Blood donation-related neurologic needle injury: evaluation of 2 years' worth of data from a large blood center

BACKGROUND: There is little information in the medical literature on t he clinical spectrum of blood donation-related neurologic needle injury and on its frequency in a blood donor population. STUDY DESIGN AND METHODS: Sixty-six cases of blood donation-related neurologic needle injury were identified from nursing reports made during a 2-year collection period involving 419,000 whole blood donations. Telephone follow-up was completed on 56 of the 66 cases to better define clinical symptoms, the donor's desire for physician consultation, recovery times, and residual effects. RESULTS: Symptoms in 66 donors included numbness or tingling (n = 54), excessive or radiating pain (n = 43), and loss of arm or hand strength (n = 8). Of the 56 donors with complete follow-up, 17 (30%) consulted a physician one or more times. Recovery times in these 56 donors were <3 days (n = 22), 4 to 29 days (n = 17), 1 to 3 months (n = 13) 3 to 6 months (n = 2), and >6 months (n = 2). Fifty-two of 56 donors achieved a full recovery, and 4 other donors had only a mild, localized, residual numbness. The incidence of blood donation-related neurologic needle injury was 1 of every 6300 donations. CONCLUSION: While donor recovery may in some cases require a great deal of time and/or physician consultation(s), total recovery appears to be the rule. The incidence of blood donation-related neurologic needle injury is relatively low.     

人参皂甙诱导的造血细胞内信号传递途径的研究

目的探讨人参皂甙（ＧＳ）刺激造血祖细胞增殖有关的细胞内信号传递途径。方法采用Ｎｏｒｔｈｅｒｎ印迹杂交法、电泳带移动阻滞实验、抗体胶结合移动实验和紫外放射交联实验。结果ＮｏｒｔｈｅｒｎＢｌｏｔ显示经ＧＳ诱导的人巨核细胞株ＣＨＲＦ２８８、Ｍｅｇ０１和ＭＯ７ｅ细胞的ＧＡＴＡ２ｍＲＮＡ水平增高,分别是未经处理细胞的１．８４,２．４３和１．５２倍。但ＧＡＴＡ１ｍＲＮＡ表达水平低,且ＧＳ处理前后也无明显变化。电泳带移动阻滞实验提示ＧＳ诱导的细胞核内ＧＡＴＡ转录调控蛋白与特定的ＤＮＡ序列结合的活性增高。抗体胶结合移动实验证实与ＤＮＡ结合的主要成分为ＧＡＴＡ２蛋白,紫外放射交联实验确定该复合物的相对分子质量约为５０×１０３,符合ＧＡＴＡ２转录调控蛋白。结论ＧＳ诱导细胞内的信号传递途径与转录因子ＧＡＴＡ２有关,ＧＡＴＡ２有介导ＧＳ刺激造血细胞增殖的作用。     

An audit of consent refusals in clinical research at a tertiary care center in India

Background and Rationale:

Ensuring research participants’ autonomy is one of the core ethical obligations of researchers. This fundamental principle confers on every participant the right to refuse to take part in clinical research, and the measure of the number of consent refusals could be an important metric to evaluate the quality of the informed consent process. This audit examined consent refusals among Indian participants in clinical studies done at our center.

Materials and Methods:

The number of consent refusals and their reasons in 10 studies done at our center over a 5-year period were assessed. The studies were classified by the authors according to the type of participant (healthy vs patients), type of sponsor (investigator-initiated vs pharmaceutical industry), type of study (observational vs interventional), level of risk [based on the Indian Council of Medical Research (ICMR) “Ethical Guidelines for Biomedical Research on Human Participants”], available knowledge of the intervention being studied, and each patient''s disease condition.

Results:

The overall consent refusal rate was 21%. This rate was higher among patient participants [23.8% vs. healthy people (14.9%); P = 0.002], in interventional studies [33.6% vs observational studies (7.5%); P < 0.0001], in pharmaceutical industry-sponsored studies [34.7% vs investigator-initiated studies (7.2%); P < 0.0001], and in studies with greater risk (P < 0.0001). The most common reasons for consent refusals were multiple blood collections (28%), inability to comply with the study protocol (20%), and the risks involved (20%).

Conclusion:

Our audit suggests the adequacy and reasonable quality of the informed consent process using consent refusals as a metric.KEY WORDS: Autonomy, consent, India, reason, refusal, risk     

Percutaneous fine needle aspiration biopsy of pancreatic carcinoma

Carcinoma of the pancreas was diagnosed in 13 patients by percutaneous fine needle aspiration. The tumor was localized by angiography in eight, ultrasound in five, and endoscopic retrograde pancreatography in three patients. In four patients aspiration was performed using two of the three localizing techniquesCytological diagnosis of carcinoma of the pancreas can be made accurately by percutaneous fine needle aspiration of the tumor and operative intervention avoided in those patients who do not require operative bypass procedures. Percutaneous fine needle aspiration can be used with equal facility with arteriography, ultrasound, or endoscopic retrograde pancreatography. There have not been complications due to fine needle biopsy, and one can expect a 77–86% positive diagnostic yield.