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.
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.
目的 總結靜脈制劑Ⅰ期臨床耐受性試驗中的護理要點。方法 2011年10月－12月，采用隨機、盲法、安慰劑平行對照試驗設計，在健康志愿者中按劑量遞增原則，逐組完成8個劑量單次靜脈滴注給藥耐受性試驗。 結果 試驗順利完成。靜脈制劑的Ⅰ期耐受性試驗中，研究護士在臨床試驗前需認真學習試驗方案，做好試驗病房、監護急救設施設備的充分準備，針對可能出現的不良反應制定切實可行的處理預案，試驗過程中密切監測，對出現的不良反應做好救治工作。特別針對靜脈制劑，須做好受試者的心理疏導，保證靜脈穿刺一次成功，減少受試者因情緒緊張、穿刺疼痛等因素干擾對試驗藥物耐受性的評價。 結論 Ⅰ期臨床耐受性試驗實施前準備充分，試驗過程中為受試者提供良好的試驗環境和心理護理，提高靜脈穿刺一次成功率，密切監測，可使試驗過程順利，并獲得客觀、準確的試驗結果。
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 review the recent studies on the multidrug resistance of breast cancer. Methods The literatures of recent years on the studies of multidrug resistance, multidrug resistance protein and breast cancer resistance protein were reviewed. Results Multidrug resistance resulted from multiple factors. How to identify the sensibility of chemotherapy drugs and select individual therapeutic regime early were important to improve the survival rate and life quality of breast cancer patients. Conclusion These studies on multidrug resistance of breast cancer are helpful to predicting the effect and outcome of chemotherapy and overcoming the barrier of drug resistance.
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.
Objective To evaluate the safety and tolerance of medicinal charcoal enteric-coated tablets in healthy volunteers. Methods A total of 44 healthy volunteers were randomly divided into 6 single-dose groups (0.5 g, 2 g, 4 g, 6 g, 8 g and 10 g) and a multiple-dose group (3 g, 3 times a day, for 14 days). The safety profile and tolerance were evaluated by observing symptoms, vital signs, and laboratory tests. Results No serious adverse event was reported for any volunteer. Abdominal distension occurred in 2 volunteers in the 4 g dose group and the 6 g dose group. One volunteer in the 8 g dose group experienced nausea and vomiting. Transient decrease in white blood cell count was observed in one volunteer in the 10 g dose group. Abdominal distension occurred in 2 volunteers of the multiple-dose group. Conclusion Based on our findings, the maximum tolerated dose of medicinal charcoal enteric-coated tablets in Chinese healthy volunteers is 10 g. The recommended dose for subsequent clinical trials is 3 g, 3 times a day.
目的 評價健康志愿受試者對通栓救心片的耐受性和安全性，為Ⅱ期臨床試驗給藥方案提供依據。 方法 2009年1月－4月，選擇健康受試者38例，隨機進入5個單次給藥組和2個連續給藥組。單次給藥組分別口服通栓救心片3、6、8、10、15片；連續給藥組口服通栓救心片2片/次和3片/次，3次/d，服藥7 d。觀察生命體征、實驗室檢查指標、臨床癥狀和不良反應。 結果 單次給藥8片和15片組各有1例有輕微頭痛、頭昏；連續給藥組有輕微頭昏或惡心的不良反應，均未經處理自動消失。 結論 健康人體對通栓救心片耐受性較好，臨床應用較安全，僅見輕微頭昏、頭痛或惡心。推薦Ⅱ期臨床試驗給藥劑量范圍是（2～3）片/次，3次/d 。
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.
Objective To analyze the distribution of pathogens, drug susceptibility and multi-drug resistant bacteria (MDRB) in elderly patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated with pneumonia. Methods The clinical data of patients whose discharge diagnosis included AECOPD with pneumonia or pulmonary infection from January 2012 to December 2015 were retrospectively analyzed. Strain identification and drug sensitivity analysis were performed in the pathogenic bacterias isolated from sputum culture. Results A total of 1 978 patients were enrolled in this study, and pathogenic bacterias were isolated from the sputum of 708 patients, including 485 cases of community-acquired pneumonia (CAP) and 223 cases of hospital-acquired pneumonia (HAP); and 786 strains of pathogens were isolated (501 strains from CAP cases, 285 strains from HAP cases), including 448 strains of Gram-negative (G–) bacilli (57.0%), 117 strains of Gram-positive (G+) cocci (14.9%), and 221 strains of fungi (28.1%). Susceptibility testing results showed that G– bacilli were highly resistant to penicillins, third generation cephalosporins, ciprofloxacin, gentamicin, etc., and G+ cocci were highly resistant to penicillin, clindamycin and erythromycin. There were 238 strains of MDRB, mainly including 69 strains of Acinetobacter baumanii [multiple drug resistance rate (MDRR)=67.6%], 27 strains of Escherichia coli (MDRR=52.9%), 25 strains of Klebsiella pneumoniae (MDRR=34.2%), 33 strains of Pseudomonas aeruginosa (MDRR=33.0%) and 24 strains of Stenotrophomonas maltophilia (MDRR=100.0%). MDRR of Enterococcus genus and methicillin-resistant Staphylococcus aureus was 50.0% and 48.0%, respectively. Conclusions The pathogenic bacterias in elderly AECOPD patients complicated with pneumonia are mainly G– bacterias, and the proportion of fungal infection tends to increase. Bacterial drug resistance is serious and the MDRB tends to increase, especially in patients with HAP. Physicians should early find out the characteristics of local pathogenic bacteria and drug sensitivity, rationally select antibiotics, reduce the occurrence of drug-resistant strains and superinfection when treating the elderly patients with AECOPD complicated with pneumonia.