Objective:To compare the efficacy and safety of LY01011,a recombinant anti-RANKL fully human monoclonal antibody injection,versus denosumab in the treatment of bone metastases from solid tumors.Methods:A randomized,double-blind,positive drug parallel-controlled,multicenter clinical trial was conducted.A total of 850 subjects were randomly assigned(1:1)to either the experimental group(424 subjects)or the control group(426 subjects).The experimental group received 13 doses of LY01011,while the control group received 3 doses of denosumab followed by 10 doses of LY01011.Results:The primary efficacy endpoint was the natural logarithmic change from baseline in urinary N-terminal telopeptide of type I collagen corrected by urinary creatinine(uNTX/uCr)at week 13.The change was-1.740(0.042 0)in the experimental group and-1.745(0.042 1)in the control group.The least-squares mean difference between groups was 0.005(90%CI:-0.088 to 0.097),indicating no statistically significant difference(P>0.05).Safety profiles,including treatment-emergent adverse events,laboratory tests,vital signs,physical examinations,and electrocardiograms,were comparable between groups(P>0.05).Conclusions:LY01011 demonstrated biosimilarity to denosumab,with favorable safety profile,tolerability,and potential for clinical application.

Objective:To compare the efficacy and safety of LY01011,a recombinant anti-RANKL fully human monoclonal antibody injection,versus denosumab in the treatment of bone metastases from solid tumors.Methods:A randomized,double-blind,positive drug parallel-controlled,multicenter clinical trial was conducted.A total of 850 subjects were randomly assigned(1:1)to either the experimental group(424 subjects)or the control group(426 subjects).The experimental group received 13 doses of LY01011,while the control group received 3 doses of denosumab followed by 10 doses of LY01011.Results:The primary efficacy endpoint was the natural logarithmic change from baseline in urinary N-terminal telopeptide of type I collagen corrected by urinary creatinine(uNTX/uCr)at week 13.The change was-1.740(0.042 0)in the experimental group and-1.745(0.042 1)in the control group.The least-squares mean difference between groups was 0.005(90%CI:-0.088 to 0.097),indicating no statistically significant difference(P>0.05).Safety profiles,including treatment-emergent adverse events,laboratory tests,vital signs,physical examinations,and electrocardiograms,were comparable between groups(P>0.05).Conclusions:LY01011 demonstrated biosimilarity to denosumab,with favorable safety profile,tolerability,and potential for clinical application.

ObjectiveTo investigate the clinical efficacy and safety of iguratimod combined with the Chinese medicine Runzaoling in the treatment of primary Sjögren's syndrome （pSS）. MethodSeventy-two patients treated in the Department of Rheumatology and Immunology of the Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine（TCM） from January 2021 to June 2022 who met the Western medical diagnosis of pSS and had the TCM syndrome of Yin deficiency and heat toxin syndrome were randomly assigned into an observation group and a control group， with 36 patients in each group. The observation group was treated with iguratimod combined with Runzaoling， and the control group was treated with iguratimod. The treatment in both groups lasted for 12 weeks. The clinical symptoms， EULAR Sjogren's syndrome patient reported index （ESSPRI）， EULAR Sjögren's syndrome disease activity index （ESSDAI）， erythrocyte sedimentation Rate （ESR）， C-reactive protein （CRP）， immunoglobulin （IgG）， Schirmer score， and saliva flow of the two groups were determined before and after treatment. Furthermore， the incidence of adverse reactions was compared between the two groups. ResultThe total response rate in the observation group was 75.0% （27 patients with response and 9 patients with no response）， which was higher than that （61.11%， 22 patients with response and 14 patients without response） in the control group （P<0.05）. After treatment， the ESSPRI， ESSDAI， and TCM syndrome scores in both groups decreased and the decreases were more obvious in the observation group than in the control group （P<0.05）. The treatment in both groups recovered the ESR， CRP， IgG， Schirmer score， and saliva flow （P<0.05）. Moreover， the observation outperformed the control group in terms of the ESR， CRP， IgG， and saliva flow （P<0.05） and had no significant difference in the Schirmer score compared with the control group. During the treatment period， 2 patients in the observation group had nausea， and 1 patient had an abnormal liver function， which were relieved after symptomatic treatment and did not affect the treatment. In the control group， 1 patient withdrew from the study due to rashes and showed no special discomfort in the follow-up 4 weeks， and 1 patient had nausea， which was relieved after symptomatic treatment. ConclusionIguratimod combined with Runzaoling has good clinical efficacy and safety in the treatment of pSS.

Objective:To explore the surgical method and therapeutic effect of repairing soft tissue defect of digit-tip with single subcutaneous pedicle V-Y advancing flap combined with skin grafting.Methods:From August 2013 to December 2020, 25 soft tissue defects of digit-tip were repaired by a single subcutaneous pedicle V-Y advancing flap combined with pedicle skin grafting. The area of the defects was 0.8 cm× 0.8 cm to 1.6 cm× 1.4 cm. The flaps were harvested from palm or lateral side of the wound and the area of flap was 0.5 cm×1.0 cm to 0.8 cm×2.5 cm. In order to make the flap transfer to a further distance, the subcutaneous fibre connection of the flap was cut-off during the operation. At the same time, cut off 1 side of subcutaneous pedicle. Finally, the advanced distance of the flap reached 0.5-1.2 cm. After the flap harvested, the medium thickness skin was removed for graft to close the donor site from the wrist striations. After the surgery, follow-up visits were conducted regularly by outpatient clinic, or via telephone or WeChat review or by home visit. Throughout the follow-up, the flap appearance, sensation and recovery of the function of digital joint were observed, together with the patient satisfaction. Results:After the surgery, the postoperative follow-up lasted for 4 months to 8 years. All 25 flaps and skin grafts were survived in first stage wound healing. The flaps and skin grafting areas had excellent texture. The fingerprint had been reconstructed with good appearance. The TPD was 4-9 mm, the functions of digital joint recovered well, and there was no complain about a discomfort at the donor site. According to the evaluation standard of Michigan hand function questionnaire, all 25 patients were very satisfied with the overall appearance and function of the hand. According to Total Angle of Motion (TAM) evaluation standard, finger mobility was excellent in all 25 patients.Conclusion:Subcutaneous V-Y advancing flap combined with skin grafting is an ideal method for repairing soft tissue defect of digit-tip. The surgery characterises a simple flap cutting, less traumatic damage, long advancing distance of flap and good repair effect.

Objective:To investigate the surgical method and therapeutic effect of reconstruction of distal blood supply of multiple segments of severed finger body by ortho phalanx artery bridge transfer.Methods:Between November, 2005 and February, 2019, 7 finger body was replanted in 7 cases with 3 segments. Due to the short middle finger body and severe bruising, the power could not pass through the middle section after the proximal finger artery anastomosis. For the long section of blood supply, in order to prevent the skin and blood vessels from separating too much and causing the middle internal artery to separate from the phalanx, after anastomosis of the middle artery, the blood supply was provided by anastomosis with the distal phalanx artery by means of the adjacent phalanx artery bridge. Four cases with vascular pedicle grafts. The skin was sewn into tube in 3 cases, and separate fingers between 3.5 and 6.0 months after operation. Four cases of posterior artery recalcitration and 3 cases of direct adjacent artery transposition. The appearance, sensation and total motion of finger joints were observed and the satisfaction of patients was investigated to evaluate the therapeutic effect.Results:Seven patients with replantation finger were all alive after operation, and the follow-up time was 5 to 40 months respectively. The total range of motion of flexion and extension of finger joints was 100°-170°, and the TPD of finger pulp was 7-12 mm, with an average of 9.6 mm. According to Michigan's functional questionnaire, 7 patients were satisfied with the overall appearance and function of their opponents. According to the evaluation standard of the replantation function of the broken finger of the Chinese Medical Association, 3 cases were excellent and 4 cases were good.Conclusion:It is a simple and effective way to reconstruct the blood supply of multi-segment severed fingers by means of adjacent finger artery bridge transfer.

To evaluate the surgical technique and clinical effect of applying Flow-through flap pedicled with superficial palmar branch of radial artery for bridging finger replantation complex defect of soft tissue and vessel. Methods From February, 2013 to March, 2018, 9 cases of severed fingers composited defect of soft tissue and vessel were treated with Flow-through flap pedicled with superficial palmar branch of radial artery.The flap was designed from the proximal end of rasceta and the donor sites were sutured directly. The size of flaps was 3.0 cm ×1.5 cm-4.0 cm×2.2 cm. The superficial branch of the radial artery in the flap was used to bridge the finger artery. And the vein of proximal and distal ends in the finger was bridged by the subcutaneous vein. The proper palmar digi-tal nerve defect was bridged by palm skin graft of median nerve. The appearance, feeling and joint function of fingers was followed-up regularly after operation. Results All transfering flaps survived and all cases were followed-up for 7 to 33 months. The donor sites got primary healing with straight scars. The appearance and texture of the flaps were satisfactory. Two-point discrimination ranged from 8 to 11 mm. The pain sensation, warmth sensation and touch sen-sation of the flaps got better. And the appearance and functions of severed fingers recovered well. Conclusion The Flow-through flap pedicled with superficial palmar branch of radial artery is easy to harvest and anastomose, which is masked and a small incision for the donor site. It is an ideal method for bridging severed fingers and repairing of fin-ger wound.

In July 2016, we used free superficial palmar branch of radial artery flap to repair one case of complete dissection of the thumb with skin defect, and achieved good result .

Objective: To assess the effect of combined treatment using cell scaffold and human fibroblast growth factor for small soft tissue defects of digits caused by trauma. Methods: From May 2012 to September 2016, twenty cases of small soft tissue defect of digits were repaired with cell scaffold combined with recombinant human basic fibroblast growth factor. The average defect area was 2.5 cm². Wounds were debrided and repaired with artificial dermis. Every 2 or 3 days the dressings were changed and the wounds were treated externally with fibroblast growth factor until cell scaffolds have been removed 3-4 weeks after surgery. Results: The group of 20 cases was followed up for 2-24 months. Wounds were healed with satisfactory appearance and no recurrence of wound or obvious hypertrophic scar was observed. No obvious functional problem was found in interphalangeal motion. Conclusions The method of repairing wound with cell scaffold combined with human fibroblast growth factor is simple and it result in healing of wounds with high quality.It provides a new choice for repairing wound in digits.

Objective To explore the surgical technique of applying the pedicle composite tissue flap based on superficial palmar branch of the radial artery to repair the soft tissue defect of thumb and evaluate the clinical ef-fect. Methods From February,2013 to March, 2016, 5 cases of the soft tissue and tendon defect of thumb were treated with the pedicle composite tissue flap based on superficial palmar branch of the radial artery. The flap was de-signed at wrist not exceeding the wrist rasceta and the donor site was sutured directly. The size of the harvested flaps was between 3.0 cm ×2.2 cm to 4.2 cm ×3.2 cm, and the sensation of thumb or the flap was reconstructed via median nerve cutaneous branch. The Extensor pollicislongus muscle tendon defect was repaired via palm tendon carried by composite tissue flap. Postoperative follow-up was done termly. Results All transfering flaps survived and all cases were followed-up for 4 to 11 months. The donor site got primary healing with a linear scar. The appearance and tex-ture of the flap was satisfactory. The two-point discrimination ranged from 8 to 11 mm. The appearance of thumb re-covered well and the digit joint had a good motion. Conclusion The pedicle composite tissue flap based on superfi-cial palmar branch of the radial artery is easy to harvest and its vascular anatomy is constant, which is masked and a small incision for the donor site. When necessary, palm tendon or median nerve cutaneous branch can be contained in the flap to form a composite transplant. It is an ideal method for repair of thumb soft tissue defect.

Objective To investigate the surgical methods and clinical effect of repairing forefoot soft tissue defects with free peroneal artery perforator flap in elderly patients.Methods From June,2011 to April,2015,17 cases of forefoot soft tissue defects repaired with free peroneal artery perforator flap in elderly patients.There were 10 cases of male and female in 7 cases with an average age of 65.8 years old ranging from 60 to 74 years.Causes of injury:traffic accident in 7 cases,heavy crushing in 9 cases,electrical bums in 1 case.Injury part:6 cases on the left side and 11 cases on the right side.Metatarsus and phalanges fracture in 9 cases,tendon injury in 5 cases.Defect area:3.0 cm × 4.0 cm-6.3 cm × 11.2 cm.Results All flaps survived.All wounds were primary healing.Skin graft survived for the foot flap donor site,and no complicated with infection.All patients were followed up from 8 to 36 months with an average of 17.6 months.The appearance of flaps were good,slight bloated.The texture and color of the flaps were close to the recipient site.Flap feel were good.Accortling to (AOFAS)criteria system,the AOFAS score of last follow-up was (77.5±13.2).Excellent in 6 cases,good in 9 cases,fair in 2 cases.VAS score was (2.6±0.4).Conclusion The free peroneal artery perforator flap with the advantages of vascular anatomy constant,blood supply is reliable,thickness moderate,etc.It is a useful clinical method to repair forefoot soft tissue defects in elderly patients.