-component-target-pathway”, 80 relevant effective ingredients were found, including B4GALT4, B4GALT2, PRKCD, GCK, GNB1, and other key targets; Endocrine system, thyroid hormone signaling pathway, nervous system, estrogen signaling pathway, and chemokine signaling pathway were key pathways related with its anti-atherosclerosis. Conclusion: According to the analysis and prediction of the enrichment information, the effect of XKST on common regulating PI3K/Akt/eNOS and Raf/MEK/ERK signaling pathway and protecting vascular endothelial cells is first prompted, thus achieving the intervention in AS.
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To evaluate the clinical effect and safety of Xinkeshu Tablets on the double heart disease in coronary heart disease with depression systematically. The relative randomized controlled trials about Xinkeshu Tablets in the treatment of double heart disease in coronary heart disease with depression from 1979 to 2015 were searched in database like CNKI, WanFang data, CBM, Embase, Pubmed, and Cochrane Library. Studies were screened, data were extracted, and methodological quality was evaluated. Meta-analysis was then performed using Review Manager 5.1 software. Totally 11 kinds of studies and 961 patients were involved in this study. Xinkeshu Tablets combined with conventional Western medicine therapy was superior to pure conventional Western medicine therapy in clinical effect of coronary heart disease and improve of HAMD scores with the RR of 1.15 (1.07, 1.23) and 1.39 (1.07, 1.79) respectively. On the basis of available evidence, Xinkeshu Tablets combined with conventional Western medicine therapy has a certain effect on the double heart disease in coronary heart disease with depression, but more clinical study with big samples and high quality should be done to confirm the efficacy and safety.
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OBJECTIVE:To observe the efficacy and safety of amlodipine besylate combined with Xinkeshu in the treatment of hypertension. METHODS:100 patients with hypertension were randomly divided into control group (50 cases) and observation group(50 cases). Control group was orally given one Amlodipine besylate tablet,once a day;observation group was additionally given 4 Xinkeshu tablets,3 times a day. The treatment course was 8 weeks. Clinical efficacy,systolic blood pressure(SBP)and di-astolic blood pressure(DBP)before and after treatment in 2 groups were observed,the incidence of adverse reactions was record-ed. RESULTS:The total effective rate in observation group was significantly higher than control group,the incidence of adverse re-actions was significantly lower than control group,the differences were statistically significant (P0.05). After treatment,the SBP and DBP in 2 groups were significantly lower than before,the differences were statistically significant(P0.05). CONCLUSIONS:The efficacy of amlodipine besylate combined with Xinkeshu is superior to amlo-dipine besylate alone in the treatment of hypertension,with better safety.
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OBJECTIVE: To study the effect of Danshen injection and Xinkeshu tablets on the metabolism of CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 in rabbits by cocktail probe substrates method. METHODS: Sixteen healthy fasted male rabbits were simultaneously given cocktail probe substrates including caffeine, tolbutamide, omeprazole, dextromethorphan and midazolam. The metabolic rates of cocktail probe substrates were determined by LC MS/MS methods at some specific time following the administration. Then the rabbits were randomly assigned to receive either Danshen injection or Xinkeshu tablets. The whole self-control trial was consisted of 3 cycles. The low, middle and high dosage (0.5, 1 and 2 mL · kg-1) of Danshen injection group would be administrated in 3 cycles in sequence. The low, middle and high dosage (90, 180 and 360 mg · kg-1) of Xinkeshu tablets group would be administrated in 3 cycles in sequence. Each cycle includes wall-out period of 7 d followed by administration of the 2 herbal medicines for consecutive 7 d. On the 15th day the cocktail probe substrates were administrated and the metabolic rates were determined. The differences of the metabolic rates between after and before admininstration of the 2 herbal medicines were assessed by one-way analysis of variance (ANOVA). RESULTS: After taking the agents of Danshen injection and Xinkeshu tablets, the metabolic rates of the five cocktail probe substrates had a tendency to decline compared with the before-administration. CONCLUSION: The outcome in vivo is in accordance with that in vitro. Danshen injection and Xinkeshu tablets can inhibit the metabolism of five CYPs (1A2, 2C9, 2C19, 2D6 and 3A4) activities in rabbits. At sometimes precautions are needed to co-administrate either Danshen injection or Xinkeshu tablets for-possible herb-drug interactions.
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Objective To establish a method of the dissolution test of Xinkeshu capsule and study the dissolution behavior of sodium Danshensu, protocatechuic aldehyde, salvianolic acid B and puerarin in Xinkeshu capsule.Methods Using the dissolution determination first law of Chinese Pharmacopoeia 2010 II edition, according to the dissolution test conditions in Japan′s“quality of medical drugs information set”, different Xinkeshu capsule were inspected in pH 1.2 solution,pH 4.0 acetate buffer, pH 6.8 phosphate buffer and water.The HPLC gradient elution method was adopted to determine the dissolution of sodium Danshensu,protocatechuic aldehyde,salvianolic acid B and puerarin in Xinkeshu capsule.ResuIts Dissolution of sodium Danshensu, protocatechuic aldehyde, puerarin and salvianolic acid B of Xinkeshu capsule sample from each manufacturer were in good condition, 45min dissolution were 80% and dissolution uniformity.ConcIusion The method is simple, accurate and reproducible for the dissolution determination of this capsule .
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Objective To observe the influence of Xin-ke-shu Capsule (XKSC) on NO and ET in patients with coronary artery disease(CAD) combined with type 2 diabetes mellitus(T2DM), and to investigate its mechanism of treatment. Methods 80 patients with CAD combined with T2DM were randomly recruited into two groups: 40 patients in the treatment group were treated by conventional therapy plus XKSC, and the 40 in the control group treated by conventional therapy exclusively. The plasma level of NO and ET was observed before and after the three-month therapeutic course. Results The plasma level of ET in the treatment group significantly decreased after the treatmaent and was lower than that in the control group(P<0.01), but NO in the treatment group elevated significantly and was higher than that in the control group (P<0.01). Conclusion Xin-ke-shu Capsule displays its effect on protecting vascular endothelia by elevating the level of NO and decreasing the plasma level of ET.
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Objective To evaluate the effects of Xin-ke-shu and Betaloc on arterial elasticity of coronary heart disease(CHD).Methods According to the results from coronary angiography,50 patients who were taking long-term treatment of coronary artery obstructions were enrolled and divided into two groups in equal number at random.They were divided into Xin-ke-shu group(n=25)and Betaloc group(n=25).The Xin-ke-shu group received Xin-ke-shu(12/d)individually and the Betaloc group received Betaloc(50mg/d)for eight weeks.Patient's heart rate was measured by the doctor.Brachial blood pressure was measured by standardized mercury cuff sphygmomanometer.Automatic pulse wave velocity(PWV)measurement system and Complior Colson device and DO-2020 were applied to examine the carotid-radial artery PWV(PWVcr)and the large arterial elastic indexes(C1 and C2)respectively.Results After eight weeks of treatment.All patient's heart rate showed significant decrease.The Betaloc group,after excluded the betaloc effect,showed significant decrease of blood pressure.The Xin-ke-shu group showed significant increase of C1 and C2,and PWVcr slowed down obviously.Conclusion Xin-ke-shu improves the small and large arterial elasticity,and attenuates the wave reflex amplitude.
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Objective:To establish a HPLC method for the content determination of Puerarin in Xinkeshu capsule.Methods:The chromatography condition included C18 silicane-bonded silica gel column(250mm?4.6mm,5?m),MeOH-1.5%HAc-CHCI_3(25:74:1) mixture as the mobile phase,detection wavelength at 250nm,1.1ml/min of flow rate.Results:Puerarin was completely separated and no interference was found. The average recovery was 99.2%,RSD was 0.87%(n=5).Conclusion:The method is accurate,quick,sensitive and replicable,which is suitable for the quality control of Xinkeshu capsule.
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Objective To establish a RP-HPLC method for determining the content of puerarin in Xinkeshu Tablets. Method The analysis was carried on a column of Zorbax Eclipse XDB-C_(18)(4.6 mm?150mm,5?m)at 25℃,with methanol-water-phosphoric acid(23:77:0.5)as mobile phase.The flow rate was 1.0 mL?min~(-1),and the detection wavelength was 250 nm.Result A good linearity was found in the range of 27.1～271.0 ng.The average recovery rate was 100.5 %,and RSD was 1.8%(n=5).Conclusion The method is simple,rapid,accurate,reproducible,and can be used to control the quality of Xinkeshu Tablets.
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Objective To study the effects of Xinkeshu capsule (mainly com po sed of Radix Salviae Miltiorrhizae, Radix Puerariae, Fructus Crataegi, Radix Not oginseng, Radix Auklandiae,etc.) on hemorheology of experimental atherosclerosis rabbits. Methods FASCO- 300 viscosity meter was used to detect whole blood v iscosity and plasma viscosity, hematocrit (Wen's tube) and erythrocyte sedimen tation (Wintrobe tube) were tested, and other items of hemorheology were exami ned. Results Xinkeshu capsule significantly inhibited the abnormal rise of who le blood viscosity, plasma viscosity, whole blood reduced viscosity, erythr ocyte aggregation index, erythrocyte sedimentation (ES), ES rate K, erythro cyte rigid index and Tk in the rabbits with atherosclerosis induced by high fat foodd( P
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AIM: To determine puerarin and tanshinone ⅡA in Xinkeshu Capsule(Radix Puerariae Lobatae,Radix et Rhizoma Salviae Miltiorrhizae) by HPLC simultaneously. METHODS: HPLC C_(18) column was used with methanol-water(85∶15) as the mobile phase. The flow rate was 1.0 mL/min,and the wave length was at 250 nm. RESULTS: There were good liner relationships for puerarin and tanshinone ⅡA with the sample input quantity at the range of 21-63 ?g(r=0.999 8) and 20.02-60.06 ?g(r=0.999 7),respectively.The average recoveries of puerarin and tanshinone ⅡA were 97.7% and 97.0%,respectively. CONCLUSION: This method is simple,accurate,effective and suitable for the quality control of Xinkeshu Capsules.
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Objective:Improving the standard identification method for Danshen and establishing an identification and determination method for Shanqi.Methods:TLC.Results:The identification methods for Dansen and Sanqi are feasible.Conclusion:Test results show the revised methods are applicable in the quality control.