Reevaluation of the post-marketing safety of Xuebijing injection based on real-world and evidence-based evaluations.

AIMS: To determine the causes of adverse reactions associated with Xuebijing injection and provide medical evidence for its safe and rational post-marketing use in clinical practice. MATERIALS AND METHODS: We used prospective nested case-control and prescription sequence analysis designs. Using data from the Hospital Information System, patients exhibiting trigger signals after receiving Xuebijing injection were classified as suspected allergic patients. Logistic regression analysis was performed on the risk factors associated with Xuebijing-induced allergic reactions. Randomized controlled and cohort studies on adverse drug reactions to Xuebijing injection were screened from databases and the results were subjected to meta-analysis. RESULTS: The overall incidence of allergic reactions or anaphylaxis tended to increase with dosage and patient's age. Moreover, compared with Xuebijing alone, co-administration of Xuebijing with other drugs or agents (including Ringer's sodium acetate solution, reduced glutathione, aspirin-DL-lysine, and torasemide) increased the risk of adverse reactions. The use of glucose as a vehicle also provoked a greater incidence of allergic reactions than that by the use of 0.9% w/v sodium chloride as a vehicle. Adverse reactions occurred more frequently in patients receiving indicated dosages than in those receiving off-label dosages. CONCLUSIONS: Adverse reactions to Xuebijing injections were correlated with vehicle type, dosage, age, and drug combination. There was no clear association between patient's condition at admission and suspected adverse reactions to Xuebijing injection. Factors influencing the adverse reactions to Xuebijing injection must be fully considered in clinical practice.

Reevaluation of the post-marketing safety of Shuxuening injection based on real-world and evidence-based evaluations.

AIM: To evaluate the factors influencing suspected hypersensitivity and adverse systemic reactions after Shuxuening injection and to provide innovative ideas and methods for the reevaluation of post-marketing safety of Shuxuening. METHODS: This study used a prospective, nested case-control study design, combined with a prescription sequence analysis design method. It classified patients who exhibited trigger signals after administration of Shuxuening injection as suspected allergic patients and made comparisons with patients who did not report adverse effects to calculate the correlation between relevant risk factors and suspected allergic reactions. Randomized controlled studies and cohort studies of the adverse drug reaction (ADR) of Shuxuening were performed using a computer database. Data retrieval was carried out by the foundation governing the individual database. Meta-analysis was performed by using R3.2.3 software to evaluate the ADRs of Shuxuening. RESULTS: The results of real-world study showed that administration of Shuxuening in combination with potassium aspartate and magnesium, atorvastatin calcium, Shengmai injection, pantoprazole sodium, or high-dose medication was a risk factor for suspected allergic reactions. Meta-analysis showed that the incidence of adverse events was 5.84% (95% CI 0.0499; 0.0674), and serious adverse reaction rate was 4.36% (95% CI 0.0188; 0.0760) when Shuxuening was used in combination with these drugs. The incidence of allergic reaction was also influenced by the vehicle, duration of treatment, single dose, and indicated vs off-label use. CONCLUSION: Risk factors for adverse reaction following the use of Shuxuening injection in patients are associated with a single dose, vehicle, type of disease, and combination with potassium aspartate, atorvastatin calcium, Shengmai injection, injection with pantoprazole sodium, and other drugs. Physicians should be careful to follow guidelines when administering this drug. We further propose that the unique methodology used in this study may be useful for reevaluation of the safety of other traditional Chinese medicines.

[Progress in decoding the impact of abiotic stress on spikelet fertility in rice]. / éžç”Ÿç‰©èƒè¿«å½±å“æ°´ç¨»é¢–èŠ±è‚²æ€§æœºç†çš„ç ”ç©¶è¿›å±•.

Recent research progress in the impact of abiotic stress on florets sterility was summarized in this review to reveal key processes in determining the floret sterility resulted from abiotic stress and their coherent connections. The spikelet fertility was mainly determined by four key processes, including behavior of tapetum, anther dehiscence and pollen release, pollen germination and fertilization. Abiotic stress affected these processes and led to the spikelet sterility. Abnormal changes at the early-stage of anther growth could impact the development of germ cell and fertilization. Damages of floret fertility caused by abiotic stress could be mitigated via some practices such as spraying exogenous plant growth substances or silicon fertilizer. Some research topics were suggested for future investigation, including the interactions of multiple stress factors on fertility, morphological and physiological effects on floral organ formation, differential responses of rice varieties to abiotic stress, and molecular mechanism of abiotic stress on floral organ development.

[Meta-analysis on incidence of adverse drug reaction induced by Shuanghuanglian injection].

To conducted a systematic review on the safety of Shuanghuanglian injection in clinical use. In this paper, data from Pubmed, Embase, the Cochrane Library, CNKI, VIP and WanFang Data were retrieved. After extracting information and evaluating research methodological quality according to inclusion and exclusion criteria, Meta-analysis was conducted by using R3.2.3 software. A total of 56 individual studies were included, in which 585 cases showed adverse reactions in a total of 11 001 patients with Shuanghuanglian injections. Meta-analysis showed that the total incidence of adverse reactions was 6.5% (95%CI 0.051 to 0.082). Subgroup analysis showed that the incidence of adverse reactions was 4.8% (95%CI (0.032 to 0.067) and 8.1% (95%CI 0.054 to 0.112) respectively in children and adults; 7.2% (95%CI 0.049 to 0.095) and 6.6% (95%CI 0.036 to 0.104) respectively in 5%-10% glucose injection and 0.9% sodium chloride injection; 6.3% (95%CI 0.047 to 0.082) and 7.0% (95%CI 0.044 to 0.099) respectively in powder injection and liquid injection; 5.8% (95%CI 0.043 to 0.075) and 8.9% (95%CI 0.049 to 0.140) respectively in cases with duration of ≤7 d and >7 d; 4.2%(95%CI 0.027 to 0.059) and 8.4% (95%CI 0.059 to 0.113) respectively in single use and combined medication. Three most frequent types of adverse reaction symptoms reported were in skin and mucosa, digestive system, and body temperature center, with an incidence of 4% (95%CI 0.03 to 0.04), 3% (95%CI 0.02 to 0.03), and 1% (95%CI 0.00 to 0.01), respectively. The systemic evaluation demonstrated that the occurrence of adverse reaction of Shuanghuanglian injection was related to age, menstruum, duration of medication and combined medication. Incidence of adverse reactions differed considerably among different damage types. From the study demonstrated above, this paper concludes that we should follow the principles of evidence-based medication of traditional Chinese medicine; use Shuanghuanglian injection singly instead of combination with other drugs in clinical use; use Shuanghuanglian injection strictly in accordance to instructions, especially for children and the elderly, whose weight should be calculated and considered in medication; intensively monitor the drug adverse reaction after use; assess the risks of adverse effects for long-term usage, and take corresponding safety measures to ensure safety.

[Predictive analysis on Shenmai injection-induced adverse reactions with Logistic model and ROC curve].

To study relevant risk factors of Shenmai injection induced adverse reactions by using Logistic model and ROC curve, and made the prediction for the occurrence of relevant adverse reactions/events. Case data of patients treated with Shenmai injection were collected by using the prospective, multi-center, large-sample, nested-case control method, in order to analyze the risk factors of Shenmai injection-induced adverse reactions/events, establish the logistic model and draw the receiver operating characteristic (ROC) curve for risk factors. During the study, 7632 patients (including 3 477 males and 4 155 females) were included, and eight of them suffered adverse reactions/events. Based on a multi-factor Logistic model analysis, the age (> or = 50 years) (OR = 5.061, 95% CI: 2.197-7.924; P = 0.001), the total number of medication days (OR = -1.020, 95% CI: -l.652 - 0.388; P = 0.002) and the single dose (OR = 0.245, 95% CI: 0.127-0.364; P = 0.000) were significant independent risk factors for Shenmai injection-induced adverse reactions/events. According to the results, ROC curves were drawn with age (> or = 50 years), the total number of days of inedication and single dose; The area under ROC curves the joint predictor (0.9753, 95% CI: 0.9443-1.000, P < 0.005) was larger than that of the other three single indexes, with a higher risk prediction value. The independent risk factors for Shenmai injection-induced adverse reactions/events included the age (> or = 50 years), the total number of days of medication and single dose. In clinical practice, the age (> or = 50 years), the total number of days of medication and the medication dose can be substituted in the joint predictor calculation formula (P = 1 / [1 + e(-(-21.58 + 5.061 x Xage - 1.020 x Xd + 0.245 x X(mL)] to predict the potential adverse reactions of patients and adjust the dosage regimen.