OBJECTIVE: To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension. METHODS: This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups. RESULTS: A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P<0.05). After 30 days of treatment, the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (P<0.05). After 180 days of treatment, brachial-ankle pulse wave velocity, ankle brachial index and albumin-to-creatinine ratio were improved in both groups, with no statistically significant differences (P>0.05). No serious treatment-related adverse events occurred during the study period. CONCLUSIONS Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470).
Humans ; Amlodipine/adverse effects* ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Hypertension/complications* ; Middle Aged ; Treatment Outcome ; Drug Therapy, Combination ; Adult ; Blood Pressure/drug effects* ; Double-Blind Method ; Aged ; Antihypertensive Agents/adverse effects*

Adult ; Aged ; Amlodipine ; adverse effects ; Drug Overdose ; diagnostic imaging ; drug therapy ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Radiography, Thoracic ; Treatment Outcome

OBJECTIVETo evaluate the protective effect of amlodipine against contrast agent-induced renal injury in elderly patients with coronary heart disease.

METHODSA total of 189 elderly patients (>60 years) with coronary heart disease undergoing coronary artery angiography were randomly assigned into amlodipine group and control group to receive amlodipine or placebo, respectively, before and after administration of the contrast agent. At 24 h, 48 h and 5 days after contrast agent administration, the parameters of renal function were measured including serum cystatin C, urea nitrogen, creatinine, creatinine clearance rate, urine β2-microglobulin, and urine N-acetyl-β-glucosaminidase.

RESULTSIn both groups, the contrast agents obviously affected the renal functions of the patients (P<0.05). At 24 h after contrast administration, the levels of serum cystatin C, urine β2-microglobulin and urine NAG were significantly lower in amlodipine group than in the control group, but the other functional parameters showed no significant difference. At 48 h after contrast administration, the glomerular and tubular functional parameters were all superior in amlodipine group (P<0.05). At 5 days, the two groups showed significant differences in such glomerular and tubular functional parameters as urea nitrogen, creatinine, creatinine clearance rate, urine β2-microglobulin, and urine NAG (P<0.05), but not in serum cystatin C level. The incidence of contrast agent-induced nephropathy was significantly lower in amlodipine group than in the control group (5/95 vs 10/94, P<0.05).

CONCLUSIONSAmlodipine offers protection against radiographic contrast agent-induced renal injury in elderly patients with coronary heart disease.

Aged ; Amlodipine ; pharmacology ; therapeutic use ; Contrast Media ; adverse effects ; pharmacology ; Coronary Angiography ; Coronary Disease ; diagnostic imaging ; Female ; Humans ; Kidney Diseases ; chemically induced ; drug therapy ; Kidney Function Tests ; Male ; Middle Aged

OBJECTIVETo investigate the effects and safety of Western medicine combined with Chinese medicine (CM) based on syndrome differentiation in the treatment of elderly polarized hypertension (PHPT), or isolated systolic hypertension with low diastolic blood pressure (DBP).

METHODSA total of 125 elderly patients with PHPT were randomly assigned to two groups: 59 in the control group treated by Western medicine and 66 in the intervention group treated by Western medicine combined with CM treatment. Based on syndrome differentiation, the patients in the intervention group were further divided into subgroups of yang-qi deficiency and yin-qi deficiency. All subjects were treated with Western medicine of Amlodipine Besylate Tablets and Irbesartan Tablets (or Irbesartan and Hydrochlorothiazide Tablets), to decrease their systolic blood pressure (SBP) slowly to 125-135 mm Hg in 2-6 weeks. In the intervention group, Shiyiwei Shenqi Capsule was given additionally to the subgroup of yang-qi deficiency at the dosage of 3-5 capsules, thrice a day, while Dengzhan Shengmai Capsule was given additionally to the subgroup of yin-qi deficiency at the dosage of 2 capsules, 2-3 times per day. For all subjects, SBP, pulse pressure (PP), and DBP were measured before treatment and at the terminal of a 6-week treatment. For subjects in the intervention group, left ventricular ejection fraction (LVEF) was also recorded.

RESULTSAfter a 6-week treatment, the SBP in the two groups and the PP in the intervention group decreased significantly compared to those before treatment (P<0.05), while the PP in the control group showed no significant difference between prior and post-treatment (P>0.05). After treatment, the DBP in the control group decreased (P>0.05), while the DBP and LVEF in the intervention group showed an increase tendency although it had no statistical significance (P>0.05). When subjects in the intervention group were classified further by the course of disease, the DBP and LVEF of subjects whose course of disease were less than 2 years, increased significantly after treatment (P<0.05).

CONCLUSIONWestern medicine combined with CM treatment based on syndrome differentiation was safer and more effective than Western medicine alone in the treatment of elderly PHPT, because it not only reduced SBP but also improved DBP, which might lower the incidence of the cardiovascular and cerebrovascular events.

Aged ; Amlodipine ; adverse effects ; pharmacology ; therapeutic use ; Antihypertensive Agents ; adverse effects ; pharmacology ; therapeutic use ; Biphenyl Compounds ; adverse effects ; pharmacology ; therapeutic use ; Blood Pressure ; drug effects ; Diastole ; drug effects ; Drugs, Chinese Herbal ; adverse effects ; pharmacology ; therapeutic use ; Female ; Humans ; Hypertension ; drug therapy ; physiopathology ; Male ; Stroke Volume ; drug effects ; Syndrome ; Tetrazoles ; adverse effects ; pharmacology ; therapeutic use

INTRODUCTIONThe need for the rational development of newer and adjuvant drugs to treat epilepsy has prompted this study of the potential anticonvulsant effect of amlodipine.

METHODSThe acute effect was studied in mice in single doses of 1 mg/kg, 2 mg/kg and 4 mg/kg of amlodipine and the chronic effect was studied in doses of 1 mg/kg and 4 mg/kg (administered daily for 21 days) using the maximal electroshock seizure and pentylenetetrazole-induced seizure models of epilepsy. Sodium valproate and normal saline were used as the standard and control, respectively.

RESULTSFor the acute study, in the maximal electroshock seizure model, the administration of 1 mg/kg of amlodipine resulted in the complete abolition of seizures in 33 percent of the mice, and this was increased to 67 percent with the administration of 4 mg/kg. In the pentylenetetrazole-induced seizure model, the administration of 1 mg/kg and 2 mg/kg amlodipine protected 33 percent of the animals from mortality, and 67 percent were protected with the administration of 4 mg/kg. For the chronic study, in the maximal electroshock seizure model, the administration of 1 mg/kg amlodipine resulted in the complete abolition of seizures in 40 percent of the mice and in 60 percent, with the administration of 4 mg/kg. In the pentylenetetrazole-induced seizure model, 50 percent of the mice were protected from mortality with 1 mg/kg amlodipine and 60 percent, with 4 mg/kg amlodipine.

CONCLUSIONThese findings indicate that amlodipine may be a good candidate as an add-on therapy for epilepsy.

Amlodipine ; therapeutic use ; Animals ; Anticonvulsants ; therapeutic use ; Calcium Channel Blockers ; therapeutic use ; Convulsants ; toxicity ; Disease Models, Animal ; Electroshock ; adverse effects ; Female ; Male ; Mice ; Mice, Inbred Strains ; Pentylenetetrazole ; toxicity ; Seizures ; drug therapy ; etiology ; prevention & control ; Time Factors ; Valproic Acid ; therapeutic use

OBJECTIVETo evaluate the efficacy of Breviscapine on essential hypertension (EH) patients complicated with micro-albuminuria of renal impairment.

METHODSSeventy-six EH patients were randomly assigned to the control group and the treated group, the former was given amlodipine, captopril/uropidil and the latter was given in addition Breviscapine intravenously dripped for 2 treatment courses. The indexes of serum creatinine (Cr), blood urea nitrogen (BUN), blood and urinary beta(2)-microglobulin (beta(2)-MG), and quantitative determination of 24 hrs urinary protein were evaluated before and after treatment.

RESULTSIn the control group, compared with before treatment, the quantitative determination of 24 hrs urinary protein got reduced significantly (P < 0.05), while in the treated group, both urinary beta(2)-MG and quantitative determination of 24 hrs urinary protein got lowered significantly (P < 0.05 and P < 0.01). But after treatment, compared with the control group, urinary beta(2)-MG and quantitative determination of 24 hrs urinary protein in the treated group were obviously reduced (P < 0.05).

CONCLUSIONBesides lowering blood pressure effectively, Breviscapine could improve the renal function significantly and reduce the urinary micro-albuminuria, hence showing promising effect on renal protection.

Adult ; Aged ; Albuminuria ; etiology ; physiopathology ; Amlodipine ; therapeutic use ; Antihypertensive Agents ; therapeutic use ; Blood Pressure ; drug effects ; Captopril ; therapeutic use ; Drug Therapy, Combination ; Female ; Flavonoids ; administration & dosage ; adverse effects ; therapeutic use ; Flushing ; chemically induced ; Humans ; Hypertension ; complications ; drug therapy ; physiopathology ; Injections, Intravenous ; Kidney Diseases ; etiology ; urine ; Male ; Middle Aged ; Proteinuria ; etiology ; physiopathology ; beta 2-Microglobulin ; urine