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.
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.
目的 探討大劑量西地蘭聯合小劑量酒石酸美托洛爾經靜脈途徑治療急性左心衰伴快速心室率心房顫動的療效與安全性。 方法 將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顫動患者，隨機分配至對照組（39例）與治療組（37例），對照組靜脈注射西地蘭，治療組靜脈注射西地蘭與小劑量酒石酸美托洛爾，分別在用藥開始時及用藥開始后全程監測收縮壓、心室率、呼吸頻率、手指脈搏血氧飽和度（SpO2）、呼吸困難程度、肺部啰音與治療2 h時尿量，記錄急性左心衰改善時間。 結果 兩組患者在治療開始時心室率（P=0.246）、呼吸頻率（P=0.390）、收縮壓（P=0.525）與SpO2（P=0.482）均無統計學意義；在治療整個過程中，兩組患者收縮壓與治療2 h尿量均無統計學意義（P=0.264）；在治療開始后30、60、90、120 min時治療組患者心室率均顯著低于對照組（P=0.000）。治療組患者從在治療開始到急性左心衰改善的時間明顯短于對照組（P=0.003）。試驗期間無1例患者出現病情惡化或死亡。 結論 在排除美托洛爾禁忌癥的前提下，在嚴密監測肺部啰音及指氧飽和度的情況下，對那些平時心功能Ⅰ~Ⅱ級的急性左心衰伴快速心室率心房顫動患者，在經靜脈途徑給予大劑量西地蘭的同時，間斷多次靜脈注射小劑量美托洛爾，能安全有效地控制過快心室率，縮短急性左心衰竭持續時間。
【摘要】 目的 評價伴骨轉移的非小細胞肺癌（non-small cell lung cancer，NSCLC）患者在接受帕米膦酸二鈉和唑來膦酸治療后的有效性和安全性。 方法 2007年6月-2008年12月，74例伴骨轉移的NSCLC，患者接受了雙膦酸鹽治療，其中50例接受帕米膦酸二鈉治療，24例接受唑來膦酸治療。帕米膦酸二鈉90 mg，靜脈滴注3 h，每4周重復1次；唑來膦酸4 mg，靜脈滴注15 min，每4周重復1次。對可能影響其骨相關事件發生時間及生存率的各種臨床﹑病理、治療方法等因素進行分析，用Kaplan-Meier曲線及Log rank檢驗生存率差異，對不良反應的發生率等采用χ2檢驗。 結果 18個月無骨相關事件生存率和總體生存率在帕米膦酸二鈉及唑來膦酸組分別為19.3%、28.9%（P=0.253）和33.4%、38.2%（P=0.745），兩組比較，差異均無統計學意義。兩組患者不良反應中帕米膦酸二鈉組8例（16.0%），唑來膦酸組6例（25.0%），兩組比較差異無統計學意義（χ2=0.200，P=0.655）。7例患者用帕米膦酸二鈉治療失敗后再用唑來膦酸治療，其中位無骨相關事件生存時間為2個月（95%CI：0~4.6）。 結論 唑來膦酸和帕米膦酸二鈉在緩解延遲骨相關事件發生時間療效和不良反應發生率相當。用帕米膦酸二鈉治療失敗后再用唑來膦酸可延緩骨相關事件發生時間。【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.
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.
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.
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.