Objective To probe the relationship between the patients′prognosis and the gene of multidrugs and drug resistance in uveal melanoma.Methods The gene expression of cyclin D1, epithelial growth factor receptor (EGFR), non-metastasis gene 23 (nm 23), P glucose protein (P-gp ) , multidrug resistance relation protein (MRP) and lung resistance protein (LRP) expression in 96 cases of uveal melanoma were detected by depigment immunohistochemistry. The patients with complete anamnesis data were observed continuously, and the follow-up results were classified. Results Among the 96 cases of uveal melanoma, the epithelioid cell type was in 21, the mixed cell type in 56, and the spindle cell type in 19 ; including 76 at intraocular stage and 20 at extraocular stage. As the level of metastasis suppress gene nm 23 expression decreased and the level of cyclin D1 and EGFR expression increased, the expression level of drug resistance genes increased. The levels of LRP and MRP had negative correlation to the expressions of nm 23 and postive correlation to the expressions of nm 23, Cyclin D1 and EGFR. In 58 patients′who were observed continuously, 19 died in 5 years and 26 survived over 5 years.Conclusion There are significant as sociation between patients′prognosis and multidrug and drug resistance gene in uveal melanoma.(Chin J Ocul Fundus Dis，2003，19：1-4)
Objective To evaluate the safety and tolerance of pegfilgrastin (PEG-G-CSF) in Chinese healthy volunteers. Methods Thirty healthy volunteers were randomly divided into five single-dose groups to receive PEG-G-CSF 15, 30, 50, 60 or 75μg/kg by hypodermic injection. The safety profile and tolerability were evaluated by observing symptoms, vital signs, laboratory tests and electro cardiogram. Results No serious adverse event was reported for any volunteer. Transient dizziness occurred in one person in the 50 μg/kg dose group, and mild dizziness and ostalgia was found in all six people in the 75μg/kg dose group, of whom one experienced transient fever and two experienced mild diarrhea. No clinically significant changes in laboratory tests and electrocardiogram were found during the follow-up period. Conclusions The maximum tolerated dose of PEG-G-CSF injection in Chinese healthy volunteers is 60 μg/kg. Doses below 60μg/kg can be well tolerated. The recommended dose for phase II clinical trials is 60 μg/kgone, one dose for each cycle of chemotherapy.
Test of tissue tolerance to domastic prosthetic materials (carbon fiber mesh, siliconized velvet, silk cloth and dacron cloth) as a subcutaneos transplant was performed in the adcominal wall of rabbit. These implants and their surroundding tissues were excied for studies at second , fourth, eighth and the twelfth weeks after operation. Ratio of fibroblast count to inflammatory cells count which is a common parameter of tissue tolerance was calculated in these four groups. The result shows that fibroblastic cell reaction elicited by carbon fiber mesh is the greates among the four prosthetic materials, the second one is dasron cloth. The inflammatory cell reaction elicited by silk is the greatest among the four materials, the second is carbon fiber mesh, and the dacron cloth the least. Tissure tolerance of dacron cloth is the best in the four prosthetic materials for implantation while sick is the worst.
目的:研究TRAIL对卵巢癌COC1/DDP细胞生长的影响，以及化疗药物DDP等对TRAIL受体（DR4、DR5）表达的影响，揭示TRAIL与COC1/DDP细胞顺铂耐药性的关系。方法:用MTT法检测不同浓度TRAIL蛋白和TRAIL与DDP联合用药对COC1/DDP细胞生长的影响，用RTPCR方法检测DDP对TRAIL受体（DR4、DR5）表达的影响。结果:①TRAIL蛋白对COC1/DDP细胞生长有抑制作用，且随着TRAIL蛋白浓度升高，细胞抑制率逐渐上升。②DDP（2.5μg/mL）对COC1/DDP细胞生长抑制作用较弱（抑制率为3.31%），DDP在加入TRAIL蛋白后对细胞生长抑制率显著升高（Plt;0.05）。③DDP使COC1/DDP细胞的DR5表达水平显著增强为正常对照组的3.54倍（Plt;0.001）。结论:TRAIL蛋白对COC1/DDP细胞生长有抑制作用，DDP与TRAIL联合使用COC1/DDP细胞生长抑制更明显，TRAIL可逆转COC1/DDP细胞对DDP的耐药性，耐药性的逆转可能与DDP导致TRAIL受体DR5水平增高促进了肿瘤细胞的凋亡有关。
PURPOSE:Studying the multidrug resistance(MDR) phenotype occurring in retinoblastoma and its mechanism. METHODS:Using the procedure of stepwise increase in drug concentrations to obtain a retinoblastoma subline which resistant to 600ng/ml vincristine (HXO-RB/VCR). Characteristics of this drug-resistant cell line were investigated by cell counting,drugcontents determinatin,drug sensitivity evaluation and radiation sensitivity test. RESULTS:This cell line was cross-resistant to VDS,MMC VP16，ADM ,DDP,CBP,but not resistant to BCNU and 5-Fu. It was proved to be collaterally sensitive to MTX,and the response to 60Co gamma;-ray was modified slightly in HXO-RB/VCR cell line. Intracellular levels of VCR was much higher in HXO-RB44 cells than in the resistant subline. Those cross-resistances can be reversed by verapamil partly. CONCLUSIONS:MDR and radiation resistance of retinoblastoma can be induced by exposing to VCR and reversed by verapamil partly. （Chin J Ocul Fundus Dis,1997,13: 6-9）
目的 总结静脉制剂Ⅰ期临床耐受性试验中的护理要点。方法 2011年10月－12月，采用随机、盲法、安慰剂平行对照试验设计，在健康志愿者中按剂量递增原则，逐组完成8个剂量单次静脉滴注给药耐受性试验。 结果 试验顺利完成。静脉制剂的Ⅰ期耐受性试验中，研究护士在临床试验前需认真学习试验方案，做好试验病房、监护急救设施设备的充分准备，针对可能出现的不良反应制定切实可行的处理预案，试验过程中密切监测，对出现的不良反应做好救治工作。特别针对静脉制剂，须做好受试者的心理疏导，保证静脉穿刺一次成功，减少受试者因情绪紧张、穿刺疼痛等因素干扰对试验药物耐受性的评价。 结论 Ⅰ期临床耐受性试验实施前准备充分，试验过程中为受试者提供良好的试验环境和心理护理，提高静脉穿刺一次成功率，密切监测，可使试验过程顺利，并获得客观、准确的试验结果。
ObjectiveTo evaluate the treatment retention rate of five new types of antiepileptic drugs:lamotrigine (LTG), topiramate (TPM), oxcarbazepine (OXC), levetiracetam (LEV) and gabapentin (GBP) and their tolerability. MethodsA total of 216 patients diagnosed as epilepsy by receiving the long-term video electroencephalography monitoring between October 2012 and October 2014 were randomized into five drug treatment groups (LTG, n=57; TPM, n=42; OXC, n=49; LEV, n=47; GBP, n=21) and received corresponding dose of drug therapy. The seizure frequency, adverse events and number of patients giving up therapy were collected and recorded via phone or interview every 4 weeks. Every follow-up retention rate of every drug group equals current patient number continuing therapy/initial patient number of this drug group×100%. When the trial ended, Kaplan-Meier curve and Cox proportional risk model were applied for statistical analysis. ResultsThe trial lasted for 106 weeks. The final retention rate of LTG was the highest (85.9%), and GBP was the lowest (14.3%). Most patients could continue the therapy until the end of the trial after 24 weeks. The leading causes of discontinuing therapy included:no efficacy, rash, sedation and aggressive behavior. ConclusionThe retention rate of new types of antiepileptic drugs is associated with these elements:drug efficacy, adverse events, individual tolerability of drug, drug accessibility and the patients' individual preference of drug administration.
Objective To investigate the correlation between pectoralis muscle CT attenuation value (PMT) and cross-sectional area (PMA) with clinical characteristics, exercise tolerance, and respiratory failure in patients with chronic obstructive pulmonary disease (COPD), providing a new perspective for COPD assessment. Methods A total of 120 COPD patients (67 in stable phase, 53 in acute exacerbation phase) admitted between January 2020 and December 2023 and 60 healthy controls in the same period were included. All participants underwent chest CT scans for the measurement of PMA and PMT. Pulmonary function indices, 6-minute walk distance (6MWD), and quality of life scores were also collected from COPD patients. Statistical analysis was conducted to explore the relationship between PMA and PMT with clinical characteristics of COPD patients, and their predictive value for exercise tolerance in stable COPD patients and respiratory failure in acute exacerbation COPD patients was evaluated. Results Both PMA and PMT were significantly lower in the COPD patients compared with the control group (P<0.05) and were significantly correlated with pulmonary function, exercise capacity, and quality of life (P<0.05). PMA was identified as an independent risk factor for exercise intolerance in stable COPD patients (OR=1.261, 95%CI 1.075-1.496, P=0.004). Receiver operating characteristic (ROC) curve analysis revealed an area under curve (AUC) of 0.849 with a cut-off value of 23.72 cm² for PMA. Both PMA (OR=1.141, 95%CI 1.002-1.299, P=0.046) and PMT (OR=1.178, 95%CI 1.085-1.293, P<0.001) were independent risk factors for respiratory failure in acute exacerbation COPD patients. The ROC curve analysis showed an AUC of 0.804 with a cut-off value of 24.15 cm² for PMA and an AUC of 0.831 with a cut-off value of 37.65 Hu for PMT. Conclusions Pectoralis muscle PMA and PMT can serve as effective indicators for assessing the severity and prognosis of COPD. A lower pectoralis muscle PMA is a risk factor for exercise intolerance in patients with stable COPD, while lower pectoralis muscle PMA and PMT are risk factors for the development of respiratory failure in patients with acute exacerbations of COPD.
ObjectiveTo study the tolerance of Ice Gardenia Pain Aerosol with single and multiple dosing in healthy Chinese volunteers, evaluate the safe dosing range and the highest tolerance dose of human body, and supply proof for the dose amount in Phase-Ⅱ study. MethodsForty subjects enrolled in Ward I of a national medicine clinical experiment institute between May and September 2014 were included in this study. For single dosing experiment, 28 eligible subjects were enrolled and assigned into 5 groups to receive a single dose of 2, 6, 10, 14 and 18 puffs per time, respectively. The patient number for each group was 4, 6, 6, 6 and 6, respectively with equal number of male and female patients in each group. For the multiple dosing treatment, 12 eligible subjects were enrolled and assigned into 2 groups to receive multiple dosing of 6 and 10 puffs per time per day, respectively, for 14 days. Both the two groups had 6 male and female patients. Tolerability was evaluated by monitoring adverse events, physical examinations, laboratory tests and electrocardiogram. ResultsTotally, 40 subjects were enrolled and all of them completed the study. No adverse events or severe adverse events were observed or reported. No abnormal laboratory test was reported 1 hour, 2, 4, 8, 12 and 24 hours after the treatment of single dosing, and multiple dosing group had no abnormal indexes or adverse events, either. The maximum single tolerance dose was 18 puffs per time, and a single dose of 2-18 puffs per time was well tolerated; Multiple dosing of 6 and 10 puffs per day, once a day for 14 days was well tolerated. ConclusionsSingle and multiple dosing of Ice Gardenia Pain Aerosol are considered to be well tolerated by healthy Chinese volunteers. The maximum single tolerance dose is 18 puffs per time; multiple dosing of 6 and 10 puffs per day, once a day for 14 days is well tolerated. We suggest that the above dosing range can be chosen in the following Phase-Ⅱ study.