Medical workers are the main designers and participants of clinical trials.In this consideration,popularization of good clinical practice (GCP)knowledge among them can improve their execution of trials,standardize basic clinical trial requirements,protect legitimate rights and health/safety of the subjects,and make the trial results more reliable.These objectives,if accomplished,will upgrade the clinical trials competency of medical institutions in China,and encourage healthy growth of the medical and pharmaceutical industry.The paper probed into the occupation qualification system of clinical trial workers and their supervision mechanism,inclusion of GCP into the continuing education system.

Objective To study the effect of pine root liquid on the fermentation Poria mycelia yield and content of water-soluble polysaccharide, and difference between fermentation Poria mycelium and the natural Poria. Methods Poria mycelia was cultured with pine root solution and non-fermented liquid, the production of water-soluble polysaccharide content was compared. The content of water-soluble polysaccharide of fermentation mycelia and natural Poria was also compared. Results The production of fermentation Poria mycelia cultured with pine root liquid increased slightly, but water-soluble polysaccharide content decreased. Water-soluble polysaccharide content in Poria mycelia was significantly higher than that in natural Poria. Conclusion Pine root solution has different effect on fermentation Poria mycelia yield and polysaccharide content. Water-soluble polysaccharide content in Poria fermentation mycelia was higher than natural Poria.

Objective To observe the curative effect and safety of interventional therapy of uterine fibroids using Embosphere and Pingyangmycin lipiodol emulsion.Methods The clinical data of 120 cases with uterine fibroids treated in our hospital were reviewed,and the patients were according to the different treatments given,divided into two groups (each with 60 cases).Patients in control group were treated with interventional therapy of Pingyangmycin lipiodol emulsion,while patients in the study group were given interventional therapy of Embosphere.The clinical efficacy and safety in the two groups were compared.Results The total efficiency in the study group was 93.33%,which was significantly higher than that in the control group (75.00%),and the difference was statistically significant (P<0.05).The comprehensive indexes after the treatment were improved in both groups compared with those before the treatment,and the improvement in the study group was significantly better than the control group (P<0.05,P<0.01).Besides,the total incidence of adverse effects in the study group was 11.67%,which was significantly lower than that in the control group (26.67%)(P<0.05). Conclusion The interventional therapy using Embosphere has better effect on uterine fibroid compared with the therapy using Pingyangmycin lipiodol emulsion,which is worthwhile to be brought into clinical application.

Objective To investigate the satisfaction of clinicians on clinical research associates (CRA)and its influencing factors,for the purpose of providing rationalized proposals on education of CRAs.Methods 141 clinicians were randomly sampled from tertiary hospital for questionnaire survey,using the 5-point Likert scale.The survey covers 4 levels,i.e.,the work attitude,professional knowledge and ability,communication skills,and project management capabilities,as well as 14 dimensions.Data processing and statistics were analyzed using SPSS 15.0 software.The attribute characteristics of the investigation subjects were analyzed using x2 of the contingency table,along with analysis of its correlation with the general satisfaction on CRAs.Results The mean values of the 12 indicators range 2.28 to 3.75,with low satisfaction in general.Among these indicators,satisfaction of the service attitude of the CRA,and of their familiarity with the pilot program and CRF completion axe the highest,respectively,74.04％and 61.70％.Satisfaction of the rest 10 indicators falls below 50.00％.The chisquare analysis showed no association between satisfaction and gender,education,job titles.The satisfaction is different(P＜0.05)between those trained and those not,while there exists a significant differences(P＜0.01)between those participating in different number of tests.Conclusion Clinicians have a low satisfaction on CRAs.It is recommended to strengthen the training,establish a CRA occupation certification system,and to strengthen the clinicians' emphasis and competency of clinical trials.These actions will normalize the industry of clinical trials and improve the level of clinical trials in China.

Objective To study the effect of continuing flushing with heparin on the prevention of tube obstruction after vacuum sealing drainage(VSD).Methods Seventy-four patients with large area of skin defects treated by VSD were randomly divided into experiment group and control group. The experiment group were managed by continuous infusion with saline at 250 mL and heparin at 12500 U (50 U/mL)in 24 h after operation,with 20 to 30 drops per minute and two times a day. The control group included 33 cases was injected with 20 mL saline when the drainage tube blocked until the VSD tube was unobstructed. The two groups were compared in terms of drainage time, drainage tube,wound healing time,rate of un-obstruction of tubes and histopathological scores.Results The drainage time and wound healing time of experiment group were significantly shorter than that of control group(P<0.05). The rate of un-obstruction of tubes was higher than the control group and so it was with the score in histopathology.Conclusion Continuous flushing with heparin can effectively reduce the incidence of VSD obstruction and promote wound healing.

BACKGROUND: After local injection of Botulinum toxin type-A (BoTX-A), not only the function of the neuromuscular conjunction was affected, but also the changes occurred remote from the injected site. F-waves result from the back fire of the motoneuron activation, which may indirectly reflect the functional state of the motoneurons.OBJECTIVE: To evaluate the remote effect of local BoTX-A injection by F-wave test.DESIGN: Self-control study based on patients with movement disorders.SETTING: Neruologic clinic in a university hospital.PARTICIPANTS: Twenty-six patients with movement disorders not received previous local BoTX-A were selected from Neurological Clinic in Renmin Hospital of Wuhan University between September 2002 and July 2003, including 19 cases with hemificiospasm, 5 Meige syndrome and 2 torticollis spasmodicus.INTERVENTIONS: F- and M-waves of ulnar and tibial nerves were recorded before 1, 12 - 24 weeks after local injection of BoTX-A in 26 patients.MAIN OUTCOME MEASURES: The following parameters were analyzed:latency(ML) and amplitude (Mamp) of M-wave, minimal (Fmin) and average latency (Fave), amplitude of negative peak(Famp), duration (Fdur), persistence (Fpcr) and chronodispersion (Fchr) of F-wave.RESULTS: No definite F-response of ulnar nerve stimulation was obtained 1 week after injection in 3 HFS patients (5 nerves) . Fave prolonged significantly on ulnar and tibal nerve and Fdur increased significantly on ulnar nerve 1 week after injection, but there was no significant difference 12 - 24 weeks later, compared with before injection. No significant correlation of the altered F-wave parameters was found with the dosage of BoTX-A.CONCLUSION: Fdur and Fave could sensitively assess the remote effect,which correlates with distance away from the injected muscle, rather than the dosage of BoTX-A.

Objective To evaluate the remote effect of local injection of botulinum toxin by use of the F-wave measures. Methods The F-wave responses as well as M-waves were recorded before injection, and at 1 week,12 to 24 weeks after local injection of botulinum toxin type-A (BTX-A) in 26 patients, including 19 with hemi-facial spasm (HFS),5 Meige syndrome and 2 torticollis spasmodicus (TS).The following parameters were analyzed: M-wave latency (ML) and amplitude (Mamp), F-wave minimal latency(Fmin) and average latency(Fave),amplitude (Famp), duration (Fdur), persistence (Fper) and chronodispersion (Fchr). The above parameters were obtained through the electric stimulation of ulnar and tibial nerves, and recorded from the abductor digiti minimi and extensor digitorum brevis, respectively. Results No definite F-wave was obtained by electric stimulation of ulnar nerve at 1 week after injection in 3 HFS patients (5 nerves). The Fave recorded from electric stimulation of ulnar and tibial nerves prolonged significantlyand Fdur from ulnar nerve increased significantly at 1 week after injection, but were not significantly different from those of pre-injection when recorded at 12 to 24 weeks after injection. No significant correlation of the altered F-wave parameters was found with the dosage of BTX-A. Conclusion Fdur and Fave could sensitively assess the remote effect of the local injection of BTX-A, the remote effect might be correlated with the distance between injected muscle and tested muscle, rather than the dosage of BTX-A.

Objective To investigate the diagnostic significance of sensory nerve action protential (SNAP) on diabetic neuropathy (DN), through measuring amplitude and amplitude ratio. Methods There were 91 patients with type 2 diabetes involing 51 cases without neurologic symptom/sign as subgroup Ⅰ, 30 cases with mild neuropathy as subgroup Ⅱ and 10 cases with severe neuropathy as subgroup Ⅲ, according to Toronto clinical scoring system (TCSS). Thirty-nine healthy volunteers with age- and gender-matched were served as controls. SNAP were antidromically recorded using surface electrodes. The observed parameters were as follows: conduction velocity and amplitude of median, radial and sural nerve, shorten for Vine, Vra and Vsu and Ame, Ara and Asu, respectively; sural/radial nerve amplitude ratio (SRAR) and median/ radial nerve amplitude ratio (MRAR). Results (1) As compared with the controls (P<0.05),conduction velocity (m/s, Vine : 46. 2 ±7.3, Vra: 45.8±6. 9, Vsu: 30. 3±9. 5) and amplitude (μV, Am: 15.4±10.5, Ar: 16.6±9.8, As: 5.9±6. 3)decreased significantly in subgroup Ⅲ; Vsu (46.2± 4. 7) significantly slowed in subgroup Ⅱ (P = 0. 002) ; both Ame (34. 5 ± 10. 2, 33. 0 ± 14. 6) and Asu (13.8± 5.6, 10.7 ± 5.5) decreased significantly in both subgroup Ⅰ and Ⅱ respectively, with Asu decreasing more significantly in subgroup Ⅱ (Z=- 3.22, P = 0. 001) ; SRAR (0. 432±: 0. 112) was significantly smaller only in subgroup Ⅰ , both SRAR (0. 330 ±0. 102) and MRAR (1. 008 ± 0. 225) were significantly smaller in subgroup Ⅱ. SRAR decreased more significantly in subgroup Ⅱ (t = - 3. 86, P = 0. 003). (2) The abnormal rate of Ame was the highest in subgroup Ⅰ (26. 0%), and Asu in subgroup Ⅱ (41.4%) ; while that of combination of Asu and SRAR (68.9%) was significantly higher than that of Asu alone (x2 = 9. 212, P = 0. 003). (3) TCSS scores were negatively related to Van (r = - 0. 583), Ame (r=-0. 406), Asu (r=-0.620) and SRAR (r=-0.527, all P<0.05), and there was no significant correlation of TCSS scores with MRAR in subgroup Ⅱ; both SRAR (r = -0.435) and MRAR (r = - 0. 319) were negatively related to the diabetic duration (both P < 0. 05). Conclusions In mild or early DN, SNAP amplitude is more sensitive than conduction velocity, combination of SRAR and Vsu may be serve as a useful indication for early diagnosis. In the DN patient, diabetic duration has more influence on the measurement of sensory NCS, and SRAR is related to the severity of neuropathy.

Objective To investigate prospectively the diagnostic significance of ulnar/median nerve amplitude ratio in motor neuron disorders.Methods Patients referral to our department between May 2009 and February 2012,due to muscle weakness,inflexible,cramps and atrophy,were consecutively enrolled.Conventional nerve conduction studies of 4 extremities (using surface electrodes) and needle electromyography were performed in all patients with fixed examiner.The compound muscle action potentials (CMAP) were recorded from abductor digiti minimi (ADM) and abductor pollicis brevis (APB) with stimulation of ulnar and median nerve at wrist,respectively.Moreover,the ratio of CMAP amplitude between ADM and APB (ADM/APB) was calculated in the patients who met the diagnostic criteria for definite amyotrophic lateral sclerosis (ALS) and Hirayama disease (HD).The patients with Guillain-Barré syndrome (GBS) and other popyneuropathies (PN) were served as case-controls,and 34 healthy volunteers (aged (45.7 ± 16.3) years) as normal-controls.Results (1) There were 78 cases with ALS,25 HD,51 GBS and 140 other PN,with the mean age(years) of 54.7 ± 11.6,17.6 ± 2.2,41.3 ± 18.4 and 57.1 ± 14.3,respectively.(2) ADM/APB in the ALS subgroup was 2.28 ±2.87 (0.12-22.38),HD0.66±0.36 (0.05-1.34),GBS 1.42 ± 1.33 (0.25-9.85),other PN 1.36 ± 1.48 (0.08-14.44) and normal-controls 1.07 ± 0.28 (0.61-1.64,F =6.872,P =0.000),respectively.(3) The areas under receiver operator characteristic curve in patients with ALS was 0.830 (s-x =0.039) and HD 0.691 (sx =0.039,P =0.000) ; the diagnostic sensitivity and specificity for ALS patients were 36.7％ and 93.3％,respectively,with cutoff value of ADM/APB =2; and the diagnostic sensitivity and specificity for HD patients were 53.6％ and 89.0％,respectively,with cutoff value of ADM/APB =0.7.Conclusions The ulnar/median CMAP amplitude ratio increases in ALS,but decreases in HD,which may be served as a relatively specific electrophysiological index.ADM/APB amplitude ratio ＞ 2.0 is suggested to be a diagnostic parameter for ALS and ＜ 0.7 for HD.

Objective To explore the relationship between plasma interleukin-11(sIL-11) level and platelet count post-chemotherapy with hematological malignancy patients and analyse a sIL-11 level which may maintain a safe platelet count so as to guide the treatment. Methods Blood samples were collected from the patients with hematological malignancy at certain time point of pre-and post-chemotherapy, and serum level of sIL-11 and platelet count were determined separately. Different statistical methods were applied to test the relationship between sIL-11 level and platelet changes. Results 99 cases finished this study. The findings are: the sIL-11 level went up and reached the peak on day 6 post-chemotherapy, while the platelet count kept dropping to the lowest on day 10, the sIL-11 peak occurred before the lowest platelet count, patients with faster sIL-11 increase may maintain a comparatively higher plateled count. 99 eases were grouped according to the lowest platelet count and compared: the group with higher platelet count tend to have higher peak sIL-11, more cases with higher peak sIL-11, with faster daily average sIL-11 increase, the lowest platelet count occurred later. Logistic regression analysis showed the factors contributed to lower platelet includes slower daily average sIL-11 increase and sIL-11 level less than 2000 pg/ml on Day4 post-chemotherapy. Conclusion There were correlation between the serum sIL-11 level and platelet counts, the platelet count change may be predicted by determining the plasma sIL-11 level post-chemotherapy. Patients with sIL-11 level less than 2000 pg/ml on Day4 post-chemotherapy may be endangered with severe thrombocytopenia, rhIL-11 or platelet transfusion treatment should be considered.