1.Efficacy and safety of flurbiprofen cataplasms versus loxoprofen sodium cataplasms in knee osteoarthritis: a randomized controlled trial.
Dong LI ; Yinchu CHENG ; Ping YUAN ; Ziyang WU ; Jiabang LIU ; Jinfu KAN ; Kun ZHANG ; Zhanguo WANG ; Hui ZHANG ; Guangwu ZHANG ; Tao XUE ; Junxiu JIA ; Suodi ZHAI ; Zhenpeng GUAN
Chinese Medical Journal 2023;136(18):2187-2194
BACKGROUND:
Clinical trial evidence is limited to identify better topical non-steroidal anti-inflammatory drugs (NSAIDs) for treating knee osteoarthritis (OA). We aimed to compare the clinical efficacy and safety of flurbiprofen cataplasms (FPC) with loxoprofen sodium cataplasms (LSC) in treating patients with knee OA.
METHODS:
This is an open-label, non-inferiority randomized controlled trial conducted at Peking University Shougang Hospital. Overall, 250 patients with knee OA admitted from October 2021 to April 2022 were randomly assigned to FPC and LSC treatment groups in a 1:1 ratio. Both medications were administered to patients for 28 days. The primary outcome was the change of pain measured by visual analog scale (VAS) score from baseline to day 28 (range, 0-10 points; higher score indicates worse pain; non-inferiority margin: 1 point; superiority margin: 0 point). There were four secondary outcomes, including the extent of pain relief, the change trends of VAS scores, joint function scores measured by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), and adverse events.
RESULTS:
Among 250 randomized patients (One patient without complete baseline record in the flurbiprofen cataplasms was excluded; age, 62.8 ± 10.5 years; 61.4% [153/249] women), 234 (93.6%) finally completed the trial. In the intention-to-treat analysis, the decline of the VAS score for the 24-h most intense pain in the FPC group was non-inferior, and also superior to that in the LSC group (differences and 95% confidence interval, 0.414 (0.147-0.681); P <0.001 for non-inferiority; P = 0.001 for superiority). Similar results were observed of the VAS scores for the current pain and pain during exercise. WOMAC scores were also lower in the FPC group at week 4 (12.50 [8.00-22.50] vs . 16.00 [11.00-27.00], P = 0.010), mainly driven by the dimension of daily activity difficulty. In addition, the FPC group experienced a significantly lower incidence of adverse events (5.6% [7/124] vs . 33.6% [42/125], P <0.001), including irritation, rash and pain of the skin, and sticky hair uncovering pain.
CONCLUSIONS
This study suggested that FPC is superior to LSC for treating patients with knee OA in pain relief, joint function improvement, and safety profile.
Humans
;
Female
;
Middle Aged
;
Aged
;
Osteoarthritis, Knee/drug therapy*
;
Flurbiprofen/therapeutic use*
;
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use*
;
Pain/drug therapy*
;
Treatment Outcome
;
Double-Blind Method
2. Comparison of proximal femoral nail antirotation versus InterTAN nail in the treatment of senile patients with unstable femoral intertrochanteric fracture
Kun ZHANG ; Jiabang LIU ; Dong LI ; Qinghua ZHANG ; Zheng PEI ; Zhao LI ; Zhenpeng GUAN
Chinese Journal of Orthopaedic Trauma 2019;21(12):1052-1058
Objective:
To compare the clinical efficacy between proximal femoral nail antirotation (PFNA) versus InterTAN nail in the treatment of senile patients with unstable femoral intertrochanteric fracture.
Methods:
A retrospective study was conducted of the 164 senile patients with unstable femoral intertrochanteric fracture who had been treated at Department of Orthopedics, Shougang Hospital Affiliated to Peking University from January 2013 to March 2018. InterTAN nailing was performed in 93 of them, including 30 men and 63 women with an age of 84.5±2.4 years; by the AO classification, there were 53 cases of type 31-A2.2, 28 cases of type 31-A2.3 and 12 cases of type 31-A3. PENA fixation was performed in the other 71 patients, including 19 men and 52 women with an age of 83.8±2.3 years; by the AO classification, there were 41 cases of type 31-A2.2, 22 cases of type 31-A2.3 and 8 cases of type 31-A3. The 2 groups were compared in terms of weight-bearing time, thigh pain, hip function, imaging complications and postoperative quality of life.
Results:
The 2 groups were comparable because there were no significant differences between them in preoperative general data (
3.Minimally invasive and open reduction plate fixation for proximal humerus fractures:range of motion of the shoulder joint
Dong LI ; Guangwu ZHANG ; Jiabang LIU
Chinese Journal of Tissue Engineering Research 2015;(39):6355-6359
BACKGROUND:The conservative treatment of humeral fracture is difficult to achieve a good reduction. Minimaly invasive percutaneous plate fixation has been widely used, and has good repair results, but the specific mechanism of action is not clear.
OBJECTIVE:To compare the repair effect of different fixation methods on proximal humerus fractures.
METHODS: From August 2011 to October 2014, we selected 96 patients with proximal humerus fractures from the Shougang Hospital of Peking University. These patients were equaly divided into two groups according to the principle of random draw. Patients in the control group were treated with open reduction and conventional surgery fixation. Patients in the treatment group received minimaly invasive percutaneous plate fixation. Operation time, intraoperative blood loss, incision length and postoperative hospital stay were recorded in both groups. At 8 weeks after treatment, patients received radiography to identify the reduction. Range of motion of the shoulder joint was scored. Within 8 weeks after treatment, the occurrence of complications was observed and compared in both groups.
RESULTS AND CONCLUSION:Intraoperative blood loss, incision length and postoperative hospital stay were significantly less in the treatment group than in the control group (P < 0.05). No significant difference in operation time was found between the two groups (P > 0.05). At 8 weeks after treatment, the excelent and good rate of reduction was significantly higher in the treatment group than in the control group (98%, 81%,P < 0.05). Flexion, abduction, external rotation and internal rotation scores were significantly higher in the treatment group than in the control group (P < 0.05). Bone compartment syndrome, vascular injury, infection and bleeding were significantly lower in the treatment group than in the control group (P < 0.05). These findings confirm that compared with open reduction and internal fixation, minimaly invasive percutaneous plate fixation of proximal humerus fractures has less impact on the body, can promote reduction of the fracture, has few complications, and contributes to the recovery of shoulder function.
4.Early goal-directed therapy in severe acute pancreatitis
Yan ZHU ; Hong CHEN ; Lei YANG ; Dachuan LIU ; Peng YANG ; Jianguo JIA ; Jiabang SUN
Chinese Journal of Hepatobiliary Surgery 2011;17(6):459-461
Objective To study the difference in outcomes between two treatment regimens of goal-directed fluid therapy in patients with severe acute pancreatitis. Methods From January 2000 to January 2010, 80 patients with severe acute pancreatitis were assigned into 2 groups. In group A,patients received fluid therapy aiming at the following goals in 24 hours: (1) Blood pressure >90/60 mm Hg;(2) CVP between 8-12 mm Hg;(3) Urine output >0. 5 ml · kg-1 · h-1. In group B, patients received fluid therapy aiming at the following goals in 6 hours (according to SSC guideline,2004): (1) mean arterial blood pressure >65 mm Hg;(2) CVP between 8-12 mm Hg;(3) Urine output >0. 5 ml · kg-1 · h-1 ;(4) central venous oxygen saturation >70%. After therapy for 3 days we measured the Marshall score, APACHE Ⅱ score, and the peri-pancreatic infection and mortality rates. Results The Marshall score was 6. 82±4. 69 and 4. 48±3. 78 in group A and B, respectively (P=0. 02). The APACHE Ⅱ score was 11. 35±5. 96 and 8. 22±4. 53 in group A and B, respectively (P=0. 01). The peri-pancreatic infection rate was 44% and 37% in group A and B, respectively, and there was no significant difference between the 2 groups (P = 0. 65). The mortality rate was 24% and 17% in group A and B. There was no significant difference between the 2 groups(P=0. 57). Conclusion Goal-directed fluid therapy in patients with severe acute pancreatitis according to the SSC guideline improved organ function but it did not reduce peri-pancreatic infection and mortality rates.
5.Primary resection and anastomosis without intraoperative colonic irrigation in left colonic cancer with complete obstruction
Xiaoan WANG ; Yajun WANG ; Fei LI ; Yu FANG ; Ang LI ; Dongbin LIU ; Jiabang SUN
Chinese Journal of Emergency Medicine 2009;18(7):744-746
Objective To assess the value of primary resection and anastomosis without intraoperative irrigation in the patients with obstructive left colonic cancer. Method Between January 2000 and January 2008, 93patients underwent primary resection and anastomosis for colonic cancers were analyzed retrospectively. Primary resection and anastomosis without intraoperative colonic irrigation (decompression by manual defecation) was performed in 43 patients with obstructive left colonic caner and traditional left-sided colectomy in 50 cases without obstruction. Both groups of patients were comparable in terms of gender, nutritional status, underlaying disease, tumor location and stage, etc ( P = 0.83,0.13,0.29,0.51,0.38). The average age of the patients with colonic obstruction was significant older than that of the cases without obstruction (61.2 ± 8.6 vs. 58.1 ±7.8, P =0.010).The operative results were compared between patients with obstructive colonic cancer and cases without obstruction.Results The mean hospital stay of the primary anastomosis group and traditional left-sided colectomy group were (16.6±7.8) d and (12.4±5.4) d respectively, and the former was significant longer than the latter (P =0.002). The costs of hospitalization in the two groups were (50192.8 ± 39727.4) RMB and (46489.3 ±29543.1)RMB respectively (P = 0.04) . The morbidity and mortality in the two groups were 25.6% (11/43) vs. 18%(9/50) (P =0.375) and 2.3% (1/43) vs. 2.0% (1/50) (P =0.714) respectively, and there were no significant difference between the two groups. Conclusions Primary resection and anastomosis without intraoperative colonic irrigation (decompression by manual defecation) compares favorably with traditional left-sided colectomy in safety and efficiency for left colonic cancer with obstruction.
6.Clinical profiles of hyperlipidemic pancreatitis
Lei YANG ; Jiabang SUN ; Dachuan LIU ; Jianguo JIA ; Fei LI
Chinese Journal of Pancreatology 2009;9(3):147-149
event and treat circular,respiratory and renal insufficiency.
7.Relationship between intra-abdominai pressure and severity in pathents with severe acute pancreatitis
Yajun WANG ; Jiabang SUN ; Fei LI ; Lei YANG ; Hong CHEN ; Dachuan LIU
Chinese Journal of Emergency Medicine 2009;18(6):632-635
Objective Previous investigations suggest that severe acute pancreatitis (SAP) is one of the main causes of intra-ahdominal pressure (lAP) increase. The aims of this study were, to evaluate the increased IAP in patients with SAP and the correlation between LAP and severity or prognosis. Method Data of 75 SAP patients admitted to Xuan-Wu Hospital of Capital Medical University intensive care unit with SAP from January 2000 to Jan-uary 2008 were collected. All the patients had at least one organ dysfunction, and they were diagnozed with en-hanced CT, lAP were monitored in the 56 patients. The 56 patients were divided into three groups according to IAP, group A (7- 15 mmHg), group B (16-25 mmHg) and group C (26-31 mmHg). Maximal APECHE Ⅱscore, maximal Ranson score, maximal C-response protein (CRP), maximal arterial lactate, maximal creatinine, organ dysfunction, length of stay and mortality were compared. Results The 56 patients (24 male and 32 female)with average age of (52±14.1) years (ranging 21 - 72 years) and average body mass index (BMI) of 28±12.5(ranging 21 - 35) were monitored with IAP. The etiologic causes of SAP were biliary in 27 patients, alcohol in 14cases, hyperlipidemia in 11 cases and idiopathic in 4 cases. The rate of intra-abdominal hypertension was 89% (50/56), and 32% (18/56) patients complicated with abdominal compartment syndrome. There were 22, 26 and 8 patients in the A, B and C groups respectively. With the increasing of IAP, the maximal APACHE Ⅱ, maximal Ranson score, maximal CRP, maximal creatinine, organ dysfunction and mortality were also increased significant-ly. The mortality of the three groups was 13.6% (3/22), 23.1% (6/26) and 62.5% (5/8) respectively (χ2 =7.56, p = 0.023), and the total mortality of the 56 patients was 25%. The hospital stay of the three groups had no significant differenee(F = 2.23,P = 0.117). Conclusions IAP may be one of the markers used to evaluate the severity of SAP, and the monitoring of IAP is useful to assess the prognosis in patients with SAP.
8.Primary resection and anastomosis with intraoperative colonic defecation in left colonic cancer with complete obstruction
Xiaoan WANG ; Yajun WANG ; Fei LI ; Yu FANG ; Ang LI ; Dongbin LIU ; Jiabang SUN
International Journal of Surgery 2009;36(5):305-307
Objective To assess the value of primary resection and anastomosis with intraoperative colonic defecation in the patients with obstructive left colonic cancer. Methods From January 2000 to January 2008, 39 patients undergoing emergency laparotomy for left colonic cancers with complete obstruction were analyzed retrospectively. Results The patients were 25 males and 14 females, with a median age of 68.5 years (range: 57~78 years). The primary tumors were located at splenic flexure (3/7.7%), descending colon (8/20.5%), sigmoid colon (15/38.5%), boundary of sigmoid colon and rectum (8/20.5%), and superior segment of rectum (5/12.8%). Primary resection and anastomosis with intraoperative colonic de-fection were performed in 18 patients with left hemicolectomy, 13 patients with sigmoid colectomy and 8 pa-tients with anterior resection. Early complications included wound infection in 4 patients (wound disruption in 1 patient) and pulmonary infection in 5 patients. One patient complicated with anastomotic leakage and intra-abdominal abscess died of tumor metastasis after reoperation. Another one died of respiratory failure secondary to pulmonary infection. Morbidity and mortality was 25.6% and 5.1% respectively. Conclusion Primary resection with intraoperative colonic defecation can be applied to patients with malignant colonic complete obstruction with good operative results.
9.Clinical characteristics and treatment of severe hyperlipidemic pancreatitis
Jianguo JIA ; Jiabang SUN ; Dachuan LIU ; Fei LI
Chinese Journal of General Practitioners 2008;7(11):766-768
Objective To summarize clinical characteristics and experiences in treatment of severe hyperlipidemic pancreatitis (SHLP). Methods A retrospective analysis for 22 cases of SHLP and 91 cases of severe acute biliary pancreatitis (SABP) hospitalized during January 1, 2000 to December 31, 2006 was carried out to compare their clinical characteristics and treatment outcomes. Results Activities of serum and urine amylase in SHLP patients at admission were (715 ± 99) and (382 ± 56) U/L, respectively, significantly lower than those in SABP patients (1551 ± 107) and (773 ± 66) U/L, respectively (P < 0.01). About 55% (12/22) of SHLP patients had pulmonary infection, 36% (8/22) with circulatory failure, 41% (9/22) with respiratory failure and 23 % (5/22) with renal failure, all significantly higher than those in SABP patients SABP [32% (29/91), 14% (13/91), 7% (6/91) and 5% (5/91), respectively, P < 0.01]. Two died of SHLP and 11 of SABP, respectively. Conclusions In diagnosis of SHLP, it should be noticed that no remarkable elevation of activities in serum and urine amylase usually, so during the course of treatment for SHLP, it is important to prevent and treat multi-organ failure, respiratory failure and renal failure in an active way.
10.Effect of low-dose glucocorticoids in septic shock
Hong CHEN ; Jianguo JIA ; Fei LI ; Lei YANG ; Dachuan LIU ; Peng YANG ; Jiabang SUN
Chinese Journal of Emergency Medicine 2008;17(5):513-516
Objective To study retrospectively the effects of low-dose glucocorticoids in outcomeof septic shock.Method The present stray was carried out by analysis of septic shock patients treated with norepinephrine or dopamine.A total of 46 patients with a confirmed diagnosis of septic shock admitted from January 2000 to October 2006 were divided into two groups:(1)ghcocorticoids treatment group(n=22),treated with glucocorticoids in addition to conventional treatment from November 2002 to October 2006;(2)conlrol group(n =24),only treated with routine treatment from January 2000 to October 2002.The differences in outcome were compared between the two groups.Results The duration of of vasopressor support was significantly shorter in treatment group com0~ed with control group.The percentage of shock reversal at 7 days was higher in treatment group than that in control group(72.73%vs.41.67%,P=0.034).Furthermore,a reduction in C-reactive protein(CRP)indicated inhibition of inflammatory response due to the effect of glucocorticoids in treatment group within 48-72 hours from admission to ICU(20.05±4.06 mg/dl vs.23.55±4.93 mg/dl,P=0.015).Therefore,APACHE Ⅱ score on 3rd day was significantly lower in treatment group than that in control group(16.76±4.87 vs.21.45±4.02,P=0.001).However,there were no statistical signifieances in the duration of mechanical ventilation,the length of ICU stay,the incidence of multiple organ dysfunction syndrome(MODS)and hospital-mortality between the two groups(P>0.05).Conclusions Tmatmeut with low-dose gheocorticoids could effectively accelerate the recovery from refractory septic shock and the early withdrawal of vasopressor.It seems to be associated with the reduced production of CRP,suggesting the effects of low-dose glucocorticoids on both stabilization of hemodynamics and inhibition of inflammatory response.The beneficial effects of low-dose steroids regimens on long-term outconm of patients with septic shock have not determined.

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