Sofosbuvir plus daclatasvir with or without ribavirin in 551 patients with hepatitis C-related cirrhosis, genotype 4.

BACKGROUND: The Daclatasvir and Sofosbuvir combination therapy (SOF/DCV) has shown efficacy in patients with chronic hepatitis C in clinical trials. AIM: To investigate the efficacy and safety of SOF/DCV for treatment of patients with hepatitis C-related liver cirrhosis genotype 4. METHODS: Multicentre study involving 551 patients with liver cirrhosis genotype 4; 432 naïve patients and 119 treatment-experienced patients. All patients received SOF (400 mg) and DCV (60 mg) daily in addition to weight-based ribavirin (RBV) for 12 weeks and when RBV is contraindicated the treatment duration was extended to 24 weeks. RESULTS: Sustained virological response at 12 weeks after end of treatment (SVR12) rate was 92% in naïve cirrhotic patients and 87% in previous treated patients (by ITT analysis). Virological failure was infrequent, occurring in 42 patients (8%) overall. Thirty-two (6%) were non responders; and 10 (2%) cases were relapsers, 31 patients (7%) were CTP-A and 11 (13.3%) patients were CTP-B (by ITT analysis). The most common adverse events were anaemia, fatigue, headache, pruritus. Serious side effects were recorded mainly in CTP-B cirrhotic patients including HCC and hepatic encephalopathy. CONCLUSIONS: The SOF/DCV combination therapy has proven efficacy and safety in treating patients with hepatitis C-related liver cirrhosis genotype 4 in a large cohort of patients in the real world.

Acute pancreatitis and hyperparathyroidism in pregnancy.

A case of acute pancreatitis associated with hyperparathyroidism in the third trimester of pregnancy is summarized, and the clinical findings are discussed. Emphasis is placed on recognition of pancreatitis and its etiology in the third trimester of pregnancy. The surgical approach to the parathyroid pathology is analyzed and its advantages espoused.

Review of internet health information quality initiatives.

BACKGROUND: The massive growth of health information on the Internet; the global nature of the Internet; the seismic shift taking place in the relationships of various actors in this arena, and the absence of real protection from harm for citizens who use the Internet for health purposes are seen to be real problems. One response to many of these problems has been the burgeoning output of codes of conduct by numerous organizations trying to address quality of health information. OBJECTIVES: Review the major self-regulatory initiatives in the English-speaking world to develop quality and ethical standards for health information on the Internet. Compare and analyze the approaches taken by the different initiatives. Clarify the issues around the development and enforcement of standards. METHODS: Quality initiatives selected meet one or more of the following criteria: Self-regulatory. A reasonable constituency. Diversity (eg, of philosophy, approach and process)-to achieve balance and wide representation, and to illustrate and compare different approaches. Historic value. A wider reach than a national audience, except when its reach is a significant sector of the Internet health information industry. The initiatives were compared in 3 ways: (1) Analysis and comparison of: key concepts, mechanism, or approach. Analysis of: the obligations that a provider has to meet to comply with the given initiative, the intended beneficiaries of that initiative, and the burdens imposed on different actors. These burdens are described in terms of their effect on the long-term sustainability and maintenance of the initiative by its developers. Analysis of the enforcement mechanisms. (2) Analysis and comparison by type of sponsoring organization, the reach of the initiative, and the sources of funding of the initiative or the sponsoring organization. (3) How the various initiatives fall under 1 of 3 key mechanisms and comparison of the advantages and disadvantages of these key mechanisms. RESULTS: The issues that affect the initiatives and future work on the quality of health information on the Internet are identified and analyzed. These issues are: (a) Three key mechanisms used in the quality initiatives (b) Sustainability issues that affect the initiatives: Burdens placed on health information providers, citizens and others. Currency and maintenance issues of the initiatives. Funding. Cost. Acceptance. Market conditions. User indifference or ambivalence. (c) Enforcement issues surrounding the initiatives (d) Adequacy of approach, scope, reach, and enforcement provisions of the various quality initiatives (e) Gaps that need to be addressed to achieve good quality of health information on the internet CONCLUSIONS: Ten conclusions are presented. A framework of action to be undertaken by the World Health Organization in the field of quality of health information on the Internet is recommended.

Clinical and pathologic correlates of stillbirths in a single institution.

BACKGROUND: To evaluate risk factors, placental and pathologic determinants of stillbirths. METHODS: A retrospective analysis of stillbirths > or = 25 weeks was performed. Clinical data was compared to a randomized control group. Statistical analysis included chi square test, student t test, and logistic regression. RESULTS: One hundred and fifteen stillbirths and 193 controls were analyzed. Maternal age, nulliparity, tobacco use, previous induced abortions, anticardiolipid antibodies, elevated maternal serum alpha feto protein, twins, and amniocentesis, were significantly associated with stillbirth. Logistic regression analysis showed only maternal age, tobacco use, small for gestational age (SGA), previous induced abortions, decreasing gestational age as independent significant variables. The stillbirth baby was 6.8 times more likely to be SGA and 11.9 times more likely to be preterm. Primary pathologic diagnoses were placental factors (37%), cord complications (28%), and fetal causes (15%), 17% had maternal risk factors only and 3% had no known risk factors. Diagnosis was suggested by pathology in 40% of cases. CONCLUSIONS: Stillbirth delivery is associated with older, nulliparous patients with prenatal complications resulting in intrauterine growth retardation and prematurity. Perinatal histopathologic examination is important in diagnosis. Utilizing an extensive testing protocol will reduce the diagnosis of unexplained stillbirth.

Prepregnancy body mass index, weight gain during pregnancy, and perinatal outcome in a rural black population.

Relationships between body mass index (BMI) and weight gain with perinatal outcome and birthweight were examined. BMI was calculated on 582 consecutive pregnant women who delivered at or >37 weeks gestational age. Statistical analysis was done using Chi-square tests, analysis of variance, and multiple logistic regression. Of those studied, 13% were underweight, 39% normal, 13% overweight, and 35% obese. Obesity was associated with increasing age (P < .01), multiparity (P < .01), previous cesarean delivery (P < .01), previous macrosomia (P = .01), previous fetal death (P = .03), hypertensive disorders (P < .01), gestational diabetes (P = .02), cesarean delivery (P = .03), and neonatal intensive care unit admission (NICU) (P = .01). The underweight group had the most low birthweight (LBW) infants and the lowest mean birthweight. Ideal weight gain occurred in 31%, inadequate weight gain in 34%, and excessive weight gain in 35%. Inadequate weight gain had increased asthma (P < .05), and hyperemesis (P = .03). Women with ideal weight gain had less smokers (P < .01), fetal distress (P < .05), cesarean delivery (P = .02), and preeclampsia (P < .001). The mean birthweight was highest in the excessive weight gain (P < .01). With multivariate analysis, previous LBW, BMI, and tobacco use were significant predictors of LBW. Normal BMI and ideal weight gain in pregnancy is associated with decreased perinatal complications and an optimum birthweight.

The efficacy of intramuscular 15 methyl prostaglandin E2 in second-trimester abortion. Coagulation and hormonal aspects.

Termination of pregnancy in the second trimester is sometimes associated with serious complications. This led to clinical investigation seeking methods superior to the traditional technique utilizing hypertonic saline. Intra-amniotic administration of naturally occurring prostaglandin F2-alpha has been developed and appears to be advantageous--especially in the area of coagulation stability. This study describes a technique for intramuscular administration of a prostaglandin analogue--15 methyl prostaglandin E2. This analogue is much more potent than the natural compound. Administration to 32 patients resulted in abortion in 28. The coagulation milieu remained completely intact and all other parameters were similar to previous published data for prostaglandin administration. There were no infections in this group of patients.

The efficacy of intravaginal 15 methyl prostaglandin F2alpha methyl ester in first and second trimester abortion.

Fifteen methyl prostaglandin F2alpha methyl ester prepared within a silastic device for intravaginal administration appears to be advantageous. This study describes the technique carried out and the results observed in 50 patients. The analogue is prepared in 1.0% and 0.5% delivery systems. Twenty-four patients received the 1.0% dosage schedule and all twenty-four patients aborted. Twenty-six patients received 0.5% and twenty-three patients aborted. The coagulation millieu and other parameters were similar to that reported for other prostaglandins.

Placental changes in fetal triploidy syndrome.

The sonographic findings in fetal triploidy syndrome include intrauterine growth retardation, hydrocephalus, oligohydramnios, and hydropic changes of the placenta. Ultrasonography can establish the diagnosis only when placental findings coexist with a fetus. Although the majority of triploid conceptions abort spontaneously in the first trimester, occasionally they will progress further, but rarely to term. Six cases are presented in which the diagnosis was suspected by early ultrasound examinations, including one case in which there was an unusually large trophoblastic cyst. Determination of the karyotype is important for the management of a pregnancy with a live fetus, and has implications for genetic counseling of subsequent pregnancies.

Midwifery, 1977.

On January 1, 1974, an autonomous midwifery service was formed at Roosevelt Hospital in New York City to provide an obstetric service to "private" patients. While the autonomy was complete, physician consultation and participation provided by the "full-time or senior resident" staff were always available. We are now aware that this plan as opposed to any other, provided the ingredient of consumer-desired empathy of the midwife coupled with instant obstetric expertise that assured every patient the availability of modern obstetric practice. Four hundred and fifty-four patients cared for by midwives were compared to a random sample of 500 patients cared for by attending obstetricians. A striking similarity in the two groups was evident. Certain items, such as operative deliveries, were higher in the private patient group. The midwifery group had a low incidence of complications, but the incidence of acute complications made it apparent that an operating room suite must be immediately available. It is eminently clear that a low-risk group can be identified but there is no possible way to identify a "no risk" population.