Sustained-release bupropion for smoking cessation in a Chinese sample: a double-blind, placebo-controlled, randomized trial.

INTRODUCTION: Bupropion is a first-line pharmacological aid for smoking cessation; however, no clinical trials have been conducted in a Chinese population. METHODS: We enrolled 248 smokers in a hospital-based, randomized, smoking cessation trial conducted at four outpatient centers in Beijing. A total of 123 participants received an 8-week course of sustained-release bupropion (Bup-SR) and 125 participants received 8 weeks of placebo. All participants received brief education and counseling on smoking cessation. We determined rates of abstinence and smoking reduction based on chemical verification and self-report at 8 and 12 weeks. RESULTS: At the end of the medication treatment (8 weeks) and at the end of the trial (12 weeks), the abstinence rates for Bup-SR were 29.3% and 39.8%, respectively, and 10.4% and 8.0% for placebo, respectively (both p < .001). Bup-SR was also superior to placebo in reducing cigarettes per day and urinary cotinine levels. CONCLUSION: Bup-SR is efficacious for smoking cessation in healthy Chinese patients treated in the outpatient setting. It is well tolerated with a few mild side effects.

[Changing characteristic of blood coagulation factors and their correlation with blood coagulation status in different hepatic diseases].

OBJECTIVE: To investigate the correlation between pro coagulation factors and anti-coagulation factors synthesized by the liver, and the correlation between fibrin degradation products (FDP) and D-dimer (D-D) concentration and coagulation proteins synthesized by extra-hepatic tissues, in different liver diseases; to explore the relationship between coagulation and bleeding in hepatic diseases. METHODS: Chronic hepatitis B (CHB) patients, CHB-related liver cirrhosis patients, CHB-related liver failure patients and healthy (normal) controls were selected for study and provided blood samples for analysis. The activity of coagulation factors (F) II, V, VII, VIII, IX, X, XI, and XII was detected using the one-stage clotting method. Coagulogram analysis, including activated partial thromboplastin time (APTT), thrombin time (TT), and prothrombin time (PT), was conducted by the solidification method. Antithrombin III (AT-III) and protein C (PC) activities were measured by chromogenic substrate assay. FDP concentration was detected using immunoturbidimetry. Tissue factor pathway inhibitor (TFPI), thrombomodulin (TM), von Willebrand factor (vWF), and tissue factor (TF) concentrations were measured by enzyme-linked immunosorbent assay (ELISA). RESULTS: With the exception of FVIII, coagulation factors and anticoagulant proteins synthesized by the liver were decreased and the coagulogram was extended for all patients. Likewise, the FDP and D-D concentrations were increased in blood. CHB patients, however, presented with increased levels of FVIII, TFPI, TM, vWF, and TF. Pairwise comparison indicated statistical differences existed among CHB, CHB-related liver cirrhosis, and liver failure patients: TFPI: 239.3+/-206.4, 315.0+/-258.6, and 319.5+/-298.1 -- higher than normal control: 104.0+/-87.1, F = 5.453, P less than 0.05; vWF: 70.3+/-29.5, 105.5+/-58.0, and 179.3+/-61.7 -- higher than normal control: 21.9+/-7.2, F = 20.104, P less than 0.05; TF: 85.9+/-85.7, 234.2+/-202.9, and 344.7+/-214.6 -- higher than normal control: 12.8+/-8.1, F = 8.619, P less than 0.05; FVIII: 157.2+/-53.4, 206.9+/-86.9, and 335.7+/-117.7 -- higher than normal control: 105.5+/-46.2, F = 13.418, P less than 0.05. CONCLUSION: In parallel to the progression of liver diseases, pro coagulation and anti-coagulation elements synthesized by the liver were reduced. In contrast, fibrinolysis activity was enhanced, which is expected to lead to an imbalance between blood clotting and anti-clotting factors. This may be an important cause for the bleeding that occurs in end-stage liver disease. Expressions of TFPI, TM, vWF, and TF significantly change in the early stage of liver diseases, as compared to normal (healthy) levels, and may represent a sensitive indicator of vascular injury.

[A multi-center randomized double-blinded, placebo-controlled clinical study on efficacy of composite sophora colon-soluble capsules in treating ulcerative colitis of internal dampness-heat accumulation syndrome type].

OBJECTIVE: To evaluate the clinical efficacy and safety of Composite Sophora Colon-soluble Capsules (CSCC) in treating patients with ulcerative colitis (UC) of internal dampness-heat syndrome type (IDHS) and compared with that of Mesalazine slow releasing granules (trade name: Etiasa). METHODS: Adopting randomized double-blinded double-simulated and positive drug controlled clinical design, 160 patients with UC of IDHS type were randomly assigned to two groups, 120 in the trial group was treated with CSCC plus Etiasa simulated placebo for 8 weeks, while 40 in the control group with Etiasa plus CSCC simulated placebo. Comprehensive therapeutic efficacy, effects on syndrome and safety of treatment were assessed, and changes of endoscopic features, Chinese medical syndrome scores and symptom score, activity index (AI) of UC, microscopic pathology in the two groups were observed and compared before and after treatment. RESULTS: After 8-week treatment, the clinical total effective rate in the two groups were 92.0% and 83.3%, the effective rate on Chinese medical syndrome in them were 91.7% and 85.0%, that on endoscopic features 92.0% and 83.3%, on microscopic changes 66.7% and 52.0%, respectively, showing insignificant difference between groups. Difference between groups in AI also showed no significance (1.03 +/- 1.87 vs 1.78 +/- 2.18, P > 0.05). However, the effects of decreasing Chinese medical syndrome score, and improving mucous pus blood stool and foul defecation in the trial group were more significantly (P < 0.05). No serious adverse event was seen in the 8-week treatment period. CONCLUSIONS: The clinical efficacy of CSCC was not inferior to, or even better than that of Etiasa. It could be taken as a substitute of chemicals if with poor effect.

[Comparative study for detecting micrometastases of lymph nodes in patients with lung cancer].

OBJECTIVE: To set up a new method to detect occult micrometastases of lymph nodes in patients with no-small-cell lung cancer (NSCLC). METHODS: We had detected 195 lymph node samples taken from 25 patients with NSCLC during the operations. Each lymph node sample was divided into two same parts in size. The one half part of lymph node should be examined by conventional histopathologic examination and immunohistochemical (IHC) staining. All the remaining lymph node samples of each patient should be mixed together for the reverse transcriptase-polymerase chain reaction (RT-PCR) if they located in the same region. As long as the presence of metastatic tumor in one lymph node was found by H&E staining, all other lymph node samples in the same region should not be detected by IHC staining or RT-PCR techniques. RESULTS: Frozen tissue sections of 135 lymph nodes that were staged as free of metastases by conventional histopathologic examination were screened by IHC staining. 31 lymph nodes showed single cell or cells clusters. Of 39 groups mixed regional lymph nodes which were diagnosed to be devoid of metastases by conventional histopathologic examination, 11 groups were found to have positive reactions to cytokeratin 19-mRNA by RT-PCR. There was a correlation between IHC staining and RT-PCR for detection of nodal micrometastases of NSCLC (U = 7.682, P = 0.0001). CONCLUSION: IHC staining analysis can facilitate the detection of occult micrometastases in lymph nodes of NSCLC, and its assessment of nodal micrometastases can provide a refinement of TNM stage for partial patients with stage I to II. RT-PCR has the same value as IHC staining in detection of lymph nodal micrometastases. RT-PCR technique can reduce expense of the detecting micrometastases in lymph nodes.

[Effect of glucocorticoid with traditional Chinese medicine in severe acute aespiratory syndrome (SARS)].

OBJECTIVE: To evaluate the effects of traditional Chinese medicine in 461 cases of severe acute respiratory syndrome(SARS) on glucocorticoid's dosage. METHOD: By using the polycentric nonrandomized concurrent controled trial and under the condition of glucocorticoid use, the patierts were divided into two groups: the integrated traditional Chinese and western mendicine(ITCWM) and simplicity western mendicine alone(WM). The observation indexes were time in hospital, pneumonia duration, mortality, glucocorticoid's gross dosage, glucocorticoid's average dosage of days and glucocorticoid use time. RESULT: In the ITCWM group, average time in hospital was shortened (P = 0.058), pneumonia duration was shortened (P = 0.057), mortality fell (P = -0.001). The median of glucocorticoid' s gross dosage was 1,277.0 mg x d(-1) in the ITCWM group, and that was 1,680.0 mg x d(-1) in the WM group (P = 0.083). The median of glucocorticoid's average dosage of days was 84.40 mg x d(-1) in the ITCWM group, and that was 115.33 mg x d(-1) in the WM group (P = 0.025). According to the analysis of 461 cases divided by stages and different ponderance, within 7 days after illness, in the ITCWM group, the glucocorticoid' s average dosage decreased. In the common type, the dosage in the ITCWM and in the WM was 146.43 mg x d(-1), and 183.64 mg x d(-1), respectively (P = 0.057), in the severe type, that was 137.71 and 177.86 mg x d(-1), respectively (P = 0.001). CONCLUSION: Compared with the group of simplicity western mendicine, in the group of integratived Chinese and western mendicine, time in hospital shorten, pneumonia duration shorten, mortality fall, simultaneity, glucocorticoid's average dosage is decreased. The use of TCM in the forepart of treatment can be capable of decreasing glucocorticoid's dosage.

Diagnosis and comprehensive treatment of esophageal leiomyoma: clinical analysis of 77 patients.

To investigate the diagnosis and comprehensive treatment of esophageal leiomyoma. The clinical data of 77 cases of esophageal leiomyoma patients were analyzed between 2005 and 2013. Its diagnosis, treatment and prognosis were analyzed. 39 cases of patients were with eating choking feeling, 18 cases presented with chest pain and weight loss and 20 cases without any symptoms. Preoperative endoscopic ultrasonography of each patient was diagnosed as possibility of esophageal submucosal tumor. 3 All patients underwent tumor enucleation, in which tumor electrotomy under gastroscope were done for 2 cases, complete video-assisted thoracoscopic (CVATS) resection of tumor for 24 cases, thoracoscope assisted small incision tumor resection for 29 cases, conventional thoracic tumor resection for 22 cases. The comparison and the difference of complete video-assisted thoracoscopic surgery group and the thoracoscope assisted small incision group for the operation time, bleeding volume, drainage volume, extubation time, hospitalization time and fasting time were not statistically significant (P < 0.05). All the patients recovered well and postoperative pathology of each patient was esophageal leiomyoma. They were followed up for 6 months to 8 years, average for 4 years, not recurrence of esophageal leiomyoma. Endoscopic ultrasonography is the most accurate method in diagnosis of esophageal leiomyoma. Esophageal leiomyoma which less than 1.0 cm in diameter, regular shape, originated in the muscularis mucosa, endoscopic electrotomy can be used as the preferred; Surgical operation is the main treatment of esophageal leiomyoma, three kinds of operation way has its own corresponding clinical indications, according to the clinical characteristics of patients and operator' habits to choose the corresponding operation way, all can achieve good treatment effect.

Endovascular stent graft placement in patients with type B aortic dissection: a meta-analysis in China.

OBJECTIVE: We summarized all published studies for endovascular stent graft placement among patients with type B aortic dissection in China with respect to clinical success, complications, and outcomes. METHODS: A meta-analysis was performed on all published studies of retrograde endovascular stent graft placement encompassing 3 or more patients with type B aortic dissection. Thirty-nine studies, involving a total of 1304 patients from January 2001 to December 2007, were included. RESULTS: The average patient age was 52 years. Procedural success was reported in 99.2% +/- 0.1% of patients. Major complications were reported in 3.4% +/- 0.1% patients, with the most severe neurologic complications in 0.6%. Periprocedural stroke was encountered more frequently than paraplegia (0.2% vs 0%). The overall 30-day mortality was 2.6% +/- 0.1%. In addition, 1.5% +/- 0.1% of patients died over a mean follow-up period of 27.1 +/- 17.5 months. Life-table analysis yielded overall survival rates of 96.9% at 30 days, 96.7% at 6 months, 96.4% at 1 year, 95.6% at 2 years, and 95.2% at 5 years. CONCLUSION: Although therapy with traditional medicines still remains the first line of treatment for type B aortic dissection, endovascular stent graft placement has shown its advantages, with a success rate of 99% or greater in a select cohort. The technical survival rate, major complications, and acute and midterm survival rates in the Chinese-language literature appeared to favorably compare with that seen in published literature. This analysis is the first to provide an overview of the currently available literature on endovascular stent graft placement in type B aortic dissection in China.

[Comparative study on molecular staging of lymph nodes in non-small cell lung cancer patients].

BACKGROUND AND OBJECTIVE: The postoperative survival of patients with non-small cell lung cancer (NSCLC) is mainly determined by clinical pathologic stage. However, recurrence is not rare in stage I NSCLC patients. This study was to explore whether conventional pathologic stages of some NSCLC were underestimated. METHODS: A total of 195 lymph nodes were taken from 25 NSCLC patients during operation. Each lymph node was cut into two parts equally: one part was subjected to hematoxylin-eosin (HE) and immunohistochemical (IHC) staining; the other part of the lymph nodes in the same region in a given patient was mixed for reverse transcription-polymerase chain reaction (RT-PCR). RESULTS: With HE staining, 30 of the 195 lymph nodes showed gross nodal metastasis, and none showed micrometastasis. IHC staining was performed on 135 lymph nodes that were identified as free of metastasis by HE staining, 31 showed micrometastasis; none showed gross nodal metastasis. Of 39 groups of mixed regional lymph nodes which were diagnosed to be free of metastasis by HE staining, 11 groups were found to be positive by RT-PCR. There was a correlation between IHC staining and RT-PCR for detection of nodal micrometastasis of NSCLC (U=7.682, P<0.001). CONCLUSIONS: HE staining can accurately detect gross nodal metastasis in NSCLC patients, but is unfit for detecting nodal micrometastasis. IHC staining can improve the detection rate of occult nodal micrometastasis. RT-PCR has similar value to IHC staining in detecting nodal micrometastasis.