Chinese Journal of Clinical Pharmacology and Therapeutics

Research update of gabapentin in neuropathic pain management

LIU Guo-Kai, HUANG Yu-Guang, LUO Ai-Lun

2003, 8(3): 241-244.

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Gabapentin may bind the α₂δsubunit of the voltage-dependent calcium ion channels at the postsynaptic dorsal horn and interrupt the series of events possibly leading to the experience of a neuropathic pain sensation. Many clinical studies have clearly demonstrated the efficacy of gabapentin in the treatment of diabetic neuropathy and postherpetic neuralgia.Gabapentin is considered an effective drug with its minimal side effects and drug interactions in the management of neuropathic pain syndromes.

Advances in inhibiting the expression of Bax and cytoprotection¹

CAO Zhi-Gang, YUAN Shou-Jun

2003, 8(3): 245-248.

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Apoptosis is involved in a variety of physiological and pathological conditions.Bax is proapoptotic member in signal pathway of apoptosis.It will contribute influencing Bax, biological effects induced by Bax knock-out, and antisense nucleotides targeted to Bax-mRNA were reviewed in this article during recent years.

Progress of cyclooxygense-2 inhibitors in treatment of Alzheimer' s disease

SU Yuan-Qi, DONG Zhi

2003, 8(3): 249-251.

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Alzheimer' s disease (AD) is the most common cause of dementia in the elderly population.The occurrence of dementia correlates with inflammation.Inflammation processes may play a critical role in the pathogenesis of the degenerative changes and cognitive impairments associated with Alzheimer' s disease.Cyclooxygense- 2 (COX-2) inhibitors are reported to be effective in reducing the risk of developing AD or cognitive impairments.Studies on this field are of important significance in the understanding the pathogenesis and therapeutic measures for AD.This review will discuss the progress in the treatment of Alzheimer' s disease by COX-2 inhibitors.

Transport mechanism of β-lactam antibiotics in intestine and kidney

ZHANG Xiu-Hong, SONG Jian-Guo

2003, 8(3): 252-254.

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Some transport systems are found both in intestine and kidney with functional and morphological similarities, such as peptide transport system, organic anion transport system, organic cation transport system, and P-glycoprotein-mediated transport system.All these transport systems participate in the transporting process of β- lactam antibiotics in different extent.It suggests that inhibitors of renal transport may also affect the drug absorption of the intestine.

Efficacy and mechanism of bifaer (prostaglandin E1)in the treatment of male patients with erectile dysfunction

MU Ye-Jun, LU Min-Qi

2003, 8(3): 255-260.

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Prostaglandin E1 cream preparation (bifaer) can relax arteria smooth muscle and adjust the release of NA in corpus cavernosum in penis.Multicenter clinical trials have conformed that bifaer shows usefulness and safety in treatment of male patients with erectile dysfunction through.

Pharmacological effects of Aloe vera

HE Chi-Yi, WU Wan-Chun, HAN Zhen

2003, 8(3): 261-264.

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Aloe vera has shown extensive actions, such as anti-tumor, anti-inf lammation, anti-bacteria, enhancing immune function, and anti-gastric mucosal lesion. It may be widely developed as medical products.

Effect of Ganoderma lucidum polysaccharides on the insulin releasing function of pancreatic islets in rats

ZHANG Hui-Na, LIN Zhi-Bin

2003, 8(3): 265-268.

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AIM: To investigate the effect of (Ganoderma lucidum) polysaccharides (Gl-PS) on the insulinreleasing function of pancreatic islets. METHODS: Pancreatic islets were isolated and incubated with 5.6 or 16.7 mmol·L ^-1 glucose and different concentrations of Gl-PS for 1 h.Then the insulin was examined.Verapamil, and verapamil combined EGTA were used to testify whether the insulin-releasing effect of Gl-PS was inhibited by these inhibitors.The effects of Gl-PS on protein expression of the glucose transporter 2(GLUT2) under 5.6 and 16.7 mmol·L^-1 glucose were also investigated. RESULTS: Gl-PS stimulated the insulin release when incubated with the glucose of 5.6 or 16.7mmol·L^-1.The insulin releasing effect of Gl-PS was partly inhibited by verapamil and completely inhibited by verapamil +EGTA. Gl-PS could promote the GLUT2 protein expression of pancreatic islets under glucose of 5.6 and 16.7 mmol·L ^-1. CONCLUSION: Gl-PS possesses insulinreleasing effect under the glucose of 5.6 and 16.7 mmol·L ^-1 due to the promotion of the GLUT2 protein expression and the subsequent facilitation of Ca^{2 +} inflow into the pancreatic B cells.

Lack effect of metabotropic glutamate receptors on neurotoxicity of PC12 cells induced by 6-OHDA1

MENG Chang-Hong, DING Jian-Hua, HU Gang

2003, 8(3): 269-272.

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AIM: To explore if metabotropic glutamate receptors (mGluRs) induces neuroprotection against 6-hydroxydopamine (6-OHDA) neurotoxicity in PC12 cells. METHODS: The alteration of the glutamate in extracellular fluid of PC12 cells was detected by high performance liquid chromatography (HPLC) with a fluorescent detector.The cytotoxic activity of PC12 cells was assayed by means of MTT colorimetric method. RESULTS: 6- OHDA dose-dependently increased glutamate release and decreased cell activity of PC12 cells, and the mGluRs ligands had no significant effect on that. CONCLUSION: The mGluR3 ligands has no protective effect on neurotoxicity of PC12 cells induced by 6-OHDA.

Down-regulation of oxidative stress is the possible mechanism of ginsenoside Rg1 protecting the substantia nigra neurons in PD mice¹

ZHOU Yi-Can, CHEN Xiao-Chun, ZHU Yuan-Gui, FANG Fang, CHEN Li-Min

2003, 8(3): 273-277.

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AIM: To explore the role of ginsenoside Rg1 as an antioxidant in preventing against 1-methyl-4- phenyl-1, 2, 3, 6- tetrahydropyridine (MPTP)-induced apoptosis of substantia nigra neurons in Parkinson' s disease (PD)mice models. METHODS: C57BL mice were administrated (sc)withMPTP to produce PD mice models.Different doses (5.0, 10.0, and 20.0 mg·kg ^-1)of Rg1 were given (ip)MPTP prior 3 days in the pretreatment groups.Nissl staining, tyrosinehydroxythase (TH) immunostaining, cleaved caspase 3 immunostaining, and TUNEL staining were used to observe the changes of nigra neurons.Meanwhile, biochemical technique was used to detect the concentration of GSH and the vitality of SOD in substantia nigra. RESULTS: Pretreatment with Rg1 could increase the concentration of GSH and descent the vitality of SOD in substantia nigra, prevent the loss of Nissl staining neurons and TH-positive neurons, and decrease the percent of cleaved caspase 3 and TUNEL-positive cells. CONCLUSION: Down-regulation of oxidative stress is the possible mechanism of ginsenoside Rg1 protecting the substantia nigra neurons in PD mice.

Protective effect of breviscapine on cerebral ischemia-reperfusion injury and therapeutic window of opportunity

HE Wei, CHEN Hui, ZENG Fan-Dian

2003, 8(3): 278-281.

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AIM: To investigate the protective effect of breviscapine (Bre)on cerebral ischemia-reperfusion injury and the therapeutic window of opportunity. METHODS: Focal cerebral ischemia-reperfusion models in rats were induced by the transient occlusion of the middle cerebral artery for 2 h, followed by reperfusion for 3 h, and the animals were administered Bre 50, and 75mg·kg ^-1, ig, qd ×7 d before transient MCAO.After the reperfusion, the influence of Bre on neurological deficit score, infarct size and brain edema were observed.The serum concentration of IL-8 was detected with radioimmunoassay (RIA), and the brain tissue EB content was examined with spectrophotometer.For the therapeutic window of opportunity, the MCAO model was induced by transient occlusion for 2 h and reperfusion for 24 h.The drugs were administered at 3 h, 4.5 h and 6 h after the onset of ischemia, respectively, and the second administration was at 22 h after reperfusion.The neurological deficit score, infarct size and brain edema were examined. RESULTS: Bre 75 mg·kg ^-1, ig, qd ×7 d before MCAO significantly reduced the neurological deficit score, the infarct size, and brain edema.The serum content of IL-8 and the brain tissue EB content decreased after ischemia-reperfusion injury.The administration of Bre beginning at 3 h after the onset of ischemia significantly reduced neurological deficit score, infarct size and brain edema, but starting treatment at 4.5 h after onset of ischemia, the neuroprotective effects decreased, and starting at 6 h after onset of ischemia did not result in significant reduction of the above indexes for brain tissue. CONCLUSION: Bre has protective effects on cerebral ischemia-reperfusion injury. The therapeutic window of opportunity of Bre in transient focal cerebral ischemia injury is no more than 4.5 h after onset of ischemia.

Relationship between nitric oxide and early ischemic brain damage induced by photochemistry in rats and the protective effects of gypenosides on the damage1

XIE Zhi-Zhong, ZHU Bing-Yang, TANG Xiao-Qing, LIAO Duang-Fang, YU Lin

2003, 8(3): 282-285.

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AIM: To investigate the relationship between nitric oxide (NO) and early ischemic brain damage induced by photochemistry and the effect of gypenosides (Gyp) on the damage. METHODS: The effects of Gyp and oxidized hemoglobin (OHb) on ischemic brain tissure areas, TBARS and H₂O contents, superoxide dismutase (SOD) activity and NO level were observed on the rat middle cerebral artery occlusion (MCAO) model induced by photochemistry. RESULTS: The middle cerebral artery occlusion for 6 h caused obvious ischemic brain damage, increased the areas of ischemic brain and the contents of H2O and TBARS, and decreased SOD activity and NO level (all P <0.05).These effects can be exacerbated seriously by OHb, but reversed by Gyp. CONCLUSION: The decrease of early cerebral NO level is an important factor to lead to ischemic brain damage.Gyp decreases ischemic brain damage by increasing early cerebral NO level and has a prophylactic protective effect on cerebral ischemic damage.

Non-inferiority clinical trial of imported herb sinupret drops in the treatment of Chinese patients with acute sinusitis

JIANG Meng, XIONG Ning-Ning, YAN Dao-Nan, LIU Yu-Xiu

2003, 8(3): 286-288.

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AIM: To evaluate efficacy and safety of the sinupret drops in the treatment of Chinese patients with acute sinusitis. METHODS: A randomized, positive-controlled (the capsules of gelomyrtol), parallelgroup, multi-central trial was carried out to evaluate the performance of the sinupret drops in Chinese patients. The assessment was blind to the investigators. RESULTS: There were no statistical differences in total curative efficacy and the approval of symptoms and signs between two groups (P >0.05).No adverse reactions were found during the trial. CONCLUSION: The sinupret drops is efficacy and safety in treatment of Chinese patients with acute sinusitis.

Protection and mechanism of compound Hippophae rhamnoids L.granule 2 on focal cerebral ischemia-reperfusion in rats

CHENG Ti-Juan, WEI Shu-Chang, ZHANG Weng-Bin, MA Jian-Xiu

2003, 8(3): 289-291.

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AIM: To study the protection and mechanism of compound Hippophae rhamnoides L.granule 2 (CHRG2) on focal cerebral ischemia-reperfusion in rats. METHODS: Focal cerebral ischemia-reperfusion model was made with suture-occluded method.The volume of cerebral infarction, the level of MDA in serum, the activities of SOD and GSH-Px in serum were measured.The behavior obstacles of rats were observed. RESULTS: After cerebral ischemia-reperfusion, the content of MDA in serum and the volume of cerebral infarction increased significantly, the activities of SOD, and GSH-Px decreased significantly.CHRG2 could effectively prevent these changes. CONCLUSION: CHRG2 shows the protection against ischemia-reperfusion injury, and the effect may be related to raising anti-peroxidation of the brain tissue.

Comparison of efficacy and safety of oral amiodarone and propafenone in patients with paroxysmal atrial fibrillation

HE Sheng-Hu, XU Xia-Hua, LIU Xiao-Dong, CHEN Shu, SUEN Lei, ZHANG Yi

2003, 8(3): 292-294.

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AIM: To compare the efficacy and safety of amiodarone and propafenone in the treatment of paroxysmal atrial fibrillation (AF). METHODS: The population consisted of 56 consecutive patients (age 39-72 years, 37 male) with recurrent symptomatic atrial fibrillation.Those patients were randomized to amiodarone group (n =28) or propafenone group (n =28).Usage of amiodarone;0.2 tid within seven to ten days, 0.2 bid within seven days.The maintain dose was 0.2 qd or 0.2 qod.Usage of propafenone;0.15 tid or qid within two weeks.The maintain dose was 0.1 tid.Follow-up evaluations were conducted at 1, 2 and 3 weeks, and 4-week intervals thereafter. RESULTS: Duration of following up was 6 months.Four patients treated with amiodarone, and two with propafenone discontinued therapy due to adverse effects.There was no life-threatening adverse effects.The whole effective rate was 82.1 %in amiodarone group and 57.1 % in propafenone group (P <0.05). CONCLUSION: Amiodarone was more effective than propafenone in treatment of paroxysmal AF, though its long-term efficacy was limited by noncardiac adverse side effects.

Experimental study on immunoregulation mechanism of compound zhongjiling

HAN Tao, ZHOU Yong, WANG Xue-Dan, GE Dong-Yu, WANG Jing, WU Yi-Ling, TIAN Shu-Yan, GAO Xue-Dong, LI Ping

2003, 8(3): 295-298.

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AIM: To approach the immunoregulation function and mechanism of compound zhongjiling. METHODS: EAMG models in Lews rats were established.By using 3H-TdR method, the effect of zhongjiling to proliferation reaction of lymphocyte in normal BALB/C spleen of mice induced by ConA and Lps and the effect of compound zhongjiling to proliferation reaction of lymphocyte in lymph node of rats was examined;by using ELISA, the effect of zhongjiling to AchRab titre and the level of IFN-γin serum of EAMG rats was examined. RESULTS: there was no significant improvement on the effect of zhongjiling to proliferation reaction of lymphocyte in normal BALB C spleen of mice induced by ConA and LPS(P <0.05).The effect of compound zhongjiling on the proliferation reaction of lymphocyte showed a significant improvement (P <0.01) in lymph node of EAMG rats induced by ConA, and the inhibition was induced by N₂AchR (P <0.01).The AchRab titre and the level of IFN-γ significantly reduced (P <0.01) in serum of EAMG rats. CONCLUSIONs: The mechanism of compound zhongjiling is not through immunosuppression, but through restraining N₂AchR antigen to induce specific immune reaction in prevention and treatment of EAMG.

Inhibition of tramadol on restlessness and its dose-response and time-effect relationship in recovery period of general anesthesia

TAO Ming-Zhe, LI Shao-Jun, BAI Zhi-Ping, HUANG Xiao-Peng, LI Han-Wei

2003, 8(3): 299-301.

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AIM: To study the effect of tramadol on restlessness in recovery period of general anesthesia and its dose-response and time-effect relationship. METHODS: 138 adult patients (ASA Ⅰ-Ⅲ) following abdominal surgery with isoflurane-balanced anesthesia were divided into 5 groups (a double-blind randomized study); control-group (n =34), T1 and T2 group (tramadol given 1 and 2 mg·kg ^-1, respectively, at the thirtieth minute before the end of operation, n =26), and T3 and T4 group (tramadol 1 and 2 mg·kg ^-1, respectively, at the end of operation, n =26).Some indices were observed including the changes of respiration and circulation, the conscious state with Robertson' s conscious scores and pain with Prince-Henry score, and the incidence and degree of adverse reaction. RESULTS: In comparison with control-group, the respiration and circulation were steady (P <0.05) in T1 and T2, with lower Prince-Henry score (P <0.01) and light restlessness, but that were not difference in T3 and T4.The time of extubation was not difference between each other, but consciousness level in the groups administered tramadol were lower than that in control group, and the lowest level existed at the end of operation in groups administered tramadol. CONCLUSION: Intravenous tramadol 1~2mg·kg ^-1 can effectively inhibit restlessness in recovery period of general anesthesia, but its effect is related to the time administered tramadol.

Study of quercatin reverse druy-resistance of leukemia cell in vitro¹

QIAO Xin-Hui, TANG Hui-Fang, SONG Lan, LONG Shi-Ying, ZHOU Di-Xian, LIU Si-Chun

2003, 8(3): 302-303.

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AIM: To explore the effect of quercetin on resistance reversal and its mechanism. METHODS: Human erythroleukemic cell line K562 and its doxorubicin- resistant counterpart K562 A02 were used in the study.Cytotoxicity was assessed by MTT assay.P-gp expression was measured with flow cytometry. RESULTS: Quercetin of 10μmol·L ^-1had no effect on the multidrug resistance reversal and P-gp expression.However, quercetin of 20 μmol·L ^-1 could increase chemosensitivity of F562 A02 and decrease the P-gp expression. CONCLUSION: Quercetin can reverse drug-resistance of K562 A02 cell to Daunorubicin.

Study of acetylation phynotype in pregnancy women¹

DONG Rui-Qian, GUO Rui-Chen, CAO Yu-Mei, XU Bing-Ying, CUI Xiu-Jun

2003, 8(3): 304-307.

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AIM: To study the influence of placenta acetyltransferase (NAT2) on acetylate phenotypes in pregnant and PIH women. METHODS: The samples of 20 ml urine were collected 2 h after a cup of 140mg-caffeine spiked coffee and the acetylator status were phenotyped by measuring the peak area of two caffeine metabolites, AFMU (5-acetylamino-6-formylamino-3-methyluracil) and 1X (1-methylxanthine) with high performance liquid chromatography (HPLC).Frequence distribution histograms were drawn to assess and compare slow and fast acetylate phenotype status among pregnant, PIH, and health women. RESULTS: The subjects were classified as slow acetylators if PAR <1.05 or as fast if PAR > 1.05, according to the data obtained from health women. The fast acetylators of pregnant and PIH women were 84.8 % and 92.9 %, respectively, much higher than that in health women by 72 %.There were no significant differences between PIH with and without urine protein.The mean AFMU/1X was lower in PIH with unusual urine protein than those without (P <0.01). CONCLUSION: The acetylator status of pregnant women can be affected by placenta acetyltransferase, and its routine determination may be used to ration drug therapy.

Experimental study on the inhibition of huangbaiye on HSV-2 in vitro

YANG Zhi-Bo, OUYANG Heng, OU Bai-Sheng, TAN Jin-Hua

2003, 8(3): 308-310.

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AIM: To study the effects of the huangbaiye in the treatment of recurrent genital herpes. METHODS: The inhibitory activity of huangbaiye on HSV-2 was observed from the cells cultured in vitro in comparison with cyclo-C and acyclovir. RESULTS: The huangbaiye showed notable direct inhibitory effects on HSV-2 in vitro.The minimal effective concentration was 2.5 g·L ^-1, the therapeutic index was 3, the inhibitory activity of huangbaiye (2.5 g·L^-1) was not less than that of cyclo-C, and the inhibition virus index was 2.83 in both huangbaiye and cyclo-C. CONCLUSION: Huangbaiye has inhibitory affect on HSV-2 in the treatment of recurrent genital herpes.

Effects of sodium nitroprusside on cardiac function and the level of nitric oxide, lipid peroxide and atrial natriuretic factor of the elderly patients with congestive heart failure

LI Shi-Yu, MA Yu-Ling, GUO Xiang-Jie, LI Zhi-Hong, FENG Guo-Wei

2003, 8(3): 311-313.

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AIM: To observe effects of sodium nitroprusside on cardiac function and the level of nitric oxide (NO), lipid peroxide (LPO) and atrial natriuretic factor (ANF) of the elderly patients with congestive heart failure (CHF). METHODS: 100 patients with CHF who were over sixty years old were randomized to sodium nitroprusside group and nitroglycerine group.The patients in nitroprusside group received intravenous drip of 20 mg sodium nitroprusside +5 %GS100 ml once a day, the basic drip rate of sodium nitroprusside was 10 -20 μg·min^-1;if the effects was bad, then the incremental increases of drip rate was 5 -10 μg·min^-1, but the basic drip rate of sodium nitroprusside was less than 100 μg·min^-1.The patients in nitroglycerine group received intravenous drip of 20 mg nitroglycerine +5 %GS 100 ml once a day;the course of therapy in each group was 5 -7 days. RESULTS: the general effective rate in sodium nitroprusside group was 96 %, and that in nitroglycerine group was 68 %.After treatment, in each group, heart rate and blood pressure were decreased, LVEF and CO increased, the level of LPO and ANF were decreased, the level of NO increased;but apparently the curative effects of sodium nitroprusside group was much better than that of nitroglycerine group (P <0.01). CONCLUSION: Sodium nitroprusside has remarkable curative effects in elderly patients with CHF and few side effects;and the elderly patients with CHF, failed to conventional treatment, can be treated by sodium nitroprusside.

Efficacy of deproteinised calf blood extract in treatment of patients with peptic ulcer disease

CAI Ning, WANG Hong-Xin, YAN Fei, WANG Zhi-Yi, YU Xiang-Guo, TANG Yi-Chao

2003, 8(3): 314-316.

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AIM: To observe the efficacy of deproteinised calf blood extract (DCBE) in the treatment of patients with peptic ulcer disease. METHODS: 60 patients were randomly divided into two groups.Treating group (n =32) received DCBE (800 mg, qd) and famotidine (100 mg, bid) and control group (n =28) received famotidine (100 mg bid).These treatments lasted for four weeks.The efficacy was determined by gastroendoscopy. RESULTS: The ulcer healing rates were 78.1 % and 46.4 %for 2 wk, and 84.4 % and 71.4 % for 4 wk in treating group and control group, respectively. CONCLUSION: DCBE has a significant effect in the treatment of patients with peptic ulcer disease.

Antitumor effects of losartan in EAC mice

CHEN Fang, WU Tie

2003, 8(3): 317-319.

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AIM: To study the antitumor effects of losartan in EAC mice. METHODS: The inhibitory rates of tumor growth and the ratio of extending viability were observed in EAC mice in three groups given losartan, 5- FU and NS, respectively. RESULTS: Comparing with the control groups, the inhibition to tumor growth was 46.3 % in losartan (12.5 mg·kg ^-1) group.But losartan did not lengthen life time in EAC mice.The inhibition to tumor growth was was 31.5 % in 5-FU (5 mg·kg ^-1) group. CONCLUSION: Losartan can inhibit the tumor growth of EAC, but not lengthen life time of the animals.

Efficacy of combined spinal and epidural anesthesia for labor analgesia

ZHANG Yong-Feng, CHENG Ming-Hua, XU Lan, ZHOU Jia-Fang

2003, 8(3): 320-322.

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AIM: To investigate the effects of combined spinal and epidural anesthesia (CSEA) on relieving and eliminating labor pain and the effects on newborns, labor process and delivery mode. METHODS: 305 cases without any obstetric and anesthetic contraindications were selected for the study group, and CSEA was applied when cervix dilated for about 3 -4 cm.305 pregnant women with similar obstetric condition as control group without any anesthesia.The labor pain, duration delivery mode and fetal status compared in the two groups. RESULTS: CSEA group showed good effect on relieving labor pain, shortening the active phase of labor course, and accelerating cervical dilation.There are no different in the incidence of fetal distress, neonatal asphyxia and postpartum hemorrhage between two groups. CONCLUSION: The CSEA is useful in relieving labor pain and accelerating labor course without any side effect on fetus.

Analgesic effects of hushentongfengwan in mice

YANG Hong-Fa, SONG Wen-Chong, WANG Yan-Yan, QIAN Jing-Ping, CHEN Chao

2003, 8(3): 323-325.

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AIM: To evaluate the analgesic effects and acute toxicity of hushentongfengwan (Hus). METHODS: The analgesic effects were tested by writhing reaction and hot-plate method and acute toxicity was observed in mice. RESULTS: Hus could restrain writhing reaction caused by acetic acid glacial, lighten the pain caused by hot-plate, and it did not show any reactions of acute toxicity. CONCLUSION: Hus had significant analgesic action.

Efficacy of mizolastine in the treatment of patients with chronic urticarial and the change of serum IL-4

CI Chao, MA Xiao-Ling, MENG Qing-Qin

2003, 8(3): 326-328.

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AIM: To evaluate the effect of mizolastine in patients with chronic urticaria and to explore the role of IL-4 in the process of chronic urticaria. METHODS: 32 cases of chronic urticaria were treated with mizolastine, and the therapeutic effects and the side-effect were evaluated.The serum IL-4 levels were tested by ELISA. RESULTS: The total effective rates were 62.5 % and 84.4 % (P <0.05) at the end of 1 wk and 2 wk, respectively.The side-effects were found in 3 cases (9.4 %).The average levels of serum IL-4 before treatment were higher than those in controls (P <0.01), but after treatment were not (P >0.05), and before treatment were significantly higher than those after treatment (P <0.01). CONCLUSIONs: Mizolastine is an effective and safe drug in the treatment of patients with chronic urticaria and the serum level of IL-4 decreases.

Pharmacokinetics and bioequivalance of aceclofenac enter-coated tablets in healthy male volunteers

HU Guo-Xin, QIU Xiang-Jun, XIE Hong, DAI Zong-Shun, WANG Gui-Zhen

2003, 8(3): 329-332.

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AIM: To study the pharmacokinetics and bioequivalence of aceclofenac enter-coated tablets in healthy volunteers. METHODS: A single oral dose of 100 mg aceclofenac and the same dose of airtal were given to 20 healthy male volunteers.Aceclofenac concentrations in plasma were determined by HPLC method.The parameters of pharmacokinetics were calculated by 3p97 program. The bioequivalence and bioavailability of the two formulations were analysed. RESULTS: The Cmax of the test and reference drug were 20 ±5 and 20 ±6 mg·L ^-1, respectively;T_max were 2.7 ±0.5 and 2.0 ±0.5 h, respectively;AUC_0-24 were 55 ± 26 and 52 ± 21 mg·h ^-1·L ^-1.The 90 % confident interval for AUC_{0 -24}- ratio and C_max-ratio of the mean values of test to reference formulations were 92.2 % -120.7 % and 91.8 % - 118.9 %, respectively.The bioavailability of the tested drug was 112 %±42 %. CONCLUSIONs: There are no significant differences between the parameters of the two formulations, and the two formulations are bioequivalence.

Evaluation of color Doppler flow imaging on the chemotherapy of gestational trophoblastic disease

ZHANG Xiao-Hong, XU Lan

2003, 8(3): 333-335.

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AIM: To investigate the value of color Doppler flow imaging (CDFI) and pulsed Doppler (PD) examination in evaluating chemotherapeutic effects of gestational trophoblastic disease (GTD). METHODS: Before and after chemotherapy, CDFI and PD were performed in 78 cases of GTD, and detected serum β-human chorionic gonadotropin (β-HCG) at the same time. RESULTS: For the blood flow of uterine muscular layer, the RI of uterine muscular layer, uterine and ovary artery in GTD, there were significant differences between before and after chemotherapy.A negative correlation was found between the increase of RI and the decrease of β-HCG (r =-0.54, P <0.001). CONCLUSION: The changes to the blood flow are the markers to evaluate chemotherapeutic effects in uterine muscular layer and the RI of uterine muscular layer, uterine artery, and ovary artery.CDFI and PD show a significant valuable for diagnosis, evaluating chemotherapeutic effects, and prognostic prediction of GTD.

Influence of tripterygium wilfordii on the children with nephrotic proteinuria

HU Guo-Hua

2003, 8(3): 336-338.

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AIM: To investigate the value and the effect of tripterygium wilfordii on decreasing proteinuria in the primary and secondary nephropathy syndrome in children. METHODS: 30 patients were confirmed the pathology classification, and given tablets of tripterygium wilfordii by 1.5 kg·d ^-1 for 4 weeks.24-hour urine volume and gastrointestinal reaction were observed, and regularly the 24-hour proteinuria quantity, hepatic and renal function, peripheral blood, and serum albumin were examined. RESULTS: 14 of 30 patients were effective after the treatment, 12 patients were improved, 7 patients were effective after 1-week treatment, and 9 patients were effective after 2 weeks.Individual patients had moderate gastrointestinal disorder;a few patients had modest ALT increase in early therapy;and all recovered after continuous treatment.The value of WBC in 3 patients decreased to 3.5 ×10⁹ L ^-1 in the whole course, but, it did not affected the administration.All patients had normal renal function. CONCLUSIONs: Tripterygium wuilfordii can effectively decrease proteinuria, and improve the symptom of primary and secondary nephropathy syndrome in children.

Clinical efficacy of daniston danshentong capsule in treatment of patients with nodular-cystic acne

YAO Chun-Hai, SU Ai-Hua

2003, 8(3): 339-340.

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AIM: To observe the clinical effects of daniston danshentong capsule in treatment of patients with nodular-cystic acne. METHODS: A group of patients (31 cases finished their observation in all 35 cases) was selected to take daniston danshentong capsule (0.25 g/capsule), 4 capsules three times daily.After continuous taking the agent for 8 weeks, the dosage changed to be 3 capsules three times daily.The treatment lasted for 12 weeks. RESULTS: The total effective rate was 83.9 %. Compared the mean number of the nodular-cystic acne before treatment (23 ±11) with that after 2 weeks of treatment (19 ±9), after 4 weeks (15 ±6), after 8 weeks (9 ±6), and after 12 weeks (7 ±7), all of the P values were less than 0.01.The effective rate increased gradually along with administration time lengthening. CONCLUSION: Daniston danshentong capsule is effective in treatment of nodular-cystic acne, and eight-week course is a suitable for the treatment.

Efficacy of ketosteril in treatment of chronic renal failure with high level of plasma Cys-C

DONG Fei-Xia, CHENG Jin-Guo, QIU Yi-Liang

2003, 8(3): 341-342.

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AIM: To observe the efficacy of ketosteril in treatment of chronic renal failure with high level of plasma Cys-C. METHODS: 60 patients with chronic renal failure were randomly divided into treatment group and control group.The control group was adopted a low protein and low phosphorum diet and correcting symptoms; the treatment group, based on the therapy of the control group, was given ketosteril;30 healthy subjects were used as the normal control to observe changes of Cys-C, Scr, TC, HB, and HDL before and after the treatment. RESULTS: The levels of Cys-C and Scr decreased after the administration of ketosteril (P <0.05). CONCLUSION: Ketosteril shows a better effect on decreasing the levels of Cys-C and Scr in patients with CRF.

Analysis on clinical usage of drugs for respiratory system diseases

WANG Jing-Hong, ZHANG Yan-Li

2003, 8(3): 343-345.

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AIM: To investigate clinical usage of drugs for respiratory system diseases. METHODS: The in-hospital records from November 2001 to February 2002 were investigated in a hospital.The usage and utilization of the drugs were analyzed with DDDs.Drug interactions were evaluated with a software (Reasonable Medication System). RESULTS: The frequency of use of antimicrobial accounted for 35 % in total.The other two kinds were anti-asthma drugs and the removing fever of ready-made traditional Chinese medicine.Some unreasonable interactions were found in this investigation. CONCLUSION: In the hospital, the usage of drugs for respiratory system diseases is rational on the whole, but drugs interaction should not been neglected.

Cost-effectiveness analysis of domestic and imported urapidil in treatment of patients with hypertention

ZHANG Jin-Ping

2003, 8(3): 346-347.

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AIM: To explore the cost-effectiveness analysis of domestic and imported urapidil in treatment of patients with hypertention. METHODS: 60 cases of severe hypertention were divided into two groups randomly; domestic urapidil (n =30) and imported urapidil group (n =30).The data were evaluated with cost-effectiveness analysis. RESULTS: Domestic and imported urapidil showed the same effectiveness in treatment of severe hypertention. CONCLUSION: Domestic urapidil is better than imported based on the cost-effectiveness analysis.

Evaluation of clinical efficacy of buflomedil in treatment of patients with ventebro basilar ischemia

YANG Tian-Hong, YANG Li-Li, HU Tai-Guo

2003, 8(3): 348-350.

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AIM: To examine the effects of buflomedil in treatment of patients with ventebro basilar ischemia. METHODS: 92 case of patients with ventebro basilar ischemia were randomly divided into two groups: buflomedil group and control group. The curative effects were observed daily. RESULTS: The total clinical effective rate were 96. 6 %in 72 hours. CONCLUSION: Buflomedil is an effective agent in the treatment of patients with ventebro basilar ischemia.

Clinical efficacy of atomolan in treatment of the patients with virus hepatitis

LUAN Ling, ZHANG Jing-Liang

2003, 8(3): 351-353.

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AIM: To observe clinical efficacy of atomolan in treatment of the patients with virus hepatitis. METHODS: 96 patients were randomly divided into 2 groups.46 patients as a control group were given conventional treatment.50 patients as a treatment group were administered atomolan 1.8 g·d ^-1 iv gtt for 1mon on base of conventional treatment. RESULTS: After the therapy, the clinical symptoms and liver function in the treatment group was improved than that in the control group.The general effect was 90.0 % and 54.3 % in 2 groups.Side effects had not been found. CONCLUSION: Atomolan is an effective agent in treatment of the patients with virus hepatitis.

Lowest sample size and its safety in clinical trials in China

ZHENG Qing-Shan, SUN Rui-Yuan, CHEN Zhi-Yang

2003, 8(3): 354-355.

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Sample size should be determined by statistical estimation from efficacy analysis, but the lowest case number is necessary for safety.By calculation of the detection rate of adverse reactions, this paper suggests that the lowest sample sizes are reasonable for Ⅱ, Ⅲ and Ⅳ stage in clinical trials in China.

International ethical guidelines for the selection of vulnerable subjects in clinical trials Extracted from CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects

BO Qing-Yan, XIONG Ning-Ning, WU Jing

2003, 8(3): 356-360.

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