Table of Content

Volume 4 Issue 1
26 March 1999

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A Randomizeilt, double-blind, controlled, trirl of HBeAg specific transfer factor in the treatment of chronic hepatitis B

YAO Guang-Bi, JI Yan-Yan, XU Dao-Zheng, ZHU Li-Min, WANG Fa-Zhi, WANG Zi-Ji, XIAN Chao, HU De-Chang, GAO Jian, WU Xiang-Hui, ZHANG Qing-Bo, ZHANG Lin-Min, ZHOU Kan

1999, 4(1):  1-5. 

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Aim The phase I and A clinical trials were to evaluate the efficacy and safety of HBeAg transfer factor (HBV-TF) in healthy volunteers and chronic hepatitis B(CHB) patients. Methods Phase I trial: Tolerance srudy was conducted in 15 healthy volun-teers in fine groups, by intramuscular injection of 0.25、0.5、1.0、2.0 mg and 4.0 mg HBV-TF very day for 14 days respectively. Cellular immune response tests including specific lymphocyte proliferation and macrophage migration inhibition, were carried out in other 14 healthy volunteer who received 2 mg HBV-TF every day for 14 days. And the dose selection trial was performed in 18 patients with CHB. Phase II trial: 109 cases of chronic hepatitis patients were given randomly HBV-TF 1 mg or placebo and other 309 cases received 1 mg or 2 mg every other day for 3 months respectively. Results 15 healthy volunteers could tolerate HBV-TF well and no adverse reactions were observed. The stimulating index of lymphocyte proliferation in 14 healthy volunteers were increased from 0.77±0.21 to 1.57±0.69 after receiving HBV-TF(P<0.01）.The macrophage migration inhibition index was decreased from 0.926 ± 0.06 to 0.784±0.089 (P<0.05). Dose seleclion study showed that both 1 mg and 2 mg were effective in the clearance of serum HBeAg and HBV-DNA.In 54 HBV-TF treated cases of the 109 cases, the clearance rate of HBeAg and HBV-DNA were 44.4% and 46.9% respectively; while in 55 placebo cases the clearance rate of HBeAg and HBV-DNA were 14.4% and 7.5% (P<0.01).309 patients were randomized into 1 mg and 2 mg treatment groups. After 3 months treatment, the HBeAg and HBV DNA clearance rate in 149 cases of 1 mg treated group were 33.6% and 29.69% respectively, while in 160 cases of 2 mg treated group the clearance rate were 46.3 and 36.2% (P<0.05).After 3 months followed up period, the efficacy in about 70% patients could still be maintained. No prominent adverse drug reaction has been observed during treatment. Conclusion HBsAga specific transfer factor, is effective and safe in the treatment of chronic hepatitis B.

A controlled double-blind study on the analgesic effect of the none-addictive propacetamol HCl on Moderate postoperative pain

JIANG Zhu-Ming, YU Bu-Wei, CAO Jin-Duo, MA En-Ling, LIU Jia

1999, 4(1):  6-11. 

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Aim To compare the analgesic effect of the noneaddictive Propacetamol HCl with that of Dolantin (Pethidine HCl) on moderate postoperative pain. Methods 120 patients aged 18~75 years old were enrolled in this study, whose postoperative pain reached moderate to severe level after abdominal surgery, gynecol6gic surgery or orthopedic surgery. In the study group,2 g Propacetamol HCl was diluted and infused intravenously while at the same time 1.0 ml saline was injected intramuscularly; in the control group, 1.6 g mannitol as dummy drug was diluted and infused intravenously while at the same time 50 mg (1.0 ml) Dolantin was injected intramuscularly. Treatment was carried out randomly and double-blindly with the observation period of 6 hr in each case. Results & Discussion There was no obvious adverse reaction or erythra during the study period. After decoding as planed, it was shown that Propacetamol HCl and Pethidine HCl had the similar safety and efficacy. Since propacetamol HCl is none-addictive, it will have a future of wide application as analgesic for moderate postoperative pain.

Double-blind comparison of olsalazine sodium and sulphasalazine in active ulcerative colitis

FAN Zhu-Ping, ZENG Min-De

1999, 4(1):  12-16. 

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Aim The effect and adverse events of olsalazine sodium were evaluated and compared with those of sulphasalazine in 149 patients with mild to moderate ulcerative colitis (active). Methods 107 patients with ulcerative colitis were randomized to receive 4 g of sulphasalazine or 2 g of olsalazine daily and were followed up for 8 weeks. Another 42 Patients were given known olsalazine. The enteroscopy were done before and after treat-ment. Results The total effective rate of olsalazine was 84.61%. The complete remission of synptoms, in clinical observation enteroscopy and histological was 75.00%, 34.62% and 55.77%, respectively, and comparable to that in SASP and opened study. The main adverse event was diarrhea. Conclusion Olsalazine sodium is effective in the treatmeat of active ulcerative colitis. The effect is comparable to SASP. The main ad-verse event was diarrhea.

Distribution of N-acetylate phenotype in Chinese children and its relationship with down's syndrome and duchenne muscular dystrophy

GUO Rui-Chen, SUN Ruo-Peng, YAN Xiu-Xian, CUI Xi, WANG Ben-Jie

1999, 4(1):  17-20. 

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Aim The distribution of N-acetylate phenotype in Chinese children and its relationship with Down's syndrome(DS) and Duchenne muscular dystrophy (DMD) was investigated. Methods Thirty-one subjects with Down's syndrome, 18 with Duchemne muscular dys-trophy and 154 healthy children were acetylate-phenotyped with caffeine as a probe drug,Urine samples were collected 2 hours after administration of 60~100 ml of 10 mg/100 ml caffeine-spiked coca cola and analyzed by high performance liquid chromatography (HPLC). The LgAFMU/1X of peak hight ratio was used to construct the frequence his-togram and probit plot and to assese slow and fast acetylator staus both in the healthy and the DS/DMD children. Results The range of lg AFMU/1X in healthy children was 0.45~1.86, and in those with DS and DMD was 0.15~1.56 and 0.15~0.38 respectively.The ratio of 0.25 [Ig(AFMU/1X)] was sellected as a cut-off and used to separate slow and fast acetylators. Slow acetylators in children with DS accounted for 41.9% (13/31) while with DMD 50% (9/18), significantly higher than 16.9% of healthy children (X² = 8.287, P<0.005 and X² = 11.367, P<0.005 respectively). Conclusions The acetylate status is polymorphic in Chinese healthy children. Slow acetylators of children with DS or DMD were more than those of healthy children. Age and sex had no significant influence to acetylate status.

Clinical comparative trial of co-artemether, and one of its components benflumetol (two formulations) in treating falciparum malaria

SUN Zhi-Wei, SHAN Cheng-Qi, LI Guo-Fu, JIAO Xiu-qing, LIU Guang-Yu, DING De-ben, WANG Jing-Yan

1999, 4(1):  21-24. 

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Aim To observe the effects and safety of co-artemether and one of its components benflumetol (two formulations) for treatment of patients with plasmodium falciparum. Methods 150 patients was recruited, with 51 patients in coartemether group (A), 50 patients in benflumetoltablet group(B), 49 patients in benflumetol group (C), The methods of double-blinding, radomization and comparison were applied and all patients were conditioned and observed for 28 days. Results The mean fever clearance time for group A, Band C was 17.1±8.6,34.0±23.2 and 29.4±24. 9 hours respectively; mean parasite clearance time was 29.7±,51.6±14.1 and 54.7±17.4 hours respectively and the cure rate for group A,B and C was 98.22% 92.0% and 95.8% respectively. No significant side-effects was observed and no significant change was found in laboratory test. Conclusion Coartemether and one of its components benflumetol (2 formulations) have good curative effect for patients with plasmodium falciparum, but coartemether is more effective than benflumetol (2 formulations) in velocity for controling symptoms and killing parasites.

Pharmacokinetic of lomefloxacin hydrochloride in infected patients

YUAN Cheng, ZHOU Da-Zheng, CAO Xiao-Zhi, WANG Jing-Xiang, LIU Hua

1999, 4(1):  25-29. 

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Aim The pharmacokinetics of lomefloxacin hydrochloride administered orally or by dripping in infected patients was studed. Methods The parameters with different dosages, fasting and non-fasting, single and multiple dsoes were compared. A hing performance liquid chromatography was used to determine the concentration of lomefloxacin in serum and urine. Results A first-order absorption and an open dubble compartment pharmacokinetics model were showed after taking the drug. When a single oral dose of 200 mg of lomefloxacin was gaven to the patiens before and after breakfast, the absorption was slightly decreased. The T_{1/2 ka} was 0.39±0.18 and 0.47±0.20 h,the T_max was 1.3±0.3 and 1.6±0.4 h respectively,but the C_max had no significant difference between before and after food. After a single oral dose of 200,400, and 600 mg of lomefloxacin, pharma-cokinetic parameters for the drug were T_1/2β was 9.8±2.9,10.7±4.0 and 11.2±3.9 h, C_max was 1.5±0.4, 2.4±0.8 and 3.8±0.9 mg·L^-1, respectively. The AUC_0-∞ were pro-portional to dose and the pharmacokinetics had a linear relationship with dose. The C_max was 3.1±0.9 mg·L^-1 after a single drip dose of 600 mg of lomefloxacin. Compared with those in the single dose, the C_max and AUC_0-∞ had marked increase with a retaining factor of 1.45 after multiple oraling dose of 400 mg twice daily for 7 days. But the parameter had no significant change with a retaining factor 1.10 after dripping 600 mg once daily for 7 days. The percentage of prototype drug urinary recovery within 24 hours was about 50% in all methods and dosages of taking drug. Conclusion Lomefloxacin is a drug that has a linear pharmacokinetic.

Antisenescent action of capsule bushenyanshou

CHEN Jin-He, WANG Hui, DING Hong, LI Qi-Xiong, KONG Rui

1999, 4(1):  30-32. 

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Aim The effect of capsule bushenyanshou (BSYS) on the antioxidative function, and the tolerance of cold and fatigue in rats was investigated. Methods The activity of erythro-cytic superoxide dismutase (SOD), the contents of brain and liver malondialdehyde (MDA) in rats and the changes of body weight, body temperature and the swimming time at (TC in mice were measured. Results Capsule BSYS(400, 800 mg/kg, ig, qd × 21d) increased erythrocytic SOD activity and markedly reduced brain and liver homogenate MDA contents in ole rat and enhanced ihe body weight and body temperature, and prolonged the swim-ming time at 0℃ in hydrocortisone-treated(15 mg/kg, sc, qd × 5 d) mice. Conclusion Capsule BSYS has a certain antisenescent action.

Experimental study on mechanism of cakium channel entry blockers in protecting liver from ischemia-reperfusion injury

WANG Wan-Tie, LIN Li-Na, XU Zheng-Jie, WANG Wei, LI Dong

1999, 4(1):  33-35. 

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Aim The mechanism of caleium channel entry blockers (CCEB) in protecting the liver from ischemia-reperfusion injury was to be explored. Methods With establishment of hepade ischemia-reperfusion injury (HIRI) model, the effects of verapamil (VP) and diltiazem(DT) on xanthine oxidase (XO), superoxide dismutase (SOD) activities and concentration of lipid peroxides (LPO) in the liver tissue and plasma during HIRI were dynamically observed in rabbits. Results The group treated with VP or DT, as com-pared with the control group, showed that XO activity and LPO content all decreased significantly (all P<0.0l)t but there was no difference for SOD activity between VP group and control group or DT group and control group (all P>0.05),. Conclusion It is indicated that mechanism of the protection afforded by CCEB was closely related to its decreasing XO activity and inhibiting lipid peroxidation during HIRI.

Protective effects of nicotinamide against interleukin-1β-induced destruction of isolated rat pancreatic islets of Langerhans

CHEN Hong, CAI De-Hong, WANG Mei

1999, 4(1):  36-39. 

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Aim The effects of nicotinamide (NA) on interleukin-ip-induced destruction of isolated rat pancreatic islets of Langerhans were observed. Method Isolated pancreatic islet cells from SD rat were cultured in monolayer in vitro. Nitrite production, insulin release, islet cell DNA and insulin content, and cell activity (MTT assay) in rat pancreatic islet cells incubated with IL-1β or/and NA (10,20 mmol/L),were measured. Results IL-lβinduced a significant increase in nitrite production, inhibited the medium insulin accumulation and the glucose-stimulated insulin, release, and decreased islet cell DNA insulin content and MTT(P<0.001).The inhibitory activities were blocked by NA in a higher dose (20 mmol/L) (P<0.001) while in a lover dose. NA (10 mmol/L) prevented the IL-lβ-induced cytotoxic effects without affecting nitrite production and the glucose-stimulated insulin release. Conclusion IL-lβ-induced nitric oxide (NO) production alone is insufficient to account for the IL-lβ-mediated islet p-cell destruction. Mechanisms of other action of the IL-1β may be involved. There may be a variety of mechanisms the protective effects of NA against cytotoxic action of IL-1β, including inhibition of NO Production, which may be related to exposure concentration of NA.

Preliminary study of propolis on caries

YONG Geng-Sen, HOU Xiao-Wei, GUO Lan-Ying, LIU Chun-Mei

1999, 4(1):  40-42. 

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Aim The preventive effect and mechanism of propolis on caries were studied. Methods Before and after chewing propolis gum, SM bacteria, plague index and salivary pH were determined in 3~4 years old children. Results Propolis gum significantly reduced the plaque index, the numbers of SM, and raised the salivary pH. Conclusion Propolis gum can depress the growth of SM and development of plaque, increase the pH value in saliva, and is usefull in preventing caries.

Protective effect of heparin on the changes of pulmonary circulation induced by chronic hypoxia-hypercapnia in rat

CHEN Cheng-Shui, CAI Kong-Chang

1999, 4(1):  43-45. 

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Aim The effect of heparin on the changes of pulmonary circulation induced by chronic hypoxia-hypercapnia(HH) in rat was studied. Methods The pulmonary ariery pres-sure, right ventricular pressure, Hct % and the muscularization of pulmonary arterioles (MPA) were examined in rals that were exposured to HH for one month and treated with or without heparin respectively. Results The development of pulmonary hypertension and increase of MPA in HH rats were significantly prevented by heparin, but the increase of MPA was still developed as compared with that in the normal control. Conclusion Heparin can partially prevent pulmonary hypertenvSi'on and muscularization of pulmonary arterioles induced by hypoxia-hypercapnia.

Recent advances in adjuvant therapies of osteosarcoma

LI Tian-Fang, XU Jing-Wen, Konttinen Yrjo, Santavirta Seppo

1999, 4(1):  52-57. 

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