Comparison and reference of foreign expedited approach for new drug review / 中国药学杂志

OBJECTIVE: To make a comparative analysis on the expedited approach for new drug review in the USA, the European Union, and Japan, and to provide references for China. METHODS: Through analyzing the mechanism and implementation performance of each expedited approach, and summarizing its characteristics, this paper puts forward some suggestions according to the situation of the reform for new drug review in China. RESULTS: Compared with the US, EU and Japan, our country is gradually laying emphasis on the value of clinical curative effect when to apply expedited approach, but there is still a large gap on system setting. CONCLUSION: Hence this paper suggests to draw lessons from foreign "multi-channel, full coverage" concept, and gradually to establish a new multi-channel system of expedited review approach on the basis of perfecting our country's priority review approach, thereby accelerating the process of new drugs which have high clinical value.

Comparison of two kinds of small incision operation in patients with diabetic cataract / 中国基层医药

Objective To compare the effects of two kinds of small incision operation in patients with diabetic cataract.Methods 100 patients with diabetic cataract were randomly divided into the two groups:the observation group(n=50,76 eyes) and the control group(n=50 cases,73 eyes).The observation group was operated through small incision non-phacoemulsification.The control group was treated with small incision phacoemulsification.The two groups of visual acuity,corneal endothelial cell density,corneal edema and postoperative astigmatism were compared. Results Two different eye surgery before the vision was no significant difference in the distribution segment(χ2 =0.297,P>0.05).Different postoperative visual acuity eye segment distribution after 3d were significantly different (χ2 =1.163,P>0.05).Different postoperative visual acuity eye segment distribution after 1m were significantly different(χ2 =0.928,P >0.05).The control group preoperative corneal endothelial cell density was (2 369 ± 261)cells/mm2,the observation group (2 403 ±277)cells/mm2.Preoperative corneal endothelial cell density was no significant difference between the two groups(t=0.467,P>0.05).Postoperative 3d and 1m,corneal endothelial cell density was (1 635 ±189)cells/mm2 and (1 706 ±196) cells/mm2 in the control group,(1 931 ±207) cells/mm2 and (1 982 ±203)a/mm2 in the observation group.The observation of corneal endothelial cell density was significantly higher(t=2.726,2.460,all P<0.05).The incidence of postoperative corneal edema were 35.6%,51.3%,and the observation group was significantly higher(χ2 =4.960,P<0.05).The incidence of postoperative astigmatism were 42.5%,26.3%,and the observation group was significantly lower than those of the control group(χ2 =5.210,P<0.05).Conclusion Two small incision surgery has advantages and disadvantages,and the effect is quite.

The comparison of the therapeutic impacts on metabolism in hepatitis C virus and human immunodeficiency virus co-infected patients / 中华内分泌代谢杂志

To explore and compare the response of the protease inhibitors or non-nucleoside reverse transcriptase inhibitors-based therapeutic impact on metabolic indices in hepatitis C virus (HCV)/human immunodeficiency virus(HIV) co-infected patients.A randomized,open,and control approach was performed to enroll 273 cases of HCV/HIV co-infected patients on their initial visits and to choose protease inhibitors(PIs group) or non-nucleoside reverse transcriptase inhibitors (NNRTIs group) based therapy treatments for one year.Laboratory results of metabolic indices before and after the treatment were collected.After treatment,the levels of triglyceride in NNRTIs and Pls groups were (1.93 ± 0.99) mmol/L and (1.62 ± 0.93) mmol/L respectively,high density lipoprotein-cholesterol were(1.28 ± 0.55) mmol/L and (1.08 ± 0.53) mmol/L,low density lipoprotein-cholesterol were (2.60 ± 1.44) mmol/L and (2.22 ± 1.16) mmol/L,fasting plasma glucose were (5.92 ± 1.21) mmol/L and (4.79 ± 0.47) mmol/L,serum creatinine were (70.5 ± 14.6) μmol/L and (56.6 ± 8.3) μmol/L,and serum amylase were(66.9 ± 27.5) U/L and(62.7 ± 33.8) U/L respectively.The difference between the two groups was statistically significant(all P＜0.01).There is a therapeutic impact on metabolic indices in patients wtih HCV / HIV co-infection after non-nucleoside reverse transcriptase inhibitors-based regimen.

MRI with microscopy coil of the proximal interphalangeal joints: preliminary study / 中华放射学杂志

nal surface coil,and it can be a promising method to diagnose interphalangeal joints lesions.

The Comparison of Recovery Characteristics Following Anesthesia with Propofol, Sevoflurane or Isoflurane in Adults Undergoing Outpatient Surgery / 대한마취과학회지

BACKGROUND:Outpatient surgery has recently grown in popularity. This trend has affected the practice of anesthesia and has also led to an increasing interest in the development and use of short-acting anesthetic and analgesic agents. METHODS: One hundred fifty patients scheduled for outpatient surgery were randomly allocated to receive propofol, sevoflurane or isoflurane anesthesia with tracheal intubation. Clinical recovery times were analyzed as emergence, recovery, cognition and discharge. All adverse events were noted. RESULTS: Sevoflurane resulted in significantly shorter times to emergence (2.9 min), recovery (4 min), cognition (5.5 min) and discharge (13.4 min) than isoflurane. Propofol resulted in shorter times to emergence (2 min), recovery (2 min), cognition (3 min) and discharge (6.6 min) than isoflurane, but these were not significant. Also, sevoflurane resulted in shorter times to emergence, recovery, cognition and discharge than propofol, but not significantly. Among the adverse events noted, the percentages of postoperative nausea and vomiting (PONV) after anesthesia were 8%, 20% and 24% for the those who received propofol, sevoflurane and isoflurane, respectively. Propofol resulted in a significantly lower incidence of PONV than sevoflurane or isoflurane. There was no significant difference between sevoflurane and isoflurane in this respect. CONCLUSIONS: Sevoflurane and propofol are better anesthetics than isoflurane for outpatient anesthesia because of their rapid recovery times and a lower incidence of postoperative nausea and vomiting.

Comparison of Behavior Problems of Children in Town and Countryside in East China / 中国心理卫生杂志

Objective:To compare behavior problems of children in town and countryside in east China Method:1983 children of 6 years old were collected from towns and countryside of Cangnan county of Zhejiang province They were assessed with Rutter's Children Behavioral Scale The rate of return was 94 3% Result:The prevalence of behavior problems in children of countryside was 12 8%, that of children of town was 7 7% In both children from town and countryside, negative rearing attitudes (i e scold and hit, indulgent), pressure of school exam were all risk factors for behavior problems In children from countryside, risk factors included mother's disadvantage factors In children from town, the risk factors included father's personal problems Conclusion:There were some difference in behavior problems and related factors of children of countryside and town

Risperidone and Olanzapine Drug Outcomes Study in Korean Patients with Schizophrenia and Schizoaffective Disorder / 신경정신의학

OBJECTIVE: Risperidone and Olanzapine, two representative atypical antipsychotics, both have so called 'atypicality' in common: however, some discrepancies are expected. Considering this, studies have been surprisingly rare that had directly compared the two drugs head-to-head. We compared the efficacy and tolerability of Risperidone and Olanzapine by retrospective chart review of the patients diagnosed as Schizophrenia and Schizoaffective disorder. This study was a part of international collaborative study, RODOS (Risperidone and Olanzapine Drug Outcomes study in Schizophrenia), and the total of 24 hospitals in Korea had participated in this study. RESULTS: Among the baseline characteristics, the duration of illness was longer in Olanzapine group. Also the proportion of first admitted patients, and that of first medicated patients were both lower in Olanzapine group. Though these baseline differences have been controlled as covariates, the proportion of responsive patients was higher, and the median value of the time to effect was shorter in Risperidone group. There was no significant difference in the rate of extrapyramidal symptoms. However, the drop-out rate due to intolerance and the rate of concomitant anticholinergic usage were significantly higher in Risperidone group compared to Olanzapine group. The rate of other somatic side effects showed no between-group difference, except weight gain which was significantly more prevalent and higher in Olanzapine group. CONCLUSION: Though Risperidone was found to be superior in efficacy, we could not draw a final conclusion since this study was a retrospective chart review without any randomization which has a severe inherent limitation. This study should not be taken as an attempt to prove one drug's superiority over the other: rather, an attempt to scrutinize each drugs' weak and strong points to provide a guideline for proper drug usage accordingly.

Application of CD Pedicle Screw in Idiopathic Thoracic Scoliosis / 대한정형외과학회잡지

Fixation with screws of Cotrel-Dubousset instrumentation was applied to replace the hooks in the treatment of scoliosis thoracic spine from 1987 by authors. The purpose of this study is to compare the result of treatment of the idiopathic scoliosis patient with pedicle screws and that with hooks and to clarify the advantages of pedicle screws in the treatment of idiopathic is scoliosis. The materials were 164 idiopathic scoliosis patients treated from 1987 to 1991 with average follow-up of 36 months(ranged 24 to 52 months). They were divided into three groups according to the fixation implants used. Forty-seven patients were treated with hooks only(hook group), 76 patients with screws and hooks(mixed group), and 41 patients with screws only(screw group). In the frontal curve correction, the hook group showed 49% of correction(preop. 59° to postop. 30°), the mixed group 60% of correction(preop. 58° to postop. 23°), and the screw group 63% of correction(preop. 51° to postop. 19°). For the patients with preoperative kyphosis less than 15°, there were significant improvement of sagittal curve in all groups from 3° to 19°. In the normokyphotic patients, there was no significant change. In rotational deformity, measured by Perdriolle method, the hook group 19% of correction, mixed group 20%, the screw group 24%. Hooks were dislodged in 17 cases and screws were found out of pedicle in 5 cases, but any neurologic complications or significant adverse effect on curve correction and loss of correction were not observed. Soft tissue infection was occurred in one patient, who was treated onservatively. In conclusion, screws fixation on the thoracic spine can be applied in the treatment of scoliosis without neurologic complications, and the screws provide rigid fixation and immediate stability after insertion with better correction in frontal, sagittal and less neurologic risk due to its extracanal placement and rigid fixation in derotation, and it makes the instrumental technique simpler, so the operation time shorter.