ObjectiveTo investigate the domestic and abroad hypertension-related clinical trial registration and to analyze the registration of hypertension-related clinical researches in China.MethodsUsing hypertension as the keyword, we searched ClinicalTrials.gov and Chinese Clinical Trial Registry (ChiCTR) from January 2008 to December 2018. We analyzed the collected data on the distribution of registered clinical researches, annual trends, sample sizes, trial progress, research types, study designs, blind methods, clinical stages, the number of participating institutions, the leading institutions, etc.ResultsThe total number of registered hypertension-related clinical trails was 4 991 all over the world, and 551 items were conducted in China. Most of the sample sizes of Chinese hypertension-related clinical trials were 100 to 999. The main types of trials were interventional studies (393 items, 71.32%), followed by observational studies (126 items, 22.87%). Randomized parallel control studies (300 items, 76.34%) were the key component of interventional studies, while cohort studies (61 items, 48.41%) were the chief component of observational studies. The main stages of clinical trials were stage Ⅲ (80 items) and stage Ⅳ (122 items). There were 369 domestic single-center clinical trials (66.97%), 89 domestic multi-center clinical trials (16.15%), and 93 international multi-center clinical trials (16.88%). Among the 93 international multi-center trials of hypertension, only 25 were led by China.ConclusionsThe number of Chinese hypertension-related clinical trial registrations increased year by year and then decreased slightly, but the amount of registrations is limited. The quantity and scale of multicenter clinical studies were not as good as America. China should strengthen the awareness of clinical research registration, strengthen the publicity and supervision of the registration of clinical researches by the department of science and management, improve the number of clinical trial registrations, make Chinese clinical researches more transparent, and strive to lead more international multi-center clinical trials.
Four hundred and eighty two paients suffering from intrahepatic bile duct stone undergoing lobectomy and segmental resection (from 1975 to 1994,9) has reported. 63% of the patient in this group underwent 1-5 operations, including different types of biliary-intestinal anastomosis (21.6%). 482 cases underwent different types of hepatectomy, including left lateral-lobetomy 321 cases (66.6%),left hemihepatectomy 80 cases(16.6%), right hemihepatectomy 19 cases (3.9%), and multiple segmental resections 39 cases (8.1%, including Ⅴ+Ⅷ 11 cases, Ⅵ+Ⅶ 28 cases). Other type hepatectomy combined with guadrate lobectomy 20 cases (4.1%). Postoperative complication rate was 10.2%, including diliary fistula. hemobilia and subdiaphragmatic and resectional surface infectioin, 85% of the patients were followed up with an excellent result of 88%. The authors emphsize that hepatic lobectomy nad segmental resection is the core of treatment and selection of operative methods depends on clinical-patholigic types of the disease.
Objective To determine the safety of the fetal olfactory ensheathing cell(OEC) transplantation in patients with chronic spinal cord injury (SCI) by examination of the magnetic resonance imaging (MRI). Methods A prospective clinical study involving 16 patients with chronic SCI was designed to investigate the feasibility and biological safety of the fetal OEC transplantation in treatment of SCI. The olfactory bulbs from the 3-4-month-old aborted human fetuses following the strict ethical guidelines were harvested and trypsinized down to single fetal OEC. These cells were then cultured for 12-17 days and were prepared for a clinical use. From November 2001 to December 2002, 16 patients with chronic SCI were randomly enrolled. The patients suffered from SCI for1.5-8 years (average 4-3 years) after the injury. The suspension (50 μl) containing about 1×106 fetal OECs was transplanted by an injection into the patients’ spinal cords above and below the injury site. All the patients were assessed before thetransplantation and were followed up with MRI for 29-42 months (average 38 mon)after the transplantation. Results No cell-related adverse effects were observed in any patient during the followup period. The follow-up with MRI did not reveal any development of optic glial tumor, tumor-like mass, new hemorrhage,edema, expanding cyst, new cyst formation, infection or disruption of the neuralstructure in the transplant site of all the patients. Conclusion This is the first clinical study demonstrating the long-term safety of theOEC therapy for SCI. The results indicate that our protocol is feasible and safe in treatment of patients with chronic SCI within 38 months after the injury. Although the size of the samples for our study was not big enough, the positive results of the study have encouraged us to make a further research in this field.
To investigate the relationship between clinicopathological features and lymph node metastasis in the primary gastric cancer and affer the basis for deciding appropriate extent of lymph node dissection, a total of 192 patients who underwent curative gastrectomy and lymph node dissection for gastric cancer were analyzed retrospectively. Result: The total rate of lymph node metastasis was 60.4%, with 28.9% of the resected lymph nodes involved. The lymph node metastasis of C, M, A region and the whole stomach were 64.6%, 57.7%, 59.1% and 90.9% respectively. The rates of the lymph node metastasis increased successively in carcinoma of early, middle and late stages (Ｐ＜0.05), the rate of the infiltrative tumor (Borr Ⅲ，Ⅳ) being 76.5% which was significantly higher than that of the circumscribed tumor (Borr Ⅰ，Ⅱ) (43.2%)。 Relating with the tumor size ＜4cm in diameter showed lesser rate, while 4-8 cm and ＞8cm in diameter showed increasingly higher metastaticrate (Ｐ＜0.01). As a result, we should decide the appropriate extent of lymph node dissection during the operation on the basis of clinicopathological stages, type of Borrmann’s, site and maximum diameter of gastric cancer along with the state of lymph node metastasis in carcinoma of different region of the stomach.
Objective To summarize the basic research and the cl inical appl ication of biodegradable interbody fusion Cage. Methods Recent l iterature concerning biodegradable interbody fusion Cage at home and abroad was extensively reviewed, and current developments of the basic research and the cl inical appl ication of biodegradable interbody fusion Cage were investigated. Results Basic research showes that the stiffness of biodegradable interbody fusion Cage is lower than that of metall ic Cage, so it can enhance interbody fusion. As interbody fusion proceeded, biodegradable interbody fusion Cage degrades constantly, but the speed of degradation can not keep in parallel with that of fusion. In addition, the tissue response to degradation products is controversy. Cl inical appl ication showes that the biodegradable interbody fusion Cage can enhance interbody fusion and maintain disc space height. The short term results are good, however, the long term results need further observation. Conclusion Biodegradable interbody fusion Cage can effectively enhance interbody fusion.
Objective To provide the anatomic basis for the posterior urethral repair via the perineal approach. Methods The anatomicconstructions andtheir relationships of the perineal approach from skin to the membranous and prostate apical urethra were observed and some related data were measured in 12 adult male specimens by microanatomy, and the procedures of urethral repair via the perineal approach were carried out in 3 fresh male specimens. Results All the blood vessels and nerves, which supplied the scrotum, the perineum, and bulbourethra, passed lateral-medially. The cavernous nerves coursed posterolaterally from the bottom to the apex of the prostate, pierced the urogenital diaphragm and passed laterally to themembranous urethra in a status of gridding, whose width was (12.11±2.32) mm.Conclusion The structures of the perineum and around the posterior urethra are complicated. The strategy for diminishing the damages to them is that all structures must be dissected strictly in the midline. Confining the dissections strictly to the range of 5 mm from the membranous urethra and resecting the apical prostatic tissues anterolaterally could avoid impairments of the cavernous nerves.
Objective To investigate the clinical characteristics， diagnosis， and treatment of gastric stromal tumor. Methods Clinical data of 217 patients with gastric stromal tumor from October 2007 to July 2011 were analyzed. Results The main clinical manifestation were abdominal pain， abdominal distension， bloody stools， abdominal mass， and so on. The tumour located at cardiac part， fundus of stomach， body of stomach， and pylorus part was 24 cases （11.0%）， 103 cases （47.5%）， 59 cases （27.2%）， and 31 cases （14.3%）， respectively. All the 217 patients underwent endoscopic or surgical resection and diagnosed by pathology and immunohistochemistry. The patients of high-low risk， low risk， intermediate risk， and high risk was 56 cases （25.8%）， 67 cases （30.9%）， 41 cases （18.9%）， and 53 cases （24.4%）， respectively. One hundred and forty patients were followed-up for 7-52 months （average 35 months）. Thirty-five patients of high risk were investigated about the drug treatment after the first operation：19 cases were treated by using imatinib （tumor progressed in 2 cases） and 16 patients were not （tumor progressed in 9 patients）. The rate of progression of patients treated by imatinib was significantly lower than another group （χ2=8.426， P=0.004）. In 11 patients with tumor progressed， tumor recurrnce in 4 cases， tumor recurrence with diffused abdominal cavity metastasis in 1 case， tumor metastasized to humerus in 1 case， metastasized to liver and abdominal cavity in 1 case， and metastasized to liver in 4 cases. Conclusions Gastric stormal tumor is lack of specific clinical manifestations. Complete excision of the tumor is the main therapy method， and imatinib can improve prognosis.
Objective To share the experience of the diagnosis and treatment of children with hand-foot-mouth disease. Methods We retrospectively analyzed 31 children with hand-foot-mouth disease in our hospital from April 2007 to June 2007 in terms of epidemiology, clinical features, treatment and prognosis. Results The average age of the children was 2.8 years, and 20 out of the 31 cases were from nurseries and kindergartens. Eighteen had clear contact history. Typical signs and symptoms, including oral ulcerative herpes and blister-like rash in extremities, were found in all cases. All the children were cured after timely diagnosis and early treatment with ribavirin, without any severe complications. Conclusion Timely treatment based on early diagnosis and considerate care are important for children with hand-foot-mouth disease. Nurseries, kindergartens and primary schools should attach great importance to relevant prophylaxis and isolation. These are essential for reducing the occurrence and prevalence of this disease.