1.
Efficacy of intrauterine Bakri balloon tamponade combined with ascending uterine artery ligation on postpartum hemorrhage
Ma G, Gao L, Li Q, Zhao X
American journal of translational research. 2021;13(5):4995-5002
Abstract
OBJECTIVE To observe the efficacy of intrauterine Bakri balloon tamponade (IBBT) combined with ascending uterine artery ligation (AUAL) in the treatment of postpartum hemorrhage (PPH) due to uterine inertia after cesarean section. METHODS A total of 92 patients with PPH due to uterine inertia after cesarean section were divided into a study group (n=46) and a control group (n=46) in accordance with the random number table. The control group was treated with IBBT alone, while the study group was treated with IBBT combined with AUAL. The clinical efficacies, hemorrhage, surgical duration, hospital stay, hemorrhage rate after removal of tamponade, recurrence rate of PPH, changes in coagulation function and quality of life were compared between the two groups. RESULTS The overall response rate (ORR) in the study group was 95.65%, remarkably higher than that of 80.43% in the control group (P < 0.05). The study group had a lesser amount of hemorrhage at 2 h and 24 h after surgery, a longer surgical duration, a shorter hospital stay, and lower hemorrhage rate after removal of tamponade and recurrence rate of PPH than the control group (P < 0.05). After treatment, prothrombin time, activated partial thromboplastin time and fibrinogen in the study group were markedly higher than those in the control group (P < 0.05). Compared with those before treatment, the scores of quality of life in the two groups were elevated at 3 months after treatment (P < 0.05), and the scores of quality of life in the study group were higher than those in the control group at 3 months after treatment (P < 0.05). CONCLUSION IBBT combined with AUAL can effectively alleviate hemorrhage and improve coagulation function and quality of life of patients with PPH due to uterine inertia after cesarean section, exhibiting a definite efficacy and a high safety profile.
2.
A multicenter, randomized phase III trial of hetrombopag: a novel thrombopoietin receptor agonist for the treatment of immune thrombocytopenia
Mei H, Liu X, Li Y, Zhou H, Feng Y, Gao G, Cheng P, Huang R, Yang L, Hu J, et al
Journal of hematology & oncology. 2021;14(1):37
Abstract
BACKGROUND Hetrombopag, a novel thrombopoietin receptor agonist, has been found in phase I studies to increase platelet counts and reduce bleeding risks in adults with immune thrombocytopenia (ITP). This phase III study aimed to evaluate the efficacy and safety of hetrombopag in ITP patients. METHODS Patients who had not responded to or had relapsed after previous treatment were treated with an initial dosage of once-daily 2.5 or 5 mg hetrombopag (defined as the HETROM-2.5 or HETROM-5 group) or with matching placebo in a randomized, double-blind, 10-week treatment period. Patients who received placebo and completed 10 weeks of treatment switched to receive eltrombopag, and patients treated with hetrombopag in the double-blind period continued hetrombopag during the following open-label 14-week treatment. The primary endpoint was the proportion of responders (defined as those achieving a platelet count of ≥ 50 × 10(9)/L) after 8 weeks of treatment. RESULTS The primary endpoint was achieved by significantly more patients in the HETROM-2.5 (58.9%; odds ratio [OR] 25.97, 95% confidence interval [CI] 9.83-68.63; p < 0.0001) and HETROM-5 (64.3%; OR 32.81, 95% CI 12.39-86.87; p < 0.0001) group than in the Placebo group (5.9%). Hetrombopag was also superior to placebo in achieving a platelet response and in reducing the bleeding risk and use of rescue therapy throughout 8 weeks of treatment. The durable platelet response to hetrombopag was maintained throughout 24 weeks. The most common adverse events were upper respiratory tract infection (42.2%), urinary tract infection (17.1%), immune thrombocytopenic purpura (17.1%) and hematuria (15%) with 24-week hetrombopag treatment. CONCLUSIONS In ITP patients, hetrombopag is efficacious and well tolerated with a manageable safety profile. Trial registration Clinical trials.gov NCT03222843 , registered July 19, 2017, retrospectively registered.
3.
Naoxueshu relieves hematoma after clot removal in acute spontaneous intracerebral hemorrhage
Song J, Nie Y, Wang P, Lu H, Gao L
Brain and behavior. 2020;:e01957
Abstract
OBJECTIVES Surgical treatment is expected to remove clot immediately in acute spontaneous intracerebral hemorrhage (SICH) patients. The aim of this study was to evaluate whether Naoxueshu could enhance the efficacy of clot removal surgery in acute SICH patients. METHODS One hundred twenty patients who had been diagnosed as SICH according to neuroimaging were enrolled in this study. They received craniotomy, decompressive craniectomy, or minimally invasive surgical evacuation as appropriate and then were randomized into two groups: the Naoxueshu group (NXS group, n = 60) and the control group (n = 60). All the patients received standard medical management while patients in NXS group also took Naoxueshu oral liquid 10 ml with three times a day for seven consecutive days. The primary outcome was the 7-day hematoma volume and secondary outcomes were 7-day National Institutes of Health Stroke Scale (NIHSS) score and 7-day cerebral edema score. RESULTS After clot removal surgery, hematoma volume in NXS group (9.5 ± 8.0) was significantly decreased than that in Control group (21.3 ± 22.9, p < .0001) 7 days after surgery. Moreover, cerebral edema was also relieved after 7-day's Naoxueshu treatment (2.5 ± 0.9 vs. 2.9 ± 0.7, p = .043). Since patients in NXS group had worse baseline NIHSS score (17.2 ± 8.1 vs. 13.7 ± 10.1, p = .039), it was reasonable to conclude that Naoxueshu treatment could improve patients' neurological function because 7-day NIHSS score of the two groups was similar. CONCLUSION Naoxueshu oral liquid could relieve hematoma volume and cerebral edema after clot removal surgery in acute SICH patients. Moreover, it had the potential to improve patients' short-term neurological function.