Risk of infection in roxadustat treatment for anemia in patients with chronic kidney disease: A systematic review with meta-analysis and trial sequential analysis
Chong S, Xie Q, Ma T, Xiang Q, Zhou Y, Cui Y
Frontiers in pharmacology. 2022;13:967532
Background: Many studies demonstrated that roxadustat (FG-4592) could increase hemoglobin (Hb) levels effectively in anemia patients with chronic kidney disease (CKD). However, its safety remains controversial. This study aims to explore the risk of infection for CKD patients treated with roxadustat, especially focused on sepsis. Methods: We thoroughly searched for the randomized controlled trials (RCTs) comparing treatment with roxadustat versus erythropoiesis stimulating agents (ESAs) or placebo in PubMed, Embase, Cochrane Library, ClinicalTrials.gov, European Union Clinical Trials Register. Both on and not on dialysis anemia patients with CKD were included. Primary outcomes contained the incidence rates of sepsis. Secondary outcomes included infection-related consequences (septic shock and other infection events), general safety outcomes [all-cause mortality, treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)] and iron parameters. Moreover, a trial sequential analysis (TSA) was conducted to assess if the results were supposed to be a robust conclusion. Results: Eighteen RCTs (n = 11,305) were included. Overall, the incidence of sepsis (RR: 2.42, 95% CI [1.50, 3.89], p = 0.0003) and cellulitis (RR: 2.07, 95% CI [1.24, 3.44], p = 0.005) were increased in the roxadustat group compared with placebo group. In non-dialysis-dependent (NDD) CKD patients, the incidence of cellulitis (RR 2.01, 95% CI [1.23, 3.28], p = 0.005) was significantly higher in roxadustat group than that in the ESAs or placebo group. Both groups showed similar results in the incidence of septic shock (RR 1.29, 95% CI [0.86, 1.94], p = 0.22). A significant increased risk of all-cause mortality [risk ratios (RR): 1.15, 95% confidence interval (CI) [1.05, 1.26], p = 0.002] was found in roxadustat treatment, and TSA confirmed the result. Compared with ESAs or placebo, both the incident rates of TEAEs (RR:1.03, 95% CI [1.01, 1.04], p = 0.008) and TESAEs (RR: 1.06, 95% CI [1.02, 1.11], p = 0.002) were significantly increased in roxadustat group. As for iron parameters, changes from baseline (Δ) of hepcidin (MD: -26.46, 95% CI [-39.83, -13.09], p = 0.0001), Δ ferritin and Δ TSAT were remarkably lower in the roxadustat group, while Δ Hb, Δ iron and Δ TIBC increased significantly versus those in ESAs or placebo group. Conclusion: We found evidence that incidence rates of sepsis and cellulitis are higher in roxadustat group compared with placebo. This may be the result of improved iron homeostasis. The risk of all-cause mortality, TEAEs and TESAEs in CKD patients also increased in patients treated with roxadustat. We need more clinical and mechanistic studies to confirm whether roxadustat really causes infection.
Comparison of Application Effects of Different Hemostasis Methods After Ischemic Cerebrovascular Intervention
Zhou Y, Xu C
Frontiers in surgery. 2022;9:850139
OBJECTIVE To explore the effects of two different hemostasis methods, namely, arterial compression devices and vascular closure devices, in the ischemic cerebrovascular intervention to provide a theoretical basis for clinical selection of hemostasis methods. METHODS A total of 302 patients who underwent ischemic cerebrovascular intervention in our hospital from January 2016 to December 2020 were selected as the research subjects and randomly divided into the control group (n = 151) and the observation group (n = 151). The patients in both groups underwent cerebrovascular intervention. The patients in the control group were treated with an artery compressor for hemostasis after the operation, while those in the observation group were treated with vascular closure devices for hemostasis. The hemostatic indexes and vascular parameters at the puncture site before and after the operation were compared between the two groups. The comfort level of the patients was assessed at 6, 12, and 24 h after the operation with the Kolcaba Comfort Scale score, and the postoperative complications were recorded. RESULTS There was no significant difference in the success rate of hemostasis between the two groups (p > 0.05). The hemostatic time and immobilization time of (2.69 ± 0.62) min and (4.82 ± 0.93) h in the observation group were lower than those in the control group with (16.24 ± 3.58) min and (7.94 ± 1.86) h (p < 0.05). The differences in the minimum inner diameter of the puncture site and its nearby vessels and the peak velocity of blood flow between the two groups before and after the operation were not statistically significant within or between groups (p > 0.05). The scores of the Kolcaba comfort scale in the observation group (80.16 ± 8.49) and (93.65 ± 9.26) at 6 and 12 h, respectively, after the operation, were higher than those in the control groups (72.08 ± 7.54) and (85.49 ± 8.63) (p < 0.05). The 24 h postoperative Kolcaba comfort scale score was (97.54 ± 9.86) in the observation group and (96.82 ± 9.64) in the control group, and the difference was not statistically significant (p > 0.05). In the control group, there were 7 cases of dysuria, 12 cases of low back pain, 14 cases of sleep disorder, 20 cases of mental stress, and 5 cases of wound bleeding, and the total incidence of complications was 38.41% (58/151). In the observation group, there were 4 cases of dysuria, 8 cases of low back pain, 10 cases of sleep disorder, 14 cases of mental stress, and 3 cases of wound bleeding, and the total incidence of complications was 25.83% (39/151). The total incidence of complications in the observation group was lower than that in the control group (p < 0.05). CONCLUSION For patients with ischemic cerebrovascular disease undergoing femoral artery puncture intervention, the use of vascular closure devices can stop the bleeding quickly, which can significantly shorten the bleeding time, and the postoperative braking time of patients is short, with high comfort and fewer complications.
Effect of thrombopoietin receptor agonist on health-related quality of life and platelet transfusion burden for patients with myelodysplastic syndromes: a systematic review and meta-analysis
Wang K, Shao Y, Li C, Bao J, Zhu W, Zhou Y
Annals of hematology. 2022
Thrombocytopenia is a common and unsolved problem in myelodysplastic syndrome (MDS) patients; we aimed to summarize the evidence of TPO-RA treatment for heath-related quality of life (HRQoL) and platelet transfusion burden of MDS patients. We searched Pubmed, Web of Science, EMBASE, and CENTRAL for randomized clinical trials (RCTs) comparing TPO-RA to placebo in MDS published until July 31, 2021. A random-effect model was used. Eight RCTs with 908 patients were identified. Only three RCTs involving eltrombopag reported HRQoL, and all three studies treated HRQoL as a secondary outcome. In these three RCTs, the HRQoL instruments used in each study were different. However, this outcome cannot be meta-analyzed because some studies did not provide complete data. Subsequent clinical trials should pay more attention to this. Compared to placebo, TPO-RA did not affect platelet transfusion incidence 0.83 (95% CI 0.60-1.15). There was no evidence for subgroup differences in the analyses of different types of TPO-RA, different additional agent, and different types of MDS risk groups. However, platelet transfusion units (RR = 0.68, 95% CI 0.53 to 0.84) were significantly decreased. The RR of patients who did not require platelet transfusion for 56 or more consecutive days was not different between groups (RR = 0.98, 95% CI 0.41 to 2.34). TPO-RA may decrease platelet transfusion units in MDS patients with thrombocytopenia. But the significance of this finding should be interpreted with caution, because too few studies were meta-analyzed.
Clinical characteristics and treatment of terlipressin-induced ischemic skin necrosis: A synthesis of 35 literature reported cases
Zhou Y, Zeng J, Song L, Wang C
Journal of clinical pharmacy and therapeutics. 2022
WHAT IS KNOWN AND OBJECTIVE The clinical features of terlipressin-induced ischemic skin necrosis are unknown. The purpose of this study is to explore the clinical features of terlipressin-induced skin necrosis. METHODS We searched Chinese and English databases to collect case reports of terlipressin-induced skin necrosis for retrospective analysis. RESULTS AND DISCUSSION A total of 42 patients (31 males and 11 females) from 35 studies were included, with a median age of 54 years (range 0.17-84). The onset of skin ischemia ranged from a few hours to 21 days. The most common clinical manifestations were bulla (15 cases, 35.7%), cyanosis (12 cases, 28.6%), necrosis (11 cases, 26.2%), and purpura (10 cases, 23.8%). The following were often affected: the legs (26 cases), 61.9%), abdomen (13, 31.0%), scrotum (10 cases, 23.8%), feet (10 cases, 23.8%), upper extremities (8 cases, 19.0%), and hands (7 cases, 16.7%). Skin biopsy showed fibrin thrombus (7 cases, 38.9%), nonspecific inflammation (6 cases, 33.3%), and necrosis (10 cases, 55.6%). After discontinuation of terlipressin, skin symptoms improved in most patients. WHAT IS NEW AND CONCLUSION Ischemic skin necrosis is a rare and serious adverse effect of terlipressin. Patients receiving terlipressin therapy should be monitored closely for terlipressin-related ischemic complications. Terlipressin should be discontinued immediately if ischemic complications occur.
Personalized tourniquet pressure may be a better choice than uniform tourniquet pressure during total knee arthroplasty: A PRISMA-compliant systematic review and meta-analysis of randomized-controlled trials
Sun C, Yang X, Zhang X, Ma Q, Yu P, Cai X, Zhou Y
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BACKGROUND Pneumatic tourniquets are widely used in total knee arthroplasty (TKA). Some surgeons prefer a uniform tourniquet inflation pressure (UTIP) for all patients; others use personalized tourniquet inflation pressures (PTIP) based on systolic blood pressure and limb occlusion pressure. However, no consensus exists regarding the optimal mode of inflation pressure during TKA. This review aimed to appraise if personalized tourniquet inflation pressures are better than uniform tourniquet inflation. METHODS The databases (Web of Science, Embase, PubMed, Cochrane Controlled Trials Register, Cochrane Library, Highwire, CBM, CNKI, VIP, Wanfang) were searched on March 2021 to systematically identify and screen the literature for randomized controlled trials involving PTIP and UTIP during total knee arthroplasty. RESULTS Thirteen randomized controlled trials, involving 1204 TKAs (1201 patients) were included in the systematic review. The meta-analysis identified a trend toward less visual analogue scale (VAS) score at rest with PTIP group at 1 day (P = .002), 2 to 3 days (P = .01), and less VAS score at activity 1 day (P < .0001), 2 to 3 days after the operation (P < .00001), and discharge (P < .0001). No significant difference was found between the groups in terms of VAS score at rest when discharge (P = 1.0). We also found no significant difference in terms of intraoperative blood loss (P = .48), total blood loss (P = .15), lower limb vein thrombosis (P = .42), and thigh bullae (P = .17). However, in the PTIP group, we found a significant higher hospital for special surgery (HSS) score (P = .007), broader knee Range of motion (P = .02), less rate of thigh ecchymosis (P = .00001), and shorter thigh circumference at 1 day (P = .006), 2 to 3 days (P = .0005), and discharge (P = .02). CONCLUSION PTIP provides a similar bloodless surgical field compared with the conventional UTIP. Furthermore, PTIP provides less pain intensity, thigh circumference, rate of thigh ecchymosis, higher hospital for special surgery, and better initial recovery of knee flexion in total knee arthroplasty. Therefore, we recommend using a PTIP method during TKA. More adequately powered and better-designed randomized controlled trials studies with long-term follow-up are required to produce evidence-based guidelines regarding the PTIP method.
Impact of tourniquet during total knee arthroplasty when tranexamic acid was used: a meta-analysis of randomized controlled trials
Sun C, Zhang X, Ma Q, Tu Y, Cai X, Zhou Y
Journal of orthopaedic surgery and research. 2022;17(1):18
INTRODUCTION The efficacy of tourniquet use during primary total knee arthroplasty (TKA) is thought to reduce intraoperative blood loss, improve surgical exposure, and optimize cement fixation. Tranexamic acid (TXA) use can decrease postsurgical blood loss and transfusion requirements. This review aimed to appraise the effects of tourniquet use in TKA for patients with tranexamic acid use. METHODS A meta-analysis was conducted to identify relevant randomized controlled trials involving TXA plus a tourniquet (TXA-T group) and use of TXA plus no tourniquet (TXA-NT group) in TKA. Web of Science, PubMed, Embase, Cochrane Controlled Trials Register, Cochrane Library, Highwire, CNKI, and Wanfang database were searched from 2010 through October 2021. RESULTS We identified 1720 TKAs (1690 patients) assessed in 14 randomized controlled trials. Compared with the TXA-NT group, the TXA-T group resulted in less intra-operative blood loss (P < 0.00001) and decreased duration of surgery (P < 0.00001), however more hidden blood loss (P = 0.0004) and less knee range of motion (P < 0.00001). No significant differences were found between two groups in terms of decrease in hemoglobin (P = 0.84), total blood loss (P = 0.79), transfusion rate (P = 0.18), drainage volume (P = 0.06), Visual Analogue Scale (VAS) at either the day of surgery (P = 0.2), 1 day (P = 0.25), 2 day (P = 0.39), 3 day (P = 0.21), 5 day (P = 0.21), 7 day (P = 0.06) or 1 month after surgery (P = 0.16), Hospital for Special Surgery (HSS) score at either 7 day (P = 0.10), 1 month (P = 0.08), 3 month (P = 0.22) or 6 month after the surgery (P = 0.92), Knee circumference (P = 0.28), length of hospital (P = 0.12), and complications such as intramuscular venous thrombosis (P = 0.81), deep venous thrombosis (P = 0.10), superficial infection (P = 0.45), deep wound infection (P = 0.64), and delayed wound healing (P = 0.65). CONCLUSION No big differences could be found by using or not tourniquet when use the TXA, though some benefits are related to operation time and less intra-operative blood loss by using tourniquet and TXA, Using the tourniquet was related to more hidden blood loss and less knee range of motion. More adequately powered and better-designed randomized controlled trials (RCTs) studies with long-term follow-up are required to validate this study.
Efficacy and safety of platelet-rich plasma in the treatment of carpal tunnel syndrome: A network meta-analysis of different injection treatments
Hong P, Zheng Y, Rai S, Ding Y, Zhou Y, Liu R, Li J
Frontiers in pharmacology. 2022;13:906075
Purpose: Carpal tunnel syndrome (CTS) is a common form of median nerve compression in the wrist caused by focal peripheral neuropathy. Platelet-rich plasma (PRP) therapy could improve the healing ability by exposing the injured tissues to high concentrations of autologous growth factors. Our study aims to compare all injective treatments for CTS and assess the efficacy and priority of PRP therapy. Methods: We searched Medline, Embase, Web of Science, Cochrane databases, and Clinicaltrial.gov until 17 October 2022. We only included data from randomized controlled trials (RCTs) that evaluated PRP injection therapy or drug injection therapy. The included RCTs measured at least one of the following three outcomes with validated instruments: in the visual analog scale (VAS), symptom severity scale (SSS), and functional status scale (FSS). Results: Overall, 19 studies with 1,066 patients were included in this study. We used the SUCRA rankings to determine the merits of various therapies. In all, 5% dextrose injections were the best treatment strategy for the VAS (MD -1.22, 95% CI -2.66 to 0.23; SUCRA = 79.2%), followed by triamcinolone (high-dose) injections (MD -0.69, 95% CI -2.11 to 0.73; SUCRA = 62.7%) and PRP injections (MD -0.39, 95% CI -1.67 to 0.89; SUCRA = 60.0%). In the SSS, the most effective intervention was hydroxyprogesterone injections (MD -0.62, 95% CI -1.09 to -0.16; SUCRA = 91.0%). The SUCRA ranking of PRP was second only to steroids and estrogen (MD -0.39, 95% CI -0.60 to -0.18; SUCRA = 60.8%). In the FSS, the best regimen strategy was hydroxyprogesterone injections (MD 0.12, 95% CI -0.30 to 0.54; SUCRA = 99.5%), followed by triamcinolone (low-dose) injections (MD -0.02, 95% CI -0.54 to 0.49; SUCRA = 87.4%) and PRP injections (MD -0.26, 95% CI -0.43 to -0.09; SUCRA = 77.1%). Conclusion: PRP is an alternative choice for CTS treatment. PRP injection is second only to steroids and estrogen in the treatment efficacy of CTS, with a wide indication and safe outcome.
Flapless osteotome-mediated sinus floor elevation using platelet-rich fibrin versus lateral approach using deproteinised bovine bone mineral for residual bone height of 2-6 mm: a randomised trial
Lv H, Sun X, Wang J, Wang H, Wang L, Zhou Y
Clinical oral implants research. 2022
OBJECTIVES To evaluate patient-reported outcomes and radiographic results of simultaneous implant placement in severely atrophic maxilla using flapless endoscope-assisted osteotome sinus floor elevation with platelet-rich fibrin (PRF), also defined as PESS, and to compare the results with those of lateral sinus floor elevation (LSFE). METHODS Patients with a residual bone height (RBH) of 2-6 mm were included in a randomised controlled trial. PESS was performed with PRF as the sole grafting material. LSFE was performed using deproteinised bovine bone matrix. Patient-reported outcomes were recorded on a visual analogue scale (VAS-pain) and visual rating scale (VRS-swelling and VRS-willingness). Peri-implant bone height (PBH), bone mineral density (BMD), and sinus grafting remodelling index were measured using CBCT immediately postoperatively and 3(rd) , 6(th) and 18(th) months post-surgery. RESULTS The study population consisted of 20 patients in each group. The RBH of two groups averaged 3.35±0.79 mm and 2.92±0.63 mm with no significant difference (p > 0.05). VAS-pain was 18.0 (IR 15.0-22.5) and 35.0 (IR 32.5-37.0) in the PESS and LSFE groups, respectively (p < 0.01). VAS-pain decreased with time in both groups. VRS-swelling was lower in the PESS group than LSFE group. VRS-willingness was higher in the PESS group than LSFE group (p < 0.01). At 18 months post-surgery, the marginal bone loss was 0.60±0.25 mm and 0.69±0.35 mm in the two groups with no significant difference (p = 0.52). CONCLUSIONS Within the limitations of this study, PESS was associated with lower postoperative morbidity and was more tolerable than LSFE. PESS could be a reliable procedure for sinus floor elevation in patients with insufficient RBH.
Observation on the effect of platelet-rich plasma combined with drugs in the treatment of herpes zoster neuralgia
Zhou Z, Hu X, Yan F, Zhou Y, He R, Ye X, Jiang Z
The International journal of neuroscience. 2022;:1-11
Purpose: To observe the effect of ultrasound-guided platelet-rich plasma (PRP) injection in the treatment of herpes zoster neuralgia (HZN).Methods: Eighty patients with HZN were randomly divided into observation group and control group, with 40 cases in each group. The observation group was treated with ultrasound-guided PRP injection of target nerves combined with drugs. The control group was treated with drugs alone. The pain scores of before treatment (T0), and 1 week (T1), 1 month (T2), 3 months (T3) and 6 months (T4) after treatment were recorded with Numerical Rating Scale (NRS). The sleep quality of patients was assessed with the Athens Insomnia Scale, and the dosage used at each time point, skin lesions, adverse reactions, and the occurrence of postherpetic neuralgia (PHN) were recorded.Results: The NRS score of the two groups after treatment showed a downward trend. Compared with T0 at each time point, the difference was statistically significant (P < 0.05). And the NRS score of the observation group was lower than control group (P < 0.05). The sleep quality of the observation group was better. The dosage of the observation group was less, and the time of herpes dry-up, scab crusting and shedding in the observation group was significantly shorter (P < 0.05). The incidence of dizziness, lethargy, ataxia and PHN in the observation group was significantly reduced (P < 0.05).Conclusion: Compared with traditional drug treatment alone, the ultrasound-guided PRP injection has the advantages of better analgesia and fewer side effects, which provides a new idea for the treatment of HZN.
The impact of tourniquet on tibial bone cement penetration in different zones in primary total knee arthroplasty: a meta-analysis
Sun C, Yang X, Zhang X, Ma Q, Yu P, Cai X, Zhou Y
Journal of orthopaedic surgery and research. 2021;16(1):198
BACKGROUND Cement mantle penetration and the cement-bone interface strength were critical to a successful primary total knee arthroplasty (TKA). It remained unclear whether decreased blood and fat in the cancellous bone achieved with the use of a tourniquet increases tibial cement mantle penetration in different zones on AP and lateral view in TKA according to criteria defined by the Knee Society Scoring System (KSS). The purpose of this study was to determine whether tourniquet use influences tibial cement mantle penetration in different zones on AP and lateral view in TKA according to KSS. METHODS We conducted a meta-analysis to identify studies involving the impact of tourniquet use and no tourniquet use on tibial bone cement penetration in primary TKA in electronic databases, including Web of Science, Embase, PubMed, Cochrane Controlled Trials Register, Cochrane Library, Highwire, CBM, VIP, Wanfang database, up to January 2021. Finally, we identified 1231 patients (1231 knees) assessed in twelve studies. RESULTS Tourniquet use increases the cumulative cement mantle penetration (P < 0.00001), mean cement mantle penetration (P = 0.004), and cement mantle in zone 3(P < 0.0001) on AP view. However, there were no significant differences in cement mantle in zone 1(P = 0.5), zone 2(P =0 .54), zone 4(P = 0.07) on AP view, and zone 1(P = 0.32), zone 2(P = 0.38) on lateral view between two groups. There were also no significant differences in length of surgery(P = 0.7), change in hemoglobin(P = 0.4), transfusion rates(P = 0.47), and complications such as muscular calf vein thrombosis(P = 0.21), superficial infection (P = 0.72), and deep vein thrombosis (P = 0.66) between two groups. CONCLUSION The application of a tourniquet increases the thickness of the tibial bone cement penetration-the increase in the thickness of bone cement penetration mainly located in zone 3 on the anteroposterior (AP) view.