BACKGROUND: The use of inserted sham acupuncture as a placebo in randomized controlled trials (RCTs) is controversial, because it may produce specific effects that cause an underestimation of the effect of acupuncture treatment. OBJECTIVE: This systematic survey investigates the magnitude of insert-specific effects of sham acupuncture and whether they affect the estimation of acupuncture treatment effects. SEARCH STRATEGY: PubMed, Embase and Cochrane Central Register of Controlled Trials were searched to identify acupuncture RCTs from their inception until December 2022. INCLUSION CRITERIA: RCTs that evaluated the effects of acupuncture compared to sham acupuncture and no treatment. DATA EXTRACTION AND ANALYSIS: The total effect measured for an acupuncture treatment group in RCTs were divided into three components, including the natural history and/or regression to the mean effect (controlled for no-treatment group), the placebo effect, and the specific effect of acupuncture. The first two constituted the contextual effect of acupuncture, which is mimicked by a sham acupuncture treatment group. The proportion of acupuncture total effect size was considered to be 1. The proportion of natural history and/or regression to the mean effect (PNE) and proportional contextual effect (PCE) of included RCTs were pooled using meta-analyses with a random-effect model. The proportion of acupuncture placebo effect was the difference between PCE and PNE in RCTs with non-inserted sham acupuncture. The proportion of insert-specific effect of sham acupuncture (PIES) was obtained by subtracting the proportion of acupuncture placebo effect and PNE from PCE in RCTs with inserted sham acupuncture. The impact of PIES on the estimation of acupuncture's treatment effect was evaluated by quantifying the percentage of RCTs that the effect of outcome changed from no statistical difference to statistical difference after removing PIES in the included studies, and the impact of PIES was externally validated in other acupuncture RCTs with an inserted sham acupuncture group that were not used to calculate PIES. RESULTS: This analysis included 32 studies with 5492 patients. The overall PNE was 0.335 (95% confidence interval [CI], 0.255-0.415) and the PCE of acupuncture was 0.639 (95% CI, 0.567-0.710) of acupuncture's total effect. The proportional contribution of the placebo effect to acupuncture's total effect was 0.191, and the PIES was 0.189. When we modeled the exclusion of the insert-specific effect of sham acupuncture, the acupuncture treatment effect changed from no difference to a significant difference in 45.45% of the included RCTs, and in 40.91% of the external validated RCTs. CONCLUSION The insert-specific effect of sham acupuncture in RCTs represents 18.90% of acupuncture's total effect and significantly affects the evaluation of the acupuncture treatment effect. More than 40% of RCTs that used inserted sham acupuncture would draw different conclusions if the PIES had been controlled for. Considering the impact of the insert-specific effect of sham acupuncture, caution should be taken when using inserted sham acupuncture placebos in RCTs. Please cite this article as: Luo XC, Liu JL, Yao MH, Chen YM, Fan AY, Liang FR, Zhao JP, Zhao L, Zhou X, Zhong XY, Yang JH, Li B, Zhang Y, Sun X, Li L. Specific effect of inserted sham acupuncture and its impact on the estimation of acupuncture treatment effect in randomized controlled trials: A systematic survey. J Integr Med. 2025; 23(6):630-640.
Acupuncture Therapy/methods* ; Humans ; Randomized Controlled Trials as Topic ; Placebo Effect ; Placebos ; Treatment Outcome

Objective:To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection in the treatment of peripheral T-cell lymphoma (PTCL) in a real-world setting.Methods:This was a real-world ambispective cohort study (MOMENT study) (Chinese clinical trial registry number: ChiCTR2200062067). Clinical data were collected from 198 patients who received mitoxantrone hydrochloride liposome injection as monotherapy or combination therapy at 37 hospitals from January 2022 to January 2023, including 166 patients in the retrospective cohort and 32 patients in the prospective cohort; 10 patients in the treatment-na?ve group and 188 patients in the relapsed/refractory group. Clinical characteristics, efficacy and adverse events were summarized, and the overall survival (OS) and progression-free survival (PFS) were analyzed.Results:All 198 patients were treated with mitoxantrone hydrochloride liposome injection for a median of 3 cycles (range 1-7 cycles); 28 cases were treated with mitoxantrone hydrochloride liposome injection as monotherapy, and 170 cases were treated with the combination regimen. Among 188 relapsed/refractory patients, 45 cases (23.9%) were in complete remission (CR), 82 cases (43.6%) were in partial remission (PR), and 28 cases (14.9%) were in disease stabilization (SD), and 33 cases (17.6%) were in disease progression (PD), with an objective remission rate (ORR) of 67.6% (127/188). Among 10 treatment-na?ve patients, 4 cases (40.0%) were in CR, 5 cases (50.0%) were in PR, and 1 case (10.0%) was in PD, with an ORR of 90.0% (9/10). The median follow-up time was 2.9 months (95% CI 2.4-3.7 months), and the median PFS and OS of patients in relapsed/refractory and treatment-na?ve groups were not reached. In relapsed/refractory patients, the difference in ORR between patients with different number of treatment lines of mitoxantrone hydrochloride liposome injection [ORR of the second-line, the third-line and ≥the forth-line treatment was 74.4% (67/90), 73.9% (34/46) and 50.0% (26/52)] was statistically significant ( P = 0.008). Of the 198 PTCL patients, 182 cases (91.9%) experienced at least 1 time of treatment-related adverse events, and the incidence rate of ≥grade 3 adverse events was 66.7% (132/198), which was mainly characterized by hematologic adverse events. The ≥ grade 3 hematologic adverse events mainly included decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and anemia; non-hematologic adverse events were mostly grade 1-2, mainly including pigmentation disorders and upper respiratory tract infection. Conclusions:The use of mitoxantrone hydrochloride liposome injection-containing regimen in the treatment of PTCL has definite efficacy and is well tolerated, and it is a new therapeutic option for PTCL patients.

Objective:To explore the value of case analysis combined with role revelation in cultivating thinking ability of surgical nursing training.Methods:A total of 87 newly recruited nurses who needed to rotate in the surgical system of Fenyang Hospital, Shanxi Medical University from January 2019 to October 2020 were selected as the study subjects. They were divided into control group ( n=43) and study group ( n=44). The control group used traditional teaching, and the study group used case analysis combined with role revelation. The clinical thinking ability of nurses was evaluated by written examination of clinical thinking ability and clinical thinking ability score table. SPSS 22.0 was used for t-test. Results:The scores of written examination of clinical thinking ability (history collection, preliminary clinical diagnosis, preliminary nursing measures, auxiliary examination interpretation, comprehensive analysis of diagnosis and treatment process, nursing and discharge diagnosis, and health education) of nurses in the study group were significantly higher than those in the control group ( P<0.05). The scores of clinical thinking ability (critical thinking ability, system thinking ability and evidence-based thinking ability) of nurses in the study group were higher than those in the control group, and the difference was statistically significant ( P<0.05). Conclusion:Case analysis combined with role revelation in the surgical nursing training of new nurses is helpful to improve the trainees' clinical thinking ability.

Objective To explore the effect and significance of electronic account books on the management of anesthesia and psychotropic drugs. Methods The data of electronic account books from January 2020 to June 2020 in the inpatient pharmacy of the hospital (observation group), and manual account books from July 2019 to December 2019 (control group) were collected respectively. The data of daily accounting time, monthly settlement accounting time and accounting accuracy between the two groups were compared and analyzed. Results The daily average time for pharmacists to manually accounting was (162.8±22.5) min, and the daily average time for pharmacists to make accounts electronically was (33.2±7.0) min. It took (245.5±7.2) min for manual accounting of monthly settlement and (46.8±2.5) min for electronic accounting of monthly settlement. The accuracy rate of daily counting records, special account books, special register and empty ampoule waste paste recovery records included in electronic accounting is up to 100%. Conclusion The implementation of electronic account books not only significantly improved the work efficiency of pharmacists, but also strengthened drug supervision, formed a comprehensive traceability system, which could ensure the safety of clinical medication, and make the management of narcotic psychotropic drugs more efficient and standardized.

Objective:To analyze the disease spectrum among children who were using hydroxychloroquine (HCQ), and evaluate the drug′s safety and compliance.Methods:From January 2008 to December 2019, children from Children′s Hospital of Fudan University who used HCQ were selected as subjects, the disease spectrum of HCQ was analyzed, and the drug safety and compliance were evaluated for the patients who were followed up for more than 6 months. Demographic information, diagnosis, initial dose, time of continuous use, cumulative dosage and related adverse reactions report, project and the results of eye test were collected.Results:A total of 528 cases used HCQ during the 12 years, with 156 male cases and 372 female cases, and age at initial medication was (10.5±3.2) years. Among them, 514 cases (97.3%) had rheumatic disease, 5 had pulmonary interstitial lesions and 9 had other system diseases. The top three of the rheumatic diseases were systemic lupus erythematosus (SLE) in 316 cases (316/514,61.5%), juvenile idiopathic arthritis in 69 cases (69/514,13.4%), and juvenile dermatomyositis in 56 cases (56/514,10.9%). During the same period, 397 cases were diagnosed with SLE, and the utilization rate was 79.6% (316/397), which was the highest compared with other diseases and increased year by year. Pulmonary interstitial lesions included 4 cases with SFTPC gene defect related interstitial lung disease. Of the 528 ceses who were treated with HCQ, 397 cases were included for evaluating HCQ′s safety and compliance, the initial dose was (4.2±1.0) mg/kg, duration was 29.6 (14.9, 48.8) months, the longest usage time was 127 months, the largest cumulative dosage was 566.8 g. The continuous usage duration ( Z=-3.191, P=0.001) of SLE was significantly higher than those of other diseases, as well as cumulative dosage ( Z=-5.355, P=0.001). All cases received comprehensive eye exams before medication, 354 cases (354/397, 89.2%) were followed up in the ophthalmological department, and 65.5% (232/354) of them could be reviewed regularly at least 1 time per year. One case suffered from severe skin adverse reactions when the drug was used for 32.7 months, and no other serious adverse reactions were reported. HCQ related retinopathy was not seen during the follow-up period. There were 5 cases stopped HCQ on their own. Conclusions:HCQ was widely used in rheumatic disease in children, especially in those with SLE. It was safe for long-time usage in children, and the medication compliance and the ophthalmic follow-up was good.

Objective:To investigate the willingness and influencing factors of mothers of very low birth weight infants (VLBWIs) in the neonatal intensive care unit (NICU) to donate breast milk or accept donated breast milk.Methods:Using the convenient sampling method, a total of 124 mothers of VLBWIs who were admitted to NICU of Children's Hospital of Fudan University from March to July 2019 were selected as investigation objects. The self-designed questionnaire was used to assess the willingness to donate breast milk, the willingness to accept breast milk donation and knowledge of breast milk donation. The survey was conducted by downloading the questionnaires through mobile terminals to analyze attitudes of mothers of VLBWIs towards breast milk donation and its influencing factors.Results:Among 124 mothers of VLBWIs, 51.6% (64/124) were reluctant to donate breast milk, mainly because they feared that the amount of breast milk after donation would affect the feeding of their children. 43.5% (54/124) did not want their children to receive donated breast milk, mainly because of doubts about the safety of donated breast milk. Adequate lactation was the main factor affecting the willingness to donate breast milk ( P<0.05) . Conclusions:It is necessary to strengthen the publicity and education on the safety of breastfeeding and breastmilk donation and improve the cognition of breastmilk donation.

Objective To investigate the epidemiological characteristics of cerebral palsy(CP)in children aged 1-6 years in China,including the incidence,prevalence,type of CP,etiology,prevention and rehabilitation status. Methods The survey was carried out by standard questionnaires,multi-center collaboration,stratified-cluster ran-dom sampling method.The surveyed adopted the following principles:streets in the city and villages in the rural areas, and the number of the urban and rural children was the same,and the proportion of children in each age group was balanced.The investigation areas included provinces and autonomous regions,including Heilongjiang,Beijing,Henan, Shandong,Shanxi,Shaanxi,Anhui,Hunan,Guangxi,Guangdong,Chongqing and Qinghai,and 323 858 children were in-vestigated.Results The incidence of CP was 2.48‰(155/62 591 cases),and the prevalence was 2.46‰(797/323 858 cases)(1-6 years old).The prevalence varied in different regions,in which the highest prevalence was 5. 40‰(54/9 998 cases)in Qinghai province,and the lowest prevalence was 1.04‰(47/45 133 cases)in Shandong province.The prevalence of the males(2.64‰,461/174 391 cases)was higher than that of the females(2.25‰, 336/149 467 cases),and the difference was statistically significant(P<0.05).The types of CP were spastic type (58.85%,469/797 cases),mixed type(13.17%,105/797 cases),dyskinetic(9.79%,78/797 cases),hypotonic (8.28%,66/797 cases),ataxia(6.25%,52/797 cases)and rigid(3.39%,27/797 cases)respectively in 797 CP children.The first three risk factors for CP were long -term exposure to harmful physical factors during pregnancy, whether there were birth defects among the three generations of relatives of the children,such as children's peers, parents or grandparents,whether there were birth defects among the children's peers,parents or grandparents,and neonatal jaundice or persistent jaundice.Among 797 CP children,79.67% of the children with CP were timely detected and treated in the local hospitals,while the other 19.93% of them were not timely treated.The places which could give them timely detection and early diagnosis and treatment were general hospitals(42.97%),Maternity and Infant Hospitals (27.03%)and Children's Hospitals(20.31%). The main rehabilitation methods for 797 children with CP were 34.58% in the hospitals or rehabilitation centers,31.61% in the communities(including at home),33.80% mainly in the medical institution,and in the communities they could also receive partially rehabilitation services. Conclusions The prevalence of CP in China is coincident with international levels.The prevalence rate of CP in males is higher than that in females.The types of CP distribution are accorded with international distribution characteristics.There were still some children with CP who could not receive timely detection and treatment.Rehabilitation at the medical institutions is the chief way and proper rehabilitation guidance should be carried out in the communities.

The repair of bone defects poses a great challenge for reconstructive surgeons. Although the development of tissue engineering has exhibited promise in replacing damaged bone, the fabrication of large constructs with functional blood vessels remains an obstacle. From the orthopedic surgeon's point of view, the generation of axially vascularized bone, which can anastomose with the recipient vessel, might be a solution to this medical problem. In this study, we aimed to prefabricate an axially vascularized bone by combining a β-TCP scaffold, arteriovenous loop (AVL), and cell sheet in a bioreactor in vivo. Twelve rabbits were randomly allocated into two groups: the experimental group (presence of AVL) and the control group (absence of AVL). The constructs were explanted at 8 weeks postoperatively. The histomorphometric results showed 42.8±5.9% of the bone area in the AVL group and 26.6±3.5% in the control group. Similarly, vessel analysis revealed the average vessel density in the AVL group (12.5±3.3) was significantly more than that in the control group (6.1±1.5, p<0.05). Our research indicated that the combination of a β-TCP scaffold, AVL and cell sheet might engineer vascularized bone. This prefabrication strategy might facilitate clinical translation of bone tissue engineering in reconstructing large bone defects.
Bioreactors ; Blood Vessels ; Bone and Bones ; Orthopedics ; Rabbits ; Surgeons ; Tissue Engineering

PurposeWith the extensive use of percutaneous radiofrequency ablation (RFA) for the treatment of hepatic carcinoma (HC), the study of MRI findings and its clinical signiifcance after RFA of HC have important value and can improve the complete ablation rate.Materials and MethodsA retrospective analysis of post-procedure MRI ifndings of 79 patients (114 lesions) with HC were performed, the size of the lesion, the signal changes and enhancement condition were observed at the ifrst, fourth and seventh month after RFA; the two different ifndings of high signal ring on MRI T1WI and local recurrence rate were analyzed.ResultsOne month after RFA, peripheral region of RFA lesion showed high signal on T1WI, and slightly lower signal on T2WI, the size of lesions was slightly larger than pre-procedure, enhancement scan showed the thin homogeneous ring enhanced around the non-enhanced lesions; 4 months later, the size of lesions were relative stable and the periphery enhancement was weaken; 7 months later, the size of lesions were reduced and showed no enhancement. For recurrence lesions, the high signal ring was incomplete on TIWI, the incomplete area showed nodular enhancement on the arterial phase, and most of nodule showed slightly lower signal on the delay phase demonstrated a feature of quick wash-in and wash-out; 7 months after RFA, recurrence rate was 6.12% in patients with complete high signal ring and 43.75% in patients with incomplete high signal ring, the difference was statistically significant (P<0.05). The total survival rate and accumulated survival rate of the patients with complete high signal ring on T1WI were higher than the patients with incomplete ring, the difference was statistically signiifcant (P<0.05).ConclusionThere are characteristic ifndings of MRI examination of liver cancer after percutaneous RFA, observation of the integrity of high signal ring on T1WI image and ifnding of dynamic enhancement scan can early evaluate efifcacy of RFA guide the selection of treatment plan.

In order to investigate the effects of electric pulses on cancer cells, we carried out the experiments with exposing HepG2 and L02 to electric pulses (1 kV/cm, l00 micros, 1 Hz) for different lengths of time (8 s, 15 s, 30 s, 60 s). Annexin V-FITC Kit and Flow cytometry were used to study the apoptosis of treated cells. The results showed that the electric pulses of 1 kV/cm, l00 micros, 1 Hz for 8 s could not induce tumor cells apoptosis. Apoptosis was observed when tumor cells were stimulated for 15 s and longer, and the apoptosis percentage increased with the increase of stimulation time. Furthermore, tumor cells were more sensitive than normal cells in response to electrical pulses. Rhodamine 123 and Laser Scanning Confocal Microscope (LSCM) were used to make a real-time study of mitochondrial transmembrane potential (Deltapsim) when the tumor cells were exposed to electric pulses for 60 s. No significant change of Deltapsim was observed within 30 s stimulation. After that, the Deltapsim increased sharply and declined later, suggesting that the mitochondrial pathway may be one of the apoptosis mechanism induced by electric pulses.
Apoptosis ; radiation effects ; Electromagnetic Fields ; Hep G2 Cells ; Humans ; Membrane Potential, Mitochondrial ; physiology ; radiation effects ; Time Factors