TNF-α inhibitor tanfanercept (HBM9036) improves signs and symptoms of dry eye in a phase 2 trial in the controlled adverse environment in China.

PURPOSE: This study evaluated the clinical safety and efficacy of tanfanercept (HBM9036) ophthalmic solution as a novel treatment for dry eye disease (DED) in a controlled adverse environment (CAE) study conducted in China. METHODS: In a single-center, double-masked, randomized, placebo-controlled study, 100 patients received 0.25% tanfanercept, or placebo, twice daily for eight weeks. A mobile international CAE® DE Model was used for patient selection with a standardized challenge endpoint. Primary efficacy endpoint was fluorescein inferior corneal staining score (ICSS) pre- to post-CAE challenge from baseline. Secondary endpoints included Schirmer's Tear Test, Tear-Film Break-Up Time, Ocular Discomfort Score, Ora Calibra® Ocular Discomfort and 4-Symptom Questionnaire, total corneal staining score (TCSS), and drop comfort. Signs and symptoms were assessed both pre- and post-CAE to evaluate the efficacy of tanfanercept on both environmental and CAE endpoints. RESULTS: The tanfanercept treatment group showed improvement in ICSS pre- to post-CAE change from baseline scores when compared to placebo (- 0.61 ± 0.11 and - 0.54 ± 0.11, respectively; mean difference = 0.07, p = 0.65). TCSS pre-post-CAE change from baseline scores was also in favor of active when compared to placebo (- 1.03 ± 0.21 and - 0.67 ± 0.21, respectively; mean difference = 0.37, p = 0.23). Schirmer's score improvement was demonstrated in favor of active (1.87 ± 0.62 mm) as compared to placebo (1.28 ± 0.62 mm; mean difference = 0.59 mm, p = 0.50). Change from baseline in mean Tear-Film Break-up Time favored active treatment over placebo (mean difference = 1.21 s, p = 0.45). Notably, the tanfanercept showed more obvious benefits for each DED sign in a subgroup of subjects ≥ 35 years of age. Tanfanercept was well tolerated with no serious adverse events occurring during the study. CONCLUSION: Tanfanercept demonstrated improvements in favor of active as compared to placebo in the signs of DED, being safe and well tolerated. These data support further evaluation of tanfanercept for the treatment of DED in China. TRIAL REGISTRATION: This study was retrospectively registered at ClinicalTrials.gov (NCT04092907) on September 17, 2019.

A novel suture bridge anchor fixation technique to treat inferior pole fractures of patella: A retrospective clinical study.

The traditional surgical methods to the fracture of the inferior patellar fracture include steel wire tension band fixation and inferior patellar resection, which have many disadvantages. In order to overcome the disadvantages of traditional surgery, we innovated and improved the double row anchor suture bridge technology to the treat the inferior patellar fracture. This study is to investigate the method, technique and clinical efficacy of double-row anchor suture bridge technique in the treatment of inferior pole fractures of patella. Between January 2019 and March 2021, 36 patients with inferior pole fractures of patella underwent the surgery with the double-row anchor suture bridge technique. 28 injury cases were caused by falls while 8 injury cases were from car crashes. The operation time, amount of intraoperative bleeding and complications were recorded. Radiological assessments and Bostman score were performed 1, 3, and 6 months post-operation and at the most recent follow-ups. The study sample consisted of 19 males and 17 females, aged 31 to 72 years old. The operation time was (54-76) minutes. All incisions healed in 1 stage. No complications such as incision infection, flap necrosis and nerve injury occurred. Patients in this group were followed up for 10 to 18 months, with an average follow-up of 12 months. All fractures healed in 10 to 20 weeks, with an average healing time of 12 weeks. At the last follow-up, the Bostman score was (27.5 ± 3.3), excellent in 32 cases and good in 2 cases, with an excellent rate of 94.4%. The range of motion of the knee joint was (-2.6 ± 2.0)° when the knee was extended and (122 ± 5.0)° when the knee was bent. The muscle strength of quadriceps femoris was grade 5. Double-row anchor suture bridge technique is applied to inferior pole fractures of patella by virtue of its various effects, such as the complete preservation of the inferior pole fragments during the operation, satisfactory fracture reduction, firm fixation, and meeting patients' requirements for early postoperative ambulation. In summary, double-row anchor suture bridge technique is an ideal surgical procedure for the treatment of the inferior pole fracture of patella with safety, reliability and high satisfaction.

Effect of Oral Tranexamic Acid on the Blood Transfusion Rate and the Incidence of Deep Vein Thromboembolism in Patients after TKA.

Purpose: To explore the effect of oral tranexamic acid treatment on the blood transfusion rate and the incidence of deep vein thromboembolism after total knee arthroplasty (TKA). Methods: 90 patients undergoing TKA admitted to First People's Hospital of Changshu City from January 2019 to January 2020 were selected and randomized into the control group and the experimental group accordingly (45 cases in each group). The control group intravenously received 20 mL/kg tranexamic acid before the incision was closed. The experimental group was given 1 g of tranexamic acid orally before anesthesia, 6 h and 12 h after the operation. Results: The experimental group witnessed better perioperative indexes in relation to the control group. The experimental group displayed better postoperative coagulation function indexes as compared to the control group (P < 0.05). Remarkably lower postoperative vascular endothelial function indexes in the experimental group than in the control group were observed. The experimental group experienced a markedly lower incidence of deep vein thromboembolism in comparison with the control group (P < 0.05). The postoperative knee society score (KSS) score of the experimental group was significantly higher than that of the control group. A significantly higher postoperative modified rivermead mobility index (MRMI) score was yielded in the experimental group in contrast to the control group (P < 0.05). The experimental group obtained lower numerical rating scale (NRS) scores at T2 and T3 as compared to the control group. Conclusion: Oral tranexamic acid is a suitable alternative for patients undergoing TKA in terms of reducing the blood transfusion rate, relieving pain, and accelerating the recovery of the patient's limbs.

Comparison of Two Surgical Approaches to Supination-External Rotation-Type Ankle Fractures.

Objective: To compare the clinical outcome and postoperative complications of the treatment of supination-external rotation-type ankle fractures using the posterolateral approach in the prone position and the lateral approach in the supine position. Methods: A retrospective cohort study was conducted in our hospital, including a total of 66 patients ranging from January 2013 to February 2016, regardless of age or sex. All the patients were classified as Lauge-Hansen supination-external rotation (SER)-type ankle fractures and were assigned to receive an open reduction and internal fixation (ORIF) through a posterolateral approach performed in the prone position (the "posterolateral approach group," 32 patients), or a lateral approach performed in the supine position (the "Lateral Approach Group," 34 patients). In the posterolateral approach group, 5 patients had Grade II fractures, 8 had Grade III fractures, and 19 had Grade IV fractures; among whom, 12 underwent fixation of the posterior malleolus with hollow screws and 6 with plates, and none of them had fixation of the distal tibiofibular syndesmosis; in the lateral approach group, 4 patients had Grade II fractures, 12 had Grade III fractures, and 18 had Grade IV fractures; among whom, 21 received fixation of the posterior malleolus, and 5 received fixation of the distal tibiofibular syndesmosis. The postoperative complications and ankle scores were recorded. Results: After 1 year of follow-up, in the posterolateral approach group, the incision healed by primary intention and sutures were removed 2 weeks after the operation in all patients; 1 patient had pain in the region posterior to the fibula, presumably peroneal tendon irritation induced by internal fixation, which disappeared after fracture union and fixation device removal; no loosening or breakage of the internal fixation device was reported; the rate of good to excellent results was 96.8% at 12 months. In the lateral approach group: 1 case of wound infection, 1 case of necrosis of lateral skin flap, and 3 cases of lateral skin irritation were reported; the rate of good to excellent results was 94.6% at 12 months. Conclusion: Compared with the traditional lateral approach, the posterolateral approach for the reduction and internal fixation of supination-external rotation-type ankle fractures performed in the prone position has more satisfactory clinical outcomes, with better reduction, more secure fixation, and smaller wound.

Surgical treatment of cardiac pheochromocytoma: a case report.

Primary cardiac pheochromocytoma is an extremely rare neoplasm. We report a 15-year-old girl who was presented with paroxysmal hypertension. An iodine-131 metaiodobenzylguanidine scintigraphy scanning showed a pheochromocytoma in her right atrial and ventricular wall. The tumor was subsequently confirmed by magnetic resonance imaging and coronary angiogram. This patient underwent a successful surgical resection of the tumor, a reconstruction of the atrial ventricular wall and right coronary artery bypass grafting. Her blood pressure remained normal thereafter. A follow-up coronary angiogram revealed a patent saphenous vein graft 4 months after the operation.