OBJECTIVETo analyze the efficacy and safety of bicyclol combined with thymosin in treatment of chronic viral hepatitis B (CHB).

METHODSA total of 135 patients with CHB were randomized into experimental group and control group. The patients in the experimental group received bicyclol orally 75 mg daily and thymosin 20 mg intramuscular injection once every 2 days for 24 weeks and those in control group received bicyclol orally 75 mg daily alone for 24 weeks. The levels of serum aminotransferase (ALT/AST), HBV-DNA, HBeAg /antiHBe were observed.

RESULTSCompared with pre-treatment levels, the serum aminotransferase levels decreased significantly in both groups, but there were no statistically significant differences between them. HBeAg negative conversion rate was significantly higher in the experimental group than in the control group (35.3 percent vs.19.4 percent, P less than 0.05). HBV DNA negative conversion rate was significantly higher in the experimental group than in the control group (36.7 percent vs. 20.9 percent, P less than 0.05). No obvious adverse events which were probably related to the drugs were observed in this study.

CONCLUSIONThe combination of bicyclol with thymosin had better effect in treatment of chronic hepatitis B ias compared with bicyvlol alone.

Adolescent ; Adult ; Biphenyl Compounds ; administration & dosage ; adverse effects ; Drug Therapy, Combination ; Female ; Hepatitis B, Chronic ; drug therapy ; Humans ; Male ; Middle Aged ; Thymosin ; administration & dosage ; adverse effects

OBJECTIVETo evaluate the efficacy and safety of bicyclol for chronic hepatitis B.

METHODThe authors searched CBMDisk, CJFD (2000-2006), CJD-CD, PubMed (1966-2006) for randomized controlled trials (RCT) comparing bicyclol versus non-antiviral interventions, interferon alpha (IFN-a) and lamivudine for treatment of chronic hepatitis B. Two reviewers performed data extraction and quality assessment independently and discussed when there was different opinion. We analyzed the data with RevMan 4.2 software supplied by Cochrane Collabration.

RESULTSFourteen RCTs involving 1782 patients were included. ALT recovery rate of bicyclol group was 69.3 percent while that of the control group was 59.0 percent, the difference was statistical significant [RR 1.24, 95 percent CI (1.01, 1.52), P=0.04]. Loss of HBeAg in the bicyclol group (22.1 percent) was higher than that of the control group (13.5 percent) [RR 1.65, 95 percent CI (1.32, 2.06), P<0.00001]. No serious adverse events were reported.

CONCLUSIONBicyclol might be beneficial to recovery of liver function and loss of serum HBV marker. However, more high quality clinical trials are needed for confirmation.

Antiviral Agents ; administration & dosage ; adverse effects ; Biphenyl Compounds ; administration & dosage ; adverse effects ; Hepatitis B virus ; drug effects ; Hepatitis B, Chronic ; drug therapy ; Humans ; Randomized Controlled Trials as Topic

OBJECTIVETo develop a UPLC method for the simultaneous determination of liquiritin, narirutin, hesperidin, ammonium glycyrrhetate, honokiol and magnolol in Huoxiang Zhengqi oral liquid.

METHODA Zorbax Eclipse C18 column was used with the mobile phase of acetonitrile and 0. 05% phosphate acid by gradient elution at the detection wavelength of 220 nm. The flow rate was 0.42 mL x min(-1) and the column temperature was 30 degrees C.

RESULTThe calibration curves were linear in the ranges of 0.001 7-0.034, 0.003 4-0.068, 0.006 4-0.128, 0.012 8-0.256, 0.003 2-0.064, 0.006 4-0.128 microg, respectively. The average recoveries were 103.3%, 98.39%, 98.29%, 102.1%, 98.45%, 102.2% with RSDs of 2.1%,1.0%, 0.50%, 2.3%, 0.9%, 2.0%, respectively.

CONCLUSIONThe UPLC method was simple, rapid and accurate, it could be used for quality control of Huoxiang Zhengqi oral liquid.

Administration, Oral ; Biphenyl Compounds ; chemistry ; Chromatography, High Pressure Liquid ; methods ; Disaccharides ; chemistry ; Drugs, Chinese Herbal ; chemistry ; Flavanones ; chemistry ; Glucosides ; chemistry ; Hesperidin ; chemistry ; Lignans ; chemistry ; Pharmaceutical Solutions ; chemistry

OBJECTIVETo investigate the effect of prescription compatibility on the pharmacokinetics of components from Dachengqi Decoction (DCQD, ) in rats.

METHODSTwenty-four male rats were randomly and equally divided into the DCQD group, Dahuang (Radix et Rhizoma Rhei, Polygonaceae) group, Houpo (Magnolia officinalis Rehd., Magnoliaceae) group, and Zhishi (Fructus Aurantii Immaturus, Rutaceae) group. The blood samples were collected before dosing and subsequently at 10, 15, 20, 30, 45 min, 1, 2, 4, 8, and 12 h following gavage. The levels of aloe-emodin, rhein, emodin, chrysophanol, honokiol, magnolol, hesperidin, and naringin in rat serum were quantified using a liquid chromatography tandem mass spectrometry (LC-MS/MS) method for pharmacokinetic study.

RESULTSThe area under the curve (AUC), mean retention time (MRT), the peak concentration (C(max)) of aloe-emodin, rhein, emodin, and chrysophanol in the DCQD group were significantly different compared with the Dahuang group (P <0.05, respectively). The mean plasma concentration, C(max), and the absorption of Dahuang's component in the DCQD group were obviously lower at each time point than those in the Dahuang group, while the elimination process of Dahuang's component was obviously delayed (P <0.05). Half-lives of aloe-emodin, chrysophanol, and rhein were also extended in the DCQD group (P <0.05, respectively). In the DCQD group, the mean plasma concentration, AUC, C(max) and absorption of honokiol, and magnolol were significantly lower (P <0.01, respectively) at each time point than those in the Houpo group, while the drug distribution half-life time (T(1/2α)), the drug eliminated half-life time (T(1/2β)), MRT, and time of peak concentration (T(max)) were significantly delayed (P <0.05, respectively). Pharmacokinetic parameters of hesperidin and naringin in the Zhishi group were not significantly different as compared with the DCQD group (P >0.05, respectively), while the MRT of naringin was significantly longer.

CONCLUSIONSThe compatibility in Chinese medicine could affect the drug's pharmacokinetics in DCQD, which proves that the prescription compatibility principle of Chinese medicine formulations has its own pharmacokinetic basis.

Administration, Oral ; Animals ; Anthraquinones ; administration & dosage ; blood ; pharmacokinetics ; Biphenyl Compounds ; administration & dosage ; blood ; pharmacokinetics ; Drug Incompatibility ; Emodin ; administration & dosage ; blood ; pharmacokinetics ; Flavanones ; administration & dosage ; blood ; pharmacokinetics ; Hesperidin ; administration & dosage ; blood ; pharmacokinetics ; Lignans ; administration & dosage ; blood ; pharmacokinetics ; Male ; Plant Extracts ; administration & dosage ; blood ; chemistry ; pharmacokinetics ; Rats ; Rats, Sprague-Dawley

PURPOSE: Chemical lights, also called Luminous Sticks, consist of a solution of diphenyl oxalate (C14H10O4) and hydrogen peroxide (H2O2). Human tissue can be damaged when the mixed solution contacts the human body. The authors report a single case of chemical injury of keratoconjunctiva by exposure to chemical lights. CASE SUMMARY: A 47-year-old man's right eye accidentally contacted the fluorescent material when breaking a Luminous Stick 7 days before being referred to our clinic. He had pain in the right eye and experienced visual loss. The patient's best corrected visual acuity in the right eye was 20/50. An ulcerative lesion with edema at the inferior bulbar and palpebral conjunctiva and coneal epithelial defect was observed upon biomicroscopic examination. The patient was hospitalized and antibiotics, steroids, mydriatic and artificial tear eye drops were applied for treatment. After 9 days of treatment, the best corrected visual acuity of the patient recovered to 20/20, and the conjunctiva and cornea were mostly healed. No complication was observed. CONCLUSIONS: Chemical lights are commonly used in concerts and festivals. If the contents contact the eyes when breaking he chemical lights, various chemical burns can occur and cause ophthalmologic complications. Since no regulations have been passed regarding chemical lights, safety education and supervision are considered to be necessary for children.
Anti-Bacterial Agents ; Biphenyl Compounds ; Burns, Chemical ; Child ; Conjunctiva ; Cornea ; Edema ; Eye ; Holidays ; Human Body ; Humans ; Hydrogen Peroxide ; Light ; Middle Aged ; Ophthalmic Solutions ; Organization and Administration ; Social Control, Formal ; Steroids ; Tears ; Ulcer ; Visual Acuity

BACKGROUNDCongestive heart failure (CHF) is a major cause of morbidity and mortality worldwide and angiotensin converting-enzyme inhibitor (ACEI) is the cornerstone in its treatment. However, CHF continues to progress despite this therapy, perhaps because of production of angiotensin II (Ang II) by alternative pathways. The present study was conducted to examine the combined effects of a chronic ACEI, ramipril, and a chronic Ang II type 1 receptor blocker, TCV116, on rat CHF after myocardial infarction (MI).

METHODSCongestive heart failure was caused by MI in rats, which was induced by ligating the left anterior descending coronary artery. The experiment protocol included sham-operated rats (Sham), MI-control rats (MI-control), MI rats treated with ramipril 3 mg/kg (MI-ramipril) or TCV116 2 mg/kg (MI-TCV116) per day, half dosage (MI-1/2R&T) or full dosage (MI-R&T) combination of the two. At 22 weeks, cardiac hemodynamic parameters such as mean arterial pressure (MAP), left ventricular systolic pressure (LVSP), maximal rate of left ventricule pressure development and decline (LV dP/dtmax) and left ventricular end diastolic pressure (LVEDP), and cardiac morphometric parameters such as heart weight (HW), left ventricular weight (LVW) and left ventricular cavity area (LVCA) were measured, mRNA expressions of cardiac molecule genes such as beta myosin heavy chain (betaMHC), B-type natriuretic peptide (BNP), transforming growth factor-beta1 (TGF-beta1), collagen I and III were quantified with reverse transcription polymerase chain reaction (RT-PCR) in the surviving septum myocardium, and survival rates were calculated.

RESULTSThere were no significant differences in MI sizes (%) among each MI related experimental groups (33 +/- 13, 34 +/- 14, 33 +/- 13, 35 +/- 13 and 33 +/- 14 for MI-control, MI-ramipril, MI-TCV116, MI-1/2R&T and MI-R&T, respectively, no statistical significance for all). Compared with sham-operated rats, MI rats without therapy showed significant increases in morphometric parameters as well as in mRNA expressions of cardiac molecule genes (P < 0.01); while their hemodynamic parameters were significantly impaired (P < 0.01), and in terms of spontaneous deaths survival rate shortened (P < 0.05). Compared with MI rats without therapy, MI rats treated with each single drug showed significant attenuation of mRNA expressions of cardiac molecule genes (P < 0.01); while their hemodynamic parameters were significantly improved (P < 0.05 or P < 0.01), and in terms of spontaneous deaths survival rate prolonged (P < 0.05). Both half and full dosage combined treatments exerted more powerful effects on improvement of cardiac phenotypic changes and on attenuation of betaMHC, BNP mRNA expressions (P < 0.05 vs monotherapy); while LVEDP was further lowered (P < 0.05 vs monotherapy). However, the total death in MI rats with full dosage combined treatment was more though there were no significant differences when compared with other treatments.

CONCLUSIONSThe results suggest that treatment with appropriate dosage combination of a chronic ACEI and a chronic ARB may further improve cardiac remodeling and cardiac function after MI.

Angiotensin-Converting Enzyme Inhibitors ; administration & dosage ; Animals ; Benzimidazoles ; administration & dosage ; Biphenyl Compounds ; administration & dosage ; Blood Pressure ; drug effects ; Drug Therapy, Combination ; Heart Failure ; drug therapy ; pathology ; physiopathology ; Male ; Myocardial Infarction ; complications ; Myocardium ; pathology ; Ramipril ; administration & dosage ; Rats ; Rats, Sprague-Dawley ; Receptor, Angiotensin, Type 1 ; drug effects ; Tetrazoles ; administration & dosage ; Ventricular Function, Left ; drug effects

OBJECTIVETo compare the effects of felodipine combined irbesartan regimen with that of felodipine combined metoprolol regimen on the sexual function in male hypertensive patients.

METHODOne hundred and twenty-three male hypertensive patients (age 25 to 60) were randomly assigned to felodipine (5 mg/d) plus irbesartan (150 mg/d, n = 64) group and felodipine (5 mg/d) plus metoprolol (47.5 mg/d, n = 59) group. Dosage of felodipine were doubled after 4 weeks if the blood pressure were > or = 140/ 90 mm Hg (1 mm Hg = 0.133 kPa). At the baseline and post 24th week treatment, sexual function of patients was assessed by the International Index of Erectile Function (IIEF) Questionaire. Serum testosterone (T), sex hormone binding globulin (SHBG), 4-hydroxynonenal (HNE), 8-hydroxy-2'-deoxyguanosine (8-OHdG) and Malonaldehyde (MDA) were measured by Radioimmunoassay (RIA), ELISA and TBA respectively.

RESULTSTotal prevalence of erectile dysfunction (ED), T, SHBG and HNE were similar between pre- and post-treatment in two groups (P > 0.05). On the other hand, the scores of the mild ED and sexual desire (SD) were improved and both serum 8-OHdG and MDA in patients with ED decreased [(146.02 +/- 60.54) ng/L vs. (139.89 +/- 62.03) ng/L, P = 0.048 and (6.59 +/- 1.75) micromol/L vs. (5.51 +/- 1.65) micromol/L, P = 0.039] in Felodipine plus Irbesartan group.

CONCLUSIONThe results suggested that Felodipine + Irbesartan regimen may be superior to Felodipine + metoprolol regimen for male hypertensive patients with mild ED.

Adult ; Antihypertensive Agents ; administration & dosage ; therapeutic use ; Biphenyl Compounds ; administration & dosage ; therapeutic use ; Drug Therapy, Combination ; Erectile Dysfunction ; chemically induced ; physiopathology ; Humans ; Hypertension ; drug therapy ; physiopathology ; Male ; Metoprolol ; administration & dosage ; therapeutic use ; Middle Aged ; Penile Erection ; drug effects ; Tetrazoles ; administration & dosage ; therapeutic use

OBJECTIVETo investigate the clinical efficacy and safety of adefovir dipivoxil (ADV) in combination with bicyclol for the treatment of chronic hepatitis B (CHB) in seniors.

METHODS96 senior patients with CHB were randomly divided into two groups, the treatment group and the control group. On the basis of routine liver protective treatment, patients in the treatment group received ADV (10 mg/d) and bicyclol tablets (25 mg, tid.) orally, and those in the control group were orally administrated ADV tablets (10 mg/d) only. The treatment course for both groups was 24 weeks. Serum ALT, AST, and alterations of virological parameters were observed before and after the treatment.

RESULTSBefore and at the end of the 24 weeks treatment, ALT level for the treatment group was (208.44 +/- 94.22) and (34.47 +/- 12.79) U/L, and those for the control group was (205.73 +/- 96.48) and (44.20 +/- 21.96) U/L, respectively (difference between groups P < 0.01). At the end of the 24 weeks treatment, ALT normalization rates for the treatment group and the control group were 76.6% and 54.5%, respectively, and AST normalization rates for them were 76.6% and 54.5%, respectively (both differences between groups P < 0.05); HBV DNA loads for the treatment group and the control group were decreased by (3.1 +/- 1.40) lgIU/ml and (2.98 +/- 1.17) lgIU/ ml, respectively (difference between groups P > 0.05). The incidence rates of adverse events between two groups were not statistically significant.

CONCLUSIONIt suggested that the treatment of ADV in combination with bicyclol for senior patients with CHB is effective and safe.

Adenine ; administration & dosage ; adverse effects ; analogs & derivatives ; Aged ; Aged, 80 and over ; Antiviral Agents ; administration & dosage ; Biphenyl Compounds ; administration & dosage ; adverse effects ; DNA, Viral ; blood ; Female ; Hepatitis B, Chronic ; drug therapy ; physiopathology ; virology ; Humans ; Liver ; physiopathology ; Male ; Middle Aged ; Organophosphonates ; administration & dosage ; adverse effects

OBJECTIVETo investigate the long-term effects of TCV116 (candesartan cilexetil) on cardiac function changes after myocardial infarction.

METHODSMyocardial infarction (MI) was induced by ligation of the left anterior descending coronary artery in rats. One week after the surgical performance,the surviving rats were randomly assigned to the following treatment groups: (1) MI rats with no therapy; (2) MI rats treated with TCV116 2 mg/kg per day; (3) Sham-operated control and (4) Sham-operated rats treated with TCV116 2 mg/kg per day. At 22 weeks, left ventricular function and cardiac histomorphometric parameters were measured, mRNA expression of cardiac genes such as beta myosin heavy chain, B-type natriuretic peptide, transforming growth factor beta1, collagen I and III quantified, and survival rates calculated.

RESULTSTreatment with TCV116 significantly improved LV function, suppressed mRNA expression of cardiac genes,and extended the survival period compared with MI rats with no therapy (P<0.05).

CONCLUSIONTreatment with long-term angiotensin II type 1 receptor blocker may improve LV function and prolong the survival of rats after MI.

Angiotensin II Type 2 Receptor Blockers ; Animals ; Benzimidazoles ; administration & dosage ; pharmacology ; Biphenyl Compounds ; administration & dosage ; pharmacology ; Heart Failure ; drug therapy ; etiology ; physiopathology ; Male ; Myocardial Infarction ; complications ; Myocardium ; metabolism ; Random Allocation ; Rats ; Rats, Sprague-Dawley ; Receptor, Angiotensin, Type 2 ; administration & dosage ; Tetrazoles ; administration & dosage ; pharmacology ; Ventricular Function, Left ; drug effects ; Ventricular Myosins ; metabolism ; Ventricular Remodeling ; drug effects

OBJECTIVETo evaluate the effect of combination therapy with peginterferon alfa-2a (Pegasys) +/- nucleos(t)ide analogues (NUC) and bicyclol in chronic hepatitis B with high ALT levels at baseline and during early treatment.

METHODSCHB patients were treated with PEG-IFNalpha-2a for a minimum of 48 weeks. All patients were followed up for 26 weeks post-treatment. Patients with HBV DNA > or = 1 x 10(8) copies/ml were combined with NUC (adefovir or entecavir) treatment. Patients with ALT > 500 U/L at baseline or ALT > 300 U/L after first injection of PEG-IFNalpha-2a received bicyclol treatment for 1-2 months (treatment group). Patients with 2 x ULN < ALT < 300 U/L and ALT < 300 U/L during treatment were enrolled into PEG-IFNalpha-2a +/- NUC antiviral monotherapy (control group). Responses defined as HBV DNA < 1 x 10(3) copies/ml, normal serum ALT, and HBeAg/HBsAg loss and seroconversion were analyzed at 26 weeks post-treatment.

RESULTSA total of 54 patients (44 HBeAg positive, 10 HBeAg negative) were divided into two groups according to combination of bicyclol: treatment group (n = 20)--those who received combinition therapy with PEG-IFNalpha-2a +/- NUC and bicyclol, and control group (n = 34)--those who were treated with PEG-IFNalpha-2a +/- NUC antiviral monotherapy. During the first month of treatment, ALT levels declined gradually in treatment group. At 26 weeks post-treatment, the rates of ALT normalization and HBV DNA below the limit of 1 x 10(3) copies/ml were similar in both groups. Six patients in treatment group achieved HBsAg seroconversion at 26 weeks post-treatment, whereas so did 4 patients of control group (30% vs. 11.8%, P = 0.044).

CONCLUSIONBicyclol could significantly relief elevation of ALT induced by the IFN treatment.

Alanine Transaminase ; blood ; Biphenyl Compounds ; administration & dosage ; adverse effects ; DNA, Viral ; analysis ; Drug Therapy, Combination ; Hepatitis B Surface Antigens ; blood ; Hepatitis B e Antigens ; blood ; Hepatitis B, Chronic ; blood ; drug therapy ; Humans ; Interferon-alpha ; administration & dosage ; adverse effects ; Polyethylene Glycols ; administration & dosage ; adverse effects ; Recombinant Proteins ; administration & dosage ; adverse effects