Low-dose PPI to prevent bleeding after ESD: A multicenter randomized controlled study
Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie. 2021;136:111251
BACKGROUND Although proton pump inhibitors (PPIs) are widely used in the prevention of gastric bleeding caused by endoscopic submucosal dissection (ESD), there is no consensus on the optimal regimen for these patients. Therefore, we aim to investigate whether intermittent use of low-dose PPI is sufficient to prevent post-ESD bleeding. METHODS This multicenter, non-inferiority, randomized controlled trial was conducted at 9 hospitals in China. Consecutive eligible patients with a diagnosis of gastric mucosal lesions after ESD treatment were randomly assigned (1:1) to receive either intermittent low-dose or continuous high-dose PPIs treatment. After three days, all patients administered orally esomeprazole 40 mg once a day for 8 weeks. The primary endpoint was post-ESD bleeding within 7 days. Analysis was done according to the intention-to-treat principle with the non-inferiority margin (Δ) of 5%. RESULTS 526 consecutive patients were assessed for eligibility from 30 September 2017 to 30 July 2019, of whom 414 were randomly assigned to low-dose (n = 209) or high-dose (n = 205) esomeprazole treatment group without dropouts within7 days. The total post-ESD bleeding is occurred in 13 (6.2 %, 95 % CI 3.3-9.6) of 209 within 7 days in the intermittent low-dose group, and 12 (5.9 %, 95 % CI 2.9-9.3) of 205 in the continuous high-dose group. The absolute risk reduction (ARR) was 0.4 % (-4.2, 4.9). One month after ESD, There are 44 patients (21.1 %, 95 % CI 15.8, 26.8) and 39 patients (19.0 % 95 % CI 13.7, 24.4) in scar stage respectively in low-dose group and high-dose group (P = 0.875).The hospital costs in the low-dose PPI group was lower than high -dose group (P = 0.005). CONCLUSION The intermittent use of low-dose PPIs is sufficient to prevent post-ESD bleeding. It might be applied in clinical practice to prevent post-ESD bleeding and reduce the costs related to PPIs.
The therapeutic value of arthroscopic microfracture technique in combination with platelet-rich plasma injection for knee cartilage injury
American journal of translational research. 2021;13(4):2694-2701
OBJECTIVE The purpose of this study was to analyze the efficacy of platelet-rich plasma (PRP) injection combined with arthroscopic microfracture technique for knee cartilage injury. METHODS Seventy-nine patients with knee cartilage injury were randomly divided into a control group (CG, n=39) and an observation group (OBG, n=40). Both of the groups were treated with the arthroscopic microfracture technique, and the OBG was additionally treated with PRP injection. RESULTS The VAS scores for pain in the affected area of the OBG were lower than those of the CG at 1, 3, 5, and 7 days after surgery (P < 0.05). Knee flexion, hyperextension, and rotation angles in the OBG were greater than those in the CG at 1 month after surgery (P < 0.05). IKDC scores in the OBG were lower than those in the CG at 1, 2, and 3 weeks after surgery (P < 0.05). The Tegner and Lysholm scores in the OBG were higher than those in the CG at 1, 2, and 3 months after surgery (P < 0.05). The complication rate in the OBG was 10.00%, which was lower than that of 28.21% in the CG (P < 0.05). CONCLUSION The efficacy of microfracture technique combined with PRP injection in the treatment of knee joint cartilage injury is significantly improved compared with that of microfracture technique alone, which can reduce postoperative complications and improve the range of motion and function of the knee joint.
Effectiveness comparisons of drug therapies for postoperative aneurysmal subarachnoid hemorrhage patients: network meta‑analysis and systematic review
BMC neurology. 2021;21(1):294
OBJECTIVE To compare the effectiveness of various drug interventions in improving the clinical outcome of postoperative patients after aneurysmal subarachnoid hemorrhage (aSAH) and assist in determining the drugs of definite curative effect in improving clinical prognosis. METHODS Eligible Randomized Controlled Trials (RCTs) were searched in databases of PubMed, EMBASE, and Cochrane Library (inception to Sep 2020). Glasgow Outcome Scale (GOS) score, Extended Glasgow Outcome Scale (GOSE) score or modified Rankin Scale (mRS) score was used as the main outcome measurements to evaluate the efficacy of various drugs in improving the clinical outcomes of postoperative patients with aSAH. The network meta-analysis (NMA) was conducted based on a random-effects model, dichotomous variables were determined by using odds ratio (OR) with 95% confidence interval (CI), and a surface under the cumulative ranking curve (SUCRA) was generated to estimate the ranking probability of comparative effectiveness among different drug therapies. RESULTS From the 493 of initial citation screening, forty-four RCTs (n = 10,626 participants) were eventually included in our analysis. Our NMA results showed that cilostazol (OR = 3.35,95%CI = 1.50,7.51) was the best intervention to improve the clinical outcome of patients (SUCRA = 87.29%, 95%CrI 0.07-0.46). Compared with the placebo group, only two drug interventions [nimodipine (OR = 1.61, 95%CI 1.01,2.57) and cilostazol (OR = 3.35, 95%CI 1.50, 7.51)] achieved significant statistical significance in improving the clinical outcome of patients. CONCLUSIONS Both nimodipine and cilostazol have exact curative effect to improve the outcome of postoperative patients with aSAH, and cilostazol may be the best drug to improve the outcome of patients after aSAH operation. Our study provides implications for future studies that, the combination of two or more drugs with relative safety and potential benefits (e.g., nimodipine and cilostazol) may improve the clinical outcome of patients more effectively.
Postoperative outcomes of tranexamic acid use in geriatric trauma patients treated with proximal femoral intramedullary nails: A systematic review and meta-analysis
Orthopaedics & traumatology, surgery & research : OTSR. 2020
BACKGROUND Recently, there has been a series of clinical studies focusing on the perioperative administration of tranexamic acid (TXA) in geriatric trauma patients undergoing proximal femoral intramedullary nail surgery. However, the safety and efficacy of TXA in these patients remains controversial. Therefore, we performed a systematic review to focus on two questions: (1) would TXA reduce perioperative blood loss in geriatric trauma patients undergoing proximal femoral intramedullary nail surgery? and (2) would TXA increase the rate of perioperative complications in geriatric trauma patients undergoing proximal femoral intramedullary nail surgery? PATIENTS AND METHODS We systematically searched electronic databases (MEDLINE, EMBASE, PubMed, and Cochrane Central Register of Controlled Trials) up to April 20, 2019. The perioperative blood loss and complication data were extracted and analysed by RevMan Manager 5.3. RESULTS Finally, five randomized controlled studies, involving 539 geriatric intertrochanteric fracture patients undergoing proximal femoral intramedullary nail surgery, were enrolled in this systematic review. Compared with the control group, the TXA group had significantly lower total perioperative blood loss (WMD=-172.84; 95% CI, -241.44 to -104.24; I(2)=0%), intraoperative blood loss (WMD=-34.20; 95% CI, -46.04 to -22.36; I(2)=0%), total perioperative hidden blood loss (WMD=-139.05; 95% CI, -213.67 to -64.43; I(2)=0%), perioperative transfusion rates (RR =-0.16; 95% CI, -0.24 to -0.08; I(2)=22%), length of hospital stay (WMD=-1.18; 95% CI, -1.91 to -0.46; p=0.001; I2=12%), and postoperative wound haematoma rates (RD=-0.05; 95% CI, -0.09 to 0.00; p=0.03; I(2)=0%). In addition, there were no significant differences between TXA and control groups in the terms of surgical time, postoperative mortality, total thromboembolic events, wound infections, cerebrovascular accidents, respiratory infections, and renal failure. DISCUSSION TXA in geriatric trauma patients undergoing intramedullary nail surgery is effective for perioperative haemostasis without increasing the incidence of postoperative complications. LEVEL OF EVIDENCE II, Systematic review and Meta-analysis.
A randomised controlled trial of fibrinogen concentrate during scoliosis surgery
Bleeding and blood transfusion are common after scoliosis surgery. Fibrinogen is essential for blood clot formation and depletes quickly during haemorrhage. We randomly allocated 102 children 12-18 years old having surgery for idiopathic scoliosis, 51 to intra-operative fibrinogen concentrate 30 mg.kg(-1) (maximum 2 g) and 51 to saline placebo. Fibrinogen reduced peri-operative blood loss by a median (95%CI) volume of 155 (5-320) ml, from a median (IQR [range]) of 1035 (818-1420 [400-3030]) ml to 885 (755-1155 [270-2645]) ml, p = 0.04. Seven and four children received allogeneic red blood cell transfusion after fibrinogen and placebo, respectively, p = 0.34. There were no side-effects.
Patients between 12 to 18 years old having surgery for idiopathic scoliosis (n= 102).
Intraoperative fibrinogen concentrate (30 mg.kg−1, maximum 2 g), (n= 51).
Saline placebo (n= 51).
Fibrinogen concentrate infusion reduced median perioperative bleeding by about 155ml compared with placebo. Fibrinogen did not reduce postoperative blood transfusion or increase postoperative haemoglobin concentration.
The effect of adjunctive intravitreal conbercept at the end of diabetic vitrectomy for the prevention of post-vitrectomy hemorrhage in patients with severe proliferative diabetic retinopathy: a prospective, randomized pilot study
BMC ophthalmology. 2020;20(1):43
BACKGROUND To investigate the effect of intravitreal conbercept (IVC) injections on the incidence of postoperative vitreous hemorrhage (VH) in eyes undergoing surgery for severe proliferative diabetic retinopathy. METHODS This was a pilot prospective, comparative, and randomized study. Thirty patients, who underwent vitrectomy for severe proliferative diabetic retinopathy, were assigned randomly to either group 1 (intravitreal conbercept [IVC] injection at the end of pars plana vitrectomy) or group 2 (no IVC injection). Postoperative follow-up was performed on the first day, first week, first month, third month, sixth month and first year after surgery. The primary outcome was the incidence of postoperative VH. Secondary outcomes were the initial time of vitreous clearing (ITVC), best-corrected visual acuity (BCVA) and central retinal thickness (CRT) after surgery. RESULTS A total of 30 eyes, from 30 patients, were included. Fifteen eyes were enrolled in the IVC group and fifteen in the control group. The incidence of early and late postoperative VH was not significantly different between the control and IVC groups. ITVC was shorter in the IVC group than that in the control group, but this was not significant (7.38 +/- 10.66 vs 13.23 +/- 17.35, P = 0.31). Final BCVA, 1 year after surgery, showed significant improvement compared to baseline in both groups. However, analysis of the BCVA at any postoperative visit after surgery showed no significant differences between the two groups. There were two cases of recurrent VH identified at 3 and 6 months after surgery in each group, requiring a second round of surgery. Foveal thickness was significantly different between the two groups at the 3-month, 6-month and 1-year follow-up visits. CONCLUSIONS In this pilot study, the effect of IVC injection in reducing the incidence of postoperative VH after diabetic vitrectomy at the end of vitrectomy was not shown. TRIAL REGISTRATION The study was registered with the Chinese Clinical Trial Registry. (Reference Number: ChiCTR1800015751).
[Acupuncture artificial menstrual cycle method for abnormal uterine bleeding-ovulatory dysfunction (spleen deficiency syndrome)]
Zhongguo zhen jiu = Chinese acupuncture & moxibustion. 2019;39(5):489-94
OBJECTIVE To compare the clinical efficacy between acupuncture artificial menstrual cycle method and medication artificial menstrual cycle method for abnormal uterine bleeding-ovulatory (AUB-O) dysfunction (spleen deficiency syndrome). METHODS Sixty patients were randomly assigned into an observation group and a control group, 30 cases in each one. 3 cases dropped out in the observation group and 27 cases were included into analysis; 2 cases dropped out in the control group and 28 cases were included into analysis. The patients in the observation group were treated with acupuncture artificial menstrual cycle method. The acupoints were selected according to different stages of menstrual cycle. The acupuncture was given for 30 min per treatment, once every other day; no treatment was given during menstrual period. Xuehai (SP 10), Sanyinjiao (SP 6), Taixi (KI 3), Guanyuan (CV 4), Qihai (CV 6), Zusanli (ST 36) and Zhangmen (LR 13) were selected after menstrual period. Taichong (LR 3), Hegu (LI 4), Yaoyangguan (GV 3), Geshu (BL 17), Ganshu (BL 18), Sanyinjiao (SP 6), Pishu (BL 20) were selected in ovulaton periods. Baihui (GV 20), Shenshu (BL 23), Yaoyangguan (GV 3), Geshu (BL 17), Sanyinjiao (SP 6), Zusanli (ST 36), Gongsun (SP 4) were selected before menstrual period. The patients in the control group were treated with medication artificial menstrual cycle method. Femoston (estradiol tablets/estradiol dydrogesterone tablets) was taken orally. The white tablets were estradiol (1 mg), while the gray tablets were estradiol (1 mg) and dydrogesterone (10 mg). The Femoston was taken once a day, white tablets for the first 14 days, then gray tablets for the last 14 days. The 28-day treatment was taken as one session, and one cycle menstrual was taken as one treatment course, and totally 3 courses were given in the two groups. The clinical symptom score was observed before and after treatment as well as in follow-up visit (3 months after treatment). The clinical efficacy was evaluated based on the total effective rate, the marked effective rate of main symptoms (including menstrual cycle, menstrual period, menstrual volume) and basal body temperature (BBT). RESULTS 1 in circle Compared before treatment, the clinical symptom score in the two groups was decreased after treatment and in the follow-up visit (P<0.05). Compared with the control group, the clinical symptom score after treatment as well as the difference of that before and after treatment had no significant difference in the observation group (P>0.05). Compared with the control group, the clinical symptom score in the follow-up visit as well as the difference of that between pre-treatment and follow-up visit had significant difference in the observation group (P<0.05, P<0.01). 2 in circle The total effective rate was 81.5% (22/27) in the observation group and 85.7% (24/28) in the control group, without significant difference between the two groups (P>0.05). 3 in circle After treatment, the marked effective rate of menstrual cycle, menstrual period, menstrual volume had no significant difference between the two groups (P>0.05); during the follow-up visit, the marked effective rate of menstrual cycle in the observation group was superior to that in the control group (P<0.05), but that of menstrual period and menstrual volume had no significant difference between the two groups (P>0.05). 4 in circle After treatment, the diphasic curve rate of BBT had no significant difference between the two groups (P>0.05); during the follow-up visit, the diphasic curve rate of BBT in the observation group was higher than that in the control group (P<0.05). CONCLUSION Acupuncture artificial menstrual cycle method has superior efficacy for AUB-O dysfunction (spleen deficiency syndrome), which has similar efficacy with medication artificial menstrual cycle method. Moreover, acupuncture has advantages in regulating menstrual cycle and improving ovulation, and has a longer curative effect.
Motherwort injection for preventing postpartum hemorrhage in pregnant women with cesarean section: A systematic review and meta-analysis
Journal of Evidence-Based Medicine. 2018;11((4):):252-260
OBJECTIVE To assess the impact of motherwort injection alone or combined with oxytocin for preventing postpartum hemorrhage in pregnant women with caesarean section. METHODS A systematic review and meta-analysis of randomized trials were performed. PubMed, EMbase, The Cochrane Central Register of Controlled Trials (CENTRAL), Chinese database Sino-Med, Chinese National Knowledge Infrastructure Database (CNKI), VIP Chinese Science and Technique Journals Database, WanFang, and ClinicalTrials.gov were searched. Randomized controlled trials (RCTs) that compared motherwort injection alone or motherwort injection combined with oxytocin in pregnant women receiving cesarean section were included. Paired reviewers independently screened abstracts and full texts for eligibility, assessed risk of bias, and extracted data. We performed random-effects meta-analyses of RCTs along with a limited number of prespecified subgroup hypotheses, and sensitivity analyses were carried out with other statistical approaches. RESULTS Forty-six RCTs (n = 7359) proved eligible. Compared with oxytocin, both motherwort injection and motherwort injection combined with oxytocin had a significantly lower blood loss within 2 hours (MD = -21.81, 95% CI -37.05 to -6.58 and MD = -53.04, 95% CI -61.68 to -44.39); lower blood loss within 24 hours (MD = -25.44, 95% CI -39.38 to -11.51 and MD = -67.81, 95% CI -78.02 to -57.60); and lower the risk of adverse events (ORPeto 0.40, 95% CI 0.16 to 0.96 and ORPeto 0.50, 95% CI 0.35 to 0.71). Motherwort injection combined with oxytocin also decreased the risk of postpartum hemorrhage (OR 0.22, 95% CI 0.14 to 0.35.) CONCLUSIONS In pregnant women with cesarean section, motherwort injection suggests an obvious benefit and less adverse event.
Is wound drainage necessary in hip arthroplasty? A meta-analysis of randomized controlled trials
European Journal of Orthopaedic Surgery & Traumatologie. 2014;24((6):):939-46.
PURPOSE The use of closed suction drainage systems for hip arthroplasty (HA) is a common practice. However, the effectiveness and safety are still questionable. Thus, the aim of this meta-analysis was to review the advantages and adverse effects of closed suction drainage systems in hip arthroplasty. METHODS All randomized or quasi-randomized trials comparing the use of closed suction drainage systems with no drainage systems for hip arthroplasty were searched in PubMed, Medicine, EMBASE and other internet databases. We assessed the methodological quality of the studies and abstracted the relevant data independently. RESULTS Sixteen studies involving 1,663 participants with surgical wounds comparing HA with and without the use of drainage were included in our analysis. Our results demonstrated blood transfusion was required more frequently the same as the persistent discharge in those who received drains. No significant differences in the incidence of wound hematoma, dehiscence or deep vein thrombosis were found between those allocated to drains and the non-drained wounds. Wound infection and the range of movement of the joint after surgery were similar between the two groups. CONCLUSIONS Based on the current evidence, there is insufficient evidence to support the routine use of closed suction drainage in hip arthroplasty. At the same time, our meta-analysis study suggested that using of closed suction drainage in HA increased requirement for postoperative blood transfusion. However, there is a moderate possibility of selection bias and publication bias in this review. Because of the limited number of studies which may weaken the strength of the evidence of our results, more samples, high-quality randomized trials are needed to increase the reliability of evidences. LEVEL OF EVIDENCE II.
The use of adjunctive hemostatic agents in tubeless percutaneous nephrolithotomy: a meta-analysis
The purpose of the study was to systematically review and assess the safety and efficacy of hemostatic agents in tubeless percutaneous nephrolithotomy. Original studies on the use of hemostatic agents in tubeless percutaneous nephrolithotomy (PCNL) from January 2001 to March 2014 were searched in Ovid, Science Direct, Pubmed, and Embase by two independent reviewers. A drop in hemoglobin (Hb), analgesic requirements, length of hospital stay, and necessity for blood transfusions were compared using Review Manager 5.2. The methods were done according to the Cochrane Handbook for interventional systematic reviews and written based on the PRISMA Statement. Seven studies involving 351 patients met the inclusion criteria for the meta-analysis. The baseline characteristics were comparable in all of the studies. The results showed that the length of hospital stay was less in the experimental group than in the control group (P < 0.05). There were no significant statistical differences in terms of a drop in Hb, analgesic requirements, and the necessity for a blood transfusion between the two groups (P > 0.05). The meta-analysis indicated that the hemostatic agents in tubeless PCNL were not expected to be unsafe or mandatory, but that they were expected to be expensive. We concluded that hemostatic agents might not be necessary in tubeless PCNL.