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Objective:To assess the efficacy and safety of 100 units of botulinum toxin A (BTX-A) intradetrusor injection in patients with overactive bladder.Methods:From April 2016 to December 2018, 17 tertiary hospitals were selected to participate in this prospective, multicenter, randomized, double-blind, placebo-controlled study. Two phases of study were conducted: the primary phase and the extended phase. This study enrolled patients aged 18 to 75 years who had been inadequately managed by anticholinergic therapy (insufficient efficacy or intolerable side effects) and had spontaneous voiding with overactive bladder. Exclusion criteria included patients with severe cardiac, renal and hepatic disorders, patients with previous botulinum toxin treatment for 6 months or allergic to BTX-A, patients with urinary tract infections, patients with urinary stones, urinary tract tumors, diabetes mellitus, and bleeding tendency. Eligible patients were randomly assigned to BTX-A group and placebo control group in a ratio of 2∶1. Two groups of patients received 20 intradetrusor injections of BTX-A 100U or placebo at the depth of the submucosal muscle layer respectively under cystoscope, including 5 injections at the base of the bladder, 3 injections to the bladder triangle, 5 injections each to the left and right walls and 2 injections to the top, sparing the bladder neck. As a placebo control group, patients received same volume of placebo containing no BTX-A and only adjuvant freeze-dried preparations for injection with the same method. A combination of gelatin, sucrose, and dextran served as adjuvants. Average micturition times per 24 hours, urinary incontinence (UI) episodes per day, average micturition volume per day, OAB symptom score(OABSS), and quality of life (QOL) score were recorded at baseline and the 2nd, 6th and 12th week after treatment. The primary efficacy endpoint was the change from baseline in the average micturition times per 24 hours at the 6th week after treatment. The secondary efficacy endpoints included the change from baseline in the average micturition times per 24 hours at 2nd and 12th week, as well as the change from baseline in the OABSS, QOL score, average frequency of urgency and UI episodes per day, urgency score, average micturition volume per day at 2nd, 6th and 12th week after treatment. Patients were followed for 12 weeks to assess adverse events (AEs). After assessed at week 12, if the micturition times has decreased less than 50% compared to baseline and the patient is willing to receive retreatment, then patients could enter the extended trial phase. In that phase, patients in both groups were injected with 100 units BTX-A from 12th week onwards and then followed up the same indicators for 12 weeks.Results:216 patients were enrolled in this trial (144 cases in the BTX-A group and 72 cases in the placebo control group). Baseline characteristics such as age (47.75±14.20 in the BTX-A group and 46.39±15.55 in the control group), sex (25 male/117 female in the BTX-A group and 10/61 in the control group), and disease duration (0.51 years in the BTX-A group and 0.60 years in the control group) were balanced between the two groups( P>0.05). A marked reduction from baseline in average micturition times per 24 hours was observed in all treatment groups at the 6th week and the reduction of the two groups was statistically different ( P<0.001 and P=0.008 respectively). Compared with the baseline, the average micturition times per 24 hours at the 6th week decreased from baseline by 2.40(0.70, 4.60)times for the BTX-A group and 0.70(-1.00, 3.30) times for the placebo control group respectively, and the difference between the two groups was considered to be statistically significant ( P=0.003). The change rates of average micturition times per 24 hours from baseline at the 6th week of the two groups were (16±22)% and (8±25)% respectively, and the difference between the two groups was statistically significant ( P=0.014). Compared with the baseline, the average micturition times per 24 hours at 2nd and 12th week decreased by 2.00(0.00, 4.00)and 3.30(0.60, 5.03)for the BTX-A group, 1.00(-1.00, 3.00)and 1.70(-1.45, 3.85)for the placebo control group respectively. The difference between two groups was considered to be statistically significant ( P=0.038 and P=0.012); the changes of average urgency times per day for the BTX-A group and the control group at the 2nd, 6th and 12th week were 2.00(0.00, 4.30)and 2.40(0.30, 5.00), 3.00(0.30, 5.70)and 0.70(-1.30, 2.70), 0.70(-1.30, 3.00) and 1.35(-1.15, 3.50), respectively. There were significant differences between two groups at the 2nd, 6th and 12th week, ( P=0.010, P=0.003 and P=0.025, respectively). The OABSS of the BTX-A group and the control group at the 6th week decreased by 1.00(0.00, 4.00)and 0.50(-1.00, 2.00) compared with the baseline, and the difference between the two groups was statistically significant ( P=0.003). 47 cases of BTX-A group and 34 cases of placebo control group entered the extended trial phase, and 40 and 28 cases completed the extended trial phase, respectively. The average micturition volume per 24 hours changed by -16.60(-41.60, -0.60)ml and -6.40(-22.40, 13.30)ml, (-35.67±54.41)ml and(-1.76±48.69)ml, (-36.14±41.51)ml and (-9.28±44.59)ml, (-35.85±43.35)ml and(-10.41±40.29)ml for two groups at the 12th, 14th, 18th and 24th week, and the difference between two groups was statistically significant at each follow-up time ( P=0.01, 0.006, 0.012 and 0.016, respectively). There was no significant difference in other parameters( P>0.05). However, adverse reactions after intradetrusor injection included increased residual urine volume (27 in the BTX-A group and 3 in the control group), dysuria (21 in the BTX-A group and 6 in the control group), urinary infection (19 in the BTX-A group and 6 in the control group), bladder neck obstruction (3 in the BTX-A group and 0 in the control group), hematuria (3 in the BTX-A group and 1 in the control group), elevated alanine aminotransferase (3 in the BTX-A group and 0 in the control group), etc. During the follow-up period, there was no significant difference in the other adverse events between two groups except the increase of residual urine volume( P<0.05). In the primary trial phase, among the 27 cases with increased residual urine volume in BTA group, only 1 case (3.70%) with PVR more than 300 ml; the PVR of 3 patients in the placebo group was less than 100 ml. The increase of residual urine volume caused by the injection could be improved or disappeared with the passage of time. Conclusions:Intradetrusor injection of Chinese BTX-A improved the average micturition times per 24 hours, the average daily urgent micturition times, OABSS, and average micturition volume per time, and reduced the adverse effects in patients with overactive bladder.Chinese BTX-A at dose of 100U demonstrated durable efficacy and safety in the management of overactive bladder.
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The incidence rate of nonalcoholic fatty liver disease (NAFLD) is gradually increasing, and NAFLD has become the most important chronic liver disease in China. At present, the pathogenesis of NAFLD has not been fully elucidated and there are still no effective drugs. From the perspectives of pathogenesis, noninvasive diagnosis, and drug action and efficacy, this article introduces the research advances in metabolomics regarding endogenous small molecule metabolites in NAFLD, so as to provide new ideas and methods for further exploration of NAFLD.
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Objective:To compare the advantages of high or low inferior mesenteric artery (IMA) ligation in laparoscopic anterior resection of rectum based on CT precise guidance.Methods:One hundred and twenty patients with rectal cancer who underwent laparoscopic anterior resection of rectum in Shanghai Sixth People′s Hospital South Campus from January 2016 to June 2020 were selected. Surgical protocol was selected according to the principle of voluntariness. Sixty-eight cases underwent high IMA ligation (high IMA ligation group), and 52 cases underwent low IMA ligation (low IMA ligation group). The perioperative conditions (operative time, intraoperative blood loss, postoperative anal exhaust time, abdominal drainage, hospitalization time and ileostomy), postoperative pathological data (proximal margin distance, distal margin distance, total number of dissected lymph nodes and number of positive lymph nodes) and postoperative recovery (anastomotic stoma fistula, urinary retention, sexual dysfunction and daily number of defecation) were recorded. The quality of life 6 months after surgery was evaluated by the quality of life instruments for colorectal cancer scale (QLQ-CR38). Patients were followed up for 6 to 36 months, and the local recurrence and distant metastasis were recorded.Results:The postoperative anal exhaust time in low IMA ligation group was significantly shorter than that in high IMA ligation group: (2.87 ± 1.04) d vs. (3.26 ± 1.00) d, and there was statistical difference ( P<0.05); there were no statistical differences in operative time, intraoperative blood loss, abdominal drainage, hospitalization time and rate of ileostomy between 2 groups ( P>0.05). There were no statistical difference in proximal margin distance, distal margin distance, total number of dissected lymph nodes and number of positive lymph nodes between 2 groups ( P>0.05). The incidences of anastomotic stoma fistula, urinary retention and sexual dysfunction in low IMA ligation group were significantly lower than those in high ligation group: 3.85% (2/52) vs. 13.24% (9/68), 3.85% (2/52) vs. 11.76% (8/68) and 5.77% (3/52) vs. 14.71% (10/68), the daily number of defecation was significantly less than that in high ligation group: (2.87 ± 0.98) times vs. (4.05 ± 1.56) times, and there were statistical differences ( P<0.05 or <0.01). The functional dimension, symptom dimension and aggregate score of QLQ-CR38 in low IMA ligation group were significantly higher than those in high ligation group: (15.46 ± 4.22) scores vs. (13.68 ± 3.56) scores, (51.82 ± 13.54) scores vs. (45.65 ± 12.42) scores and (67.28 ± 14.28) scores vs. (59.33 ± 12.85) scores, and there were statistical differences ( P<0.05 or <0.01). There were no statistical difference in the rates of local recurrence and distant metastasis between 2 groups ( P>0.05). Conclusions:The application of low IMA ligation based on CT precise guidance in laparoscopic anterior resection of rectum can obtain the same surgical effect as the high IMA ligation. It can promote the recovery of gastrointestinal function after surgery, reduce the risk of complications, have less effect on the defecation function, which can improve the life quality after the surgery.
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Objective:To investigate the short-term clinical effect of using fibular flap with preserving the continuity of fibula in hip preservation surgery for femoral head necrosis.Methods:From September, 2017 to November, 2020, 13 cases of femoral head necrosis were repaired with fibular flap. The fibular flaps were cut with an improved method for preserving the continuity of the fibular cortex, and the donor sites were sutured directly. The fibuls were inserted into the femoral heads with single or double segment folding support. Autogenous iliac crest combined with platelet-rich plasma(PRP) was used for impaction of bone grafting in femoral head, and the fibular flaps were anastomosed with 1 artery and 2 veins. All follow-up data were obtained, including bone union by X-ray and CT as well as the functional recovery of the hip joint and donor site. Statistical analysis was performed. P<0.05 was considered statistically significant. Results:The followed-up time ranged from 6 to 23 months. The fibular bones were significantly thicker and the incisions healed well at the donor sites. There was neither abnormal sensation in toes, dorsal foot, and lateral of the leg, nor significant influence on foot function. The hip joint activities were normal. The outcome was proved to be remarkable according to the Harris score(from 58.9±10.6 points before surgery to 81.7±10.6 points after surgery), the difference was statistically significant ( P<0.05) . Conclusion:The method of the improved fibular flap in hip preservation surgery is beneficial to the repair and reconstruction of the necrotic femoral head since the donor area is less traumatic, and a satisfactory clinical effect can be obtained.
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Objective@#To explore the method of replanting severed piercing finger micro tissue blocks.@*Methods@#From February, 2001 to October, 2016, 16 cases of severed piercing finger micro tissue blocks were replanted with debridement. The trunk or branch of proper palmar digital artery was anastomosed. Vascular collocations were used such as venous arterialization when there was no anastomotic artery available. Regular postoperative followed-up was performed to observe the recovery of tissue survival, appearance, sensation of flap, and joint function.@*Results@#One case had partial epidermal necrosis, and healed after change of dressing. The finger-disconnected micro tissue blocks of other 15 cases survived well. After 6 months to 2 years of follow-up, the replanted micro tissue blocks were ruddy in color and recovered from S3 to S4. The appearance of the 16 fingers was good, and the function of joints was restored.@*Conclusion@#The finger-disconnected micro tissue blocks should be actively replanted. With skilled microsurgical techniques, the anastomosis of the arterial or venous artery will ensure the success of replantation and survived, as well as to restore good function and appearance.
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Objective To explore the method of replanting severed piercing finger micro tissue blocks. Methods From February, 2001 to October, 2016, 16 cases of severed piercing finger micro tissue blocks were re鄄planted with debridement. The trunk or branch of proper palmar digital artery was anastomosed. Vascular collocations were used such as venous arterialization when there was no anastomotic artery available. Regular postoperative fol鄄lowed-up was performed to observe the recovery of tissue survival, appearance, sensation of flap, and joint function. Results One case had partial epidermal necrosis, and healed after change of dressing.The finger-disconnected micro tissue blocks of other 15 cases survived well.After 6 months to 2 years of follow-up, the replanted micro tissue blocks were ruddy in color and recovered from S3 to S4. The appearance of the 16 fingers was good, and the function of joints was restored. Conclusion The finger-disconnected micro tissue blocks should be actively replanted. With skilled microsurgical techniques, the anastomosis of the arterial or venous artery will ensure the success of replantation and survived, as well as to restore good function and appearance.
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<p><b>OBJECTIVE</b>To investigate the clinical features of adrenocortical adenoma's diagnosis and treatment in patients aged 60 years or above.</p><p><b>METHODS</b>A retrospective study was performed with a total of 249 patients aged 60 years or above who suffered from adrenocortical adenoma and treated in Peking Union Medical College Hospital from January 2004 to January 2014.The clinical features, treatments and prognosis of the 249 patients aged 60 years or above were compared with another 249 patients which were randomly selected during the same period aged from 30 to 50 years.t-test or χ(2) test was used to analyze the data between the two groups.</p><p><b>RESULTS</b>Endocrine examinations were performed in all 249 patients aged 60 years or above.There were 144 patients diagnosed as non-functional adrenocortical adenoma, 94 cases as aldosterone-producing adenoma and 11 cases as Cushing adenoma.For the patients aged 60 years or above, the rate of cardio-cerebral vascular incident in non-functional adrenocortical adenoma group was 26.4%(38/144), which was significantly lower than that of the aldosterone-producing adenoma and Cushing adenoma group(54.3%, 57/105)(χ(2)=20.027, P=0.000). There were 91.5%(65/71) of the patients aged 60 years or above who got a relief in low blood potassium symptoms after the operation.Forty-nine point one percent(53/108) of the non-functional adrenocortical adenoma patients aged 60 years or above had a better control of their blood pressure level, while functional adrenocortical adenoma group were 64.0%(48/75) which indicated that the functional adrenocortical adenoma patients have a better control of their blood pressure then the non-functional adrenocortical adenoma patients after the operation(χ(2)=3.987, P=0.046). There were 37.1% of the patients aged 60 years or above whose fasting blood-glucose was higher than 7.1 mmol/L, while the patients aged from 30 to 50 years was 14.1%(χ(2)=22.02, P=0.000). The differences in plasma aldosterone and blood potassium between the patients aged 60 years or above and the patients aged from 30 to 50 years had statistical significance(t=10.48, -2.58; P=0.00, 0.01).</p><p><b>CONCLUSIONS</b>Most of the adrenocortical adenoma in patients aged 60 years or above is non-functional adrenocortical adenoma.Among who, patients with aldosterone-producing adenoma tend to have lower plasma aldosterone concentration and higher blood potassium level then the patients aged from 30 to 50 years.The patients aged 60 years or above with functional adrenocortical adenoma are tend to have severe cardio-cerebral vascular incidence.A few of non-functional adrenocortical adenoma patients who combine with hypertension can benefit for the operation.</p>
Subject(s)
Adult , Humans , Middle Aged , Adrenocortical Adenoma , Diagnosis , Therapeutics , Aldosterone , Metabolism , Blood Pressure , Hypertension , Prognosis , Retrospective StudiesABSTRACT
<p><b>OBJECTIVE</b>To estimate the diagnostic accuracy of magnetic resonance(MR) in restaging of rectal cancer after preoperative chemoradiotherapy(CRT).</p><p><b>METHODS</b>Comprehensive search of literature concerning the diagnosis of MR for rectal cancer after preoperative CRT was performed from databases of PubMed, EMbase, OVID and WOK. Sensitivity and specificity of MR on restaging of rectal cancer after preoperative CRT were investigated by SAS and MetaDiSc software.</p><p><b>RESULTS</b>Thirteen articles including 749 patients were enrolled in this meta-analysis. For T3-T4 stage, sensitivity of MR was 82.1%(95%CI:67.9%-90.9%), specificity was 53.5%(95%CI:39.3%-67.3%), and diagnostic odds ratio(DOR) was 5.34(2.73, 6.59). For lymph node involvement, sensitivity of MR was 61.8%(95%CI:50.7%-71.8%), specificity was 72.0%(95%CI:61.3%-80.7%), and DOR was 4.33(95%CI:2.84-6.59). For circumferential resection margin(CRM) by MR, pooled sensitivity was 85.4%(95%CI:60.5%-95.7%), specificity was 80.0%(95%CI:57.4%-92.3%), and DOR was 27.62(95%CI:13.03-58.55).</p><p><b>CONCLUSIONS</b>Restaging accuracy of T3-T4 and lymph nodes involvement of rectal cancer after preoperative CRT by MR is not high. MR may be a good method to make reassessment of CRM. To avoid overtreatment for T0-T2, negative lymph node and circumferential resection of rectal cancer, restaging by MR after preoperative CRT is important.</p>
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Humans , Chemoradiotherapy , Magnetic Resonance Imaging , Magnetic Resonance Spectroscopy , Neoplasm Staging , Rectal Neoplasms , Pathology , TherapeuticsABSTRACT
Objective To evaluate the bonding condition of hydroxyapatite (HA)/zirconia ( ZrO2 ) composite and bone interface and the ability of HA/ZrO2 in repair of bone defects.Methods Bone defect models were established in the lumbar vertebral body of 24 Beagle dogs and were implanted with HA/ZrO2 gradient composite (Group A ),HA/ZrO2 unilayer composite (Group B ),pure ZrO2 (Group C) and pure HA (Group D) successively.Dogs were sacrificed and lumbar vertebral specimens were harvested 6,12,16 weeks postoperatively and before the sacrifice at postoperative 6 and 12 weeks,the dogs were intramuscularly administered of quadracycline for fluorescence labeling.The interface bonding and repair of bone defects were observed through X-ray films,histomorphology and biomechanical test.Results The X-ray films displayed that the Group A achieved more formation of osteotylus and better repair of bone defects with the extension of the implantation period,followed by the Groups B and D and that the Group C had relatively worse results.Histomorphology study showed that the fluorescence labeling was enhanced gradually from 6 to 12 weeks in the Group A,with its growth from the edge of the implanted material to the inner part and its tight adhesion to the material,indicating active osteogenesis and massive bone formation.While the fluorescence labeling of the Groups B,C and D centered in the edge of implanted materials without presence in the material inner part.The mineralization rate of the four materials at 6 and 12 weeks had significant differences ( P ＜ 0.05).Synostosis rates at 6,12 and 16 weeks were the highest in the Group A,with the rate of up to (90.26 ±3.82) ％ at 16 weeks (P ＜0.05 ).Biomechanical test showed the maximum shear strengths at 6,12,16 weeks in the Group A were (2.64±0.16) MPa,(2.95 ±0.19) MPa and (3.45 ±0.23) MPa respectively (P＜0.05).Conclusion HA/ZrO2gradient biocomposite bonds well with the bone and possesses good repair ability for bone defects and hence is an ideal novel material for bone defect reconstruction.
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Objective To observe the effect of MG-132 on NF-κB signal path of cartilage and synovium in a rat model of knee osteoarthritis.Methods The rat models of knee osteoarthritis were established by performing anterior cruciate ligament amputation and partial medial meniscectomy.Totally 144 adult SD rats were randomly divided into 4 groups:MG-132 group,100 ml 0.007 g/L MG-132 solution was injected in to the knee joints of rat model 24 h after surgery; DMSO group,100 ml 0.1％ DMSO solution was injected 24 h after surgery; sham surgery group,merely the knee capsulotomy was performed and no solution was injected;control group,100 ml 0.007 g/L MG-132 solution was injected into the knee joints.The cartilage and synovium specimens were obtained at 2,4,12 weeks postoperatively.Pathomorphological observation was taken.The levels of NF-κB p65,I-κB,TNF-α and IL-1β at mRNA were detected by real-time PCR,and the activityof 20S proteasome was measured by fluorospectrophotometry.Resnlts The Mankin score of MG-132 groupwas lower than that of DMSO group.The Mankin scores of sham surgery and control groups were lower thanthose of MG-132 and DMSO groups with significant difference.The mRNA levels of NF-κB p65,IL-1 β,TNF-α of cartilage and synovium in MG-132 group were lower than those of DMSO group with significant differenceexcept for NF-κB p65 of synovium at 2 weeks and IL-1β of cartilage at 12 weeks.The mRNA levels of I-κB of cartilage at 2 weeks and I-κB of synovium at 4 weeks in MG-132 group were higher than those in DMSO group with statistical significance.Conclusion MG-132,the proteasome inhibitor,could postpone the progress of osteoarthritis through alleviating synovial inflammation and defending the articular cartilage.
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Objective To investigate a more pedect method for a nice outward appearance of a reconstructed thumb.Methods A free one-stage plasty second toe transfer for thumb reconstruction by interchanging the whole skin-nail flap from the great toe with another one from the second toe.Results There were 12 cases in this group,following-up 6-9 months in 8 cases,7 cases was excellent and 1 cases was good.The reconstructed thumb got a nice looking and more normal function while no blight to the great toe occurred.Conclusion It is an effective new procedure in ameliorating outward appearance of the reconstructed thumb by transferring the free moulded second toe.
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<p><b>OBJECTIVE</b>To report a case and a firstly described pedigree with Ehlers-Danlos syndrome in China.</p><p><b>METHODS</b>Clinical materials of a case of Ehlers-Danlos syndrome type IV and a pedigree of 6 members with 4 generations were analyzed. Dilated internal jugular vein in the proband was removed operatively. The diagnosis, surgical treatment, and postoperative complications were retrospectively summarized. Etiology, clinical characteristics and classification of Ehlers-Danlos syndrome were also analysed.</p><p><b>RESULTS</b>Vessels of the proband in the pedigree were crisp and easily lacinated during the precedure for removal of his internal jugular vein. Repeat postoperative hemotomas were found though complete stanching was made during operation. The patient successfully recovered after prompt debridement in operative theatre and needle sucking. The other 5 members of the pedigrees all had the triads of Ehlers-Danlos syndrome, but no combined vascular diseases were found in them.</p><p><b>CONCLUSIONS</b>Though the morbidity rate was extremely low, green attention should be paid to the high mortality rate and complication of Ehlers-Danlos syndrome during surgical management of in patients with Ehlers-Danlos syndrome type IV. Surgeons should be aware of the ponderance of its complications and combined diseases to avoid fatal intraoprative vascular lacination and incontrollable hamorrhage.</p>
Subject(s)
Humans , China , Ehlers-Danlos Syndrome , Pedigree , Retrospective StudiesABSTRACT
Objective To investigate the clinical features, diagnosis and treatment of cardiac pheochromocytoma. Methods The clinical data of 3 cases (2 males and 1 female) who were 17,40 and 35 years old,respectively,were analyzed.They all presented with headache, sweating, palpitations and hypertension.Before operation 24-hour urinary catecholamine excretion was examined for the 17-year-old man and the woman twice with the results as follows.In the 17-year-old man,epinephrine (E) was 1.84,150.28 ?g/24h (normal range,4.08?2.34 ?g/24h);norepinephrine (NE):734.77,508.00 ?g/24h (normal range,28.67?11.98 ?g/24h);dopamine (DA):823.00,620.31 ?g/24h (normal range,225.76?104.83 ?g/24h).In the woman,E was 12.40,16.03 ?g/24h;NE:1778.92,1243.96 ?g/24h;DA:1517.47,926.89 ?g/24h.All the 3 patients had positive result with Tc-99m-Otretide scintigraphy,and all underwent orthotopic excision of tumors under cardiopulmonary bypass. Results During operation,the tumors of 2-5 cm in size were seen to lie at the base of the aorta,left atrium and interauricular septa respectively,and grew invasively like carpet,thus were difficult to remove. Postoperative pathology of 3 cases confirmed the diagnosis of cardiac pheochromocytoma.After follow-up for 8-24 months,3 cases had a mean fall of 30 mmHg in systolic pressure and 20 mmHg in diastolic pressure,respectively.The 17-year-old man had decline in cardiac function that was proved by Tc-99m-Otretide scintigraphy test;another male patient suffered from arrhythmias 1 month after operation,and was found to have tumor remains by PET test.Myocardial infarction occurred in the female patient. Conclusions Cardiac pheochromocytoma is a rare tumor, and its diagnosis is rather difficult and complex.Surgical excision is very difficult with the possibility of complications.