Common Problems and Quality Control in Clinical Rehabilitation Intervention Studies / 中国康复理论与实践

Based on the experience of our team combined with literature analysis, there were some problems in study of clinical intervention, mainly in the aspects of clinical trial registration, construction of intervention programs, recruitment and compliance of research objects, intervention fidelity, selection of outcome indicators and data collection and analysis. It is necessary to understand the importance of clinical trial registration and follow the registration procedure, establish an intervention program based on the theoretical framework, focus on the factors that impede or promote the recruitment of objects to ensure the sample size, formulate strategies to improve the compliance and intervention fidelity of the intervention objects and select the appropriate outcome indicators， apply appropriate data collection and analysis methods based on the content of the study, and thus improve the quality of intervention researches.

Clinical observation of preoperative administration of enteral nutrition support in gastric cancer patients at risk of malnutrition / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To evaluate safety and efficacy of preoperative administration of enteral nutrition support in gastric cancer patients at risk of malnutrition.</p><p><b>METHODS</b>A single center randomized controlled clinical trial was performed in 60 gastric cancer patients in West China Hospital from May to October 2012. Thirty patients were given enteral nutrition support(Ensure(R)) manufactured by Abbott Laboratories for ten consecutive days before surgical operation in the treatment group, and 30 patients were given an isocaloric and isonitrogenous homogenized diet in the control group for 10 days as well. The laboratory parameters of nutritional status and hepatorenal function were observed and compared between the two groups on admission, preoperative day 1 and postoperative day 3, respectively. Clinical observations, such as nausea and vomiting, were carried out until patients were discharged.</p><p><b>RESULTS</b>Before the intervention, there were no significant differences in the baseline characteristics between the two groups. The levels of serum albumin [(33.9±5.6) g/L vs. (31.0±5.3) g/L, P<0.05], and hemoglobin[(103.4±7.7) g/L vs.(96.6±10.5) g/L, P<0.01] were significantly improved in the treatment group on postoperative day 3. However, the levels of body mass index, lymphocyte count, liver and renal function, serum glucose, sodium, and potassium were not significantly different between the two groups(all P>0.05). Moreover, two patients with nausea and one with vomiting in each group were found. In clinical observation period, no severe treatment-related adverse event were observed.</p><p><b>CONCLUSION</b>The enteral supplement with Ensure(R) in gastric cancer patients at risk of malnutrition during preoperative period is effective and safe, which is superior to homogenized diet and an appropriate choice for gastric cancer patients with nutritional risk.</p>

Consideration on relative issues of gastrointestinal stromal tumor / 中华胃肠外科杂志

Nowadays one of the hot research topics in gastrointestinal surgery is gastrointestinal stromal tumor (GIST). However, mechanisms of their formation and development, and the causes of recurrence following R0 resection, have not been fully understood. This article aims to investigate some important issues concerning the neoplastic essences of GIST including the genomics, bionomics, drug resistance and immunotherapy.

Influence of ecoimmunonutrition supplement on intestinal mucosa morphology and gut barrier function in rats after operative stress / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To investigate the effects of ecoimmunonutrition supplement on intestinal microecology, epithelial tight junctions, and barrier function in rats with surgical stress.</p><p><b>METHODS</b>Seventy SD rats after surgical trauma were randomly divided into four groups:(1) placebo group,(2)total parenteral nutrition(TPN) group,(3)enteral nutrition(EN) group and (4)ecoimmunonutrition (EEN)group respectively. Rats received isocaloric and isonitrogenous nutrition. Nutrients were administered via the neck vein and the needle jejunostomy for five days. The homogenated tissues of liver, lung, and mesenteric lymph nodes were cultured to determine the bacterial translocation rate. The transmembrane binding proteins(occludin) was measured by immunohistochemistry. The ultrastructure and morphology of intestinal epithelial tight junctions in the intestine were observed by electron microscope. The feces in cecum was cultured for anaerobic bacterial growth and analysed.</p><p><b>RESULTS</b>The amounts of lactobacteria and bifidobacteria in EEN group were significantly higher than those in TPN group(P<0.05). The expression levels of occludin in the intestine was significantly higher in EEN group than that in TPN and EN group. Furthermore, the intestinal epithelial tight junction and microvilli of EEN group were more intact compared with those of TPN group. The bacterial translocation rates of liver, lung and mesenteric lymph nodes were significantly lower in EEN and EN group than those in TPN group(P<0.05).</p><p><b>CONCLUSION</b>Application of ecoimmunonutrition can protect intestinal mucosal barrier in rats with operative stress, increase the expression of occludin, maintain the gut epithelial tight junction, and eliminate gut bacterial translocation.</p>

Impact of growth hormone with hypocaloric nutrition on nitrogen balance and blood glucose in patients after gastrointestinal operation / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To evaluate the impact of recombinant human growth hormone (rhGH) combined with hypocaloric nutrition on nitrogen balance and blood glucose in patients after gastrointestinal operation.</p><p><b>METHODS</b>Forty-eight patients undergone abdominal operations were randomly divided into either subcutaneous rhGH (0.15 IU/kg) or placebo (menstruum) injection daily for 7 days postoperatively. These two groups had similar nutritional intakes. Body weight, blood cell count, liver and renal function, plasma albumin, prealbumin, transferrin and fibronectin were measured at day 1 before operation as baseline and day 3 and day 10 after operation by standard laboratory techniques. Nitrogen balance and blood glucose were measured from day 3 to day 9 after operation.</p><p><b>RESULTS</b>At postoperative day 10, the cumulative nitrogen balance and the level of plasma fibronectin were significantly higher in rhGH group [13.21 g,(104.77+/-19.94) mg/L] than those in placebo group [-6.88 g, (93.03+/-16.03) mg/L] (P<0.05). Furthermore, at day 4 and from day 6 to day 9 after operation, daily nitrogen balance was higher in rhGH group than that in control group (P<0.05). Mean blood glucose level was significantly higher in rhGH group from day 3 to day 6 after operation [(7.68+/-2.15) vs (5.95+/-2.34) mmol/L, P<0.05]. But hyperglycemia could be controlled well by insulin treatment.</p><p><b>CONCLUSION</b>Growth hormone combined with hypocaloric nutrition is effective and safe in promoting positive nitrogen balance and protein synthesis in post-operative patients, which is also beneficial to the improvement of nutritional status and prognosis.</p>

Experimental study of the hepatocyte growth factor contributing to lymphangiogenesis and lymphatic metastasis in gastric cancer / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To investigate relationship between the expression of hepatocyte growth factor(HGF) and lymphatic vessel formation in gastric cancer(GC), and to further clarify the possible ways of HGF promoting GC lymphangiogenesis and lymphatic metastasis.</p><p><b>METHODS</b>The expression of HGF, VEGF-C, c-Met and microlymphatic density(MLD) in tumor and non-tumor areas of 60 cases of GC and 20 cases of peptic ulcer (PU) were evaluated by immunohistochemistry. The relationships between MLD and clinicopathologic features of GC were analyzed.</p><p><b>RESULTS</b>The proteins of HGF, VEGF-C, and c-Met were overexpressed in GC tissues, which were significantly higher than those in normal gastric and PU tissues (P<0.001). The MLD of GC was also significant higher than those of normal gastric tissue and PU tissues (P<0.05). C-Met was expressed on enlarge lymphatic vessels in GC and PU tissues. MLD was positively correlated with the expression of HGF in GC (P<0.001).</p><p><b>CONCLUSION</b>HGF as well as VEGF-C is a lymphangiogenic factor in GC. HGF can directly or indirectly stimulate lymphangiogenesis and contribute to lymphatic metastasis in GC.</p>

Efficacy and safety of adjuvant post-surgical therapy with imatinib in gastrointestinal stromal tumor patients with high risk of recurrence: interim analysis from a multicenter prospective clinical trial / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of postoperative adjuvant chemotherapy with imatinib in gastrointestinal stromal tumor(GIST) patients who had high risk of recurrence.</p><p><b>METHODS</b>A prospective, open-label, multi-center trial conducted in sixteen teaching hospitals in China was carried out. The criteria of the enrolled patients included age more than 18 years old, CD117 positive GIST, tumor size more than 5 cm, pathological mitosis counts more than 5/50 HPF, and treatment beginning within 4 weeks after complete resection and with imatinib (400 mg, once a day) for at least 12 months. The 1, 3 year recurrence rates, disease free survival, overall survival rate and quality of life were evaluated.</p><p><b>RESULTS</b>From Aug. 16th 2004 to Sep. 13th 2005, there were totally 74 patients screened and 57 patients (34 men, 23 women) enrolled in the imatinib treatment group. The primary tumors were located in the stomach in 50.9%, the small intestine in 38.6% and the colorectum in 10.5% of the cases. All the patients received radical resection. Until the cut-off date of interim analysis, there was no evidence of tumor relapse or metastasis in all patients and no death was reported either. Among the 57 enrolled patients with intention to treat(ITT), twelve patients finished the protocol (per protocol, PP). The disease free survival was (268.3 +/-120.2) d in ITT analysis, and (396.7+/-38.2) d in the PP analysis. The incidence of adverse effect was 44.4% . The score in quality of life showed no statistically significant difference between the baseline visit and the follow-up visits.</p><p><b>CONCLUSION</b>Imatinib is a promising postoperative adjuvant chemotherapy in GISTs patients with high risk of recurrence, and the adverse effects are receivable.</p>

Protective effect of epidermal growth factor on isograft mucosal structure after small bowel transplantation in rat / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To investigate the effects of epidermal growth factor(EGF) on mucosal structure after small bowel transplantation in rat.</p><p><b>METHODS</b>Total small bowel transplantation was performed in inbred Wistar(RT1k) rats heterotopically, either total parenteral nutrition(control group, n=10) or TPN supplemented with epidermal growth factor(EGF group, n=10) was given to the recipients from the second day to 10th day after operation. The changes of morphology, ultrastructure, mucosal protein and DNA contents were determined.</p><p><b>RESULTS</b>The height of mucosal villus,the depth of crypt, the thickness of mucosa and the surface area of villus were (284.47+/-31.58)microm, (98.78+/-10.83 microm, (389.56+/-31.72)microm and (0.089+/-0.009 )mm(2) respectively in EGF group,and (176.45+/-14.62)microm, (74.45+/-8.34)microm, (259.38+/-24.65) microm, and (0.041+/-0.005)mm2 respectively in the control group. The morphological parameters were significantly higher in EGF group than those in the control group. Mucosal protein content was (84.65+/-8.32)mg/g wet wt in EGF group,significantly higher than (53.73+/- 11.45) mg/g wet wt in the control group(P=0.012). DNA content was also significantly higher in EGF group than that in the control group. [(0.86+/0.10)mg/g wet wt vs (0.51+/-0.06)mg/g wet wt, P=0.008]. Nearly normal ultrastructure of the graft enterocyte was maintained in EGF group, while atrophic microvilli and broken mitochondrial crista were observed in the control group.</p><p><b>CONCLUSION</b>EGF can preserve the mucosal structure of the graft, maintain the integrity of the ultrastructure of graft enterocyte after small bowel transplantation in rat.</p>

Study on association between the expression of galectin- 3 and the peritoneal metastasis in gastric cancer / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To investigate the association between the expression of galectin- 3 protein and peritoneal metastasis in gastric cancer.</p><p><b>METHOD</b>The expressions of galectin- 3 was detected in matching- samples including primary gastric cancer lesions,lymph node metastases,peritoneal metastases and paratumor normal tissues by immunohistochemistry. All specimens were gained from 35 patients who had synchronous peritoneal metastasis from gastric cancer.</p><p><b>RESULTS</b>The over- expression of galectin- 3 was observed in 97% (34/35) of the gastric cancer lesions, the peritoneal metastases and the lymph node metastases,whereas in 14% (5/35) of paratumor normal tissues. There were significant differences in the expression of galectin- 3 between paratumor normal tissues and the gastric carcinoma lesions,peritoneal metastases and lymph node metastases (P< 0.05),but there were no significant differences among the gastric cancer lesions,the peritoneal metastases,and the lymph node metastases (P> 0.05).</p><p><b>CONCLUSION</b>The expression of galectin- 3 in gastric cancer lesions can be used as a biological marker of peritoneal metastasis from gastric cancer before operation and as a prognostic factor of gastric cancer.</p>

Oral combination chemotherapy of 5'-deoxy-5-fluorouridine (furtulon) and cyclophosphamide for advanced breast cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of the oral combination chemotherapy of furtulon (FTL) and cyclophosphamide (CTX) for advanced breast cancer (ABC).</p><p><b>METHODS</b>From Jun 2000 to Jun 2002, eighty-three patients with ABC were treated with the two oral drugs as combined chemotherapy. The mean number of cycles was 5, median number of cycles was 6 (range 2-6).</p><p><b>RESULTS</b>The overall response rate was 45.8%, The median time to progression was 6 months. The treatment was well tolerated, with related Grade 3 clinical adverse effect being only nausea and vomiting in 2 patients (2.4%) and mild hematologic toxicities.</p><p><b>CONCLUSION</b>Oral combined chemotherapy of FTL and CTX, being convenient and safe, is effective for patients with advanced breast cancer.</p>

Researching Progress of Tumor Lymphangiogenesis and Lymphatic Metastasis / 中国普外基础与临床杂志

Objective To understand the features of lymphatic vessel,and to summarize the foundation and mechanism of the promotion and inhibition of tumor lymphangiogenesis recorded on the current studies of animal ex- periments and clinical researches.Methods The related literatures of the structural features of lymphatic vessel, lymphatic endothelial molecular markers,the origin of lymphatic tumors,the molecular mechanisms and regulatory factors were reviewed,and the relationship between tumor lymphangiogenesis and lymphatic metastasis,the treat- ment targeting at the formation of the anti-tumor lymphatic vessel and its existing problems were also analyzed.Re- suits Hyperplasia of lymphatic vessels occurred during the process of tumor formation and progression.The struc- tural features of the lymphatic vessels in the tumor were conducive to tumor lymphatic metastasis.In recent years, methods of anti-lymphangiogenesis and inhibition of tumor lymphatic metastasis had achieved considerable success in animal experiments.However,there were still a lot of problems need to be solved.Conclusion Tumor lymphangio- genesis has a significantly positive correlation between tumor lymphatic metastasis and patients'prognosis,which may indicate that treatment against the formation of tumor lymphatic vessel maybe effective.