Objective To compare the therapeutic effect of cannulated screws fixation at different time points through different reduction methods on the heal ing of displaced femoral neck fractures. Methods From January 1997 to September 2007, 240 patients with displaced femoral neck fracture were treated, including 121 males and 119 females aged 22-79 years old (average 56 years old). All cases were fresh and close fractures. According to the fractured part, there were 133cases of subcapital fracture, 64 of transcervical fracture and 43 of basal fracture. According to Garden classification, there were 105 cases of type III and 135 of type IV. Cannulated screws fixation was performed on all the patients, and the time from injury to operation was 6 hours to 7 days. Fifty-five cases received closed reduction and 59 cases received l imited open reduction as emergency treatment, while 65 cases received closed reduction and 61 cases received l imited open reduction as selective operation. Different groups were compared in terms of the heal ing rate of fracture, the excellent and good rate of reduction as well as the excellent and good rate of fixation. Results There was no significant difference between the closed reduction and the l imited open reduction in terms of operation time and bleeding volume (P gt; 0.05). Postoperatively, all wounds healed by first intention, no infection was observed, avascular necrosis of femoral head occurred in 44 cases, and the rate of avascular necrosis of femoral head in the l imited open reduction at emergency group was less than that of other 3 groups (P lt; 0.01). All the patients were followed up for 12-72 months (average 38 months), 193 cases got fracture heal ing at 10-23 months after operation (average 14 months). For the closed reduction as emergency operation group, the l imited open reduction as emergency operation group, the closed reduction as selective operation group, and the l imited open reduction as selective operation group, the heal ing rate of fracture was 74.55%, 91.53%, 69.23% and 86.89%, respectively; the excellent and good rate of reduction was 73.73%, 94.92%,70.77% and 91.80%, respectively; the excellent and good rate of fixation was 76.36%, 93.22%, 73.85% and 88.52%, respectively. The heal ing rate of fracture, the excellent and good rate of reduction as well as the excellent and good rate of fixation in the l imited open groups were higher than that of the closed reduction groups (Plt; 0.01), and there was no significant difference between the emergency operation groups and the selective operational groups (Pgt; 0.05). Conclusion The reduction methods have significant influences on the heal ing of fractures after cannulated screws fixation of the displaced femoral neck fracture, and the operation time has no obvious effect on fracture heal ing.
Objective To investigate the advances and clinical efficacy evaluation method on neoadjuvant chemotherapy in patients with gastric cancer. Methods Literatures on the advances and clinical efficacy evaluation method on neoadjuvant chemotherapy in patients with gastric cancer were reviewed and analyzed. The agreement between computed tomography (CT), endoscopic ultrasound (EUS), magnetic resonance imaging (MRI) and positron emission tomography (PET) and the results of histopathology and survival was analyzed.Results CT and EUS were the method of efficacy evaluation commonly used at present, but the evaluation indexes and criteria were controversial, and the criteria for solid tumors seemed to be not feasible for gastric cancer. Diffusionweighted imaging (DWI) method needed more investigation, while PET held advantage in early selection of patients without response accurately.Conclusion There is no uniform standard for clinical efficacy evaluation yet, so an integration of diverse imaging methods may be the best choice to improve the accuracy of neoadjuvant chemotherapy in patients with gastric cancer.
Stem cell transplantation is one of the main methods to treat thromboangiitis obliterans (TAO). In recent years, research on the treatment mechanism of stem cell transplantation has made some progress. The results of a number of stem cell clinical trials specifically for TAO have been published. Some new stem cell types have gradually been used in the clinic. There is no major dispute over security. In addition, research shows that the efficacy of stem cell transplantation is affected in many ways, and some factors have a certain predictive effect on the possibility of amputation after transplantation. This paper reviews the clinical research progress of stem cell transplantation for TAO, and aims to provide some basis for the better use of stem cell transplantation in the treatment of TAO.
The prominent feature and form of clinical diagnosis and treatment of traditional Chinese medicine is individualization, which has generated difficulty for clinical evaluation and has restricted the production of high-level evidence for traditional Chinese medicine for a long time. Based on the complexity and dynamics of individualized information under the characteristics of time and space, this paper references the theory of space-time of system science to analyze the individualized data of diagnosis and treatment of traditional Chinese medicine and summarizes the concept of the long time course for clinical evaluation. Based on the concept of the long time course, this paper starts with the origin of clinical evaluation, which is the construction of clinical problem elements named PICO, introduces dynamic evaluation factors, explores the construction of individualized dynamic evaluation method of traditional Chinese medicine, and provides demonstration and examples for the design and implementation of individualized clinical research in future.
Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
Objective To explore the effectiveness, safety and applicability of focused ultrasound (FU) in rural patients with cervicitis-related diseases. Methods Patients with cervicitis-related diseases (n=8 352) from 80 township health centers of 9 counties in Chongqing were enrolled in this multicenter clinical study, and they were treated with CZF Model of FU for one time and then were visited in the following 3 months. According to the category 4 scoring method and the curative index, the effectiveness, safety and applicability in 7027 cases (1 156 mild cases, 5 312 moderate cases, 559 severe cases) with complete records were analyzed. The influencing factors were also analyzed with logistic regression analysis. Results A total of 6 413 cases (91.26%) were treated within 5 minutes. After 3-month follow-up, the total effective rate was 99.59%, and 5 012 cases (71.32%) were cured. Just little or medium amount of vaginal bleeding occurred in 656 cases (9.34%) after treatment, while only 12 cases (0.17%) had bleeding in the similar amount tomenstruation, which were relieved by hemostasis and anti-inflammatory treatment. Conclusion As a promising new therapy, focused ultrasound therapy for treating cervicitis-related diseases is safe and effective, with little postoperative bleeding and short-term of vaginal effusion, so it is suitable to be popularized in rural areas.
ObjectiveTo observe the efficacy of intravitreal injection of conbercept (IVC) combined with subthreshold micropulse laser photocoagulation (SMLP) in the treatment of diabetic macular edema (DME). MethodsA randomized controlled trial. From December 2020 to January 2022, 100 patients (100 eyes) with DME diagnosed by examination in Shanxi Aier Eye Hospital were included in the study. The patients were randomly divided into IVC group (50 eyes) and IVC+SMLP group (50 eyes). All the eyes were treated with IVC once a month for 3 times, and the eyes in IVC+SMLP group were treated with SMLP within 2 weeks after IVC. All affected eyes were examined by best corrected visual acuity (BCVA), which was statistically converted to logarithm of the minimum angle of resolution (logMAR) visual acuity. The central macular thickness (CMT) was measured by optical coherence tomography. Before the treatment, the logMAR BCVA of patients in IVC group and IVC+SMLP group were 0.56±0.04 and 0.55±0.03, respectively. The CMT were (437.36±11.35) μm and (434.58±10.88) μm, respectively. There was no significant difference in logMAR BCVA and CMT between the two groups (t= 0.476, 1.027; P＞0.05). The patients were followed up for 12 months after treatment. The times of IVC and the changes of BCVA and CMT were compared between the two groups. Independent sample t-test was used to compare the logMAR BCVA, CMT and times of IVC between groups. ResultsAfter 12 months treatment, the logMAR BCVA of IVC group and IVC+SMLP group were (241.63±29.79) μm and (240.47±30.46) μm, respectively. Compared with those before treatment, 12 months after treatment, the BCVA of the two groups increased significantly (t=7.014, 5.608; P＜0.001), while CMT decreased significantly (t=8.126, 6.013; P＜0.001). There was no significant difference in BCVA and CMT between the two groups (t=0.835, 0.764; P＞0.05). The number of IVC in IVC group and IVC+SMLP group were (8.15±2.04) times and (5.91±1.80) times, respectively, and the difference was statistically significant (t=5.210, P＜0.001). ConclusionsBoth IVC+SMLP and IVC alone can effectively reduce CMT and increase BCVA in patients with DME. Combination therapy can reduce the number of IVC.
There are many problems in the selection of outcomes in clinical trials of traditional Chinese medicine (TCM), such as insufficient research on the applicability of outcomes, insufficient research of individualized outcomes for syndrome differentiation and treatment, incomplete selection methods for overall/comprehensive evaluation outcomes, lack of evidence in the importance of outcomes for researchers, and insufficient reflection of the humanistic value of outcomes. Although the core outcome sets (COS) may help clinical trialists to select outcomes to a certain extent, the COS has not been widely used at present, and the judgment of the importance of the outcomes in the COS is mainly based on the personal experience of the participants. The lack of methodology will also lead to multiple COS in the same disease area. The authors believe that it is necessary to improve the methodology of outcomes research, especially in the development of COS. Developing evidence and humanistic values framework may be a potential way to help researchers select core outcomes in clinical efficacy evaluation of TCM.
Acute pharyngitis belongs to the category of “acute throat impediment” in traditional Chinese medicine (TCM), which has a high incidence and is easy to recur. In clinical practice of TCM, Chinese patent medicines with the effects of clearing heat and detoxifying, reducing swelling and relieving pain are widely used in the treatment of acute pharyngitis. These medicines have the advantages of definite efficacy, low side effects, and low risk of developing drug resistance. However, at present, there are no standardized clinical diagnostic and therapeutic evaluation norms for acute pharyngitis in TCM, which has hindered the application of TCM in the prevention and treatment of acute pharyngitis and the development of new TCM preparations. Therefore, the China Association of Chinese Medicine initiated this expert consensus, which was led the formulation by Xiyuan Hospital, China Academy of Chinese Medical Sciences. This expert consensus integrates the current best evidence and extensive clinical expert experience from the front line, covering seven aspects: applicable scope, diagnosis in both Chinese and Western medicine, syndrome classification and evaluation scales, basis for efficacy evaluation, and time for efficacy evaluation. It has formed 8 types of TCM syndromes for acute pharyngitis, as well as the diagnostic criteria, syndrome classification and evaluation scales, evaluation basis for efficacy, and scoring standards for syndromes and diseases. This expert consensus can be used to standardize the diagnosis of the TCM syndromes of acute pharyngitis, as well as the core indicators and evaluation methods for syndrome and disease efficacy, with the aim of providing references for clinical practice and scientific research on acute pharyngitis.
ObjectiveTo evaluate the clinical efficacy of medical absorbent pads in the treatment of wouds. MethodsA total of 200 patients treated in the Wound Treating Center of a first-class hospital between November 2014 and August 2015 were randomly divided into trial group and control group with 100 patients in each. Patients in the trial group received medical absorbent pads, while patients in the control group received the treatment of Zetuvitò E. All patients received four times of treatment. Then we used self-made observation record form to evaluate such indexes as water absorption and compliance of the dressing, patients' pain and secondary trauma scores and the score of skins around the wounds. ResultsThere was no significant difference in water absorption property and compliance between the two groups (P>0.05). But the score of visual analogue scale was lower in the trial group than that in the control group at the fourth dressing changing (P<0.05), and the score of secondary trauma was also lower in the trial group than that in the control group at the third and fourth dressing changing (P<0.05). ConclusionThe medical absorbent pads used in the trial group can relieve pain and promote wound healing. It can be used for the treatment of wounds, and also has better effectiveness and safety.