Some conclusions drawn from explanatory randomized controlled trial (ERCT) lack practical value in application under real-world clinical settings, and there are also some limitations on the generalization of pragmatic randomized controlled trial (PRCT) results. In some countries, real-world studies (RWSs) have been conducted to explore the effectiveness and safety of clinical interventions or postmarketing drugs, which is a new tendency in clinical researches. By reviewing some RWSs carried out in Western countries, we sum up the basic characteristics of the research design, and discuss the differences and connections between PRCT and RWS. The design ideas of RWS are different from PRCT. Researchers in RWS tend to perform long-term evaluation based on large quantities of subjects and quite large sample and focus on outcome measures which are clinically meaningful. Strict control on data collection, management and analysis are very important to RWS and PRCT. Owing to the complexity of clinical interventions and evaluation, PRCT is not completely suitable for clinical researches in traditional Chinese medicine (TCM). It is an inevitable tendency to apply RWS in clinical trials of TCM. We can explore the efficacy of TCM interventions through PRCT, and better understand the effectiveness through RWS. RWS will become a powerful approach to TCM clinical trials and postmarketing evaluation of Chinese medicines.

Objective To establish a real-time fluorescent quantitative RT-PCR for detecting SARS-Coronavirus (CoV) mRNA in gargling liquid and serum of SARS patients.Methods The assay is based on simplified nested fluorescent RT-PCR. Total RNA was extracted from gargling liquid and serum by using high performance system and reverse-transcription by antisense primer.The specific TaqMan probe was designed according to the published DNA sequence of SARS-CoV polymerase and labeled with FAM and TAMRA. Standard curves for SARS-CoV quantification were prepared with serial dilutions of the recombinant plasmid.Results The method is highly sensitive and specific. The sensitivity of assay was 1?105 copies/L. The positive rate of SARS-CoV mRNA in the gargling liquid of patients was 65.0% (26/40) and 11.5% (6/52) in suspected patients, respectively. SARS-CoV mRNA was not detectable in the gargling liquid from 40 healthy individuals. The positive rate of SARS-CoV mRNA in the serum of SARS patients was 25.6% (10/39). PCR amplification products of 6 suspected patients with SARS-CoV mRNA were confirmed by sequencing and the sequence data were consistent with that of BJ01 AY278488.Conclusions Real-time fluorescent quantitative RT-PCR should be a rapid, specific tool for early diagnosis of SARS-CoV infection.

Objective: To explore the expression and significance of MMP-9 and TIMP-1 in gastric carcinoma.Methods: S-P immunohistochemical method was used to examine the expression of MMP-9 and TIMP-1 in 47 specimens of gastric carcinoma.Results: MMP-9 and TIMP-1 were expressed predominantaly in the peritumor stromal cells than tumor cells themselves.The expression level of MMP-9 and TIMP-1 correlated with lymph node metastasis (P0 05).Conclusion: The results suggests that MMP-9 and TIMP-1 might be important biological makers for determining the malignant behave of gastric carcinoma.

Objective: To probe into TCM pattern of primary hyperlipemia and its relationship with gender, age, BMI, laboratory indices such as TC,TG, LDL-C, HDL-C, ApoAI, ApoB of the 120 patients with primary hyperlipemia. Methods: Logistic regression analysis wan used to analyze the associativity of TCM syndrome and objective indexes of primary hyperlipemia. Results: Logistic regression analysis showed that TCM syndromes of primary hyperlipemia had some relation with laboratory indices. Conclusion: TCM syndromes of primary hyperlipemia had some relation with laboratory indices. The lipemia laboratory indices can be one of the objective basis of TCM diagnosis. The main syndromes were stagnation of phlegm-turbid and syndrome of yang deficiency of both of spleen and kidney, the main pathogenesis were deficiency of spleen and kidney, intermingled phlegm and blood stasis. The main treatment methods were invigorating spleen and tonifying kidney, supplementing qi and nourishing heart, promoting blood flow and dissipating phlegm.

Objective To investigate the risk factors of extrahepatie recurrences after curative resection of primary hepatocellular carcinoma (HCC). Methods Clinicopathologic data of 238 curative resected cases of primary HCC were retrospectively reviewed for parameters affecting postoperative extrahepatic recurrences. Results During a median follow-up of 34 months (7 - 78 months), extrahepatic recurrences were observed in 32 out of 238 patients (13.4%). According to univariate analysis, the risk factors for extrahepatic recurrences were preoperative serum a-fetoprotein (AFP) level of > 1000 ng/ml,aspartate aminotransferase level of > 50 IU/L, presence of hepatic vein invasion, neighboring organ invasion, tumor satellites, and lack of tumor capsule formation. Preoperative serum AFP levels of > 1000 ng/ml, hepatic vein invasion, neighboring organ invasion proved to be independent risk factors by multivariate analysis. Conclusions Extrahepatic recurrences after curative resection of HCC was found to be related to preoperative serum AFP level of > 1000 ng/ml, hepatic vein invasion, and neighboring organ invasion.

ObjectiveTo observe the changes of the levels of serum TNF-α and IL-6 in patients with hypertensive disorders in pregnancy(HDIP),to explore the significance of serum TNF-α and IL-6 in HDIP.MethodsThe levels of serum TNF-α and IL-6 in 30 patients with HDIP( 11 cases with gestational hypertension,11 casses with mild preeclampsia,8 cases with severe preeclampsia) and 18 healthy pregnant women were detected.ResultsThe levels of serum TNF-α in HDIP were( 1.88 ±0.48) μg/L,(2.32 ±0.40) μg/L and(2.35 ± 0.42) μg/L,The levels of serum IL-6 of HDIP were (99.54 ± 31.62) ng/L,( 120.53 ± 26.42)ng/L,( 140.83 ± 22.13 ) ng/L respectively,the serum levels of TNF-α and IL-6 in healthy pregnant women were( 1.63 ± 0.32)μg/L and(95.82 ± 30.65 )ng/L,there was significant difference among them ( all P ＜ 0.05 ).ConclusionThe serum levels of TNF-α and IL-6 in HDIP were higer than those in healthy pregnant women,and vascular endothelium cell injury should play an important role in the pathogenesis and development of HDIP.

Objective To assess hepatitis B virus(HBV)and hepatitis C virus(HCV)infections in different anatomic location of cholangiocarcinoma(CC)and relationship with abnormal p53 expression.Methods A total of 411 CC samples including intrahepatic cholangiocarcinoma(ICC 312 cases);perihilar cholangiocarcinoma(PHC,73 cases)and distal cholangiocarcinoma(DC,26 cases)underwent serologic test for HBsAg and anti-HCV using microparticle enzyme immunoassay.Abnormal p53 expression was detected in formalin-fixed.paraffin-embedded CC tissues by immunohistochemistry.Results Seropositivity for HBsAg and anti-HCV were found in 48.4%(151/312)and 2.9%(9/312)of ICC cases,and in 10.9%(8/73)and zero of PHC,and in 7.7%(2/26)and zero of DC,respectively.Abnormal p53 expression was detected in 30.1%(94/312)of ICC cases.23.3%(17/73)of PHC cases and 19.2%(5/26)of DC cases.There was no correlation between seropositivity of HBsAg and anti-HCV and p53 overexpression among three groups of CC. Conclusions HBV but not HCV infection may be associated with the development of ICC.p53 abnormality may not play a significant role in HBV-associated carcinogenesis of ICC.

OBJECTIVE To explore the mechanism of methylamphetamine (MA) on heart toxicity. METHODS The effects of MA on delayed rectifier potassium current (IK) and action potential (AP) were analyzed in isolated decreased AP from 121.6 to 106.0 mV and delayed the action potential duration (APD), but had no effect on the resting potential. The 10%, 25%, 50%, 75% and 90% of APD (APD10, APD25, APD50, APD75 and APD90)inhibited the membrane potential of rapidly activating delayed rectifier potassium current (IKr) and slowly activating delayed rectifier potassium current (IKs), downward shifted the Ⅰ -Ⅴ curve, but had no effect on the curve shape and could be partly recovered after flushing. The tail current IKr was blocked concentration-dependently after simiarly inhibited by MA. CONCLUSION MA has inhibitory effects on Ik and AP in ventricular myocytes,which may be one of the possible electrophysiological mechanisms of the cardiac damage caused by MA.

Objective To evaluate the techniques and the effects of resection of giant hepatic tumors in the caudate lobe of the liver. Methods The clinical data of 33 patients with primary liver carcinoma or benign tumor (>10 cm) in the caudate lobe of the liver surgically treated in our hospital from January 2000 to January 2007 were retrospectively analyzed. Results The total of 33 huge liver tumors with a median diameter of 12.3 cm (10.2-15.3cm) were successfully resected. The types of the hepatectomies conducted were as follows:isolated total caudate lobectomy in 7cases, partial cau-date lobectomy in 8, caudate lobectomy plus other extended hepatectomy in 18. The median operative time was 218 min (120-360 min) and the median intraoperative blood loss 958 ml (400-7000 ml),with operative mortality and morbidity being 0 and 27%, respectively. The postoperative 1-, 3- and 5-year survival rates for the patients with primary liver cancer were 76 %,52% and 24%, respectively. Con-clusion The hepatic tumors of caudate lobe, when larger than 10 cm in diameter, frequently involves all the hepatic portal,hepatocaval confluence and retrohepatic IVC. Though it is sophisticated in tech-nique, surgical resection of this kind of tumor is safe, effective and of the first choice.

Following more and more new drugs are authorized into market, new, serious or unexpected adverse drug reactions appear frequently, which is a serious threat to people health and life. Through making laws and guidelines, governments of various countries aim to strengthen and standardize the surveillance and reporting of postmarketing drugs. The drugs management department of our country are doing related jobs positively, but there are some problems, such as drug risk-menagement is not emphasized well, and the management department lacks clarity on operating related regulations. This article tries to explore foreign countries' laws and regulations on the surveillance and reporting of postmarketing drugs, aiming to provide reference for our courtry.
Adverse Drug Reaction Reporting Systems ; legislation & jurisprudence ; organization & administration ; China ; Humans ; Internationality ; legislation & jurisprudence ; Legislation, Drug ; Marketing of Health Services