Objective To investigate the efficacy and safety of amniotic membrane transplantation in the treatment of severe chemical burns.Methods Amniotic membrane transplantation were performed in 41 patients(41eyes)suffered with severe chemical burns,in which 26 cases were alkaline burns,15 cases were acid burns.Results 41 cases were followed up about 6-24 months,the effective rate were 92.7%,alkaline burns were 92.3%,acid burns were 93.3%.Conclusions Amniotic membrane transplantation is an effective and safe method for the treatment of chemical burns.

Objective:To investigate the endothelialization and intermediate and long-term patency rate of prostheses seeded by CD34+ stem cells.Methods:sixteen crossbred dogs were randomized into 2 groups.Prostheses covered with ePTFE or Dacron were implanted into the abdominal aorta artery(AAA) and inferior vena cava(IVC).Twelve dogs were implanted by prostheses seeded by CD34+ stem cells,4 dogs were implanted by autogenous blood only as control.The prostheses were explanted at thirty or sixty or one hundred days.Light and electron microscopy were applied to examine endothelialization of prostheses.CD34 factor stain was used to identify endothelial cells.Results:All venous prostheses implanted by autogenous blood were blocked.Others were patent.Confluent endothelial cells appeared on the neointima of seeded prostheses.There were no endothelial cells in the no-implanted prostheses.Conclusion:Endothelialization and higher patency rate might be achieved in the prostheses covered with ePTFE or Dacron that were implanted by CD34+ stem cells.

Objective:This paper is to evaluate the curative effect of Self-made Jishen prescription combined with conventional western medicine in the treatment of type 2 diabetic kidney disease (DKD) with both deficiency of both qi and yin and blood stasis.Methods:A total of 80 patients from February 2019 to July 2020 with the syndrome of deficiency of both Qi and Yin with blood stasis in the DKD Ⅲ stage of Ruzhou Jiren Diabetes Hospital were selected. Those patients who met the diagnostic criteria were randomly divided into 2 groups, the control group and the treatment group, according to registration orders, with 40 in each group. The control group was treated with conventional western medicine therapy, and the treatment group was treated with modified self-made Jishen prescription on the basis of the control group. The treatment of both groups lasted for 3 months. Traditional Chinese Medicine (TCM) symptoms were scored before and after the treatment; hexokinase method was used to detect FPG, sarcosine oxidase method was used to detect SCr and eGFR were calculated, latex enhanced turbidimetric inhibition immuno assay method was used to detect hypersensitive C-reactive protein (hs-CRP), the sandwich ELISA was used to detect transforming growth factor-β1 (TGF-β1), and HbA1c was detected by high performance liquid chromatography; 24 h urine was collected, and 24 hUTP was detected by pyrogallol red-molybdenum method; and the clinical efficacy was evaluated.Results:The total effective rate was 87.5% (35/40) in the treatment group and 67.5% (27/40) in the control group. The difference between the two groups was statistically significant ( Z=-2.72, P=0.006). After treatment, hs-CRP [(2.52±1.02) mg/L vs. (3.21±1.22) mg/L, t=2.74], TGF-β1 [(32.2±6.52) mg/L vs. (38.3±6.8) mg/L, t=-4.97], 24 hUTP [(120.91±38.84) mg vs. (144.84 ±49.69) mg, t=-5.94] in the treatment group were significantly lower than those in the control group ( P<0.05); eGFR [(66.23±4.91)ml?min -1?1.73m -2vs. (59.69 ±4.51) ml?min -1?1.73m -2, t=6.61] in the treatment group was significantly higher than that of the control group ( P<0.05). The TCM Symptom Score after treatment in the treatment group was significantly lower than that of the control group ( P<0.01). Conclusion:For the patients with T2DM kidney disease of Phase Ⅲ with Deficiency of both Qi and Yin and Blood Stasis, the treatment of self-made Jishen prescription combined with conventional western medicine can inhibit the inflammatory reaction and renal interstitial fibrosis, improve the glomerular filtration rate, and reduce the excretion of urine protein.

This study aims to provide evidence for clinical practice by systematically reviewing the efficacy and safety of Gusongbao preparation in the treatment of primary osteoporosis(POP). The relevant papers were retrieved from four Chinese academic journal databases and four English academic journal databases(from inception to May 31, 2022). The randomized controlled trial(RCT) of Gusongbao preparation in the treatment of POP was included after screening according to the inclusion and exclusion criteria. The quality of articles was evaluated using risk assessment tools, and the extracted data were subjected to Meta-analysis in RevMan 5.3. A total of 657 articles were retrieved, in which 15 articles were included in this study, which involved 16 RCTs. A total of 3 292 patients(1 071 in the observation group and 2 221 in the control group) were included in this study. In the treatment of POP, Gusongbao preparation+conventional treatment was superior to conventional treatment alone in terms of increasing lumbar spine(L2-L4) bone mineral density(MD=0.03, 95%CI[0.02, 0.04], P<0.000 01) and femoral neck bone mineral density, reducing low back pain(MD=-1.69, 95%CI[-2.46,-0.92], P<0.000 1) and improving clinical efficacy(RR=1.36, 95%CI[1.21, 1.53], P<0.000 01). Gusongbao preparation was comparable to similar Chinese patent medicines in terms of improving clinical efficacy(RR=0.95, 95%CI[0.86, 1.04], P=0.23). Gusongbao preparation was inferior to similar Chinese patent medicines in reducing traditional Chinese medicine syndrome scores(MD=1.08, 95%CI[0.44, 1.71], P=0.000 9) and improving Chinese medicine syndrome efficacy(RR=0.89, 95%CI[0.83, 0.95], P=0.000 4). The incidence of adverse reactions of Gusongbao preparation alone or combined with conventio-nal treatment was comparable to that of similar Chinese patent medicines(RR=0.98, 95%CI[0.57, 1.69], P=0.94) or conventio-nal treatment(RR=0.73, 95%CI[0.38, 1.42], P=0.35), and the adverse reactions were mainly gastrointestinal discomforts. According to the available data, Gusongbao preparation combined with conventional treatment is more effective than conventional treatment alone in increasing lumbar spine(L2-L4) bone mineral density and femoral neck bone mineral density, reducing low back pain, and improving clinical efficacy. The adverse reactions of Gusongbao preparation were mainly gastrointestinal discomforts, which were mild.
Humans ; Bone Density ; Low Back Pain ; Medicine, Chinese Traditional ; Osteoporosis/drug therapy*

Objective:To observe the possible toxicity of long-term intravenous injection of Tanreqing injection in Beagle dogs， so as to provide experimental data for its clinical safe medication. Method:A total of 32 Beagle dogs （16 males and 16 females） were randomly divided into the low- （2.5 mL·kg^-1）， medium- （5.0 mL·kg^-1）， and high-dose （10.0 mL·kg^-1） Tanreqing injection groups and control group according to their body mass indices， with eight dogs in each group. In the waking state， the dogs were treated with intravenous injection of corresponding drugs into the medial cephalic vein of forelimb for 13 weeks， followed by four-week drug withdrawal. After the observation of general condition， body mass， and food consumption， the Beagle dogs were subjected to electrocardiography， ophthalmoscopy， hematological examination， serum biochemistry， and blood coagulation test in the middle of medication （week 6）， at the end of medication （week 13）， and during recovery （week 17）. Then the gross anatomy was conducted for calculating the major organ coefficients and observing the histopathological changes. Result:No obvious toxic reaction was found in each group， but the decreased fibrinogen and increased Kupffer's cells phagocytizing yellow-brown pigment in hepatic sinusoids were observed in the high-dose Tanreqing injection group following three months of medication. Reduction of fibrinogen was not observed in recovery period， but Kupffer's cells that phagocytized yellow-brown pigment still existed. Conclusion:The intravenous injection of Tanreqing injection at 2.50 mL·kg^-1 （low dose）， 5.00 mL·kg^-1 （medium dose） or 10.00 mL·kg^-1 （high dose） for three months in Beagle dogs resulted in no obvious toxic reaction. However， it is still suggested to test the liver function and blood coagulation after long-term administration of high-dose Tanreqing injection.

ObjectiveTo confirm the clinical efficacy and safety of Yishen Yangxin Anshen tablets in the treatment of insomnia （heart-blood deficiency and kidney-essence insufficiency syndrome）. MethodA randomized block， double-blind， placebo-controlled， multi-center clinical trial design method was adopted， and a total of 480 patients with insomnia due to deficiency of heart blood and insufficiency of kidney essence （treatment group-control group 3∶1） from seven hospitals （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， The First Clinical Hospital， Jilin Province Academy of Traditional Chinese Medicine（TCM）， The Second Affiliated Hospital of Liaoning University of TCM， The First Affiliated Hospital of Henan University of Chinese Medicine， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine） were enrolled. The treatment group was given Yishen Yangxin Anshen tablets and the control group received placebo tablets （4 tablets/time， 3 times/day， 4 weeks of administration， 4 weeks of follow-up after drug withdrawal）. The sleep dysfunction rating scale （SDRS） score， pittsburgh sleep quality index （PSQI） score， TCM， polysomnography （PSG） indicators from four hospital （Guang'anmen Hospital， China Academy of Chinese Medical Sciences， Henan Province Hospital of TCM， Hebei General Hospital， The First Hospital of Hunan University of Chinese Medicine）， and other efficacy indicators were compared between the two groups before and after treatment. Through general physical examination， laboratory examination， and observation of adverse events， the safety of the drugs was evaluated. ResultThe baseline indexes of the two groups showed no significant difference and thus the two groups were comparable. After treatment， the total score of SDRS in the treatment group was lower than that in the control group （P<0.01）. After drug withdrawal for 4 weeks， the total score of SDRS demonstrated no significant change in the treatment group as compared with that at the end of treatment， indicating that the rebound change of curative effect was not obvious. After treatment， the total score of PSQI in the treatment group decreased as compared with that in the control group （P<0.01）， and the change of total score of PSQI in the treatment group was statistically significant （P<0.05） after drug withdrawal for 4 weeks but small， indicating that the rebound change of curative effect was not obvious. After treatment， the total effective rate about the TCM symptoms in the treatment group was higher than that in the control group （χ²=137.521，P<0.01）. After treatment， the disappearance rates of single indexes in the treatment group， such as difficulty in falling asleep， easily waking up after sleeping， early awakening， short sleep time， dreamfulness， palpitation， forgetfulness， dizziness， mental fatigue， and weakness of waist and knee， increased compared with those in the control group （P<0.01）. After treatment， the treatment group demonstrated fewer awaking times （AT）， longer total sleep time （TST）， lower ATA/TST ratio， and higher sleep efficiency （%） than the control group （P<0.05）. No abnormal value or aggravation related to drugs was observed in either group. The incidence of adverse events in the treatment group and the control group was 5.57% and 8.40% respectively. No serious adverse events or adverse events leading to withdrawal happened in either group. ConclusionYishen Yangxin Anshen tablets is effective and safe for patients with insomnia of deficiency of heart-blood and insufficiency of kidney-essence.

Along with the increase of clinical application, the safety of traditional Chinese medicine gained more and more attentions. In particular, the safety evaluation of Chinese medical injections has become a mandatory task should be completed by pharmaceutical companies under the supervision of China Food and Drug Administration(CFDA). Due to the weak foundation of previous studies, the safety issues of Chinese medical injections have not been fully understood, and lack of scientific and rational risk management programs. Clinical safety centralized monitoring(CSCM) is an important method for post-market safety evaluation of Chinese medicine. Due to the lack of appropriate norms and procedures, the quality of similar research is uneven, and the results vary. Combined with practical experience with experts' suggestions, we developed this expert consensus on the design and implementation of CSCM from three stages (design, implementation and report) with 20 technical points, which will provide technical support for future CSCM studies.