Objective To prospectively evaluate the safety and therapeutic efficacy ofdalteparin in patients with high risk non-ST- elevation acute coronary syndromes (ACS) during percutaneous coronary intervention (PCI). Met...Objective To prospectively evaluate the safety and therapeutic efficacy ofdalteparin in patients with high risk non-ST- elevation acute coronary syndromes (ACS) during percutaneous coronary intervention (PCI). Methods A total of 175 patients with high risk non-ST-elevation ACS were randomly assigned to 2 groups [dalteparin group and unfractionated heparin (UFH) group]. The patients in dalteparin group were given dalteparin at a dose of 5,000U subcutaneously soon after diagnosis and then an additional 60U/ kg intravenous bolus ofdalteparin before emergent PCI. Vascular access sheaths were removed immediately after PCI or coronary artery angiography; the patients in UFH group were given UFH intravenously at a dose of 25mg just before PCI and an additional 65mg bolus was administered if angiographic findings showed that the patients were suitable for percutaneous transluminal coronary angioplasty (PTCA). Sheaths were removed at 4-6 hours after PCI; Results Eighty-three patients in dalteparin group underwent PCI while 82 patients in UFH group underwent PCI; anti-Xa activities of 52 patients in daltepafin group were measured. The average anti-Xa activity was (0. 83± 0.26) U/ml at 15 minutes after intravenous injection of dalteparin and anti-Xa〉0.SU/ml was obtained in 96.1% of the patients; hematomas at puncture sites were significantly fewer in dalteparin group as compared with UFH group (2.3% vs 9.2%, P 〈 0.05); none of the patients in 2 groups suffered major bleeding events. No death, acute arterial reocclusion or emergent revascularization events occurred at 30 days after PCI. Conclusions Our study demonstrated that early subcutaneous injection ofdalteparin at a dose 5,000U after diagnosis and an additional 60U/kg intravenous bolus ofdalteparin before PCI is safe and efficacious for patients with high risk non-ST-elevation ACS undergoing emergent PCI.展开更多
There is the deviation on the understanding of acupuncture "safety" in healthcare research and the development of international standards. How to interpret and contextualize the "safety" is the point to break thro...There is the deviation on the understanding of acupuncture "safety" in healthcare research and the development of international standards. How to interpret and contextualize the "safety" is the point to break through it. In the aspects of contextual elements and stakeholders, using the literature reviews and theoretic approach, the concept of "safety" is attempted to be specified and the differences between health care research and international standard development to be discussed. The article aims to outline the general conceptual framework of "safety". Consequently, an approach is explored to the term-based analysis in acupuncture international standard development.展开更多
Objective To discuss the individualized operation standard and its safety on the deep acupuncture at Tianshu (天枢 ST 25). Methods Acupuncture was applied to Tianshu (天枢 ST 25)) in 39 patients. The individualiz...Objective To discuss the individualized operation standard and its safety on the deep acupuncture at Tianshu (天枢 ST 25). Methods Acupuncture was applied to Tianshu (天枢 ST 25)) in 39 patients. The individualized standard depth of insertion at the acupoint was determined as the penetrating the peritoneum with needle by 1 to 2 mm. The regression analysis was adopted to analyze the impacts of abdominal circumference (AC, cm) on the peritoneal position via CT cross-section scanning and image survey. Results The formula of rational needling depth at Tianshu (天枢 ST 25) with individualized deep acupuncture was: depth=-0.562+0.045. AC. Conclusion The depth of insertion at Tianshu (天枢 ST 25), determined as penetrating the peritoneum with needle by 1 to 2 mm is safe and feasible, which may be applicable and have the guidance significance for the assessment of clinical operation and safety on the deep acupuncture at the other acupoints on the abdominal region.展开更多
OBJECTIVE: To assess the effectiveness and safety of Kuntai capsule and hormone replacement therapy in treatment of perimenopausal syndrome.METHODS: Articles were retrieved from the databases Cochrane Database of Syst...OBJECTIVE: To assess the effectiveness and safety of Kuntai capsule and hormone replacement therapy in treatment of perimenopausal syndrome.METHODS: Articles were retrieved from the databases Cochrane Database of Systematic Reviews,Pub Med, Chinese National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Database. Only randomized controlled trials were included; 15 trials involving1243 patients were identified from January 2005 to April 2015. A systemic review and Meta-analysis of publications was performed. The review was limit-ed to randomized controlled trials that compared Kuntai capsule and hormone replacement therapy to treat perimenopausal syndrome for at least 3months. The primary outcome assessed was the treatment efficacy at 3 months, including effective rate of Kupperman menopausal scores, Kupperman menopausal scores, and blood estradiol(E2) or blood follicle stimulating hormone(FSH) levels.Other outcomes assessed were safety or adverse events, such as gastrointestinal complaints, breast distending pain, or vaginal bleeding.RESULTS: Kupperman menopausal scores showed no significant difference in effective rate [odds ratio(OR): 1.05, 95% confidence intervals(CI): 0.71 to1.55] and changes in FSH level [mean difference(MD): 2.14, 95% CI:-2.36 to 6.65]. There was a significant statistical difference in Kupperman menopausal scores(MD:-1.14, 95% CI:-2.03 to-0.25)and changes in E2level(MD:-16.41, 95% CI:-18.83to-13.69). There were fewer adverse events in the Kuntai capsule group than in the hormone replacement therapy group(OR: = 0.35, 95% CI: 0.25 to0.48, P < 0.01).CONCLUSION: Compared with hormone replacement therapy, Kuntai capsule can improve perimenopausal symptoms and blood E2 levels, and reduce the incidence of adverse events.展开更多
Purpose: To evaluate the efficacy of intramedullary Kirschner wires for the treatment of unstable tibial shaft fractures in children. Methods: This prospective study was conducted at the Department of Orthopaedic Su...Purpose: To evaluate the efficacy of intramedullary Kirschner wires for the treatment of unstable tibial shaft fractures in children. Methods: This prospective study was conducted at the Department of Orthopaedic Surgery in Maharishi Markandeshwar Medical College from June 2005 to June 2010. Sixty-six children having closed fracture of the tibial shaft with a mean age of 7.7 years (range, 2-14 years) were recruited from emergency and outpatient department. They were treated with percutaneous intramedullary Kirschner wires. The clinical results of our study were rated on the basis of the criteria of union, nonunion, delayed union or malunion. All children were followed for one year. Results: Children achieved union in a mean time of 8 weeks (range, 6-10 weeks). Postoperatively, three children (4.55%) had delayed union, one (1.52%) valgus deformity of lower leg, three (4.55%) post- operative knee pain and twelve (18.18%) skin irritation at pin site. Wires were removed after 8-22 weeks without any complications. No patient was lost to follow-up. The results were excellent in 95.45% and good in 4.55% children. Conclusion: This technique is cost-effective, simple, quick to perform, safe and reliable and avoids pro- longed hospitalization with good results.展开更多
Objective: To compare the risk angle and safety angle of n eedli ng Ya me n (GV 15) betwee n the atla nto-axial dislocati on (AAD) patients and healthy subjects. Methods: A total of 177 AAD patients diagnosed and trea...Objective: To compare the risk angle and safety angle of n eedli ng Ya me n (GV 15) betwee n the atla nto-axial dislocati on (AAD) patients and healthy subjects. Methods: A total of 177 AAD patients diagnosed and treated at the Center of Upper Cervical Vertebra of Beijing Chin a-Japa n Frie ndship Hospital betwee n January 2010 and January 2018 were in eluded in the AAD group. Ano ther 207 healthy subjects were included in the normal group. There were totally 191 males and 193 females. The MRI sean was performed for the cervical vertebrae to measure the risk angle and safety angle of acup un cture at Ya me n (GV 15) on the sagittal image. Results: In the AAD group, the risk angle was (13.14±3.99)° and the relative safety angle was (10.31±3.23)° for the perpendicular needling, while the oblique needling risk angle was (9.09±3.09)° for the male;the risk angle was (12.12±2.74)° and the relative safety angle was (10.56±2.09)° for the perpendicular needling, while the oblique needling risk angle was (9.70±2.95)° for the female. In the normal group, the risk angle was (7.89±1.59)° and the relative safety angle was (10.21±3.55)° for the perpendicular needling, while the oblique needling risk angle was (16.07±1.77)° for the male;the risk angle was (6.93±1.45)° and the relative safety angle was (10.70±2.94)° for the perpendicular needling, while the oblique needling risk angle was (14.89±2.18)° for the female. The perpendicular needling risk angles for the males and females in the AAD group were larger than those in the normal group, and the differences were statistically significant (both P<0.01);for the inner-group comparison, there was no sigrHficant difference in the perpendicular needling risk angle between the male and the female in the AAD group (P>0.05);however, the perpendicular needling risk angle for the male was larger than the female, and the differenee was statistically significant in the normal group (P<0.01). There were no sign讦icant differences in the relative safety angle for both the male and the female between the AAD group and the normal group (both P>0.05). For the inner-group comparison, there was no sign讦icant differenee in the relative safety angle between the male and the female (P>0.05). The oblique needling risk angles for both the males and females were smaller in the AAD group than those in the normal group, and the differences were statistically sign讦icant (both P<0.01);the oblique needling risk angle for the male was not significantly different from that for the female in the AAD group (P>0.05);in the normal group, the oblique needling risk angle for the male was larger than that for the female, and the differenee was statistically significant (P<0.01). Conclusion: Un der the AAD condition, the risk angle and safety angle of acup un cture at Ya me n (GV 15) cha nge significantly, perpe ndicular n eedli ng should be better if performed slightly lower tha n the horiz on tai di recti on, and the oblique needling should be safer across the occipital foramen toward the occipital bone.展开更多
文摘Objective To prospectively evaluate the safety and therapeutic efficacy ofdalteparin in patients with high risk non-ST- elevation acute coronary syndromes (ACS) during percutaneous coronary intervention (PCI). Methods A total of 175 patients with high risk non-ST-elevation ACS were randomly assigned to 2 groups [dalteparin group and unfractionated heparin (UFH) group]. The patients in dalteparin group were given dalteparin at a dose of 5,000U subcutaneously soon after diagnosis and then an additional 60U/ kg intravenous bolus ofdalteparin before emergent PCI. Vascular access sheaths were removed immediately after PCI or coronary artery angiography; the patients in UFH group were given UFH intravenously at a dose of 25mg just before PCI and an additional 65mg bolus was administered if angiographic findings showed that the patients were suitable for percutaneous transluminal coronary angioplasty (PTCA). Sheaths were removed at 4-6 hours after PCI; Results Eighty-three patients in dalteparin group underwent PCI while 82 patients in UFH group underwent PCI; anti-Xa activities of 52 patients in daltepafin group were measured. The average anti-Xa activity was (0. 83± 0.26) U/ml at 15 minutes after intravenous injection of dalteparin and anti-Xa〉0.SU/ml was obtained in 96.1% of the patients; hematomas at puncture sites were significantly fewer in dalteparin group as compared with UFH group (2.3% vs 9.2%, P 〈 0.05); none of the patients in 2 groups suffered major bleeding events. No death, acute arterial reocclusion or emergent revascularization events occurred at 30 days after PCI. Conclusions Our study demonstrated that early subcutaneous injection ofdalteparin at a dose 5,000U after diagnosis and an additional 60U/kg intravenous bolus ofdalteparin before PCI is safe and efficacious for patients with high risk non-ST-elevation ACS undergoing emergent PCI.
基金Supported by the Fundamental Research Funds for the Central Public Welfare Research Institute:ZZ201711010
文摘There is the deviation on the understanding of acupuncture "safety" in healthcare research and the development of international standards. How to interpret and contextualize the "safety" is the point to break through it. In the aspects of contextual elements and stakeholders, using the literature reviews and theoretic approach, the concept of "safety" is attempted to be specified and the differences between health care research and international standard development to be discussed. The article aims to outline the general conceptual framework of "safety". Consequently, an approach is explored to the term-based analysis in acupuncture international standard development.
基金Supported by National "The 11th Five-Year" Science and Technology Support Program: 2006 BAI 12 B 05-1
文摘Objective To discuss the individualized operation standard and its safety on the deep acupuncture at Tianshu (天枢 ST 25). Methods Acupuncture was applied to Tianshu (天枢 ST 25)) in 39 patients. The individualized standard depth of insertion at the acupoint was determined as the penetrating the peritoneum with needle by 1 to 2 mm. The regression analysis was adopted to analyze the impacts of abdominal circumference (AC, cm) on the peritoneal position via CT cross-section scanning and image survey. Results The formula of rational needling depth at Tianshu (天枢 ST 25) with individualized deep acupuncture was: depth=-0.562+0.045. AC. Conclusion The depth of insertion at Tianshu (天枢 ST 25), determined as penetrating the peritoneum with needle by 1 to 2 mm is safe and feasible, which may be applicable and have the guidance significance for the assessment of clinical operation and safety on the deep acupuncture at the other acupoints on the abdominal region.
文摘OBJECTIVE: To assess the effectiveness and safety of Kuntai capsule and hormone replacement therapy in treatment of perimenopausal syndrome.METHODS: Articles were retrieved from the databases Cochrane Database of Systematic Reviews,Pub Med, Chinese National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Database. Only randomized controlled trials were included; 15 trials involving1243 patients were identified from January 2005 to April 2015. A systemic review and Meta-analysis of publications was performed. The review was limit-ed to randomized controlled trials that compared Kuntai capsule and hormone replacement therapy to treat perimenopausal syndrome for at least 3months. The primary outcome assessed was the treatment efficacy at 3 months, including effective rate of Kupperman menopausal scores, Kupperman menopausal scores, and blood estradiol(E2) or blood follicle stimulating hormone(FSH) levels.Other outcomes assessed were safety or adverse events, such as gastrointestinal complaints, breast distending pain, or vaginal bleeding.RESULTS: Kupperman menopausal scores showed no significant difference in effective rate [odds ratio(OR): 1.05, 95% confidence intervals(CI): 0.71 to1.55] and changes in FSH level [mean difference(MD): 2.14, 95% CI:-2.36 to 6.65]. There was a significant statistical difference in Kupperman menopausal scores(MD:-1.14, 95% CI:-2.03 to-0.25)and changes in E2level(MD:-16.41, 95% CI:-18.83to-13.69). There were fewer adverse events in the Kuntai capsule group than in the hormone replacement therapy group(OR: = 0.35, 95% CI: 0.25 to0.48, P < 0.01).CONCLUSION: Compared with hormone replacement therapy, Kuntai capsule can improve perimenopausal symptoms and blood E2 levels, and reduce the incidence of adverse events.
文摘Purpose: To evaluate the efficacy of intramedullary Kirschner wires for the treatment of unstable tibial shaft fractures in children. Methods: This prospective study was conducted at the Department of Orthopaedic Surgery in Maharishi Markandeshwar Medical College from June 2005 to June 2010. Sixty-six children having closed fracture of the tibial shaft with a mean age of 7.7 years (range, 2-14 years) were recruited from emergency and outpatient department. They were treated with percutaneous intramedullary Kirschner wires. The clinical results of our study were rated on the basis of the criteria of union, nonunion, delayed union or malunion. All children were followed for one year. Results: Children achieved union in a mean time of 8 weeks (range, 6-10 weeks). Postoperatively, three children (4.55%) had delayed union, one (1.52%) valgus deformity of lower leg, three (4.55%) post- operative knee pain and twelve (18.18%) skin irritation at pin site. Wires were removed after 8-22 weeks without any complications. No patient was lost to follow-up. The results were excellent in 95.45% and good in 4.55% children. Conclusion: This technique is cost-effective, simple, quick to perform, safe and reliable and avoids pro- longed hospitalization with good results.
文摘Objective: To compare the risk angle and safety angle of n eedli ng Ya me n (GV 15) betwee n the atla nto-axial dislocati on (AAD) patients and healthy subjects. Methods: A total of 177 AAD patients diagnosed and treated at the Center of Upper Cervical Vertebra of Beijing Chin a-Japa n Frie ndship Hospital betwee n January 2010 and January 2018 were in eluded in the AAD group. Ano ther 207 healthy subjects were included in the normal group. There were totally 191 males and 193 females. The MRI sean was performed for the cervical vertebrae to measure the risk angle and safety angle of acup un cture at Ya me n (GV 15) on the sagittal image. Results: In the AAD group, the risk angle was (13.14±3.99)° and the relative safety angle was (10.31±3.23)° for the perpendicular needling, while the oblique needling risk angle was (9.09±3.09)° for the male;the risk angle was (12.12±2.74)° and the relative safety angle was (10.56±2.09)° for the perpendicular needling, while the oblique needling risk angle was (9.70±2.95)° for the female. In the normal group, the risk angle was (7.89±1.59)° and the relative safety angle was (10.21±3.55)° for the perpendicular needling, while the oblique needling risk angle was (16.07±1.77)° for the male;the risk angle was (6.93±1.45)° and the relative safety angle was (10.70±2.94)° for the perpendicular needling, while the oblique needling risk angle was (14.89±2.18)° for the female. The perpendicular needling risk angles for the males and females in the AAD group were larger than those in the normal group, and the differences were statistically significant (both P<0.01);for the inner-group comparison, there was no sigrHficant difference in the perpendicular needling risk angle between the male and the female in the AAD group (P>0.05);however, the perpendicular needling risk angle for the male was larger than the female, and the differenee was statistically significant in the normal group (P<0.01). There were no sign讦icant differences in the relative safety angle for both the male and the female between the AAD group and the normal group (both P>0.05). For the inner-group comparison, there was no sign讦icant differenee in the relative safety angle between the male and the female (P>0.05). The oblique needling risk angles for both the males and females were smaller in the AAD group than those in the normal group, and the differences were statistically sign讦icant (both P<0.01);the oblique needling risk angle for the male was not significantly different from that for the female in the AAD group (P>0.05);in the normal group, the oblique needling risk angle for the male was larger than that for the female, and the differenee was statistically significant (P<0.01). Conclusion: Un der the AAD condition, the risk angle and safety angle of acup un cture at Ya me n (GV 15) cha nge significantly, perpe ndicular n eedli ng should be better if performed slightly lower tha n the horiz on tai di recti on, and the oblique needling should be safer across the occipital foramen toward the occipital bone.