Real-World Effectiveness and Safety of Hydrogen Inhalation in Chinese Patients with Type 2 Diabetes: A Single-Arm, Retrospective Study.

Aim: To evaluate the real-life effectiveness and safety of Chinese patients with type 2 diabetes mellitus (T2DM) receiving hydrogen inhalation (HI) treatment as a supplementary treatment. Methods: This retrospective, multicenter, observational 6-months clinical study included T2DM patients maintaining HI, visited at 4 time points. The primary outcome is the mean change in glycated hemoglobin (HbA1c) at the end of the study compared to baseline. The secondary outcome is analyzing the mean change of fasting plasma glucose (FPG), weight, lipid profile, insulin dose and homeostasis model assessment. Linear regression and logistics regression are applied to evaluate the effect of HI after the treatment. Results: Of the 431 patients comprised, it is observed a significant decrease in HbA1c level (9.04±0.82% at baseline to 8.30±0.99% and 8.00±0.80% at the end, p<0.001), FPG (165.6±40.2 mg/dL at baseline to 157.1±36.3mg/dL and 143.6±32.3mg/dL at the end, p<0.001), weight (74.7±7.1kg at baseline to 74.8±10.0kg and 73.6±8.1kg at the end, p<0.001), insulin dose (49.3±10.8U/d at baseline to 46.7±8.0U/d and 45.2±8.7U/d, p<0.001). The individuals in subgroup with higher baseline HbA1c and longer daily HI time duration gain greater HbA1c decrease after 6 months. Linear regression shows that higher baseline HbA1c level and shorter diabetes duration are significantly in relation to greater HbA1c reduction. Logistics regression reveals that lower weight is associated with a higher possibility of reaching HbA1c<7%. The most common adverse event is hypoglycemia. Conclusion: HI therapy significantly improves glycemic control, weight, insulin dose, lipid metabolism, ß-cell function and insulin resistance of patients with type 2 diabetes after 6 months. Higher baseline HbA1c level and shorter diabetes duration is related to greater clinical response to HI.

[Mid- and long-term effectiveness analysis of distraction arthroplasty in treatment of moderate to severe ankle arthritis].

Objective: To investigate the mid- and long-term effectiveness of external fixator distraction arthroplasty in the treatment of moderate to severe ankle arthritis. Methods: The clinical data of 23 patients with moderate to severe ankle arthritis treated with external fixation distraction arthroplasty who met the selection criteria between January 2007 and November 2019 were retrospectively analyzed. There were 20 males and 3 females; the age ranged from 21 to 65 years, with an average age of 43.7 years. Etiology included 8 cases of primary ankle arthritis, in which 5 cases combined with varus deformity; 15 cases of traumatic ankle arthritis, the cause of injury was 5 cases after ankle fracture surgery, 3 cases after Pilon fracture surgery, 5 cases of chronic ankle instability and repeated sprain, and 2 cases of other causes. According to Takakura staging system, there were 4 cases of stage ⅢA, 12 cases of stage ⅢB, and 7 cases of stage Ⅳ; according to Giannini staging system, there were 5 cases of stage Ⅱ and 18 cases of stage Ⅲ; according to Cheng staging system, 16 cases were in stage Ⅲ, and 7 cases stage Ⅳ. American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score and visual analogue scale (VAS) score were used to evaluate the improvement of ankle pain and function before operation and at last follow-up, and the data were analyzed according to different etiological groups. At last follow-up, the surgical results were evaluated subjectively and objectively. The changes of ankle joint space before operation and at last follow-up were compared. The patients were divided into two groups according to their age: ≤45 years old group [young group, 10 cases, aged (35.62±7.41) years old] and >45 years old group [middle-aged and elderly group, 13 cases, aged (54.20±6.20) years old]. The AOFAS ankle-hindfoot score and VAS score were compared before and after operation between the two groups, and the influence of age on distraction arthroplasty was analyzed. Results: The external fixator was removed after 3 months of continuous distraction,12 patients got infection around the wire tunnels. All the 23 patients were followed up 13-143 months, with an average of 56.9 months; the follow-up time was (43.46±32.77) months and (69.80±37.79) months in the young group and middle-aged and elderly group, respectively. At last follow-up, the AOFAS ankle-hindfoot score and VAS score significantly improved when compared with those before operation ( P<0.05). According to etiological analysis, there was no significant difference in AOFAS ankle-hindfoot score and VAS score before and after operation ( P>0.05) in Pilon fracture patients, while the significant difference was found in remaining patients ( P<0.05). There was significant difference in AOFAS ankle-hindfoot score before operation between the young group and the middle-aged and elderly group ( t=2.110, P=0.040), but no significant difference in preoperative VAS score and the differences in VAS score and AOFAS ankle-hindfoot score before and after operation between the two groups ( P>0.05). The subjective and objective results of pain evaluation at last follow-up showed that 4 patients had no pain, 12 patients had moderate pain relief, 5 patients had mild pain relief, and 2 patients had no significant pain relief; among the 10 patients who were followed up more than 5 years, there were 2, 5, 2, and 1 patient, respectively; 2 patients who were followed up more than 10 years had moderate pain relief. At last follow-up, the ankle joint space was (3.7±0.4) mm, which significantly increased when compared with before operation [(1.5±0.2) mm] ( t=1.791, P=0.002). The ankle joint space was (2.9±0.5) mm in 10 patients who were followed up more than 5 years, and 3.3 mm and 3.0 mm in 2 patients who were followed up more than 10 years. Conclusion: Distraction arthroplasty of the ankle joint can achieve satisfactory results in patients with moderate to severe ankle arthritis (except for arthritis caused by Pilon fracture), and age has no significant effect on distraction arthroplasty.

[Application of posterior median longitudinal W-shaped incision combined with layer-by-layer combing suture in acute closed Achilles tendon rupture].

OBJECTIVE: To explore the effectiveness of posterior median longitudinal W-shaped incision combined with layer-by-layer combing suture in the treatment of acute closed Achilles tendon rupture. METHODS: The clinical data of 32 patients with acute closed Achilles tendon rupture who met the selection criteria between August 2015 and February 2019 were retrospectively analyzed. There were 25 males and 7 females, with an average age of 33 years (range, 21-48 years). All of them were closed rupture of Achilles tendon caused by sports injury. Physical examination on admission: the rupture space of Achilles tendon was palpable; Thompson sign was positive; the rupture of Achilles tendon was confirmed by MRI and ultrasonography before operation, the distance between the broken end and the insertion point of Achilles tendon was 2-8 cm, with an average of 3.5 cm. The average time from injury to operation was 2.7 days (range, 1-10 days). During the operation, the posterior median longitudinal W-shaped incision of Achilles tendon was used to expose the broken end of Achilles tendon, and the deep and shallow double Kessler end-to-end suture+layer-by-layer combing suture were used to suture the Achilles tendon, and the skin incision was sutured by "V-Y"advancement. The postoperative complications were observed; the healing of Achilles tendon was observed by ultrasonography; at last follow-up, Arner Lindholm criteria was used to evaluate ankle function. RESULTS: The 32 patients were followed up 8-24 months, with an average of 12 months. The incision healed by first intention, without the complications of skin necrosis, nonunion, delayed healing, and infection, scar hyperplasia or ulcer, and symptom of peroneal nerve injury. No Achilles tendon rupture and deep infection occurred during the follow-up period. The ultrasonography examination showed that the Achilles tendon was healing. At last follow-up, according to Amer Lindholm evaluation standard, the results of ankle function was excellent in 26 cases and good in 6 cases. CONCLUSION: The treatment of acute closed Achilles tendon rupture with a posterior median longitudinal W-shaped incision combined with deep and shallow double Kessler end-to-end suture+layer-by-layer combing suture is effective, which can fully exposed the incision, the quality of Achilles tendon anastomosis is reliable, and it can effectively avoid wound complications and iatrogenic injury of gastrocnemius nerve.

Y-Shaped Tendon Graft-A Technique in the Reconstruction of Posttraumatic Chronic Boutonniere Deformity.

PURPOSE: Current reconstruction strategies for chronic posttraumatic boutonniere deformities have variable outcomes and are prone to complications. This study aimed to describe the clinical outcomes of a Y-shaped tendon graft technique. METHODS: In this retrospective case study, we reviewed the files of 18 patients treated with the Y-shaped tendon graft between January 2010 and January 2017. The technique involves release of the central slip, lateral bands, and transverse retinacular ligaments at the proximal interphalangeal (PIP) joint, total excision of scar tissue in the central slip and at the insertion site, and construction of 3 1.5-mm unicortical holes at the base of the middle phalanx, through which a Y-shaped graft of the palmaris longus is inserted to reconstruct the central slip and stabilize the lateral bands in a dorsal position. Clinical evaluations included measuring the active range of motion in the PIP joint and distal interphalangeal (DIP) joint, grip strength, Souter score, and the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score. RESULTS: The mean age of patients was 36.1 years, and 12 of the 18 patients were men. The average follow-up period was 23 months (range, 13-38 months). The preoperative PIP joint extension deficit was 48.0° ± 5.0° compared with 10.9° ± 9.3° after surgery. The preoperative DIP joint active flexion was 34.4° ± 8.0° compared with 71.4° ± 8.6° after surgery The outcomes based on the Souter score were 11 excellent, 5 good, and 2 poor. The QuickDASH score was 17.7 ± 6.4 before surgery and 11.2 ± 7.2 after surgery. CONCLUSIONS: The Y-shaped tendon graft can be a useful procedure for the correction of chronic boutonniere deformity; in our patient series, this provided good or excellent results in 16 of 18 patients. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

[Repair of limb wounds with free profunda artery perforator flap in posteromedial femoral region].

OBJECTIVE: To explore the effectiveness of free profounda artery perforator flap (PAPF) in the posteromedial femoral region for the treatment of traumatic skin defects of limbs. METHODS: Between March 2015 and April 2017, 11 cases of traumatic limb skin defect with deep tissue exposure were treated with free PAPF in posteromedial femoral region. There were 7 males and 4 females, with an average age of 39 years (range, 26-54 years). There were 4 cases of upper limb skin defect and 7 cases of lower limb skin defect. The causes of injury included 6 cases of traffic accident injury, 3 cases of machine crush injury, and 2 cases of crush injury. The size of wounds ranged from 11 cm×7 cm to 18 cm×11 cm. The time from post-traumatic admission to flap repair were 4-9 days (mean, 7.3 days). The size of free PAPF ranged from 15 cm×9 cm to 22 cm×13 cm. The donor site of 8 cases were closed directly; 3 cases could not be closed directly, and skin grafting was used to cover the wound. RESULTS: The time of skin flap harvest was 40-90 minutes (mean, 47 minutes). All flaps and skin grafts survived and the wounds healed by first intention. All the 11 patients were followed up 6-19 months (mean, 12 months). The skin flaps were soft in texture, similar in color to the skin around the injured limbs, without obvious pigmentation and hair overgrowth. Three of them underwent second-stage skin flap thinning. At last follow-up, the limb function of all patients recovered well. Longitudinal scar could be seen in the donor site of the flap, and the location was concealed. All patients did not complain that scar of the donor site affected their sexual life during the follow-up. CONCLUSION: Free PAPF can achieve satisfactory results in repairing skin defects of extremities. The flaps have the advantages including constant perforator branches, simple operation, and concealed donor site.

Large Scale Triboelectric Nanogenerator and Self-Powered Flexible Sensor for Human Sleep Monitoring.

The triboelectric nanogenerator (TENG) and its application as a sensor is a popular research subject. There is demand for self-powered, flexible sensors with high sensitivity and high power-output for the next generation of consumer electronics. In this study, a 300 mm × 300 mm carbon nanotube (CNT)-doped porous PDMS film was successfully fabricated wherein the CNT influenced the micropore structure. A self-powered TENG tactile sensor was established according to triboelectric theory. The CNT-doped porous TENG showed a voltage output seven times higher than undoped porous TENG and 16 times higher than TENG with pure PDMS, respectively. The TENG successfully acquired human motion signals, breath signals, and heartbeat signals during a sleep monitoring experiment. The results presented here may provide an effective approach for fabricating large-scale and low-cost flexible TENG sensors.

Clinical experience of multiple flaps for the reconstruction of dorsal digital defects.

OBJECTIVE: In this report, we present our experience with reconstruction of the skin defects on the dorsum of the digits using multiple flaps. METHODS: Between November 2010 and March 2013, 45 patients with dorsal digital defects underwent reconstruction using homodigital dorsal digital fasciocutaneous flap (n = 17), heterodigital dorsal digital fasciocutaneous flap (n = 14), dorsal metacarpal artery fasciocutaneous flap (n = 8) and free venous flaps (n = 6). The average flap size was 1.5 × 1.5 cm to 2.0 × 2.5 cm. Donor sites were covered with full-thickness skin graft. RESULTS: All flaps survived completely and the donor sites healed without complications. The mean follow-up period was 18 weeks. During the follow up period, 7 patients treated with reverse homodigital fasciocutaneous flaps developed swelling in the distal portion of flaps, 3 patients treated with reverse dorsal metacarpal artery fasciocutaneous flaps developed mild swelling in the distal portion of flaps but survive well, and 4 patients treated with free venous flaps experienced venous congestion. Of the 14 patients treated with heterodigital fasciocutaneous flaps, there were 11 cases with a retrograde pedicle and 3 cases with a direct pedicle. No full-thickness graft necrosis was noted. CONCLUSION: Multiple options are available for the repair of skin defects on the dorsum of the digits. Besides, the use of a heterodigital fasciocutaneous flap was a simple, safe, and less invasive regimen for repairing dorsal digital skin defects.

Safety and efficacy evaluation of a human acellular nerve graft as a digital nerve scaffold: a prospective, multicentre controlled clinical trial.

This study developed a human acellular nerve graft (hANG) as an alternative to autogenous nerve and reports on its safety and efficacy. There were two groups comprised of 72 patients that received digital nerve repair with hANG (test) and 81 that received conventional direct tension-free suture repair of the nerve defect (control). The efficacy of the treatment was evaluated by static 2-point discrimination (s2PD) and Semmes-Weinstein monofilament testing. Safety was evaluated by local wound response and laboratory testing. Mean age of patients in the test group was 33.0 ± 11.1 years (range 18-61 years) and in the control group 36.9 ± 13.4 years (range 15-77 years) (p = 0.0470). Mean time from injury to repair in the test group was 23.7 ± 52 days (range 0-200 days) and in the control group 1.5 ± 10.4 days (range 0-91 days) (p = 0.0005). Mean length of nerve graft was 1.80 ± 0.82 cm (range 1-5 cm). All surgeries were performed successfully and without complications. The excellent and good rate of s2PD in the test group was 65.28% and 95% CI was 51.98-78.93%. s2PD in the test group improved over time and average distance was 12.81 ± 5.99 mm at 6 months postoperatively. No serious adverse or product-related events were reported. These results indicate that hANG is a safe and effective for the repair of nerve defects of 1-5 cm in size.

[Effectiveness comparison between two kinds of procedures for treatment of totally degloved hand].

OBJECTIVE: To compare the effectiveness between toe transfer combined with an abdominal flap and bag-shaped abdominal flap for treatment of totally degloved hand. METHODS: Between January 2005 and January 2012, 18 patients with totally degloved hand were treated by two kinds of techniques. Those patients were divided into 2 groups according to the technique. The bag-shaped abdominal flap was used in 8 cases (group A), and toe transfer with a dorsal is pedis skin flap combined with abdominal S-shaped tile-joint subdermal vascular network flaps was performed in 10 cases (group B). There was no significant difference in gender, age, injury cause, injury degree, and interval between injury and operation between 2 groups (P > 0.05). The static two-point discrimination (s2PD), grip power of the reconstructed hand, time of returning to work, and active total range of motion (ROM) of the operated finger were compared between 2 groups to assess the effectiveness. RESULTS: All flaps and skin grafts survived in 2 groups. One flap suffered vascular crisis at 2 days after operation and survived after surgical exploration in group B. All patients were followed up 12-24 months (mean, 16 months). At last follow-up, group B showed a better recovery of s2PD of the thumb and ROM, and shorter time of returning to work than group A (P < 0.05), but no significant difference was found in grip power of the reconstructed hand and s2PD of the other fingers between 2 groups (P > 0.05). CONCLUSION: The technique of toe transfer combined with an abdominal flap is better than traditional bag-shaped abdominal flap with the advantages of easy dissection, less time of operation, and satisfactory functional recovery.

[Long-term effectiveness of tendon allograft for repairing tendon defect].

OBJECTIVE: To observe the long-term effectiveness of tendon allograft to repair tendon defect. METHODS: Between October 1996 and September 1999, 24 patients with tendon defect were treated with tendon allograft which was cultured with deoxyguanosine and preserved at low-temperature or ultra-deep-low-temperature. There were 19 males and 5 females, aged from 12 to 46 years with an average of 25.9 years. These patients included 7 cases of total extensor tendon defect of 2nd-5th fingers, 7 cases of index finger extensor tendon defect, 3 cases of deep flexor tendon defect of 2nd-5th fingers, 1 case of ring finger deep flexor tendon defect, 3 cases of long extensor tendon defect of 2nd-5th toes, 2 cases of long extensor hallucis tendon defect, and 1 case of shoulder adduction missing. The sizes of tendon defect ranged from 5 to 15 cm. The mean time from injury to operation was 1.3 months (range, 2 hours to 3 months). RESULTS: Incisions healed by first intention. No deep infection, infectious diseases, and obvious immune rejection occurred. All patients were followed up from 10 to 12 years with an average of 10.8 years. When compared with contralateral sides, at 10 years of follow-up, 1 patient lost 6-100 flexion function; after 10.6 years, flexion tendon releasing was performed; allografted tendon had normal color and elasticity with decreased diameter and with mild and moderate adherence; and after releasing, function was improved. According to Hand Surgery Association assessment standard, the results were excellent in 12 cases, good in 6, and poor in 6; the excellent and good rate was 75%. CONCLUSION: Tendon allograft which is cultured with deoxyguanosine and preserved at low-temperature or ultra-deep-low-temperature is safe to use in clinical, which has good long-term effectiveness in treating tendon defect.

Aesthetic reconstruction of thumb or finger partial defect with trimmed toe-flap transfer.

A new concept of esthetic reconstruction for partial loss of distal finger segment was introduced. In a series of 77 patients, 80 thumb or finger partial defects of lateral, dorsal, or volar half, or composite tissue defect of the finger body were reconstructed with lateral skin-nail flap, dorsal skin-nail flap, pulp flap, or composite tissue transplant taken from corresponding part of the toes. The blood circulations were reestablished by anastomosing digit arteries of the toe transplants and fingers. Seventy-eight fingers in 75 patients of this series were successfully reconstructed. The overall survival rate was 97.5%. Follow-up examinations made half to 12 years postoperatively showed normal length, outward appearance, and function of the reconstructed digits. Their nails are preserved or reconstructed. The pulps are full. Sweating is present. 2-PD was 4-6 mm. Esthetic reconstruction can achieve the goal of mending any part of tissue loss precisely with good result.

[Decorative repair and reconstruction of subtotal thumb and finger defect with trimmed toe flap transfer].

OBJECTIVE: In partial loss of distal finger segment, a corresponding part of the toe tissue compound is harvested and transplanted for repair or reconstruction. This new procedure gives forth a new concept and is called decorative repair or reconstruction. METHODS: In a series of 77 patients with 88 thumb and/or finger subtotal defects in forms of lateral half, dorsal half or volar half composite tissue defects were reconstructed with lateral nail-skin flap, dorsal skin-nail flap or pulp flap taken from corresponding part of the toes. The blood circulations were re-established by anastomosing digital arteries of the toe transplants and fingers. RESULTS: In this series 75 patients with 78 fingers reconstructed are successful. The overall survival rate is 97.5%. Follow-up examinations made half to 12 years postoperatively showed the fingers are having a normal length, outward appearance and function. There are nails preserved. The pulps are full. Sweating function are present. Two-point-discrimination tests are between 4-6 mm. CONCLUSION: By decorative reconstruction of subtotal dorsal, lateral, or volar halves defect of thumb and/or fingers by transplanting corresponding part of soft tissue taken from the toe has the merit of repair of any parts of tissue loss precisely what is needed. This procedure is better than any traditional toe-to-hand transfer and realizing the exact meaning of decorative reconstruction.