Objective Qin Kai Ling injection (QKL) is made upon traditional Chinese medicine formulation “An Gong Niu Huang Wan”, is widely used to treatment a lot of diseases. This review aims to assess the safety of QKL. Methods We searched Chinese databases CNKI, VIP from 1987 to April 2009. Two authors extracted the data. Results Totally 1 486 cases were included in this review. We unable to answer the question about the incidence of adverse drug reaction/adverse event (ADR/AE) induced by QKL due to absence of total numbers of producing and market information. It was estimated based on the limited data that the possibility of ADR/AE by using QKL should be low. We found some ADR/AE may induced by incorrect use of QKL, such as used in infants, and some incompatibility drugs were used together with QKL, four patients died in private clinics or patient’s home. We unable to distinguish the ADR or AE based on the poor reported data. Conclusion Current weak evidence shows that QKL has a low risk of ADR/AE. The use of QKL in some ADR/AE cases may be questionable. The reporting of ADR/AE needs to be much improved based on “Recommendation for reporting traditional Chinese medicine adverse drug reaction”.
Since the public clinical trial registration system was launched twelve years ago in China, as the primary register of the WHO International Clinical Trial Registry, the Chinese Clinical Trial Registry (ChiCTR) has largely promoted the development of clinical trial registration in China, particularly in recent three years. The quantity of registered trials has increased rapidly and 3939 studies were registered in ChiCTR in 2017. An increasing number of investigators, Institutional Review Boarders and funding agencies were taking the trial registration into account in the medical research ethics issues these years. Considering the large number of workforce in public health, limited researchers knew clinical trial registration very well, even with misunderstandings. For instance most of them do not know the purpose of trial registration and the principle of local registration. A lot of Chinese medical journals editors have been working together with us to promote the development of clinical trial transparency in last ten years, and they have made outstanding contributions. We would like to appeal more medical journals to join the great revolution of medical research.
ObjectiveTo detect the expression of Ki-67 in papillary thyroid carcinoma (PTC) and investigate its clinical significance. MethodsA retrospective analysis was conducted on PTC patients treated at West China Hospital of Sichuan University from August 2024 to February 2025. The relation between the Ki-67 expression in the postoperative pathological tissues and clinicopathologic features was analyzed. Additionally, the concordance of Ki-67 expression between the preoperative fine-needle aspiration samples and postoperative pathological tissues was evaluated by Bland-Altman analysis. The significance level was set at α=0.05. ResultsA total of 290 PTC patients met the inclusion and exclusion criteria were enrolled. Patients with classical PTC, M1 classification, TNM stage Ⅳ, and those achieving thyroid stimulating hormone (TSH) suppression targets at one month postoperatively had higher Ki-67 expression than those with follicular variant PTC, M0 classification, TNM stages Ⅰ–Ⅲ, or inadequate TSH suppression (all P＜0.05). No significant differences were observed in other subgroups (P>0.05). Furthermore, Bland-Altman analysis of 27 paired samples showed a mean bias of 1.269% between preoperative and postoperative measurements. Elevated variability occurred in high Ki-67 cases, with 11.1% (3/27) exceeding ±6% limits of agreement. ConclusionsThe study demonstrates that Ki-67 expression correlates with malignant attributes including tumor aggression and advanced disease. It may serve as a prognostic biomarker for assessing malignant potential in PTC.
Objectives To explore potential important factors that impacts the quality of Chinese trials. Methods We randomly selected clinical studies registered in the Chinese Clinical Trial Registry during March 15th, 2016 to December 31st, 2016. The randomized controlled trials protocols were retrieved to assess the quality based on the SPIRIT guideline, their data management plan and statement of sharing individual participant data were also investigated. Results 457 studies were randomly selected from 2 205 studies by a rate of 1∶4. Among them, 393 were randomized controlled trials. Pre-market trials of new medicines conducted by the State Clinical Study Bases had better quality of protocols. In total, 4 protocols were rated as high quality (1.02%) and 21 as higher quality (5.34%). 129 studies in 457 (28.23%) described a correct data management system including a paper case record form and an electronic data capture. 392 studies (85.77%) stated that public sharing IPD will be available. Conclusions Poorly developed protocol and lack of professional data management system are common issues in some Chinese clinical studies. We feel confident that most Chinese investigators are good in learning considering that they are willing to share the IPD of their studies. Providing education and technical support focus on three technical aspects are crucial: introducing SPIRIT for developing protocol, providing standardized data management system, and introducing the concept of transparency include sharing IPD which is an essential requirement of clinical study ethics.