Objective To explore the effectiveness and safety of ziprasidone in the treatment of female patients with schizophrenia. Methods A before-after study design with prospective consecutive data collection was adopted. From June 2006 to May 2007, 30 female patients with schizophrenia discharged from the Second Veterans Hospital of Shanxi Province were included. Ziprasidone 60-120 mg/d was orally administered for 6 weeks. Positive and Negative Syndrome Scale (PANSS) and Treatment Emergent Symptom Scale (TESS) were measured before the treatment and at the end of Week 2, 4 and 6 after the treatment, respectively.Results At Week 6, the significant improvement rate and the total improvement rate were 86.67% and 93.33%, respectively; the incidence of side effects was 86.67%. Conclusion Ziprasidone is safe and effective in the treatment of schizophrenia. Since it will not increase body weight or the level of prolactin, it can be especially applied to female schizophrenic patients.
ObjectivesTo explore the characteristics of the international clinical studies using objective performance criteria (OPC) and provide a reference to design clinical trials and determine external controls.MethodsPubMed, The Cochrane Library and EMbase databases were searched for all clinical studies which used OPC. Two reviewers independently screened literature, extracted data and descriptive analysis was then performed.ResultsA total of 51 English language articles were included. Merely one was published in 2001, and others were published between 2010 and 2018. Twenty-seven articles (27/51, 52.9%) were published between 2017 and 2018, with accumulated impact factors of 411. In the article referring to the reasons for using the objective performance criteria, reasons for using OPC study was primarily the difficulties of randomization and comparison (8/11, 72.7%). Articles with cardiovascular disease and peripheral vascular disease accounted for 86%, and articles on the effectiveness or safety of medical devices accounted for 76.5%. Single-arm trial (40), randomized controlled trials (2), case-control studies (2), case series (5) and diagnostic tests (2) were included. OPCs were mostly derived from the data of clinical trials of other similar products, national standards, specialist association standard and meta-analysis of multiple clinical studies. A total of 27 articles (27/51, 52.9%) used hypothesis testing to compare research results with objective performance goal, and 24 articles (24/51, 47.1%) used the confidence interval method.ConclusionsOPC studies are primarily used for safety intervention and effect evaluation. OPC studies are developing very rapidly, especially in the field of cardiovascular studies. Methodological details are reported reasonably sufficient. Reasons for using OPC study are primarily the difficulties of randomization and comparison. Factors such as source of the OPC, sample size, and comparison method should be taken into account. The application of the OPC can not only solve the difficulties of the implementation of numerous clinical research, but also provide new insights for solving the practical difficulties of clinical research in the real-world.
Objective To investigate the cl inical directive significance of three-dimensional reconstruction of CT in treating mandibular angle hypertrophy. Methods Between March 2009 and January 2011, 18 patients with mandibular angle hypertrophy were treated using the three-dimensional reconstruction technology of CT. All patients were female, aged20-36 years with an average of 25 years. Eighteen patients included: 14 single mandibular angle hypertrophy, 3 mandibular angle hypertrophy with masseter hypertrophy, and 1 mandibular angle hypertrophy with bilateral asymmetry; 6 cases of ptosis of mandibular angle, 9 cases of prominent mandibular angle, and 3 cases of introversive mandibular angle. According to the types of mandibular angle hypertrophy, the surgical methods could be correctly chosen. The procedure was planned and simulated; the osteotomy l ine was marked and the osteotomy was measured on the workstations of three-dimensional reconstruction. Results No fracture of mandible occurred in the operation. Facial nerve temporary attack occurred in 1 case and recovered at 3 months after operation. All patients were followed up 6-12 months (mean, 7.6 months). After 6 months of operation, the effectiveness was satisfactory in 15 cases, basically satisfactory in 2 cases, and unsatisfactory in 1 case (bilateral asymmetry). Conclusion Based on three-dimensional reconstruction technology of CT, surgical design performed on the model will promote the accuracy of operation. Basically symmetrical appearances can be achieved with satisfactory results.
Effectiveness-implementation hybrid designs can test the effectiveness of interventions and the outcomes of implementation strategies concurrently and accelerate the transformation of research results into routine practice. This paper introduced three types of effectiveness-implementation hybrid designs and corresponding reporting guidelines, including standards for reporting implementation studies, cluster randomized design and CONSORT 2010, stepped-wedge cluster randomized design and extended version CONSORT 2018, qualitative research and COREQ reporting guideline, and provide references for domestic researchers to produce research reports on effectiveness-implementation hybrid design.
Objective To investigate the operative technique and the effectiveness of perforator flaps for the treatment of elderly patients with ischia-sacral ulcers. Methods Between January 2005 and June 2010, 29 elderly patients with ischia-sacral ulcers were treated. There were 16 males and 13 females, aged from 61 to 75 years (mean, 68 years), including 11 cases of degree III and 18 cases of degree IV according to the standard of the National Pressure Ulcer Advisory Panel(NPUAP). The disease duration was from 5 months to 10 years (median, 5.5 years). The size of ulcers ranged from 7 cm × 6 cm to 12 cm × 10 cm. Of them, 8 cases were companied by cerebral vascular disorders, 6 cases by Alzheimer disease, 11 cases by paraplegia, and 4 cases by others. The flap size ranged from 8 cm × 6 cm to 14 cm × 12 cm. The donor sites were sutured directly. Results Distal flap necrosis occurred in 3 cases (10.3%) 2 days after operation and healed after symptomatic treatment, and the remaining flaps survived and wound healed by first intention with first intention rate of 89.7%. The incisions of donor sites healed primarily. Two cases (6.9%) had infection 1 week after operation and 1 case (3.4%) had wound dehiscence 10 days after operation. Twenty-seven patients were followed up 6 months to 5 years (mean, 3 years). Two cases recurred at 1 and 3 years after operation, respectively. One died of infection, and the other healed by debridement and suture. The flaps of other patients had good texture, color, and elasticity. Conclusion As long as the indications are controlled strictly, good effectiveness can be achieved in the treatment of elderly patients with ischia-sacral ulcers by using perforator flaps.
ObjectiveTo investigate the correlation between the effectiveness and the changes of spine-pelvic sagittal parameters for patients with spondylolisthesis before and after operation. MethodsA retrospective analysis was made on the clinical data of 32 patients with single segmental degenerative lumbar spondylolisthesis at L4 who accorded with the inclusion criteria between June 2011 and January 2014 (trial group). There were 13 males and 19 females, aged 51-67 years (mean, 59 years). According to Meyerding degree, there were 21 cases of degree I, 10 cases of degree Ⅱ, and 1 case of degree Ⅲ. All patients were treated with transforaminal lumbar interbody fusion (TLIF) surgery. Thirty-five healthy adults at the age of 46-67 years (mean, 57 years) were enrolled as normal controls (control group). The standing position lumbar lateral X-ray films (T12-S1, bilateral femoral head) were taken at pre- and post-operation to measure the pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS), lumbar lordosis (LL), disc height (DH), and slip percentage (SP); the visual analogue scale (VAS) and Oswestry disability index (ODI) were recorded. Pearson correlation analysis was used to analyze the correlation between the preoperative various spine-pelvic sagittal parameters and the VAS score and the ODI. After operation, Pearson correlation analysis was used to evaluate the correlation between the changes of these parameters and the improve rates of VAS score and ODI. ResultsAll patients of trial group were followed up 15-22 months (mean, 18 months). At last follow-up, the VAS score, ODI, PT, SS, LL, SP, and DH were significantly improved when compared with preoperative values (P<0.05), except for PI (t=-1.445, P=0.158). There was no significant difference in PT, SS, LL, and DH between trial and control groups at last follow-up (P>0.05); PI was slightly bigger than that of control group (t=8.531, P=0.043). Pearson correlation analysis showed that there was a correlation between spine-pelvic sagittal parameters of PI, PT, SS, and LL (P<0.05); preoperative parameters (except for LL and DH) had correlation with ODI and VAS scores (P<0.05). Postoperative parameters (except for PI) had correlation with the improve rates of ODI and VAS scores (P<0.05), especially for the changes of PT and the improvements of ODI and VAS scores. ConclusionThere is a correlation between the changes of spine-pelvic sagittal parameters at pre- and post-operation and effectiveness in patients with lumbar spondylolisthesis. The correlation between the changes of PT and the improvement rates of ODI and VAS scores is more marked. The good effectiveness is closely related with the improved PT.
To investigate the effectiveness of T-locking plate in treating medial clavicle fracture so as to find out a therapy with safety and stabil ity. Methods Between October 2006 and January 2009, 13 patients with medial clavicle fracture were treated with open reduction and T-locking plate fixation. There were 9 males and 4 females, aged 18-68 years (mean, 47 years), including 7 cases of traffic accident injury, 4 cases of fall ing injury from height, and 2 cases of heavy object hit injury. The locations were left side in 5 cases and right side in 8 cases. All cases were closed fracture. The disease duration was 1 hour to 14 days. Results All incisions healed by first intention after operation. The X-ray films showed good reduction of fracture and internal fixation. All the 13 patients were followed up 12-18 months (mean, 15 months). The average fracture heal ing duration was 8 weeks (range, 6-12 weeks). No compl ication of infection, nerve or blood vessel injury, hemopneumothorax, or internal fixation loosening or failure occurred. The anatomical medial clavicle structure as well asappearances and functions were restored. According to Rockwood’s score method, the results were excellent in 11 cases and good in 2 cases. Conclusion The internal fixation of T-locking plate in treating medial clavicle fracture has the advantages of good stabil ity and low risk. Besides, the patients can do functional exercises early and the shoulder joint function can be improved in great degree.
ObjectiveTo review the present clinical evaluation of treatment for chronic low back pain. MethodsThe literature on the effectiveness evaluation method of chronic low back pain was reviewed and summarized. ResultsMany scoring systems are used to assess the treatment for chronic low back pain through the evaluation of pain and functional disability. The function evaluations are divided into general and disease-specific evaluations. Currently the most widely used evaluation systems are as follows: short-form 36 health survey scale (SF-36), Oswestry disability index (ODI), Roland-Morris disability questionnaire (RDQ), Japanese Orthopaedic Association (JOA) low back pain scoring system, Quebec back pain disability scale (QBPDS), and Macnab criteria. Visual analogue scale (VAS) and numerical rating scale (NRS) are usually used to evaluate the pain degree. ConclusionThere are many effectiveness evaluation methods of chronic low back pain, but there is still a lack of more comprehensive, concise, and practical evaluation method. Further studies are required to develop it.
ObjectiveTo compare the effectiveness between the method of simple posterior debridement combined with bone grafting and fusion and internal fixation and the method of one-stage anterior radical debridement combined with bone grafting and fusion and posterior internal fixation in the treatment of thoracolumbar brucella spondylitis so as to provide the reference for the clinical treatment. MethodsA retrospective analysis was made on the clinical data of 148 cases of thoracolumbar brucella spondylitis between January 2002 and January 2012. Simple posterior debridement combined with bone grafting and fusion and internal fixation was used in 78 cases (group A), and one-stage anterior radical debridement combined with bone grafting and fusion and posterior internal fixation in 70 cases (group B). There was no significant difference in gender, age, disease duration, involved vertebral segments, erythrocyte sedimentation rate (ESR), visual analogue scale (VAS) score, neural function grade of America Spinal Injury Association (ASIA), and kyphosis Cobb angle before operation between 2 groups (P > 0.05). The peri operation period indexes (hospitalization time, operation time, and intraoperative blood loss) and the clinical effectiveness indexes (VAS score, ASIA grade, Cobb angle, and ESR) were compared; the bone fusion and the internal fixation were observed. ResultsIncision infection and paravertebral and/or psoas abscess occurred in 2 and 3 cases of group A respectively. All incisions healed by first intention and 2 cases had pneumothorax in group B. The operation time and the hospitalization time of group A were significantly shorter than those of group B (P < 0.05), and the intraoperative blood lossof group A was significantly lower than that of group B (P < 0.05). All of the cases in 2 groups were followed up 14-38 months, 25 months on average. The VAS, ESR, and Cobb angle were significantly decreased at each time point after operation when compared with preoperative ones in 2 groups (P < 0.05), but no significant difference was found between 2 groups (P > 0.05). The neurological function was significantly improved at 3 months after operation; there were 1 case of ASIA grade C, 14 cases of grade D, and 63 cases of grade E in group A, and there were 1 case of grade C, 11 cases of grade D, and 58 cases of grade E in group B; and difference was not significant (Z=0.168, P=0.682). The grafting bone fusion was observed in both groups. The fusion time was (8.7±0.3) months in group A and (8.6±0.4) months in group B, showing no significant difference (t=0.591, P=0.601) was found. At last follow-up, no loosening or fracture of internal fixation was found. ConclusionBased on regular medicine therapy, the effectiveness of the two methods is satisfactory in the treatment of thoracolumbar brucella spondylitis as long as the operation indications should be controlled strictly.
ObjectiveTo evaluate clinical curative effect of sphincter preservation method of improved minimally invasive surgery to primary cure for horseshoe-shaped perianal abscess. MethodsOne hundred and twenty hospitalized patients diagnosed as horseshoe-shaped perianal abscess were analyzed by prospective, random, single-blind, parallel-group design method, and were randomly divided into two groups, one group of sphincter preservation method of improved minimally invasive surgery (observation group), another group of traditional method of hanging line drainage and multiple incisions of radian shape (control group). The cure rate, long-term recurrence, postoperative pain score within 9 d, hospitalization time, incision healing time, scar area after healing, postoperative anal function score and perioperative and long-term complications were compared in these two groups. ResultsAll the operations were successfully completed in these two groups. There were 56 cases of primary healing in the observation group and 55 cases of primary healing in the control group. Compared with the control group, the postoperative pain score on day 2-4 or on day 7-9 was lower (P < 0.05), the incision healing time was shorter (P < 0.05), and the postoperative anal function score was lower (P < 0.05) in the observation group. There was no incision infection and hemorrhoea in these two groups. The hospitalization time, scar area after healing, incidence rate of urinary retention, hepatic and renal dysfunction, and the total white blood cells > 10.0×109/L had no significant differences between these two groups (P > 0.05). There was no long-term recurrence, anal stenosis, and anal incontinence during following-up of 6 months in these two groups. ConclusionPreliminary research results show that sphincter preservation method of improved minimally invasive surgery to primary cure for horseshoe-shaped perianal abscess has a reliable clinical curative effect, fast healing, and less postoperative complications.