高效液相色谱法测定人血清和尿中盐酸青藤碱浓度及药代动力学研究

用RP-HPLC法,以三唑仑为内标,反相C₁₈为分析柱,乙腈—0.01mol·L^-1磷酸二氢钠—四甲基乙二胺(46∶54∶0.22v/v)为流动相,磷酸调至pH6.9,检测波长263nm,测定血清和尿中盐酸青藤碱浓度,线性范围分别为6～480ng·mL^-1和0.06～3μg·mL^-1,平均回收率75.88%和91.35%,日内日间误差小于5%,最低检测浓度血清4ng·mL^-1,尿40ng·mL^-1。8名健康男性志愿者单次口服盐酸青藤碱片80mg,测定血清及尿浓度,该药符合二室开放模型,体内消除符合一级动力学消除过程,主要药代动力学参数:T_1/2α0.791±0.491h,T_1/2β9.397±2.425h,T_{max 1.040±0.274h,Cmax246.604±71.165ng·mL^-1,AUC 2651.158±1039.050ng·h·mL^-1,CL 0.033±0.01ng·mL^-1。}     

Single data extraction generated more errors than double data extraction in systematic reviews

BACKGROUND AND OBJECTIVE: To conduct a pilot study to compare the frequency of errors that accompany single vs. double data extraction, compare the estimate of treatment effect derived from these methods, and compare the time requirements for these methods. METHODS: Reviewers were randomized to the role of data extractor or data verifier, and were blind to the study hypothesis. The frequency of errors associated with each method of data extraction was compared using the McNemar test. The data set for each method was used to calculate an efficacy estimate by each method, using standard meta-analytic techniques. The time requirement for each method was compared using a paired t-test. RESULTS: Single data extraction resulted in more errors than double data extraction (relative difference: 21.7%, P = .019). There was no substantial difference between methods in effect estimates for most outcomes. The average time spent for single data extraction was less than the average time for double data extraction (relative difference: 36.1%, P = .003). CONCLUSION: In the case that single data extraction is used in systematic reviews, reviewers and readers need to be mindful of the possibility for more errors and the potential impact these errors may have on effect estimates.     

Transition from meeting abstract to full-length journal article for randomized controlled trials

Context  Not all research presented at scientific meetings is subsequently published and, even when it is, there may be inconsistencies between these results and what is ultimately printed. Although late-breaking trials sessions are now integrated into several major scientific meetings and the results are often promptly and prominently communicated, no studies have examined the publication fate and degree of consistency between meeting abstracts or presentations and subsequent full-length article publications for randomized controlled trials (RCTs) presented at these sessions. Objective  To compare RCT abstracts presented in the late-breaking trials session vs other sessions at a major scientific meeting and subsequent full-length publications. Design  RCTs were identified by hand searching abstract proceedings booklets and related Web sites for the American College of Cardiology scientific meetings (1999-2002). Subsequent full-length articles were identified via electronic databases. Main Outcome Measures  Publication fate and degree of consistency between meeting abstract results and subsequent full-length publication results. Results  The 86 late-breaking RCTs were significantly larger (median, 2737 patients vs 896; P<.001), were more likely to be preceded by a published design paper (27 [31%] vs 13 [13%]; P = .002), had higher quality scores when eventually published (mean Jadad score 2.69 vs 2.19; P = .01), and were less likely to report favorable results for the intervention than the 100 randomly chosen comparison RCTs presented in other sessions (50 [58%] vs 75 [75%]; P = .01; odds ratio 0.46; 95% confidence interval, 0.24-0.90). RCTs presented at the late-breaking trials sessions were significantly more likely to be published (79 [92%] vs 69 [69%]; P<.001) and appeared earlier after presentation (median 11.5 months vs 22.0 months; P<.001) than RCTs presented in other sessions, an association that persisted even after adjusting for sample size, conclusion of study, and RCT design: adjusted hazard ratio, 1.80 (95% confidence interval, 1.24-2.61). Sixty (41%) of the 148 RCTs that were subsequently published exhibited discrepancies between the efficacy estimate reported in the meeting abstract vs the one reported in the full-length article for the primary outcome. The mean change in effect was 0.44 SDs and in 20 cases (14%), the point estimate was statistically significant in only 1 member of the pair. The discrepancy rate was the same for late-breaking RCTs as for RCTs presented in other American College of Cardiology sessions (P = .92). Conclusions  Late-breaking trials were larger, more likely to be preceded by a design paper, and less likely to report positive results than RCTs presented at other sessions, but discrepancies between the meeting abstract results and subsequent full-length publication results were common even for late-breaking trials.      

Comparison of major and minor depression in older medical inpatients with chronic heart and pulmonary disease

Depressed medical inpatients with congestive heart failure (CHF) and/or chronic pulmonary disease (CPD) were examined to determine characteristics distinguishing major depression (N=413) from minor depression (N=587). Consecutively admitted patients age 50 or over were screened for depressive disorder with the Structured Clinical Interview for Depression (SCID-IV). CHF/CPD patients with major depression differed from those with minor depression not only on number and severity of depressive symptoms but also on race/ethnicity, comorbid psychiatric illnesses, dyspnea, life stressors, social support, and previous antidepressant therapy. CHF/CPD patients with major and minor depression have distinct psychosocial and physical characteristics that distinguish one from another.     

Granulocyte colony-stimulating factor for hepatitis C therapy-associated neutropenia: systematic review and economic evaluation

Summary. Hepatitis C virus (HCV) treatment requires maximal adherence to pegylated interferon (Peg‐IFN) and ribavirin to achieve a sustained virologic response (SVR). Neutropenia is the most common cause for Peg‐IFN dose reduction. Our objectives were to evaluate the effectiveness, safety and cost‐effectiveness of granulocyte colony‐stimulating factor (G‐CSF) versus Peg‐IFN dose reduction for HCV therapy‐associated neutropenia in treatment naïve adults. We conducted a systematic review to identify controlled trials and observational studies. Study selection, quality assessment and data extraction were completed independently by two investigators. Cost‐effectiveness and cost‐utility analyses compared G‐CSF with dose reduction. Nineteen studies were included. In one trial, the SVR for those receiving G‐CSF was 54.5% (95% CI: 34.7–73.1) compared with 26.3% (95% CI: 11.8–48.8) for dose reduction. The remaining studies were case series or retrospective cohorts and provided weak evidence for the relationship between SVR and G‐CSF. The risk of adverse events, including infection, associated with G‐CSF was low (13.1%; 95% CI: 8.0–20.8) and clinically insignificant. G‐CSF had an incremental cost‐effectiveness ratio of $41 701 per SVR achieved in genotype 1, and $16 115 per SVR achieved in genotype 2 or 3. Estimates were robust under a variety of resource and intervention scenarios. While administration of G‐CSF may enable patients to remain on or resume optimal HCV therapy, there was weak evidence that this improves the likelihood of SVR compared with dose reduction. Adverse effects of G‐CSF are mild. The economic evaluation was inconclusive.     

Bacterial contamination of health care workers' pagers and the efficacy of various disinfecting agents

Health care workers in our facility were surveyed, and their pagers were cultured before and after disinfection with various agents. All pagers were contaminated with bacteria, including the pathogens Staphylococcus aureus, Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella spp. and methicillin-resistant S. aureus. Disinfection reduced bacterial contamination. No risk factors for pager contamination with pathogens were identified.     

The efficacy and safety of exogenous melatonin for primary sleep disorders a meta-analysis

BACKGROUND: Exogenous melatonin has been increasingly used in the management of sleep disorders. PURPOSE: To conduct a systematic review of the efficacy and safety of exogenous melatonin in the management of primary sleep disorders. DATA SOURCES: A number of electronic databases were searched. We reviewed the bibliographies of included studies and relevant reviews and conducted hand-searching. STUDY SELECTION: Randomized controlled trials (RCTs) were eligible for the efficacy review, and controlled trials were eligible for the safety review. DATA EXTRACTION: One reviewer extracted data, while the other verified data extracted. The Random Effects Model was used to analyze data. DATA SYNTHESIS: Melatonin decreased sleep onset latency (weighted mean difference [WMD]: -11.7 minutes; 95% confidence interval [CI]: -18.2, -5.2)); it was decreased to a greater extent in people with delayed sleep phase syndrome (WMD: -38.8 minutes; 95% CI: -50.3, -27.3; n=2) compared with people with insomnia (WMD: -7.2 minutes; 95% CI: -12.0, -2.4; n=12). The former result appears to be clinically important. There was no evidence of adverse effects of melatonin. CONCLUSIONS: There is evidence to suggest that melatonin is not effective in treating most primary sleep disorders with short-term use (4 weeks or less); however, additional large-scale RCTs are needed before firm conclusions can be drawn. There is some evidence to suggest that melatonin is effective in treating delayed sleep phase syndrome with short-term use. There is evidence to suggest that melatonin is safe with short-term use (3 months or less).