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 To investigate the effect of continuous renal replacement therapy (CRRT) on rhabdomyolysis with acute kidney injury (AKI) following multiple wasp stings. Methods We designed a prospective study which enrolled 132 patients who developed rhabdomyolysis after multiple wasp stings between January 2013 and December 2016 in Jianyang People’s Hospital, West China Hospital of Sichuan University and Anyue People’s Hospital. Among these, 62 patients with AKI were treated with CRRT. The modality of CRRT was continuous veno-venous hemofiltration (CVVH). CVVH was performed for at least 48 hours by using Prismaflex and M100-AN69 hemofilter. Hemofiltration was accomplished using predilution bicarbonate with the replacement fluid rate of 2 000–2 500 mL/h [30–35 mL/(kg·h)]. Heparin or low-molecular-weight heparin was used for anticoagulation, with blood flow rate of 180–200 mL/min. Then intermittent hemodialysis was performed when patients’ condition became stable. Mortality, kidney recovery, biochemical indicators and length of stay were collected. Results Fifty-one patients met the inclusion criteria finally, and four (7.8%) of them died during hospitalization, and the remaining 47 patients survived with completed treatment and follow-up. At 3, 7, and 14 days after treatment, the creatine kinase, myoglobin and lactate dehydrogenase of the patients all decreased significantly and gradually, and returned to normal level finally. Kidney function was recovered in 45 (95.7%) patients within 3 months, and 2 patients suffered chronic kidney disease. The patients’ hemoglobin recovered to normal level at (30.5±11.3) days. Conclusion Rhabdomyolysis and AKI were severe complications following multiple wasp stings, and early CRRT may bring significant benefits to such patients.