Background: Basic principles of clinical trials of nonpharmacologic treatment are similar to those of pharmacologic treatment, but its some special characteristics should be discussed. Objective: To explore the design characteristics of clinical surgery trial through the example of tunnel thread-drawing therapy for simple anal fistula. Design, setting, participants and interventions: The clinical trial was designed as a prospective, controlled, randomized multicenter trial. The patients came from Longhua Hospital, Yueyang Hospital of Integrated Traditional Chinese and Western medicine, and Affiliated Hospital of Jianxi University of Traditional Chinese Medicine. Stratified random was performed according to the subtype of anal fistula including low and high anal fistula. Full analysis set was applied to analyze the baseline data, and per protocol set was used in efficacy and safety analysis. The intervention was tunnel thread-drawing method. Classical therapy of thread-drawing method was employed as positive control. Main outcome measures: The primary outcomes were course of recovery and cure rate. Quality of life score was used as secondary outcome and anal maximum constriction pressure was considered as safety outcome. Results: Optimal efficiency testing method was used to estimate sample size. A total of 244 subjects were recruited and 236 subjects completed the trial. There was no significant difference in the cure rate of the low and high anal fistula between the treatment group and control group. There was a significant difference in the course of recovery in the patients with low and high anal fistula between treatment group and control group (P<0.01). To the patients with low anal fistula, the course of recovery in the treatment group was (22.26+/-8.67) d, and the course of recovery in the control group was (31.41+/-11.39) d. To the patients with high anal fistula, the course of recovery in the treatment group was (24.73+/-8.15) d, and the course of recovery in the control group was (32.20+/-12.60) d. There was no significant difference in the scores of quality of life in the patients with low anal fistula between the treatment group and control group (P>0.05). The trial showed that the tunnel thread-drawing therapy was significantly more effective than classical method for improving the anal sphincter function and patient satisfaction with treatment in the patients with high anal fistula. However the other items of quality of life in the two groups did not show significant difference. There was no any adverse event report in each group. There was no significant difference in the anal maximum constriction pressure in the treatment group before and after the operation. Conclusion: The trial shows that the tunnel thread-drawing therapy for simple anal fistula can shorten the course of recovery and improve the patients' quality of life. The training about surgical intervention and clinical implementation program is important in clinical surgery trial. Blind is absolutely difficult to implement and placebo cannot be used in this kind of trial.

Objective To assess quantitative and subjective image quality in computed tomography pulmonary angiography (CT-PA)with dual-energy subtraction methods,and to select the best dual-energy subtraction method.Methods 30 consecutive patients underwent CTPA using a single tube,fast voltage switching technique.One set of routine poly-chromatic images (RPI),two sets of monochromatic images with different optimal contrast-to-noise ratios (OCNR)and three sets of dual-energy subtraction images (DE-SI)were obtained by a dedicated workstation with dual-energy software (AW4.5 Advantage WS;GE Healthcare).For all the six sets of images,CNR and the score of global subjective image quality were calculated.Results DESI 3 got the highest CNR,and DESI 1 got the next high CNR.In global subjective image quality,DESI 1 got the highest score.However,when compared with DESI 2,no significant difference was found.Conclusion CTPA with dual-energy subtraction technique is feasible.DESI 1 affords the best bal-ance between quantitative analysis and subjective evaluation compared with other sets of images.

Objective To explore the CT appearance of thoracic lymphonodus in AIDS patients with immune reconstitution in-flammatory syndrome(IRIS)after highly active antiretroviral therapy (HAART).Methods The data of thoracic CT in 24 AIDS pa-tients after HAART with enlarged thoracic lymphonodus in IRIS were collected,and the chest CT appearance was analyzed.Results Of the 24 cases of AIDS patients with IRIS after HAART,1 9 cases were complicated with pulmonary tuberculosis,which includ-ed 5 cases with cervical tuberculous lymphadenitis,3 cases were co-infected with bacterium and fungi,1 case was infected by penicil-lium marneffei,1 case by pneumocystis carinii.The enlarged thoracic lymphonodus were primarily located in 4R region(20/24), secondly in 2R region(1 1/24)and 4L region(1 1/24),in which the density was uniform or non-uniform,edge clear or unclear,some parts of lymphonodus were fused together but not calcified.The minor axis of enlarged lymphonodus was 1 1.0-25.0 mm except X region,enhanced uniformly in 2 cases.Obstructive pneumonia and pulmonary consolidation were found in 2 cases with enlarged lym-phonodus,which were located in 10R region.Pleural effusion was found in 13 cases with greatest depth of about 22 mm,pericardial effusion was found in 5 cases with greatest depth of about 24 mm.Conclusion The enlarged thoracic lymphonodus in AIDS patients with IRIS affer HAART are mainly involved in the region of 4R,2R and 4L,with or without pleural effusion and pericardial effusion.

Objective To explore the value of transperineal prostate biopsy guided by contrast-enhanced ultrasound(CEUS)and MR diffusion weighted imaging (DWI).Methods 128 patients with suspected prostate cancer were analyzed.Both MR diffusion weighted imaging(MRDWI)and contrast-enhanced ultrasound(CEUS) were applied before prostate tissue was biopsied .The suspected lesion was confirmed by specialists of MRI , Ul-trasound and Urological together .The regular six normal sites addition to suspected lesion were biopsied .Biopsy specimens were sent to pathological examination separately with defined puncture site .The sensitivity, specificity and accuracy of MRDWI , CEUS alone and the combination of two methods were analyzed .Results Of the 858 prostatic specimens from 128 patients , 278 specimens were positive , with 172 specimens found by MRDWI and 114 specimens found by CEUS .As for 278 positive specimens , 137 specimens were diagnosed by MRDWI cor-rectly rather than CEUS , and 79 specimens were diagnosed by CEUS correctly rather than MRDWI , 35 specimens were diagnosed by either MRDWI or CEUS and 27 specimens were diagnosed by neither MRDWI nor CEUS .The sensitivity,specificity,accuracy of biopsy guided by MRDWI , CEUS and both of them in diagnosis of prostate cancer were 61.87%,85.00%,77.51%;41.01%,93.97%,76.81% and 90.29%,80.52%,83.68%,respec-tively.The sensitivity and accuracy of biopsy guided by both MRDWI and CEUS were higher than MRDWI or CEUS alone, with statistically significant difference(P<0.05).Conclusions Suspicious lesions may be found more frequently by MRDWI than CEUS , however two methods can complement each other .Sensitivity and accura-cy of biopsy can be improved by the combination of MRDWI and CEUS , which should be recommended in future clinical practice , without increasing the number of needle .

Objective To study the changes of the bone density and metabolic makers in patients with lupus nephritis (LN) after long time prednisone treatment.Methods All patients were women.The healthy controls (group A, n =20),the patients with normal renal function (group B, n =25) were studied before and after 2 and 4 month prednisone treatment.Dual energy X ray absorptiometry was used to measure bone mineral density (BMD) in the lumbar spine at L2～L4,femoral neck,Ward′s triangle,great trochanter (GT) and ultradis (ULT).Simultaneously,the serum calcium,phosphate,alkaline phosphate enzyme,PTH M,BGP,24 hour urine calcium,creatinine and other biochemical indices were examined in all of them.Results ① There were no significant differences in BMD between both groups ( P

OBJECTIVE: To investigate the clinical features and operation treatment of the congenital middle ear cholesteatoma. METHOD: A retrospective review of clinical and surgical records of 10 patients with congenital middle ear cholesteatoma were performed. All patients were treated by surgeries,5 of 10 cases deal with one-stage tympanoplasty after drum exploration by external auditory meatus, 3 cases dealed with closed mastoidotympanectomy and tympanomastoidectomy, 2 cases dealed with open mastoidotympanectomy and tympanomastoidectomy. RESULT: The cholesteatomas were located at or around the posterior tympanum or mesotympanum in 5 patients, confined to the tympanic cavity and attic in 3 patients, advanced cholesteatoma that extended from the tympanic cavity into the mastoid antrum was seen in 2 patients. The mean postoperative PTA was 30 dB HL, the mean ABG was within 20 dB, after six months. No residual or recurrence of cholesteatoma was found. CONCLUSION The congenital cholesteatoma often originates from the posterior or anterior of the middle ear, with hiding lesion, thus result in severe conductive hearing loss. Imaging examination plays an important role in diagnosing and treating of congenital cholesteatoma. Early stage surgical treatment can obtain a good hearing reconstruction effect.
Adolescent ; Adult ; Child ; Child, Preschool ; Cholesteatoma ; congenital ; surgery ; Cholesteatoma, Middle Ear ; surgery ; Ear, Middle ; physiopathology ; Female ; Follow-Up Studies ; Humans ; Male ; Retrospective Studies ; Tympanoplasty ; methods ; Young Adult

Adult ; Branchio-Oto-Renal Syndrome ; diagnosis ; Child, Preschool ; Craniofacial Abnormalities ; diagnosis ; Diagnostic Errors ; Female ; Humans ; Male

The thread-dragging therapy, as a new external treatment of traditional Chinese medicine, could eliminate pathogenic factors and restore the vital qi by promoting qi and activating blood circulation to advance tissue repair in treating refractory sinus tracts or fistulae. This article reviewed its origin and development, and introduced its use in treating refractory sinus tracts or fistulae.

Objective To evaluate the processing line and the range of thoracolumbar (T10-L2) vertebral pedicle channel for vertebral reconstruction.Methods The thoracolumbar vertebrae (T10-L2) of thirty fresh specimens were performed CT scan,slice thickness of 1 mm without interval.Each vertebral body was reconstructed using the software Mimics 10.0 and measured each vertebral body pedicle axis length (L),pedicle length (L0),width (W) and height (H0),vertebral height (H),pedicle entry point in the sagittal plane angle (α) and the pedicle entry point in the cross-section angle (β),and further calculated the volume through vertebral pedicle channel for vertebral reconstruction.Results The average thoracolumbar (T10,T11,T12,L1,and L2) vertebral pedicle axis length was 32.64±5.66,31.80±6.41,38.46±3.52,40.31±4.39,and 42.72±3.36 mm prospectively.The average vertebral pedicle length was 12.38±2.06,11.77±2.15,14.63±2.34,15.46±3.04 and 14.37±1.64 mm.The average pedicle width was 5.09±0.26,5.79±1.10,7.35±1.87,7.17±0.69 and 7.14±0.84 mm.The average pedicle height was 9.76±1.43,10.83±0.77,11.16±0.78,11.33±1.26 and 11.16±0.96 mm.The average vertebral height was 18.12±0.88,19.48±1.02,21.25±1.27,22.88±0.68 and 23.20±0.93 mm.The average α angle was 25.06°±3.84°,30.87°±7.28°,25.12°±5.18°,20.55°±1.54° and 21.74°±2.58°.The average β angle was 43.60°±4.52°,49.48°±10.30°,41.97°±5.19°,40.29°±6.49° and 42.85°±6.47°.The average volume of one side of vertebral body after vertebral reconstruction respectively was 1.02±0.36,1.30±0.43,1.96±0.67,1.84±0.48 and 1.94±0.41 cm3,the corresponding percentage of total vertebral volume was 53.95％,55.68％,52.67％,49.53％ and 48.14％.Conclusion It is possible to use the pedicle channels for vertebral body reconstruction,reduction the end-plates and filling bone graft inside vertebral body.