目的 探讨心理干预措施对改善妇科恶性肿瘤患者的生命质量的作用及有效性。 方法 对2008年11月－2010年11月收治的87例妇科恶性肿瘤患者，随机分为试验组与对照组，试验组43例，实施心理干预及常规治疗；对照组44例，采取常规治疗；并对两组患者入院后及出院前生存质量、心理状况以问卷调查方式进行资料收集，用以比较、评价心理干预对改善妇科恶性肿瘤患者生命质量的作用及效果。 结果 妇科恶性肿瘤患者抑郁发生率为56.3%（49/87），焦虑发生率为62.1%（54/87）； 心理干预后两组患者组间各指标比较，试验组患者的总体健康状况、生存质量、角色功能、情绪功能、认知功能得分比对照组增高（P＜0.05）；试验组患者疲倦、恶心呕吐、失眠、食欲下降、便秘症状、抑郁、焦虑得分比对照组得分下降（P＜0.05）。 结论 心理干预可改变妇科肿瘤患者的负性心理倾向，缓解抑郁、焦虑等情绪，减轻化疗药物所引起的系列副作用，能有效提高其生活质量。
Objective To investigate the effectiveness in the treatment of single segment thoracic vertebra tuberculosis by limited decompression combined with epidural absorbable haemostat covering and vertebral plate reconstruction based on one-stage posterior approach, debridement, bone fusion, and internal fixation. Methods Between September 2005 and March 2010, 90 cases of single segment thoracic vertebra tuberculosis were treated by using limited decompression combined with epidural absorbable haemostat covering and vertebral plate reconstruction based on one-stage posterior approach, debridement, bone fusion, and internal fixation in 44 patients (treatment group) and by one-stage posterior approach, bone fusion, and internal fixation in 46 patients (control group). There was no significant difference in gender, age, disease duration, affected segment, Cobb angle, Frankle grade, erythrocyte sedimentation rate (ESR), and Oswestry disability index (ODI) between 2 groups (P gt; 0.05). Results All incisions healed by first intension. All 90 cases were followed up 24-44 months (mean, 38 months). There was no significant difference in ESR between 2 groups at 1 week and 3 months after operation (P gt; 0.05). Postoperative iconography indicated that the bone fusion rate of the treatment group was 100% and no epidural cicatricial tissue or failure of internal fixation was observed, showing significant difference when compared with control group (3 cases having failure of internal fixation) (P=0.032). The Cobb angles were significantly corrected after operation when compared with preoperative angles in 2 groups (P lt; 0.05). At 2 years after operation and at last follow-up, the Cobb angle and correction loss in treatment group were significantly better than those in control group (P lt; 0.05). The ODI and Frankel grade were significantly improved at last follow-up when compared with preoperative ones in 2 groups (P lt; 0.05); the treatment group was significantly better than the control group in the ODI, improvement rate of ODI (P lt; 0.05), and in Frankel grade (Uc=4.368, P=0.000). Conclusion Compared with conventional operation method, it is an ideal operation method to use limited decompression combined with epidural absorbable haemostat covering and vertebral plate reconstruction based on one-stage posterior approach, debridement, bone fusion, and internal fixation for treatment of single segment thoracic vertebra tuberculosis, with minimal wound, less complications, and good function recovery.
Objective To compare the combination of Xiao Chai Hu Tang and interferon versus the simple interferon for the management of chronic hepatitis B (CHB) in terms of clinical therapeutic effect and safety. Methods Such databases as PubMed, CBM disc, CNKI, VIP, Japana Centra Revuo Medicina were searched to include the randomized control trials (RCTs) of treating chronic hepatitis B by using Xiao Chai Hu Tang plus interferon as the treatment group and the interferon as the control group. The quality of the inclusive methodology was evaluated by two reviewers independently. RevMan5.0.24 software was employed for meta-analyses. Results Seven RCTs involving 668 patients were included and all of them were classified as Grade C methodologically. The results of meta-analyses demonstrated: compared with the simple interferon treatment, adding Xiao Chai Hu Tang to interferon was able to significantly increase the HBV-DNA negative conversion ratio (RR=1.44, 95%CI 1.18 to 1.76, P=0.000 4) and the HBeAg negative conversion ratio (RR=1.54, 95%CI 1.21 to 1.94, P=0.000 4); when the intervention duration was more than 12 weeks, the ALT normalization rate was improved significantly (24 weeks: RR=1.39, 95%CI 1.17 to 1.66, P=0.000 2; 12 weeks: RR=1.79, 95%CI 1.23 to 2.61, P=0.002) and the incidence of flu-like symptoms induced by interferon was significantly reduced (liver-protection treatment: RR=0.54, 95%CI 0.40 to 0.73, Plt;0.000 1; Non-liver-protection treatment: RR=0.75, 95%CI 0.59 to 0.95, P=0.02). The funnel plot was asymmetric, indicating publication bias. Conclusion Although Xiao Chai Hu Tang maybe has certain potential supplementary benefits to interferon for the management of CHB. The results of the above meta-analyses should be interpreted prudently because there exit disparities in domestic and international trails with the shortage of double blind or multi-centered clinical trials with high quality. The current evidence provides no way to compare the combination of Xiao Chai Hu Tang plus interferon with the simple interferon for the treatment of CHB and no accurate conclusion in terms of clinical therapeutic effects and safety.
Objective To systematically evaluate the efficiency of fertility-sparing surgery (FSS) compared with radical comprehensive surgery (RCS) in early stage epithelial ovarian cancer (eEOC). Methods We searched databases including PubMed, EMbase, The Cochrane Library (Issue 8, 2016), Web of Knowledge, CBM, WanFang Data and CNKI to collect the studies about FSS compared with RCS for eEOC from ineaption to August 10th, 2016. Two reviewers independently evaluated the eligibility of identified studies and extracted the data. Then, meta-analysis was performed using Stata 12.0 software. Results Eight studies involving 2 561 patients were included. The results of meta-analysis showed that: compared with RCS, the aggregated RR of overall survival (OS) of FSS (univariate analysis: RR=1.03, 95%CI 0.98 to 1.07,P=0.815; multivariate analysis: RR=0.81, 95%CI 0.52 to 1.28,P=0.255), the cumulative disease free survival (DFS) of FSS (univariate analysis: RR=1.02, 95%CI 0.96 to 1.09,P=0.968; multivariate analysis: RR=1.24, 95%CI 0.65 to 2.39,P=0.115) and the recurrence of FSS (RR=0.86, 95%CI 0.57 to 1.30,P=0.902), there was no significant difference. This pattern also emerged in the subgroup analysis for FIGO IA and IC patients, and the results showed that there was no significant difference between FSS and RCS in IA patients (OS: RR=0.99, 95%CI 0.98 to 1.02,P=0.186; DFS: RR=1.01, 95%CI 0.95 to 1.06,P=0.541); and IC patients (OS: RR=0.95, 95%CI 0.86 to 1.04,P=0.251; DFS: RR=0.94, 95%CI 0.80 to 1.11,P=0.664). Conclusion In eEOC, FSS does not have a negative effect on oncological outcomes compared with RCS. However, well-designed and large-scale trials are needed to verify this outcome in the future.
Compared with traditional clinical trials, the real-world studies set higher requirements on the authenticity (reality), applicability, and timeliness of the evidence obtained. In this paper, we brought up a hypothesis that creating synergies between observational and experimental studies may meet these requirements. And then it was discussed in three aspects including providing evidence, research design and execution. In addition, data analysis facilitated generating efficient and robust evidence which was in support of decision making. Finally, some enlightenment may be offered for Traditional Chinese Medicine evaluation methods based on the synergies of both study types.
Objective To evaluate the clinical effectiveness and safety of gastrodin injection in the treatment of vertigo. Methods A multi-center, single-blind randomized controlled trial was designed to study 240 vertigo patients who were randomly allocated into the treatment and the control groups.Patients in the treatment group were treated with gastrodin injection 600 mg, intravenously guttae, daily for 7 days, while those in the control group were treated with betahistin 30 mg, intravenously guttae, daily for 7 days. All data were analyzed by SAS. CMH (Cochran’s and Mantel-Haenszel) method was used to compare the clinical effect between the two groups. Nonparametric statistics and t-test were used in baseline data analysis. Results ① The clinical effectivenes on vertigo: according to the intention-to-treat (ITT) analysis, the clinical control rate and effective rate in the treatment group (n=117) were 71.19% and 90.60%, respectively, while 54.17% and 77.50% were in the control group (n=120). A statistic significance difference was found between the two groups (P=0.005 and P=0.004 for control and effective rate respectively).According to the per-protocol population (PP) analysis, the clinical control rate and effective rate in the treatment group (n=116) were 72.41% and 91.38%, respectively, and were 54.70% and 77.78% in the control group (n=117). Statistic significance was found between the two groups (P=0.005 and P=0.004 respectively). ITT and PP analysis revealed similar results. ② The clinical effect on vestibular function: the clinical control rate and effective rate were 62.26% and 81.13% respectively in the treatment group (n=53), and were 42.37% and 76.27% in the control group (n=58). Statistic significance was found in the clinical control rate but was not found in the effective rates between the two groups (P=0.029 and P=0.504, respectively). ITT and PP analysis revealed the same results. ③ Adverse drug reactions (ADRs) were slight to moderate. ADRs rates were 8.33% in the treatment group (n=120) and 10.83% in the control group (n=120), respectively. No statistic significance was found between the two groups(P=0.538). Conclusions Gastrodin injection and betahistine injection are safe and effective drugs for vertigo; gastrodin injection is better than betahistine injection in relieving vertigo symptoms.
Objective To detect the expression of thromhospondin-1 （TSP-1） in gastric cancer and metastaticlymph node tissues， and to study its relationship of TSP-1 to clinicopathologic parameters or tumor angiogenesis. Methods The TSP-1 and vascular endothelial growth factor （VEGF） expressions and microvessel density （MVD） were evaluated by immunohistochemistry in 72 specimens obtained by gastric resection from patients with gastric cancer， including corres-ponding adjacent normal gastric mucosa tissues （distant from cancer ≥5 cm） and lymph nodes surrounding cancer. A semiquantitative scoring system was used for evaluating the staining. The relationship of TSP-1 to VEGF expression， MVD， or clinicopathologic parameters was analyzed. Results ① TSP-1 positive expression rate was 45.8% （33/72） in the primary gastric cancer tissues， 90.3% （65/72） in the corresponding adjacent normal gastric mucosa tissues， and 50.8% （30/59） in the metastatic lymph nodes tissues. The expressions of TSP-1 in the primary gastric cancer tissues and metastatic lymph nodes tissues were significantly lower than those in the adjacent normal gastric mucosa tissues （χ2=32.710，P=0.000；χ2=25.298， P=0.000）. The expression of TSP-1 had no statistical significance in the primary gastric cancer tissues as compared with in the metastatic lymph nodes tissues （χ2=0.327， P=0.568）. ② The expression of TSP-1 in the metastatic lymph nodes tissues was significantly lower than that in the non-metastatic lymph nodes tissues （Z=-2.573， P=0.010）. ③The expression of TSP-1 in the primary gastric cancer tissues and metastatic lymph nodes tissues suggested a negative correlation with VEGF （rs=-0.309， P=0.008；rs=-0.269， P=0.040） and MVD （rs=-0.348， P=0.003；rs=-0.272， P=0.037）. Conclusions TSP-1 expression is down-regulated and has a negative correlation with VEGF and MVD in the primary gastric cancer and the metastatic lymph nodes tissues. According to the present results， it seems likely that TSP-1 is a tumor angiogenesis inhibitor.
Objective To construct gene silence adenovirus vector targeting both transglutaminase 2 （TG2） and Mer receptor tyrosine kinase （Mertk） synchronously and detect the gene silence function of it. Methods The interfering plasmids targeting TG2 protein and Mertk protein were constructed firstly， then the H1 promoter and RNA interfering （RNAi） sequence were cut and ligated to pAdTrack for constructing pAdTrack/TG2/Mertk. The pAdTrack/TG2/Mertk was transfected into BJ5183 bacterial cells which contained pAdEasy-1， then the plasmid was detected by enzyme digestion after recovery. Adenovirus were harvested after that pAdTrack/TG2/Mertk was infected into HEK293 cells. The virus titer was measured after repeated amplification. The RAW264.7 cells were infected by pAdTrack/TG2/Mertk， pAdTrack/TG2， pAdTrack/Mertk， and pAdTrack/green fluorescent protein （GFP）， respectively. Then the expression levels of TG2 protein and Mertk protein of mouse macrophages were detected by Western blot after infection. Results The virus titer of pAdTrack/TG2/Mertk plasmid was 6.13×1010GFU/mL. The pAdTrack/TG2/Mertk plasmid which contained 2 promoters and 2 RNAi sequences was identified successfully by enzyme digestion. Compared with pAdTrack/GFP group and pAdTrack/Mertk group （there was no significant differece between the 2 groups）， the expression levels of TG2 protein of mouse macrophages which infected with pAdTrack/TG2/Mertk or pAdTrack/TG2 decreased obviously （P＜0.01）， but there was no significant difference between the later 2 groups. Compared with pAdTrack/GFP group and pAdTrack/TG2 group （there was no significant difference between the 2 groups）， the expression levels of Mertk protein of mouse macrophages which infected with pAdTrack/TG2/Mertk or pAdTrack/Mertk decreased obviously too （P＜0.01）， but there was no significant difference between the later 2 groups. Conclusion Gene silence adenovirus vector plasmid targeting both TG2 and Mertk synchronously is constructed successfully， and the pAdTrack/TG2/Mertk can reduce the expressions of TG2 protein and Mertk protein of mouse macrophages obviously.
N-of-1 trial design offers a methodologically sound approach to determining optimum treatment for an individual patient and solves some limitations of randomized controlled trials. This design could offer an efficient method of reaching a personal treatment regime tailored to suit individual needs and preferences. The paper introduces practical application, objects and the implementation process of N-of-1 trial, to explore its design points and implementation.
Objective To explore the model and significance of medical and surgical nursing teaching reform, so as to promote the development of academic disciplines and the quality-oriented education.Methods With the method of cluster sampling, the reform object of four-year nursing undergraduates of Grade 2006 and 2007 of Sichuan University, the reform content of the neurological system recorded in both medical and surgical nursing taught in the semester of Autumn 2008 and Autumn 2009, and with the pilot reform of neuropathies nursing teaching, the integration of medical and surgical nursing teaching reform was performed through lesson preparations, theoretical classroom instruction and clinical probation. Results The medical and surgical nursing teaching reform obtained a significant result. Compared with the undergraduates without integration reform of Grade 2004 and 2005, the students of Grade 2006 and 2007 were more satisfied (92.25 vs. 72.97; χ2=19.806, P=0.000) with both the increased real benefited academic hours and the double-increased clinical probation hours without any change of the total teaching hours. Conclusion The integration teaching of both medical and surgical nursing can promote the cultural convergence, and is conducive in fostering students’ holistic thinking and in integration and effective uses of resources.