OBJECTIVE: To compare the clinical efficacy between penetrating needling of three eye acupoints combined with sodium hyaluronate eye drops and sodium hyaluronate eye drops alone for the treatment of dry eye. METHODS: A total of 156 patients (312 eyes) with dry eye were randomly assigned to an observation group and a control group, with 78 patients (156 eyes) in each group. The control group was treated with sodium hyaluronate eye drops, one drop per eye, four times daily, for 4 weeks. In addition to the sodium hyaluronate treatment, the observation group received penetrating needling of three eye acupoints. Acupoints included bilateral Cuanzhu (BL2), Sizhukong (TE23), Sibai (ST2), and Jingming (BL1). Needling was performed once daily, four times a week, for 4 weeks. The subjective ocular symptom scores, neuropathic pain symptom inventory-eye (NPSI-Eye) scores, ocular surface disease index (OSDI) scores, corneal fluorescein staining (FL) scores, tear break-up time (BUT), SchirmerⅠtest (SⅠT), central tear meniscus height (TMH), and tear levels of interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α) were evaluated before and after treatment in the two groups. Clinical efficacy was also compared between the two groups. RESULTS: After treatment, both groups showed significant improvements in subjective ocular symptom scores, NPSI-Eye scores, OSDI scores, FL scores, and reductions in tear IL-6 and TNF-α levels (P<0.01). Additionally, BUT, SⅠT, and TMH were increased significantly in both groups (P<0.01). After treatment, the subjective ocular symptom scores, NPSI-Eye score, OSDI score, FL score, and tear levels of IL-6 and TNF-α in the observation group were lower than those in the control group (P<0.01, P<0.05), while BUT, SⅠT, and TMH were significantly improved compared to the control group (P<0.01). The markedly effective rate and total effective rate in the observation group were 83.3% (65/78) and 100.0% (78/78), respectively, which were higher than 52.6% (41/78, P<0.01) and 92.3% (72/78, P<0.05) in the control group. CONCLUSION The penetrating needling of three eye acupoints combined with sodium hyaluronate eye drops can effectively alleviate symptoms of dry eye, reduce inflammatory response, and has superior efficacy to sodium hyaluronate eye drops alone.
Humans ; Hyaluronic Acid/administration & dosage* ; Male ; Female ; Dry Eye Syndromes/genetics* ; Middle Aged ; Acupuncture Points ; Ophthalmic Solutions/administration & dosage* ; Adult ; Aged ; Treatment Outcome ; Acupuncture Therapy ; Interleukin-6/genetics* ; Young Adult ; Tumor Necrosis Factor-alpha/metabolism*

OBJECTIVE: To evaluate the risks and benefits of different resuscitation fluids in patients with early sepsis and septic shock by observing and comparing clinical indicators, clinical outcomes, and the concentration changes of glycocalyx biomarkers, and to determine how to appropriately select suitable resuscitation fluids for sepsis patients to aid fluid therapy. METHODS: A single center, prospective, randomized controlled trial was conducted. Patients with early sepsis and septic shock who have required fluid resuscitation after capacity status assessment admitted to the department of critical care medicine of Fourth Hospital of Hebei Medical University from April to October 2023 were enrolled. Patients were randomly assigned to either the experimental group (balanced crystalloid solution+albumin) or the control group (balanced crystalloid solution) by a random number table method. Clinical data of both groups of patients before and after resuscitation at 3, 8, and 24 hours were monitored, and blood samples were collected, enzyme-linked immunosorbent assay (ELISA) was used to measure the concentration of plasma glycocalyx biomarker syndecan-1. The 28-day and 90-day survival rates and complications were also assessed. RESULTS: A total of 66 patients were enrolled, including 44 in the experimental group and 22 in the control group. The baseline data of two groups were balanced and comparable. There was no statistically significant difference in the plasma concentration of syndecan-1 between the experimental group and the control group before and after resuscitation, and both showed a trend of first increasing and then decreasing. However, the plasma syndecan-1 level in the control group at 8 hours and 24 hours after resuscitation were significantly higher than the baseline level before resuscitation [ng/L: 19.02 (14.41, 27.80), 18.95 (12.40, 22.50) vs. 14.67 (11.57, 21.14), both P < 0.05], while there was no statistically significant difference at any time point within the experimental group. The correlation analysis between plasma syndecan-1 level and lactic acid, albumin, and sequential organ failure assessment (SOFA) in all patients showed that a positive correlation between syndecan-1 level and SOFA score before resuscitation (r = 0.247, P = 0.046), and a negative correlation between syndecan-1 level and albumin level at 24 hours after resuscitation (r = -0.308, P = 0.012). There were no statistically significant differences in 28-day and 90-day mortality, length of hospital stay, length of intensive care unit (ICU) stay, duration of mechanical ventilation, blood purification time, number of organ injuries, and complications between the two groups. However, the baseline albumin level in the experimental group was significantly lower than that in the control group (g/L: 28.7±4.5 vs. 31.6±4.2, P < 0.05). Analysis of clinical treatment data showed that compared with the control group, the experimental group had lower absolute lactate level at 8 hours and 24 hours after resuscitation [mmol/L: 8 hours was 1.30 (1.00, 1.88) vs. 1.60 (1.30, 3.05), 24 hours was 1.15 (0.80, 1.78) vs. 1.55 (1.08, 2.05), both P < 0.05], and higher lactate clearance rate [8 hours was 45% (27%, 56%) vs. 20% (-4%, 46%), 24 hours was 55% (34%, 70%) vs. 34% (-14%, 59%), both P < 0.05]. However, there were no statistically significant differences in the amount of fluid resuscitation, use of vasoactive drugs, and oxygenation index between the two groups during the resuscitation process. Multivariate Logistic regression analysis showed that body mass index (BMI) was independently correlated with 90-day mortality [odds ratio (OR) = 1.991, 95% confidence interval (95%CI) was 1.023-3.387, P = 0.043]. CONCLUSIONS There are no significant difference in plasma syndecan-1 level during fluid resuscitation of early sepsis and septic shock patients using balanced crystalloid fluid and balanced crystalloid fluid combined with albumin resuscitation, and there are no statistically significant differences in the impact on 28-day and 90-day prognosis, length of hospital stay, complications, and other aspects of the patients. However, compared to balanced crystalloid fluid, the combination of balanced crystalloid fluid and albumin for fluid resuscitation in sepsis patients has lower lactate level and better lactate clearance effect, but further validation is still needed through large-scale randomized controlled trials.
Humans ; Clinical Relevance ; Crystalloid Solutions/administration & dosage* ; Fluid Therapy/methods* ; Glycocalyx/metabolism* ; Isotonic Solutions/administration & dosage* ; Prospective Studies ; Resuscitation/methods* ; Sepsis/therapy* ; Shock, Septic/therapy* ; Syndecan-1/blood*

PURPOSE: The measurement of heart rate variability (HRV) is a non-invasive method to analyze the balance of the autonomic nervous system. The aim of this study was to compare the changes of HRV and base deficit (BD) during the treatment of trauma patients. METHODS: Forty-three trauma patients with a low injury severity scores (ISS < 24) and negative base excess on admission were included in this study. Based on the BD changes, patients were divided into three groups: 'end pointed' group (n = 13), patients' BDs instantly cleared after primary hydration; 'needs further resuscitation' group (n = 21), patients' BDs did not reach the end point and thus required further hydration or packed red blood cells transfusion; and 'hydration minimal change' group (n = 9), patients' BDs lower than 2.5 mmol/L at the onset of admission and thereafter had minimal change (near normal range). The changes in HRV during fluid resuscitation were detected and compared to BD changes in their arterial blood gases. All data were analysed using the SPSS software Version 15.0. Repeated measures ANOVA was used to determine the changes in HRV, heart rate, blood pressure, and BD among groups. RESULTS: A significant reverse correlation was found between the BD ratio and the HRV ratio (r = -0.562; p = 0.01). The HRV of patients with aggravated BDs after fluid resuscitation was decreased. There was an increase in HRV at the time of BD clearance. A decrease in HRV after primary crystalloid hydration bore a significant connection with the need for an ICU (p = 0.021) and transfusion of packed red blood cells (p < 0.001). CONCLUSION Increase in HRV may be a new non-invasive index for the end point of resuscitation in trauma patients.
Adolescent ; Adult ; Aged ; Autonomic Nervous System ; physiopathology ; Crystalloid Solutions ; administration & dosage ; Fluid Therapy ; Heart Rate ; Humans ; Injury Severity Score ; Middle Aged ; Resuscitation ; methods ; Wounds and Injuries ; diagnosis ; physiopathology ; Young Adult

OBJECTIVE: To develop methods for determining a suitable sample size for bioequivalence assessment of generic topical ophthalmic drugs using crossover design with serial sampling schemes. METHODS: The power functions of the Fieller-type confidence interval and the asymptotic confidence interval in crossover designs with serial-sampling data are here derived. Simulation studies were conducted to evaluate the derived power functions. RESULTS: Simulation studies show that two power functions can provide precise power estimates when normality assumptions are satisfied and yield conservative estimates of power in cases when data are log-normally distributed. The intra-correlation showed a positive correlation with the power of the bioequivalence test. When the expected ratio of the AUCs was less than or equal to 1, the power of the Fieller-type confidence interval was larger than the asymptotic confidence interval. If the expected ratio of the AUCs was larger than 1, the asymptotic confidence interval had greater power. Sample size can be calculated through numerical iteration with the derived power functions. CONCLUSION The Fieller-type power function and the asymptotic power function can be used to determine sample sizes of crossover trials for bioequivalence assessment of topical ophthalmic drugs.
Administration, Topical ; Clinical Trials as Topic ; methods ; Cross-Over Studies ; Humans ; Models, Theoretical ; Ophthalmic Solutions ; pharmacokinetics ; Sample Size ; Therapeutic Equivalency

Pleural effusion after hepatectomy is associated with significant morbidity and prolonged hospital stays. Several studies have addressed the risk factors for postoperative pleural effusion. However, there are no researches concerning the role of the initial 12-h operative fluid volume. The aim of this study was to evaluate whether the initial 12-h operative fluid volume during liver resection is an independent risk factor for pleural effusion after hepatectomy. In this study, we retrospectively analyzed clinical data of 470 patients consecutively undergoing elective hepatectomy between January 2011 and December 2012. We prospectively collected and retrospectively analyzed baseline and clinical data, including preoperative, intraoperative, and postoperative variables. Univariate and multivariate analyses were carried out to identify whether the initial 12-h operative fluid volume was an independent risk factor for pleural effusion after hepatectomy. The multivariate analysis identified 2 independent risk factors for pleural effusion: operative time [odds ratio (OR)=10.2] and initial 12-h operative fluid volume (OR=1.0003). Threshold effect analyses revealed that the initial 12 h operative fluid volume was positively correlated with the incidence of pleural effusion when the initial 12-h operative fluid volume exceeded 4636 mL. We conclude that the initial 12-h operative fluid volume during liver resection and operative time are independent risk factors for pleural effusion after hepatectomy. Perioperative intravenous fluids should be restricted properly.
Adult ; Aged ; Female ; Fluid Therapy ; adverse effects ; Hepatectomy ; adverse effects ; methods ; Humans ; Male ; Middle Aged ; Operative Time ; Pleural Effusion ; epidemiology ; etiology ; Postoperative Complications ; epidemiology ; etiology ; Rehydration Solutions ; administration & dosage ; adverse effects

PURPOSE: Dry eye syndrome is commonly thought of as an inflammatory disease, and we have previously presented data showing the effectiveness of topical TNF-α blocker agents for the treatment of this condition. The purpose of this study was to investigate the effectiveness of the TNF-α blocking agent HL036337 compared to cyclosporine A for the treatment of dry eye induced inflammation in order to establish whether HL036337 represents a more effective method for suppressing inflammation. The efficacy of HL036337 and cyclosporine A was determined using an experimental murine dry eye model. METHODS: The TNF-α blocker HL036337 is a modified form of TNF receptor I. Using dry eye induced C57BL/6 mice (n = 45), corneal erosion was measured at day 4 and 7 after topical treatment with cyclosporine A or HL036337. To determine the effective treatment dose, 0.25, 0.5, 1, 2.5, and 5 mg/mL of HL036337 were topically administered twice per day to dry eye induced murine corneas for 1 week. RESULTS: The optimal concentration of the TNF-α blocker HL036337 for treatment of dry eye induced corneal erosion was determined to be 1 mg/mL. Dry eye induced corneal erosion was improved after 1 week with topically applied cyclosporine A and HL036337 at 1 mg/mL. CONCLUSIONS: HL036337 administered topically at 1 mg/mL effectively improved corneal erosion induced by dry eye. This finding may also suggest that inhibition of TNF-α can improve dry eye syndrome.
Animals ; Cornea/diagnostic imaging ; Disease Models, Animal ; Dose-Response Relationship, Drug ; Dry Eye Syndromes/diagnosis/*drug therapy ; Female ; Mice ; Mice, Inbred C57BL ; Microscopy, Acoustic ; Ophthalmic Solutions/administration & dosage ; Tumor Necrosis Factor-alpha/*antagonists & inhibitors

OBJECTIVETo investigate the efficacy of oral sweet solutions in relieving pain caused by vaccination in infants aged 1 to 12 months.

METHODSRelated databases were searched to find related randomized control trails (RCTs). The quality of these RCTs was evaluated. The Meta analysis was performed using RevMan 5.3.

RESULTSA total of 20 RCTs involving 2 376 infants were included, and quality assessment showed that 6 RCTs had grade A quality and 14 had grade B quality. The Meta analysis showed that compared with sterile water, 25%-75% oral sweet solution significantly reduced crying time (WMD=-21.16, 95%CI -39.66 to -2.77, P<0.05) and the proportion of crying time (the duration of crying /3-minute periods after the injection) (WMD=-13.83, 95%CI -20.88 to -6.78, P<0.01), while the crying time showed no significant difference between the group treated with oral administration of 12% sucrose solution and non-intervention group. Co

ONCLUSIONSOral sweet solution (25%-75%; 2 mL) given 2 minutes before vaccination can effectively relieve the pain caused by vaccination in infants aged 1-12 months.

Crying ; Humans ; Infant ; Pain ; prevention & control ; Solutions ; Sucrose ; administration & dosage ; Vaccination ; adverse effects

OBJECTIVETo dicuss the clinical efficacy of Timolol Maleate Eye Drops in the treatment of superficial infantile hemangiomas. Methods From April 2012 to May 2014, 210 patients with superficial infantile hemangiomas were included. According to the parents' choice, a total of 176 cases were treated with Timolol Maleate Eye Drops as the treatment group, and the 34 cases who received the treatment of "wait and see" was included in the control group. In the treatment group, the gauzes were dipped into the eye drops and putted evenly on the surface of the hemangioma, 3-4 times daily and lasted for more than 20 minutes. The gauze should completely cover the surface of the tumor. The follow-up periods were 3 weeks and 6 months after treatment with the pictures to record the treatment effect. The therapeutic effect was graded as: grade I (unable to control the growth of the hemangioma), II (the growth of the hemangioma stagnated), III (hemangioma significantly subsided), IV (the hemangioma completely disappeared). The effective rate included the cases with grade II and above grade II . The cure cases included the cases with grade IV. The data was analyzed with the statistical software SPSS 17.0 and the Chi-square test (P < 0.05).

RESULTS3 cases in the treatment group showed eczema action. Tumor ulcer happened in 1 case in treatment group. The side effect rate was 2.3% . The results at 3 weeks following in the treatment group showed that the growth of the hemangioma were stagnated in 154 cases. The color of hemangioma became darker in different degrees than before, and the texture of the hemangioma became soft in majority of children, and the thickness of hemangioma became thinner in some cases. However, only 4 cases showed the hemangiomas were subsided, 18 cases showed the color of the part of the hemangiomas were brighter than before, and 12 cases of the hemangiomas remained original state in the control group. The results of 6 weeks following the treatment showed that 18 patients in the treatment group reached the standard of the grade IV, 84 patients reached the standard of the grade III, 60 patients achieved in the standard of grade II, and only 14 patients showed the volume of hemangiomas were increased as grade I. The effective rate was 58. 0% , and the cure rate was 10. 2% in treatment group. In control group, no children reached the standard of the grade IV, 4 cases reached the standard of grade III, 13 cases who remained original state reached the standard of grade II, and 17 cases showed the volume of hemangiomas continued to increase as grade I . The effective rate was 11. 8% , and the cure rate was 0. By comparison, the effective rate and the cure rate in the control group were relatively lower than those in the treatment group (P < 0.05).

CONCLUSIONSThe efficacy of Timolol Maleate Eye Drops in the treatment of superficial infantile hemangioma is exact, especially in the proliferative phase of the infantile hemangioma. It is safe and easy to perform with mild side effect. It should be selected as first-line treatment.

Administration, Topical ; Adrenergic beta-Antagonists ; administration & dosage ; Child ; Hemangioma ; drug therapy ; Humans ; Ophthalmic Solutions ; administration & dosage ; Skin Neoplasms ; drug therapy ; Timolol ; administration & dosage ; adverse effects ; Treatment Outcome ; Watchful Waiting

BACKGROUND/AIMS: To evaluate the efficacy of proton pump inhibitors (PPIs) in reducing rebleeding and bleeding-related death rates after endoscopic gastric variceal obliteration (GVO) using N-butyl-2-cyanoacrylate (NBC). METHODS: This study enrolled 341 patients who were consecutively diagnosed with and treated for bleeding gastric varices. The patients were divided into PPI and non-PPI groups, and their endoscopic findings, initial hemostasis outcomes, rebleeding and bleeding-related death rates, and treatment-related complications were analyzed. RESULTS: The rate of initial hemostasis was 97.1%. rebleeding occurred in 2.2% of patients within 2 weeks, 3.9% of patients within 4 weeks, 18.9% of patients within 6 months, and 27.6% of patients within 12 months of the GVO procedure. A previous history of variceal bleeding (relative risk [RR], 1.955; 95% confidence interval [CI], 1.263 to 3.028; p = 0.003) and use of PPIs (RR, 0.554; 95% CI, 0.352 to 0.873; p = 0.011) were associated with rebleeding. Child-Pugh class C (RR, 10.914; 95% CI, 4.032 to 29.541; p < 0.001), failure of initial hemostasis (RR, 13.329; 95% CI, 2.795 to 63.556; p = 0.001), and the presence of red-colored concomitant esophageal varices (RR, 4.096; 95% CI, 1.320 to 12.713; p = 0.015) were associated with bleeding-related death. CONCLUSIONS: The prophylactic use of PPIs reduces rebleeding after GVO using NBC in patients with gastric variceal hemorrhage. However, prophylactic use of PPIs does not reduce bleeding-related death.
Adult ; Aged ; Aged, 80 and over ; Chi-Square Distribution ; Enbucrilate/*administration & dosage/adverse effects ; Endoscopy, Gastrointestinal ; Esophageal and Gastric Varices/complications/diagnosis/mortality/*therapy ; Female ; Gastrointestinal Hemorrhage/diagnosis/etiology/mortality/*therapy ; Hemostasis, Endoscopic/adverse effects/*methods/mortality ; Humans ; Logistic Models ; Male ; Middle Aged ; Multivariate Analysis ; Odds Ratio ; Proton Pump Inhibitors/adverse effects/*therapeutic use ; Recurrence ; Retrospective Studies ; Risk Factors ; Sclerosing Solutions/*administration & dosage/adverse effects ; Sclerotherapy/adverse effects/*methods/mortality ; Time Factors ; Treatment Outcome ; Young Adult

PURPOSE: To evaluate and compare the toxic effects of eyedrops containing a fixed combination of 2.0% dorzolamide and 0.5% maleate timolol with or without preservatives on rabbit corneal endothelium. METHODS: This study was performed with 22 eyes of New Zealand white rabbits. Dorzolamide/timolol eyedrops with preservative (Cosopt group) or without preservative (Cosopt-S group) were diluted with a balanced salt solution at a 1 : 1 ratio. We injected 0.1 mL of diluted Cosopt into the anterior chamber of left eyes and an equal volume of diluted Cosopt-S into the anterior chamber of right eyes. Corneal thickness, corneal haze, and conjunctival injection were measured before and 24 hours after treatment. Endothelial damage was compared between both eyes by vital staining (alizarin red/trypan blue staining), live/dead cell assay, TUNEL assay, and scanning electron microscopy. RESULTS: Corneal endothelial damage was severe in the Cosopt group. Cosopt-treated eyes exhibited remarkable corneal edema and prominent apoptosis of endothelial cells. In addition, the live/dead cell assay revealed many dead cells in the endothelium, and scanning electron microscopy analysis showed that corneal endothelial cells exhibited a partial loss of microvilli on the surface as well as extensive destruction of intercellular junctions. However, in the Cosopt-S group, corneal edema was mild and the damage to the corneal endothelium was minimal. CONCLUSIONS: The main cause of corneal endothelial toxicity was due to the preservative in the dorzolamide/timolol fixed combination eyedrops, and not the active ingredient. Thus, it appears to be safer to use preservative-free eyedrops during the early postoperative period.
Animals ; Anterior Chamber/drug effects ; Apoptosis ; Corneal Edema/chemically induced/*pathology ; Disease Models, Animal ; Drug Combinations ; Endothelium, Corneal/drug effects/*pathology ; In Situ Nick-End Labeling ; Ophthalmic Solutions ; Rabbits ; Sulfonamides/administration & dosage/*toxicity ; Thiophenes/administration & dosage/*toxicity ; Timolol/administration & dosage/*toxicity