蛛网膜下腔-硬膜外联合阻滞麻醉用于分娩镇痛效果观察

目的 探讨两种分娩镇痛方法的效果．方法 采用蛛网膜下腔及硬膜外腔联合给予低质量浓度麻醉药及镇痛药和单纯硬膜外腔阻滞的方法分别对３０例实产妇进行分娩镇痛,比较组的镇痛效果,不良反应及对产程,分娩方式,产后出血量,胎儿及新生儿等的影响,并与５０例正常未干预组产妇比较。结果 联合组效果较好,单纯组镇痛作用欠佳且增加阴道分娩的助产率。     

Diagnostic value of the PDD method in evaluation of vulvar lesions

The purpose of this study was to evaluate the efficiency of photodynamic diagnostics (PDD), a method used in the diagnosis of vulvar lesions, and to determine its position and efficacy among diagnostic techniques generally used up to now. The projected purpose of the study in cases of vulvar lesions was realised by performing a detailed comparative analysis of sensitivity, specificity and diagnostic efficacy of PDD and vulvoscopy, as compared with histological evaluation of excised lesions.     

Use of mifepristone to ripen the cervix and induce labor in term pregnancies

OBJECTIVE: This study was undertaken to determine the efficacy of mifepristone for ripening the cervix and inducing labor in term pregnancies. STUDY DESIGN: In a double-blind placebo-controlled dose-finding study, 346 women received 50, 100, 200, 400, or 600 mg of mifepristone or placebo. The main endpoint for efficacy was the number of patients in whom labor occurred between 12 and 45 and 54 hours after treatment or who had a Bishop score 6 or greater. Maternal and fetal tolerability was also studied. RESULTS: No significant efficacy was observed whatever the dose of mifepristone. Mifepristone was well tolerated by the mother and fetus. CONCLUSION: Mifepristone, at doses up to 600 mg, does not induce labor within 54 hours in patients with unfavourable cervical status.     

Effects of birth centre care on fathers' satisfaction with care,experience of the birth and adaptation to fatherhood

The objective of this longitudinal study was to determine the predictive role of birth self‐efficacy beliefs in primiparous women's childbirth experiences (n=230). The study had three aims: (1) to determine whether birth self‐efficacy beliefs predict pain tolerance and pain perceptions in labour, (2) whether self‐efficacy beliefs predict obstetric events and birth satisfaction, and (3) whether the relationships between self‐efficacy and pain, and self‐efficacy and obstetric events and self‐efficacy and satisfaction persist when key cognitive, behavioural, social, and demographic covariates are accounted for. A New Zealand‐based longitudinal observational study set was designed. Participants (self‐selected primiparous women) completed the Childbirth Self‐Efficacy Inventory (CBSEI) and cognitive and behavioural constructs at 15 and 35 weeks gestation. Postpartum measures included pain tolerance, labour pain and distress, number and type of obstetric events and birth satisfaction. Hierarchical multiple regressions indicated that stronger birth self‐efficacy beliefs predicted decreased pain and distress in labour, but not pain tolerance. Also, stronger self‐efficacy predicted increased birth satisfaction. The relationships remained significant when covariates were controlled for. The practice implications are that supporting and developing primiparous women's strong birth self‐efficacy beliefs will have an impact on their pain experiences and feelings of satisfaction but is unlikely to influence obstetric events.     

A multinational evaluation of the efficacy, safety and acceptability of the Protectaid contraceptive sponge.

OBJECTIVE: The Protectaid sponge (Gefar Pharma, Switzerland) is a new feminine barrier contraceptive method containing three low-dose spermicidal agents. In order to evaluate its efficacy and safety profiles, an international, multicenter study has been conducted in four countries. METHODS: Healthy, presumably fertile and sexually active women were enrolled in this study and were followed at 15 days, 3, 6, 9 and 12 months. Contraceptive efficacy was assessed by a pregnancy test, while safety was evaluated by performing gynecological examinations as well as reporting adverse events. The 'acceptability' of the sponge by the women was assessed through a standard questionnaire. RESULTS: A total of 129 women were enrolled in the study, generating 1182 cycles of use of the sponge. The overall efficacy rate was 77%, with no significant influence of age or parity. Acceptability was high, with 85% of subjects being symptom- or problem-free while using the sponge. Finally, the safety profile was very good, with no clinically significant evidence of local or systemic adverse reactions. CONCLUSION: The new Protectaid sponge is a safe and effective non-hormonal contraceptive method for women.     

Diagnostic value of the photodynamic method in the evaluation of lesions of the uterine cervix

The purpose of this study was to assess the efficacy of the photodynamic diagnosis (PDD) method in the diagnosis of lesions of the uterine cervix, as well as to establish its place and efficacy among currently available diagnostic techniques. In the case of lesions located on the cervix, the projected aim of the study was intended to be realised by performing a detailed comparative analysis of the examination results of the following: PDD, cytology, colposcopy and testing for the presence of viruses, as compared with histological evaluation of performed biopsies.     

Clinical study of the use of a new tri-phasic pill

The paper reports the results of a study to assess the contraceptive efficacy of a new triphasic pill (Trinovum - Cilag AG). The pill was administered to 50 women aged between 18 and 41 years for 12 months, giving a total of 600 menstrual cycles. Data confirm the value of this pill which ensures excellent contraceptive efficacy and is well tolerated by patients with very few adverse effects.     

Effectiveness of passive immunisation against respiratory syncytium virus in a group of premature infants with birth weight below 1000 grams

Respiratory syncytial virus (RSV) is a major cause of respiratory tract infection during the child's first year of life. Those who survive neonatal intensive care are commonly rehospitalized. In the absence of vaccine, passive immunoprophylaxis is the preferred approach. Safety and efficacy of Palivizumab (Synagis) was proven in the Impact-RSV Trial, conducted in the USA, Canada and UK. The aim of the study was to determine efficacy of humanized monoclonal RSV antibody in prematures infants born 25-32 week gestation with weight birth below 1000 g with and without broncho-pulmonary dysplasia. We compared the hospitalization rates and morbidity between two groups of children who received palivizumab and without any protection. We confirm the efficacy and safety of Synagis. The outcome of this study supports the use of palivizumab prophylaxis in high-risk children.     

Efficacy and tolerability of linezolid in treating severe skin and soft tissue infections caused by Gram-positive pathogens.

BACKGROUND AND PURPOSE: Linezolid, an oxazolidinone, has shown efficacy in the treatment of adults with nosocomial or community-acquired pneumonia; skin and soft tissue infections; and infections due to methicillin-resistant Staphylococcus aureus. The purpose of this open-label, single-arm, multicenter study was to evaluate the efficacy and tolerability of linezolid in patients from the Asia-Pacific Region with severe Gram-positive skin and soft tissue infections. METHODS: 166 patients at 27 sites in 7 countries from the Asia-Pacific region were enrolled. The patients had severe skin infection involving the deeper layers or extensive surface area. Patients received 7 to 28 days of treatment with linezolid by clinical judgment. All patients received intravenous linezolid 600 mg twice a day initially and were switched over to an equivalent oral dose (600 mg twice a day) when the investigator discerned clinical improvement. The primary efficacy endpoint in this study was clinical outcome at the follow-up visit, 14 to 21 days after completion of treatment (test of cure), and the secondary efficacy variable was microbiologic response at test-of-cure. RESULTS: 166 patients received the study medication and were included in the intent-to-treat analysis. The clinical success rate was approximately 93% in both the intent-to-treat and clinically evaluable populations at the end of treatment and test-of-cure visits. In the modified intent-to-treat and microbiologically evaluable populations, the microbiologic success rates at the test-of-cure visit were 88.9% and 93.8%, respectively. The most frequent treatment-emergent adverse events were nausea (13%), dizziness (8%), anemia (7%), and vomiting (5%). CONCLUSIONS: Linezolid was effective and well tolerated in patients with severe skin and soft tissue infections caused by Gram-positive pathogens.     

A multinational evaluation of the efficacy,safety and acceptability of the Protectaid® contraceptive sponge

Objective The Protectaid^® sponge (Gefar Pharma, Switzerland) is a new feminine barrier contraceptive method containing three low-dose spermicidal agents. In order to evaluate its efficacy and safety profiles, an international, multicenter study has been conducted in four countries. Methods Healthy, presumably fertile and sexually active women were enrolled in this study and were followed at 15 days, 3, 6, 9 and 12 months. Contraceptive efficacy was assessed by a pregnancy test, while safety was evaluated by performing gynecological examinations as well as reporting adverse events. The 'acceptability' of the sponge by the women was assessed through a standard questionnaire. Results A total of 129 women were enrolled in the study, generating 1182 cycles of use of the sponge. The overall efficacy rate was 77%, with no significant influence of age or parity. Acceptability was high, with 85% of subjects being symptom- or problem-free while using the sponge. Finally, the safety profile was very good, with no clinically significant evidence of local or systemic adverse reactions. Conclusion The new Protectaid sponge is a safe and effective non-hormonal contraceptive method for women.     

左奥硝唑氯化钠注射液治疗厌氧菌性盆腔感染的多中心临床研究

目的 评价左奥硝唑氯化钠注射液(其他名称:优诺安)治疗厌氧菌引起的盆腔感染的临床有效性及安全性.方法 2007年2至10月,采用多中心、随机、双盲、阳性药物、平行对照试验设计方法,将武汉大学中南医院、南京医科大学第一附属医院、华中科技大学同济医学院附属协和医院,南京市第一医院、皖南医学院戈矶山医院就诊的、经筛选符合厌氧菌性盆腹腔感染标准的143例患者随机分为观察组70例,对照组73例.观察组患者用左奥硝唑氯化钠注射液0.5 g,静脉滴注,0.5～1 h内滴完,每天两次,5～7 d为一疗程;对照组用奥硝唑氯化钠注射液静脉滴注,用药剂量及疗程同观察组.比较两组患者用药后的临床治愈率、细菌清除率和不良反应发生率.结果 疗程结束时,临床治愈率观察组为80%(56/70),对照组为81%(59/73),两组比较,差异无统计学意义(P＞0.05);观察组厌氧菌细菌清除率为97%(36/37),对照组厌氧菌细菌清除率为92%(22/24),两组比较,差异也无统计学意义(P＞0.05);不良反应发生率观察组为3%(2/70),对照组为22%(16/73),两组比较,差异有统计学意义(P＜0.05).结论 左奥硝唑氯化钠注射液用于厌氧菌性盆腔感染的治疗有效、安全.     

A comparison of prostaglandin E2 gel and prostaglandin F2 alpha gel for preinduction cervical ripening

The unfavorable cervix remains a major obstacle to the successful induction of labor. Reported are results from an ongoing study of topical prostaglandin preparations used to effect preinduction cervical ripening. The current study compares the efficacy of 40 mg of prostaglandin (PG) F2 alpha versus 5 mg of PGE2, applied to the cervix in a methyltylose gel the night before attempted induction of labor. A prospective double-blind protocol was used similar to that which previously established the efficacy of the 5 mg of PGE2 preparation versus placebo at this institution. Results indicate the superiority of the PGE2 preparation as measured by change in Bishop score, Pitocin requirement, rate of cervical dilatation, and percentage of failed inductions. Cesarean section rates were similar in the two study groups, and no fetal or maternal morbidity was attributable to the preinduction ripening technique.     

Assessment of gonadotropin therapy in male hypogonadotropic hypogonadism

The objective of this study was to determine the efficacy of gonadotropin therapy in men with hypogonadotropic hypogonadism. Gonadotropin therapy is a safe and effective therapy for hypogonadotropic hypogonadism.     

A comparison of ritodrine, terbutaline, and magnesium sulfate for the suppression of preterm labor

Ritodrine, terbutaline, and magnesium sulfate have all been used in the United States as tocolytic drugs. Studies have shown each of these drugs to be effective in suppressing preterm labor. The current study was undertaken in order to compare their relative safety and efficacy and to evaluate the effectiveness of a second drug when the first-used drug failed to stop contractions. No differences in efficacy could be demonstrated between the drugs; however, there was a marked difference in the incidence of maternal side effects. Because of an unacceptable level of side effects, we have stopped the use of terbutaline at our institution.     

左炔诺孕酮和小剂量米非司酮用于紧急避孕的临床观察

目的 观察单方左炔诺孕酮和小剂量米非司酮用于紧急避妥的效果、副反应及对月经的影响。方法 采用随机、双盲的多中心对比方法,交在未保护性交或避孕失败７２小时内要求紧急避孕的妇女随机分为左炔诺孕酮（左炔）组（６４３例）和米非司酮（米非）组（６３３例）,左炔组每次服用左炔诺孕酮０．７５ｍｇ,间隔１２小时,共２次;米非组单次服用米非司酮１０ｍｇ,１２小时后服空白片,地预期下次月经第７天随诊,判断避孕效果,记     

Influence of clinical and ultrasound factors on the efficacy of misoprostol in first trimester pregnancy failure

An observational study including 276 patients with early pregnancy failure was performed to evaluate the clinical and ultrasound factors influencing the efficacy of misoprostol in the treatment of first trimester pregnancy failure. Gestational age did not influence the efficacy of this treatment and the success rate was inversely proportional to parity.     

A long-term study of the efficacy and acceptability of a single-rod hormonal contraceptive implant (Implanon) in healthy women in China.

OBJECTIVE: To investigate the contraceptive efficacy, cycle control and acceptability of Implanon, a new single-rod, progestogen-only contraceptive implant. METHODS: In a non-comparative, open, multicenter study, a contraceptive implant containing the progestogen etonogestrel was inserted into 200 healthy women. The study duration was 2 years, with an optional extension up to 4 years. RESULTS: Women were exposed to Implanon for 644.6 woman-years. There were no pregnancies during the study. Per 90-day reference period, the median number of bleeding-spotting days ranged between 18 and 21 and the median number of bleeding-spotting episodes was two. The mean overall incidence of prolonged bleeding fell markedly during the study, from 69% in the first reference period to 26% in the 16th period. The most common adverse events were related to disturbed bleeding pattern and amenorrhea. Heavy or prolonged bleeding caused 18 subjects to withdraw from the study. Only a few subjects discontinued the study early due to irregular bleeding (2%) or amenorrhea (2%). A slight increase in mean body weight was observed. The implant was removed in an average time of 2.9 min. CONCLUSIONS: Implanon demonstrated excellent contraceptive efficacy for 4 years of use and was well tolerated. The incidences of prolonged bleeding and amenorrhea both fell markedly with continued implant use. Because of its single-rod design, Implanon was quickly removed with few complications and proved to be a highly acceptable method of contraception.     

Tension-free vaginal tape efficacy in relation to collagen quantity of pubocervical fascia

OBJECTIVE(S): To investigate whether the quantity of collagen types I and III in the pubocervical fascia of women with genuine stress incontinence (GSI) affects the efficacy of the tension-free vaginal tape (TVT) procedure. METHODS: Sixty-three patients participated in the study and were divided in 2 groups as follows: 37 patients with GSI and pelvic organ prolapse stage I (group 1), and 26 patients with pelvic organ prolapse stage I but not GSI (control group). Urodynamic studies confirmed the diagnosis of GSI. Biopsies were obtained during surgery from the pubocervical fascia. RESULTS: The quantity of collagen types I and III was statistically significantly reduced in patients with GSI compared to the control group. The efficacy of the TVT procedure in patients with a significant reduction in collagen type I was an 82.1% cure. In patients with a significant reduction in collagen type III, the TVT efficacy was an 85.1% cure. The efficacy of the TVT procedure was not statistically significantly different between patients with GSI and a significant reduction in collagen types I and III, and patients with no reduction in collagen types I and III. CONCLUSIONS: The significantly reduced quantity of collagen types I and III in the pubocervical fascia of women with GSI does not affect the efficacy of the TVT procedure at an average of 25 months of follow-up.     

Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial

IntroductionThe prevalence of erectile dysfunction (ED) is increased in men with metabolic syndrome compared with the general population.AimThe aim of this study was to evaluate the efficacy and safety of vardenafil vs. placebo in men who had ED and metabolic syndrome.MethodsThis was a 12‐week, double‐blind, randomized, multicenter, parallel‐group, placebo‐controlled prospective study in men with ED and metabolic syndrome (assessed by the International Diabetes Federation criteria). Vardenafil was administered at a starting dose of 10 mg, which could be titrated to 5 mg or 20 mg after 4 weeks, depending on efficacy and tolerability.Main Outcome MeasuresPrimary efficacy measures were the erectile function domain of the International Index of Erectile Function (IIEF‐EF) and Sexual Encounter Profile (SEP) diary questions 2/3. Secondary efficacy measures included SEP1, a diary question assessing ejaculation, the percentage of men achieving “return‐to‐normal” erectile function, and the percentage of men who titrated to a different dose. Adverse events (AEs) were recorded throughout the study.ResultsThe intent‐to‐treat population included 145 men (vardenafil, N = 75; placebo, N = 70). Baseline least squares IIEF‐EF domain scores were low (vardenafil: 12.0; placebo: 12.7), indicative of moderate‐to‐severe ED. Vardenafil was statistically significantly superior to placebo for all primary efficacy measures (P < 0.0001) and showed nominally statistically significant superiority compared with placebo for SEP1/ejaculation success rates (P = 0.0003 and P < 0.0001, respectively) and the percentage of subjects reporting “return‐to‐normal” erectile function (P = 0.0004). Treatment‐emergent AEs were mild‐to‐moderate in severity and consistent with the known AE profile of phosphodiesterase type 5 inhibitors.ConclusionsThis is the first study to assess the efficacy and safety of vardenafil, taken alone, for ED therapy in a population of men who all had metabolic syndrome. Although baseline erectile function in these patients was low, vardenafil treatment was associated with significant improvements in erectile function and rates of successful intercourse, and was well tolerated. Schneider T, Gleißner J, Merfort F, Hermanns M, Beneke M, and Ulbrich E. Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo‐controlled trial. J Sex Med 2011;8:2904–2911.     

A double-blind, controlled comparison of piperacillin and cefoxitin in the prevention of postoperative infection in patients undergoing cesarean section

Data are presented from a randomized, double-blind multicenter trial (six study sites, involving 346 patients) in which piperacillin was compared with cefoxitin as a prophylactic agent for patients undergoing cesarean section. One hundred and sixty-nine patients received piperacillin and 177 received cefoxitin; in each instance, the total dosage was 6 grams. Strict criteria were used to evaluate safety and efficacy. The courses of all of the patients were evaluable for safety and 183 courses were evaluable for efficacy (136 efficacy-evaluable courses were from patients treated with piperacillin and 147, from those treated with cefoxitin). Postoperative infection was prevented in 89 per cent of the patients treated with piperacillin and in 93 per cent of the those treated with cefoxitin. The difference was not statistically significant. The data from each of the individual study sites, as well as the pooled data, indicated that the short term perioperative administration of piperacillin in patients undergoing a cesarean section was as safe and effective as cefoxitin with regard to prophylactic response, duration of hospitalization and the usage of other systemic antibiotics.