Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

Objective:To investigate the perinatal outcomes and risk factors of perinatal complications in preg-nant women with hypertrophic cardiomyopathy(HCM).Methods:A retrospective analysis was carried out on clini-cal data of 100 pregnant women with HCM who delivered in Obstetrical Cardiology Intensive Care Center of Shanghai Renji Hospital between Jan.2000 and Dec.2022.Analyze the incidence of perinatal complications inclu-ding miscarriage,premature birth,small for gestational age infants,neonatal asphyxia,neonatal cardiac malforma-tions and perinatal mortality.Independent risk factors of perinatal complications in pregnant women with HCM were identified using univariate and multivariate Logistic regression.Results:①The mean age was 29.21±4.41 years old,the average gestational age upon admission is 34.46±6.43 weeks.There were 16 patients with a fam-ily history of cardiomyopathy(16％),21 cases with obstructive HCM(21％)and 79 cases of non-obstructive HCM(79％),91 cases with abnormal ECG(91％),mainly with ST-T changes(77 cases,77％).The average in-terventricular septum was 19.39±6.13mm by echocardiography.②Among the 100 pregnancies of 100 HCM pa-tients,6 cases(6％)were miscarriages,94 newborns survived(94％),including 91 cases of cesarean section(91％)and 3 cases of vaginal delivery(3％).The predominant perinatal complications were preterm delivery(39 cases,39％),small for gestational age(5 cases,5％),neonatal asphyxia(3 cases,3％)and neonatal cardiac malformation(2 cases,2％).There were no perinatal deaths.③Univariate Logistic regression analysis showed that pre pregnancy heart function ≥ Grade Ⅱ,increased left atrial diameter,and concomitant pulmonary hyperten-sion were risk factors for perinatal complications in pregnant women with HCM(OR＞1,P＜0.05).Multivariate Lo-gistic regression analysis found that pre pregnancy heart function ≥ Grade Ⅱ was an independent risk factor for predicting the occurrence of perinatal complications in pregnant women with HCM(OR 6.270,P＜0.05).Conclu-sions:HCM during pregnancy can induce poor perinatal outcome.More attention should be paid to risk assess-ment and pregnancy management.Early detection of risk factors can reduce the incidence of perinatal complica-tions.

Objective:To investigate the perinatal outcomes and risk factors of perinatal complications in preg-nant women with hypertrophic cardiomyopathy(HCM).Methods:A retrospective analysis was carried out on clini-cal data of 100 pregnant women with HCM who delivered in Obstetrical Cardiology Intensive Care Center of Shanghai Renji Hospital between Jan.2000 and Dec.2022.Analyze the incidence of perinatal complications inclu-ding miscarriage,premature birth,small for gestational age infants,neonatal asphyxia,neonatal cardiac malforma-tions and perinatal mortality.Independent risk factors of perinatal complications in pregnant women with HCM were identified using univariate and multivariate Logistic regression.Results:①The mean age was 29.21±4.41 years old,the average gestational age upon admission is 34.46±6.43 weeks.There were 16 patients with a fam-ily history of cardiomyopathy(16％),21 cases with obstructive HCM(21％)and 79 cases of non-obstructive HCM(79％),91 cases with abnormal ECG(91％),mainly with ST-T changes(77 cases,77％).The average in-terventricular septum was 19.39±6.13mm by echocardiography.②Among the 100 pregnancies of 100 HCM pa-tients,6 cases(6％)were miscarriages,94 newborns survived(94％),including 91 cases of cesarean section(91％)and 3 cases of vaginal delivery(3％).The predominant perinatal complications were preterm delivery(39 cases,39％),small for gestational age(5 cases,5％),neonatal asphyxia(3 cases,3％)and neonatal cardiac malformation(2 cases,2％).There were no perinatal deaths.③Univariate Logistic regression analysis showed that pre pregnancy heart function ≥ Grade Ⅱ,increased left atrial diameter,and concomitant pulmonary hyperten-sion were risk factors for perinatal complications in pregnant women with HCM(OR＞1,P＜0.05).Multivariate Lo-gistic regression analysis found that pre pregnancy heart function ≥ Grade Ⅱ was an independent risk factor for predicting the occurrence of perinatal complications in pregnant women with HCM(OR 6.270,P＜0.05).Conclu-sions:HCM during pregnancy can induce poor perinatal outcome.More attention should be paid to risk assess-ment and pregnancy management.Early detection of risk factors can reduce the incidence of perinatal complica-tions.

Objective:To investigate the perinatal outcomes and risk factors of perinatal complications in preg-nant women with hypertrophic cardiomyopathy(HCM).Methods:A retrospective analysis was carried out on clini-cal data of 100 pregnant women with HCM who delivered in Obstetrical Cardiology Intensive Care Center of Shanghai Renji Hospital between Jan.2000 and Dec.2022.Analyze the incidence of perinatal complications inclu-ding miscarriage,premature birth,small for gestational age infants,neonatal asphyxia,neonatal cardiac malforma-tions and perinatal mortality.Independent risk factors of perinatal complications in pregnant women with HCM were identified using univariate and multivariate Logistic regression.Results:①The mean age was 29.21±4.41 years old,the average gestational age upon admission is 34.46±6.43 weeks.There were 16 patients with a fam-ily history of cardiomyopathy(16％),21 cases with obstructive HCM(21％)and 79 cases of non-obstructive HCM(79％),91 cases with abnormal ECG(91％),mainly with ST-T changes(77 cases,77％).The average in-terventricular septum was 19.39±6.13mm by echocardiography.②Among the 100 pregnancies of 100 HCM pa-tients,6 cases(6％)were miscarriages,94 newborns survived(94％),including 91 cases of cesarean section(91％)and 3 cases of vaginal delivery(3％).The predominant perinatal complications were preterm delivery(39 cases,39％),small for gestational age(5 cases,5％),neonatal asphyxia(3 cases,3％)and neonatal cardiac malformation(2 cases,2％).There were no perinatal deaths.③Univariate Logistic regression analysis showed that pre pregnancy heart function ≥ Grade Ⅱ,increased left atrial diameter,and concomitant pulmonary hyperten-sion were risk factors for perinatal complications in pregnant women with HCM(OR＞1,P＜0.05).Multivariate Lo-gistic regression analysis found that pre pregnancy heart function ≥ Grade Ⅱ was an independent risk factor for predicting the occurrence of perinatal complications in pregnant women with HCM(OR 6.270,P＜0.05).Conclu-sions:HCM during pregnancy can induce poor perinatal outcome.More attention should be paid to risk assess-ment and pregnancy management.Early detection of risk factors can reduce the incidence of perinatal complica-tions.

Objective:To investigate the perinatal outcomes and risk factors of perinatal complications in preg-nant women with hypertrophic cardiomyopathy(HCM).Methods:A retrospective analysis was carried out on clini-cal data of 100 pregnant women with HCM who delivered in Obstetrical Cardiology Intensive Care Center of Shanghai Renji Hospital between Jan.2000 and Dec.2022.Analyze the incidence of perinatal complications inclu-ding miscarriage,premature birth,small for gestational age infants,neonatal asphyxia,neonatal cardiac malforma-tions and perinatal mortality.Independent risk factors of perinatal complications in pregnant women with HCM were identified using univariate and multivariate Logistic regression.Results:①The mean age was 29.21±4.41 years old,the average gestational age upon admission is 34.46±6.43 weeks.There were 16 patients with a fam-ily history of cardiomyopathy(16％),21 cases with obstructive HCM(21％)and 79 cases of non-obstructive HCM(79％),91 cases with abnormal ECG(91％),mainly with ST-T changes(77 cases,77％).The average in-terventricular septum was 19.39±6.13mm by echocardiography.②Among the 100 pregnancies of 100 HCM pa-tients,6 cases(6％)were miscarriages,94 newborns survived(94％),including 91 cases of cesarean section(91％)and 3 cases of vaginal delivery(3％).The predominant perinatal complications were preterm delivery(39 cases,39％),small for gestational age(5 cases,5％),neonatal asphyxia(3 cases,3％)and neonatal cardiac malformation(2 cases,2％).There were no perinatal deaths.③Univariate Logistic regression analysis showed that pre pregnancy heart function ≥ Grade Ⅱ,increased left atrial diameter,and concomitant pulmonary hyperten-sion were risk factors for perinatal complications in pregnant women with HCM(OR＞1,P＜0.05).Multivariate Lo-gistic regression analysis found that pre pregnancy heart function ≥ Grade Ⅱ was an independent risk factor for predicting the occurrence of perinatal complications in pregnant women with HCM(OR 6.270,P＜0.05).Conclu-sions:HCM during pregnancy can induce poor perinatal outcome.More attention should be paid to risk assess-ment and pregnancy management.Early detection of risk factors can reduce the incidence of perinatal complica-tions.

Objective:To investigate the perinatal outcomes and risk factors of perinatal complications in preg-nant women with hypertrophic cardiomyopathy(HCM).Methods:A retrospective analysis was carried out on clini-cal data of 100 pregnant women with HCM who delivered in Obstetrical Cardiology Intensive Care Center of Shanghai Renji Hospital between Jan.2000 and Dec.2022.Analyze the incidence of perinatal complications inclu-ding miscarriage,premature birth,small for gestational age infants,neonatal asphyxia,neonatal cardiac malforma-tions and perinatal mortality.Independent risk factors of perinatal complications in pregnant women with HCM were identified using univariate and multivariate Logistic regression.Results:①The mean age was 29.21±4.41 years old,the average gestational age upon admission is 34.46±6.43 weeks.There were 16 patients with a fam-ily history of cardiomyopathy(16％),21 cases with obstructive HCM(21％)and 79 cases of non-obstructive HCM(79％),91 cases with abnormal ECG(91％),mainly with ST-T changes(77 cases,77％).The average in-terventricular septum was 19.39±6.13mm by echocardiography.②Among the 100 pregnancies of 100 HCM pa-tients,6 cases(6％)were miscarriages,94 newborns survived(94％),including 91 cases of cesarean section(91％)and 3 cases of vaginal delivery(3％).The predominant perinatal complications were preterm delivery(39 cases,39％),small for gestational age(5 cases,5％),neonatal asphyxia(3 cases,3％)and neonatal cardiac malformation(2 cases,2％).There were no perinatal deaths.③Univariate Logistic regression analysis showed that pre pregnancy heart function ≥ Grade Ⅱ,increased left atrial diameter,and concomitant pulmonary hyperten-sion were risk factors for perinatal complications in pregnant women with HCM(OR＞1,P＜0.05).Multivariate Lo-gistic regression analysis found that pre pregnancy heart function ≥ Grade Ⅱ was an independent risk factor for predicting the occurrence of perinatal complications in pregnant women with HCM(OR 6.270,P＜0.05).Conclu-sions:HCM during pregnancy can induce poor perinatal outcome.More attention should be paid to risk assess-ment and pregnancy management.Early detection of risk factors can reduce the incidence of perinatal complica-tions.

Objective:To investigate the perinatal outcomes and risk factors of perinatal complications in preg-nant women with hypertrophic cardiomyopathy(HCM).Methods:A retrospective analysis was carried out on clini-cal data of 100 pregnant women with HCM who delivered in Obstetrical Cardiology Intensive Care Center of Shanghai Renji Hospital between Jan.2000 and Dec.2022.Analyze the incidence of perinatal complications inclu-ding miscarriage,premature birth,small for gestational age infants,neonatal asphyxia,neonatal cardiac malforma-tions and perinatal mortality.Independent risk factors of perinatal complications in pregnant women with HCM were identified using univariate and multivariate Logistic regression.Results:①The mean age was 29.21±4.41 years old,the average gestational age upon admission is 34.46±6.43 weeks.There were 16 patients with a fam-ily history of cardiomyopathy(16％),21 cases with obstructive HCM(21％)and 79 cases of non-obstructive HCM(79％),91 cases with abnormal ECG(91％),mainly with ST-T changes(77 cases,77％).The average in-terventricular septum was 19.39±6.13mm by echocardiography.②Among the 100 pregnancies of 100 HCM pa-tients,6 cases(6％)were miscarriages,94 newborns survived(94％),including 91 cases of cesarean section(91％)and 3 cases of vaginal delivery(3％).The predominant perinatal complications were preterm delivery(39 cases,39％),small for gestational age(5 cases,5％),neonatal asphyxia(3 cases,3％)and neonatal cardiac malformation(2 cases,2％).There were no perinatal deaths.③Univariate Logistic regression analysis showed that pre pregnancy heart function ≥ Grade Ⅱ,increased left atrial diameter,and concomitant pulmonary hyperten-sion were risk factors for perinatal complications in pregnant women with HCM(OR＞1,P＜0.05).Multivariate Lo-gistic regression analysis found that pre pregnancy heart function ≥ Grade Ⅱ was an independent risk factor for predicting the occurrence of perinatal complications in pregnant women with HCM(OR 6.270,P＜0.05).Conclu-sions:HCM during pregnancy can induce poor perinatal outcome.More attention should be paid to risk assess-ment and pregnancy management.Early detection of risk factors can reduce the incidence of perinatal complica-tions.

Objective:To investigate the perinatal outcomes and risk factors of perinatal complications in preg-nant women with hypertrophic cardiomyopathy(HCM).Methods:A retrospective analysis was carried out on clini-cal data of 100 pregnant women with HCM who delivered in Obstetrical Cardiology Intensive Care Center of Shanghai Renji Hospital between Jan.2000 and Dec.2022.Analyze the incidence of perinatal complications inclu-ding miscarriage,premature birth,small for gestational age infants,neonatal asphyxia,neonatal cardiac malforma-tions and perinatal mortality.Independent risk factors of perinatal complications in pregnant women with HCM were identified using univariate and multivariate Logistic regression.Results:①The mean age was 29.21±4.41 years old,the average gestational age upon admission is 34.46±6.43 weeks.There were 16 patients with a fam-ily history of cardiomyopathy(16％),21 cases with obstructive HCM(21％)and 79 cases of non-obstructive HCM(79％),91 cases with abnormal ECG(91％),mainly with ST-T changes(77 cases,77％).The average in-terventricular septum was 19.39±6.13mm by echocardiography.②Among the 100 pregnancies of 100 HCM pa-tients,6 cases(6％)were miscarriages,94 newborns survived(94％),including 91 cases of cesarean section(91％)and 3 cases of vaginal delivery(3％).The predominant perinatal complications were preterm delivery(39 cases,39％),small for gestational age(5 cases,5％),neonatal asphyxia(3 cases,3％)and neonatal cardiac malformation(2 cases,2％).There were no perinatal deaths.③Univariate Logistic regression analysis showed that pre pregnancy heart function ≥ Grade Ⅱ,increased left atrial diameter,and concomitant pulmonary hyperten-sion were risk factors for perinatal complications in pregnant women with HCM(OR＞1,P＜0.05).Multivariate Lo-gistic regression analysis found that pre pregnancy heart function ≥ Grade Ⅱ was an independent risk factor for predicting the occurrence of perinatal complications in pregnant women with HCM(OR 6.270,P＜0.05).Conclu-sions:HCM during pregnancy can induce poor perinatal outcome.More attention should be paid to risk assess-ment and pregnancy management.Early detection of risk factors can reduce the incidence of perinatal complica-tions.

Objective:To investigate the perinatal outcomes and risk factors of perinatal complications in preg-nant women with hypertrophic cardiomyopathy(HCM).Methods:A retrospective analysis was carried out on clini-cal data of 100 pregnant women with HCM who delivered in Obstetrical Cardiology Intensive Care Center of Shanghai Renji Hospital between Jan.2000 and Dec.2022.Analyze the incidence of perinatal complications inclu-ding miscarriage,premature birth,small for gestational age infants,neonatal asphyxia,neonatal cardiac malforma-tions and perinatal mortality.Independent risk factors of perinatal complications in pregnant women with HCM were identified using univariate and multivariate Logistic regression.Results:①The mean age was 29.21±4.41 years old,the average gestational age upon admission is 34.46±6.43 weeks.There were 16 patients with a fam-ily history of cardiomyopathy(16％),21 cases with obstructive HCM(21％)and 79 cases of non-obstructive HCM(79％),91 cases with abnormal ECG(91％),mainly with ST-T changes(77 cases,77％).The average in-terventricular septum was 19.39±6.13mm by echocardiography.②Among the 100 pregnancies of 100 HCM pa-tients,6 cases(6％)were miscarriages,94 newborns survived(94％),including 91 cases of cesarean section(91％)and 3 cases of vaginal delivery(3％).The predominant perinatal complications were preterm delivery(39 cases,39％),small for gestational age(5 cases,5％),neonatal asphyxia(3 cases,3％)and neonatal cardiac malformation(2 cases,2％).There were no perinatal deaths.③Univariate Logistic regression analysis showed that pre pregnancy heart function ≥ Grade Ⅱ,increased left atrial diameter,and concomitant pulmonary hyperten-sion were risk factors for perinatal complications in pregnant women with HCM(OR＞1,P＜0.05).Multivariate Lo-gistic regression analysis found that pre pregnancy heart function ≥ Grade Ⅱ was an independent risk factor for predicting the occurrence of perinatal complications in pregnant women with HCM(OR 6.270,P＜0.05).Conclu-sions:HCM during pregnancy can induce poor perinatal outcome.More attention should be paid to risk assess-ment and pregnancy management.Early detection of risk factors can reduce the incidence of perinatal complica-tions.

Objective:To study the cut-off values of urinary microalbumin (mAlb), transferrin (TRF) and α1-microglobulin (α1-MG) during pregnancy in pre-eclampsia (PE) with proteinuria.Methods:A total of 210 pregnant women were enrolled in Renji Hospital from January 2016 to December 2019, including 92 (43.8%) cases of PE pregnant women and 118 (56.2%) cases of normal pregnant women. According to the diagnostic test evaluation method, the positive predictive values, negative predictive values and accuracy of non-pregnant cut-off values of urinary mAlb, TRF and α1-MG for the quantitative determination of 24-hour proteinuria were analyzed. The receiver operating characteristic (ROC) curve was applied to determine the optimal cut-point values of urinary mAlb, TRF and α1-MG during pregnancy.Results:(1) The diagnostic study of non-pregnant adults urinary mAlb, TRF and α1-MG cut-off values for the determination of 24-hour proteinuria value: when urinary mAlb was 30.0 mg/L, TRF was 2.5 mg/L, α1-MG was 12.5 mg/L as the cut-off value, the positive predictive values of the corresponding 24-hour proteinuria value≥ 300 mg were 88.1% (89/101), 88.2% (90/102) and 78.9% (75/95), its negative predictive values were 97.2% (106/109), 98.1% (106/108) and 85.2% (98/115), its diagnostic accuracy were 92.9% (195/210), 93.3% (196/210) and 82.4% (173/210), respectively. As the 24-hour proteinuria value≥ 300 mg was the golden standard, there were significant differences between the diagnostic method of the non-pregnant cut-off value of urinary mAlb, TRF and the golden standard ( P<0.05). There was no significant difference between the diagnostic method of the non-pregnant cut-off value of urinary α1-MG and the golden standard ( P>0.05). (2) Research on the ROC curve and the optimal cut-point value of urinary mAlb, TRF and α1-MG value: as the 24-hour proteinuria value≥ 300 mg as the criterion, the ROC curve of urinary mAlb, TRF and α1-MG were 0.992, 0.984 and 0.907, respectively. The optimal cut-point values of urinary mAlb, TRF and α1-MG were 86.5 mg/L (Youden index=0.927), 5.5 mg/L (Youden index=0.923), and 15.4 mg/L (Youden index=0.687). (3) The diagnostic study of the optimal cut-point value of urinary mAlb, TRF and α1-MG for the determination of 24-hour proteinuria value: according to the ROC results, when urinary mAlb was 86.5 mg/L, urinary TRF was 5.5 mg/L, and urinary α1-MG was 15.4 mg/L as the cut-off value, the positive predictive values of the corresponding 24-hour proteinuria value≥300 mg were 98.9% (86/87), 95.7% (88/92), 87.7% (71/81), and its negative predictive values were 95.1% (117/123), 96.6% (114/118), 83.7% (108/129), and its accuracy were 96.7% (203/210), 96.2% (202/210), 85.2% (179/210). As the 24-hour proteinuria value≥ 300 mg was the golden standard, there was no significant difference between the diagnostic method of the best cut-off values of urinary mAlb, TRF, α1-MG and the golden standard ( P>0.05). Conclusion:It is recommended to define the cut-off values of mAlb, TRF and α1-MG as 86.5 mg/L, 5.5 mg/L and 15.4 mg/L, respectively, during pregnancy.