1.
Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study.
Ha, CW, Park, YB, Choi, CH, Kyung, HS, Lee, JH, Yoo, JD, Yoo, JH, Choi, CH, Kim, CW, Kim, HC, et al
BMC musculoskeletal disorders. 2017;(1):223
Abstract
BACKGROUND This randomized, double-blind, multi-center, non-inferiority trial was conducted to assess the efficacy and safety of a cross-linked hyaluronate (XLHA, single injection form) compared with a linear high molecular hyaluronate (HMWHA, thrice injection form) in patients with symptomatic knee osteoarthritis. METHODS Two hundred eighty seven patients with osteoarthritis (Kellgren-Lawrence grade I to III) were randomized to each group. Three weekly injections were given in both groups but two times of saline injections preceded XLHA injection to maintain double-blindness. Primary endpoint was the change of weight-bearing pain (WBP) at 12 weeks after the last injection. Secondary endpoints included Western Ontario and McMaster Universities Osteoarthritis index; patient's and investigator's global assessment; pain at rest, at night, or in motion; OMERACT-OARSI responder rate; proportion of patients achieving at least 20 mm or 40% decrease in WBP; and rate of rescue medicine use and its total consumption. RESULTS Mean changes of WBP at 12 weeks after the last injection were -33.3 mm with XLHA and -29.2 mm with HMWHA, proving non-inferiority of XLHA to HMWHA as the lower bound of 95% CI (-1.9 mm, 10.1 mm) was well above the predefined margin (-10 mm). There were no significant between-group differences in all secondary endpoints. Injection site pain was the most common adverse event and no remarkable safety issue was identified. CONCLUSIONS This study demonstrated that a single injection of XLHA was non-inferior to three weekly injections of HMWHA in terms of WBP reduction, and supports XLHA as an effective and safe treatment for knee osteoarthritis. TRIAL REGISTRATION ClinicalTrials.gov ( NCT01510535 ). This trial was registered on January 6, 2012.
2.
Intravitreal triamcinolone and bevacizumab as adjunctive treatments to panretinal photocoagulation in diabetic retinopathy.
Cho, WB, Moon, JW, Kim, HC
The British journal of ophthalmology. 2010;(7):858-63
Abstract
BACKGROUND/AIMS: To evaluate efficacy of intravitreal triamcinolone (IVTA) and bevacizumab (IVB) as adjunctive treatments to panretinal photocoagulation (PRP). METHODS In 91 eyes of 76 patients (clinically significant macular oedema (CSME) 46 eyes; no CSME 45 eyes) with severe diabetic retinopathy, PRP with IVTA (IVTA group, 30 eyes) or PRP with IVB (IVB group, 31 eyes) or PRP only (PRP group, 30 eyes) was performed. Primary outcome measures were changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) at 1 and 3 months. Secondary outcome measures were proportion of visual gain or loss, and decreased or increased CMT. RESULTS There was significant worsening in BCVA from 0.26 to 0.29 at 1 and 3 months (p=0.031) in the PRP group. In eyes with CSME, there was significant improvement of BCVA from 0.33 to 0.27 at 1 and 3 months (p=0.012) in IVTA group. In eyes without CSME, PRP group showed significant worsening in BCVA from 0.18 to 0.26 at 1 month (p=0.008) and 0.27 at 3 months (p=0.005). There was significant improvement in CMT in IVTA and IVB groups: in eyes without CSME, there was significant increase in CMT from 209.75 to 259.00 microm at 1 month (p=0.023) and to 276.14 microm at 3 months (p=0.011) in the PRP group; in eyes with CSME, the proportion of eyes with visual gain and decreased CMT was significantly higher in the IVTA group (75% and 100%, respectively) than in the IVB group (37.5% and 62.5%, respectively). CONCLUSIONS IVTA and IVB may be effective adjunctive treatments to PRP, minimising the risk of PRP-induced macular oedema and visual loss.
3.
Comparative outcome between chemoradiotherapy and lateral pelvic lymph node dissection following total mesorectal excision in rectal cancer.
Kim, JC, Takahashi, K, Yu, CS, Kim, HC, Kim, TW, Ryu, MH, Kim, JH, Mori, T
Annals of surgery. 2007;(5):754-62
Abstract
OBJECTIVE To evaluate comparative outcome between adjuvant postoperative chemoradiotherapy (postoperative CRT) and lateral pelvic lymph node dissection (LPLD) following total mesorectal excision (TME) in rectal cancer patients. BACKGROUND Although TME results in lower rate of locoregional recurrence compared with conventional surgery, these 2 treatment modalities following TME have not adequately been appraised until the present trend of preoperative chemoradiotherapy. PATIENTS AND METHODS Between 1995 and 2000, patients with stage II and III rectal cancer underwent TME plus postoperative CRT (n = 309) or LPLD (n = 176). Patients in the postoperative CRT group received 8 cycles of 5-fluorouracil plus leucovorin and 45 Gy pelvic radiotherapy. Patients in the LPLD group underwent lateral lymph node dissection outside the pelvic plexus. RESULTS The 5-year overall and disease-free survival rates were 78.3% and 67.3% in the postoperative CRT group, respectively, and 73.9% and 68.6% in the LPLD group, respectively, without significant differences between these groups. Patients in the LPLD group with stage III lower rectal cancer had a locoregional recurrence rate 2.2-fold greater than those in the postoperative CRT group (16.7% vs. 7.5%, P = 0.044). Multivariate analysis showed that APR and advanced T-category (T4) were significantly associated with locoregional recurrence, whereas lymph node metastases, high preoperative serum carcinoembryonic antigen, and APR were significantly associated with shortening of disease-free survival. CONCLUSIONS Postoperative-CRT and LPLD following TME resulted in comparable survival rates, but the locoregional recurrence rate was higher in the LPLD group. These findings suggest that initial surgery is appropriate for rectal cancer patients who are candidates for low anterior resection without extensive local disease (T1-T3), regardless of lymph node status.