COVID-19 vaccine and pregnancy: A safety weapon against pandemic

The ongoing COVID-19 pandemic is raising great concern all over the world. The recent introduction of vaccines has offered reason for optimism, however, new issues have arisen, such as vaccine reluctance. The safety of vaccines for pregnant women is one of the most serious of these concerns. The purpose of this review article is to provide updated international vaccine recommendations, results of ongoing studies and clinical trials, and the role of gynecologists in counseling the women to understand the risks versus benefits as well as form an informed decision towards vaccine acceptance for COVID-19.Although COVID-19 infection increases the risk of severe morbidity and mortality in pregnant women, pregnant women were not included in the initial vaccine trials. As a result, safety information is scarce. Nations have differing recommendations, though many have recently approved the COVID-19 immunization in pregnancy following a risk-benefit analysis. The Joint Committee on Vaccination and Immunization (JCVI) of the United Kingdom recently approved an mRNA vaccination for pregnant women. Vaccination is recommended by the CDC, ACOG, ARFM, and WHO. India recently took a stand, with the ICMR and the Ministry of Health and Family Welfare recommending vaccination during pregnancy and lactation.     

Adverse drug events in hospitalized patients A comparison of doctors, nurses and patients as sources of reports

Objective: This study investigated the relative value of adverse drug events reported by doctors, nurses and patients. Methods: The study was conducted on a total of four wards: the paediatric and internal medicine wards (including geriatric patients) of two peripheral hospitals in the Netherlands. Adverse drug events were collected by spontaneous reporting (doctor and nurse reports) and by daily ward visits, during which the patients were interviewed by a hospital pharmacist (patient reports). Criteria for relative value of the reported adverse drug events were the number of potentially serious reactions, the number of reactions not mentioned in the patient information leaflet and the number of reactions reported to new drugs (5 years or less on the Dutch market). No formal causality assessment was applied. Results: Over a period of 2 months in 1996 (Hospital I) and 2 months in 1997 (Hospital II) a total of 620 patients were included in the study and adverse drug events were reported in 179 (29%) of these cases. Doctors reported a statistically significant larger number of serious (26% of all doctor reports; odds ratio (OR) 3.2; confidence interval (CI) 1.2–8.7) and unknown (39%; OR 2.5; CI 1.0–6.0) adverse drug events than patients themselves during the daily ward visit. Doctors also reported more serious and unknown adverse drug events than nurses. Adverse reactions to new drugs were reported during the daily ward visit only (8% of all daily ward visit reports). Conclusion: This study reconfirms that doctors are the main source for reports of serious and unknown adverse drug events in hospitalized patients. However, patients themselves seem to report more adverse reactions to new drugs (during the daily ward visit). By focusing on patients using new drugs, the daily ward visit might become cost-effective. This needs to be explored in future studies. Received: 10 September 1998 / Accepted in revised form: 30 November 1998     

Statins and peripheral neuropathy

Within the past 3 years seven cases of reversible peripheral neuropathy apparently caused by statins have been reported. Here we report seven additional cases associated with long-term statin therapy, in which other causes of neuropathy were thoroughly excluded. The neuropathy was in all cases axonal and with affection of both thick and thin nerve fibers. The symptoms of neuropathy persisted during an observation period lasting from 10 weeks to 1 year in four cases after statin treatment had been withdrawn. We suggest that long-term statin treatment may be associated with chronic peripheral neuropathy. Received: 6 July 1998 / Accepted in revised form: 1 October 1998     

Compliance and adverse drug reactions: a prospective study with ethinylestradiol using continuous compliance monitoring

Summary This study examined the relationship between adverse reactions and patient compliance with ethinylestradiol at 40 g twice daily versus 20 g four times daily. In a randomized study 61 female patients with primary- infertility were prescribed the drug twice daily (n = 31) or four times daily (n = 30). Ethinylestradiol was administered for 7 days before the sperm cervical mucus penetration-test was performed for hormonal standardization of the cervical mucus quality. Drug compliance was measured by continuous monitoring using the Medication Event Monitoring System. Two parameters were evaluated: percentage of prescribed doses taken (administration compliance) and adherence to the prescribed dose schedule (regimen compliance, number of days with two or four dosing events recorded). Adverse drug reactions were assessed using a standardized questionnaire. Fourty-four women experienced side effects, of which 81% were rated by patients as being mild. Patient compliance was higher with the twice daily than with the four times daily regimen: 85% versus 65% prescribed doses taken (P<0.05). There was no significant difference in compliance comparing patients with and without adverse reactions (82% versus 72%, respectively), but compliance was lower and more irregular with at least 3 versus one or two adverse reactions reported: 54% versus 84% in administration compliance and 31% versus 58% in regimen compliance (P<0.05). Compliance was also lower in patients with nausea and vomiting than in those without these symptoms, 59% versus 91% and 34% versus 66% (P<0.005), respectively, and lower with moderate or severe compared to mild side effects; 48% versus 85% and 25% versus 59% (P<0.005). Thus the mere occurrence of side effects was not associated with low compliance. However, the number and nature of symptoms and their intensity as perceived by patients may have considerably influenced drug use behavior.Abbreviations ADR adverse drug reactions - SCMPT sperm cervical mucus penetration-test Prof. Dr. E. Weber died 7 December 1992     

利培酮与氯丙嗪治疗精神分裂症对心电图的影响

目的 :了解和比较利培酮与氯丙嗪对心电图的影响。方法 :对服用利培酮及氯丙嗪的精神分裂症患者分别定期心电图检查 ,时间为服药后 2、4周。结果 :利培酮组和氯丙嗪组出现异常分别为 11.5 %和 4 2 .5 % ,两者有显著性差异 (P <0 .0 5 )。结论 :利培酮对心电图影响明显低于氯丙嗪。     

药物不良事件的防范研究

目的：探讨心内科病房药物不良事件(ADE)的防范特征。方法：由药师深入心内科病房，集中监测药物不良事件。主要监测内容是药物不良事件的存在与否，可否防范及严重程度。结果：5个月研究期间共鉴定ADE64次，其中28％可以防范。在重度ADE中，50．0％可防范；在中度ADE中，33．3％可防范；在轻度ADE中，可防范的比例最少，为13．6％。结论：药物不良事件中有相当一部分可以防范，而且越是严重的ADE就越有可能被防范。应该采取有效的措施来防范药物不良事件。     

七叶皂苷钠的临床应用、不良反应及药理学研究

目的：了解文献报道有关注射用七叶皂苷钠的各种临床应用、不良反应，为临床合理用药提供参考。方法：对国内近几年来应用注射用七叶皂苷钠的临床应用、不良反应进行整理归纳和分析。结果：注射用七叶皂苷钠的临床应用主要有脑梗塞、格-巴综合征和面神经炎等。不良反应主要有静脉炎、过敏反应和肾损害等。结论：注射用七叶皂苷钠因其独特的药理作用，在临床上仍然是不可缺少的药物。临床医师、药师应提高警惕，加强对其不良反应的监测和防治以确保用药安全。     

药源性过敏性休克522例分析

目的 :探讨发生药源性过敏性休克的特点和规律。方法 :检索中文医药卫生期刊1998年～2003年报道的药源性过敏性休克个案 ,并进行统计、分析。结果 :抗微生物药物、中草药、生物制品的过敏性休克发生率及死亡率居前3位 ;静脉用药发生率最高 ,占61 30% ;速发型过敏性休克比例极大 ,占78 73% ;药源性过敏性休克与性别、年龄无关。结论 :用药前询问过敏史 ,严格用药指征 ,观察用药后反应 ,方能确保用药安全。