ObjectiveTo suggest the importance of taking notice of oral chemotherapy drugs in cancer patients, and the importance of drug-use evaluation in patients with insufficient kidney functions, by reporting one death case caused by multiple organ failure because of myelosuppression after oral tegafur, gimeracil and oteracil potassium (S-1) capsules for 10 days in a patient with insufficient kidney functions. MethodsThrough the analysis of one patient who died of multiple organ failure due to degree-Ⅳ myelosuppression and the related literature review, we discussed the necessity of individualized administration of clinical chemotherapy. ResultsThe patient had grade-Ⅱ renal insufficiency before chemotherapy and did not undergo dihydropyrimidine dehydrogenase (DPYD) gene test. Myelosuppression occurred 10 days after oral chemotherapy drugs. The white blood cells, neutrophils and platelets decreased progressively, and then developed into degree-Ⅳ suppression. Finally the patient died of multiple organ failure. Conclusions Genetic variation and renal insufficiency may cause differences in drug metabolism. The reduced urinary excretion of guimet pyrimidine (CDHP), the inhibitors of dihydropyrimidine dehydrogenase which is the 5-fluorouracil (5-FU) metabolic enzyme, may lead to elevated plasma concentration of 5-FU, thereby increasing myelosuppression and other adverse reactions. If DPYD gene detection results show low enzyme activity, it can cause lethal toxicity through deceleration of 5-FU metabolism and high concentration of blood. DPYD gene dzetection should be performed if allowed, and individualized treatment plan should be formulated after comprehensive evaluation. The overall situation of the patients should be considered before treatment, and then individualized drugs should be administered.
Abstract: Objective To compare the midterm patency rates of individual and sequential saphenous vein grafts (SVG) as coronary bypass conduits of offpump coronary artery bypass grafting (OPCAB) and evaluate the impact of the grafting techniques (individual or sequential grafts) on the graft patencyafter OPCAB. Methods The clinical data of 398 patients in General Hospital of the People’s Liberation Army receiving OPCAB with individual and sequential grafts from June 2005 to March 2009 were retrospectively analyzed. There were 301 males and 97 females with their age ranged from 53 to 82 years (63.6±10.3 years). A total of 714 distal coronary anastomoses on 448 SVG were assessed by using 64multislice computed tomography (64MSCTA) at an average of 19.8±23.6 months (3 months to 5 years) after OPCAB procedure. The blood flow of grafts in the proximal segment of individual and sequential SVG and the patency rates of grafts and anastomoses were compared, and the effect of different locations on the patency rate of the anastomoses was analyzed. Results The mean blood flow in double SVG (37.11±16.70 ml/min vs. 25.15±14.24 ml/min, P0.042) and in triple SVG (37.56±19.58 ml/min vs. 25.15±14.24 ml/min, P=0.048) were both significantly higher than the flow in single SVG. The anastomoses on the sequential conduits had better patency (95.1％ vs. 90.1％, P=0.013). The patency of sideto side anastomoses was better than that of endtoside anastomoses (97.0% vs. 93.1%, P=0.002) and that of the individual endtoside anastomoses (97.0% vs. 90.1%, P=0.041). There was no significant difference between distal anastomoses in sequential and those in single grafts (P=0.253). No significant difference was observed between the two methods in regard to the three major coronary systems (including the anterior descending branch, the right coronary artery, and the circumflex branch). However, anastomoses on sequential grafts had superior patency to those on individual grafts in the right coronary system (P=0.008). Conclusion The midterm patency of a sequential SVG conduit after OPCAB is excellent and generally superior to that of an individual one. The best runoff coronary artery should be placed at the distal end and the poor coronary vessels should be arranged in the middle of the grafts.
Survival data include the occurrence and duration of an event. As most survival data are distributed irregularly, the Kaplan-Meier method is often used in survival analysis; however, studies usually only report the Kaplan-Meier curve and median survival time and do not provide the original survival data, which creates issues for subsequent secondary research. This study introduced a systematic method whereby image processing software and R software were used to process and extract survival data from published Kaplan-Meier curves. It also introduced the specific steps required to obtain survival data using an example to show the accuracy and feasibility of the extraction method and provided references for the effective secondary use of survival data.
The characteristics of traditional Chinese medicine (TCM) practice include treatment based on syndrome differentiation and holism, which determines it is difficult to reflect the individualized therapeutic evaluation and overall regulation of TCM through traditional randomized controlled trials, which is based on quantitative evaluation. The implementation of N-of-1 trials will provide opportunities for quantitative evaluation of individualized therapeutic evaluation of TCM. Using mixed methods research, such as exploratory sequence design, interpretive sequence design or convergent design can provide abundant data to individualized therapeutic evaluation of TCM in different aspects, which may reflect holism and humanities characteristics of TCM in individual level.
Objective To explore the application of individualized transiliac crest nail-grafting guide plate prepared by computer-aided design and three-dimensional (3D) printing technology in deep pelvic external fixator implantation. Methods Five patients with pelvic fractures were collected between May 2017 and February 2018. There were 4 females and 1 male with an average age of 52 years (range, 29-68 years). Pelvic fractures were classified as type B in 3 cases and type C in 2 cases by Tile classification. The interval between injury and operation was 6-14 days (mean, 9 days). The preoperative CT images of pelvic fractures were collected. The data was reconstructed by 3D imaging reconstruction workstation. An individualized transiliac crest nail-grafting guide plate was designed on the virtual 3D model. The individualized transiliac crest nail-grafting guide plate and the solid pelvic model were produced with the 3D printing technology. The individualized transiliac crest nail-grafting guide plate was used for intraoperative deep pin position on iliac crest after the preoperative simulation. The follow-up CT scans were used to determine the differences in distance from anterior superior iliac spine, convergence angle, and caudal angle between the preoperative plan and postoperative measurement. Results During the operation, the individualized transiliac crest nail-grafting guide plate was used to guide the placement of 20 pins. X-ray film and CT examination showed that all pins were well positioned. The average depth of pins was 83.16 mm (range, 70.13-100.53 mm). Fitted 3D reconstruction images showed that the entry point and orientation of the pins were all consistent with preoperative schemes. Compared with the planned nail path, there was no significant difference in the distance from anterior superior iliac spine, convergence angle, and caudal angle in the actual nail path (P>0.05). No loosening and rupture of pin, no damage of blood vessels and nerve, and shallow or deep infection occurred during 3 months follow-up, and the incisions healed by first intention. All patients were satisfied with the treatment process. The ranges of motion of hip and knee were normal, and the visual analogue scale (VAS) score was 0-3 (mean, 0.5). Conclusion The individualized transiliac crest nail-grafting guide plate technique is the improvement of traditional technique. It can increase accuracy and effective depth of pin position, enable patients to obtain pelvic mechanical stability quickly after operation, and reduce the risk of complications related to nail path.
Objective To evaluate the deviation between actual and simulated screw placement after cervical pedicle screw placement assisted by 3D printed navigation template, and analyze the correlation between screw placement deviation and navigation pipe length. Methods A total of 40 patients undergoing cervical 1-7 pedicle screw insertion assisted by 3D printed navigation template in Zigong Fourth People’s Hospital between February 2018 and August 2020 were included in this prospective study. These patients were divided into 3 groups randomly, including 12 patients with a 5-mm pipe length (5 mm group), 13 patients with a 10-mm pipe length (10 mm group), and 15 patients with a 15-mm pipe length (15 mm group). Three-dimensional modeling was performed on preoperative cervical CT images of these patients and simulated pedicle screw was placed. Individualized pedicle screw navigation templates were designed according to the position and direction of simulated pedicle screws, and 3D printing was performed on the cervical model and navigation templates. Preoperative 3D printed model and navigation templates were used to simulate the surgical process to confirm the safety of screws. During the operation, pedicle screw placement was performed according to the preoperative design and simulated surgical process. The postoperative CT images were registered with the preoperative CT images in 3D model. The safety of screw placement was evaluated by the postoperative screw placement Grade, and the accuracy of screw placement was evaluated by measuring the deviation of screw placement point and the deviation of screw placement direction in horizontal plane (inclination angle) and sagittal plane (head inclination angle). The influence of different navigation pipe lengths on the safety and accuracy of screw placement was analyzed. Results A total of 164 pedicle screws were inserted with navigation template assistance, including 48 screws (38 in Grade 0 and 10 in Grade 1) in the 5 mm group, 52 screws in the 10 mm group (all in Grade 0), and 64 screws (52 in Grade 0 and 12 in Grade 1) in the 15 mm group, and the difference in the grade among the three groups was statistically significant (P<0.05). When the navigation pipe length was 5, 10, and 15 mm, respectively, the screw entry point deviation was (1.87±0.63), (1.44±0.63), and (1.66±0.54) mm, respectively, the inclination angle deviation was (2.72±0.25), (0.90±0.21), and (1.84±0.35)°, respectively, and the head inclination angle deviation was (8.63±1.83), (7.15±1.38), and (8.24±1.52)°, respectively. The deviations in the 10 mm group were all significantly less than those in the other two groups (P<0.05). Conclusions In the cervical pedicle screw placement assisted by navigation template, all the screws were Grade 0 or Grade 1, with high safety. The mean deviation of the screw entry point is within 2 mm, with high accuracy. When the length of navigation pipe is 10 mm, the safety and accuracy of screw placement can be fully guaranteed.
Individual patient data meta-analyses are conducted through development of collaboration with trial investigators, central collection and checking of individual patient data of all eligible trials, and pooling of patient data to produce the best estimate of effects of health care interventions. They ensure study data to be update, accessible, reliable and complete so as to minimize the risk of bias, and are the gold standard of systematic reviews addressing effects of health care interventions. Meta-analyses using individual patient data enable higher flexibility of data analyses and more completeness and balance of results interpretation. The study conduct differs between individual patient data versus conventional meta-analyses. This article discussed the steps of conducting individual patient data meta-analyses.
ObjectiveTo evaluate feasibility and clinical effect of individual therapy for venous ulceration of lower extremity. MethodsFrom February 2012 to February 2014, 360 cases (totally 421 lower limbs) treated by the individual therapy were analyzed retrospectively. There were 126 male and 234 female patients, with a mean age of 53 years (ranging from 45 to 78 years). The venous ulceration occurred in left limb for 176 cases, right limb for 123 cases, and both limbs for 61 cases. The individualized treatment plans were performed for all the patients according to the color Doppler before the operation. The perforating vein was ligated during the operation, and elastic stockings were wore after operation. The operation time, postoperative VAS pain score, perioperative complications, ulcer healing and recurrence were recorded. ResultsThe operations were completed in all the patients, the average operation time was 35 min. The average VAS pain score was 2.6 at 8 h after operation, the pain was disappeared nearly at 24 h after operation. The time of returning to normal activity was 3 d. The incision bleeding occurred in 5 cases, the ulcer infection occurred in 32 lower limbs. The patients were followed-up for 12 months to 24 months, all the ulcers were healed, there were 9 cases of recurrence. ConclusionIndividual therapy for venous ulceration of lower extremity is safe, effective, fewer complications, fast ulcer healing, and less postoperative pain.
The method of evaluating clinical efficacy of traditional Chinese medicine is one of the hotspots in the field of traditional Chinese medicine in recent years. How to dynamically evaluate individual efficacy is one of the key scientific problems to explain the clinical efficacy of traditional Chinese medicine. At present, there are no recognized methods of evaluating individual efficacy of traditional Chinese medicine. In this study, we provided a method of dynamically evaluating individual efficacy of traditional Chinese medicine based on Bayesian N-of-1 trials after analyzing the current status of researches on methods of evaluating individual efficacy of traditional Chinese medicine. This method has the advantages of both N-of-1 trials and Bayesian multilevel models. It is feasible to evaluate individual efficacy of traditional Chinese medicine from the perspective of the design and analysis method. This study can provide an important basis for enriching and improving the methodology of evaluating individual efficacy of traditional Chinese medicine.
ObjectiveTo investigate the classification and treatment strategies of symptomatic severe osteoporotic vertebral fracture and collapse. MethodsBetween August 2010 and January 2014, 42 patients with symptomatic severe osteoporotic vertebral fracture and collapse were treated, and the clinical data were retrospectively analyzed. According to clinical symptom and imaging materials, 23 cases were classified as type I (local pain, limitation of motion, no neurological symptom, and no obvious deformity), 12 cases as type II (slight neurological symptom and kyphotic Cobb angle ≤ 30°), and 7 cases as type III (severe neurological symptom and kyphotic Cobb angle <30°). In 23 type I patients, 17 underwent percutaneous vertebral augmentation, 6 underwent posterior pedicle screw fixation strengthened with bone cement combined with percutaneous vertebral augmentation. In 12 type II patients, they were treated with local spinal decompression and internal fixation strengthened with bone cement. In 7 type III patients, 5 underwent posterior osteotomy, and 2 underwent one stage posterior approach of vertebral resection and reconstruction. The visual analogue scale (VAS), Oswestry disability index (ODI), and local kyphotic Cobb angle were used to evaluate the neurological function. The complications were recorded. ResultsThe operation was successfully completed in all patients. Wound infection and ketoacidosis secondary to stress blood glucose rise occurred in 1 case of type III patients respectively, and were cured after corresponding treatment; primary healing of wound was obtained in the other patients. The patients were followed up from 6 to 36 months (mean, 11.6 months). The nerve function was improved in 17 cases, and micturition disability was observed in 2 cases. Asymptomatic cement leakage occurred in 13 cases (30.95%) (7 cases in type I, 4 cases in type II, and 2 cases in type III). No bone cement dislocation and internal fixation failure were found during follow-up. The VAS score, ODI, and the local kyphotic Cobb angle at 1 week and last follow-up were significantly improved when compared with preoperative ones (P<0.05), but no significant difference was found between at 1 week and last follow-up (P>0.05). ConclusionIn order to improve the effectiveness and reduce the risk and complications of operation, individualized strategies should be performed according to different types of severe osteoporotic vertebral fracture and collapse.