Objective To explore the feasibility of high-pressure injection to transfer human thrombomodulin (hTM) gene into arterial wall of rabbits.Methods Eighty-four healthy New Zealand rabbits were randomly divided into three groups: pcDNA3.1/hTM plasmid group (n=28), pcDNA3.1(+)/neo plasmid group (n=28) and untransfected group (n=28). After gene transfection, the model of arterial injury-blocking was established. Then, the expressions of hTM mRNA and protein in arterial wall were examined by RT-PCR and immunohistochemistry at 3 d, 7 d, 14 d and 28 d after operation. Results Seventeen rabbits died accidentally from the day of operation to 3 d after operation. The expressions of hTM mRNA of different time points in pcDNA3.1/hTM plasmid group were significantly higher than that in pcDNA3.1(+)/neo plasmid group and untransfected group (Plt;0.01). For the expressions of hTM mRNA at different time points in pcDNA3.1(+)/neo plasmid group and untransfected group, the difference of inter-group and intra-group was not significant (Pgt;0.05). hTM protein was expressed in every group and mainly localized in the inner lining of arterial wall. The expressions of hTM protein at different time points in pcDNA3.1/hTM plasmid group were significantly higher than that in pcDNA3.1(+)/neo plasmid group and untransfected group (Plt;0.05). The expression of hTM protein at different time points in pcDNA3.1(+)/neo plasmid group and untransfected group kept relative constancy, the difference of inter-group and intra-group was also not significant (Pgt;0.05). Conclusion High-pressure injection is feasible to transfer pcDNA3.1/hTM plasmid into arterial wall of live animals.
目的 探讨大剂量西地兰联合小剂量酒石酸美托洛尔经静脉途径治疗急性左心衰伴快速心室率心房颤动的疗效与安全性。 方法 将2005年6月－2012年2月收治的76例急性左心衰伴快速心室率心房颤动患者，随机分配至对照组（39例）与治疗组（37例），对照组静脉注射西地兰，治疗组静脉注射西地兰与小剂量酒石酸美托洛尔，分别在用药开始时及用药开始后全程监测收缩压、心室率、呼吸频率、手指脉搏血氧饱和度（SpO2）、呼吸困难程度、肺部啰音与治疗2 h时尿量，记录急性左心衰改善时间。 结果 两组患者在治疗开始时心室率（P=0.246）、呼吸频率（P=0.390）、收缩压（P=0.525）与SpO2（P=0.482）均无统计学意义；在治疗整个过程中，两组患者收缩压与治疗2 h尿量均无统计学意义（P=0.264）；在治疗开始后30、60、90、120 min时治疗组患者心室率均显著低于对照组（P=0.000）。治疗组患者从在治疗开始到急性左心衰改善的时间明显短于对照组（P=0.003）。试验期间无1例患者出现病情恶化或死亡。 结论 在排除美托洛尔禁忌症的前提下，在严密监测肺部啰音及指氧饱和度的情况下，对那些平时心功能Ⅰ~Ⅱ级的急性左心衰伴快速心室率心房颤动患者，在经静脉途径给予大剂量西地兰的同时，间断多次静脉注射小剂量美托洛尔，能安全有效地控制过快心室率，缩短急性左心衰竭持续时间。
Objective To study the effects of edaravone on the lung injury of severe acute pancreatitis （SAP） in rats. Methods Thirty-six SD rats were randomly divided into three groups: normal control group, model group and edaravone group, and SAP was induced by intraductal administration of 5% sodium taurocholate. Edaravone was given in edaravone group, while normal saline was given in normal control group and model group. After operation 6 h rats were executed, and dry/wet weight (D/W) ratio of lung was counted, and malondialdehyde (MDA) content, superoxide dismutase (SOD) activity in serum and lung were detected, respectively. In addition, the levels of tumor necrosis factor-α (TNF-α), interleukin-1, -6 (IL-1, -6) of serum were detected.Results The MDA contentof serum and lung and the levels of TNF-α, IL-1, IL-6 in model group were markedly higher than those in normal control group and edaravone group, but D/W ratio of lung, SOD activity of serum and lung were significantly lower (Plt;0.05). Conclusion Edaravone can alleviate lung injury of rats caused by SAP.
【摘要】 目的 评价伴骨转移的非小细胞肺癌（non-small cell lung cancer，NSCLC）患者在接受帕米膦酸二钠和唑来膦酸治疗后的有效性和安全性。 方法 2007年6月-2008年12月，74例伴骨转移的NSCLC，患者接受了双膦酸盐治疗，其中50例接受帕米膦酸二钠治疗，24例接受唑来膦酸治疗。帕米膦酸二钠90 mg，静脉滴注3 h，每4周重复1次；唑来膦酸4 mg，静脉滴注15 min，每4周重复1次。对可能影响其骨相关事件发生时间及生存率的各种临床﹑病理、治疗方法等因素进行分析，用Kaplan-Meier曲线及Log rank检验生存率差异，对不良反应的发生率等采用χ2检验。 结果 18个月无骨相关事件生存率和总体生存率在帕米膦酸二钠及唑来膦酸组分别为19.3%、28.9%（P=0.253）和33.4%、38.2%（P=0.745），两组比较，差异均无统计学意义。两组患者不良反应中帕米膦酸二钠组8例（16.0%），唑来膦酸组6例（25.0%），两组比较差异无统计学意义（χ2=0.200，P=0.655）。7例患者用帕米膦酸二钠治疗失败后再用唑来膦酸治疗，其中位无骨相关事件生存时间为2个月（95%CI：0~4.6）。 结论 唑来膦酸和帕米膦酸二钠在缓解延迟骨相关事件发生时间疗效和不良反应发生率相当。用帕米膦酸二钠治疗失败后再用唑来膦酸可延缓骨相关事件发生时间。【Abstract】 Objective To retrospectively evaluate the efficacy and safety of pamidronate disoclium and zoledronic acid in treating non-small-cell lung cancer (NSCLC) patients with bone metastasis. Methods This study included 74 patients who were treated with bisphosphonate between June 2007 and December 2008. Fifty were treated with pamidronate disodium, and 24 with zoledronic acid. Pamidronate disodium was administered intravenously once for 3 hours every 4 weeks at a dose of 90 mg. Zoledronic acid was given intravenously once for 15 minutes every 4 weeks at a dose of 4 mg. Various clinical, pathological factors and treatment methods related to the occurring time of skeletal related events (SRE) and survival rate were analyzed. Kaplan-Meier curve and Log rank were adopted to detect the difference in survival rate between patients treated with different medicine, and we used χ2 test to discover the rate of adverse events of the patients. Results Eighteen-month SRE-free survival and overall survival rate in the pamidronate disodium and zoledronic acid group were 19.3% vs. 28.9% (P=0.253), and 33.4% vs. 38.2% (P=0.745) respectively. There were 8 (8/50) cases of adverse events in the pamidronate disodium group, and 6 (6/24) in the zoledronic acid group (χ2=0.200, P=0.655). The SRE-free survival time for seven patients who were treated with zoledronic acid after pamidronate disodium failed was 2 months (95%CI: 0-4.6). Conclusions Compared with zoledronic acid, pamidronate has equal efficacy in delaying SRE and incidence of adverse effects. Administering zoledronic acid after pamidronate failed can also delay the occurring time of SRE.
The quality of clinical trials is key to determine the value of a clinical research and whether it can transform achievements. In this paper, the characteristics and direction of the implementation of quality control in clinical trials in China, and the characteristics of quality control in clinical trials of Chinese medicine are discussed, and the development direction of quality control in clinical trials in China is explored in order to improve the overall level of clinical trials in China.
ObjectiveTo compare the predictive value of the two concepts for complications by comparing the incidences of surgical complications associated with different tip-apex distance (TAD) and calcar referenced tip-apex distance (Cal-TAD) in the treatment of femoral intertrochanteric fractures with Asian type proximal femoral nail (APFN) fixation. MethodsA total of 188 cases of femoral intertrochanteric fractures treated with APFN fixation between January 2014 and December 2018 were collected according to inclusion criteria. TAD and Cal-TAD were measured on the X-ray film at immediate after operation; the patients were divided into two groups according to the measurement results: <25 mm and ≥25 mm. Gender, age, and fracture side and AO type were recorded. The patients in each group were reviewed whether there was delayed fracture union or nonunion, whether the screw blade moved axially, whether the femoral neck collapsed or even screw blade cut out, whether the internal fixator became loose or broken within 12 months after operation. Then statistical analysis was performed. ResultsThere were 119 patients with TAD<25 mm and 69 patients with TAD≥25 mm, and 142 patients with Cal-TAD<25 mm and 46 patients with Cal-TAD≥25 mm. There was no significant difference in gender, age, or fracture side and AO type between groups (P>0.05). During the follow-up, 6 patients (5.04%) with TAD<25 mm, 10 patients (14.49%) with TAD≥25 mm had complications, and 1 patient (0.70%) with Cal-TAD<25 mm and 15 patients (32.61%) with Cal-TAD≥25 mm had complications. There were significant differences in the incidence of complication between the patients with different TAD, between the patients with different Cal-TAD, and between patients with TAD<25 mm and Cal-TAD<25 mm (P<0.05). ConclusionIn the operation of femoral intertrochanteric fracture with APFN fixation, surgical complications can be significantly reduced when TAD or Cal-TAD was controlled within 25 mm, Cal-TAD is more significant in the prediction of postoperative complications.
Objective To analyze the efficacy of and recurrence mode after adjuvant radiotherapy for lower thoracic esophageal squamous cell carcinoma (TESCC) patients after radical operation with anastomosis above aortic arch. Methods Sixty-three patients with lower TESCC who received adjuvant radiotherapy after R0 radical operation with anastomosis above aortic arch between February 2011 and February 2019 were retrospectively enrolled. The clinical tumor volume (CTV) included anastomotic stoma, and lymph node drainage area in mediastinum and upper abdomen. The survival status, recurrence and metastasis of tumors, and the influencing factors were analyzed. Results The 1-, 2-, and 3-year overall survival rates were 98.3%, 83.3%, and 63.7%, respectively. The median disease-free survival (DFS) was 33 months [95% confidence interval (23.2, 42.8) months], and the 1-, 2-, and 3-year DFS rates were 76.3%, 58.5%, and 41.7%, respectively. Patients with N0-1 had longer DFS than those with N2-3 (median: not reached vs. 15 months, P=0.045). The recurrence rate of anastomotic site was 7.9%. The recurrence rates of lymph nodes in supraclavicular region, upper middle mediastinum, and upper abdomen were 4.8%, 15.9%, and 1.6%, respectively. The distant metastasis rate was 17.5%. The incidence of grade 2-3 radiation pneumonitis, grade 3 anastomotic stenosis, and grade 3 tracheal fistula were 4.8%, 3.2%, and 1.6%, respectively. Conclusions N2-3 is a poor prognostic factor for such patients. Regional lymph node recurrence is mainly revealed in the middle and upper mediastinum. Whether the CTV should include anastomotic stoma and lymph node drainage area in lower mediastinum and upper abdomen is questionable.
Objective To explore the feasibility and safety of liver transplantation （LT） in treatment of upper gastrointestinal hemorrhage in patients with portal hypertension， and to compare the therapeutic effects with conventional operation （CO）. Methods The clinical data of 303 patients with bleeding portal hypertension from Feb. 2009 to Feb. 2012 in the department of hepatobiliary and pancreatic surgery of First Affiliated Hospital of Zhejiang University were retrospectively analyzed. One hundred and one patients received LT procedure （LT group）， whereas the other 202 patients received CO procedure （CO group）. Postoperative follow-up period was 8-44 months （average 26 months）. Results Liver function before operation in CO group was significantly better than that in LT group（P＜0.01）. The mortality of CO group and LT group were 7.4%（14/189） and 3.0%（3/101， P=1.00）， respectively. The rebleeding rate of patients underwent LT was 2.0%（2/101）， significantly lower than that of CO group 〔9.5%（18/189）， P＜0.05〕. The vanish rate of esophagogastric varice in patients underwent LT was 86.1%（87/101）， significantly lower than that of CO group 〔54.5%（86/189）， P＜0.01〕. Conclusions LT treatment for bleeding portal hypertension is feasible and safe. Patients with good liver function despite hemorrhage history may be managed satisfactorily with conventional surgery. LT is the only curative treatment for patients with portal hypertension in end-stage liver disease.