Objective To investigate the clinical characteristics and treatment of severe H1N1 influenza during pregnancy and postpartum.Methods Clinical data of 7 pregnant women and 2 postpartum women with severe H1N1 influenza admitted from October to December 2009 were reviewed. Results Three pregnant women underwent caesarean section during hospitalization. The main symptoms included fever ( in9 cases, and fever lasted more than 3 days in 7 cases) , cough and sputum ( in 9 cases) , and dyspnea ( in 7 cases) . Asthenia and muscular soreness were not serious, and there were no accompanying symptoms of digestive tract. Moist rales were heard in 5 cases. White blood cell count decreased in 3 cases, neutrophils increased in 6 cases, and lymphocytes reduced in 7 cases. Hepatic enzymes were abnormal in 4 cases, and myocardial enzymes were abnormal in5 cases. 8 patients had hypoxemia, with PaO2 less than 40 mmHg in5 cases. Chest X-ray films and CT showed double pneumonia in 9 patients. 9 patients were given oseltamivir antiviral treatment. 8 cases were given antibiotic therapy. 5 patients with bilateral severe pneumonia and respiratory failure were given corticosteriod therapy. 5 severe patients were treated with non-invasive ventilation. One case switched to invasive ventilation and eventually died. Conclusions Pregnant and postpartum women with influenzaH1N1 are likely to develop into severe condition which is commonly rapidlyprogressive and even life-threatening. The main causes of death are pneumonia and acute respiratory distress syndrome.
Objective To improve the sensitivity and broaden the applicability of N-of-1 trials in traditional Chinese medicine (TCM), the clinical application and methodology of single-case experimental designs (N-of-1trials, multiple-baseline designs; MBDs) were expounded, compared, and discussed. Methods This paper introduced the current utility of N-of-1 trials in TCM research, introduced MBDs, and compared the methodologies of N-of-1 trials, MBDs and crossover design. Finally, two design schemes to improve the sensitivity and applicability of N-of-1 trials were illustrated. Results N-of-1 trials conformed to the TCM concept of treatment based on syndrome differentiation; however, due to the complex composition of TCM, the results were easily affected by carryover effect. In MBDs, the intervention was introduced in a staggered way, no washout period was needed, and the required sample size was small. MBDs were generally used to preliminarily indicate the effect of intervention; however, the statistical analysis was relatively complicated, and there were few MBDs used in clinical trials of TCM at present. Compared with crossover trials, single-case experimental designs had advantages and disadvantages. N-of-1 trials might best reflect the individualized treatment of TCM and a suitable statistical model (e.g., hierarchical Bayesian statistical method) was expected to improve the sensitivity and applicability of N-of-1 trials in TCM. Combining clinical trial designs (e.g., the combination of N-of-1 trials and MBDs) would complement the limitations of N-of-1 trials, and expand the scope of conditions applicable for study. Conclusion N-of-1 trials have both advantages and disadvantages in TCM research. Improved statistical models or combined study designs will improve the sensitivity and broaden the applicability of N-of-1 trials in TCM.
Objective A series of N-of-1 trials were conducted to evaluate the effect of traditional Chinese medicine (TCM) individualized syndrome differentiation on stable bronchiectasis, and to explore a clinical trial method that is consistent with the characteristics of TCM. Methods The original plan was for 3 cycles, with each cycle consisting of two observation periods: experimental and control. Take the medication for 3 weeks each period and then stop for 1 week. Because the results were not as expected, another cycle of trials was added (a total of 4 cycles). The trial period was treated with individualized syndrome differentiation prescription and the control period was treated with placebo. The outcome measures were Likert scale score of general symptoms (primary outcome), Likert scale score of respiratory symptoms, CAT score, 24h sputum volume and TCM symptom score. Data analysis (including residual effects and stage effects analysis) used group-designed independent sample t tests, paired t tests or non-parametric tests, mixed effects models, and Bayesian analysis. Results A total of 31 participants were formally enrolled, with 24 completing all four cycles. Independent sample t-tests and mixed-effects models showed no significant period or carryover effects. Bayesian analysis showed that there were residual effects on some outcome measures of some individuals. Six participants showed statistically significant differences in overall symptom Likert scale scores (P<0.05). Bayesian analysis found that TCM was more effective than placebo in more individuals. No significant differences were found between individualized TCM and placebo at the group level for all outcome measures. Conclusion This study method highly simulates the clinical practice of TCM, with good operability and patient compliance, and has no obvious residual effect of TCM on the whole, which can provide the best individualized evidence-based medicine evidence of short-term efficacy of TCM. Bayesian analysis can improve the sensitivity of individual statistics.